Document jRG1odVrzVj7GRRj8m2XN9bZ

Til: Jeppe Kramer Jrgensen (EM-DEP) ( @em.dk) Fra: Stellan Nrreskov Wulff (ffi@medicoindustrien.dk) Titel: SV: Mde ml. EM/Medicoindustrien Sendt: 20-09-2023 14:12 Bilag: 230907_MedTech_Europe_PFAS_Position_Paper_final.pdf; Kre Jeppe, Jeg vender lige tilbage ang. PFAS, da vores europiske ssterorganisation MedTech Europe netop har frdiggjort et position paper omkring PFAS med input fra branchen, herunder ogs os. I materialet er ogs en rkke eksempler p, hvor kritisk en rolle PFAS spiller i noget medicinsk udstyr. Som det fremgr, er det en kompleks sag, nr det kommer til brugen af PFAS -- og her har vi en alvorlig bekymring om, hvorvidt der politisk er tilstrkkelig forstelse for, at det vil have alvorlige patientsikkerhedsmssige implikationer, hvis ikke medicinsk udstyr undtages -- eller som minimum fr en mellemlang udfasningshorisont (med undtagelse af enkelte srligt specificerede udstyrskategorier). Samtidig arbejder vi p europisk niveau videre omkring D4, D5 og D6 -- og her forventer jeg, at vi ogs kommer til at forme et endeligt position paper eller i hvert fald et lidt mere konkret input. Med venlig hilsen, Stellan Nrreskov Wulff Chef for Politik og Kommunikation -- Director of Public Affairs & Communications Mobil: +45 48 80 75 35 Telefon: +45 49 18 47 07 MEDICO INDUSTRIEN MEDTECH DENMARK Bge AU 5, 2970 Hrsholm medicoindustrien.dk nino Flg os: Denne mail er fra Medicoindustrien. Mailen og vedhftede filer er fortrolige og kan indeholde juridiske informationer. Medicoindustrien kan ikke gres ansvarlig for rd og vejledning. Fra: Jeppe Kramer Jrgensen (EM-DEP) < @em.dk> Sendt: 3. september 2023 15:16 Til: Stellan Nrreskov Wulff <ffi@medicoindustrien.dk> Emne: SV: Mde ml. EM/Medicoindustrien Kre Stellan Tak for opflgningen og den udfrlige gennemgang. Det er meget gavnligt. Lad os vende i lbet af ugen og evt. kort i morgen til vores flles mde. Mvh. Jeppe Fra: Stellan Nrreskov Wulff <ffi@medicoindustrien.dk> Sendt: 2. september 2023 21:02 Til: Jeppe Kramer Jrgensen (EM-DEP) <M_ @er .dk> Emne: SV: Mde ml. EM/Medicoindustrien Kre Jeppe, Her kommer som aftalt en update omkring D4, D5 og D6, som er vsentlige i noget medicinsk udstyr, hvorfor det er vores vurdering, at et forbud vil have negative patientsikkerhedsmssige konsekvenser. Ligeledes flger info omkring PFAS, som er et vsentligt opmrksomhedspunkt for os i jeblikket. D4, D5 og D6: Kort om D4, D5 og D6: Inden for medicinsk teknologi bruges stofferne som silikoner i medicinsk udstyr, i IVD-tests samt i ar- og stomiprodukter. En fordel ved cyclosiloxaner er, at de er kemisk stabile og biokompatible, hvilket betyder, at de sandsynligvis ikke vil forrsage allergiske reaktioner eller medfre andre negative bivirkninger i kroppen. De er samtidig hydrofobe, hvilket betyder, at de ikke blander sig med vand og p den mde kan forhindre dannelse af biofilm. Status omkring udfasning af D4, D5 og D6: Der er lagt op til, at begrnsningen skal glde for fremstilling, markedsfring og brug af D4/D5/D6 p grund af deres PBT- og vPvB-egenskaber. Der er dog blevet foreslet en undtagelse for "Placing on the market of D5 and D6 for use as medical devices, as defined in Directive 93/42/EEC or in the Regulation (EU) 2017/745, for the (i) treatment/care of scars and wounds, (ii) prevention of wounds, and (iii) care of stoma." Har man ikke je for disse undtagelser, vil det selvsagt kunne vre problematisk i et patientsikkerhedsmssigt perspektiv, ligesom det vil have en negativ effekt for producenter og leverandrer af disse teknologier. PFAS Et andet - meget vigtigt - opmrksomhedspunkt er PFAS: Det er ikke nogen hemmelighed, at der er et stort fokus bde nationalt og europisk p udfasning af PFAS. Det kan f meget alvorlige konsekvenser for branchen, hvis ikke medicinsk udstyr undtages, da PFAS - ligesom i pharma - har stor betydning for produkternes funktionalitet og patientsikkerhed. I lovforslagets nuvrende form er der tre mulige udfasningshorisonter for PFAS: Den korte med 18 mneders overgangsperiode Den mellemkorte med 12 r + 18 mneders overgangsperiode Undtagelse fra udfasning Det er umiddelbart kun API'er (pharma), som er helt undtaget. Medicinsk udstyr opdeles i stedet efter udstyrskategori i den korte og mellemkorte udfasningshorisont (se tabel E.109 s. 327 i vedhftede). Tilgangen, hvor der tages stilling til hver enkel udstyrskategori, er i vores jne dybt uhensigtsmssig, da listen for udstyr med mellemkort tidshorisont er ufuldkommen. Til trods for en hringsproces i samarbejde med vores kollegaer i MedTech Europe og deres netvrk bliver vi lbende kontaktet af medlemmer, hvor deres udstyr ikke fremgr af listen for mellemkort sigt. Hvis lovforslaget stemmes igennem i sin nuvrende form, har disse medlemmer kun 18 mneder til at udfase PFAS i udstyr og produktion, hvilket ikke vurderes til at vre realistisk og derfor kan f dybt alvorlige konsekvenser for patienter og medicobranchen. Der er blandt vores medlemmer forstelse for, at industrien har et miljansvar, herunder at bidrage til minimering af PFAS i naturen, men dette ansvar m ikke udvande patienthensynet. Ved en s simpel tilgang til PFAS-udfasning, som der lgges op til, risikerer udstyr at udg af markedet inden for to r med de alvorlige konsekvenser til flge, som er skitseret ovenfor. I stedet mener vi, at man skal g andre veje: Alt medicinsk udstyr br undtages - ligesom pharma - eller som minimum f mellemkort sigte ift. udfasning med undtagelse af enkelte specificerede udstyrskategorier. I relation til ovenstende punkt skal det bemrkes, at det er vores vurdering, at en mellemkort frist er innovationshmmende, da virksomheder kan vre tilbageholdende med at bygge produktionsanlg til eksisterende udstyr, sfremt PFAS indgr i udstyr og/eller i produktionen, og virksomhederne ikke kender til PFAS-alternativer p nuvrende tidspunkt. Grunden til, at branchen er afhngig af PFAS er, at stofferne har unikke kemiske egenskaber (herunder coating, ligesom det degenerer kun ved meget hje temperaturer), som er vanskelige at erstatte inden for f r - hvis overhovedet. Iflge MDR skal substitutioner af materiale / stof i udstyr som minimum have tilsvarende (helst bedre for at det giver mening for virksomheden) risikoprofil, fr en substitution i udstyret kan godkendes. Som du formentlig er orienteret om, er der i regi af Miljstyrelsen nedsat en taskforce omkring PFAS: Eksperter skal stte retning for PFAS-indsats - Miljstyrelsen (mst.dk). Sammenstningen af denne task-force bestende udelukkende af forskere illustrerer meget godt, at fokusset rent politisk pt. ligger p det miljmssige og knap s meget p det sundheds- og markedstilgngelighedsmssige. Det bekymrer os. Ser frem til at drfte nrmere omkring ovenstende. Med venlig hilsen, Stellan Nrreskov Wulff Chef for Politik og Kommunikation -- Director of Public Affairs & Communications Mobil: +45 48 80 75 35 Telefon: +45 49 18 47 07 MEDICO INDUSTRIEN MEGIEffie=2~ Bge Alle 5, 2970 Hrsholm medicoindustrien.dk aF l os: El Denne mail er fra Medicoindustrien. Mailen og vedhftede filer er fortrolige og kan indeholde juridiske informationer. Medicoindustrien kan ikke gres ansvarlig for rd og veiledning. Fra: Jeppe Kramer Jrgensen (EM-DEP) <~em.dk> Sendt: 22. august 2023 16:59 Til: Stellan Nrreskov Wulff <ffi@medicoindustrien.dk> Emne: SV: Mde ml. EM/Medicoindustrien Yes, sorry. D4, D5 og D6 (1) Fra: Stellan Nrreskov Wulff <ffie@nnedicoindustrien.dk> Sendt: 22. august 2023 16:56 Til: Jeppe Kramer Jrgensen (EM-DEP) <~~> Emne: SV: Mde ml. EM/Medicoindustrien Hej Jeppe, Perfekt -- vi ses d. 4. september C) Du hrer fra os ang. REACH -- det er D4, D5 og D6, right? Mh., Stellan Med venlig hilsen, Stellan Nrreskov Wulff Chef for Politik og Kommunikation -- Director of Public Affairs & Communications Mobil: +45 48 80 75 35 Telefon: +45 49 18 47 07 MEDICO INDUSTRI EN MEDTECH DENMA -- AKT 821746 -- BILAG 8 -- [ 120b. 230907_MedTech_Europe_PFAS_Position_Paper_final ] -- MedTech Europe Position on the Proposal for A REACH Universal PFAS Restriction 7 September 2023 POSITION PAPER www.medtecheurope.org Contents Executive summary ......................................................................................................................................1 Chapter 1: Uses of PFAS in the medical technology sector ........................................................................3 Chapter 2: Challenges in finding alternatives in the medical technology sector ..........................................4 Chapter 3: Specificities of the medical technology sector ............................................................................5 Supply chain complexities ........................................................................................................................6 A strict sectorial regulatory system: human health, environmental protection and safety aspects ..........7 Different levels of risks: The case of fluoropolymers ................................................................................8 Chapter 4: A workable PFAS transition pathway for the medtech sector ....................................................9 Chapter 5: About MedTech Europe........................................................................................................... 11 Annex 1: Case studies............................................................................................................................... 12 Annex 2: Non-exhaustive list of uses of PFAS in medical technologies ................................................... 22 Annex 3: Non-exhaustive list of types of PFAS used in medical technologies ......................................... 23 Annex 4: Overview of the design cycle steps required for a medical technology ..................................... 24 Annex 5: PFAS and Fluoropolymers Emissions Bibliography................................................................... 27 www.medtecheurope.org Executive summary MedTech Europe shares the ambition of the EU Chemicals Strategy for Sustainability 1 to boost innovation for chemicals that are both safe and sustainable by design. The sector is committed to the highest standards of chemicals risk management measures and is working with its suppliers to continuously improve the performance of its products and processes. At the same time, the medtech sector is ensuring the timely availability of lifesaving and life-sustaining technologies to satisfy patients' health needs. Medical technologies are regulated under stringent sectoral legislation, i.e., Regulation (EU) 2017/745 on Medical Devices (MDs) and Regulation (EU) 2017/746 on In-Vitro Diagnostics (IVDs) 2, which has been adopted after enacting the EU REACH Regulation 1907/2006. These sector specific regulations lay down requirements for the design, safety, quality, performance, alternatives assessment and validation of MDs and IVDs, which are processes that require a significant amount of time and R&D, in addition to the continuous search for alternatives for chemicals proposed for phase-out at EU level. The proposed EU REACH Restriction of perand polyfluoralkyl substances (PFAS) is one such example. In addition, the PFAS Restriction proposal is of unprecedented scale not only in terms of number of substances in scope, but also their varied physical, chemical and hazardous properties, and the amount of essential medical technologies impacted. PFAS uses in the medical technology sector or its supply chain occur due to their combination of different and essential properties including chemical resistance, heat resistance, durability, lubricity, low dielectric constant and/or biocompatibility. PFAS substances play a key role in achieving the required high performance and durability of the technologies critical to precision and reliability of medical applications, especially in the light of the above mentioned sectoral legislation. Given the need for such a combination of essential properties, there is often no alternative available to the use of PFAS in many medical technologies, their (sterile) packaging or upstream manufacturing processes. Often, the only proposed alternative is another type of PFAS. In addition, any alternative must also fulfil all other regulatory requirements for use in medical technologies, including, required validations, aging tests, change of tooling and production processes, biocompatibility tests, clinical trials for certain devices, regulatory approvals and registrations, according to sector specific legislation (i.e., MDR and IVDR). Without successful completion of such required regulatory assessments and the necessary time to carry them out, a potential alternative material is neither able nor allowed to replace a given PFAS for use in MDs or IVDs. Consequently, MedTech Europe's primary preoccupation with the unique PFAS Restriction proposal in terms of its enormeously vast scope combined with tight timelines is geared towards preventing any supply shortages of medical technologies to the detriment of millions of patients when considering a gradual transition to PFAS-free alternatives wherever technically feasible, MDR/IVDR proof and capable of ensuring the intended purpose of the medical technology to the continued benefit of patients. 1 European Commission, Chemicals Strategy website, available at: https://environment.ec.europa.eu/strategy/chemicals- strategy/implementation_en 2 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices www.medtecheurope.org Page 1 of 29 The current PFAS Restriction proposal would result in significant impacts on the quality and availability of treatments for patients in the EU. Due to the unavailability of suitable alternatives to PFAS some products would have to be removed from the market. Certain diseases and conditions could no longer be treated at all or no longer be adequately treated, such as for example, by devices required for minimally invasive interventions. If these devices disappeared, the alternative options would be open, maximally invasive surgeries, which vulnerable patients often cannot undergo or do not survive. For certain patients, there are no alternatives to interventional procedures with subsequent impact on their lives. Companies have been working with their suppliers to map PFAS uses in medical technologies and continue to find further use cases as time goes on. Due to the sheer number of substances in scope of the Restriction proposal and highly complex multitiered healthcare supply chains sometimes involving thousands of suppliers, there is the high risk that uses of PFAS that have not been identified by the end of the ECHA consultation period would fall outside the scope of derogations and would therefore not be permitted for use. Finally, the medical technology sector is constantly looking for ways to innovate state-of-the-art technologies. PFAS offer many benefits in medical technologies, due to the unique combination of properties they offer in a single material. The Restriction of this entire class of substances risks halting future medical technology innovation. Industry needs clarity and legal certainty regarding research priorities for alternative substances, since the discovery of viable alternatives to the thousands of different PFAS substances, cannot be accomplished and incorporated into medical technologies at the same time. For the way forward with the PFAS Restriction proposal, MedTech Europe recommends: 1. An overall patient-centric approach whereby patient safety needs are considered when transitioning away from PFAS (where technically and economically feasible). 2. A realistic transition pathway to non-PFAS alternatives that are reliable and feasible for medical technologies (including their manufacturing and supply chain) to avoid shortages of medical technologies for patients and practitioners. Sufficiently broad derogations should allow sufficient time to first identify all PFAS uses in medical technologies, and to subsequently move to alternatives where these are proven to be technically viable, available and in conformity with the sector specific MD and IVD Regulations as well as fit for the intended purposes of the medical technology. A realistic timeline must consider the sector's complex supply chain dependencies as well as the long development timelines and steps to ensure compliance with the sectorial legislation (please see MedTech Europe response to ECHA consultation3). 3. A differentiated approach to high risk and low risk PFAS in line with Article 68.1 REACH, which requires a proof of "unacceptable risk" for enacting a REACH Restriction: high risk PFAS should be targeted first. Fluoropolymers have a proven history of use and safety in medical technology applications and differ distinctly from the broader PFAS group. They should therefore be subject to a more flexible approach including an at least 13.5 year derogation and transitional period in medical technology applications and a review possibility for its prolongation where duly justified. 3 MedTech Europe's response to ECHA public consultation, Part 33 is available here: https://echa.europa.eu/documents/10162/28562aa5-2396-c7fa-efc3-f9ba60a30ff9 www.medtecheurope.org Page 2 of 29 4. A safeguard mechanism for cases where no alternatives will be available, and for newly identified non-derogated cases or potentially missed use cases to ensure quality and continued access to essential medical technologies containing PFAS or requiring PFAS for their manufacturing, as well as their upstream supply chain. 5. An inclusion of upstream suppliers and manufacturing in medtech derogations: Where medical devices and IVDs are granted the necessary derogations, these need to include the materials and components supplied to the medtech sector as well as manufacturing processes and process aids to be workable. 6. An enabling R&D framework that supports medical technology manufacturers in the unprecedented challenge of finding numerous use-specific, fit-for-purpose alternatives to PFAS medtech applications that are also satisfying MDR/IVDR regulatory requirements without compromising patients' lives or health. In this paper, we substantiate our requests by providing further background information regarding: PFAS use cases in the medical technology sector (Chapter 2, Annex 2 and Annex 3), The sector's specificities in terms of supply chain complexities and sector specific, regulatory environmental,human health and safety considerations (Chapter 3), MedTech Europe's suggested key building blocks for a workable transition pathway (Chapter 4), as well as Underlying case studies (Annex 1), An overview of the redesign steps in practice (Annex 4) and A scientific PFAS and Fluoropolymers Emissions Bibliography (Annex 5). Chapter 1: Uses of PFAS in the medical technology sector PFAS are used in medical technologiesdue to their combination of specific properties, including, but not limited to, chemical resistance, heat resistance, durability, lubricity, and biocompatibility. PFAS uses in medical technologies can occur: either in a component or coating of a component of the final medical device (MD) or in vitro diagnostic device (IVD); or as a processing aid used during device or upstream manufacturing and testing; or in the device part of an integral drug device combination; or as cell replacement therapies; or in their packaging. PFAS substances play a key role in achieving the required high performance and durability of the technologies, which are critical, e.g., for precision and reliability of medical applications, especially in the light of the applicable sectoral legislations, i.e., Regulation (EU) 2017/745 on Medical Devices (MDs) and www.medtecheurope.org Page 3 of 29 Regulation (EU) 2017/746 on In-Vitro Diagnostics (IVDs). These regulations lay down strict requirements for the design, safety, quality, performance, alternatives assessment and validation of MDs and IVDs to ensure the protection of patients' lives. A non-exhaustive list of the various uses of PFAS in medical devices and IVDs can be found in Annex 1, and a non-exhaustive list of the different types of PFAS used in medical technologies can be found in Annex 2 of this paper. Chapter 2: Challenges in finding alternatives in the medical technology sector Given the need for such a combination of essential properties, there are either no alternatives, or only "proposed options of alternatives" available to the use of PFAS in many medical technologies, their (sterile) packaging, washing, upstream or manufacturing processes, which could potentially deliver similar functionalities. The challenge is that the technical properties based on inertness (such as oil, water, thermal, biological, chemical and fire resistance) are the very reason why PFAS are also of concern in the environment (mainly its persistence). Because of the unique properties of PFAS, often the only proposed alternative to a given PFAS use is another type of PFAS. To identify an alternative for a PFAS use, first, a proposed alternative is assessed by material scientists for its possibility. If a possible alternative is identified, the whole development cycle has to be followed from analysis and (in silico) evaluation, early feasibility assessment and test, to physical verification and validation including aging testing, biocompatibility tests including extractable and leachable tests, pre-clinical and/or clinical evaluation as required by the stringent sector-specific legislation. When that has been successful the regulatory steps have to be taken before the product can be placed on the market. Until the very last step in the development cycle of/for a potential alternative, it is possible that the use may be not deemed acceptable in the medical technology and a new alternative would have to be considered. For more details of the steps of the design cycle, please see Annex 4 - "Overview of the design cycle steps required for a medical technology". Product, material and chemical innovation is a constant and integrated process. New products often include clinical improvements, improved treatment methods, and sustainable innovations (e.g., substitution of the most hazardous chemicals where feasible). The product life cycle of medical technology, due to its development time and required regulatory obligations, varies between years to decades, while the chemical and sustainability agenda in the European Union installs changes at an ever faster pace. This misalignment can be improved by properly taking into account the differences between new medical products and existing products already placed on the market, when setting sustainability requirements (including chemical restrictions). This will integrate the medical and sustainable innovation and ultimately bring new healthcare products more efficiently to patients. As regards indirect uses (i.e., a PFAS used by a supplier to manufacture a supplied part) the described process can only start once a supplier declares the presence of a PFAS in a part to the medical device manufacturer. www.medtecheurope.org Page 4 of 29 An insufficiently broad framing of derogations or insufficient time to find suitable alternatives to current PFAS uses in medical technologies are likely to have consequences for patients, such as: Potential patient death. Percutaneous interventional procedures rely on the guidewire device to the target lesion. Without guidewire, there will be no life saving procedures. For example, stenting is needed for a severe heart attack patient, or dialysis for chronically ill patients to save his/her life. Longer procedure times or increased stress to the patient, e.g., PFAS coatings of catheters and PTFE contained tubes allow for their smooth insertion into the vasculature. Without the PTFE coating or PTFE tubing, clinicians may confuse the wire sticking to the vessel for a larger, more critical vessel blockage and not be able to differentiate in the severity of the issue. Guidewires that "stick" to the vasculature can cause thrombosis and patient harm. Negative impacts on the quality of treatments: Medical device procedures (such as endoscopic procedure) being replaced with much more invasive and higher-risk procedures (such as open-heart surgery), which would significantly increase patient trauma and may be detrimental to vulnerable patients, such as elderly, multi-disease patients. Invasive procedures often lead to increased or repeated hospital stays, longer recovery times, increased cost for the patient, and delayed re-entry into the workforce if applicable. Subsets of patients with pre-existing conditions and/or comorbidities may not even be eligible for open surgery. A discontinuation of life-saving technologies and services (e.g., procedures for stenting, heart valve repairing and replacement, catheters, implants, life-saving replacement therapy in case of organ failure, and capital equipment used in related procedures, leading to patients being untreated or suboptimally treated) and IVD uses (e.g., instruments, diagnostic testing kits), leading to undiagnosed conditions, whereby e.g., the lives of patients suffering from organ failure will be at risk. An increased incidence of puncture wounds, thrombosis, inability to deliver the device to the targeted lesion, device malfunction and/or the inability of the surgeon to sufficiently visualize the surgical site. Complications during treatment and other negative impacts on the patient's wellbeing, e.g., no or improper interventail procedure at cardiac emergency, vein complications and tissue damage during interventional access, and improper healing in the case of hernia meshes. This may cause patient death or delay the patient's treatment and adversely affect post-treatment life. Additionally, the increased treatment times and complications will not only adversely impact the patient's overall health, but also the economic state of the patients and their families and the health system. An inability to manufacture or source critical components for medical technologies, e.g., humanitarian medical devices. It may cause suppliers to terminate their production and hence disrupt the distribution of medical technologies within the EU. Additionally, a shortage of possible alternative materials (e.g., the same category of the materials, but from a different supplier) may arise due to a sudden high demand from several manufacturers. Chapter 3: Specificities of the medical technology sector Medical technologies are strictly regulated under sectorial legislation for performance, safety, and risk management. Therefore, medical technologies containing PFAS are considered safe for the patient and user, www.medtecheurope.org Page 5 of 29 due to the rigorous validation processes and biocompatibility tests they are obliged to undergo. In addition, certain requirements exist for the justification and labelling of chemicals used in medical technologies. Where changes in the chemical or material composition occur, long and comprehensive validation processes are triggered (see Annex 4 - "Overview of the design cycle steps required for a medical technology"). It should also be noted that the multiple regulatory initiatives running in parallel to PFAS in the chemical's domain (e.g., BPA + BoSC, DEHP, microplastics, lead, etc.) also lead to alternative substitution requirements and collectively are creating a heavy burden on industry R&D ressources. When many material and design change dossiers are submitted to regulatory bodies around the world simultaneously, they will be overwhelmed by the volumes resulting in probable delays in marketing the product in the EU. Resources may be better allocated towards new medical technology innovation, rather than phasing out chemical uses from approved safe technologies that are essential for many patients. Human ressources that would otherwise be dedicated to treating new disease states, seeking solutions for new patient populations, and solving unmet clinical needs would likely be displaced to research in PFAS-free alternatives for existing products. European society, especially patients, will suffer due to dependence onold medical technologies or missing and reduced treatment options. Supply chain complexities The medical technology sector represents over 500,000 products, services and solutions available on the Union market. Individual devices differ greatly in terms of complexity. It is not uncommon for routinely used devices to have hundreds and thousands of components. Supply chains can be up to 30 tiers from materials to the final device. A single component of such products being banned due to a missed identification of its PFAS relevance or due to a too narrow or too short derogation (exact wording) can make the concerned devices and medical treatments unavailable for patients. Given to the broad relevance of PFAS in industry and the unprecedented scope of the proposed Restriction, the current disclosure requirements, such as via safety data sheets, SVHC declarations or other means are insufficient to build the basis for identification and evaluation of all relevant PFAS uses in time within the expected legislative timeline. In the absence of a workable regulatory obligation to disclose whether the provided products, components and materials contain PFAS or use PFAS for their manufacturing, there is a high likelihood that the medical technology sector is not yet aware of all uses of PFAS in components they use, or in the manufacturing of these components. Right now, there are also no single standardised analytical methods for all PFAS available. Against this background, it is questionable whether the proposed Restriction could be adequately enforced in connection with the import of PFAS containing products from third countries. A Restriction of PFAS containing substances within the EU may cause suppliers to terminate their production and hence disrupt the distribution of medical technologies within the EU. Additionally, a shortage of possible alternative materials may arise due to a sudden high demand from several manufacturers. In the end, all these aspects affect patients and customers, because the provision with the respective devices could not be ensured. www.medtecheurope.org Page 6 of 29 A strict sectorial regulatory system: human health, environmental protection and safety aspects Human Health protection Risk management is conducted in line with medical technology regulations (e.g., EU MDR and IVDR) and (harmonized) standards, as well as local governance biocompatibility studies and toxicology studies. The existing regulations (e.g., EU MDR 2017/745 Chapter VI; EU MDR 2017/746 Chapter VI) require that manufacturers shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements, as well as provide requirements for conducting of clinical investigations. Existing international standards (e.g., EN ISO 14155) address good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical technologies. In addition, manufacturers have established risk management systems (in accordance with EN ISO 14971). As part of the risk management, all known and foreseeable risks, and any undesirable side-effects, are minimised and need to be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use. Furthermore, in order to ensure patient safety, the use of device materials must undergo rigorous biocompatibility testing in accordance with the ISO 10993 series on "Biological evaluation of Medical Devices, as part of standard medical device risk management requirements", as part of the standard risk management process. To illustrate, fluoropolymers and perfluoropolyether biomaterials are commonly used in medical technologies and other biomedical industries. The usage of these materials has been well-proven to be biocompatible and safe for patient use (over 45 years on the market) and well-regulated (EU MDR approvals and other regions' regulatory approvals). Environmental protection and safety Main PFAS emissions within the control of the sector are primarily emissions during manufacturing and end of life management. As regards emissions during manufacturing, EU Directive 2010/75/EU on industrial emissions (integrated pollution prevention and control)4, which has just been revised, applies on manufacturing sites of the sector in the EU. Besides, many companies' manufacturing processes are for example governed by the ISO 14001 standard, an established and internationally recognized management process for minimizing environmental impact in manufacturing. PFAS is an exceptionally broad term used to describe thousands of distinct chemicals with a diverse array of properties and uses in society. There are clear and important distinctions between the chemical, physical, and toxicological properties of various types of PFAS materials, which need to be acknowledged in the proposed Restriction. Certain PFAS have a high molecular weight, which generally makes them too large to be bioavailable and they are not mobile in the environment, posing a low environmental risk. Measuring environmental emissions should be based on the type of PFAS generated/manufactured in certain facilities. 4 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control), available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0075 www.medtecheurope.org Page 7 of 29 As regards end of life management, the sectorial legislations (e.g., EU MDR 2017/745, Annex I, Section 14.7; EU IVDR 2017/746, Annex I, Section 13.6) rule that devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. Instructions for safe disposal are provided in the individual medical technology's Instruction for Use (IFU) (e.g., EU MDR 2017/745, Annex I, 23.4 (v)). If the device does not have specific disposal requirements due to the manufacturer's risk assessment or another applicable material regulation (i.e., electronics disposal under the Directive 2012/19/EU on waste electrical and electronic equipment (WEEE), the IFU commonly instructs to dispose of the product in accordance with the locally applicable legislation and the healthcare facilities' biohazard waste procedures. The medical technology sector uses mainly PFAS-containing materials that are applied in articles used in the healthcare environment and laboratory settings (e.g., hospital biohazard disposal is typically treated via incineration). Degradation emissions of PFAS to air from the incineration of fluorinated polymers is highly dependent on the waste treatment conditions5. Control of amounts of such emissions, if any, would be also subject to the European Industrial Emissions Directive 2010/75/EC. Besides, the medical technology sector has been very active in exploring novel methodologies in a highly regulated environment. R&D talent is exploring chemical recycling, modular medical technologies, recycled sterilizable packaging, and even re-use of certain medical devices. These resources are also evaluating more sustainable manufacturing practices (such as electronification), carbon footprint reduction, invention/investigation of new biomaterials, and many more. Different levels of risks: The case of fluoropolymers The majority of medical technology manufacturers are not producers of the underlying chemicals or resins that form the fluoropolymers in their finished devices. These device manufacturers receive materials as polymeric products or intervening component parts in chemically stable forms, which are then used to manufacture or assemble medical technologies. Therefore, the use case of these fluoropolymers is either for a manufacturing aid or the material remains in the final medical technology product, where the material may or may not be patient contacting. Furthermore, uses may be in the up-stream manufacturing of those components or manufacturing aids. The use is subject to strict control measures and external certification under the MRD and IVDR. The fluoropolymers used in medical applications meet the criteria set out by the OECD for polymers of low concern6. They do not present toxicity concerns and are not degrading into perfluoroalkyl acids (PFFAs). They are not bioavailable, not bioaccumulative, are not mobile in the environment and pose no potential for long-range transport (LRT). Thus, fluoropolymers do not impact drinking water, plants, or crops. Fluoropolymers have unique physicochemical properties that constitute a low concern distinction within the PFAS group as they are "chemically stable, biologically stable/inert, negligibly soluble in water, non- 5 Wahlstrm, et al., 2021. Eionet Report - ETC/WMGE 2021/9, Emissions of PFAS to air from the incineration of fluorinated polymers, page 60 6 OECD, Data Analysis Of the Identification of Correlations Between Polymer Characteristics and Potential for Health or Ecotoxicological Concern, page 10, January 2009, available at: https://www.oecd.org/env/ehs/risk-assessment/42081261.pdf www.medtecheurope.org Page 8 of 29 bioavailable, non-bioaccumulative; and non-toxic" 7 . Emissions during the manufacturing processes of medical technologies are controlled and meeting local regulatory requirements. Per Table 1 of the PFAS Restriction proposal, annual polymeric PFAS used in the medical device industry make up only 2.75% of the total (mid) estimated amount used across the major use sectors. The emissions percentage is even lower for medical devices, at 0.38% of all polymeric PFAS emitted to the environment across all major use sectors. Furthermore, because of their long history in the highly regulated healthcare field, fluoropolymers have an extensive biological safety testing history and long track record of clinical safety. This stands in contrast to certain classes of low molecular weight PFAS that have been the key focus for public health concern. Fluoropolymers (and their applications in implantable and invasive medical devices) have been extensively studied, especially regarding biological safety. If the PFAS Restriction proposal were enacted as suggested, R&D resources in corporates are likely to be focused on seeking a fluoropolymer alternative and withdrawn from other R&I areas. In addition, enacting the Restriction as proposed would contradict the goals of a circular economy, as products in use would have to be scrapped earlier than necessary due to a lack of spare parts and the implicit ban of refurbishment and repair. There should be a differentiated approach to high risk and low risk PFAS in line with Article 68.1 REACH, which requires a proof of "unacceptable risk" for enacting a REACH Restriction: high risk PFAS should be targeted first. A more flexible approach including an at least a 13.5-year derogation period in medical technology applications and a review possibility for its prolongation should be applied to fluoropolymers. Their history of use and safety in medical technology applications are proven and they differ distinctly from the broader PFAS group. Chapter 4: A workable PFAS transition pathway for the medtech sector The timeline required for a transition to PFAS-free materials for medical technology depends on various factors: A multi-tier supply chain and the medical technology sector's main role as a downstream user of chemicals and components. As for most PFAS, there currently is no workable regulatory obligation for relevant information disclosure in the supply chain. The medical technology sector is likely not yet aware of all PFAS uses in components they use or in the manufacturing of those components; A proposed alternative is not the same as a validated alternative; Medical technologies are regulated under stringent sectoral legislation, which lays down requirements for their design, safety, quality, performance, alternatives assessment and validation. These are processes that require a significant amount of time and R&D, in addition to the continuous search for alternatives for chemicals proposed for phase-out at EU level; 7 Henry, et al., 2018. A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers. Integrated Environmental Assessment and Management 14(3): 316-334. http://dx.doi.org/10.1002/ieam.4035 See also Plastics Europe, Association of Plastics Manufacturers, Fluoropolymers Product Group, Fluoropolymers vs. Side-Chain Fluorinated Polymers www.medtecheurope.org Page 9 of 29  Additional factors are the high complexity of products containing PFAS components, and the high number of products that a company will have to substitute concurrently. To ensure the availability of vital medical technologies, MedTech Europe recommends: 1. An overall patient-centric approach whereby patient safety needs are considered when transitioning away from PFAS (where technically and economically feasible). 2. A transition pathway to non-PFAS alternatives for medical technologies (including their manufacturing and supply chain) based on realistic timetables that allow sufficient time to first identify all PFAS uses in medical technologies, and to subsequently move to alternatives where these are proven to be technically viable, available and in conformity with the sector specific MD and IVD Regulations. A realistic transitional timetable to non-PFAS alternatives needs to be reliable and feasible to avoid a shortage of technologies for patients and practitioners. A realistic timeline must consider the sector's complex supply chain and dependency on the supply chain, as well as the long development timelines and steps to ensure compliance with the sectorial legislation. Due to the large amount of medical technologies and their variety in terms of complexity, chemical design, and material design, there is no one-size-fits-all solution to the length of transitional time for all PFAS. The derogation periods vary due to the high level of uncertainty, such as: Whether proposed alternatives meet the required functional properties; The variety of products, its risk profile and the function of the PFAS containing material in the medical technology; The different level of risks of PFAS used in the medtech sector, such as high risk PFAS and fluoropolymers; The uncertainty of the future regulatory outlook and the application of the essential use concept, when the PFAS Restriction will enter into force or when the proposed derogations expire. 3. A sufficiently broad approach to the derogations for IVDs and MDs to prevent imminent supply shortages: As we work on the proposed PFAS Restriction, we are continuously identifying new PFAS uses. A detailed list of derogations at this stage can only be non-exhaustive and therefore runs the risk that applications will be missed. There is the risk that many of the PFAS uses in the sector are not known yet and will therefore not be taken into account at this stage. 4. A safeguard mechanism for cases where no alternatives are available, and for newly identified non-derogated cases to ensure quality and continued access to medical technologies containing PFAS or requiring PFAS for their manufacturing, as well as their upstream supply chain: For some of the medical technology uses of PFAS, the 13.5-year transitional period is not sufficient to find and validate a potential alternative, also considering the material and product design cycle and time for change implementation (please refer to Annex III - "Non-exhaustive list of types of PFAS used in medical technologies"). A 13.5-year transitional period creates the misleading assumption that an alternative will be available once this time has elapsed. This can however not be taken for granted considering the reasons mentioned above. As the technical conditions, regulatory requirements etc. differ significantly, the feasibility of PFAS substitution in one case does not mean that substitution is possible in other cases. In some cases, even if there is an alternative, it may have inferior benefit/risk assessment and/or performance. Besides, a similar mechanism for newly identified non-derogated cases is necessary to www.medtecheurope.org Page 10 of 29 ensure continued access to essential medical technologies containing PFAS to patients and practitioners (e.g., see complex supply chain section). 5. A differentiated approach to high risk and low risk PFAS in line with Article 68.1 REACH, which requires a proof of "unacceptable risk" for enacting a REACH Restriction: high risk PFAS should be targeted first. Fluoropolymers have a proven history of use and safety in medical technology applications and differ distinctly from the broader PFAS group. They should therefore be subject to a more flexible approach including an at least 13.5-year derogation period in medical technology applications and review possibility for its prolongation in the absence of a suitable alternative. 6. A realistic transitional timetable to non-PFAS alternatives that are reliable and feasible to avoid a shortage of technologies for patients and practitioners. Due to the large amount of medical technologies and their variety in terms of complexity, chemical and material design, there is no one-size-fits-all solution to the length of transitional time. A realistic timeline must consider the sector's complex supply chain and dependency on the supply chain, as well as the long development and regulatory approval timelines and steps to ensure compliance with the sectorial legislation. 7. Derogation extension for upstream suppliers and manufacturing: Where IVDs and medical devices obtain the necessary derogations, we rely on our suppliers to also have derogations for the materials and components they supply us with, but also for the manufacturing processes and aids. Otherwise the derogations for our "end uses" would become mostly obsolete, discriminating EU-based manufacturers. Furthermore, where an alternative material/component to PFAS should be made available, that material/component would then need to undergo validation processes under sectoral legislation to ensure patient safety and quality and performance of the finished product. If a time limited derogation is granted for the PFAS use in the supply chain of the medtech sector, the newly supplied material would nonetheless still need to be tested, validated and approved for use in the respective medical technology, and therefore sufficient time would be needed. 8. An enabling R&D framework that supports medical technology manufacturers in the unprecedented challenge of finding numerous use-specific, fit-for-purpose alternatives to PFAS medtech applications that are also satisfying MDR/IVDR regulatory requirements and not compromising patients' lives or health. Research priorities with respect to phase-out substances should be clear. Chapter 5: About MedTech Europe MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions. For more information, please see: www.medtecheurope.org. www.medtecheurope.org Page 11 of 29 Annex 1: Case studies8 MedTech Europe list a few examples of case studies illustrating the challenges for medical technologies with the PFAS Restriction proposal in its present form: 1. Implantable and invasive medical devices Among the implantable and invasive medical devices, there are interventional cardiac occluders and endoprostheses, surgical vascular grafts, cardiovascular patches, surgical sutures, implantable ophthalmic applications, hernia mesh, endoscopes or cleaning solvents, to name a few. Fluoropolymer-containing or coated medical devices have been implanted in patients for 45+ years safely and effectively. Fluoropolymers are biocompatible, bioinert, are stable when implanted, durable, non-toxic, chemically and heat resistant, provide a low coefficient of friction, allow tissue growth, and are strong and flexible. Currently, there are no alternatives that meet all these properties and/or have the successful clinical history of fluoropolymers. Replacement of materials used in implantable [and invasive] medical devices (and their manufacturing processes) is a drastically more complex and resource-intensive undertaking than in most other applications and industries. It is estimated that development, validation, clinical studies, and regulatory approval of a material substitution in implantable medical devices would take ~20 years for a single device. For patient contacting and implantable devices, special requirements for carcinogenic, mutagenic and reprotoxic (CMR) and endocrine disrupting (ED) substances apply. The usage of CMR and/or ED substances requires justification, which includes a risk-benefit analysis. Currently, over 1,200 CMR/ED substances need to be addressed under Section 10.4 of MDR. Fluorinated polymer processing aids (PPA's) as well as the upstream supply chain need to be derogated to allow the manufacturer to continue medical device fluoropolymer manufacturing. 2. Complex equipment - e.g., equipment for organ replacement (active medical devices), packaging and spare parts One example of concerned complex equipment are devices, which are used to replace essential body functions in case of acute or chronic organ failure, keeping hundreds of thousands of patients alive worldwide. Spot-checks by a single manufacturer already identified more than a hundred different components, consisting of several different fluoropolymers. Uses include e.g., parts of valves that must be biocompatible. Further parts, which are common industry standard like O-rings, batteries or electronic components, certainly exist and will further increase the number of concerned parts. Besides, the above-described active medical devices, PFAS are also relevant for manufacturing and packaging of needed single-use disposables. Qualification of potential alternatives must be done for each concerned component individually, considering the specific technical and regulatory conditions. In the majority of components, a material change would also impact the tools used in production. This significantly increases the time and efforts required. Besides design of current and future devices, also the already phased-out products must be considered. Concerned devices are investment goods, are intended to be used in clinics and hospitals for several years. Thus, the availability of spare parts for maintenance and repair of devices must be ensured for the whole use phase, i.e., approx.. 10 years after stop of production. Each change of the product design and related tools must follow strict rules 8 For more case studies, please refer to MedTech Europe's response to ECHA public consultation, Part 33, available at: https://echa.europa.eu/documents/10162/28562aa5-2396-c7fa-efc3-f9ba60a30ff9 www.medtecheurope.org Page 12 of 29 and processes to comply with applicable quality, safety and regulatory requirements. Experiences with past substance replacements (which were less complex and affected less numerous changes of materials) already indicate that a substitution of PFAS, if feasible at all, would take a significant number of years. Needed internal and external resources for technical qualification, bio-compatibility assessments and regulatory affairs for the required number of parallel substitution projects within such short timeframe are currently not available. Furthermore, such analysis of potential alternative materials, design changes, change of tools etc. could only start after identification of a component containing PFAS. The active medical devices consist of thousands of components and materials, partially designed and manufactured in-house, partially, especially in case of electrical components, manufactured and supplied in a multi-tier supply chain. Due to the broad scope and low threshold values of the proposed PFAS Restriction, existing PFAS disclosure and resulting data is incomplete and mostly limited to obvious cases, e.g., if fluoropolymers are the specified material of a supplied mono-material component. Experience with RoHS showed that generation of reliable and complete material compliance data takes years. In case of spare parts for products, availability of needed detailed PFAS data and willingness to invest in evaluation and re-design of components by concerned suppliers is highly questionable. 3. IVD reageants PFAS substances are used in IVD devices such as IVD testing kits for hemostasis products (at an extremely low concentration and volume) which detect blood coagulation. They are used as well as heat-transfer agent in IVD clinical chemistry diagnostic testing instruments, which is essential to the functioning of the instrument. The PFAS substance is needed to maintain the temperature of the reaction cuvette. It ensures that the reaction which detects the disease or condition occurs under the correct conditions for a correct patient result. Manufacturers of IVD reagents and systems fluids are required under specific regulations to adhere to design change procedures that can take between 3 to 12 years to complete in order to meet the requirements for reasons of safety and performance. They are also subject to regulatory approvals in every country where sold (can be up to 42 months). This is for one substance only. When considering that a group of PFAS could be banned which may include up to thousands of PFAS substances, the redesign may take more than 12 years when for multiple products. The minimum approval time in case of materials with contact to blood or similar criticality is approximatively 3 years and can further exceed this range, e.g., if local registration updates require additional clinical studies. In case of materials with contact to high aggressive (THF, Chloroform and Acetonitrile) or similar criticality, the minimum approval time is approximatively 3 years and can further exceed this range. Additional use of PFAS in IVDs include that of trifluoroacetic acid (TFA) as identified in section A.3.10.1.14. of Annex XV of the proposed Restriction as an additive to the mobile phase in high-performance liquid chromatography applications and as an ingredient. Additionally, polymeric PFAS materials are widely used in IVD manufacturing process, including tubing, O-rings, Teflon stir bars, greases, water treatment, etc., i.e., essential uses of PFAS not ending up in the finished IVD. Unfortunately, no derogation has been given for these use cases. The reason for using these PFAS materials is primarily the same reason for uses in the IVD reagents which includes material compatibility, inertness, low coefficient of friction, etc. Not having a derogation to produce IVDs using PFAS materials could have a significant impact on the supply of IVD reagents upon the effective date of the Restriction. www.medtecheurope.org Page 13 of 29 4. Prefilled syringe stopper - A device constituent of an integral drug-device combination Glass prefilled syringes are today widely used within the Union market for health treatments. We estimate that approximately 200+ marketed drugs in prefilled syringes9 are sold across the European Union annually. Due to their sensitive nature many of these drugs (in prefilled syringes) use a PFAS (ETFE) coated stopper. Examples of indications of these drugs include but are not limited to multiple sclerosis, rheumatoid arthritis, and neutropenia. The PFAS coated stopper plays a key role by providing a barrier effect against extractables from the rubber, minimizing the risk of interaction between the rubber stopper and the Drug during its shelflife (up to 3-5 years). A well known-example for which a non-coated stopper (PFAS free) resulted in an adverse health effect is the "Eprex" case for which interaction with rubber extractables led to an increased incidence of pure red cell aplasia10. For sensitive Drugs substitution of PFAS coated stopper by PFAS free stoppers is not immediately possible. Even if redesign efforts have been initiated there is today no PFAS free stopper available on the market that has the same properties as the PFAS coated stoppers with regards to extractable impurities. With existing PFAS free stoppers, the risk of adverse health effect for sensitive drugs is high as impurities can extract/leachate from the rubber and interact with the Drug through the 3-5 years shelf life. With no derogation the impact of European citizen health will be critical as it will result in Key Drugs shortages (200+ Biologics sold on the EU market with PFAS coated stoppers). No derogation will also have a high impact on innovation and future new drugs launches on the European Market. We estimate that there are approximately 100+ biologic drugs11 in clinical trials across the European Union that are expected to be launched in a prefilled syringe device with PFAS coated stoppers. A 12 year derogation is at minimum needed as redesign is mandatory and Glass prefilled syringes are highly regulated products: requirements of both, Medical Device Regulation (EU 2017/745) and Human Medicine Directive (2001/83 EC) have to be met when making a change leading to long timelines. Redesign efforts have been initiated but we estimate that more than 12 years are needed for substitution, including, among other, the following steps: Stabilities Studies by pharmaceutical companies12 Manufacturing qualification Regulatory approval from the device side13 and the drug side14 Industrial ramp We estimate that 240 to 480 millions units of PFAS coated stoppers are used on the EU market for marketed drugs and clinical trials across EU. Transformation of this supply capacity will require significant time and investments as all manufacturing equipment will have to be converted to produce PFAS free stoppers, this includes rubber stopper manufacturers and pharmaceutical filling drug lines that will have to be upgraded. 5. Blood Glucose Meters (IVD) for diabetes treatments Diabetes is one of the big health topics with an incidence of one in eleven adults in the EU. Blood glucose measurements are one of the most important pillars of the therapy, usually performed by the patient. Therefore, many home-use self-analysers, such as the blood glucose meters (BGMs) are designed as affordable appliances. Alternative materials, since they are quite rare, can be very cost intensive, and - 9 From IQVIA database (https://www.iqvia.com/) -detailed report can be shared upon request 10 "The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes"-Kidney International, Vol. 67 (2005), pp. 2346-2353 11 Estimation was made from Global data 2023 (https://www.globaldata.com/) and IQVIA (https://www.iqvia.com/) databases- detailed report can be shared on request. 12 ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management - Scientific guideline 13 Notified body Opinion on Annex I of (EU) 2017/745 shall be obtained on the device side of the integral Drug device combination. 14 Variation to the existing marketing authorization approval www.medtecheurope.org Page 14 of 29 together with lengthy design change and development periods - increase the cost of manufacturing immensely. Identifying a non-PFAS containing alternative, will make the distribution of affordable medical devices for all patients even harder. Patient safety is the first and foremost responsibility of a medical device manufacturer. Therefore, as for basically all medical devices, the design change processes required to change materials are extensive and lengthy. Even if a material with comparable properties is found, the process until it can be registered on the different markets can take several years. This does not include the time of the registration process with the countries itself, which is also time consuming. This again would influence the cost for patients and customers, as well as the healthcare system. Since medical devices make up for a rather small part of material usage worldwide, a restriction of PFAS containing substances within the EU may cause suppliers to terminate their production and hence disrupt the distribution of medical devices within the EU. Additionally, a shortage of possibly alternative materials may arise due to a sudden high demand from several manufacturers. In the end, this affects the patients and customers, because the provision with the respective devices cannot be ensured. 6. Flame retardant properties in patient monitoring equipment Medical devices are required by the EU MDR to comply with EU safety standards, which include a requirement that plastic parts that are associated with electrical circuits are flame resistant. The choice of plastic is limited as medical devices such as patient monitors and patient ventilators need to be tough and must not easily damaged by for example impacts from hard objects or by being dropped. Impacts can easily occur in emergency situations. Plastics commonly used for medical devices therefore require flame retardants. PFAS such as PTFE are used in plastics as flame retardant and drip protection. The requirements from standards such as IEC 60601-1 and UV-L0 in relation to fire resistance and flammability specify maximum temperature in case of skin contact and have special considerations for oxygen-rich environments due to patients receiving oxygen. Research by members have not found a suitable replacement that is available with the same performance and which is not a regrettable substitution, in particular for material thickness of less than 1mm. The search for alternative materials is a lengthy process and includes obtaining samples of PFAS-free polymers and extruding for testing, redesigning parts, verification and validation, and undergoing comprehensive technical and clinical testing. EU MDR requires strong evidence that new designs do not have a lower level of patient safety or a reduction of clinical benefits as a result of new materials used in the devices. A realistic timetable is needed to allow sufficient time to move to alternatives in conformity of medical regulations. 7. Other case studies illustrating the specific redesign challenges Guidewire for coronary and peripheral interventional application Guidewires are an integral part of vascular intervention. They are utilized to access target vessels, cross lesions, and deliver other devices that can administer therapy to the target region of the vessel or treat the diseased vessel. Without guidewires, both coronary and peripheral interventional procedures cannot be conducted. Though there are many design requirements for guidewires dependent on the lesion type and clinical presentations, one requirement is universal for all guidewires, i.e., low friction, which allows the guidewires to travel through tortuous vessel to the target lesion without damaging patient tissues. At the distal end of the guidewire, hydrophilic coating can be applied to reduce the friction. However, at the proximal portion of the guidewire, a hydrophobic dry/wet lubricious coating is needed, because the physician needs www.medtecheurope.org Page 15 of 29 to manipulate the wire with their hand during an interventional procedure. The physician cannot manipulate a wire with a fully hydrophilic coating, which either is too slippery when fully hydrated or tacky when the coated surface is not wet. Alternatives to the use of PTFE as the coating on the proximal end of the guidewire have been evaluated multiple times over the past 10 years. In each case, a suitable replacement that could maintain the friction performance of PTFE could not be found unless it is another PFAS coating. The performance evaluation included direct friction measurements as well as in-vitro bench testing where the alternative materials demonstrated inferior performance relative to PTFE coated controls. Percutaneous interventions are premised on accessing and treating a diseased segment of vessel through an access point a distance from the diseased segment. The guidewire is the fundamental tool used by interventionalists to establish the pathway from the access site to the diseased segment. Any redesign of the guidewire coating still needs to meet the basic requirement of guidewire deliverability with minimum resistance in tortuous anatomy and in the delivery of therapeutic devices, while maintaining low profile. Any increase in friction could limit the ability to access complex anatomy or the delivery of therapeutic devices which will limit treatment options for a significant portion of patients that can be treated today. Therefore, a redesign of the guidewire coating will not meet the customer need without a dry lubricious coating. Printing inks for markings on medical devices and on the device part of an integral drug-device combination Fluorinated wax is used, by itself or in combination with other waxes as an anti-rub and slip additive in printing inks. These are required for the properties such as slip or lower coefficient of friction, scratch resistance, rub and abrasion resistance, matting effect and hydrophobicity. Printing inks are used to create markings for identification, scale, measurement, size, and other functional attributes on medical devices and on the device part of an integral drug-device combination. The alteration of any of the above listed properties will result in fading away and removal of marking on the device. In case of medical devices such as syringes, inaccurate markings or lack of such markings will result in errors in the medication provided by the healthcare provider because they will not be able to know if the right quantity of the drug has been given to the patient. This will adversely impact the health of the patient due inaccurate amounts of drug administered. The consequences could be lethal. Misidentification of a medical device or drug device combination products in the absence of proper printing inks could result in errors in the treatment of the patient. There are no currently available known alternatives, which are ready for evaluation through R&D. Once an alternative would be identified for the ink formulation, qualification of the alternative would be required for the mentioned applications. Alternatives will likely require extensive biocompatibility testing and may also require clinical trials, dependent on the application and location of the printing inks. Alternatives may trigger process changes at multiple sites across multiple locations and due to the variety of sophisticated high-volume manufacturing methods, significant process development is anticipated after the formulation is finalized and passes all the biocompatibility testing increasing the substitution timeline. A derogation of 12 years once an alternative is identified is needed to evaluate alternatives, validate, qualify and implement the most promising alternative. Robotic arms PFAS (FEP, ETFE, PFA) are used in main cable assembly of robotic arms of an angiography system. Combination of more than 20 individual cables, which are not in contact with patient or user as they are a fixed installation inside the instrument with different functions: high-Voltage cables, power supply cables, www.medtecheurope.org Page 16 of 29 control cables, signal cables etc. Most of the individual cables are multifilament cables. Parts of the cable assembly are heavily and quickly bended when the medical device is in operation. PFAS are used for insulation action as the thickness of insulation is a key factor of cable assembly bending capability. PFAS substitutes will cause an increase of thickness of the whole cable assembly. Bending performance (bend radius, bend velocity) will decrease and lead to a downgrade of system performance. A thicker cable assembly will no longer fit into the robot construction. They are also used for their sliding and non-sticking properties, as low friction sliding of the individual cables among each other is essential for the bending capability of the cable assembly. PFAS substitutes (i.e., use of fabric hoses) show poorer sliding properties. Bending performance (bend radius, bend velocity) will decrease and wear will increase. This will lead to a downgrade of system performance, reduced lifetime and reliability of the individual cables. Especially in angiography systems reliability is of maximum importance, as the systems are operating during emergency surgery, and a system failure can be fatal. Finally, they are used for their flame retardant properties, because fire safety requirements are extremely high for medical systems in clinical environment. The unique characteristic of PFAS is the combination of insulation properties, non-stick properties, mechanical strength and flame retardant properties in one substance. There is no comparable material available to fulfil all these requirements in parallel. 100% substitution will be impossible due to the wide range of outstanding properties of PFAS. Substitution with downgraded system performance and significant change of system design will probably be possible with a 12 year derogation once an alternative has been identified. It is impossible to replace the part until mid2025. Time for development is not sufficient, no matter how much resources are provided for this task: development of cable assembly with alternative materials, reliability-tests/EMV-tests /safety-test, several iterations to optimize results, approval of product change. Therefore, the product would have to be taken from the market, as only 50% of PFAS in the cable can possibly be replaced prior mid-2030 (in the case where a 5 year derogation is granted), limited to parts of the cable where installation space is not restricted and the movement stress during system operation is less challenging. Some construction redesigns have to be done. At their end-of-life, the robotic arm is taken back, resold, or upgraded. Magnetic resonance imaging systems (MRI systems) PTFE is used in cables and sleeving in low temperatures due for its insolation action, as PTFE has a very low dielectric constant, which means that it does not absorb much energy from electromagnetic fields. This makes it an excellent insulator for use in low-temperature environments, where other materials may be prone to electrical breakdown. In addition, PTFE has a very high dielectric strength, which is the maximum electric field that a material can withstand before electrical breakdown occurs. This property makes PTFE an excellent insulator for use in high-voltage applications, which are common in many low-temperature environments. PTFE has a very low thermal conductivity which means that it does not transfer heat very well. This is important in low-temperature environments where maintaining a stable temperature is critical. PTFE insulation can help to reduce unwanted heat transfer and maintain a stable operating temperature. PTFE is highly resistant to chemicals, including most solvents and acids. This makes it an excellent choice for use during manufacturing when the cables may be in contact with other chemicals such as lubricants or adhesives where chemical reactions may be a concern. www.medtecheurope.org Page 17 of 29 PTFE maintains flexibility for cable bending and positioning without cracking during temperature transition from room temperature to extreme low temperature where other materials may become brittle and crack. Such cracks will compromise electrical insulation properties and result in irreparable damage to the magnet system. At the moment, there is no technical alternatives known with similar properties as PTFE against extreme conditions (low temperature to 4K Celsius). It is impossible to identify suitable alternative materials for the specific working conditions of the applications and completion of all design changes, safety and reliability tests within 2 years. Therefore, the product would have to be taken from the market, and thus, it would reduce the accuracy of diagnosis (e.g., of cancer or neurological disorders), but also the quality of life (impact on monitoring the effectiveness of new drugs/therapies development in pharmaceutical industries). At their end-of-life, MRI scanners are taken back, refurbished, resold, or they are upgraded, repaired or reused. Blood Gas Systems PFAS (PTFE) are used in main cable assembly of varying lengths and conductor count in Blood Gas systems, in special developed detector cable for extra durability in terms of dynamic movements. Structural Polystyrene Foam is used in instrument housings. PTFE insulators can be very thin and minimally impact thermal measurements while still providing the necessary electrical insulation around a thermistor or thermocouple component. PTFE is used to satisfy UL 94 V-0 requirements to self-extinguish and open flame is essential to satisfy fire safety standards for medical equipment. It is used in mold-release applications to allow molded part to be removed from the mold with fewer ejection pins. This is required to maintain flatness/smoothness specifications for fluidic seals. Substitution materials do not meet all of the requirements of the current design. Any alternative will downgrade system reliability and endanger clinical availability. No alternative has yet been identified for each application. Given the time required to identify alternatives, approve new vendors, convert old vendors to new suppliers, qualify untested materials, complete engineering verification and clinical validation, there will not be an alternative ready by 2025. As of mid-2023, we continue to discover new places where PFAS is used in the manufacture of our products. Many products are made with vendor proprietary formulations that are found to include PFAS. Plastic molded parts that do not contain PFAS have trace amounts of PFAS found in mold release agents used by the vendor. Electronics production and components continue to identify PFAS in components previously believed to be PFAS-free. There is no confidence that any of the above products can be certified 100% PFAS free within 2 years. The main challenges are identifying all PFAS in the supply chain; coordinating with many vendors and design changes simultaneously across all affected products; legacy products on existing last time buy (LTB) inventory must either undergo extensive redesign, or premature end-of-life (EoL); and finding equivalent performance with PFAS-free materials. When it comes to the end-of-life, instruments can be used for many thousands, or even millions of tests over their service life. Readers are refurbished when returned by customers to be re-sold, re-using the vast majority of parts within them (only swapping out damaged or non-functional parts). Electronics and Printed Circuit Board Assembly (PCBAs) can be recycled. www.medtecheurope.org Page 18 of 29 Multi-use cartridges and Single-use cards are biohazardous waste, which is typically incinerated depending on user laboratory disposal practices, possibility of autoclaving if not incinerated. Instruments not refurbished must be incinerated. PFAS is in some wiring components, printed circuit board assemblies, moving mechanical assemblies (within hinges, sides, other bearing surfaces), and the structural foam of the enclosure. Oxygen sensor is deep within the measurement cartridge in a location the user cannot access. Service personnel do not access the biohazardous components, which includes the oxygen sensor. In-vitro diagnostics devices (IVDs): Laboratory Systems IVDs are used to detect patient illnesses, infectious diseases and to determine the effectiveness of medical treatment. PFAS are used for insulation and chemical resistance purposes, as chemical resistance in IVD tubing is of the utmost importance. The use of tubing in IVDs is extensive and varies from product-to-product. If PFAS is present in tubing, but PFAS-free tubing is required in the future, the impact of a change is highly significant. There is a potential presence of PFAS in tubing purchased from suppliers and/or use of PFAS in suppliers' tubing production processes to ensure that chemical resistance is ensured. If tubing or electronic wire components made of or containing PFAS must be changed, potentially hundreds of IVD laboratory diagnostics devices are impacted, and 100% of the Laboratory Systems portfolio that include automated liquid handling would be affected. Tubing: The use of tubing in IVDs is extensive, as it is used to transport patient samples through an IVD analyser and to combine the patient sample with chemical substances (reagents). A patient sample is combined with reagents via tubing, resulting in a chemical reaction that a sensor detects. The IVD devices' software is custom-programmed to report the clinical result of the IVD test, based upon the signal generated by the chemical reaction and detected by the sensor. When tubing contacts patient samples and reagents, IVDs must be tested extensively to ensure that: 1) tubing materials do not cross-react with an individual's patient sample, 2) tubing materials do not cause contamination from one patient sample to another, 3) tubing materials do not cause contamination from one reagent to another, 4) tubing materials used to transport a sample from one device to another device do not result in cross-reactivity or contamination and 5) that software properly interprets and reports patient results. This process is called "validation". If various types of tubing in IVD instruments contain PFAS, but patient results meet product claims registered via medical regulatory authorities, hundreds of unique devices and patient tests must re-validated. The validation could require up to 15 years to complete due to the complexity of validation testing. Electrical wire insulation: Insulation of electric wires on custom printed circuit boards, power cords and other internal wiring is necessary to: ensure that a specific current must be consistently maintained by the insulated wire component; to protect the wire from heat generated by other parts withing the IVD device; and to ensure that the wire component does not present a heat source that can damage other parts of the IVD device. If PFAS are used in conjunction with electrical wire insulation, extensive testing will be required if substitute parts have a "like-to-like" performance to ensure the following: 1) expected patient results are maintained (e.g., that no change to insulated electric wires properties occurs), 2) no change to the longevity of parts occurs, 3) no software changes are required as a result of the part change and 4) conformance to www.medtecheurope.org Page 19 of 29 international standards related to electronic products is maintained. If a "like-for-like" replacement of an electronic part is not available, extensive validation of parts with different electronic properties would be required, with a potential timeline of 10-15 years. Conclusion OR impact: If the IVD products could not be placed on the market, healthcare institutions would be required to make capital investments for alternative devices. It is not likely that any institution would be able to maintain their current level of care due to costs to purchase new devices elsewhere. In addition, there are certain tests that are unique to the products, if those test were no longer available for devices, patient care would be compromised for certain disease states. Over 650 million test assays per year in the EU are performed with affected devices. If hospitals and/or patient sample diagnostic laboratories are unable to purchase the IVD devices, alternative tests (assays) for the wide range disease states would not be commercially available and will not meet the high level of accuracy provided by the impacted devices. As a result, patient's conditions may be more difficult to diagnose and treat as other, less suitable methods would have to be used (if they exist). In addition, regulatory body approvals do not allow lower-level performance products to be placed on the market, as such approval would be withdrawn if the adopted parts that do not meet performance claims. As such, this would mean that products which would otherwise support patients from being diagnosed and/or treated, would no longer be able to be placed on the market. Intensive care devices and systems The following products have, for example, already been identified as being affected by the PFAS Restriction proposal: Intensive care ventilators, Anesthesia machines, Incubators, Patient Monitoring Systems, Medical media supply systems, Hospital Gas Management Systems. In these products, fluoropolymers such as PTFE, PVDF, PFA, FKM are essential materials in the following components: Hoses, seals and other gas-carrying parts, Electrochemical sensors, Lubricants, Valve coatings. The materials are indispensable mainly because of their resistance to aggressive media. More specifically: Hoses, seals and other gas-carrying parts in medical devices must be permanently resistant to pure oxygen and, for example, anesthetic gases, In electrochemical sensors fluoropolymers are used as membranes in strongly acidic electrolytes (e.g., sulfuric acid) or in the electrodes to control their wetting and prevent dissolution. In lead-free oxygen sensors, introduced due to the RoHS Directive, the materials must also withstand free oxygen radicals that would permeate all other plastics. www.medtecheurope.org Page 20 of 29 Furthermore, all electronic components contained in these products rely on semiconductors, the production of which is impossible without PFAS. Producing semiconductors in Europe is a declared goal of the EU Commission. This goal would be thwarted by a comprehensive PFAS ban. At the production plants, components made of fluoropolymers ensure durability, energy savings and safe operation. A broad PFAS ban would result in the unavailability of the necessary production equipment to manufacture the products, including their spare parts. Emissions: No emissions of PFAS into the environment are to be expected from these products and the materials they contain. The materials can be considered as harmless to health and as neither fulfilling the criteria of Article 68 of the REACH Regulation nor those of the justification of the present Restriction proposal. According to information from upstream suppliers, the production of the materials is possible without emissions of harmful PFAS chemicals into the environment. This can be ensured by appropriate regulatory measures. The products are in use for a very long time, in some cases over 20 years. Proper disposal at the end of life is ensured, among other things, by the requirements of the WEEE Directive and other voluntary take-back and recycling offers that go beyond WEEE. In the interests of the circular economy, we would welcome an obligation to return waste to the manufacturer, but this has so far been prevented by European waste shipment regulations. In the pyrometallurgical recycling processes and any incineration of residual waste, the fluoropolymer components are usually thermally destroyed and converted into hydrogen fluoride, which is mineralized as fluoride in the flue gas cleaning process. We are not aware of any emissions of PFASs that are harmful to health from this pathway. Even in the case of deposition, the materials would behave chemically inert in the long term and would not cause emissions to the environment. Substitution possibilities: According to the current state of knowledge, there will never be alternative materials that meet all the necessary requirements due to chemical-physical laws. Manufacturers and the regulatory authorities are not prepared to accept any compromises in terms of the functional safety of the products, because human lives depend on it. Due to the high cost, fluoropolymer materials are only used where absolutely necessary. Derogations: Only a broad exemption for the use and manufacture of fluoropolymer materials in professional and industrial applications could ensure that all vital products remain available. A specific exemption for the manufacture and use of fluoropolymers (in each case including accessories and spare parts) represents a minimum requirement, but one that appears insufficient for the reasons stated above. Any time limit should at least be designed in such a way that the exemption is reviewed at the end of the time limit and does not lapse without replacement (analog to the RoHS Directive). The limit values for non-polymeric PFAS in articles must be based on the possibilities of chemical analysis in order to make the Restriction proposal manageable and to avoid legal uncertainties. The limit value of 25 ppb mentioned in the Restriction proposal is far below the measurement limit of the available analytical methods. Such intensive care equipments like ventilators, anaesthesia devices and neonatal care incubators will no longer be available because less reliable products would not get an approval by the authorities. Equipment already in use at the hospitals would not work anymore after a short period because spare parts could also not be placed on the market anymore. Thousands of patients would most likely die. www.medtecheurope.org Page 21 of 29 Annex 2: Non-exhaustive list of uses of PFAS in medical technologies Below is a non-exhaustive table of different uses of PFAS in medical technologies (MDs and IVD reageants and instruments): Uses of PFAS in MDs, and in the device part of integral drug-device combination Blood contact invasive devices such as e.g., endoscopes, grafts/covered stents, catheter component to improve the device deliverability, catheter tubings for infusion of medication and IV fluids and drug-eluting stent (DES) - blood flow within/between arteries and veins and for DES to control drug release to inhibit the vessel renarrowing; Medication contact components - minimise drug-device interactions; Surgical sutures: pledgets made of PTFE serve as suture abutments when suturing soft tissue. They are essential in heart valve operations; Fluoropolymers, like PTFE and PVDF, are used in several components for the treatment of serious acute and chronic diseases, and also components such as stents, guidewires, catheters, dilators; Implantable and invasive medial devices, such as cardiac patches, felts and fabrics; In hernia meshes for rapid healing of hernia; Cleaning of medical devices as cleaning solvents in vapor degreasing applications; Reprocessing devices of medical devices via cleaning, disinfection and sterilization; Surgical drapes and gowns; Ophthalmic products (endotamponades- in surgery to reposition a detached retina, eye drops, contact lenses); Medical tapes and wound dressings; Medical imaging devices, such as ultrasounds and minimal invasive endoscopes; Not MD-specific uses in other materials and components such as electrical components and batteries of active medical devices; Medical equipment for continuous patient monitoring; Printing inks that are used to create markings for identification, scale, measurement, size, and other functional attributes on medical devices and on the device part of an integral drug-device combination; Packaging. Uses of PFAS in IVD reageants and instruments IVD testing kits for haemostasis products that detect blood coagulation; Heat-transfer agent in IVD clinical chemistry diagnostic testing instruments, which is essential to the functioning of the instrument; Surfactant properties in in vitro diagnostic assays, which allow measures of various parameters such as magnesium concentration in serum, plasma and urine; Fluoropolymers like PTFE and PVDF are used in several components for analytical instruments; Others: Coating on the dispense tip, tubing and tubing connectors, distributors, plugs, washers, seals and gaskets, syringe pump valves, O-rings and sealants, fittings, PTFE coated tank, dry lubrication of moving mechanical parts, manufacturing equipment, without which the assays cannot be manufactured, filtration media; Packaging. For a more exhaustive list of medical technology uses, please consider MedTech Europe's input to the public consultation on the PFAS Restriction proposal, Part 33. www.medtecheurope.org Page 22 of 29 Annex 3: Non-exhaustive list of types of PFAS used in medical technologies Below is a non-exhaustive table of different types of PFAS used in medical technologies (medical devices and IVD reagents and instruments): Types of PFAS used in MDs, and in the device Types of PFAS used in IVD reagents and part of integral drug-device combination instruments PTFE; PTFE; FEP; FEP; Perfluoropolyether; PVDF; PVDF; FKM/FPM fluoroelastomers; PVDF-HFP; Perfluorinated acrylates (C6 - C14); Hydrophobic surface treatments - surface FFKM/FFPM perfluoroelastomers; PCTFE; ETFE; bound or reacted fluoropolymers of Hexafluor propanol; undisclosed composition; Trifluoroacetic acid; PTFE coatings Trifluoroacetic acid anhydride; Specialty fluorinated lubricants; Trifluoromethane-sulfonic acid anhydride ; FKM/FPM fluoroelastomers; Trifluorotoluene; FFKM/FFPM perfluoroelastomers; Methyl trifluoromethanesulfonate. PTFE and PVDF suture materials; Semifluorinated alkanes (for example 1- (Perfluorhexyl)octane and 1- (Perfluorobutyl)pentane). For a more exhaustive list of medical technology uses, please consider MedTech Europe's input to the public consultation on the PFAS Restriction proposal, Part 33 Note: As mentioned above, the medical technology sector is a downstream user of materials and components. Companies have been working with their suppliers to map the uses of PFAS in medical technologies and continue to find new uses over time. The EU REACH Restriction proposal for per- and polyfluoroalkyl substances (PFAS) includes over 10,000 PFAS substances, including polymers. Many of these substances are currently not regulated under existing hazardous substance legislation under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or in European legislation. Due to the grouping approach and the long list of PFAS substances, this runs the risk that in the future, new uses of PFAS will be found, which are not covered by one of the derogations and then will not be permitted. www.medtecheurope.org Page 23 of 29 Annex 4: Overview of the design cycle steps required for a medical technology High-level required steps: Step 1: Generic testing Finding an alternative, that performs as well as or better than the former substance/material/technology: Changing to an alternative material must follow medical device regulations Evaluate feasibility for alternate options, product development, verification/validation, aging testing, biocompatibility testing, pre-clinical studies, clinical trial, and regulatory submissions and approvals 10+ years to redesign per impacted product; multiple product changes will result in longer timelines from testing to selecting an alternative (see below for detailed steps) Step 2: Specific device testing (indicative best-case timings) Material feasibility testing (incl. pre-clinical, animal safety testing and design verification) - at least 1 year Sample testing / making parts for testing, including industrialisation / Change of manufacturing processes and tools - at least 1 year Formal Verification & Validation (V&V) testing - at least 1 year Biocompatibility testing - at least 6 months up to 2 years dependent on the device type Clinical phase submissions/approvals - at least 6 months Clinical trial enrollment - at least 2.5 years Clinical trial follow-up - at least 1 year Clinical trial report - at least 3 months Quality Lab Regulatory submissions - at least 1 year CE regulatory approval - at least 18-24 months; 5-26 months if for the rest of the world (regulatory approval timing assumes regulatory bodies could support these product submissions without delays) Procurement time - at least 1-3+ years15 High-level required steps Identify potential materials and supplier for alternatives Exemplary process steps required depending on scope of individual materials require replacement Evaluate new material(s) based on: - Material properties (e.g., electrical resistivity, tensile strength, durability, chemical resistance, temperature resistance, biocompatibility, etc.) - Intended use/function of material (one alternative may not be suitable for all application) Evaluate Suppliers: - Supplier capabilities & costs 15 This could be highly variable, depending on the Technology Readiness Level of the material, which is especially relevant if a new substance has to be invented to replace the given PFAS. For example, if the new substance has only been synthesized at lab-scale, then the upstream supplier may spend years on scale-up, to make the substance available at a commercial production scale. Ideally, an alternative could be identified which is already available commercially, butthis cannot be ensured for PFAS, and all uses. www.medtecheurope.org Page 24 of 29 Define/Select potential alternative(s) material/supplier and frame project Test alternative(s) - Suppliers Quality Management Systems (QMS) & Documentation to ensure traceability - System integration feasibility in Entreprise Resource Plannig (ERP) system for data exchange - Select material or multiple alternatives by balancing risks on costs and timeline for testing - Establish project plan & test plan to define resources to introduce alternative material - Secure project funding & resources for material testing & implementation: o Management buy in for decision (constraints depending on financial capabilities and availability of resources) o Technical project lead o Supplier (capability to provide sample for testing) o R&D (evaluate risks for contamination and/or suitability of material used) o Manufacturing for functional testing o Regulatory for impact on global registrations - Initiate change control process and collect stakeholder inputs: o Evaluate Regulatory constraints o R&D Evaluate scope & documents required update due to material change (risk management) Define test lab Initiate risk assessment for new material Design Failure Mode and Effect Analysis (DFMEA)/ Process failure mode and effects analysis (PFMEA) o Manufacturing Evaluate risks and establish conditions for functional testing to evaluate alternatives without impacting regular production (risk for contamination and other control measures required for test execution) o Procurements & Software Quality Assurance (SQA) Setup new supplier - Produce parts for testing - Prepare test setup - Identify Quality lab and contract new lab if required (NDA where required) - Formal V&V process: Execute testing and evaluate manufacturing process capabilities www.medtecheurope.org Page 25 of 29 Select & Implement alternative - If required, return manufacturing condition to regular production after functional & V&V testing until test outcome (>3 month lead time if Biocomp and Packaging Tests are additionally required to simulate material stability and behavior on long term performance). - Biocompatibility tests including extractable and leachanle test Execute Change Control Process - Approve alternative material - Approve and implement new supplier (agree on contract and condition) - Update technical documentation (drawing, DMFEA/PFMEA, technical summary files, IFU, labeling, material specification, etc.) - Update of manufacturing procedures & process (Design transfer), if needed update or source/setup production equipment - Update IFU & Labeling update or register new product - Regulatory product registration if required (510k, CE and others where required) - Initial sample testing - Market release (Customer training, Marketing campaign etc.) - Compliance assessment of new material and local requirements for substances www.medtecheurope.org Page 26 of 29 Annex 5: PFAS and Fluoropolymers Emissions Bibliography 1. C.D Campbell, D.H Brooks, M.W Webster and H.T Bahnson, The use of expanded microporous polytetrafluoroethylene for limb salvage: a preliminary report, May 1976, National Library of Medicine, available at: https://pubmed.ncbi.nlm.nih.gov/1265654/ 2. Shih-Chao Hsu et al., Assessing the Safety of Expanded Polytetrafluoroethylene Synthetic Grafts in Living Donor Liver Transplantation: Graft Migration Into Hollow Viscous Organs - Diagnosis and Treatment Options, July 2017, Med Sci Monit., available at: https://pubmed.ncbi.nlm.nih.gov/28683053/ Conclusion - ePTFE use in LDLT [liver donor liver transplant] continues to have wide safety margin, with a complication rate of only 1.52% 3. Luis J. Zurera et al., Safety and efficacy of expanded polytetrafluoroethylene-covered transjugular intrahepatic portosystemic shunts in children with acute or recurring upper gastrointestinal bleeding, March 2015, Pediatr Radiol, available at: https://pubmed.ncbi.nlm.nih.gov/25430967/ Conclusion - safety and efficacy of expanded PTFE-covered TIPS were satisfactory in this small series of children with acute or recurrent GI bleeding 4. Scott Shadfar et al, Safety and Efficacy of Expanded Polytetrafluoroethylene Implants in the Surgical Management of Traumatic Nasal Deformity, August 2015, JAMA Otolaryngol Head Neck Surg., available at: https://pubmed.ncbi.nlm.nih.gov/26110468/ Conclusion - ePTFE implants can be used at the level of the nasal dorsum...with a low risk of complications 5. A.M Belousov et al., Safety of mesh with fluoropolymer coating during intra-abdominal placement in large animals: results of the pilot study, 2023, Khirurgiia (Mosk), available at: https://pubmed.ncbi.nlm.nih.gov/36748870/ Conclusion - implanted, fluoropolymer coated prostheses did not cause any clinically significant adverse reactions or complications 6. Elliot Pressman et al., TeflonTM or Ivalon: a scoping review of implants used in microvascular decompression for trigeminal neuralgia, February 2020, Neurosurg Review, available at: https://pubmed.ncbi.nlm.nih.gov/31786660/ Conclusion - Teflon is an effective material for treatment of long-term symptoms related to trigeminal neuralgia 7. XIENCE, Examples of implantable PFAS 8. Lloyd J. Winchell et al., Per- and polyfluoroalkyl substances thermal destruction at water resource recovery facilities: A state of the science review, 2020, Wiley Online Library 9. EPA, Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances, December 2020 10. Carl Hanser Verlag, Closing the Recycling Loop, Up-Cycling of End-of-Life Fluoroplastics ,June 2014, Kunstsoffe International 11. PlasticsEurope, Guide for the Safe Handling of Fluoropolymer Resins, November 2012 12. Shivangi Sharma et al., Biocompatible Polymers and its Applications, 2020, Elsevier 13. Charles Baquey et al., Fluorinated Biomaterials for Cardiovascular Surgery, INSERM www.medtecheurope.org Page 27 of 29 14. David W. Grainger, Fluorinated Biomaterials, 2011 15. Fang Liu and David W. Grainger, Fluorinated Biomaterials, 2011 16. Arnold S. Breitbart and Valrie J. Ablaza, Implant Materials, Chapter 7, Grabb and Smith's Plastic Surgery, 2007 17. J. Bakker, B. Bokkers and M. Broekman, Per- and polyfluorinated substances in waste incinerator flue gases, RIVM report, 2021 18. Barbara J. Henry et al., A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers, Integrated Environmental Assessment and Management, February 2018, available at: https://setac.onlinelibrary.wiley.com/doi/10.1002/ieam.4035 19. Stephen H. Korzeniowski et al., A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integrated Environmental Assessment and Management, June 2022, available at: https://setac.onlinelibrary.wiley.com/doi/10.1002/ieam.4646 20. Aleksandrov et al., Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential formation of per- and Poly-Fluorinated Alkyl Substances (PFAS) in flue gas, Chemosphere, 2019 21. Ammar A, et al., Neural tissue compatibility of Teflon as an implant material for microvascular decompression, Neurosurgical Review Vol 13, 1990, pp. 299-303 22. Anderson BVC et al., Trends in polymer development, Science, 1980, pp. 208, 626 23. Barber HD et al., Using a dense PTFE membrane without primary closure to achieve bone and tissue regeneration, Journal of Oral Maxillofacial Surgery, Vol 65, 2007, pp. 748-752 24. Bartee BK and Carr JA, Evaluation of a high-density polytetrafluoroethylene (n-PTFE) membrane as a barrier material to facilitate guided bone regeneration in the rat mandible, Journal of Oral Implantology, Vol 21(2), 1995, pp. 88-95 25. Bartee BK, The use of high-density polytetrafluoroethylene membrane to treat osseous defects: Clinical reports, Implant Dentistry, Vol 4(1), 1995, pp. 21-26 26. Calnan J, The use of inert plastic material in reconstructive surgery, British Journal of Plastic Surgery, Vol 16, 1963, p. 1 27. Curry PT et al., Chromosomal aberrations in Chinese hamster ovary (CHO) cells conducted with test article extracts, IPE-NAMSA PTFE Vascular Graft Biocompatibility Report, 2005 28. Dunn DS et al., Cytotoxicity study using the agarose overlay method (solid), IPE-NAMSA PTFE Biocompatibility Report, 2005 29. Durucu C et al., Medialization laryngoplasty with Gore-Tex: An animal study, Journal of Voice, 3 July 2006 30. Friedneberg ZB, Bone growth into Teflon sponge, Surgery, Gynecology and Obstetrics, Vol 116, 1963, p. 588 31. Gourlay SJ et al., Biocompatibility testing of polymers: In vivo implantation studies, Journal of Biomedical Materials Research, Vol 12, 1978, p. 219 32. Harrison JH, The use of Teflon as a blood vessel replacement in experimental animals, Surgery, Gynecology and Obstetrics, Vol 104, 1975, p. 81 33. Homsy CA, Biocompatibility of perfluorinated polymers and composites of these polymers, Biocompatibility of Clinical Implant Materials, Williams OF, ed., Chap. 3 Vol II, 1982, pp. 59-77 www.medtecheurope.org Page 28 of 29 34. Homsy CA and Anderson MS, Functional stabilization of soft tissue and bone prostheses with a porous low modulus materials system, Biocompatibility of Implant Materials, Williams DF, Ed., 1976, Chap. 10 35. Homsy CA et al., Rapid in vitro screening of polymers for biocompatibility, Journal of Macromolecular Science, Chemistry, Vol 3, 1970, pp. 615-634 36. Lamb JW et al., A comparison of porous and non-porous Teflon membranes plus demineralized freeze-dried bone allograft in the treatment of class II buccal/lingual furcation defects: A clinical re- entry study, Journal of Periotology, Vol 19(12), 2001, pp. 1580-1587 37. Lindberg PB et al., A new experimental model for studies of local inflammatory reactions, Swedish Dentistry Journal, Vol 15(5), 1991, pp. 235-243 38. Rice RM et al., Biocompatibility testing of polymers: In vitro implantation studies with in vivo correlation, Journal of Biomedical Materials Research, Vol 12, 1978, p.43 39. Sullivan B et al., Stabilization of Thompson femoral head prosthesis with a porous stem coating: A case report, Clinical Orthopedics, Vol 132, 1978, p. 136 40. U.S. Food and Drug Administration, Minutes of Panel Hearings, General and Plastic Surgery Devices Classification Panel, Washington DC, 24 March 1978 41. Von Recum AF et al., Biocompatibility tests of components of an implantable cardiac assist device, Journal of Biomedical Materials Research, Vol 12, 1978, pp. 743-765 42. Wilsnack RE et al., Human cell culture testing of medical devices and correlation to animal tests, Biomaterials, Medical Devices and Artificial Organs, Vol 1, 1973, pp. 543-562 43. Wilsnack RE, Quantitative cell culture biocompatibility testing of medical devices and correlation to animal tests, Biomaterials, Medical Devices and Artificial Organs, Vol 4, 1976, pp. 235-261 44. Wood JA, et al., Acute systemic toxicity, IPE-NAMSA PTFE Vascular Graft Biocompatibility Report, 2005 45. Wood JA, et al., Intracutaneous toxicity, IPE-NAMSA PTFE Vascular Graft Biocompatibility Report, 2005 46. Wood JA et al., Ocular irritation study in the rabbit, IPE-NAMSA PTFE Vascular Graft Biocompatibility Report, 2005 47. Joint Research Center, Supply chain analysis and material demand forecast in strategic technologies and sectors in the EU - A foresight study, March 2023, available at: https://publications.jrc.ec.europa.eu/repository/handle/JRC132889 48. GSI Environmental, Technical Support Document in Response to ECHA Annex XV Restriction Proposal for PFAS, Gujarat Fluorochemical's RAC Comment Letter, June 2023 49. Produkt Kanzlei, Legal Observations, Proposal for a restriction of Per- and polyfluoroalkyl substances (PFAS) according to Regulation (EC) No. 1907/2006 (REACH), March 2023 50. Dr. Gehrmann et al., Pilot-Scale Fluoropolymer Incineration Study: Thermal Treatment of a Mixture of Fluoropolymers under Representative European Municipal Waste Combustor Conditions 51. Stefen H. Korzeniowski et al., A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integrated Environmental Assessment and Management, June 2022, available at: https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4646?af=R www.medtecheurope.org Page 29 of 29 -- AKT 821746 -- BILAG 9 -- [ 131a. SV Mde ml. EMMedicoindustrien ] -- Til: Jeppe Kramer Jrgensen (EM-DEP) ( @em.dk) Fra: Stellan Nrreskov Wulff (ffi@medicoindustrien.dk) Titel: SV: Mde ml. EM/Medicoindustrien Sendt: 02-09-2023 21:01 Bilag: 230616 Draft Annex D4D5D6 Post ISC_LS_final-ComReg - Medicoindustrien.docx; rest_pfas_annex_e_31106_en - Medicoindustrien.pdf; Kre Jeppe, Her kommer som aftalt en update omkring D4, D5 og D6, som er vsentlige i noget medicinsk udstyr, hvorfor det er vores vurdering, at et forbud vil have negative patientsikkerhedsmssige konsekvenser. Ligeledes flger info omkring PFAS, som er et vsentligt opmrksomhedspunkt for os i jeblikket. D4, D5 og D6: Kort om D4, D5 og D6: Inden for medicinsk teknologi bruges stofferne som silikoner i medicinsk udstyr, i IVD-tests samt i ar- og stomiprodukter. En fordel ved cyclosiloxaner er, at de er kemisk stabile og biokompatible, hvilket betyder, at de sandsynligvis ikke vil forrsage allergiske reaktioner eller medfre andre negative bivirkninger i kroppen. De er samtidig hydrofobe, hvilket betyder, at de ikke blander sig med vand og p den mde kan forhindre dannelse af biofilm. Status omkring udfasning af D4, D5 og D6: Der er lagt op til, at begrnsningen skal glde for fremstilling, markedsfring og brug af D4/D5/D6 p grund af deres PBT- og vPvB-egenskaber. Der er dog blevet foreslet en undtagelse for "Placing on the market of D5 and D6 for use as medical devices, as defined in Directive 93/42/EEC or in the Regulation (EU) 2017/745, for the (i) treatment/care of scars and wounds, (ii) prevention of wounds, and (iii) care of stoma." Har man ikke je for disse undtagelser, vil det selvsagt kunne vre problematisk i et patientsikkerhedsmssigt perspektiv, ligesom det vil have en negativ effekt for producenter og leverandrer af disse teknologier. PFAS Et andet -- meget vigtigt - opmrksomhedspunkt er PFAS: Det er ikke nogen hemmelighed, at der er et stort fokus bde nationalt og europisk p udfasning af PFAS. Det kan f meget alvorlige konsekvenser for branchen, hvis ikke medicinsk udstyr undtages, da PFAS -- ligesom i pharma -- har stor betydning for produkternes funktionalitet og patientsikkerhed. I lovforslagets nuvrende form er der tre mulige udfasningshorisonter for PFAS: o Den korte med 18 mneders overgangsperiode o Den mellemkorte med 12 r + 18 mneders overgangsperiode o Undtagelse fra udfasning Det er umiddelbart kun API'er (pharma), som er helt undtaget. Medicinsk udstyr opdeles i stedet efter udstyrskategori i den korte og mellemkorte udfasningshorisont (se tabel E.109 s. 327 i vedhftede). Tilgangen, hvor der tages stilling til hver enkel udstyrskategori, er i vores jne dybt uhensigtsmssig, da listen for udstyr med mellemkort tidshorisont er ufuldkommen. Til trods for en hringsproces i samarbejde med vores kollegaer i MedTech Europe og deres netvrk bliver vi lbende kontaktet af medlemmer, hvor deres udstyr ikke fremgr af listen for mellemkort sigt. Hvis lovforslaget stemmes igennem i sin nuvrende form, har disse medlemmer kun 18 mneder til at udfase PFAS i udstyr og produktion, hvilket ikke vurderes til at vre realistisk og derfor kan f dybt alvorlige konsekvenser for patienter og medicobranchen. Der er blandt vores medlemmer forstelse for, at industrien har et miljansvar, herunder at bidrage til minimering af PFAS i naturen, men dette ansvar m ikke udvande patienthensynet. Ved en s simpel tilgang til PFAS-udfasning, som der lgges op til, risikerer udstyr at udg af markedet inden for to r med de alvorlige konsekvenser til flge, som er skitseret ovenfor. I stedet mener vi, at man skal g andre veje: o Alt medicinsk udstyr br undtages -- ligesom pharma - eller som minimum f mellemkort sigte ift. udfasning med undtagelse af enkelte specificerede udstyrskategorier. o I relation til ovenstende punkt skal det bemrkes, at det er vores vurdering, at en mellemkort frist er innovationshmmende, da virksomheder kan vre tilbageholdende med at bygge produktionsanlg til eksisterende udstyr, sfremt PFAS indgr i udstyr og/eller i produktionen, og virksomhederne ikke kender til PFAS-alternativer p nuvrende tidspunkt. Grunden til, at branchen er afhngig af PFAS er, at stofferne har unikke kemiske egenskaber (herunder coating, ligesom det degenerer kun ved meget hje temperaturer), som er vanskelige at erstatte inden for f r - hvis overhovedet. Iflge MDR skal substitutioner af materiale / stof i udstyr som minimum have tilsvarende (helst bedre for at det giver mening for virksomheden) risikoprofil, fr en substitution i udstyret kan godkendes. Som du formentlig er orienteret om, er der i regi af Miljstyrelsen nedsat en taskforce omkring PFAS: Eksperter skal stte retning for PFAS-indsats - Miljstyrelsen (mst dk) Sammenstningen af denne task-force bestende udelukkende af forskere illustrerer meget godt, at fokusset rent politisk pt. ligger p det miljmssige og knap s meget p det sundheds- og markedstilgngelighedsmssige. Det bekymrer os. Ser frem til at drfte nrmere omkring ovenstende. Med venlig hilsen, Stellan Nrreskov Wulff Chef for Politik og Kommunikation -- Director of Public Affairs & Communications Mobil: +45 48 80 75 35 Telefon: +45 49 18 47 07 MEDICO INDUSTRIEN MEDTECH DENMARK Bge Alle 5, 2970 Hrsholm medicoindnstrien.dk Flg os: Denne mail er fra Medicoindustrien. Mailen og vedhftede filer er fortrolige og kan indeholde juridiske informationer. Medicoindustrien kan ikke gres ansvarlig for rd og vejledning. Fra: Jeppe Kramer Jrgensen (EM-DEP) < @em.dk> Sendt: 22. august 2023 16:59 Til: Stellan Nrreskov Wulff <ffi@medicoindustrien.dk> Emne: SV: Mde ml. EM/Medicoindustrien Yes, sorry. D4, D5 og D6 Fra: Stellan Nrreskov Wulff <ffiPmedicoindustrien.dk> Sendt: 22. august 2023 16:56 Til: Jeppe Kramer Jrgensen (EM-DEP) < @em.dk> Emne: SV: Mde ml. EM/Medicoindustrien Hej Jeppe, Perfekt -- vi ses d. 4. september CI Du hrer fra os ang. REACH -- det er D4, D5 og D6, right? Mh., Stellan Med venlig hilsen, Stellan Nrreskov Wulff Chef for Politik og Kommunikation -- Director of Public Affairs & Communications ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.15. Petroleum and mining ......................................................................................... 494 E.3. Other impacts .............................................................................................................517 E.3.1. Human health impacts .......................................................................................... 517 E.4. Practicability and monitorability.....................................................................................520 E.4.1. Practicability of restriction options ..........................................................................520 E.5. Proportionality.............................................................................................................535 Appendices to Annex E............................................................................... 536 Appendix E.2. .................................................................................................................... 536 Appendix E.4. .................................................................................................................... 536 References ............................................................................................... 537 TABLES Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table E.1. Annual production volume and associated profits in the EU............................4 E.2. NPV (in 2020) of producer surplus losses of PFAS producers ..........................5 E.3. Annual production volume and associated profits in the EU............................6 E.4. NPV (in 2022) of producer surplus losses of the raw material supply chain ........6 E.5. Overview of estimation of job loss ..........................................................7 E.6. Estimated soc ial costs of unemployment in NPV (2020). ...............................8 E.7. PFAS manufacturing - Summary table on assessment of c osts and benefits ..... 10 E.8. Assumptions for projecting tonnage volumes and emissions. ....................... 14 E.9. Projected yearly PFAS use in the TULAC sector of the EEA........................... 17 E.10. Projected yearly PFAS emissions in the TULAC sector of the EEA ................. 17 E.11. Overview of extent to whic h alternatives have been identified .................... 19 E.12. Overview of key groups of alternatives deemed relevant for TULAC.............. 21 E.13. Summary of performance and test standards for PPE ............................... 28 E.14. Broad assessment of tec hnical feasibility of alternatives for TULAC sub-uses. . 33 E.15. Characteristics of restriction options .................................................... 44 E.16. Total mean emissions and emission reduction of RO1 ............................... 45 E.17. Estimated number of companies in different Euratex industry branc hes ........ 48 E.18. Estimated number of companies in different TULAC sub-sectors. ................. 49 E.19. Broad assessment of most likely reaction of affected companies ................. 51 E.20. Range of sales losses resulting from business closures.............................. 56 E.21. Margins in different TULAC sub-sectors,................................................ 59 E.22. Information on differences in unit pric es ............................................... 61 E.23. Conc lusions on total economic impacts on directly affected companies.......... 64 E.24. Assessment of offsetting potential in different TULAC sub-sectors................ 72 E.25. Sold production volumes for EEA countries in 2019;................................. 75 E.26. Summary of import and export data (2018) provided by Euratex. ............... 76 E.27. Conclusion on magnitude of consumer surplus losses ............................... 79 E.28. Range of employment losses (at company level) ..................................... 85 E.29. Home textiles - Summary table on assessment of costs and benefits,........... 87 E.30. Consumer apparel - Summary table on assessment of costs and benefits, ..... 94 E.31. Professional apparel - Summary table on assessment of costs and benefits,. 100 E.32. Technical textiles - Summary table on assessment of costs and benefits, .... 109 E.33. Leather - Summary table on assessment of costs and benefits,................. 121 E.34. Home fabric treatments (sprays) - Summary table on assessment of costs .. 127 ii ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.35. Automotive use (Noise and vibration insulation).................................... 132 Table E.36. Assumptions for projecting tonnage volumes and emissions..................... 141 Table E.37. Projected yearly PFAS use and emissions in the food contact materials ....... 142 Table E.38. Assessment summary for alternative substances................................... 145 Table E.39. Summary of the Identified Alternatives to PFAS Barrier Coatings............... 146 Table E.40. Characteristics of restriction options benchmark sc enarios. ...................... 153 Table E.41. Total mean emissions and emission reduction ...................................... 154 Table E.42. Comparison of the Costs of Alternatives Used in Paper............................ 156 Table E.43. Assessment of substitution costs per kg for PFAS .................................. 157 Table E.44. Comments from the stakeholder consultation for packaging ..................... 159 Table E.45. Business data on the European market............................................... 162 Table E.46. Quantification of the mass of a fluoropolymer coating............................. 166 Table E.47. Estimates of the price increase per pan required ................................... 167 Table E.48. Statistics for the European food and drink industry. ............................... 168 Table E.49. Estimated cost of job losses for some component manufacturers............... 170 Table E.50. Indicative estimate of time for transition away from fluoropolymers ........... 171 Table E.51. Estimated cost of job losses for some component manufacturers............... 175 Table E.52. Consumer cookware and home kitchen appliances - Summary table........... 177 Table E.53. Industrial food, drink and feed processing - Summary table ..................... 179 Table E.54. Non-stic k coatings in industrial and professional bakeware - Summary table 182 Table E.55. Paper and board packaging - Summary table ....................................... 185 Table E.56. Plastic packaging - Summary table on assessment of costs and benefits,..... 187 Table E.57. Other packaging applications - Summary table ..................................... 189 Table E.58. Projected yearly PFAS use, emissions and waste in the metal plating sector . 191 Table E.59. Information on non-fluorinated alternatives for chrome plating. ................ 193 Table E.60. Charac teristics of restric tion options and maximum additional emission sc enario. ............................................................................................................... 196 Table E.61. Total mean emissions and emission reduction of RO-1............................ 197 Table E.62. Conclusions on total economic impacts on directly affected companies........ 202 Table E.63. Hard chrome plating - Summary table on assessment of costs and benefits, 205 Table E.64. Decorative chrome plating, plating on plastic ....................................... 208 Table E.65. Manufacture of metal products - Summary table ................................... 210 Table E.66. Projected yearly PFAS use and emissions in the consumer mixtures ........... 212 Table E.67. Total mean emissions and emission reduction of RO1 ............................. 215 Table E.68. Consumer mixtures (and musical instruments) - Summary table............... 218 Table E.69. Projected yearly PFAS use and emissions in the cosmetics....................... 221 Table E.70. Examples of non-PFAS used in cosmetics. ........................................... 222 Table E.71. Total mean emissions and emission reduction of RO1 ............................. 223 Table E.72. EEA cosmetic products market 2019, Retail Sales Prices ......................... 224 Table E.73. Summary of estimated number of formulations containing PFAS ............... 227 Table E.74. Assumed share of reformulations per year in the baseline ....................... 227 Table E.75. Estimated net reformulation costs due to restriction............................... 228 Table E.76. Cosmetics - Summary table on assessment of costs and benefits, ............. 229 Table E.77. Cost-effectiveness of recent REACH restrictions. ................................... 230 Table E.78. Projected yearly PFAS use and emissions in the ski wax.......................... 231 Table E.79. Non-fluorinated ski wax alternatives. ................................................. 232 Table E.80. Total mean emissions and emission reduction of RO1 ............................. 234 Table E.81. Price ranges and averages of ski waxes reviewed in 2020........................ 235 Table E.82. Estimated market value of ski wax used in the EEA................................ 236 Table E.83. Ski wax - Summary table on assessment of costs and benefits, ................ 240 Table E.84. Projected yearly PFAS use and emissions in the fluorinated gases.............. 242 Table E.85 Characteristics of restrict ion options benchmark scenarios........................ 254 Table E.86. Total mean emissions and emission RO1 ............................................. 254 Table E.87. Summary of Information on the Costs of Alternative Options.................... 262 Table E.88. Summary of Information on the Costs of Alternative Options.................... 264 Table E.89. Value Chain for HVACR in the EU. ..................................................... 268 Table E.90. Summary of economic effects on the use of fluorinated gases .................. 269 Table E.91. Comparison of Insulation properties of HFO and HCFO............................ 273 iii ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.92. Potential Effects Through the Value Chain. .......................................... 278 Table E.93. Value chain for fluorinated aerosol propellants...................................... 281 Table E.94. Value Chain for Cover Gases Used for Magnesium Casting. ...................... 282 Table E.95. Cost Comparison for Consumption of SO2 and HFC-134a......................... 283 Table E.96. Operational and Cost Data for Use of Cover Gases................................. 283 Table E.97. Refrigeration - Summary table on assessment of costs and benefits,.......... 289 Table E.98. Air conditioning and heat pumps - Summary table................................. 292 Table E.99. Maintenance of HVACR equipment and national/local limitations................ 293 Table E.100. Foam blowing agents - Summary table on assessment of costs ............... 297 Table E.101. Solvents - Summary table on assessment of costs and benefits,.............. 300 Table E.102. Propellants - Summary table on assessment of costs and benefits,........... 304 Table E.103. Magnesium casting - Summary table on assessment of costs and benefits, 307 Table E.104. Fire suppressants - Summary table on assessment of costs and benefits, .. 309 Table E.105. Preservation of cultural paper-based materials - Summary table.............. 312 Table E.106. Insulating gas in electrical equipment - Summary table......................... 314 Table E.107. Projected yearly PFAS use and emissions in the medical devices .............. 316 Table E.108. Overview of properties of ePFTE tubing ............................................. 319 Table E.109. Characteristics of restriction options and maximum additional emission benchmark scenarios. ................................................................................... 327 Table E.110. Total mean emissions and emission reduction of RO1 ........................... 328 Table E.111. Medical devices - Summary table on assessment of costs and benefits,..... 338 Table E.112. Projected yearly PFAS use and emissions in the transportation................ 347 Table E.113. Alternatives for PFAS substances used in transportation products ............ 349 Table E.114. Alternatives for sealing applications. ................................................ 351 Table E.115. Summary of the identified alternatives to fluorinated gases.................... 355 Table E.116. Characteristics of restriction options and maximum additional emission scenarios. .................................................................................................. 361 Table E.117. Total mean emissions and emission reduction of RO1 and of maximum additional emission scenarios ....................................................................................... 362 Table E.118. European transport industry data. ................................................... 365 Table E.119 Levels of response to the 2nd stakeholder consultation .......................... 365 Table E.120. Summary of information on the costs of a CO2 based alternative ............. 368 Table E.121. PFAS use in transport (including automotive, aircraft, rail, marine, ........... 372 Table E.122. Hydraulic fluids for anti-erosion/anti-corrosion purposes........................ 376 Table E. 123 MAC (Mobile Air Conditioning) systems - Summary table ....................... 379 Table E.124. Transport refrigeration - Summary table on assessment of costs ............. 382 Table E.125. MAC and refrigeration in military applications - Summary table ............... 385 Table E.126. Projected yearly PFAS use and emissions in the electronics .................... 388 Table E.127 Stakeholder information received in the 2nd stakeholder consultation........ 390 Table E.128. List of available non-PFAS substances and technics in Electronics,............ 396 Table E.129. Characteristics of restriction options and the worst -case maximum additional emission (benchmark) scenarios. ..................................................................... 397 Table E.130. Total mean emissions and emission reduction of RO1 and maximum additional emission (benchmark)................................................................................... 398 Table E.131. Electronics - Summary table on assessment of costs and benefits, ........... 403 Table E.132. Semiconductors - Summary table on assessment of costs and benefits, .... 406 Table E.133. Projected yearly use and PFAS emissions in the energy sector ................ 411 Table E.134. List of available non-PFAS substances and technics in Energy sector......... 414 Table E.135. Characteristics of restriction options and benchmark scenarios. ............... 418 Table E.136. Total mean emissions and emission reduction of RO1 ........................... 419 Table E.137. Energy - Summary table on assessment of costs and benefits,................ 421 Table E.138. Assumptions for projecting tonnage volumes and emissions. .................. 426 Table E.139. Projected yearly PFASs use and emissions in the building ...................... 427 Table E.140. Comparison of fabric performance (table 3.2 in Llorens (2015)). ............. 434 Table E.141. Characteristics of RO1. ................................................................. 455 Table E.142. Total mean emissions and emission reduction of RO1 ........................... 455 Table E.143. Overview of economic impacts of a ban of polymeric PFASs.................... 456 Table E.144. Overview of economic impacts of a ban of polymeric PFASs.................... 457 iv ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.145. Overview of economic impacts of a ban of non-polymeric PFASs.............. 460 Table E.146. Polymeric PFASs in mixtures used as building materials......................... 462 Table E.147. Polymeric PFASs in articles used as building materials........................... 465 Table E. 148 Non-polymeric PFASs in building materials and construction products ....... 470 Table E.149. Assumptions for projecting tonnage volumes and emissions ................... 475 Table E.150. Projected yearly PFAS use and emissions in the lubricants ..................... 476 Table E.151. Characteristics of restriction options................................................. 484 Table E.152. Total mean emissions and emission reduction of RO1 ........................... 485 Table E.153. Substitution costs as estimated by stakeholders. ................................. 488 Table E.154. Economic impacts related to a ban of PFASs in lubricants....................... 489 Table E.155. PFASs in lubricants - Summary table................................................ 491 Table E.156. Projected yearly PFAS use and emissions in the petroleum..................... 494 Table E.157. Summary of uses and properties of non-polymeric PFAS in the oil............ 496 Table E.158. Summary of uses and properties of fluoropolymer in the petroleum.......... 496 Table E.159 Overview of technical considerations for alternatives ............................. 503 Table E.160. Characteristics of restriction options................................................. 506 Table E.161. Total mean emissions and emission reduction..................................... 506 Table E.162. Number of enterprises, employment, turnover and value....................... 507 Table E.163. Number of enterprises, employment, turnover and value....................... 508 Table E.164. Overview of information available on workers and users involved............. 508 Table E.165. Overview of economic impacts of a ban of non-polymeric PFAS ............... 509 Table E.166. Overview of economic impacts of a ban of fluoropolymers...................... 510 Table E.167. Petroleum and mining - Summary table ............................................ 513 Table E.168. Current health impacts in the general population................................. 518 Table E.169. Selected PFAS substances and the percentage fluorine.......................... 523 Table E.170. Available analytical methods for PFAS in selected matrices..................... 527 Table E.171. Available analytical methods for PFAS in selected matrices..................... 530 FIGURES Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure E.1. Expected PFAS use and emissions in EEA under the baseline in the TULAC ..... 18 E.2. Time path of mean emissions under the baseline, .................................... 47 E.3. Expected PFAS use and emissions in EEA under the baseline .................... 142 E.4. Time path of mean emissions under the baseline, RO1, ........................... 155 E.5. Bun tin with severely degraded coating ............................................... 165 E.6. Expected PFAS use and emissions in EEA under the baseline in the metal .... 192 E.7. Time path of mean emissions under the baseline, RO1, ........................... 198 E.8. Time path of mean emissions under the baseline and RO1 ....................... 215 E.9. Time path of mean emissions under the baseline scenario........................ 223 E.10. Expected PFAS use and emissions in EEA under the baseline ................... 231 E.11. Time path of mean emissions under the baseline and RO1...................... 235 E.12. Expected PFAS use and emissions in EEA under the baseline ................... 244 E.13. Time path of mean emissions under the baseline, RO1, ......................... 259 E.14. Expected PFAS use and emissions in the EEA under the baseline .............. 317 E.15. Illustration of the "Substitution Hopper" (RINA, 2021). .......................... 325 E.16. Time path of mean emissions in the medical devices sector .................... 332 E.17. Expected PFAS use and emissions in EEA under the baseline ................... 347 E.18. Time path of mean emissions in the transport sector............................. 364 E.19. Expected PFAS use and emissions in EEA under the baseline ................... 389 E.20. Time path of mean emissions in the electronics and semiconductor sector .. 400 E.21. Expected PFAS use and emissions in EEA under the baseline ................... 412 E.22. Time path of mean emissions under the baseline, RO1 .......................... 420 E.23 Expected PFASs use and emissions in EEA under the baseline .................. 428 E.24. Expected PFAS use and emissions in EEA under the baseline ................... 477 E.25. Time path of mean emissions from the use of PFAS-based lubricants......... 486 E.26. Expected PFAS use and emissions in EEA under the baseline ................... 495 v ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.27. Time path of mean emissions under the baseline, ................................ 507 vi ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Annex E Impact Assessment E.1. Risk Management Options For details on risk management options, see section 2.2. of the main report. E.2. Impact Assessment for specific uses E.2.1. PFAS manufacturing E.2.1.1. Baseline For all PFASs, there is an expectation of market growth in the absence of regulatory action leading to an overall inc rease in EU-produc tion or import, or both, of PFAS as a substance or in articles. No spec ific data is available for produc tion growth of PFAA and PFAA prec ursors produced in the EU-27 although there is an expectation of global growth in demand from downstream uses related to the textile industry, one of the most extensive users of non-polymeric PFASs As default a steady growth of 2%/y is taken by the Dossier Submitters in absence of other information. For fluorinated gases the picture is mixed. The market is increasing, and growing volumes of fluorinated gases are needed, however the EU-28 production of HFCs has decreased while HFO import increased (EEA, 2021). The alternative to HFCs, i.e. HFOs, are mainly produced in Asia and the United States of America and imported into Europe (Booten et al., 2020; Seidel and Ye, 2016). The Dossier Submitters are not aware of a production location of HFOs in the EU-27. Therefore, the annual growth of the EU- 28 produc tion during the last 10 years has been calculated based on reported tonnages by the EEA. These figures show an annual decline of 10% in the production of HFCs. This trend is taken by the Dossier Submitters as representative (negative) annual growth figure due to the regulatory phase down of HFC use. For polymeric PFAS, only for fluoropolymers detailed information is available. In 2022 PTFE is the most applied fluoropolymer but PVDF and FEP will have a growing market share. For FEP this is largely because of the growing electronics market (FEP is used extens ively in cables like LAN cables) as well as solar cell and fiber optic applications. PVDF is expected to grow enormously due to its increasing applications in lithium-ion batteries (i.e. used in electrified transport) and architectural coatings. Expected EEA fluoropolymer consumption growth is for a large part driven by initiatives such as the Green Deal. Applications driving the anticipated growth include hydrogen fuel cells, coatings for photovoltaic and wind power, REDOX (reduction-oxidation) flow batteries and lithium-ion batteries, and water electrolysis for the hydrogen economy. For some of the uses non PFAS substances are available. A substantial growth in the fluoropolymer films market in Europe is anticipated due the growing transportation sector ac ross the region. Fluoropolymer films have a wide range of applic ations in c onstruction, transportation, industrial proc essing, food and pharmac euticals, packaging, and others. The global leading producer of fluoroplastics, AGC chemicals1, estimated a global annual increase of fluoroplastic consumption of 4-4.5% until 2023. More recent data suggest a global growth rate of 5.6% for PTFE alone between 2020 -2027 (InvestSaudi, 2021). The Dossier Submitters take a yearly growth rate of 5% as representative for the polymeric PFAS 1 https://www.agcce.com/fluoroplastics/, date of access: 2023-01-11. 1 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) production in the EU-27. E.2.1.2. Alternatives In general, the manufacturing/production of PFAS has the sole purpose to produce PFASs, therefore analyses of alternatives for PFASs manufacture as such has no meaning. The availability, hazards and feasibility of PFAS-free alternatives to PFAS substances in many downstream applications and products is assessed for each of the sectors affected. E.2.1.2.1. Polymerisation aids in manufacture of fluoropolymers During the manufacturing of about 40-50% of all fluoropolymers other non-polymeric PFASs (such as PFOA, PFNA, PFHxA, 6:2 FTSA) are used as polymerisation aid to produce fluoropolymers (see also A.2.1.4.1.). In the section below we assess the state of play as regards the introduction of alternative non-PFAS polymerisation aids in fluoropolymer manufac t ure. Technical feasibility For dec ades, the ammonium salts of perfluorooctanoic acid (PFOA) and perfluorooctylsulfonic acid (PFOS) have been used in aqueous emulsion polymerization to produce fluoropolymers. With the recognition of the environmental and health concerns associated with long chain functional perfluoroalkyls, fluoropolymer manufacturers began the development of alternative emulsifiers and different polymerization techniques. The challenge was to ensure that fluoropolymers could still be safely manufactured while minimizing emulsifier emissions and use. Currently, industry is in transition to use non-PFAS polymerisation aids, at least for the manufacturing of PTFE, PVDF and FKM. It is not clear whether all PTFE, PVDF and FKM can already be produced without PFAS polymerisation aids at industry level however four major PFAS producers announced they can produce their fluoropolymers PTFE and PVDF without PFAS polymerisation aids (see Annex A.2.1.). Other types of fluoropolymers still require the use of fluorinated polymerisation aids for their manufac ture. According to industry (Drohmann et al., 2021), fluorinated polymerisation aids are used to achieve ultra-high molecular weights which are needed to obtain the desired properties for the critical sectors of chemical industry, aerospace, automotive, medical devices, pharmacological applications, semiconductors, etc. Currently it is not possible to remove fluorinated polymerisation aids from these manufac turing proc esses that account for about 17% of the global production of fluoropolymers (Sales et al., 2022). In the 2nd stakeholder consultation, it was stated that fluoropolymer resin manufacturing industry is working to develop non-fluorinated polymerisation aids as an alternative to fluorinated polymerisation aids, wherever possible. Different manufacturers are likely to be at different stages of development with various fluoropolymers and the ir respective grades. Their work on alternatives was based on information in recent patent applications. When c ommerc ialised, this will signific antly further inc rease the percentage of fluoropolymers made without the use of fluorinated polymerisation technology. While it is difficult to anticipate a date when 100% of the fluoropolymer production will be possible without the use of fluorinated polymerisation aids, key industrial players expect that within 10 years (i.e. before 2032) they will be at or very c lose to that objective (Sales et al., 2022). Human health and environmental hazards For the non-PFAS alternative polymerisation aids relevant for fluoropolymer manufacture, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) were assessed. Additionally, it was assessed whether the 2 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. In relation to the non-PFAS alternative polymerisation aids relevant for fluoropolymer manufacture, the list of alternatives contained 10 identified alternative substance s or group of substances to long chain PFAS as processing aids. The data is however not sufficient for further evaluation. For one group of substances named "siloxane and silic one polymers", it is indicated that it may contain residues of D4, D5 and D6 cyclic siloxanes. D4, D5 and D6 cyclic siloxanes are known PBT/vPvB substances and in addition D4 is considered an endocrine disruptor. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.1.3. Overall, the human and environmental hazards of alternatives to long chain PFASs polymerization aids are unknown.Environmental impacts Production of fluorinated production aids itself can lead to emissions of many poly- and perfluorinated by-products, both highly volatile and water soluble (Hopkins et al., 2018). Secondly, the fluorinated polymers, such as PTFE, are themselves processed at high temperatures of 340-400 C, using up to 0.5% w/w of perfluoro- and polyfluoro-emulsifiers and dispersing agents inc luding ADONA, HPFO- DA and other PFOA replac ements (Table A.6) (Gomis et al., 2015). E.2.1.4. Economic and other impacts of RO1 The following section describes the economic and other impacts of RO1: Full restriction of produc tion of all PFAS with entry into forc e after a transitional period of 18 months. E.2.1.4.1. Economic impacts: Producer surplus losses Loss of turnover of suppliers that are unable to import PFAS into the EEA due to the proposed restriction has not been estimated as it is expected that almost all of the relevant profits are incurred by companies located outside the EEA. The number of main production sites of PFAS in the EU is estimated to be around 20 (A.2.1.3.1.) mainly producing PFAS monomer and polymer. There is a limited production of fluorinated gases for refrigerant use in the EU. Estimated annual production volumes for the EEA are presented in Annex A.2. Polymeric PFAS contain both fluoropolymers and perfluorpolyethers; however only for fluoropolymers detailed information is available. A rough estimate of the sales value c an be made by multiplying the produc ed volume of PFAS by the average market price. Market prices are highly dependent on the type of PFAS, the c ostumer and level of c ompetition. Therefore, only a rough indic ation c an be provided by the Dossier Submitters as these details are not known. A wide variety of prices per tonne of PFAAs and PFAA precursors has been reported by stakeholders during the Call for Evidence varying from 10 000 and 90 000 to several million euros for specialised applications. Due to the absence of any other reliable estimates, the midpoint of the 10 000 and 90 000 interval (i.e., 50 000) is taken by the Dossier Submitters as representative price per tonne. The price for PFAAs and PFAA precursors are used as a proxy for all non-polymeric PFAS and non-fluorinated gasses. Regarding the price of fluorinated gases, the price monitoring for HFC refrigerants and their alternatives carried by Kleinschmidt (2020), the average price of HFC blends (R404A; R410A; R407C and R134a) in Q3/2019 was between 18 000 and 40 500 per tonne. It is unknown to the Dossier Submitters which HFCs are produced in the EEA and some of the fluorinated gases in the abovementioned blends do not fall into the scope of the proposed restriction. However, in 3 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) absence of any other information, the midpoint of the 18 000 and 40 500 interval (i.e., 29 250) is taken by the Dossier Submitters as representative price per tonne HFC. Prices for polymeric PFAS are based on information for fluoropolymers and vary widely. Ranges from 8 000 to five million euros have been reported by stakeholders in the CfE. However, some of the higher prices reported by companies most likely referred to the price of a product (article) manufactured using fluoropolymers. PlasticsEurope report s an overall price per tonne fluoropolymer produced in the EU28 of 21 000 for 2020 and is taken by the Dossier Submitters as representative pric e per tonne (Wood, 2022). An indication of the profit margin for the fluoropolymers can be derived from public information. An EBITDA margin of 21% is reported for the sale of fluor products in a presentation by Chemours and similar figures were reported during the CfE by other companies (Chemours, 2020). In absence of other information, the Dossier Submitters take this profit margin as representative for all PFAS groups. Table E.1 shows the estimated profit in the production of PFAS per PFAS group. Table E.1. Annual production volume and associated profits in the EU. Numbers are in two significant figures and based on 2020 prices and volumes. PFAS group PFAA and PFAA precursors Fluorinated gases Polymeric PFAS Source: Own calculations Production volume in EU (t/y ) 86 000 96 000 75 000 based on data Average market price (/t) 50 000 29 000 21 000 colla ted by the Dossier Assumed profit margin (%) 21 21 21 Submitters. Estimated profit (million /y) 900 580 330 In case of a full ban the Dossier Submitters expect most production facilities in the EU-27 to stop operating after entry into force of the proposed restriction. Some facilities might be able to continue at a reduced product ion capacity to produce PFAS for those uses that are derogated under RO1 (see A.3.17.). Continuation of EU manufacture under RO1 depends on the specifics of the required PFAS for derogated uses and the state of competitiveness of these EU production facilities compared to non-EU competitors. The total tonnage of PFAS used as active substance is estimated at ~6 000 t/y. It is not known to the Dossier Submitters to what degree PFAS substances are used as active ingredient in the derogated biocidal, plant protection and medicinal product uses are produced in the EU-27 or imported. Therefore, the closure of all production facilities in the EU-27 is taken by the Dossier Submitters to estimate an upper boundary of the potential producer surplus losses. The total net present value (NPV) of the producer surplus losses is estimated in Table E.2 using a 3% discount rate, as proposed in the most recent version of the `Better Regulation Guidelines and Toolbox' published by the European Commission for market goods (EC, 2021a; EC, 2021b). The NPV values (see Table E.2) are for 2020 and the analysed time period starts in the anticipated year of implementation of the proposed restriction (2025). 4 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.2. NPV (in 2020) of producer surplus losses of PFAS producers for different time periods after the anticipated implementation of the proposed restriction in 2025. A discount rate of 3% and PFAS group specific yearly growth rates are applied. Numbers are in two significant figures and based on 2020 prices and volumes . NPV of producer surplus losses in PFAS group million euros 30 years 50 years PFAA and PFAA precursors 21 000 33 000 Fluorinated gases (HFCs only) 1 800 1 800 Polymeric PFAS 15 000 30 000 Total 38 000 65 000 Source: Own calculations based on data collated by the Dossier Submitters. The Dossier Submitters have no reliable information to determine the value of the production fac ilities after c losure. However, some of the losses from the premature retirement of assets are expected to be recouped through either resale of equipment or as s crap value. No information is available to estimate the magnitude of this recouperation, however the Dossier Submitters expect this magnitude to be insignificant compared to the producer surplus losses. In addition to producer surplus losses in the manufacturing of PFAS, producer surplus losses can also occur in the supply chain supplying raw materials to PFAS manufacturers. Closure of all PFAS production facilities in the EU-27, which is taken by the Dossier Submitters to estimate an upper boundary of the potential producer surplus losses in PFAS manufacturing, is likely to affect raw material suppliers. The main feedstock for overall PFAS production is hydrofluoric acid (HF) together with chloroform used in the production of fluoropolymers. The main application of HF is in the production of fluorocarbons and almost 70% of the HF is used for fluorinated organic substances (see Annex A.2.1). In 2015, European HF production reac hed 232 000 t with a value estimated around 270 million EUR2. Chloroform is mainly used as an industrial intermediate to manufac ture fluoropolymers but it also has other uses as an industrial extraction solvent or laboratory agent3. Chloroform is registered under REACH with a total yearly volume (production and/or import) between 100 000 to <1 000 000 t by 14 active registrants in a joint registration. The EU Risk Assessment Report on chloroform indic ates 84% of c hloroform produc ed in Europe is used as feedstock in Europe to produce HCFC- 22 (out of scope) and reports an estimated production volume of 302 800 t for 2002 in the European Community (EURAR, 2007). This HCFC-22 is subsequently used as feedstock in the produc tion of fluoropolymers (now) or as refrigerant (R-22) and foam blowing agent (in the past). Production for the latter uses has been phased out. The share of HCFC -22 used for fluoropolymer production at the time of reporting the total production volume is estimated at around 50% based on Booten et al. (2020). This would indicate that about 42% of the chloroform produced in Europe would serve as feedstock in the production of fluoropolymers. An indication of current market prices for HF and chloroform is taken from www.chemanalyst.com. As of June 2022, the European reported price per tonne for HF is $2298 (~2 300) and $827 (830) for chloroform. An accurate estimate of producer surplus losses in the raw material supply chain cannot be made by the Dossier Submitters as the anticipated response by the EU producers of HF and chloroform (e.g. export; alternative EU market; closures or operating at reduced capacity) is not known. However, it is likely producer surplus losses will occur in the raw material supply chain as HF and chloroform are predominantly used for PFAS manufacturing. As an indication of the magnitude of potential producer surplus losses in the raw material 2 https://www.eurofluor.org/what-is-hf/, date of access: 2023-01-11. 3 https://www.chlorinated-solvents.eu/products/chloroform-cfm/, date of access: 2023-01-11. 5 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) supply chain the Dossier Submitters calculate the upper boundary of producer surplus losses after 30 and 50 years after implementation of the proposed restriction. As conservative approach the Dossier Submitters assume no alternative sales markets are available for the HF and chloroform volumes used in the PFAS manufacturing after closure of the PFAS manufacturing locations. Reported EU production volumes for HF and chloroform are extrapolated to 2022 volumes using a steady 2% annual growth. In absence of other information, the same profit margin is applied as for PFAS manufacturing (Table E.3). Table E.3. Annual production volume and associated profits in the EU of the raw material supply chain. Numbers are in two significant figures and based on 2022 prices and estimated volumes. Raw material HF Chloroform Production volume in E U(t/y ) 270 000 450 000 % used for PF A S manufacturing 70 42 Average market price (/t) 2 300 830 Assumed profit margin (%) 21 21 Estimated profit (million /y) 90 33 The estimated producer surplus losses are the upper boundary of expected costs due to the proposed restriction (Table E.4). Downstream users of the produced PFAS will to some extent switch to other chemical substances as alternative to PFAS. Therefore, some of the expected profit losses are offset by other ac tors, i.e. the producers of alternative c hemic al substances. The magnitude of the losses that can potentially be offset is dependent on whether the alternative c hemic al substances are produc ed in the EU and the associated profit margins. Table E.4. NPV (in 2022) of producer surplus losses of the raw material supply chain for PFAS producers for different time periods after the anticipated implementation of proposed restriction in 2025. A discount rate of 3% and a generic 2% growth rate are applied. Numbe rs are in two significant figures and based on 2022 prices and volumes. Raw material HF Chloroform Total NPV of producer surplus losses in million euros 30 years 50 years 2 200 3 400 800 1 200 3 000 4 600 E.2.1.4.2. Economic impacts on customers Distributors and formulators of PFAS, e.g. drying, powder generation, mixing and/or bulking of PFAS substances, could incur producer surplus losses. The Dossier Submitters have no information on, e.g. number of sites in Europe, profit margin and/or volumes, to estimate potential producer surplus losses. Producer surplus losses of distributors and formulators may already be accounted for in the producer surplus estimation for PFAS manufacturers if formulation and distribution costs would be included in the reported average market prices (see Table E.1). Economic impacts on the different sectors that use PFAS are described in the different usespec ific sections below in Annex E. E.2.1.4.3. Other impact on society As a result of RO1, the Dossier Submitters anticipate closure of all the PFAS production facilities in the EU-27. This will most likely result in job losses and therefore costs to society. Direct employment in the production of 49 000 t/y fluoropolymers is estimated at 4 500 fulltime jobs ac ross the EU- 28 (Wood, 2022). No data on the number of direc t employees in the production of fluorinated gases or PFAA and PFAA precursors is available. In absence of 6 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) reliable data, the Dossier Submitters assume direct employment is linearly correlated with the production tonnages. In addition, the same out put per worker is assumed in all PFAS manufacturing. This would imply a direct employment in the production of polymeric PFAS of 6 900 employees, for fluorinated gases 8 800 employees and for PFAA and PFAA precursors of 7 900 employees. In addition to job losses due to closure of the PFAS production locations, job losses are likely in the raw materials supply chain if no alternative sales markets are available for HF and chloroform volumes used in the PFAS manufacturing. In the production of HF gas around 300 people are directly employed at nine HF production sites in four European countries 2. The number of people directly employed in the production of chloroform in Europe is unknown to the Dossier Submitters. In absence of reliable data, the Dossier Submitters assume the direct employment is linearly correlated with the production tonnages of both HF and chloroform. In addition, the same output per worker is assumed in HF and chloroform. This would imply a direc t employment in the production of chloroform of 510 employees. In a simplified approac h, the Dossier Submitters only assume job losses for the share of HF and c hloroform tonnage used for PFAS manufacturing are relevant. Therefore, the number of people dire ctly employed in the produc tion HF and c hloroform used in PFAS production is estimated at 210 for both sectors (Table E.5). Table E.5. Overview of estimation of job loss based on direct employment in the manufacture of PFAS and in the raw material supply chain. Numbers are in two significant figures. Category PFAA and PFAA precursors Fluorinated gases (HFCs only) Polymeric PFAS HF production for PFAS manufacture Chloroform production for PFAS manufacture Total Number of direct jobs 7 900 8 800 6 900 210 210 24 000 The monetisation of the social costs due of unemployment follows the approach set out by ECHA 2016 (Dubourg, 2016). In this approach the loss of unemployment is estimated considering the following impacts: The value of output/wages lost during the period of unemployment The c osts of job searc h, hiring and firing employees The scarring effect, i.e. the impact of being made unemployed of future employment and earnings The value of leisure time during the period of unemployment. The discounted net present value (in 2014) of the social costs of losing one job in the EU-28 was estimated at 87 000, equal to 2.7 times the average annual gross wage. This ratio varies across different member states, mainly driven by the country specific average duration of unemployment. Production locations of PFAS and of the raw material supply chain are distributed across Europe, supporting the use of an EU-average ratio. The average duration of unemployment decreased from 18 to 16 months since the approach was published by ECHA. The Dossier Submitters consider this change in unemployment duration not substantial enough to redo ECHA's assessment and takes the ratio of 2.7 as representative for the calculation of the societal costs of unemployment. The EU-27 average annual gross wage for the manufacturing of chemicals is estimated at ~ 47 000 in 2019/2020 pric es based on Eurostat sector data (CfE). The NPV in 2020 of the social costs of losing one job in the manufacturing of chemicals sector is estimated at 130 000 by multiplying the average annual gross wage by 2.7. The Dossier Submitters expect the proposed restriction to be implemented in 2025 with an entry into force in 2027. T herefore, the expected job losses do not take place before 2027. A discount rate of 3% yields a total NPV (2020) for expected societal costs due to job losses of the proposed restriction of 7 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 2.3 billion (see Table E.6). Table E.6. Estimated social costs of unemployment in NPV (2020). Category Number of direct jobs lost PFAA and PFAA precursors Fluorinated gases (HFCs only) Polymeric PFAS HF production for PFAS manufacture Chloroform production for PFAS manufacture Total 7 900 8 800 6 900 210 210 24 000 Social costs of unemployment in the chemical manufacture sector (euro) Discount factor 130 000 0.81 NPV (2020 in million euro) 810 910 710 22 22 2 500 E.2.1.5. Economic and other impacts of RO2 The following sec tion describes the economic and other impac ts of RO2: Proposed restriction of all production of PFAS, except for sector- and use-specific derogations with entry into force of 18 months. The proposed use-specific derogations are mainly time-limited to five or 12 years and are described in the main dossier . E.2.1.5.1. Economic impacts: Producer surplus losses In RO2, the proposed derogations allow the time-limited manufacture and placing on the market of PFAS for the specific uses described in the derogations. The Dossier Submitters have limited information on the volumes of PFAS used in the proposed derogations. In addition, it is unknown if the specific PFAS used in the derogations are manufactured in Europe or are imported. Some European facilities might be able to continue at a reduced production capacity depending on the specifics of the required PFAS and the competitiveness of the production facility compared to import. As this information is not available to the Dossier Submitters, no reliable estimate of producer surplus losses can be produced for RO2. The upper bound of the producer surplus loses for RO2 assumes EU-production locations of PFAS are not capable to produce only PFAS for those uses proposed to be temporarily derogated from the restriction at competitive margins compared to import. This upper bound has the same producer surplus losses as estimated for RO1. Depending on the volumes; derogation duration and specifics of PFAS used in the proposed derogations the producer surplus losses for RO2 could be lower. However, the expected reduction in producer surplus losses is limited. As example, in case 50% of the PFAS production in Europe could continue for supply to derogated uses only, the estimated NPV of the total producer losses in RO2 would be ~3 500 to 8 000 million lower for PFAS producers and ~290 to 670 million lower in the raw material supply chain. This example does not account for lower profit margins that are likely when production volumes are lowered significantly. E.2.1.5.2. Economic impacts on customers In RO2, distributors and formulators of PFAS, e.g. drying, powder generation, mixing and/or bulking of PFAS substances, would be allowed to process PFAS for the specific uses and durations described in the derogations. The expected reduction in costs for distributors and formulators under RO2 compared to RO1 is limited for the same reasons as mentioned in the section above. As with producer surplus loses for PFAS manufacturing, the expected reduction of producer 8 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) surplus losses in RO2 compared to RO1 for distributors and formulators limited. E.2.1.5.3. Other impact on society As indicated above, some European facilities might be able to continue at a reduced produc tion c apacity depending on the specifics of the required PFAS and the c ompetitiveness of the production facility compared to import. As this information is not available to the Dossier Submitters, no reliable estimate of job losses, and the social cost of unemployment can be produced for RO2. The upper bound of the social c ost of unemployment for RO2 assumes EU-production locations of PFAS are not capable to produce only PFAS for the use in the proposed derogations at competitive margins compared to import. This upper bound has the same social cost of unemployment as estimated for RO1. Depending on the volumes; derogation duration and specifics of PFAS used in the proposed derogations the social cost of unemployment for RO2 could be lower. However, the expected reduction in social cost of unemployment is limited. As example, in case 50% of the PFAS production in Europe could continue for supply to derogated uses only, the estimated NPV of the total social c ost of unemployment in RO2 would be ~170 to 370 million lower. 9 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.1.6. Summary of cost and benefit assessment Table E.7 summarises the outcomes of the assessment of costs and benefits for the manufacturing of PFAS. More detailed information can be found in the accompanying text following the table. Table E.7. PFAS manufacturing - Summary table on assessment of costs and benefits , based on a general transition period of 18 months . Restriction option RO1; Full restriction of all production of PFA S Duration of derogation No t a p p licable RO2; Restriction of all production of PFA S with use-specific derogations: derogation for the use of polymerisation aids in the production of polymeric PFA S (except for PTFE, PVDF and FKM) 5 ye ars 12 ye ars A lternatives Environmental impact Cost impact Other aspects Analyses of alternatives for PFAS is pe rformed at the level of use in the various sectors. Use of PFAS as polymerisation aids in manufacture of f lu o ro polymers: Sufficie ntly strong e vidence that te chnically and e conomically fe asible alternatives exist for nonpolym eric PFAS as polymerisation aids in the production of PTFE, PVDF and FKM. Sufficie ntly strong e vidence that te chnically and e conomically fe asible alternatives for nonpolym eric PFAS as polymerisation aids in the production of all other type s of polymeric PFAS will be come available within 10 years. Evide nce for an evaluation of e x pected e missions is lack ing. High producer surplus losses (order of magnitude: ~42 bn EURO NPV over 30 years) a s a re sult of business closure s [sufficiently strong e vidence] due to (i) a high share of business closures [sufficiently strong e vidence], (ii) high producer surplus losses at com pany le vel due to high margins [sufficiently strong e vidence], (iii) an unk nown offsetting potential, i.e. producer surplus losses are balanced out to some e xtent by producer surplus gains by producers of alte rnative-based products [no e vide nce] and (iv) high producer surplus losses in the wider supply chain [sufficiently strong e vidence]. High employment losses (order of magnitude: ~2.5 bn NPV) a s a re sult of high share of business closure s [sufficiently strong e vide nce]. Sufficie ntly strong e vidence that Evide nce for an evaluation of No information is available to n/a te chnically and e conomically e x pected e missions is quantify a difference in the producer fe asible alternatives for non- lack ing. surplus losses betwe en R O1 and polym eric PFAS as polymerisation RO2. aids in the production of all other type s of polymeric PFAS will be come available within 10 years from 2022. Weak evidence available that producer surplus losses from business closure s are re duced Evide nce for an evaluation of com pared to R O1 n/a e x pected e missions is lack ing. 10 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Conclusion Duration of derogation A lternatives Environmental impact Cost impact Other aspects If a re striction of all production of PFAS with use-specific derogations is considered, a re striction of the use of PFAS as polymerisation aid in the m anufacturing of PTFE, PVDF and FKM is proposed. For the use of PFAS as polymerisation aid in the m anufacturing of all other fluoropolymers, a re striction with a five year derogation after the transition period is proposed. 11 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The assessment of alternatives in relation to PFAS manufacturing for a full restriction with a transition period of 18 months is based on expert judgement, evidenc e from the CfE and 2nd stakeholder c onsultation supplemented with literature with regards to use of nonPFAS polymerisation aids. The evidenc e is suffic iently strong that technically and ec onomic ally feasible alternatives for PFAS production are unavailable for the quantities required and that the substitution potential is low under RO1 and RO2. This is since PFAS manufacturing has the sole purpose to produce PFAS substances. The evidenc e is suffic iently strong that technically and ec onomic ally feasible alternatives for non-polymeric PFAS as polymerisation aids are available for the quantities required in the produc tion of PTFE, FKM and PVDF and that the substitution potential is high under RO2. This is since four major PFAS producers have recently indicated t o substitute to non-PFAS polymerisation aids. The evidenc e is suffic iently strong that technically and ec onomic ally feasible alternatives for non-polymeric PFAS as polymerisation aids are currently not available for the quantities required in the production all types of fluoropolymers but will become available within 10 years from 2022. The substitution potential is high under RO2. This is since industry indicated that some types of fluoropolymers still require the use of fluorinated polymerisation aids while at the same time there is a trend towards developing non-fluorinated polymerisation aids with key industrial players expect that this transition within 10 years. The assessment of benefits in relation to PFAS manufacturing for a full restriction with a transition period of 18 months is based on expert judgement, evidence from Annex A on manufacture, import and export, market growth projections. The assessment of costs in relation to PFAS manufacturing for a full restriction with a transition period of 18 months is based on expert judgement, evidence from Annex A on manufac ture, import and export, market growth projec tions and: Literature and public databases, e.g. production volumes; direct employment and sales prices of HF and Chloroform Principles relating to social costs of unemployment; The CfE, e.g direct employment, sales prices of fluorinated gases and fluoropolymers and profit margins; For PFAS manufacturing the Dossier Submitters assessed (i) producer surplus losses resulting from company closures, as well as producer surplus losses in the supply chain and (ii) employment losses. Producer surplus losses for PFAS manufacturing are determined based on an assessment of (i) the most likely reaction of affected companies, (ii) the production volumes of the different PFAS groups, (iii) the average market prices and profit margins of the different PFAS groups and (iv) the projected production growth rates for the different PFAS groups. Producer surplus losses in the raw material supply chain are determined based on an assessment of (i) the production volumes of raw material used for PFAS manufacturing, (ii) the average market prices and profit margins of the raw materials and (iii) the projected produc tion growth rates for the raw materials. The Dossier Submitters consider that the evidence is sufficiently strong that the socioec onomic c osts to industry in the form of produc er surplus losses from business c losures are high under a full restriction (RO1). This is based on the assessment of alternatives pointing towards a high share of company closures, high producer surplus losses due to high margins, no information on the offset potential and high impacts on the wider supply chain. 12 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider that the evidence is weak that the socio-economic costs to industry in the form of produc er surplus losses from business c losures are reduced under a full restriction with derogations (RO2). The Dossier Submitters consider that the evidence is weak to exactly quantify the socioeconomic costs to industry in RO1 due limited information and subsequent assumptions in production volumes, sales values and profit margins of the different PFAS groups. In addition, there is no information on the offset potential. The quantified socio-economic costs are an indication of the order of magnitude. The Dossier Submitters consider that no suitable evidence is available to quantify a difference in the socio-economic costs to industry between RO1 and RO2 due lack of information on production volumes and profit margins for PFAS produced under RO2. Employment losses for PFAS manufacturing and in the wider supply chain are determined based on an assessment of (i) number of direct jobs involved, (ii) the average gross wage and (iii) the ratio between the annual gross wage and the social cost of losing a job. The Dossier Submitters c onsider based on the assessment of alternatives pointing towards a high share of business closures that the evidence is sufficiently strong that the socio-economic c osts to society in the form of employment losses are high under a full restric tion (RO1). The Dossier Submitters consider that the evidence is weak that the socio-economic costs to society in the form of employment losses are reduced under a full restriction with derogations (RO2). The Dossier Submitters consider that the evidence is weak to exactly quantify the socioeconomic costs to society in RO1 due limited information and subsequent assumptions in direct job losses. The quantified socio-economic costs are an indication of the order of magnitude. The Dossier Submitters consider that no suitable evidence is available to quantify a difference in the socio-economic costs to society between RO1 and RO2 due lack of information on production volumes under RO2 and associated jobs losses. 13 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.2. TULAC (Textiles, Upholstery, Leather, Apparel and Carpets) E.2.2.1. Baseline The assessment of the time path of PFAS use (tonnage) and emissions under the baseline sc enario c onsiders expected growth rates for different PFAS groups as shown in Table E.8. Table E.8. Assumptions for projecting tonnage volumes and emissions . PFAS groups Assumption (2020 - 2070) Non-polymeric C2 - C3 substances Under the baseline scenario, it is assumed that usage in all sectors grows at the standard steady 2% rate year on year. The physical properties and water/oil repellence of ultrashort-chain substances is likely to differ from longer (C 5) chains based on industry responses, with a loss in oil repellence in particular. Therefore, it is assumed that the growth rates for C 5 and above will be different to C 2-C 3 on the basis that the specific application is different, i.e., C 2-C 3 is unlikely to act as a true substitute for C 5/C 6 chemistries. Non-polymeric C4 substances Under the baseline scenario, it is assumed that use in technical textiles continues to grow at 2% annually in lieu of any market data. Based on the C fE, it is assumed that use in home textiles and consumer apparel remains broadly static. The stakeholder 4 interviews suggest that there may be more demand in home textiles than consumer apparel, which has now moved strongly towards fluoropolymers. Therefore, a 1% increase annually for home textiles and a 1% decline annually for consumer apparel, applied year on year from 2021 - 2050, is assumed. Non-polymeric C5 substances It is assumed that these substances follow the same trend as C 4 chemistry. Non-polymeric C6 substances The C fE suggested that there was a strong market preference for C 6 as the natural replacement for C 8 due to its water and oil repellence capabilities. Where there are ongoing REAC H restrictions on longer chain PFASs (C 9 - C 14), it could be expected that C 6 would remain dominant. A steady 2% annual growth year on year from 2021 - 2050 is assumed for the baseline scenario. Non-polymeric C9-C14 substances In August 2021, a group restriction was included as Entry #68 in Annex XVII, REAC H on perfluorinated carboxyl acids (C 9-C 14 PFC As; see Regulation (EU) 2021/1297) and those substances that may degrade to them. This means that they are restricted from 25 February 2023 and from 4 July 2023 for the use in certain textiles. Other non-polymeric substances The "Other non-polymeric PFAS" category primarily includes longer chain PFASs C 14, aromatic compounds and salts of reactions. This includes the use of some PFAS groups as process aids for the manufacture of non-fluorine-based textile polymers. In lieu of any additional supporting information, it is assumed that 4 TEGEVA, AGC , Daikin. 14 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PFAS groups Assumption (2020 - 2070) there is a steady growth of 2% annually across all applications. Fluoropolymers (all substances) The fluoropolymer market is expected to grow very strongly in the short to medium term, but it is unclear how sustainable that is in the longer term. Therefore, for home textiles, consumer apparel, professional apparel and technical textiles 8% growth annually between 2020 and 2025 is assumed (based on market reports), thereafter it falls to 5% growth annually between 2026 and 2030. For medical textiles and other textiles 5% growth annually between 2020 and 2030 is assumed, where these applications may cover more niche markets. It is assumed that strong growth is unsustainable in the longer term with use across all sectors falling to a steady 2% continued growth between 2030 and 2040, and then 1% growth from 2040 to 2050, assuming market saturation may be reached at a future point. Side-chain fluorinated polymers Due to the growing awareness and concerns around side -chain fluorinated polymers as a source of non-polymeric PFAS emissions, it is assumed that growth becomes static in the consumer apparel market. For professional apparel and other textiles a steady growth of 2% annually is assumed. Emission estimates are derived from use (tonnage) data by developing a basic source-flow model in order to make use of the data from the market analysis and substance identification. One key caveat of this approach is that on a more general level a very large number of PFAS substances have been identified as being in use or potentially in use (around 120 unique substances). Additionally, many of these unique substances appear in mixtures as combinations of substances, and furthermore in some mixtures it may be the case that spec ific substances are present as an impurity, rather than an intentional use (note that the data from stakeholders under the CfE does not always make clear what are impurities and what are intentional uses). The quality of market data also varies significantly from substance to substance. Therefore, the approach taken has not tried to develop estimates on a substance-by-substance basis but adopted a grouping approach (see Annex B.9.2.1 for further details). Where availability of data varies significantly on a substance-by-substance basis a key benefit of using grouping approac hes is that impac ts of varying spec ific data are lessened. Still, it means the estimates provided will have a higher uncertainty attached to them overall. However, this approach c an still provide useful data to estimate the orders of magnitude for emissions when comparing PFAS groups and different sectors. For ease of presentation the PFAS groups were further aggregated into three main categories, i.e. shortchain non-polymeric PFAS, long-chain non-polymeric PFAS, and fluoropolymers, respectively. Emission estimates presented in this section cover emissions during the use and production phase. The TULAC use phase covers a very wide set of applications with the specific emissions varying on an application-by-application basis. Broadly the current approach identified the following major application types: Home textiles Consumer apparel Professional apparel (including PPE) Technical textiles 15 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Leather Other textile/textile-related applications. To align continuity with an earlier study conducted by the European Commission in 2020 (Wood, 2020b), a holistic approach to how emissions may occur across all these application types, based on setting (indoor/outdoor use) and frequency of cleaning (including laundry)/wetting, was used. Furthermore, the ECHA R.16 Environmental exposure assessment guidance (ECHA, 2016), including Environmental Release Category (ERC) default emission fac tors to guide estimates, was used to derive emission estimates (see Annex B for further details). The start year of the projection of tonnage and emission estimates is 2020 as presented in Table E.9 and Table E.10. Based on the assumptions set out in Table E.8 above, PFAS use and emissions in the TULAC sector are expected to grow under the baseline scenario. Moreover, by 2050 PFAS use and emissions will have broadly doubled. It should be noted that this is largely driven by continued demand for fluoropolymers in the TULAC sector. 16 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.9. Projected yearly PFAS use in the TULAC sector of the EEA between 2020 and 2070 in tonnes (mean values based on market data). PFAS substance group 2020 2025 2030 2035 2040 2045 2050 2060 2070 Non-poly C 2-C 3 substances 6 225 6 873 7 588 8 378 9 250 9 722 Non-poly C 4 substances1 All polymeric2 14 268 71 723 15 773 100 595 17 414 128 382 19 227 141 750 21 228 72.207 22 311 156 504 Overall total use 92 216 123 241 153 597 169 355 102 685 188 537 1 Includes also PFAA precursors. 2 Includes also perfluoroalkyl ethers (PFPEs). 3 Total values can differ from the sum of estimates for PFAS group categories due to averaging of growth rates. Source: Own calculations based on data collated by the Dossier Submitters. 10 218 23 449 172 877 206 544 11 287 25 902 190 964 228 153 12 468 28 612 210 943 252 023 Table E.10. Projected yearly PFAS emissions in the TULAC sector of the EEA between 2020 and 2070 in tonnes (mean values based on market data). PFAS substance group 2020 2025 2030 2035 2040 2045 2050 2060 2070 Non-poly C 2-C 3 substances 1 471 1 624 1 793 1 980 2 186 2 298 Non-poly C 4 substances1 4 666 5 152 5 688 6 280 6 934 7 287 All polymeric2 16 643 23 342 29 791 32 892 36 315 38 167 Overall total use 22 780 30 118 37 272 41 152 41 358 47 752 1 Includes also PFAA precursors. 2 Includes also perfluoroalkyl ethers (PFPEs). 3 Total values can differ from the sum of estimates for PFAS group categories due to averaging of growth rates. Source: Own calculations based on data collated by the Dossier Submitters. 2 415 7 659 40 114 50 188 2 668 8460 44 311 55 439 2 947 9 345 48 974 61 266 17 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). It is important to note that the assessment does not account for use volumes and emissions relating to textiles use d for noise and vibration insulation in automotives as this use only became known during the 2nd stakeholder consultation and no volume data is available to the Dossier Submitters. Figure E.1 shows expected PFAS use and emissions (all PFASgroups) for the TULAC sector as a whole, based on available market data and assumptions on growth rates shown in Table E.8. Growth rates adopted for PFAS use were also applied to emission projections. Figure E.1. Expected PFAS use and emissions in EEA under the baseline in the TULAC sector (mean values) [tonnes] ; Source: Own assessment based on TULAC market data collated by the Dossier Submitters. E.2.2.2. Alternatives E.2.2.2.1. Technical feasibility The existence of technically feasible non-PFAS alternatives is one key fac tor determining the impact of the proposed restriction of PFASs on society as it determines the options available to companies to achieve compliance. Where technically feasible alternatives exist, substitution is a possible option for affected companies. Whether substitution is chosen as the preferred reaction to the proposed restriction depends - amongst other factors - on whether individual c ompanies c onsider it ec onomic ally viable for them to substitute. Where technically feasible alternatives do not exist, company closures will occur as a result of the proposed restriction. Given the importance of the most likely behavioural reaction of companies to unders tand the costs associated with the restriction proposal, the extent to which technically feasible alternatives are available for different sub-uses is desc ribed below. TULAC-specific inputs to the CfE did not include information on specific alternative substances, the technical performance of possible alternatives or their availability. One respondent, however, reported possible alternative substance groups with an ability to provide water repellence, namely: Paraffin-based formulations; Polysiloxanes; Modified melamine resins; Polyurethanes; and Dendrimers. 18 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Given the limited extent of information received during the CfE, desktop research5 was conducted as part of the dossier preparation to identify possible alternative substances. While no PFAS-free alternative provides a universal solution, alternatives could be identified for some of the sub-uses. An overview of the extent to which alternatives have been identified for different applications of PFASs based on this research is provided in Table E.11 below. Identified alternative substances can generally be grouped in the following (substance) groups: Hydrocarbons - including, for example, paraffin-based and melamine-based alternatives and waxes; Silicones; Polyurethane; Dendrimers; and Nanomaterials (EPA-DK, 2015)6. Alternative technologies relying on spinning and weaving of the textile have also been identified as a chemical-free option for providing water repellence. Such techniques are based on control of the surface roughness and weaving density. One available technology, for example, provides water repellence as a result of fibre swelling when in c ontact with moisture. The size inc rease of fibres closes the weave and thereby prevents penetration of the fabric by water, while allowing body vapour to escape. Table E.11. Overview of extent to which alternatives have been identifi ed for different TULAC sub-uses (based on desktop research). Sub-use TULAC Home textiles Consumer apparel Professional apparel Technical textiles General, i.e. relevant for multiple subcategories C arpets and rugs C urtains and blinds Textile based coverings (e.g. fabrics for soft-furnishings, tablecloths, bedding) Outdoor wear Indoor wear Sportswear Footwear Accessories Professional sportswear and footwear PPE for industrial and professional use (other than sportswear) Outdoor technical textiles Medical applications High performance membranes Number of identified alternative substances by chemical name and/or CAS number 49 4 No use-specific substances identified 5 5 No use-specific substances identified No use-specific substances identified No use-specific substances identified No use-specific substances identified No use-specific substances identified No use-specific substances identified No use-specific substances identified No use-specific substances identified No use-specific substances identified 5 This desktop research covered (i) safety data sheets (SDSs), (ii) other information sources of known producers/associations, (iii) scientific peer-reviewed literature identified through PubMed and Google Scholar, (iv) publications of national and regional environmental agencies, (v) publications of non governmental organisations, (vi) documents prepared in relation to REAC H, i.e. Risk Management Option Analyses (RMOAs), Annex XV restriction reports as well as RAC and SEAC documents relating to a sub-set of PFASs; and (vii) documents prepared in relation to the Stockholm C onvention, e.g. risk management evaluations and `Analysis of Alternatives' (AoA) reports. 6 According to EPA-DK (2015), substances with repellent properties containing nanomaterials are used as textile coatings for providing required properties while avoiding a significant increase in weight, thickness or stiffness. Functionalities like water repellence and stain resistance are achieved by embedding fabrics with tiny fibres (nano-whiskers) that form an air cushion around the fibre. 19 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Leather Other e.g. indoor and outdoor wear, footwear, professional sportswear and footwear Home fabric treatments (sprays) Automotive use - Noise and vibration insulation7 Number of identified alternative substances by chemical name and/or CAS number 3 1 This use has been identified as part of the 2nd stakeholder consultation. No information on alternatives was therefore collected as part of the desktop research. The outcome of the research (summarised in Table E.11) suggests that alternatives for TULAC uses are available but that the existence of alternatives might be better in relation to uses in (or in relation to) home textiles and consumer apparel, including leather-based products. Issues in relation to the existence of technically feasible alternatives might exist in relation to professional apparel and technical textiles. While no use-specific alternatives were ident ified for these uses, as shown in Table E.11, some of the alternatives identified for TULAC in general (covered in the first row of the table) might however be relevant. This conclusion is generally in line with what has been revealed by the CfE. In fact, none of the 25 stakeholders completing the section on alternatives of the CfE indicated that technically feasible alternatives were available for professional apparel and technical textiles. The same applies to additional stakeholder interviews that were conducted at the time. For many applic ations, responses to the CfE furthermore revealed that the biggest c hallenge with respect to the technical feasibility of alternatives is the replication of the multitude of functionalities simultaneously provided by PFASs. Suitable alternatives seem to be lacking especially in relation to uses for which functions beyond water repellence are required. A review of the broad categories of relevant chemical alternatives, i.e. dendrimer, hybrid (silicone/hydrocarbon), hydrocarbons, nanotechnologies, polyurethane and silicones with respect to functionality suggested that they are inferior to PFASs in relation to oil and dirt repellence. While silicone-, hydrocarbon and polyurethane-based products can according to information provided by one stakeholder in the 2nd stakeholder consultation - in principle - provide some oil repellenc e, this ability is limited to the use on hard surfaces (and not irregular surfac es like textiles). During c onsultations and the literature review, it became apparent that none of the PFAS-free finishing agents currently available on the market meet the same levels of performanc e with respect to repellence against blood, solvents, fuels and liquid c hemic als as those containing PFAS. Table E.12 links the different sub-uses of TULAC to the key groups of alternatives identified during the preparation of the dossier based on information from literature and information obtained during consultation with stakeholders, i.e. both the CfE and 2nd stakeholder consultation as well as stakeholder interviews. 7 Three stakeholders submitting TULAC -specific information to the 2nd stakeholder consultation reported the use of PFASs for insulation purposes in automotives. Non-woven textiles are reported to be used for covering the surface of automobile sound absorption parts use d in engine bays and other soundgenerating components. One stakeholder also mentioned that such insulation serves the purpose of insulating against vibration in addition to noise. Water -and oil-repellence are described as essential functionalities provided by PFASs for this use. 20 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.12. Overview of key groups of alternatives deemed relevant for TULAC and their relevance in relation to the sub-uses of TULAC. Sub-use Home textiles Consumer apparel C arpets and rugs C urtains and blinds Textile based coverings (e.g. fabrics for softfurnishings, tablecloths, bedding) Outdoor wear Indoor wear Sportswear Footwear Accessories Dendrimer X 10 i X 9 iii X 9 iii X 9 ii X 9 ii X 9 ii X 9 ii X 9 iii Hy br id (Silicone/ hy dr o c a r bon)8 X X X Hy dr o carbons9 X X X X X X X X X X X X X Nano- Po ly ur e tha ne technologies Silicones X 11 i X X 10 iii X 10 iii A lte r na tiv e technologies X 10 ii; 12 X 10 ii X 10 ii; 11 X 10 ii; 11 X 10 iii X 11 X 11 X 11 X 11 X 11 X 13 X 12 X 12 Professional apparel Professional sportswear and X 9 ii X 14 X 10 ii; 13 X 13 X 12 8 Information for this alternative is solely based on information from literature and/or the C fE. 9 Information for this alternative is, with the exception of information for leather applications and professional apparel, bas ed on information from literature and/or the C fE. 10 Based on information from literature and/or the C fE, this alternative is reported to be used for (i) carpets, (ii) clothing made of cotton, polyester or blends and (iii) non-clothing textiles made of cotton, polyester or blends. 11 Based on information from literature and/or the C fE, this alternative is reported to be used for (i) carpets, (ii) clothing a nd (iii) non-clothing textiles. 12 Submissions to the 2nd stakeholder consultation reported the use of polyure thane membranes in outdoor textiles, sportswear and footwear. One submission also highlighted that polyurethane -based and silicone-based hydrophobic textile treatments have shown there potential in all relevant consumer apparel applications in recent years. 13 One alternative technology, for example, provides water repellence as a result of fibre swelling in contact with moisture - with the size increase of fibres closing the weave and thereby preventing penetration of the fabric by water. The use of this te chnology is reported to encompass application in jackets, coats, down jackets, ski wear, hats, shoes. 14 A submission to the 2nd stakeholder consultation reported the proven use of polyurethane membranes in most professional sportswear and footwear and PPE for industrial and professional use (other than sportswear) as a replacement for PTFE membranes. This stakeholder also reported that polyurethane based as well as silicone-based and hydrocarbon-based hydrophobic textile treatments have shown there potentia l in some professional apparel applications. 21 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Technical textiles Leather Other Dendrimer footwear PPE for industrial and professional use (other than sportswear) Outdoor technical textiles Medical applications High performance membranes e.g. indoor and outdoor wear, footwear, professional sportswear and footwear Home fabric treatments (sprays) Automotive use - Noise and vibration insulation Hy br id (Silicone/ hy dr o c a r bon)8 Hy dr o carbons9 X 13 X X 17 Nano- Po ly ur e tha ne technologies Silicones X 13 X 13 X 16 X 15 X 15 X 16 X X A lte r na tiv e technologies X 15 15 Information from one manufacturer of PPE suggested that an alternative weave construction could replace existing PFAS -based coatings in some PPE. 16 A submission to the 2nd stakeholder consultation reported the proven use of polyurethane membranes in all three categories of technical textiles. 17 A test and research institute submitting leather-specific information to the 2nd stakeholder consultation reported polyurethane and other polymer coatings as well as paraffins and waxes as possible alternative in relation to leather applications. 22 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) With respect to home textiles, dendrimers, silicone/hydrocarbon blends, hydrocarbons, polyurethane and silic ones have been identified as relevant alternatives based on information from literature, stakeholder interviews and the CfE. In line with the conclusions based on the identification of alternatives in literature sources (presented in Table E.11), alternatives for use in home textiles seem to be generally available and substitution is thought to be a possible option for affected stakeholders. An extensive scientific study, i.e. Glge et al. (2022), comes to the same conclusion for carpets. An assessment of the availability of technically feasible alternatives in relation to curtains and textile based coverings was however not conducted. Based on an extensive literature review covering peer-reviewed journal articles, monographs, reports produced by industry, product descriptions and patents, and consultation with PFAS manufacturers and downstream users, the study c oncluded that substitution of PFASs in c arpets is tec hnically (and economically) feasible. Information on voluntary industry commitments for eliminating PFASs c ompiled by the Natural Resourc es Defense Council in a study supported by the United Nations Environment Programme points in the same direction. While voluntary commitments are reported to be dominated by apparel brands, the home textile sector is reported to be another sector making significant progress with phasing-out PFASs, especially in relation to carpets and rugs. In relation to carpets and rugs, commitments to completely eliminate PFASs from products by 2020 have been made by both manufacturers and retailers active in the sector. Actors having made commitments in relation to upholstery and home textiles more general have also been identified (SAICM, 2021). The conclusion that alternatives for use in home textiles are generally available is further supported by TULAC-specific information gathered during the 2nd stakeholder consultation in response to the question whether the listed alternatives known to the Dossier Submitters are technically feasible in the product/process of the responding stakeholder. Only one answer specific to home textiles was received but this stakeholder indicated that the listed alternatives were deemed technically feasible. With respect to consumer apparel, information from literature, stakeholder interviews and the CfE suggests that dendrimers, silicone/hydrocarbon blends, hydrocarbons, polyurethane and silicones are possible alternatives to PFASs. Alternative technologies have also been identified as relevant. The specific alternative technology described in the paragraph preceding Table E.11 has already been applied in products available on the market, with application areas being reported as (down) jackets, coats, ski wear, hats and shoes. In line with the conclusions reached as a result of the identification of alternatives in literature sources above, alternatives for consumer apparel applications can thus be considered to be generally available. A general trend of phasing out PFASs, in fac t, appears to have developed in relation to this use based on recent restrictions on individual PFASs, especially as a result of inc reasing c onsumer pressure. Non-governmental organisation (NGO) initiatives have also promoted suc h developments. By 2018, Greenpeac e's Detox c ampaign, whic h was launched in 2011, had, for example, resulted in significant substitution among the 80 companies, including fashion, sportswear, luxury, retail and outdoor brands as well suppliers, which had committed to stop using hazardous chemicals in clothing production by 2020. Of these 80 companies, which together account for 15% of global clothing production, 72% of companies had achieved complete elimination of per-and polyfluorinated chemicals from their products, while the remaining companies were making good progress18. Information on voluntary industry commitments for eliminating PFASs by 2020 compiled by the Natural Resources Defense Council in a study supported by the United Nations Environment Programme confirms this with commitments having been made by both high-end and low-end brands. Industry commitments for phasing out PFASs are reported to be dominated by fashion and apparel brands - with the successes of many fashion brands pointing to substantial phase -out opportunities according to the study. While sport and outdoor brands are reported to face 18 https://www.greenpeace.org/international/press-release/17739/greenpeace-report-clothingindustry-shows-progress-in-cutting-hazardous-chemicals/, date of access: 2023-01-11. 23 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) more c hallenges with respect to replic ating required func tionalities, the study stresses that a c onsiderable number of outdoor brands have c ompletely substituted away from PFASs. The study assumes that substitution should be equally feasible for sportswear given that required functionalities in sportswear and outdoor wear may likely be similar but the number of industry commitments are reported to be low in comparison (SAICM, 2021). More recent developments confirm the assumption that substitution is equally feasible for sportswear. Gribkoff19 mentions that two major sportswear c ompanies reported that they have eliminated all PFASs from their products, with one having stopped using PFASs at the end of 2021. Another high- end sportwear brand reports to be phasing out PFASs, while others are reporting more c oncrete substitution plans with one c ompany intending to stop the use of intentionally added PFASs by the end of 2022 and another company reporting to eliminate PFAS finishes by 2023. Substitution is therefore thought to be a possible option for stakeholder affected by the proposed restriction. Further evidence supporting this conclusion was received during the 2nd stakeholder consultation. In response to the question in the 2nd stakeholder consultation whether the listed alternatives known to the Dossier Submitters are technically feasible in the product/process of the responding stakeholder, three of five stakeholders providing information specific to consumer apparel indicated that the alternatives are feasible to their process/product. In addition, TULAC-specific information submitted to the 2nd stakeholder consultation provided additional evidence for the use of polyurethane in consumer apparel. One stakeholder reported that polyurethane (as well as polyester-based) membranes have been used in all relevant c onsumer apparel produc ts for dec ades and are a proven alternative for PTFE membranes in consumer apparel - especially outdoor wear, sportswear and footwear. According to this stakeholder, polyurethane-based alternatives as well as silicone-based and paraffin-based (i.e. hydrocarbon-based) alternatives for the hydrophobic treatment of textiles, i.e. a treatment rendering the textile water repellent, have also demonstrated their potential in all consumer apparel applications in recent years - with substitution from PFAS-based treatments to alternative treatments having started in 2008. Another stakeholder reported that PTFE membranes in outdoor textiles have already been replaced by alternatives, such as polyurethane membranes, by several well-known industrial actors. A large fashion chain furthermore reported that they have completely substituted away from PFASs since 2013 and are satisfied with the performance of alternatives. According to this stakeholder, nonfluorinated water repellents are the standard in their industry. Similarly, another stakeholder supplying water repellent outdoor wear reported that they have been supplying PFAS-free produc ts for many years. For professional apparel applications, information from literature, stakeholder interviews and the CfE suggests that dendrimers and polyurethane might be possible alternative for some professional sportswear and footwear applications due to dendrimers having been reported as alternatives for the use of clothing made of cotton, polyester or blends; and polyurethane having been described as an alternative for clothing textiles in general. In addition, alternative technologies might also be relevant for both professional sportswear and footwear, given that the specific technology described in the paragraph preceding Table E.11 has already been applied in products available on the market, with application areas being reported as (down) jackets, coats, ski wear, hats and shoes. Alternative technologies might also be relevant in relation to certain PPE applications. Information from one manufacturer of PPE suggests that an alternative weave construction could replace existing PFAS-based coatings in some PPE. For other PPE-related applications of PFASs, e.g. face masks, information submitted to the CfE suggests that alternatives might be available in the near future. In c ontrast, other stakeholders note that there are c urrently no suitable technically feasible alternatives for PPE - with one stakeholder, for example, 19 https://www.ehn.org/pfas-clothing-2656587709.html, date of access: 2023-01-11. 24 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) stating that they are focussing on reducing the amount of PFASs used and improving emission prevention given that alternatives are not deemed to be available in the next 10 to 12 years. With respect to footwear, one stakeholder submitting information to the 2nd stakeholder c onsultation notes that water repellence in c ombination with good water vapour permeability is crucial for PPE and that alternatives cannot replicate these functions/properties at a comparable level. A simultaneous reduction of tear strengths is also reported for the use of such alternatives. In line with the conclusions reached as a result of the identification of alternatives in literature sources, some alternatives might thus be available for use in professional apparel, but the availability of technically feasible alternatives seems to be more limited than for home textiles and consumer apparel applications - with alternatives not being suitable for all relevant applications. Further evidence supporting the conclusion that alternatives are not known for all relevant applications is available from TULAC-specific answers to the question whether listed alternatives are technically feasible for the company's product/processes, which was asked in the 2nd stakeholder consultation. One stakeholder provided information specific to professional sportswear and footwear and indicated that the listed alternatives known to the Dossier Submitters are not technically feasible for the product/process of the company. Even stronger evidenc e is available in relation to PPE applic ations. Of 17 stakeholders providing PPE-specific information, only one stakeholder indicated that the mentioned alternatives are technically feasible for its product/process. The share of respondents indicating that alternatives are technically feasible is thus considerably lower than for consumer apparel - confirming the general conclusion that substitution is a less likely option in relation to PPE than for consumer apparel. One stakeholder submitting TULAC-specific information to the 2nd stakeholder consultation furthermore notes that no alternative for the processing aid used for producing a material qualified for the use in PPE Category III20 is available. Information provided in the 2nd stakeholder consultation however also provides additional evidenc e supporting the conclusion that technically feasible alternatives are available for some of the professional apparel applications. The stakeholder that also submitted information on the proven use of polyurethane (as well as polyester-based) membranes in all relevant c onsumer apparel over several dec ades, highlighted that polyurethane (as well as polyesterbased) membranes are also a proven alternative to PTFE membranes in professional apparel - both professional sportswear and footwear as well as PPE. These alternatives are reported to have been used in most professional apparel applications for decades. Polyurethane-based, silicone-based and hydrocarbon-based hydrophobic textile treatments have also shown their potential in some professional apparel applications in recent years according to this stakeholder. According to the stakeholder, a switch to such water repellent treatments can happen instantly in many areas of application, including, for example, PPE for law enforc ement. While there is thus some evidence that technically feasible alternatives are available for at least some PPE applications, it is important to note that alternatives need to be chosen ac c ording to spec ific protection needs and standards that are required in different segments of the professional textile market. For example, in the medical sector, repellence to bodily fluids is nec essary to avoid the transmission of diseases and in defenc e, firefighting, and the oil and gas industry repellenc e of non-polar stains is also part of the hazard management. With a view of developing a more detailed understanding of the specific types of PPE for which 20 Regulation (EU) 2016/425 distinguishes between three types of PPE, whereby C ategory I covers PPE protecting against minimal risks, more specifically superficial mechanical injury, contact with cleaning materials of weak action or prolonged contact with water, contact with hot surfaces not exceeding 50 C, damage to the eyes due to exposure to sunlight, and atmospheric conditions that are not of an extreme nature (EC , 2016a). C ategory III covers PPE protecting against risks that may cause very serious consequences such as death or irreversible damage to health. Examples are PPE protecting users against substances and mixtures which are hazardous to health, harmful biological agents and bullet w ounds or knife stabs. C ategory II covers PPE protecting users against risks not listed under C ategory I and III. 25 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) technically feasible alternatives are not deemed to be available, a further examination on professional textiles linked to PPE as specified in Regulation (EU) 2016/425 was undertaken by the Dossier Submitters. This examination aimed to determine whether their functionality and performanc e warrants the c ontinued use of PFASs or whether alternatives are available. The results of this examinat ion are set out in Table E.13. PPE requires CE marking, by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in European Union (EU) legislation (EC, 2016a). This means that a set of European (EN) standards must be met for PPE that is placed on the EU market. Table E.13 contains a summary of critical properties and test standards relevant to PPE in which PFASs are commonly used. It also notes the PPE regulation risk category that the c ritic al properties relate to and whether PFASs are required to fulfil this property or not. As indic ated in Table E.13, the Dossier Submitters c onclude that there are some Category III PPE applic ations, i.e.: Protection against (liquid and gaseous) chemicals, including aerosols and solid partic les, and mic roorganisms; PPE applications for firefighting; and Use, c are, and maintenanc e of some Category III PPE workwear (e.g. reimpregnation done by laundries); Where PFASs are likely to be required to comply with the legal requirements according to Annex I of the PPE regulation (EU 2016/425). It is furthermore c onc luded that PFASs are not necessary to meet the technical requirements of Category I and II in Annex I of the PPE regulation, as technically feasible non-PFAS alternatives are available. With respect to PPE specifically designed for use by the armed forces or in the maintenance of law and ord er, to which the PPE regulation does not apply, the Dossier Submitters conclude that PFASs are likely to be required. These conclusions are mirrored by information submitted during the 2nd stakeholder consultation. In line with the above conclusion that PFASs are required for protection against liquid chemicals, one stakeholder submitting TULAC-specific information to the 2nd stakeholder consultation, for example, notes that they are not aware of any alternatives to PFASs than can provide the required performance level for chemical repellence and penetration for washable EN13034 Type 6 fabrics. Similarly, an industry stakeholder submitting information for PPE in relation to firefighting to the 2nd stakeholder consultation also stresses that PFASs are required for firefighting ac tivities. In line with the Dossier Submitters' c onc lusion, the stakeholder reports that there is no alternative product or process known that provides the full spectrum of required protection in relation to firefighting. With respect to PPE for military activities, information submitted to the 2nd stakeholder consultation by two national defence ministries is also in line with the conclusion reached by the Dossier Submitters that PFASs are required for PPE for military activities. Both ministries report protection against chemic al, biologic al, radiological and nuclear (CBRN) agents and fire as the key protections provided by relevant PPE. The reduction of fire risks is also reported as crucial with respect to other textiles used in the military context, e.g. textiles in military vehicles. PFASs are reported as crucial for providing these functions. According to both ministries, water and oil repellence are reported as the key functionalities to be provided by alternatives to PFASs with a view of enabling protec tion against fire and c hemic al, biological, radiological and nuclear (CBRN) agents. While silicon waxes, dendrimers, nanomaterials as well as long-chain polymers were investigated as alternatives to PFASs, none of them are able to fulfill the minimum requirements according to one of the national ministries. In relation to CBRN protection, the second ministry submitting information to the 2nd stakeholder consultation highlights that the main technical challenge with reaching minimum rating levels for oil repellenc e (in ac cordance with standard EN ISO 14419) and water repellence (defined in accordance with the Bundesmann method, i.e. EN 39865) is reaching such levels 26 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) simultaneously. Compliance with oil repellence ratings is described as the major challenge in this respect. In addition, one of the ministries highlights that PFASs are used to provide waterrepellent functionalities in a variety of clothing, e.g. different kinds of combat clothing in temperate areas, navy uniforms and flight jac kets. With respect to water repellenc e, several alternatives exist according to this ministry but all of them provide a lower level of water repellence than PFASs. Based on information available to the Dossier Submitters, technically feasible alternatives thus seem to be available to replace a potentially significant share of PFASs currently used in PPE. During stakeholder consultations following the 2nd stakeholder consultation, three companies in the PPE sector indicated that around 20% of PFASs used in PPE they put on the European Economic Area (EEA) market is used in relation to PPE protecting against Category III risks, i.e. the category for which PFASs continue to be necessary. The remaining 80% were used in PPE protecting against Category I or II risks. It is however important to note that the three aforementioned companies only account for a limited share of the market, with their total annual use volume of PFASs being approximately three tonnes. It is therefore uncertain whether the aforementioned information is representative for the entire market . There is thus a potential for replac ing PFASs in PPE, also due to indic ations from c onsultations that there may be an overuse of PFASs, with PPE with a higher level of protection being used than required. Overuse of PFASs could, for example, result from PPE customers' wish to equip their entire workforce at the facility with uniform clothing - with the tasks that require the highest level of protection setting the standard for the PPE used by all w orkers. 27 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.13. Summary of performance and test standards for PPE compiled based on stakeholders' answers and publicly available sources regarding the potential need for PFASs to get the required property. Critical properties (performance) Electrostatics Liquid chemicals Protection against chemicals Protection against microorganisms Standards for protective clothing (Mostly from CEN/TC 162) EN 1149 series EN 13034:2005+A1:2009 EN 14605:2005+A1:2009 EN 16523-1:2015+A1:2018 EN ISO 17491-3, -4:2008 EN ISO 17491-4:2008 EN ISO 19918:2017/A1:2021 EN ISO 6530:2005 EN ISO 374-1:2016/A1:2018 EN ISO 17491-3, -4:2008 EN ISO 17491-4:2008 EN ISO 19918:2017/A1:2021 EN ISO 6530:2005 EN ISO 374-1:2016/A1:2018 Risk categories21 Conclusion II III(a) Substances and mixtures which are hazardous to health III(a) Substances and mixtures which are hazardous to health III(c) Harmful biological agents PFASs not required PFASs required PFASs required PFASs required Liquid and gaseous chemicals, including aerosols and solid particles EN 464:1994 product standard has been superseded by: EN 943-1:2015+A1:2019 EN 943-2:2019 III(a) Substances and mixtures which are hazardous to health PFASs required Rationale for conclusion Electrostatic properties are not reached by PFASs but with antistatic fibres. Repelling liquids with low surface tension cannot be done with non-PFASs. Repelling liquids with low surface tension cannot be done with non-PFASs. So-called barrier fabric to reinforce the knitted polyethylene terephthalate (PET) in the critical zones is common, whereby 70% of the barrier fabric is based on expanded polytetrafluorethylene (ePTFE) and the remaining 30% is based on breathable polyurethane barrier membranes (Karim et al., 2020). Repelling liquids with low surface tension cannot be done with non-PFASs. For gaseous chemicals and aerosols, ePTFE membranes are required for protection (Feng et al., 2018). There may be some applications concerning solid particles where ePTFE membranes are not required (Oltmanns et al., 2016). 21 Risk categories according to Regulation (EU) 2016/425 (PPE), Annex I. 28 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Critical properties (performance) Against rain Standards for protective clothing (Mostly from CEN/TC 162) EN 343:2019 Splashes of molten metal23 EN 348:1992 For firefighting a c tiv itie s EN 469:2020 High visibility EN ISO 20471:2013 Risk categories21 Conclusion Rationale for conclusion I(e) atmospheric conditions that are not of an extreme nature PFASs will not necessarily be needed to fulfil EN 343. PFASfree options can provide satisfactory protection against water. III(e) High-temperature environments the effects of which are comparable to those of an air temperature of at least 100 C III Subcategories (a) - (m) PFASs not required PFASs required II PFASs not required PFAS-free durable water repellent (DWR) provides good protection and PFASs will not necessarily be needed to fulfil EN 343, if only water repellence is needed to fulfil the C E-certification. There is however a risk of not fulfilling highest C lass 422 without PFASs if the oil and fuel pretreatment cannot be made optional in the certification, but that must be tested and evaluated. Likely ePTFE membranes may be used in combination with some sort of water repellent treatment that may be non-PFAS. The protection of flammability and heat radiation is reached by using flame inherent fibres (such as aramid fibres) to prevent flammability and heat reflective fabrics to prevent heat radiation. Required properties: Heat and flame High visibility Protection against chemicals including aerosols, solid particles, and microorganisms Others depending on the emergency situation PFAS will not automatically be needed to achieve high visibility. Washing garments regularly to avoid getting the high visibility material permanently dirty is an alternative option. 22 Water penetration with 4 levels, where C lass 4 is the most stringent requirement. 23 See also "Heat and flame". 29 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Critical properties (performance) Heat and flame Use, care, and maintenance (e.g reimpregnation done by laundries) Cuts against handheld chainsaws (National) ballistics standards/riot suits24 Standards for protective clothing (Mostly from CEN/TC 162) EN ISO 11612:2015 C EN/TR 14560:2018 (guidance PPE heat and flame) C EN/TR 15419:2017 (guidance PPE chemical protection) C EN/TR 17330:2019 (guidance PPE heat and cold) EN 24920 (spray test) AATC C 118 (oil repellence grade) EN 20811(waterproofness) DIN 32763 (chemical resistance) EN ISO 6530:2005 (penetration of chemicals mainly with low volatility) EN ISO 11393 series National standards such as BS7971-10 & protection against Molotov cocktails25 and other accidental risks. Risk categories21 Conclusion III(e) High-temperature environments the effects of which are comparable to those of an air temperature of at least 100 C III(a) substances and mixtures which are hazardous to health PFASs not required PFASs required III(c) harmful biological agents III(l) bullet wounds or knife stabs III(l) bullet wounds or knife stabs PFASs not required PFASs not required Rationale for conclusion Since PFASs are oil repellent there is additional protection with added PFAS, since oil and dirt can act as risk factors regarding flammability. However, to achieve the required protection against flammability, PFASs are not necessarily needed. The protection of flammability is reached by using inherent fibres which provide the protection. See: "Liquid and gaseous chemicals, including aerosols and solid particles"; and "Protection against microorganisms" C onventional fabric is not cut-resistant against a running chainsaw. Therefore, certain cut-resistant fabrics need to be used. If the bullet proof Kevlar (aramid) garment gets wet, it does not work. This means that an effective durable water repellent (DWR) treatment with non-PFAS should be sufficient. 24 Regulation (EU) 2016/425 (PPE) does not apply to PPE specifically designed for use by the armed forces or in the maintenance of law and order. 25 See" Heat and flame". 30 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) With respect to technical textiles, information from literature, stakeholder interviews and the CfE suggests that technically feasible alternatives are generally not available - with stakeholder input suggesting that longer transition periods of up to 10 years are required for tec hnical textiles. One stakeholder, for example, noted in the CfE that there are c urrently no alternatives available for use in medic al textiles. This is line with the c onc lusions reac hed as a result of the identification of alternatives in literature sources above, whic h suggests issues in relation to the existence of technically feasible alternatives for technical textiles. Responses to the 2nd stakeholder consultation question of whether the listed alternatives known to the Dossier Submitters are technically feasible in the product/process of the responding stakeholder provide additional evidence in support of this conclusion. Of eight stakeholders providing information specific to technical textiles, only one stakeholder indicates that the alternatives known to the Dossier Submitters are technically feasible for their specific application. In relation to PFAS applications in medic al textiles, one stakeholder submitting information to the 2nd stakeholder consultation notes that there are currently no technically feasible alternatives to PFASs for medic al gowns. While small quantities of PFASs allow for the delivery of the desired performance, while exhibiting additional required properties, such as chemical inertness and biocompatibility, that ensure the safe and effective use of the products, alternatives with the desired properties could not be ident ified yet. Similarly, one stakeholder providing information in relation oil- and water-repellent PFASbased finishes in industrial filter applications such as coalescing filters highlights that no alternative is known that is able to provide both water and oil repellence. With respect to PTFE-based membranes for filtration of very fine particles with high chemical and temperature resistance, the same stakeholder notes that the chemical and temperature resistance of potential alternatives is insuffic ient. A produc er of filtration products for applic ation in a wide variety of industries furthermore notes that PTFE's unique performanc e properties c annot be matched by any known non-PFAS alternative. The stakeholder is aware that some suppliers produce alternatives to PTFE membrane or PFAS-coated products but these suppliers use PFASs for processing fibres in a media slurry as part of the filter media process. Such alternatives are therefore no viable alternative in relation to the proposed restriction. While suc h filter media c an also be produc ed without the use of PFASs, these alternatives still need to be trialled, tested and validated by downstream users - with doubts being expressed that these alternatives would work in all applic ations. In addition, one stakeholder submitting TULAC-specific information to the 2nd stakeholder c onsultation provided information on the tec hnical feasibility of alternatives for two different applications of PFASs in technical textiles for outdoor use. The use of fluoropolymers, specifically PVDF, as a top coat finish on polyvinylchloride-coated (PVC-coated) fabrics used for outdoor upholstery, marine applic ations and tents is reported to inc rease the durability of PVC-coated fabrics from three years to 10-15 years. This topcoat also provides resistance against ultraviolet (UV) radiation and protection against soiling. According to the stakeholder, no alternative is available that is as efficient as fluoropolymers for protecting coated fabrics in a durable manner. In addition to fluoropolymers, non-polymeric PFASs are used in the underlying solid coating layer consisting of PVC or acrylic for water repellence and oil repellence purposes or as yarn treatment. Such yarn treatments prevent the penetration of water along the yarn - thereby increasing its durability. According to the stakeholder, nonpolymeric PFASs are the only option for jointly providing water and oil repellence. While researc h on alternatives for non-polymeric PFASs is ongoing, no suitable alternative has been identified for the moment due to constraints linked to the fabrication process, material compatibility issues and concerns on the performance in the final application with respect to fire and UV resistance. Alternatives known to the Dossier Submitters are described as potentially being suitable for providing water repellence. Other information submitted to the 2nd stakeholder consultation, however, contradicts the conclusion that alternatives are not available for most technical textile applications to some 31 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) extent. The same stakeholder that provided information on the proven use of polyurethane (as well as polyester-based) membranes for consumer and professional apparel mentioned that such membranes are also a proven alternative for PTFE membranes used in outdoor tec hnical textiles, medic al applic ations and high-performance membranes. As a result, the Dossier Submitters recognize that alternatives seem to be less generally available for technical textiles than for consumer applications for instance, but also notices that substitution might be a possible option for stakeholders in relation to - at least - some technical textile applications. With respect to leather, information from literature, stakeholder interviews and the CfE suggests that silic one/hydrocarbon blends and silic one are possible alternatives to PFASs and that technically feasible alternatives are available. This is in line with conclusions reached based on the identification of alternatives in literature sources (presented in Table E.11) which revealed some use-specific alternative substances. Further evidence supporting the conclusion that suitable alternatives exist is available from the 2nd stakeholder consultation. In relation to leather applications in automotives, one stakeholder reported that they have been able to identify an alternative whose oil and soil repellence properties are close enough to PFAS-based products and that they have as a result started to substitute away from PFASs. In addition, two other stakeholders reported that they are not using PFASs in relation to automotive upholstery and other textile uses in passenger compartments. Whether this refers to textile or leather coverings is however unclear. Contrasting information is however provided by other stakeholders. One stakeholder reported that a transition to alternatives is not possible within three years and that they would not be able to offer light coloured interiors to customers when PFASs are banned but it is again unclear whether this refers to text ile or leather coverings. Another stakeholder providing information for automotive interiors also expresses concerns in relation to the feasibility of alternatives given that alternatives only offer water repellence, instead of a combination of water repellence, oil repellence and protection against soiling. A third stakeholder highlights that the use of PFASs is important for creating durable interior surfaces in automotives as PFASs provide a wear-resistant protective shell guarding the surfaces against c ommon types of abrasion, e.g. scratching, marring and rubbing. According to this stakeholder, no alternatives showing an acceptable performance level could be identified despite extensive researc h. Apart from the leather-specific submission relating to leather applications in automotives, only one other industry stakeholder provided leather-specific information to the 2nd stakeholder consultation. Submitted information relates to leather-based gloves for professional and sport applications. In contrast to the information provided for leather in automotives, this stakeholder reported that listed alternatives known to the Dossier Submitters are not technically feasible in their product/process. Particular concerns are related to the lower level of water repellence of alternatives leading to a requirement to change gloves more often during the day. In addition to the information provided by industry stakeholders, a test and research institute reported polyurethane and other polymer c oatings as well as paraffins and waxes as possible alternative in relation to leather applic ations. In conclusion, some alternatives for leather applications seem to be available. With respect to home fabric treatments (sprays), one silicone-based alternative was identified as use-specific alternative based on the identification of alternatives in literature as shown in Table E.11. Some of the general alternatives identified in relation to TULAC might however also be relevant. The use of non-wovens used for insulation purposes in automotives has been identified as part of the 2nd stakeholder consultation. No conclusion on the availability 32 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) of technically feasible alternatives has therefore been reached based on literature, stakeholder interviews and the CfE. The use was mentioned by three stakeholders submitting TULAC-specific information to the 2nd stakeholder consultation. Non-woven textiles treated with PFAS are reported to be used for covering the surface of automobile sound absorption parts used in engine bays and other sound-generating components for noise insulation purposes. One stakeholder also mentioned that such insulation serves the purpose of insulating against vibration in addition to noise. Water- and oil-repellence are described as essential functionalities provided by PFASs for this use as they help with maintaining performanc e levels of relevant parts. Stain-resistance and protection against soiling are also reported as a relevant functionalities provided by PFASs. According to information provided by one stakeholder, the use of PFASs is essential for achieving complianc e with United Nations Regulation No 51 (UNR-51) and (EU) No 540/2014 noise regulations. Based on information from upstream actors in this stakeholder's supply chain, alternative substances or technologies are not available at this moment. Even if alternative technologies or substances were identified in due course, significant time would be required for the substitution away from PFASs. This is due to the significant amount of time - a minimum of 10 to 15 years - that is needed to develop and evaluate c omponents and vehicles with a view to meeting type approval requirements. In conclusion, technically feasible alternatives seem to be available for home textile and consumer apparel applications as well as leather applications as shown in Table E.14. With respect to professional apparel and technical textiles, alternatives for at least some applications seem to be available based on the information provided in TULAC-specific submissions to the 2nd stakeholder c onsultation. With respect to PPE, this is c onfirmed by the assessment on the necessity of PFASs for different types of PPE detailed in Table E.13. An alternative was also identified for home fabric treatments. No alternatives are known in relation to the use of non-wovens in automotives for noise and vibration insulation purposes. With a view of illustrating how c onclusions on the existenc e of technical feasible alternatives have changed based on additional information that was provided, the first stage of information collection, i.e. the CfE (which was complemented by stakeholder interviews and a literature review), and the second stage in the form of the 2nd stakeholder consultation are treated separately in Table E.14. Table E.14. Broad assessment of technical feasibility of alternatives for TULAC sub -uses. Sub-use Home textiles Consumer apparel Conclusion based on CfE, stakeholder consultation interviews, consulted literature A lte r na tiv e based products already available on the market Technical feasibility of a lte r na tiv e s Yes Partial - depending on required functionality Alternatives available where only water repellence is required Yes Yes Functions other than Conclusion following 2nd stakeholder consultation A lte r na tiv e based products already available on the market No change to conclusion No change to conclusion: Technical feasibility of a lte r na tiv e s No change to conclusion: One additional stakeholder confirmed the technical feasibility of alternatives No change to conclusion 33 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Professional apparel Technical textiles Conclusion based on CfE, stakeholder consultation interviews, consulted literature A lte r na tiv e based products already available on the market Technical feasibility of a lte r na tiv e s water repellence are not deemed to be critical for this use No No Conclusion following 2nd stakeholder consultation A lte r na tiv e based products already available on the market Several stakeholders report use of alternatives for products already placed on the market Yes Technical feasibility of a lte r na tiv e s Partial Alternatives cannot replicate certain required functionalities, e.g. oil repellence, stain resistance (ability to resist contamination with liquid soils) Some promising alternatives in the Research & Development (R&D) stage are mentioned E.g. polyurethane membranes are reported to be a proven alternative for both professional sportswear and PPE 2nd stakeholder consultation reveals information pointing towards proven use of alternatives, but many stakeholders also report that known alternatives are not feasible for their product PFAS use is identified as being necessary for some C ategory III PPE applications, while alternatives are deemed feasible for C ategory I and II No No Yes Partial Alternatives cannot replicate certain required functionalities, e.g. oil repellence, stain resistance (ability to resist contamination with liquid soils) E.g. polyurethane membranes are reported to be a proven alternative for membranes used in outdoor technical textiles, medical applications and high performance membranes 2nd stakeholder consultation reveals information pointing towards proven use of alternatives, but many stakeholders also report that known alternatives are not feasible for their product 34 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Leather Other: Home fabric treatments (s pr a y s ) Conclusion based on CfE, stakeholder consultation interviews, consulted literature A lte r na tiv e based products already available on the market Technical feasibility of a lte r na tiv e s ? Partial - depending on required functionality, e.g. water, oil, and stain repellence Alternatives available where only water repellence is required ? Partial - depending on required functionality, e.g. water, oil, and stain repellence Conclusion following 2nd stakeholder consultation A lte r na tiv e based products already available on the market ? Technical feasibility of a lte r na tiv e s Yes Stakeholder reports alternative whose oil and soil repellence properties are close enough to PFASbased products No change to conclusion No change to conclusion Alternatives available where only water repellence is required Other: Not assessed Not assessed No No A uto mo tiv e use - Noise and vibration insulation E.2.2.2.2. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT (persistent, bioccumulative and toxic) or vPvB (very persistent and very bioaccumulative) criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHA's dissemination site. The ECHA webpage was last consulted on this data in January 2022. In relation to TULAC, the list of alternatives contained 19 unique CAS numbers. Twelve (12) of the substances with unique CAS were classified according CLP (Classification, Labelling an Packaging of Chemicals; harmonised classification or self-classification). Ten (10) of the substances with unique CAS number did, according to their registration dossier, not fulfil the PBT or vPvB criteria and for the remaining substances, no data was found, meaning that none of these substances were known to fulfil the PBT or vPvB criteria. Two of the substances with unique CAS number may contain residues of D4, D5 and D6, cyclic siloxanes . D4, D5 and D6, and cyclic siloxanes are considered to be PBT/vPvB substances and D4 is considered to be an 35 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) endocrine disruptor. These substances were: alkyl polysiloxane solution and emulsion of polydimethylsiloxane, cationic. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. The list contained an additional 30 substances with unique substance names for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. The following substances in t his selection, may contain residues of D4, D5 and D6, cyclic siloxanes (hazards mentioned above): aminofunctional polysiloxanes, organic silic on compound, polysiloxane and polyester, siloxane dispersion with modified polyamide, solvent-dilutable silic one solution, water-based silic one emulsion. E.2.2.2.3. Availability Information on whether alternatives identified as technically feasible are available to EEA companies in sufficient quantities is very limited. Information on the total volume of alternatives produced and supplied to the EEA is not available from the CfE and the 2nd stakeholder consultation. One interviewed stakeholder however reported that dendrimers are available on a large sc ale in the EEA, while hydroc arbons for use in industrial applic ations are also available and already used. Information on the amount of alternatives required following the entry-into-force of the restriction is also unavailable. As such, the Dossier Submitters cannot conclude on whether substitution will be prevented by supply shortages of relevant alternatives. Information in Wood (2020b), however suggests, that availability of alternatives in sufficient quantities is not the main challenge in relation to substitution. According to manufac turers and industry stakeholders, the main c hallenge would not be meeting industry demand for alternatives already on the market but the development of new alternatives for applic ations for whic h no tec hnically feasible alternatives are known. E.2.2.2.4. Substitution potential As mentioned in section E.2.2.2.1, the existence of technically feasible alternatives determines the options available to affected companies to achieve compliance, e.g. substitution or closure of business (or business unit). Whether substitution takes place depends - amongst other factors such as the availability of alternatives (covered in section E.2.2.2.3) - on whether individual companies consider it economically viable to them to substitute. The substitution potential in relation to TULAC is thus dependent on the technical and ec onomic feasibility of alternatives and their availability in suffic ient quantities. With a view of informing the assessment of the impac ts of the restric tion, whic h are heavily determined by the extent to which companies substitute, this section draws overall conclusions on the substitution potential in relation to different TULAC sub-uses, based on the evidenc e from: Literature, including documents developed by industry (e.g. safety data sheets (SDSs) and other documents of known producers/associations), academia (e.g. scientific peer-reviewed literature), non-governmental organisations as well as public actors (e.g. public ations of national and environmental agenc ies and a variety of doc uments produced for regulatory processes under REACH26 and the Stockholm Convention27); The CfE, supplemented with information from stakeholder interviews; and The 2nd stakeholder consultation, more specifically answers (from a non-representative sample of stakeholders) to the question whether the listed alternatives known to the Dossier Submitters are technically feasible in the product/process of the responding stakeholder. In relation to the sub-use home textiles, all sources of evidence described in section E.2.2.2.1 point to the conclusion that technically feasible alternatives exist, with five of seven 26 RMOAs, Annex XV restriction reports, RAC and SEAC opinions. 27 Risk management evaluations, Analysis of Alternative (AoA) reports. 36 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) alternative substance groups, i.e. dendrimers, hybrid blends, hydrocarbons, polyurethanes and silicones, being identified as relevant. The conclusion of the Dossier Submitters that tec hnically feasible alternatives exist is c onfirmed by an extensive scientific study, i.e. Glge et al. (2022), which assesses the availability of technically (and economically) feasible alternative for c arpets only (and not c urtains and textile based coverings) based on a review of a wide variety of doc uments28, inc luding industry doc uments and peer-reviewed ac ademic literature, and consultation with PFAS manufacturers and downstream users. Another study, i.e. SAICM (2021), corroborates this conclusion through a compilation of real-life cases of substitution based on voluntary industry commitments. Commitments to eliminate PFASs from products by 2020 have been made by both manufacturers and retailers active in the sector according to SAICM (2021). These practical examples point to the economic feasibility of the identified alternatives. Based on the above evidence, the Dossier Submitters c onsider that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives for home textiles. Information on whether the alternatives are available in the quantities required for use in home textiles is very limited. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters c onclude by default that tec hnically and economic ally feasible alternatives exist in sufficient quantities for use in home textiles. As a result, the Dossier Submitters consider that there is sufficiently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months. As a result, no derogation is proposed and further assessed for home textiles. In relation to the sub-use consumer apparel, all sources of evidence described in Section E.2.2.2.1 point to the conclusion that technically feasible alternatives for use in consumer apparel exist. Six of seven alternative substance groups, i.e. dendrimers, hybrid blends of silicones and hydrocarbons, hydrocarbons, polyurethanes, silicones and alternative technologies have been identified as relevant for consumer apparel based on literature, the CfE and stakeholder interviews. Information on real-life cases of substitution as a result of NGO initiatives and voluntary industry commitments corroborates the conclusion that technically and economically feasible alternatives exist. Greenpeace's Detox Campaign (launc hed in 2011), for example, had by 2018 resulted in substitution by fashion, sportswear, luxury, retail and outdoor brands - with 72% of the 80 involved companies having achieved complete elimination of per-and polyfluorinated chemicals from their products and the remaining companies having made good progress29. The compilation of real-life cases of substitution based on voluntary industry commitments to eliminate PFASs by 2020 in SAICM (2021) revealed that commitments have been made by both high-end and low-end brands and include fashion, apparel, outdoor and sport brands (in relation to which the number of industry commitments is however reported to be low in comparison). More recent cases of c ompleted or ongoing substitution intended to be completed in 2022 or 2023 in the sportswear industry are mentioned by Gribkoff30. Submissions to the 2nd stakeholder consultation also point to the established use of alternatives in c onsumer apparel - both in relation to the use of membranes and hydrophobic textile treatments. In response to the question in the 2nd stakeholder c onsultation whether the listed alternatives known to the Dossier Submitters are technically feasible in the product/process of the responding stakeholder, three of five stakeholders providing information specific to consumer apparel indicated that the alternatives are feasible to their process/product. Based on the above evidence, the Dossier Submitters c onsider that there is sufficiently strong 28 The literature review covered peer-reviewed journal articles, monographs, reports produced by industry, product descriptions, patents, and consultation with PFAS manuf acturers and downstream users. 29 https://www.greenpeace.org/international/press-release/17739/greenpeace-report-clothingindustry-shows-progress-in-cutting-hazardous-chemicals/, date of access: 2023-01-11. 30 https://www.ehn.org/pfas-clothing-2656587709.html, date of access: 2023-01-11. 37 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) evidenc e for the existence of technically and ec onomic ally feasible alternatives for c onsumer apparel. Information on whether the alternatives are available in the quantities required for use in c onsumer apparel is very limited. As no evidenc e is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters c onclude by default that technically and ec onomic ally feasible alternatives exist in suffic ient quantities for use in c onsumer apparel. As a result, the Dossier Submitters consider that there is sufficiently strong evidenc e to c onclude that the substitution potential is high under a full ban with a transition period of 18 months. As a result, no derogation is proposed and further assessed for consumer apparel. In relation to the sub-use professional apparel, evidence on alternatives is conflicting to some extent. The desktop research based on the literature sources mentioned above as well as information from the CfE point to the conclusion that technically feasible alternatives might not be available. No use-specific alternatives were identified for (i) professional sportswear & footwear and (ii) PPE as shown in Table E.11. (Some of the general alternatives identified for TULAC could however be relevant for these uses). Similarly, none of the stakeholders responding to the section on alternatives in the CfE (25 stakeholders) indicated that technically feasible alternatives are available. Some of the information from the 2 nd stakeholder consultation also points in this direction. An analysis of answers from a nonrepresentative sample to the question whether listed alternatives are technically feasible for the company's product/processes, for example, corroborates this conclusion. The vast majority of responding stakeholders, i.e. one (of one) stakeholder providing information specific to professional sportswear and footwear and 16 (of 17) stakeholders providing information for PPE, in fact, indicated that the mentioned alternatives are not technically feasible. In relation to professional sportswear and footwear (a sub-category of professional apparel), two of the seven alternative groups, i.e. dendrimer and polyurethane, are however deemed to be applicable given that dendrimers are reported to be used for clothing made of polyester and blends of polyester and cotton and polyurethanes are reported as alternative for clothing in general. An alternative technology providing water repellence is furthermore reported to be applied in ski wear and shoes (amongst other applications), which suggests that it is relevant for professional sportswear and footwear. Information from the 2nd stakeholder consultation corroborates the conclusion that some alternatives are available. One stakeholder reports the proven use of polyurethane membranes in most professional sportswear and footwear as a replacement of PTFE membranes. The same stakeholders reports that polyurethane-based, silicone-based and hydrocarbon-based hydrophobic textile treatments have demonstrated their potential in some professional apparel applic ations. As a result, five of seven alternative groups, i.e. dendrimers, hydrocarbons, polyurethane, silicones and alternative technologies are deemed to be relevant to professional sportswear and footwear. In relation to PPE (a sub-category of professional apparel), information from one stakeholder suggests that an alt ernative weave c onstruction c ould replac e existing c oating in some PPE. Information from the 2nd stakeholder consultation further corroborates the conclusion that alternative are available for some applic ations with one stakeholder reporting the proven use of polyurethane membranes in PPE as a replacement of PTFE membranes. The same stakeholder reports that polyurethane-based, silicone-based and hydrocarbon-based hydrophobic textile treatments have demonstrated their potential in some professional apparel applications. As a result, four of seven alternative groups, i.e. hydrocarbons, polyurethane, silicones and alternative technologies are deemed to be relevant to some extent for PPE. An additional analysis conducted by the Dossier Submitters to further strengthen the evidence base and resolve the problem of conflicting evidence focused on comparing stakeholder information on functionalities provided by PFASs and alternatives with performance 38 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) requirements set under EU legislation to determine whether the required performance can only be achieved using PFASs. For six of 13 categories, PFASs are found to be required - whic h explains the existenc e of c onflic ting evidence for PPE when assessing it as a c ategory as a whole. For professional sportswear and footwear, the Dossier Submitters consider based on the above evidence (and the evidence underlying the assessment of alternatives for other TULAC applications) that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives. The evidence is however considered to be somewhat weaker than for home textiles and consumer apparel due to the existence of some conflicting evidence, e.g. contradicting information from stakeholders providing information to the 2nd stakeholder consultation. Overall, sufficiently strong evidence pointing to the existence of technically and economically feasible alternatives for professional sportswear and footwear, e.g. information from the 2nd stakeholder consultation pointing to the proven use of alternatives, strong evidence for consumer apparel applications (which are deemed to be comparable to some extent) and evidence for PPE for the protection again rain (which is deemed to be a good indicator for the existence of alternatives for professional sportswear and footwear), is however deemed to be available. For PPE, the Dossier Submitters consider based on the above evidence that there is sufficiently strong evidence for the existence of technically feasible alternatives for seven of 13 applications, while alternatives are considered to do not exist for other applications, i.e.: PPE for protection against (i) liquid chemicals, (ii) chemicals, and (iii) liquid and gaseous c hemic als, inc luding aerosols and solid particles (Risk c ategory III(a) relating to substances and mixtures whic h are hazardous to health); PPE for protection against microorganisms (Risk category III(c) relating to harmful biological agents); PPE applic ations for firefighting (Risk c ategory III, subc ategories (a) - (m)); and Use, care and maintenance of some Category III workwear. Based on sufficiently strong evidence from other TULAC sub-sectors, e.g. consumer apparel, listed alternatives are also deemed to be economically feasible for PPE. Both for professional sportswear and footwear as well as PPE, information on whether the alternatives are available in the quantities required is very limited. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters conclude by default that alternatives exist in sufficient quantities for relevant professional apparel applications. As a result, the Dossier Submitters consider that there is suffic iently strong evidence to c onclude that the substitution potential is high for professional sportswear and footwear and seven of 13 PPE applications under a full ban with a transition period of 18 months, while the substitution potential is low for the other PPE applications. As a result, the following derogations are proposed and further assessed: Personal protective equipment (PPE) intended to protect users against risks as specified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) and (c) Personal protective equipment (PPE) in professional firefighting ac tivities intended to protect users against risks as spec ified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) - (m) Impregnation agents for re- impregnating of artic les referred to above In relation to the sub-use technical textiles, evidence on alternatives is c onflic ting to some extent. The desktop research based on the literature sources mentioned above as well as information from the CfE point to the conclusion that technically feasible alternatives might not be available. No use-specific alternatives were identified for (i) outdoor technical textiles, 39 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (ii) medical textile applications and (iii) high performance membranes, as shown in Table E.11. (Some of the general alternatives identified for TULAC could however be relevant for these uses). Similarly, none of the stakeholders responding to the section on alternatives in the CfE (25 stakeholders) indicated that technically feasible alternatives are available. Some of the information from the 2nd stakeholder c onsultation also points in this direction. An analysis of answers from a non-representative sample to the question whether listed alternatives are technically feasible for the c ompany's product/processes shows that the vast majority of responding stakeholders, i.e. seven (of eight) stakeholders providing information for technical textiles indicated that the mentioned alternatives are not technically feasible, with the dominant share of submissions relating to high performance membranes. In relation to outdoor technical textiles, some application-specific stakeholder information submitted to the 2nd stakeholder consultation corroborates this conclusion, with one stakeholder reporting that no alternative is available that is comparable in terms of durable protection to fluoropolymer topcoat finishes on PVC-coated fabrics used for outdoor upholstery, marine applications and tents. Alternatives to non-polymeric PFASs used in the underlying coating layer for water and oil repellence purposes and as yarn treatment s have not been identified despite ongoing research but alternatives listed by the Dossier Submitters are described as potentially suitable for providing water repellence. One of the seven alternative substance groups, i.e. polyurethane, is deemed to be applic able based on another submission to the 2nd stakeholder consultation reporting the proven use of polyurethane membranes as an alternative to PTFE membranes in outdoor technical textiles. While application-specific submissions to both the CfE and the 2nd stakeholder consultation explicitly state that no alternatives are available for use in medical textiles, another submission to the 2nd stakeholder consultation reports the proven use of polyurethane membranes as an alternative to PTFE membranes in relation to this application. As for outdoor technical textiles, polyurethane is thus deemed to be applicable for medical textile applic at ions. With respect to high performance membranes, some individual submissions to the 2nd stakeholder consultation specifically state that alternatives are not available for coalescing filter as well as PTFE-based membranes for the filtration of very fine particles. Another stakeholder reports that some suppliers provide alternatives to PTFE membranes and PFAScoated products, but that these suppliers use PFASs during the production process. While production without PFASs seems possible, such alternatives still need to be trialled and validated. As for outdoor technical textiles, one of the seven alternative substance groups, i.e. polyurethane, is furthermore deemed to be applicable for high performance membranes based on a submission to the 2nd stakeholder consultation reporting the proven use of polyurethane membranes as an alternative to PTFE membranes in relation to this a pplication. For outdoor technical textiles, the Dossier Submitters c onsider based on the above evidence (and the evidence underlying the assessment of alternatives for other TULAC applications) that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives. The evidence is somewhat weaker than for home textiles and consumer apparel due to the existence of some c onflic ting evidence, e.g. information from the CfE and 2nd stakeholder c onsultation pointing to the unavailability of alternatives for technical textiles as a whole as well as a lac k of c omparable alternatives for outdoor technical textiles. Overall, the Dossier Submitters consider, however, that sufficiently strong evidence pointing to the existenc e of technically and economically feasible alternatives for outdoor technical textiles, for whic h water repellenc e is deemed of most importanc e, exists, e.g.: Information from the 2nd stakeholder consultation pointing to the proven use of alternatives for membranes used in outdoor technical textiles, which also highlights their economic feasibility; Stakeholder input from the 2nd stakeholder consultation suggesting that alternatives known to the Dossier Submitters could - with respect to water repellence - be suitable as an alternative for non- polymeric PFASs used in c oating layers; 40 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sufficiently strong evidence for consumer apparel applications (which are deemed to be comparable to some extent); and Evidence for PPE for the protection against rain suggest ing that PFASs will not be required to ac hieve relevant protection standards. With respect to medical textile applications, the Dossier Submitters consider based on the above evidence that the evidence on the technically feasibility of alternatives for relevant applic ations is inc onclusive. No c onc lusion on the substitution potential under a full ban with a transition period of 18 months can thus be drawn. As medical textile applications, by definition exc lude uses within or on the patients suc h as bandage s and refer to artic les such as mattress protectors and curtains around beds, the Dossier Submitters consider that conclusions relating to the substitution potential of home textiles might be relevant to some extent. With respect to high performance membranes, the Dossier Submitters consider based on the above evidence there is sufficiently strong evidence that technically feasible alternatives do not exist for all types of high performance membranes. The evidence is somewhat weaker that for home textiles and consumer apparel due to the existence of some conflicting evidenc e, e.g. information from the 2nd stakeholder c onsultation reporting the proven use of polyurethane membranes as an alternative to PTFE membranes. Information on whether relevant alternatives are available in the quantities required for use in relevant technical textiles is very limited. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters conclude by default that relevant alternatives exist in sufficient quantities for relevant technical textile applications. As a result, the Dossier Submitters consider that there is sufficiently strong evidence to conclude that the substitution potential for outdoor technical textiles is high under a full ban with a transition period of 18 months, while it is low for high performance membranes. The substitution potential for medical textile applications is unclear due to the inc onc lusive evidence base. As a result, the following derogation is proposed and further assessed: Textiles for the use in filtration and separation media used in high performance air and liquid applications in industrial or professional settings that require a combination of water- and oil repellenc e. In relation to the sub-use leather applications, evidence on alternatives is conflicting to some extent. The desktop research based on the literature sources mentioned above identified three use-specific alternatives for leather applications. (Some of the gene ral alternatives identified for TULAC could also be relevant for these uses). Four of seven alternative substance groups, i.e. hybrid blends of silic ones and hydrocarbons, hydrocarbons, polyurethane and silicones, are identified as technically feasible alt ernatives based on information from literature, the CfE and the 2nd stakeholder consultation. Two of them, i.e. hydrocarbons and polyurethanes, were identified solely based on stakeholder input from a test and research institute submitting information to t he 2nd stakeholder consultation. Information from another stakeholder submitting information relating to leather applications in automotives to the 2nd stakeholder consultation corroborates the conclusion that technically feasible alternatives exist. This stakeholder reports to have started to substitute away from PFASs after having identified an alternative whose oil and soil repellenc e properties are c lose enough to PFAS-based products. In relation to automotive upholstery, two further stakeholders report that they are not using PFASs, while three other stakeholders report that alternatives are not technically feasible due to preventing the supply of light -coloured interiors, their inability to provide oil and soil repellence and worse protection against c ommon types of abrasion, such as scratching, marring and rubbing. To what extent these submissions refer to leather (instead of textile) coverings is however unclear. Another stakeholder submitting information in relation to leather-based gloves also reports that the listed alternatives known to the Dossier Submitters are not technically feasible, with particular 41 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) concerns being expressed in relation to the lower level of water repellence leading to a requirement to c hange gloves more often. The Dossier Submitters consider based on the aforementioned evidence for leather applications and the evidence for consumer apparel pointing to the economic feasibility of named alternatives that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives for leather applications. The evidence is, however, considered to be somewhat weaker than for home textiles and consumer apparel due the existenc e of some c onflicting evidence. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters c onclude by default that technically and ec onomic ally feasible alternatives exist in suffic ient quantities for use in leather applications. As a result, the Dossier Submitters consider that there is sufficiently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months. As a result, no derogation is proposed and further assessed for leather applications. In relation to the sub-use home fabric treatments (sprays), the conclusion on the substitution potential is only based on evidenc e from: Literature, including documents developed by industry (e.g. safety data sheets (SDSs) and other documents of known produc ers/associations), academia (e.g. scientific peer-reviewed literature), non-governmental organisations as well as public actors (e.g. public ations of national and environmental agenc ies and a variety of doc uments produced for regulatory processes under REACH31 and the Stockholm Convention32). The desktop research based on the literature sources mentioned above identified one usespecific alternative for home fabric treatments. (Some of the general alternatives identified for TULAC could however also be relevant for these uses). Only silicone-based alternatives are identified as technically feasible alternatives. No information specific to this application was provided during the CfE and 2nd stakeholder consultation. The Dossier Submitters consider based on the above evidence resulting from an extensive literature review taking into account information from a variety of actors , no contradictory evidence from consultation with stakeholders (and evidence relating to home textiles and consumer apparel) that there is sufficiently strong evidence for the existence of technically feasible alternatives for home fabric treatments. No information on the economic feasibility of alternatives for this specific application is available. Based on evidence for home textiles and consumer apparel pointing to the economic feasibility of the named alternative group, the Dossier Submitters however consider that alternatives are also economically feasible. Information on whether the alternatives are available in the quantities required for use in home fabric treatments is very limited. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters c onclude by default that technically and ec onomic ally feasible alternatives exist in suffic ient quantities for use in home fabric treatments. As a result, the Dossier Submitters c onsider that there is sufficiently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months. As a result, no derogation is proposed and further assessed for home fabric treatments. In relation to textiles for the use in automotives, more specifically engine bays , for noise and vibration insulation, the conclusion on the substitution potential is in contrast 31 RMOAs, Annex XV restriction reports, RAC and SEAC opinions. 32 Risk management evaluations, Analysis of Alternative (AoA) reports. 42 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) to other sub-uses only based on evidence from: The 2nd stakeholder c onsultation, during whic h three stakeholders reported the use of PFASs in relation to textiles used in engine bays for insulation purposes. Information on alternatives was only provided by one of these stakeholders. The literature sources mentioned for other sub-uses33 were not part of the assessment of alternatives for this use. As this use was identified as part of the 2nd stakeholder consultation, which took plac e after the desktop research assessing these documents, information on alternatives for this use was not collected from literature. For the same reason, the question in the 2nd stakeholder c onsultation asking whether the listed alternatives known to the Do ssier Submitters are tec hnically feasible in the produc t/process of the responding stakeholder was not of use for this application. Information from one stakeholder submitting information to the 2nd stakeholder consultation suggests that the use of PFASs is essential for achieving compliance with noise regulations. Based on information from upstream actors in this stakeholder's supply chain, alternative substances or technologies are not available at the time of preparing this restriction proposal. The Dossier Submitters c onsider based on the above evidence that the evidence is weak that technically feasible alternatives do not exist for textiles for the use in engine bays and that the substitution potential is low under a full ban with a transition period of 18 months. The evidence is considered to be weak due to only being based on one source type, i.e. the 2nd stakeholder c onsultation, and due to being based on information from one stakeholder only. As a result, the following derogation is marked for rec onsideration after the Annex XV report consultation and further assessed: [Textiles for the use in engine bays for noise and vibration insultation used in the automotive industry] E.2.2.3. Environmental impacts Environmental impacts are assessed in comparison to t he baseline scenario discussed in section E.2.2.1, assuming business-as-usual and, consequently, on-going PFAS use and emissions. The analysis of environmental impacts focuses on two restriction options (ROs): RO1, adopting a ban of all PFAS used in TULAC; RO2, adopting a ban on PFASs in combination with use-specific derogations. Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation. Environmental impacts of RO1 are analysed quantitatively. In contrast, for the use-specific derogations emission data were largely lacking. Still, there is information to which PFAS group emissions will belong. Therefore, environmental impac ts of RO2 are evaluated qualitatively in relation to maximum additional emission sc enarios, i.e. a full derogation of the relevant PFAS groups. Note that these maximum additional emission sc enarios do not represent restriction options but are used for comparative purposes only. Table E.15 below summarizes the c haracteristics of the restriction options, and the maximum additional emission sc enarios. 33 I.e.: Documents developed by industry (e.g. safety data sheets (SDSs) and other documents of known producers/associations), academia (e.g. scientific peer-reviewed literature), non-governmental organisations as well as public actors (e.g. publications of national and environmental agencies and a variety of documents produced for regulatory processes under REAC H and the Stock holm C onvention). 43 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.15. Characteristics of restriction options and of maximum additional emissions scenarios. Restriction option a bbr e v ia tion Short description Derogations Transition period after entry into force Duration of derogation RO1 Full ban --- 18 months --- RO2 (5 years) RO2 (12 years) Ban with use-specific derogations Ban with use-specific derogations Derogations for defined uses of PFAS in the textile sector, causing additional emissions of PFAAs (C 6) incl. PFAA precursors (sidechain polymers), and of fluoropolymers (incl. PFPEs) 18 months 18 months 5 years 12 years Maximum additional emission scenario Ban with full derogation of entire PFAS groups PFAAs (incl. side-chain polymers); fluoropolymers (incl. PFPEs) 18 months 5 years Maximum Ban with full PFAAs (incl. side-chain additional emission derogation of entire PFAS groups polymers); fluoropolymers (incl. PFPEs) 18 months 12 years scenario *Maximum additional emission scenarios denote worst-case emission scenarios (assuming a full derogation of a particular PFAS group) against which emissions of proposed use -specific derogations are evaluated qualitatively. They do not represent restriction options. For calculating the expected emission reduction, the assumed entry -into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.16 shows mean emissions and the expected mean emission reduction for a time path of 30 and 45 years (starting in 2025). 44 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.16. Total mean emissions and emission reduction of RO1 and maximum additional emission scenarios (TULAC sector, in tonnes). Restriction option Mean total emissions [t] 2025-2055 Baseline RO1 Maximum additional emission scenario `5-year derogation of all PFAAs incl. PFAA precursors'* Maximum additional emission scenario `12-year derogation of all PFAAs incl. PFAA precursors'* Maximum additional emission scenario `5-year derogation of all fluoropolymers incl. PFPEs'* Maximum additional emission scenario `12-year derogation of all fluoropolymers incl. PFPEs' 2025-2070 Baseline RO1 Maximum additional emission scenario `5-year derogation of all PFAAs incl. PFAA precursors'* Maximum additional emission scenario `12-year derogation of all PFAAs incl. PFAA precursors'* Maximum additional emission scenario `5-year derogation of all fluoropolymers incl. PFPEs'* Maximum additional emission scenario `12-year derogation of all fluoropolymers incl. PFPEs'* 1 431 511 65 871 98 975 152 372 158 330 300 435 2 335 403 65 871 98 975 152 372 158 330 300 435 Mean total emission reduction [t] --1 365 640 1 332 536 1 279 139 1 273 181 1 131 076 --2 269 532 2 236 429 2 183 031 2 177 073 2 034 968 Mean total emission reduction [%] --95 93 89 89 79 --97 93 94 93 87 RO1 achieves a total PFAS emission reduction of about 95% of baseline emissions. Environmental impacts of RO2 are discussed qualitatively below for each proposed derogation. Proposed derogation: Personal protective equipment (PPE) intended to protect users against risks as spec ified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) and (c): During stakeholder c onsultations, three companies in the PPE sector indic ated that about 20% of the PFASs used in PPE in the EEA were used in PPEs protecting against Category III risks. The remaining 80% were used in PPE protecting against Category I or II risks. Since these companies account for a small fraction of the market volume (their total annual quantity of PFAS use in PPE artic les for the EEA market is approximately three tonnes), these estimates cannot be extrapolated to the entire EEA market for PPE. As a consequence, a precise 45 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) quantification of the amount of non-polymeric and polymeric PFASs used in relevant PPE was not possible. Based on existing evidence, an estimation of expected additional emissions assuming a full derogation of the PFAS covered by the proposed derogation (i.e. PFAAs, including PFAA precursors (side-chain fluorinated polymers) and fluoropolymers (in particular PTFEs)) can be provided. A 5-year derogation of PFAAs and PFAA precursors would cause additional emissions of about 1 260 t, and of about 2 700 t assuming a 12-year derogation. Total maximum additional emissions of a 5-year derogation of fluoropolymers including PFPEs would account of about 3 860 t, and of about 5 370 t assuming a 12-year derogation, respectively. While the fraction of PPE use for risk category III in the EEA is small (about 20%, see above), PFAS releases from textile treatment can be assumed to be high (ERC 5, 50% total release). There is sufficiently strong evidence that a derogation of PFAS use in PPE (either for 5 or 12 years) will cause substantial additional emissions which are below additional emissions under (worst-case) scenarios. Proposed derogation: Personal protective equipment (PPE) in professional firefighting activities intended to protect users against risks as specified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) - (m) The proposed derogation c omprises PFAAs inc luding PFAA prec ursors (side -chain fluorinated polymers) and fluoropolymers (in partic ular PTFEs). The evaluation of the quality of available evidence, and of expected environmental impacts, is equivalent to the aforementioned derogation. Proposed derogation: Impregnation agents for re-impregnating of articles referred to above The proposed derogation comprises PFAAs including PFAA precursors (side -chain fluorinated polymers). The derogation is proposed corresponding to the potentially exempted uses of PPE (see the aforementioned derogations). The evaluation of the quality of available evidence, and of expected environmental impacts, is equivalent to the evaluation of the first listed derogation. Proposed derogation: Textiles for the use in filtration and separation media used in high performance air and liquid applic ations in industrial or professional settings that require a combination of water- and oil repellence The proposed derogation c omprises PFAAs inc luding PFAA prec ursors (side-chain fluorinated polymers) and fluoropolymers (in particular PTFEs). Filters/membranes are likely to cause emissions under the baseline to a lesser extent compared to the first listed derogation, for example due to an assumed lower release factor (ERC 12a, low release), and provided that wear of these filters/membranes occurs under low mechanical impact. If, however, wear oc c urs under high mec hanic al impac t (ERC12b), emissions from filter/membrane use c an be expected to be higher (ERC 20% instead of 2.5%), and may then not be considered negligible. The evaluation of the quality of available evidence and expected environmental impacts of this derogation are nevertheless equivalent to the first listed derogation. Potential derogation marked for reconsideration: Textiles for the use in engine bays for noise and vibration insulation used in the automotive industry As mentioned in section E.2.2.1 the assessment does not account for use volumes and emissions relating to textiles used for noise and vibration insulation in automotives as this use only became known during the 2nd stakeholder consultation and no volume data is available to the Dossier Submitters. The environmental impacts of this derogation could therefore also not be assessed. Overall, it can be concluded that the reduction of expected environmental impacts is highest under RO1 (full ban of all PFASs after the transition period). Additional emissions resulting from the use-specific derogations proposed can be expected to be significantly smaller 46 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) compared additional emissions under maximum additional emission scenarios. It is generally more effective to derogate PFAS groups for a shorter time period (5 years). The reason is obvious - derogations which stretch over 12 years will cause higher additional emissions. Moreover, as illustrated in Figure E.2, the expected market growth in the TULAC sector (see section E.2.2.1 for further details), will c ause emissions to increase over time, leading to an increasing PFAS pollution burden in the environment. Furthermore, considering the strong evidence regarding additional emissions from the individual derogations, total emissions of all derogations are likely to be significant, though still much lower compared to the maximum additional emission scenarios. Figure E.2. Time path of mean emissions under the baseline, RO1 and maximum additional emission scenarios (TULAC sector, in tonnes); Source: Own calculations based on data collated by the Dossier Submitters. E.2.2.4. Economic and other impacts E.2.2.4.1. Economic impacts: Producer surplus losses As mentioned in Sec tion E.2.2.2, the availability of technically feasible alternatives is one key factor determining the economic impacts associated with a restriction as it determines the options available to affected c ompanies to ac hieve c omplianc e, e.g. substitution or c omplete closure of business (or business unit). Depending on the reac tion c hosen by affected c ompanies, different types of c osts are faced. A company that substitutes, for example, faces Research & Development (R&D) costs in relation to the identification and testing of relevant alternatives and the reformulation/redesign of the product. The company might, furthermore, face one-off costs for purchasing and installing new equipment, so-called capital costs, if the switch to alternatives makes changes to the production process necessary. In addition, companies might also face changes in operating costs such as changes in raw material costs resulting, for example, from differences in the unit cost of the alternative in comparison to the cost of PFAS and/or a higher volume of the substance being required. Changes to the production process might also result in more energy use with assoc iated c ost inc reases for c ompanies. If suc h c ost inc reases can be passed on to customers via higher product prices, limited economic impacts on affected companies are expected. If the ability to pass on costs to customers is limited, e.g. due to high competition, companies will face profit losses. A company that stops production in response to the restriction also faces profit losses - although at a higher magnitude. In addition, it might face costs in relation to dismantling plants. 47 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Given the difference in the type of costs incurred by companies depending on their reaction, the total economic impacts on affected companies in each sub-sector depend on four factors, i.e.: The number of companies in each sub-sector that is affected by the restriction; The most likely reaction of affected companies in each sub-sector, i.e. the share of c ompanies that substitute or stop produc tion; The cost that a company faces as a result of substitution or a stop of production; and The ability of c ompanies that substitute to pass on higher c osts to their c ustomers. Limited information on the number of affected companies in relevant TULAC subsectors is available. Based on information from a briefing of the European Environment Agency, published in 2019, around 171 000 companies are active in the textile industry, including the apparel industry (EEA, 2019). According to EURATEX (2022), the number of active companies has decreased since, with around 143 000 companies estimated to having been active in the textile and clothing industry in the EU-27 as of 2021, with a turnover of 147 billion. This inc ludes fabric produc ers, produc ers of man- made fibres and yarns as well as producers of home textiles, knitwear producers, producers of clothing and accessories, underwear, workwear as well as industrial and technical textiles. Around 67% of those companies are reported to be active in the clothing industry with a turnover of 65.3 billion, while the remaining approximately 48 000 c ompanies are ac tive in the textile industry, which, amongst others, includes the production of man-made fibres. While a more precise split on the number of companies per sub-sector is not provided, EURATEX (2022) reports that the leading contributors to total EU-27 production are the clothing and accessories industry (accounting for 31%) as well as the industrial and technical textile industry (accounting for 17% of total EU-27 produc tion), as shown in Table E.17, whic h also provides information for the other industry branches. Assuming that the share of total EU- 27 production is a representative indic ator of the number of companies in each industry sector, the Dossier Submitters estimated the number of companies active in each TULAC sub-sector. The number of companies associated with each of the industry branches mentioned by Euratex is presented in Table E.17, while Table E.18 provides an overview of the number of companies per TULAC sub-sector. Table E.17. Estimated number of companies in different Euratex industry branches based on EU-27 production shares for 2021. Clothing & accessories Industrial & technical textiles Fabrics Home textiles Knitwear Man-made fibers Yarns Underwear Workwear Share of EU-27 production (according to EURATEX (2022)) 31% 17% 15% 14% 6% 5% 5% 4% 2% Estimated number of companies (rounded to the nearest 100) 44 800 24 500 21 700 20 200 8 700 7 200 7 200 5 800 2 900 Relevant TULAC sub-sector C onsumer apparel Technical textiles --Home textiles C onsumer apparel ----C onsumer apparel Professional apparel Linking industry branches reported by Euratex with TULAC sub-sectors in the way described in the right-hand column of Table E.17, the Dossier Submitters estimate that around 59 300 companies are active in the consumer apparel sector, as shown in Table E.18. The lowest 48 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) number of affected companies is estimated for the professional apparel industry . As the underlying data from Euratex is related to workwear, the estimated number of companies for professional apparel is deemed to cover PPE only, while companies producing professional sportswear and footwear are deemed to be covered by the estimate for consumer apparel. Table E.18. Estimated number of companies in different TULAC sub -sectors. Sub-use Home textiles Consumer apparel Professional apparel Technical textiles Leather Other Estimated number of companies (rounded to the nearest 100) 20 200 59 300 2 900 24 500 No information available No information available While the estimated numbers of companies per sub-sector need to be treated with caution given the lack of specific information on the extent to which spec ific sub-sectors are dominated by a small number of key market players instead of being constituted by a number of companies with a comparable production volume, the general picture of more companies being active in sectors with less specialisation requirements, e.g. consumer apparel, is in line with general expectations of the Dossier Submitters. This is due to the fact that barriers to entry suc h as time- and c ost-intensive c ertification requirements are generally lower in such sectors encouraging market entry of new actors. In addition, industrial/institutional downstream users purc hasing highly-specialised TULAC products for their applic ations, e.g. high performance membranes and PPE, might be more inclined to continue purchasing products from well-known and renowned suppliers than new suppliers entering the market in comparison to households purchasing products like home textiles and consumer apparel. In light of these considerations, the number of companies estimated to be active in the technical textile industry based on Euratex data might be deemed rather high given the expected significant barriers to market entry in relation to some types of technical textiles, e.g. high performance membranes. As the technical textile sector, however, incorporates se veral spec ialised sub-sectors, inc luding sectors with likely less barriers to entry such as the market for outdoor technical textiles, the existence of a high number of companies cannot be ruled out. According to EURATEX (2022), nearly 89% of companies active in the textile and clothing industry in the EU-27 are micro companies with up t o nine employees, while 11% are small and medium-sized enterprises with up to 250 employees. Only 0.2% of companies are large companies with more than 250 employees. The number of companies producing articles containing PFAS could not be identified by the Dossier Submitters. According to information received in the CfE, the major users of PFASs are c ompanies produc ing c onsumer apparel followed by the home textile sector and technical textile sector. Neither information received during the CfE, nor informat ion collected during the 2nd stakeholder consultation allowed for an estimation of the affected number of companies per sub-sector. While no information on the number of affected companies is available, information on the share of produc tion and the associated estimation of the number of c ompanies in eac h sector (presented in Table E.17 and Table E.18) and information from the CfE (described above) indic ating that the major users of PFASs are c ompanies producing c onsumer apparel followed by home textiles and technical textiles suggests that the total number of affected companies might be highest in these industry sectors. Quantitative information on the most likely reaction of affected companies in each subsector, i.e. the share of companies that substitute or stop production, is limited. While 49 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) industry was asked in the 2nd stakeholder consultation to indicate what the economic and social impact in terms of changes in employment numbers would be for their organisation if a restriction would take effect in three years, the Dossier Submitters deemed the number of c ompanies providing information too low for developing representative quantitative estimates on the share of affected companies that would substitute rather than cease operation. The information rec eived during the 2nd stakeholder c onsultation was however used to develop an overview of potential differences between sub-sectors with a view of supplementing conclusions that can be drawn based on information on the availability of technically feasible alternatives and the substitution potential (presented in section E.2.2.2). For this purpose, companies were allocated to relevant TULAC sub-sectors based on the provided description of their specific use, or where this was not provided, additional online research on the c ompany. The most likely reaction of each company was then either directly determined based on a c lear indic ation on the reaction provided through the description of economic impac ts or, where this was not available, deduced from the information that the stakeholder provided in response to the questions on: Whether the listed non-PFAS alternatives are technically feasible in the process/product of the stakeholder; Whether the listed non-PFAS alternatives are economically feasible in the process/product of the stakeholder; and Whether the stakeholder company is actively working on finding alternatives. With respect to home textiles, only one stakeholder provided information, which precludes a meaningful conclusion on the extent of companies that would substitute rather than stop production. Similarly, no meaningful conclusion can be drawn for leather applications in relation to clothes and accessories, while information provided in relation to textile and/or leather uses for automotive interiors in the passenger compartment reveals a trend towards business closures. Information provided by five stakeholders active in t he consumer apparel industry suggests a mix of reactions in response to a proposed restriction of PFASs, with a rather equal split between c ompanies indic ating that they do not need to take any ac tion, as they have already completed the transition, and companies implementing an alternative or c losing their business (or business unit). Information provided in relation to the production of professional apparel and technical textiles (which is dominated by information relating to high performanc e membranes) suggests a c lear tendency towards c losure of business as reaction to a complete ban of PFASs with very few or no respondents already using alternatives or being expected to substitute in response to the restriction proposal based on the information provided. While this information provides some useful additional evidence, the conclusions should be treated with caution given the aforementioned small sample size and likely response bias - with companies facing business closures being thought to disproportionately respond to the 2nd stakeholder consultation (in comparison to companies that substitute) in an attempt to provide evidence for derogations and companies that face no major c hanges being more likely to not respond to the 2nd stakeholder consultation. Information on the most likely reactions of stakeholders active in different sub-sectors derived from the 2nd stakeholder consultation should thus be used in conjunction with conclusions that can be drawn based on the technical feasibility of alternatives. Table E.19 therefore provides an overview of conclusions that can be reached based on the stakeholder c onsultation on the economic impac ts and information on the availability of technically feasible alternatives. 50 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.19. Broad assessment of most likely reaction of affected companies in different TULAC sub-sectors to the restriction of PFAS. Sub-use Conclusion on most likely reactions based on information on technical feasibility of alternatives and substitution potential (Source: CfE and 2nd stakeholder consultation, stakeholder consultation interviews, consulted literature) Conclusion on most likely reactions based on information on economic impacts at company level (Source: 2nd stakeholder consultation) Home textiles Consumer apparel Professional apparel Mainly substitution, due to: Five of seven alternative substance groups being identified as relevant; Products based on alternatives already being available on the market, which points to the economic feasibility of identified alternatives as well as customer acceptance (despite potential difference in functionality) Mix of substitution and closure of business assumed, due to: Six of seven alternative substance groups be ing identified as relevant; Products based on alternatives already being available on the market, which points to the economic feasibility of identified alternatives as well as customer acceptance; The consumer apparel sector being the sector with the most pronounced trend to substitution as a result of voluntary industry commitments and consumer pressure; Successful substitution by both high-end and low-end brands; and A good technical feasibility of alternatives as functions other than water repellence a re not deemed to be critical for this use. Given the high market penetration of alternatives, substitution is however deemed to be a less promising endeavour for companies that still use PFASs. Such companies face potentially significant competition of stakeholders that have already successfully substituted and might be able to offer products at lower prices, e.g. due to having completed the amortization of R&D and capital costs. As a result, some business closures might occur. Mix of substitution and closure of business, with some tendency towards business closures (especially in relation to PPE) assumed due to: Five of seven alternative (substance) groups having been identified as relevant for professional sportswear and footwear and four of seven groups having been identified as relevant for PPE; and The conclusion of the Dossier Submitters that technically feasible alternatives do not seem to exist for several C ategory III PPE applications. No conclusion on trend possible Rather equal split between companies indicating that they do not need to take any action, as they have already completed the transition, and companies implementing an alternative or closing their business This information supports the conclusion that a high share of companies affected by the restriction might stop operating despite the availability of technically feasible alternatives. Information provided in relation to the professional apparel industry suggests a clear tendency towards business closures as reaction to a ban of PFASs with very few or no stakeholders submitting information already using 51 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Conclusion on most likely reactions based on information on technical feasibility of alternatives and substitution potential (Source: CfE and 2nd stakeholder consultation, stakeholder consultation interviews, consulted literature) Conclusion on most likely reactions based on information on economic impacts at company level (Source: 2nd stakeholder consultation) Technical textiles Leather Mix of substitution and closure of business, with tendency towards business closures assumed for some applications, e.g. high performance membranes, due to: Limited implementation of alternatives on the market; Information pointing to challenges with the replication of the multitude of functionalities simultaneously provided by PFASs; but Stakeholder information pointing to the proven use of an alternative in relation to all types of technical textiles; and A good substitution potential for outdoor technical textiles (despite differences in functionality) as described in Section E.2.2.2.4. Mainly substitution, due to: Four of seven alternative substance groups being identified as technically feasible; Products based on alternatives being implemented on the market, e.g. for automotive interiors; and Alternatives being identified that allow for the provision of functionalities beyond water repellence at a comparable level, which was initially thought to be a co ncern. alternatives or being expected to substitute in response to the restriction. Information provided in relation to the technical textile industry (which is dominated by information relating to high performance membranes) suggests a clear tendency towards business closures as reaction to a ban of PFASs with very few or no respondents already using alternatives or being expected to substitute in response to the restriction. No conclusion on trend possible Other: Home fabric treatments (sprays) The identification of relevant alternatives by some stakeholders is thought to encourage other stakeholders to invest in R&D efforts as the perceived chance of success increases. The seemingly more limited market penetration of alternatives facilitates winning market shares, which might be a further encouraging factor for affected companies. Mainly substitution, due to: Silicone-based alternatives having been identified as re levant; and No relevant information provided 52 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Conclusion on most likely reactions based on information on technical feasibility of alternatives and substitution potential (Source: CfE and 2nd stakeholder consultation, stakeholder consultation interviews, consulted literature) Conclusion on most likely reactions based on information on economic impacts at company level (Source: 2nd stakeholder consultation) Other: Automotive use - Noise and vibration insulation Home textiles based on alternatives already being available on the market, which points to the economic feasibility of identified alternatives as well as customer acceptance of potential differences in performance (in relation to functions othe r than water repellence) Mainly business closures assumed, due to: No alternatives being known; and Implementation of alternatives, if/once identified, being described as a time-consuming process. No relevant information provided 53 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) In addition to the above considerations, the extent of affected companies that opts for substitution rather than ceasing their operations in response to a proposed restriction of PFASs is affected by the time that is required for completing substitution and implementing the product on the market. If the required timeframe conflicts with the expec ted entry-into-force of the restric tion proposal, business c losures are imminent even if tec hnically feasible alternatives exist. Based on the expected entry-into-force of the proposed restric tion in 2025 and a standard transition period of 18 months for all sec tors, substitution processes requiring a timeframe significantly exceeding 3.5 years are the refore deemed to trigger business closures. With respect to home textiles, one stakeholder submitting information in relation to PFASbased processing aids for carpet production to the 2nd stakeholder consultation reports that three to five years are needed for completing the transition once a suitable alternative is identified. Given that the minimum timeframe reported in the 2nd stakeholder consultation is in line with the timeframe available until the expec ted entry-into-force date of the proposed restriction and that substitutions in this sector have already been undertaken or are in progress, e.g. as a result of voluntary industry commitments described in Section E.2.2.2, business closures are expected to be triggered by the perceived market potential rather than concerns in relation to the timeframe available for substitution. With respect to consumer apparel, one stakeholder submitting information for footwear applic ations to the 2nd stakeholder c onsultation notes that two to three years are required for completing the substitution process once an alternative has been identified as suitable. Due to many successful examples of completed transitions away from PFAS and the reported timeframe being in line with the timeframe available until the expected entry-into-force date of the proposed restriction, business closures are expected to be triggered by the perceived market potential rather than concerns in relation to the timeframe available for substitution. The timeframe of two to three years for completing the substitution process in footwear applic ations is also reported to be applic able for footwear applic ation in regulated areas, i.e. in PPE. Another stakeholder submitting information to the 2nd stakeholder consultation in relation to PPE indicates that the development of a new product based on an alternative is not the most time-consuming aspect in the substitution process. Problems with respect to time rather arise in relation to the certification of produc ts and products that are already on the market. According to the stakeholder, the normal life cycle of PPE consists of many years, with PPE that is already on the market relying on re-impregnation. If re-impregnation is not possible as a result of the rest riction, the protective performance of products is lost and products need to be replaced. As a result, complete substitution to PPE that does not rely on the use of PFAS is reported to take several years. Another stakeholder submitting information to the 2nd stakeholder consultation specifies that one to two years are required for certification, including dossier preparation and testing, once a product has been designed that meets the requirements of relevant EU regulation for PPE. With respect to PPE providing protection against splashes of liquid c hemic als in line with EN 13034 Type 6, the c ertification proc ess is reported to take around four months on average by a stakeholder submitting information to the 2nd stakeholder consultation. While this is a category of PPE for which PFASs are deemed to be required to achieve certification levels according to the Dossier Submitters' analysis presented in Table E.13, it provides a good indication of the approval time required for other PPE categories for which substitution is deemed feasible. A manufacturer of PPE for industrial applic ations and fire-fighters furthermore suggests that three years are required for achieving approval of PPE using alternatives to PPE. Further information on the overall timeframe required for substitution, not only for certification, is also available from the 2nd stakeholder consultation. One stakeholder estimates that 12 to 18 months are needed once a suitable alternative has been identified - with relevant steps including wash tests and certification for fabrics as well as garments. Another stakeholder submitting information in relation to PPE to the 2nd stakeholder 54 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) consultation also mentions that fabrics must be approved for application in garments before these can be placed on the market. All intermediary producers along the supply chain are reported to require time to conduct relevant tests and carry out approvals. This process is estimated to take between 18 and 36 months. Additional time is reported to be required afterwards for scaling-up processes. In line with this estimate, one stakeholder providing information on face masks in consultation prior to the 2nd stakeholder consultation suggests that at least three years are needed to adopt alternatives onc e the feasibility of alternatives is demonstrated. As timeframes for completing substitution processes reported by different stakeholders all refer to timeframes of less or around three years, business closures are not expected to be triggered by concerns in relation to the timeframe required for substitution alone. With respect to technical textiles for medical applications, such as surgical gowns, any changes to products made must be properly assessed under the Medical Device Regulation (EU Regulation 2017/745) with a view of determining potential implic ation on the safety and efficacy of the product. Regulatory requirements range from internal documentation to complete re-approval. According to a stakeholder submission to the 2nd stakeholder consultation, the average approval time for surgical gowns varies from days up to several years depending on the significance of the change. More specific information is provided by two other stakeholders submitting information for medical textile applications to the 2nd stakeholder consultation. According to one stakeholder, who also refers to legal re qualification requirements when new substances are employed in the medical sector, approval of produc ts under legal approval schemes takes between three and ten years on average. The other stakeholder notes that fabrics used in such applications must pass tests before being placed on the market. As for PPE, all intermediary producers along the supply chain are reported to require time to c onduct relevant tests and c arry out approvals - with between 18 and 36 months being required for this process based on the stakeholder's best knowledge. Additional time is reported to be needed for scaling-up processes afterwards. Based on the large variation in required timeframes reported for medical textiles, with estimates ranging from days to ten years for approval alone, no clear conclusion on the required timeframe for substitution can be drawn by the Dossier Submitters. The timeframe of 18 to 36 months for tests and approval along the supply c hain reported for medical textiles is also reported to be relevant for filtration applications. Another stakeholder submitting information to the 2nd stakeholder consultation reports a much shorter time frame for approval. Approval of filtration media in line with the VDI 3926 test 34 is reported to take three months on average. Information on the total timeframe required for substitution is also available from both stakeholder consultation efforts preceding the 2nd stakeholder consultation and the 2nd stakeholder consultation itself. A stakeholder providing information based on its past experience with substitution from C8 to C6 substances in filtration applic ations reports that substitution took eight to ten years. A supplier of filters for mist and dust removal in a variety of industrial applications submitting information to the 2nd stakeholder consultation reports a shorter timeframe of at least three years for commercializing the alternative technology and receiving customer validation and approval. Substitution might thus be feasible in the timeframe available until the restriction takes full effect but some uncertainty prevails - especially based on practical experiences from the past. Textile- or leather-based coverings in automotive interiors are also subject to validation and certification requirements prolonging the required timeframe for substitution and implementation of new alternative-based products on the market. A stakeholder submitting information to the 2nd stakeholder c onsultation notes that re- design of produc ts needs to be complemented with re-validation of all products according to the technical specifications of original equipment manufacturers (OEMs) as well as re-certification according to International 34 The VDI 3926 test is a standard test for the evaluation of cleanable filter media. It is a standard developed by the "Verein Deutscher Ingenieure e.V" which translates as association of German engineers. 55 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Automotive Task Force (IATF) standards. The average approval time in this sector is described as two to four years, with complete transition to the alternative requiring up to five years. In contrast, another stakeholder submitting information to the 2nd stakeholder consultation, reports that more than one year would be required for completing the transition to the alternative once a suitable alternative is identified. For other leather applications, e.g. gloves, a stakeholder submitting information to the 2nd stakeholder c onsultation reports a timeframe of two to three years for completing substitution once a suitable alternative is known. In conclusion, substitution is deemed to be feasible for the majority of relevant application in the timeframe until the restriction takes full effect as several stakeholders report timeframes of less than or around three years. While information for automotive applications also refers to longer timeframes, such timeframes are deemed to represent an indication of the maximum time required given the complexity and high certification needs associated with automotive applic ations. Suc h timeframes are thus not deemed to be relevant for the entire leather industry. Business closures are thus expected to be triggered by the perceived market potential rather than concerns in relation to the timeframe available for substitution. As mentioned above, the cost that a company faces as a result of substitution or a stop of production is an additional key determinant of the total economic impacts on affec ted c ompanies resulting from the proposed restric tion. With respect to business closures, the extent of producer surplus/profit losses faced by TULAC- producing c ompanies depends on both the typic al annual sales volume of c ompanies in each industry sector as well as the margin in the sectors, i.e. the difference between production costs faced by a company and the revenue resulting from the typical annual sales volume. Information on sales losses at company level has been received during the 2nd stakeholder consultation in which stakeholders were asked to provide information on the economic impact on their company if the use of PFASs is prohibited in three years. While the sample of quantitative estimates is limited and has been further reduc ed by unc laritie s with respect to the nature of the numbers reported by stakeholders, e.g. unclarity on whether reported numbers refer to annual sales values or sales values over several years, they provide some insights into sales values in different sub-sectors. For all relevant TULAC sub-sectors, Table E.20 presents the number of c ompany- specific estimates for sales losses provided as well as the relevant range. Table E.20. Range of sales losses resulting from business closures based on information provided in the 2nd stakeholder consultation. Sub-use Home textiles Consumer apparel Professional apparel Technical textiles Leather Other: Home fabric treatments (sprays) Other: Automotive use - Noise and vibration insulation Sample size, i.e. number of companies providing useable quantitative information on sales losses n/a n/a 6 5 n/a n/a n/a Reported annual sales losses in million euro Minimum n/a n/a 1.2 10 n/a n/a n/a Reported annual sales losses in million euro Maximum n/a n/a 200 50 n/a n/a n/a 56 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Based on the information submitted to the 2nd stakeholder consultation, it thus seems reasonable to assume that sales losses as a result of business closures range from a few million to several hundred million euros per company. No information on significant differences in annual sales values between different sub-sectors is available to the Dossier Submitters. Producer surplus/profit losses to companies active in the TULAC industry resulting from business closures are dependent on the margin in the sector, i.e. the difference between production costs and revenue, which might differ between sub-sectors. If margins are low, the impac ts from foregone sales on c ompanies active in the sector will be les s pronounced. Regardless of the margin, business closures could furthermore have wider impac ts on industry through indirec t impac ts on c ompanies active in the supply c hain whose sales revenues c ould also be negatively affected. Such indirect impacts on industry will be most pronounced for sub-sectors, where the market penetration of alternatives is low and business closures are the dominant reaction of affected companies as the extent to which market shares of companies ceasing operation will be taken over by other EU companies active in the TULAC industry, i.e. early adopters of alternatives, is more limited. As a result, the impacts on the wider industry will not only inc lude impac ts on produc ers of PFASs but also suppliers of other production inputs, e.g. synthetic fibres. An assessment of the expected extent of indirect impacts on industry in relation to different sub-sectors is provided in Table E.24. While no quantitative information on typical margins is available to the Dossier Submitters, some indications can be provided based on a general understanding of the level of competition in different sub-sectors - with highly competitive industries with a high number of active companies usually having lower margins t han industry sectors with a very limited number of ac tive c ompanies. Mass markets produc ing goods for the general public , i.e. the home textile industry, consumer apparel industry as well as the leather industry are deemed to be industries with generally low margins given the high number of relevant companies and the pric e-sensitive nature of the market, in whic h pric e is thought to be a key fac tor c onsidered by the c ustomer in its purc hasing decision. Variations in margins c an however be expected in these sub- sectors due to the existenc e of high-end and low-end brands. Overall, margins in relation to textiles for use in engine bays of automotives and the professional apparel and technical textile industry are deemed to be higher than in the aforementioned industry sectors given the smaller target market for many product types, e.g. professional sportswear and footwear and PPE, and/or higher up- front c osts for suppliers, e.g. in relation to R&D c osts for more complex products and certification costs, which suppliers will likely aim to recoup through higher margins. Higher up-front costs are deemed to be especially relevant in relation to PPE, high performance membranes as well as textiles for the use in engine bays. Given the higher barriers to entry into the market, e.g. due to certification needs for several product types, competition in these market segments is also deemed to be lower than, for example, in the home textile and consumer apparel industry, enabling higher pric e margins. As a result, company closures in the professional apparel and technical textile industry (especially in relation to high performance membranes) as well as in relation to textiles for the use in engine bays are deemed to be associated with higher producer surplus losses per company than company closures in the home textile, consumer apparel and leather industry. Margins for outdoor technical textiles are deemed to be lower than for other technical textiles due the larger target market, with products being of relevance for the general public and the more pric e-sensitive nature of the market. Information on potential costs associated with dismantling plants as well as potential difference across sub-sectors is not available. It is also unknown to what extent companies stopping produc tion in response to the restriction can recoup losses from premature retirement of their produc tion assets through sale35, scrappage36 or deployment. 35 A production asset has resale (or salvage) value if it can be sold to a new user in its existing form. 36 A production asset can be considered to have scrap value if it cannot be sold in its current form, and 57 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Information on the margins in different industry sectors is also beneficial for understanding the magnitude of producer surplus losses resulting from substitution given that they are one factor determining the extent to which companies internalize substitution costs instead of passing them on to their customers. High margins providing opportunities to internalize costs without endangering profitability might enc ourage affected c ompanies to opt for substitution rather than business closure even if high up-front investments, e.g. for R&D activities, are required. The decision on whether costs will be internalized or passed on to customers will however also be dependent on an understanding of the extent to which customers in each sector and their demand for the product is sensitive to price changes. Confidence about the possibility of c harging higher pric es to c ustomers, without undue sales reductions, might also encourage affected companies to opt for substitution rather than business closure. Margins as well as the price elasticity of demand37 in different sub-sectors thus play a crucial role in determining whether affected companies opt for substitution and whether they would bear the costs associated with substitution in the form of producer surplus losses or whether these c osts would rather be borne by c ustomers through inc reased product pric es. Given these interlinkages, Table E.21 provides an overview of the Dossier Submitters' conclusions on margins and the price elasticity of demand in different sub-sectors and the associated implications in relation to the share of aff ected companies opting for substitution and the relevant actors in soc iety that will likely fac e the costs of the restriction. A low margin might negatively impact the share of substitution by discouraging affected companies from opting for substitution given that it is more likely that substitution endangers the profitability of their business. A high pric e elastic ity of demand might also negatively impac t the share of substitution as companies know that they will not be able to easily recoup the costs inc urred for R&D activities, whose outcome is uncertain, as well as potential investments in new machinery by increasing prices charged to their customers. Companies would instead have to accept a negative impact on their margins. A low price elasticity of de mand, in turn, might encourage affected companies to make the necessary investments and opt for substitution especially if positive examples of substitution exist - as they are aware that there is likely a good opportunity for recouping the costs at a later stage. A low price elasticity of demand also makes it more likely that costs will be fully passed on to customers, especially if the profit margin is already low. If the pric e elastic ity of demand is high, while profit margins are low, companies might, in contrast, try to limit cost increases for customers as much as possible and pass on only a share of the costs. instead can only be sold for parts (in particular, chemical process equipment is often made of highgrade steel that may have a robust scrap value). 37 The price elasticity of demand indicates the extent to which the quantity demanded changes due to a price change, assuming that other factors that influence demand are unchanged. 58 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.21. Margins in different TULAC sub-sectors, possible implications on the share of affected companies opting for substitution and actors facing the costs resulting from substitution. Sub-use Size of profit margin Home textiles Consumer apparel Professional apparel Technical textiles Low Low High High, for high performance membranes Price elasticity of demand * High High Low Low, for high performance membranes Possible implications on share of affected companies opting for substitution Negative Negative Expected extent to which companies pass on costs to customers * Partial Partial Positive High Positive, for high performance membranes High, for high performance membranes Low, for other High, for outdoor Negative, for Partial, for outdoor technical technical textiles outdoor technical outdoor technical textiles and and medical textiles and textiles and medical applications medical medical applications applications applications Leather Low High Negative Partial Other: Home Low High Negative Partial fabric treatments (s pr a y s ) Other: High Low Positive High Automotive use - Noise and v ibr a tio n insulation * The pric e elasticity of demand is deemed to be the c ruc ial determinant of the ability of c ompanies to pass on c osts. Together with the margin, it determines the extent to whic h c ompanies are expec ted to pass on c osts in eac h sub-sector. The c onclusions of the Dossier Submitters on this aspec t differ from the c onclusions drawn in a c onsultancy report titled "The use of PFAS and fluorine-free alternatives in textiles, upholstery, c arpets, leather and apparel", that was produc ed for the European Commission (Direc torate General for Environment) and published in Oc tober 2020. The report c oncludes in the table titled "Evaluation of potential alternatives by TULAC use c ategory" that the ability for passing on c osts is high for the home textile and c onsumer apparel industries, medium for the leather industry and low for the professional apparel and tec hnical textile industries. The main argument for the low and medium ability are differences in the level of competition faced from outside the EU, with "signific ant c ompetition" being reported for sectors for whic h a low ability to pass on costs is reported and "some competition" being reported for sectors for whic h a medium ability to pass on c osts is reported (Wood, 2020b). In c ontrast, the Dossier Submitters conclude that the ability to pass on costs is: Low (not high, as reported in Wood (2020b)) for home textiles and consumer apparel as a result of the high price elasticity of demand; High (not low, as reported in Wood (2020b)) for professional apparel and technical textiles as a result of the low pric e elastic ity of demand; and Low (not medium, as reported in Wood (2020b)) for leather due to the high price elasticity of demand. 59 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters do not consider competition to be a key determinant of the pric e elastic ity of demand (and c onsequently the ability to pass on c osts) and rather c onsiders it to be a key determinant of the profit margin. Sectors with high levels of competition usually have lower margins than sec tors of an oligopolistic or monopolistic nature. The Dossier Submitters also deem the level of non-EU competition for the home textile and consumer apparel to be comparable if not higher than for other sectors and therefore does not agree with the assessment of competition levels in Wood (2020b). As the proposed restriction would also apply to imported art icles, the Dossier Submitters also consider it more relevant to assess the level of competition with EU actors that already produce PFAS-free products than with non-EU actors. Many companies in the consumer apparel industry have, for example, already subst ituted and offer PFAS-free products, which is deemed to increase pressures on price (for reasons further described below) and limit the ability of actors that will substitute in response to the restriction to pass on c osts. Especially in the consumer apparel industry, the ability to pass on costs to customers is also deemed to be limited by competition with companies that have already substituted. Many companies, including well-known brands, already have substituted away from PFASs. Such companies will likely be able to offer their products at increasingly lower prices over time following upscaling of their processes, e.g. as a result of increasing demand for their products, and the associated decreasing marginal costs, and as a result of having completed t he amortization of R&D and c apital c osts. Companies substituting to alternatives in response to the restriction are thus expected to face high pressures in relation to price, which limits their ability to pass on costs. This limited ability to pass on cost s as a result of (i) the expected high price elasticity of demand, (ii) generally low margins, and (iii) price pressures resulting from competition with EU companies that have already adopted alternatives increases the producer surplus losses that a company opting to substitute might face. In addition to the loss in produc er surplus from internalizing investment c osts, such c ompanies might also face producer surplus losses from losing (parts of) their market share to EU companies which already adopted alternatives prior to the announcement and implementation of the restriction, e.g. due to a more renowned brand profile for their products. Total costs incurred by a company in relation to substitution comprise: Costs associated with research on alternatives and re-development of products; One-off costs for new equipment; and/or Changes in operating costs, e.g. higher raw material c osts resulting, for example, from differences in the unit cost of the alternative in comparison to the cost of PFASs or a higher volume of the substance being required. With respect to the costs associated with Research & Development (R&D)38, very limited information on the costs incurred by an affected company is available. While one stakeholder submitting information to the CfE reported that the company invests an estimated 5% to 6% of their annual sales value into R&D activities each year to develop new and innovative solutions, it is not clear to what extent such a budget would be sufficient for researc h on alternatives to PFASs and produc t re-development. The Dossier Submitters also assume that such costs might vary significantly between sectors, with R&D activities in relation to applications with more complex functionality requirements being deemed more time-intensive and costly than R&D activities in relation to products that, for example, only require water repellence. R&D costs incurred by companies in the home textile, consumer apparel and leather industry are therefore deemed to be lower than costs incurred by companies supplying professional apparel (especially PPE), technical textiles (especially high performance membranes) and textiles for use in engine bays of automotives. In relation to capital costs, i.e. costs for new equipment, manufacturers of alternatives 38 It is important to note that R&D costs also constitute an investment in an intangible asset that may have value to the company. 60 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) indicated that alternative textile finishes are applied in the same way as PFAS-based textile treatments. Minimal costs in relation to the purchase of new equipment are therefore antic ipated by the Dossier Submitters. Additional information on this aspect was not received during the CfE and 2nd stakeholder consultation. No information is available on whether different types of equipment are required for using alternatives in relation to other relevant applications, e.g. membranes. The use of alternatives is however reported to be associated with longer processing times. This increase in processing times could affect production capacities and result in the need for additional machinery. The extent to which production capacities are affected and the costs associated with equipment used by companies in the sec tor is, however, unknown. While some information on changes in operating costs resulting from differences in unit costs of alternatives in comparison to PFASs and differences in required volumes is available, quantitative information on cost differences between PFAS- and alternative-based textile treatments is a key data gap. For fluoropolymers, information provided by one stakeholder during the CfE suggests that fluoropolymer applications are not motivated by price but solely functionality considerations. The use of polymers is reported to be limited to special applications - with fluoropolymers being replaced by cheaper alternatives wherever possible given that their use has no economic advantages. As a result, increases in operating cost due to higher unit costs of alternatives are deemed unlikely by the Dossier Submitters in relation to uses of fluoropolymers. Information from the 2nd stakeholder consultation that the production costs of polyester- or polyurethane-based membranes are lower than that of PTFE-based membranes supports this conclusion. In addition, some information on differences in unit prices and volumes required in comparison to PFAS is available for five of the seven substance groups identified as s uitable alternatives, as shown in Table E.22. Table E.22. Information on differences in unit prices and loading of alternative substance groups in comparison to PFAS. Chemical group Dendrimer Hy br id (Silicone/ Hy dr o c a r bo n) Hy dr o c a r bo ns Loading (in comparison to PFAS) Much higher Application volume is two to four times higher, according to information from manufacturer Higher UNIPERL dosage is higher than average fluorocarbon dosage, according to information provided by manufacturer Higher Absolute price of alternative (/kg) ~10/kg (for Ruco-Dry Eco) C ost depends on application, country, purchase quantity and customer, according to information provided by manufacturer ~ 10/kg (for UNIPERL HDS) 15-20/kg (for ZelanTM), according to stakeholder interview Unit purchasing price (in comparison to PFAS) n/a n/a n/a 61 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Chemical group Nanotechnologies Loading (in Absolute price of comparison to PFAS) alternative (/kg) n/a n/a Unit purchasing price (in comparison to PFAS) <15% higher, according to information provided by manufacturer for Plasmaguard Part 3 product But no increase in cost per unit on finished goods Po ly ur e tha ne n/a n/a Lower (in comparison to fluoropolymers) Silicones n/a n/a n/a A lte r na tiv e n/a n/a n/a technologies With respect to applications of PFASs for the purpose of water repellence, consultation with manufacturers of alternatives indicates that the overall raw material cost associated with using an alternative is more or less the same as the raw material c ost associated with PFAS. While unit prices of alternatives providing water repellency is lower in some cases, the a mount of the substance that is required can be up to 50% higher in comparison to C6 technologies leading to broadly comparable costs. This is in line with conclusions drawn by EPA-DK (2015) which concludes that alternatives provide acceptable f unctionality at comparable costs in applications where oil and alcohol repellence as well as repellence of oil-based dirt is not required. In relation to textile treatments, increases in operating costs are however expected. In interviews conducted in support of the preparation of the dossier, it was indicated that the use of alternatives could lead to textile maintenance requirements which could impact the processing cost. Information specific to textile and non-woven treatment auxiliaries for textile finishes that are based on side-chain fluorinated polymers was also provided in the 2nd stakeholder consultation. In line with the information provided above in relation to water repellence, alternatives to side-chain fluorinated polymers providing water and oil repellence are reported to be c heaper. The stakeholder, however, reports that the use of alternatives leads to higher raw material costs overall due to higher dosage requirements, with required volumes being around twic e as high as for side-chain fluorinated polymers. Increases in other operating costs are also described. As a result of a higher sensitivity of alternatives in comparison to sidechain fluorinated polymers, companies are reported to incur higher production costs due to the need for additional production steps (including additional washing steps), and additional chemical additives. While information on whether the use of alternatives leads to higher raw material costs for the chemical itself is mixed and seems to depend on the required functionality, the Dossier Submitters conclude that some increases in operating costs are likely as a result of the additional production steps. In addition to inc reases in operating c osts, additional costs in relation to re-certification and approval of their products will also be incurred by some companies. Such costs are deemed to be especially relevant for companies producing PPE and technical textiles, more specifically medical applications and high-performance membranes, as well as companies produc ing non-wovens or textiles for use in automotives. No information on the magnitude of c osts is available to the Dossier Submitters. 62 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Quantitative information on the total costs per company associated with substitution is also limited. One company submitting TULAC-specific information to the 2nd stakeholder consultation in relation to the use of a PFAS-based processing aid in relation to a material qualified for the use in PPE Category III reports that total costs of at least 100 million are expected - including costs associated with research on alternatives, subsequent process developments, asset retrofits and qualification requirements. In relation to filtration applications, one company providing information during the 2nd stakeholder consultation reported that past substitution efforts from one PFAS to another PFAS were associated with costs of 5 million. Given the limited sample of and wide variation in cost estimates, no conclusions on the typical cost incurred by a company in relation to substitution in response to a restric tion proposal of PFASs c an be drawn by the Dossier Submitters. Table E.23 summarises the information on the key components determining the total ec onomic impac ts on affected c ompanies resulting from a full ban of PFASs. It also provides some overarching conclusions on the total producer surplus losses incurred by affected companies in each sub-sector. 63 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.23. Conclusions on total economic impacts on directly affected companies resulting from a full ban of PFASs. Home textiles Consumer apparel Professional apparel Technical textiles Leather Other: Home fabric treatments (s pr a y s ) Number of affected companies Number of companies 20 200 estimated to be active in the sub-sector 59 300 (including companies producing professional sportswear and footwear) Share of companies affected by the restriction proposal due to using PFASs Unknown, but not all companies are deemed to use PFASs based on information from voluntary industry commitments The share of companies using PFASs is deemed to be higher than for consumer Unknown, but the share of companies using PFASs is deemed to be comparatively low given existing substitution trends 2 90039 (which only covers companies producing PPE, not professional sportswear and footwear) Unknown, but the share of companies using PFASs is deemed to be comparatively high 24 500 Unknown, but the share of companies using PFASs is deemed to be comparatively high Unknown Unknown Unknown, but the share of companies using PFASs is deemed to be comparatively high as substitution does not seem to be as widespread as for home Unknown Other: A uto mo tiv e use - Noise and vibration insulation Unknown Unknown 39 C ompanies producing professional sportswear and footwear are not included in this estimate, which is based on Euratex data re lating to workwear. Given the comparatively small customer base for professional sportswear, the number of companies active in this industry branch is however considered to be low. As such, the Dossier Submitter is confident that the number of companies activ e in the professional apparel industry is smaller than the number of companies in other sub-sectors even when considering professional sportswear and footwear. 64 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Home textiles Consumer apparel Professional apparel Technical textiles Leather apparel. Conclusion: Number of Medium40 companies affected by the proposed restriction (in comparison to other TULAC sub-sectors) Most likely reaction of affected companies Most likely Based on No conclusion reaction information possible on impacts at company level from 2nd stakeholder consultation High Rather equal split between closure of business & substitution Low41 C lear tendency towards business closures High42 C lear tendency towards business closures (especially in relation to high performance membranes as submitted information is dominated by information relating to this textiles Unknown No conclusion possible Other: Home fabric treatments (s pr a y s ) Other: A uto mo tiv e use - Noise and vibration insulation Unknown Unknown No relevant information provided No relevant information provided 40 A considerable share of companies in the home textile industry is deemed to already use alter natives. A percentage share is not known. It is noted that the share of companies that still uses PFASs in the home textiles industry is higher than in the consumer apparel industry, howev er the number of companies active in the consumer apparel sector is significantly higher compared to the home textiles sector. As a result, the number of affected companies has been classified as `medium' for home textiles and `high' for consumer apparel. 41 The share of companies in the professional apparel industry that use PFASs is deemed to be comparatively high. Given the small number of companies estimated to be active in the sector, even a high share of companies using PFASs implies that the number of affected companie s is `low' in comparison to other sectors. 42 The share of companies in the technical textile industry that use PFASs is deemed to be comparatively high. A percentage share is not known. The share is however deemed higher than in the home textile industry, where significant progress with phasing -out PFASs has been made - also as a result of voluntary industry commitments (see Section E.2.2.2). Substitution in the technical textile sector appears more limited, with information from the 2nd stakeholder consultation pointing towards proven use of alternatives, while many stakeholder however report that known alternatives are not feasible for their product. Due to the slightly higher number of companies active in the sector and the higher share of companies that are deemed to still use PFASs, the number of affected companies in the technical textile industry is classified as `high', while it is classified as `medium' for the home textile industry. 65 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Home textiles Based on information on technical feasibility of a lte r na tiv e s Mainly substitution Conclusion: Expected share Low of business closures (in comparison to other TULAC sub-sectors) Consumer apparel Professional apparel Technical textiles Leather Mix of reactions - with some business closures given the high market penetration of PFAS-free products Medium Mix of reactions with tendency towards business closures (especially in relation to PPE) High43 application) Mix of reactions with tendency towards business closures for some applications, e.g. high performance membranes, while substitution is more likely for outdoor technical textiles High (for high performance membranes) Mainly substitution Low Other: Home fabric treatments (s pr a y s ) Mainly substitution Low Other: A uto mo tiv e use - Noise and vibration insulation Mainly business closures High Low (for outdoor technical textiles) Unclear for medical applications, but potentially lower than for high performance membranes 43 In relation to the professional apparel, information received during the 2nd stakeholder consultation reveals a clearer tendency towards business closures, which is higher than for the consumer apparel industry (classified as `medium'). The expected share of business closures is t herefore reported as `high'. This is deemed to hold despite the availability of alternatives for some applications, e.g. professional sportswear, as the sector for profe ssional sportswear is deemed to be a niche sector with a limited number of competitors. A high share of substitution for producers of professional sportswear would thus not affect the conclusion for professional apparel as a whole. 66 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Home textiles Consumer apparel Professional apparel Technical textiles Leather Other: Home fabric treatments (s pr a y s ) Costs at company level Business Sales value closure: Cost per company per company Producer active in the sector (in surplus losses44 comparison to other TULAC sub- sectors) Substitution: Cost per company active in the sector Costs for dismantling plants Research & De v e lo pment (R&D) costs Capital costs Operating costs Sales losses are deemed to range from a few million to several million euros per company No sector-specific information is available Low Low High High (for high Low Low performance membranes) Unknown Unknown Unknown Low (for outdoor technical textiles and medical applications) Unknown Unknown Unknown Medium Low Some Medium Low Some High (especially in relation to PPE) High (for high performance membranes) Medium Low Some Low (for outdoor technical textiles and medical applications) Low Some Low Some Medium Unknown Unknown Other: A uto mo tiv e use - Noise and vibration insulation High Unknown High Low Some 44 This row refers to the magnitude of the producer surplus loss at company level, which is dependent on the margin. As such, th e categorization mirrors the categorization of the size of profit margins provided in Table E.21. 67 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Home textiles Consumer apparel Professional apparel Technical textiles Leather Certification costs Total cost45 Medium Ability to pass on costs to customers Expected extent to which Partial companies pass on costs to customers Medium Partial Some (for PPE) Medium (in relation to professional sportswear) High (in relation to PPE) Some (for medical applications and high performance membranes) Medium (in relation to outdoor technical textiles and medical applications) High (in relation to high performance membranes) Medium High High (for high performance membranes) Partial Partial (for outdoor technical textiles and medical applications) Other: Home fabric treatments (s pr a y s ) Other: A uto mo tiv e use - Noise and vibration insulation Some Unknown46 High Partial High 45 Given the limited sample of and wide variation in cost estimates provided by stakeholders, no conclusions on the typical cost incurred by a company in relation to substitution in response to a restriction of PFASs can be drawn by the Dossier Submitters. The indication provide d here represents a conclusion based on the information provided for different cost components (shown in the preceding row s). 46 Information pointing to some additional capital costs as a result of changes in processing times which might result in the ne ed of additional machinery relate to textile finishes. Similarly, information pointing to increases in operating costs is rel ated to the application of textile finishes. This information is not of relevance for the production of home fabric treatments, which is why the level of substitution costs for home fabric treatmen ts is unknown. 68 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Home textiles Consumer apparel Professional apparel Total economic impacts on affected companies at sector level Conclusions Total Total producer A high level of Total producer on total producer surplus losses total producer surplus losses economic surplus loss: are limited by surplus losses are impacts on Company (i) the is expected, exacerbated by affected closures expected low despite low (i) the companies number of margins, due considerable company to (i) the high share of closures and absolute company (ii) the low number of closures, and level of company (ii) the high margins, which closures (in level of limit the light of the big margins. producer size of the surplus losses sector and the at company medium share level. of company closures). Total producer surplus loss: Substitution Producer surplus losses are significant, despite comparatively low costs at company level due to (i) a medium number of companies being affected, Producer surplus losses are significant, despite comparatively low costs at company level due to (i) a high number of companies being affected, (ii) the Producer surplus losses are limited by (i) the low number of companies deemed to be active in the sector, (ii) the low share of substitution, and especially Technical textiles Total producer surplus losses are exacerbated by (i) the comparatively high number of companies, (ii) the possibly considerable share of company closures (especially in relation to high performance membranes), and (iii) the high level of margins for high performance membranes Producer surplus losses are significant, especially due to the (i) the high share of substitution in relation to outdoor technical textiles, (ii) the likely considerable number of Leather Total producer surplus losses are limited by (i) the expected low share of company closures and (ii) the low level of margins. Producer surplus losses are exacerbated by (i) substitution being deemed the dominant reaction to the proposed Other: Home fabric treatments (s pr a y s ) Total producer surplus losses are limited by (i) the expected low share of company closures and (ii) the low level of margins. Producer surplus losses are exacerbated by (i) substitution being deemed the dominant reaction to the proposed restriction, and (ii) partial internalization Other: A uto mo tiv e use - Noise and vibration insulation Total producer surplus losses are likely significant given (i) the expected high share of business closures, and (ii) the high level of margins. Producer surplus losses are limited due to the low share of substitution. 69 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Home textiles Consumer apparel Professional apparel Technical textiles Leather Other: Home fabric treatments (s pr a y s ) (ii) substitution being the reaction of the majority of affected companies, and (iii) partial internalization of costs. medium extent of substitution, and (iii) partial internalization of costs. (iii) a good ability to pass on costs to customers, which outweighs comparatively high substitution costs (especially in relation to PPE) at company level. companies being active in this mass market industry (due to the low barriers to entry) and (iii) partial internalization of costs in this industry, which outweighs the comparably low costs at company level to some extent. restriction, and (ii) partial internaliza- tion of costs, which outweighs the compara- tively low costs at company level to some extent. of costs. Other: A uto mo tiv e use - Noise and vibration insulation 70 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The total impact on EU industry in the form of changes in producer surplus is not solely determined by total economic impac ts on affected companies, i.e. the producer surplus losses resulting from substitution and business closures, assessed in Table E.23. Further relevant determinants of the total impac t on the respective EU industry sec tors are: The extent to which producer surplus losses resulting from business closures of affected companies are offset by gains in producer surplus of EU companies that already provide alternative-based products; and The extent of indirect impacts on companies, other than suppliers of PFASs, in the supply chain. The capability of companies already supplying alternative-based products to offset impacts without inc urring high c osts themselves, whic h would limit the extent of offsetting, depends on a variety of factors including the market share of affected firms, the degree of specialisation and the extent of spare capacity. A high-level assessment of the extent of offsetting in each sub-sector is provided in Table E.24. Possibilities for offsetting producer surplus losses are deemed to be highest in the consumer apparel sector where many companies have already transitioned and the degree of specialization is comparatively low. The extent of indirect impacts on EU upstream actors, other than suppliers of PFASs, is mainly influenced by the extent of business closures in a sub-sector. While substitution will impact the sales of EU companies producing PFASs (which, at EU level, will be balanced out - at least to some extent - by increased sales of other chemicals), major impacts on other suppliers, e.g. producers of synthetic fibres, are not expected as a result of substitution. Business closures of EU companies might, in contrast, lead to a reduction in the sales volumes of such EU suppliers - unless those are balanced out through increased sales to competitors of the business that closed down, i.e. companies that substitute in response to the restriction as well as existing suppliers of alternat ive-based products. The extent of supply-chain impacts in each sub-sector are assessed in Table E.24 - taking into account (i) the expected share of business closures in each sub-sector as well as (ii) the offsetting potential. The impacts on the supply chain are deemed to be highest for the professional apparel and technical textile industries and in relation to textiles for use in engine bays. 71 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.24. Assessment of offsetting potential in different TULAC sub-sectors in the EU as well as producer surplus losses in the upstream supply chain. Home Consumer Professional Technical Leather Other: Home Other: textiles apparel apparel textiles fabric A uto mo tiv e treatments use - Noise (s pr a y s ) and vibration insulation Potential for producer surplus gains of EU companies that already provide alternative -based products (Offsetting potential)47 Extent of competition High High Low Low High High Low (`High' in relation to outdoor technical textiles) Market share of affected Medium Low High High High Unknown High companies Degree of specialization Low Low High High Low Low High (`Low' in relation to outdoor technical textiles) Other barriers to entry Low Low High High Low Low High e.g. extensive investment (`Low' in requirements, relation to long-standing customer outdoor relationships technical textiles) 47 The criteria employed for assessing the potential for offsetting producer surplus losses of companies directly affected by the restriction are based on the SEAC guidance on assessing changes in producer surplus published in September 2021 (EC HA, 2021b). According to EC HA (2021b), the five criteria and the offset potential are related as follows: The offsetting potential is high if (i) the sector is associated with a high level o f competition; (ii) the market share of affected companies is low (as this renders it more likely that other companies can supply additional volumes without the need for making investments themselves), (iii) the extent of specializations is low (as this increases the possibility of oth er companies to take over market shares), (iv) the sector is associated with low barriers to entry (as this increases the contestability of the market); and (v) a high share of competito rs is located in the EU (as producer surplus gains of non-EU companies are not considered as part of socio-economic assessments related to EU legislation, and therefore do not constitute an offset). 72 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Share of EU competitors Unknown Unknown out of all competitors providing non-PFAS products Conclusion: Offsetting Medium High potential Producer surplus losses in upstream supply chain Expected share of Low Medium business closures Unknown Low High Unknown Unknown Low Low High (for high Low performance membranes); Unknown Unknown Low Unknown Low High Low (for outdoor technical textiles) Conclusion: Extent of producer surplus losses in upstream supply chain Low - due to the small extent of business closures Low - while the extent of business closures is higher than in the home textile industry, the offsetting potential is also higher High - due to the high extent of business closures and low offsetting potential Unclear for medical applications, but potentially lower than for high performance membranes High - due to the high extent of business closures (for some technical textile applications) and low offsetting potential Low - due to the small extent of business closures Low - due to the small extent of business closures High - due to the high extent of business closures and low offsetting potential 73 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.2.4.2. Economic impacts on customers In addition to the changes in producer surplus described in section E.2.2.4.1, a restriction of PFASs might also impact the customers of companies that use PFASs for the production of goods in the textile, upholstery, leather, apparel and c arpet (TULAC) industry, i.e. industrial or professional downstream users and households. Negative impacts on customers might inc lude: Consumer surplus losses, resulting from an inc rease in the pric e of the good at which it is offered to the customer; Welfare losses and/or costs resulting from changes in the characteristics of the good, i.e. its quality and lifetime, or the absence of the product (in case substitution is not feasible); and Additional costs - e.g. increased energy costs - incurred when using the good. The extent of consumer surplus losses associated with price changes resulting from substitution is determined by (i) the change in the market price of the good which reduces the difference between the price that the customer has to pay and the maximum price the customer would be willing to pay, and (ii) the change in the quantity that is purchased in consequence of the price change. Changes in the quantity purchased in comparison to the baseline thus exacerbate consumer surplus losses. The extent to which the quantity purchased by customers changes depends on the price elasticity of demand for the good. For some goods, demand is very sensitive to price changes and a price increase will lead to a reduc tion in the quantity that is purc hased. For other goods, the quantity of the good that is purchased does not change (much) as a result of the price change as customers deem it necessary to have access to the good and assign less importance to the price in their purchasing decision. The extent of consumer surplus losses in different sub-sectors is therefore assessed based on (i) the magnitude of additional costs associated with substitution in each sub-sector and the extent, analysed in sec tion E.2.2.4.1, to which c ompanies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into account the extent to which this volume will be replaced by alternative-based products (based on a consideration of the substitution share). As mentioned in section E.2.2.4.1, the textile and clothing industry in the EU-27 had a turnover of 147 billion in 2021 (EURATEX, 2022)48. Exports accounted for 58 billion in the same year (EURATEX, 2022), which implies that sales to EU customers equalled approximately 89 billion. In the same year, goods of a value of 106 billion were imported (EURATEX, 2022). A large share of textiles and clothing available to customers in the EU-27 was thus imported. Imports played an even bigger role in the clothing industry, where imports (at a value of 72 billion) exceeded the overall turnover of EU companies of 65.3 billion as well as the turnover based on sales to EU customers of around 32.3 billion (EURATEX, 2022). Some information on the volumes of goods that are sold in different sub-sectors is also available. These are used as a basis for c oncluding on the magnitude of the volume of goods containing PFASs in each sub-sector. Table E.25 provides estimates of the sold production volume in 2019 at sub-sector level based on PRODCOM49 data. Sold production volumes thereby refer to the volume of goods sold by producers located in the EU, Norway and 48 This includes fabric producers, producers of man-made fibres and yarns as well as producers of home textiles, knitwear producers, producers of clothing and accessories, underwear, workwear as well as industrial and technical textiles. 49 PRODC OM (abbreviated from the French term "Production C ommunitaire") is an annual survey producing data on the production of industrial goods in the EU. 74 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Iceland50. Estimates at sub-sector level have been derived by linking PRODCOM codes to relevant TULAC sub-sectors. For ease of comparison, PRODCOM data, which is presented in a variety of units, e.g. kilogram, cubic metres, pairs, items, has furthermore been converted to tonnes. Assumptions used to derive these estimates are provided below the table. Table E.25. Sold production volumes for EEA countries in 2019; calculated based on PRODCOM data. Sub-use Sold volume (2019) Units Home textiles C arpets and rugs 1 568 818 * tonnes C urtains and blinds 161 662 * tonnes Upholstery 940 400 ** tonnes Consumer apparel Indoor and outdoor 1 347 547 *** tonnes wear Sportswear 45 412 *** tonnes Footwear - - Accessories - - Professional apparel Professional sportswear - - and footwear PPE for industrial and 101 187 ** tonnes professional use (other than sportswear) Technical textiles Outdoor technical 582 152 **** tonnes textiles 1 265 **** number of items Medical applications - - High performance - - membranes Leather Leather based goods 173 973 ** tonnes Indoor and outdoor 10 150 *** tonnes wear Footwear 711 548 ***** tonnes Professional sportswear - - and footwear Other Home fabric treatments - - (sprays) Automotive use - Noise - - and vibration insulation * Cubic metres (m2) c onverted to (thousands of) kilogram (kg) based on a c onversion rate of (i) 2 kg/m2 for c arpets and rugs and (ii) 1 kg/m2 for c urtains. ** Number of items c onverted to (thousands of) kilogram (kg) based on a c onversion rate of (i) 20 kg/item for upholstered furniture, (ii) 1 kg/item for professional apparel and (iii) 1 kg/item for leather products. *** Mix of number of items and number of pairs c onverted to (thousands of) kilogram (kg) based on c onversion rate of (i) 0.25 kg/item for c onsumer c lothing, (ii) 0.5 kg/item for sportswear and (iii) 1 kg/pair for footwear. **** Two separate values are presented for this sub-category as no c onversion factor was identified. ***** Number of pairs c onverted to (thousands of) kilogram (kg) based on a c onversion 50 According to the 2021 edition of "European business statistics user's manual for PRODC OM", PRODC OM data includes information from two countries that are not an EU Member State, i.e. Norway and Iceland, while no data from three EU Member States (C yprus, Luxembourg and Malta) is included based on the small economic size of the country, which exempts these countries from the duty to provide data (Eurostat, 2022). As the third EEA country that is not part of the EU, i.e. Liechtenstein, is also a country with a small economic size, PRODC OM data is deemed representative for the EEA. 75 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) rate of 1 kg/pair. The volumes provided in Table E.25 refer to the entire volume of goods sold in 2019, regardless of whether they were sold to EU or non-EU customers. Reported values thus also include exports. While potential changes to the market price of relevant goods will also affect non-EU customers, associated consumer surplus losses faced by non-EU customers are not further considered as assessments of the socio-economic impacts under REACH typically focus on impacts on the EU/EEA. Consumer surplus losses associated with imports (for which volume data is provided in Table E.26) are, however, relevant. As the proposed restriction applies to both locally produced as well as imported articles, non-EU producers of PFAScontaining goods might also decide to substitute in order to be able to continue supplying products to the European market. Price changes of a similar magnitude as for locally produced goods can thus be expected for imported goods. Table E.26. Summary of import and export data (2018) provided by Euratex . Sub-use Home textiles Consumer apparel Professional apparel Technical textiles Leather Other C arpets and rugs C urtains and blinds Upholstery Indoor and outdoor wear Sportswear Footwear Accessories Professional sportswear and footwear PPE for industrial and professional use (other than sportswear) Outdoor technical textiles Medical applications High performance membranes Leather based goods Indoor and outdoor wear Footwear Professional sportswear and footwear Home fabric treatments (sprays) Automotive use - Noise and vibration insulation Imported into EU-28 (t) 450 657 123 082 88 028 2 862 574 79 046 - Exported from EU-28 (t) 251 333 9 339 8 356 167 971 427 154 - - - 859 662 124 639 - 270 127 66 519 - - - - - Given that it is the total volume of goods sold to EU customers that is of relevance for consumer surplus losses resulting from the proposed restriction, Table E.27 provides an estimate of the order of magnitude of the volume of goods supplied to EU customers, taking into ac count the sold production volumes in Table E.25 as well as informat ion on EU-28 import and export volumes for 2018 plac ed at disposal by Euratex, which are displayed in Table E.26. While this import and export data does not refer to the same year as the sold production volumes in Table E.25, which represent 2019 data, they constitute the best basis for providing an indication of the volume of goods supplied to EU customers in different sub-sectors as no other information of a comparable level of granularity is available to the Dossier Submitters. As the market situation is deemed to not have changed much between 2018 and 2019 given that both years fall before the start of the Covid-19 pandemic , the Dossier Submitters consider it appropriate to use 2018 data as a proxy for import and export volumes in 2019 in the absenc e of other data. As the main purpose c onsists of c reating an understanding of the order of magnitude of consumer surplus losses in different sectors (instead of an exact monetary 76 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) estimation), the available datasets are also deemed to be an appropriate basis for the estimation despite the differences in the geographical scope (whereby data on sold production refers to the EU-28 plus Norway and Iceland, while import and export data covers the EU28). Combining information on the volume of goods supplied to European customers in relation to each sub-use with information on, firstly, the magnitude of additional costs associated with substitution in each sub-sector together with the extent to which companies are expected to pass on costs to customers and, secondly, the price elasticity of demand, Table E.27 provides information on the expected magnitude of consumer surplus losses in relation to each subuse. Of the sub-sectors for which the magnitude of substitution costs could be determined, pric e c hanges are deemed to be lowest in relation to home textiles, consumer apparel, leather and outdoor tec hnical textiles given that c ompanies in these industries are expec ted to face lower substitution costs than other sub-sectors and are expected to only partially pass on increased costs resulting from substitution to their customers. For all of these sub -uses, consumer surplus losses are however deemed to be exacerbated by more significant changes in the quantity purchased as a result of the high price elasticity of demand. While price changes in the professional apparel industry (especially in relation to PPE), the technical textile industry (especially in relation to high performance membranes) and the automotive industry are expected to be higher than in the aforementioned sectors, consumer surplus losses are deemed to be limited by the smaller impact on purchased quantities given the lower pric e elast icity of demand. As such, the Dossier Submitters consider the annual volume of goods (containing PFASs) sold to EU customers to be the main determinant of differences in the magnitude of consumer surplus losses for different sub-uses. As shown in Table E.27, the annual volume of goods (i.e. PFAS-containing and PFAS-free goods) sold to European customers is estimated to be highest with respect to consumer apparel and home textiles. The difference in sales volumes be tween home textiles and consumer apparel is likely underestimated as the estimation for consumer apparel is only based on one of the four relevant product types, i.e. indoor and outdoor wear, as no data was available for footwear and accessories, and the sold production, and import and export data for sportswear was found to be contradictory, as described in more detail in the table note. While the estimated volume is lowest for professional apparel, this estimate needs to be treated with caution, as it is solely based on sold production data for PPE and does not account for professional sportswear and footwear due to a lack of data. Similarly, the volume for technical textiles is deemed to be underestimated as the volume for outdoor technical textiles is not accounting for information on sold production volumes provided as number of items in Table E.25, and does not include medical textiles sold by EU companies as well as locally produced and imported high performanc e membranes due to a lack of data. The volume of leather-based products purchased annually is also deemed to be underestimated as it is based on data on only three of four relevant product categories (as no data was available for professional sportswear and footwear). The estimate also does not account for imports due to a lac k of data. Given that the volumes are deemed to be underestimated for all uses except home textile, the Dossier Submitters, nevertheless, consider the conclusions on the comparative magnitude of sales volumes to be robust. While the exact share of products produced in as well as imported into Europe that contain PFASs is unknown, information presented in Section E.2.2.2 indicates an existing trend to substitution predominantly in relation to consumer apparel but also home textiles, where various voluntary industry commitments have been made. As such, the market penetration of alternatives is deemed to be highest in the c onsumer apparel sec tor followed by the home textile sector. With respect to products containing PFAS, the Dossier Submitters therefore consider the difference in sales volumes between the home textiles and consumer apparel, on the one hand, and professional apparel, technical t extiles and leather-based goods to be smaller than for the whole market. Information submitted to the CfE (already mentioned in Section E.2.2.4.1) revealing that the major users of PFASs are companies producing consumer apparel followed by the home textile sector and technical textile sector is not deemed to 77 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) contradict this conclusion as the high use volumes are deemed to be a result of the sheer size of these sectors. As a result of the size of the sector, the Dossier Submitters conclude that the volume of goods in relation to which consumer surplus losses could occur, i.e. the share that is containing PFAS, is still higher in the home industry and consumer apparel sectors than in the other assessed sectors despite the higher market penetration of alternatives. As a result, total consumer surplus losses triggered by changes to price resulting from substitution are expected to be highest in relation to consumer apparel and home textiles, followed by tec hnical text iles and leather-based goods. 78 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.27. Conclusion on magnitude of consumer surplus losses resulting from price changes associated with substitution in relation to different TULAC sub-uses under a full ban of PFASs. Sub-use Home textiles Consumer apparel Professional apparel Technical textiles Magnitude of costs associated with substitution per company according to Table E.23 Medium Medium Medium/High Medium/High Expected extent to which companies pass on costs to customers Partial Partial High Partial (for outdoor technical textiles and Price elasticity of demand Annual volume of goods (with and without PFAS) sold to EU customers Estimated Magnitude volume (t, (in based on comparison 2018/2019 to other data) sectors) Annual volume of goods (containing PFAS) sold to EU customers High 3 063 619 High High 4 042 150 * High Low 101 187 (which Low only covers PPE) ** High (with the exception of high 1 296 326 (mainly covering outdoor Medium High (and the entire volume will likely be replaced by PFAS-free products given the high share of substitution) High (and the entire volume will likely be replaced by PFAS-free products given the medium share of substitution and the potential of substituting companies to take over market share from companies ceasing production) Low (and given that substitution is only an option for some types of PPE, consumer surplus losses from price changes will likely only be incurred in relation to a share of the volume reported here, but substitution and associated consumer surplus losses will also be incurred in relation professional sportswear and footwear) Medium (and the majority of the volume will likely be replaced by PFAS-free products given the high share of substitution for outdoor Expected magnitude of consumer surplus losses from price changes (compared to other TULAC sub-sectors) High High Low Medium 79 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sub-use Magnitude of Expected Price Annual volume of goods Annual volume of goods Expected costs extent to elasticity (with and without PFAS) (containing PFAS) sold to EU magnitude of associated which of sold to EU customers customers consumer with companies demand Estimated Magnitude surplus substitution pass on volume (t, (in losses from per company costs to based on comparison price changes according to Table E.23 customers 2018/2019 data) to other sectors) (compared to other TULAC sub-sectors) medical performa technical technical textiles) applications) nce textiles) *** membran High (for es) high performance membranes) Leather Medium Partial High 895 671 ** Medium Medium (and the entire volume will Medium likely be replaced by PFAS-free products given the high share of substitution) Other: Home Unknown Partial High n/a n/a n/a Unknown fabric treatments (s pr a y s ) Other: High High Low n/a n/a n/a Low, due to Automotive use the low - Noise and substitution v ibr a tio n share insulation * This estimate is based on information for indoor and outdoor wear only. Data on sportswear has not be used as the reported volume for sold production of 45 412 t is much lower than the export volume of 427 154 t. As such, at least one of the available volumes must be incorrect, which is why data for this use has not be taken forward. ** This estimate is only based on estimate of the sold production volume as no data on import and export volumes are available. *** This estimate is based on (i) information for outdoor technical textiles, whereby information on sold production volumes provided as number of items in Table E.25 is not taken into c onsideration, and (ii) import data for medic al applic ations. (No information on sold production volumes is available for medical applications). 80 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) In addition to the consumer surplus losses resulting from price changes, socio-economic impac ts on c ustomers under a full ban might also oc c ur in the form of c hanges in quality or in the worst case - the complete absence of products based on the non-existence of technically feasible alternatives. Products, for which a full ban of PFASs is likely to lead to products not being available to EU customers as a result of technical feasibility considerations include, for example, Category III PPE for the protection against liquid and gaseous chemicals, inc luding aerosols and solid partic les, and mic roorganisms, and PPE for firefighting ac tivities. A full ban of PFAS would also prevent maintenance, i.e. re-impregnation, of Category III workwear already in use. For these products, alternatives to PFASs are not able to provide the required functionalities at the level that is necessary to reach the requirements set out in EU legislation according to the assessment of the Dossier Submitters presented in Section E.2.2.2. As the provision of products of lower quality (below the set standard) is not acceptable for such products, a complete restriction of PFASs would actually result in the complete unavailability of suitable PPE for these types instead of changes to the quality of PPE on the market. The same applies for non-wovens used for insultation purposes in automotives. According to stakeholder information (presented in Section E.2.2.2), alternatives do not allow to meet relevant standards, e.g. those set in noise regulations. The absence of such products is assoc iated with wider impac ts, e.g. impacts on industrial production processes in other sectors in Europe due to the non-availability of PPE. In relation to PPE, some room for using products with lower performance levels might however exist according to information provided by stakeholders (presented in Section E.2.2.2). Stakeholders reported that PPE with higher protection levels might be overused as a result of companies providing workers with PPE with higher protection than legally necessary for their activities - for example, due to the wish to equip the entire workforce with uniform clothing. As a result, some customers might be able to switch to different types of PPE available on the market for some applications without a negative impact on the protection of PPE users. A lower performanc e level of alternatives with respect to the key func tionalities provided by PFASs does however not preclude the adoptions of such alternatives in all sub-sectors. In relation to leather applications in automotives one stakeholder responding to the 2 nd stakeholder consultation, for example, noted (as reported in Section E.2.2.2) that they have been able to identify an alternative whose oil and soil repellenc e properties are c lose enough to PFAS-based products and that they have as a result started to substitute away from PFAS. Customers would thus fac e some c hanges in the c haracteristics of goods. Where companies decide to substitute despite knowledge of differences in the performance level of alternatives in c omparison to PFASs, c onsumer surplus losses as result of a c hange in produc t pric es will be c omplemented by welfare losses and/or c osts resulting from c hanges in the characteristics of the goods, i.e. its quality and lifetime. Changes in the quality of the good thereby refer to changes in functionality, e.g. the level of oil and soil repellence of leather-based seat c overings and furniture. A negative c hange in the quality of the good will either result in welfare losses, if the user takes the c hange as given, or result in higher c osts, if the user attempts to counteract the change in quality through compensation measures, e.g. the use of a seat/furniture cover. Negative changes in lifetime also typic ally result in higher costs as downstream users will replace the good in shorter intervals. As stated in Wood (2020b), longer durability of products can thereby be the result of either the functionality itself being more long-lasting (e.g. the product being water repellent for longer) or of the provision of additional functionalities (in comparison to alternatives) that are beneficial for preventing staining of the product and might thus prevent early disposal of products. As noted in Section E.2.2.2, information submitted to the CfE revealed that the biggest differenc e between PFASs and alternatives is their c apacity to provide several func tionalities simultaneously. While reaching broadly comparable levels of water repellence tends not to be a concern, identified alternatives reach lower levels of performance for other functionalities. A review of relevant chemical alternatives, i.e. dendrimer, silicone/hydrocarbon b lends, hydrocarbons, nanotechnologies, polyurethane and silicones, suggested, for example, that 81 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) they provide inferior oil and dirt repellence. More specifically, a stakeholder submitting information to the 2nd stakeholder consultation stressed in relation to hydrocarbons, polyurethanes, and silicones that these alternatives are - in principle - able to provide some oil repellenc e but only when used on hard surfac es and not on irregular surfac es like textiles. According to the stakeholder, PFASs and these alternatives also differ in their durability resulting in negative impacts on the length of the service life of goods treated with alternatives. If used by producers of textile goods, the use of these alternatives would thus lead to changes in the quality and lifetime of the good. In the case of hydrocarbons, for example, quality losses (in relation to oil repellenc e) and negative impac ts on lifetime of the good are likely in relation to home textiles, consumer apparel as well as leather applications as hydroc arbons were identified as relevant alternatives for these applic ations in Table E.12. In sec tion A.3.3.1, oil repellenc e (in addition to water repellence) was however only identified as a key functionality provided by PFASs in relation to home textiles, sportswear and footwear and leather applic ations, while for other types of c onsumer apparel, i.e. outdoor wear, indoor wear and ac c essories, only water repellenc e was identified as a key func tionality provided by PFASs. Quality losses in relation to oil repellence are thus of less importance for outdoor and indoor wear as well as accessories. The Dossier Submitters therefore acknowledge that some welfare losses and/or additional c osts as a result of c hanges in the quality or the lifetime of the good are likely to oc cur as a result of a restriction. Quantification of such impacts is not possible due to (i) uncertainties with respect to the annual volume of PFAS-based products sold in each sub-sector, (ii) uncertainty about the extent of companies that substitute, (iii) a lack of detailed information on the extent to which different alternatives will be chosen by affected companies and (iv) detailed (quantitative) information on the extent to which alternatives differ in functionality and the associated consequences. The choice of alternatives by companies is of particular relevance in this respect and the Dossier Submitters note that even the existence of a technically feasible alternatives with closely comparable funct ionality to PFASs does not necessarily prevent the occurrence of quality losses completely as knowledge about this alternative might not be available to all industry actors. The stakeholder providing information for leather applications in automotives in t he 2nd stakeholder consultation (previously referred to in Section E.2.2.2 as well as this section), for example, reported that they found an alternative whose oil and soil repellence properties is close enough to PFASs and that they have as a result started to substitute. In relation to the use of fluoropolymers (for anti- soiling purposes) in the manufacture of leather products, silicone-based products are furthermore reported by Drohmann et al. (2021) to be an alternative that could provide a comparable performanc e with respect to soil repellence with resistance to coffee being the sole exception. In c ontrast, another c ompany stated in the 2nd stakeholder c onsultation in relation to the use of PFASs for textiles in automotives that alternatives cannot replicate the oil and soil repellence level of PFASs. As such, conclusion of different stakeholders on the technical feasibility of alternatives with respect to oil and soil repellence varies. This might be due to differing requirements of companies but could also be due to knowledge differences with respect to alternatives - with some of the alternatives potentially being the result of recent successful R&D processes. Especially in relation to the first stakeholder, it can - given the unspecific information on the identity of the alternative - not be ruled that the substance used c onstitutes a substance currently unknown to the Dossier Submitters. For some applic ations, the extent of unavoidable quality losses c ould thus be smaller than antic ipated based on the most widely known alternatives. While newly developed alternatives would not be implemented widely in the short t erm given the confidential nature of R&D results, the Dossier Submitters c onsider it likely that companies producing goods of higher quality (based on these alternatives) would take over market share from producers of goods of lower quality over time - if the lower quality is deemed unacceptable by customers, and that these alternatives would become more widely known over time. Overall, quality losses are deemed to be most limited in relation to consumer apparel applications, more specifically indoor and outdoor wear as well as accessories, as these applications only require water repellence, according to the key functionalities provided by PFASs identified in Sec tion A.3.3.1. Consumer sportwear and footwear as well as other textile 82 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) applications require the simultaneous provision of several functionalities rendering quality losses more likely and extensive than in relation to the aforementioned consumer apparel applications. While water repellence can be obtained with alternatives (as mentioned above), their performance is slightly lower than that of PFASs according to stakeholder information received in the CfE. Small changes in product quality could thus occur, e.g. there could be c hallenges c oncerning their technical performanc e under severe c onditions. In general, such quality losses, as well as changes in durability, seem however acceptable to customers ac c ording to information submitted to the CfE by another stakeholder. In the 2nd stakeholder consultation, a big fashion chain, that has completely subst ituted away from PFAS, furthermore, reported that they are satisfied with the performance of alternatives and that non-fluorinated water repellents are the standard in their industry. As such, changes in the quality of indoor and outdoor wear and accessories as result of a full ban of PFASs are deemed to be negligible by the Dossier Submitters. Impac ts on c ustomers from a shorter lifetime of such products in the form of additional costs are deemed more significant in relation to consumer apparel. One stakeholder reported in the CfE that use of alternatives results in a higher replacement frequency or more frequent re-impregnation as alternatives withstand household laundering much less. Another factor that could - according to the Background Document to the opinion on the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances (ECHA, 2021a) - generally lead to a reduced lifetime of consumer apparel and/or additional c leaning c osts is the lower performanc e of alternatives with respect to functions like oil and stain repellence. Referring to a study on PFAS coatings of school uniforms in the United Kingdom concluding that the use of stain-resistant textile finishes is not associated with a lower washing or replacement frequency, the Dossier Submitter for the restriction of PFHxA however stated that these functionalities might not be as important to c ustomers as claimed by industry (ECHA, 2021a). As a result, the Dossier Submitters conclude that changes in the lifetime of consumer apparel due to a restriction of PFASs are probably mostly resulting from the lower capability of alternatives to withstand household laundering. The extent to which the lifetime of consumer apparel might be reduced as a result as well as the magnitude of costs for re-impregnating goods to counteract this deficiency to avoid disposal are unknown to the Dossier Submitters. A reduction in the lifetime of the good is also possible in relation to home textile applications and textiles used for automotive interiors. As noted in the Background Document to the opinion on the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances, the use of alternatives providing a lower level of oil repellence and other functionalities like soil repellence might result in a reduced lifetime of home textiles as well as increased cleaning efforts. Such impacts were repeatedly mentioned by stakeholders in the Annex XV rerport consultation conducted in relation to the restriction on PFHxA (ECHA, 2021a). Customers might thus face inc reased costs for cleaning home textiles and automotive interiors or purchasing washable and replaceable covers, or - in the worst case - replacing home textiles more often. If such actions for counteracting the changes in functionality are not taken, customers might face welfare losses due to the inferior aesthetic appearance of their home and automotive interiors. Stakeholder information also points to possible negative impacts on the lifetime of outdoor technical textiles. As mentioned in Section E.2.2.2.4, the substitution potential for outdoor technical textiles is high. A relevant alternative with respect to PTFE membranes used in outdoor technical textiles, for example, was reported by one stakeholder in the 2nd stakeholder consultation (as previously noted in Section E.2.2.2). This stakeholder reported that polyurethane- and polyester-based membranes are a proven alternative. Information on differences in the quality and lifetime of PFAS-based and alternative-based products is however not available. With respect to PFAS-based top coat finishes for, amongst other applic ations, outdoor upholstery and tents, stakeholder information from the 2nd stakeholder consultation however points towards a potentially significant loss in the lifetime of products as a result of a proposed restriction on PFASs. The lifetime of outdoor upholstery and tents is reported to be around three to five times shorter if PVDF is not applied as top coat finish on PVC-coated fabrics, with PVDF-coated fabrics lasting 10 to 15 years in comparison to t hree years without the top coat. Drohmann et al. (2021) furthermore states that PVDF coatings in 83 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) itself last between two and five decades and are thus signific antly more durable than other coating technologies available for construction textiles. While requiring fewer re -coatings, PVDF coatings also have the benefit that the associated recoating process does - in contrast to other technologies - not create volatile organic compounds. A reduced lifetime of outdoor technical textiles, such as outdoor cushions and seating, was also mentioned in stakeholder responses to the Annex XV report consultation conducted in relation to the restriction on PFHxA. Stakeholders c laimed that the reduced dirt, oil and soil repellence of alternatives would lead to visual impairments and reduced lifetime of goods (ECHA, 2021a). For other products, e.g. some types of PPE, a full ban of PFASs is deemed to lead to their unavailability - as mentioned above - as alternatives to PFASs are deemed to not provide the required functionalities at the level that is necessary to reach the requirements set out in EU legislation. According to the assessment of the Dossier Submitters summarised in Table E.13, some types of PPE do, however, not require the use of PFASs to reach legally prescribed standards. One example is PPE for Risk Category I(e), i.e. atmospheric conditions that are not of an extreme nature, as alternatives are deemed to provide a sat isfactory level of water repellence. Substitution to alternatives might however lead to some quality losses for such types of PPE. With respect to footwear, for example, one stakeholder reported in the 2nd stakeholder c onsultation that it is c ruc ial that water repellenc e is c ombined with good water vapour permeability. According to the stakeholder, this combination cannot be replicated at a comparable level by alternatives, whose use would also read to a reduction of tear strengths. Downstream users of PPE, both those types for which substitution to alternatives is deemed feasible as well as those for which PFASs are deemed to be required to reach required performance standards, are furthermore expected to incur additional costs for replacing PPE earlier than planned. As mentioned in section E.2.2.4.1, PPE that is already on the market relies on re-impregnation to provide its protective performance. If relevant PFAS -based products are not available anymore as a result of the proposed restriction, relevant PPE would need to be replaced before reaching the end of its lifetime. With respect to high performance membranes, information on whether suitable alternatives are available is mixed. While some stakeholders mentioned in the 2nd stakeholder consultation - as described in more detail in section E.2.2.2 - that no alternatives with an adequate performance level are currently known for PFAS-based finishes in industrial filter applications such as coalescing filters as well as PTFE-based membranes for filtration of very fine particles, another stakeholder points to the proven use of polyurethane (as well as polyester-based) membranes in relation to high performance membranes. Overall, the Dossier Submitters rec ognized in sec tion E.2.2.2 that alternatives seem to be less generally available for high performance membranes than for consumer applications for instance but noticed that substitution is likely a possible option for at least some technical textile applications. This is generally in line with the c onclusions reached in relation to the restriction of PFHxA, for which the Dossier Submitters suggest a derogation for filtration and separation media used in high performanc e air and liquid applic ations that require a c ombination of water-and oil repellence properties, despite acknowledging that some alternatives might already be available or will become so in the near future. Some substitution might thus occur in relation to the highperformance membranes in response to a full ban of PFASs but changes to the characteristics of membranes, i.e. quality and lifetime, are likely. The use of alternatives in membrane filters could lead to a c hange in pressure properties (porosity) and a reduction in lifetime of the filter. In relation to fluoropolymer membranes designed for the removal of microbiological c ontaminants from air and proc ess fluids, filtration efficiency would also decrease accord ing to stakeholder information from the 2nd stakeholder consultation. Without PFASs, filters themselves are claimed to degrade which would lead to contamination downstream. In relation to filters for the removal of dusts and mists in industrial processes, non-PFAS filtration solutions are reported to be associated with lower process efficiency and a shorter lifetime of the filter by one stakeholder in the 2nd stakeholder consultation. As a result of the shorter lifetime, the use of alternative filtration solutions is associated with higher process downtimes for user ac cording to the stakeholder. Due to higher drops in pressure ac ross filters, the use of non-PFAS filtration solutions is also reported to lead to increases in energy use. With respect to coalescing filters, for which stakeholder information suggests that no alternatives 84 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) might be available, stakeholder information highlights that this would lead to failure or a shortened lifetime of industrial equipment. Given that such filters are required in nea rly all industry sec tors, the economic impac ts are reported to be wide -ranging. E.2.2.4.3. Other impacts on society As mentioned in section E.2.2.4.1, a restriction proposal of PFASs is deemed to lead to business closures in affected sub-sectors. The share of business closures (summarised in Table E.23) is deemed to be particularly high in the professional apparel industry, the technical textile industry (more specifically with respect to the production of high-performance membranes) as well as in relation to the production of automotive textile applications. While the number of companies using PFASs is unknown to the Dossier Submitters, estimates of the number of c ompanies ac tive in different sub-sectors range from a few thousand to tens of thousands. Business closures can thus be expected to affect a significant number of companies in the EU. As such, a proposed restriction of PFASs will also likely lead to considerable employment losses. Some information on employment losses at company level has been received in the course of the 2nd stakeholder consultation in which stakeholders were asked to provide information on the economic and social impact on their company if the use of PFASs is prohibited in three years. While the sample of quantitative estimates is limited (and therefore not deemed representative), these estimates provide some insights into possible employment losses at company level in different sub-sectors. For all relevant TULAC sub-sectors, Table E.28 presents the number of company-specific estimates for job losses provided as well as the relevant range. Table E.28. Range of employment losses (at company level) resulting from business closures based on information provided in the 2nd stakeholder consultation. Sub-use Home textiles Consumer apparel Professional apparel Technical textiles Leather Other: Home fabric treatments (spray s) Other: Automotive use - Noise and vibration insulation Sample size, i.e. number of companies providing useable quantitative information on employment losses n/a n/a 6 7 n/a n/a 1 Reported number of jobs lost (at company level) Minimum n/a n/a 6 25 n/a n/a 20 Reported number of jobs lost (at company level) Maximum n/a n/a 2 000 430 n/a n/a 20 Based on the information submitted to the 2nd stakeholder consultation, it thus seems reasonable to assume that job losses as a result of business closures range from less than 10 jobs to several thousand jobs per company in the TULAC industry. Due to the unc ertainty about the number of c ompanies that would c ease operation and a lack of representative data on the average number of employees in relevant companies (which might differ between sub-sectors depending on how labour-intensive the associated production process is), the magnitude of employment losses in sub-sectors could however not be estimated. The uncertainty about the number of c ompanies that would c ease operation is a particular concern in relation to the c onsumer apparel industry, the professional apparel industry, the technical textile industry and in relation to textiles for use in engine bays, which are the sectors with a medium or high share of business closures. Given the high total number 85 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) of affected companies in these sub-sectors and the significant share of business closures, costs associated with employment losses might be substantial. Given the high share of substitution in relation home textiles, leather applications and home fabric treatments, employment losses are deemed to be low in these sub-sectors. No evidence pointing towards changes in the skills and qualifications required in the TULAC supply chain or the job quality of workers as a result of substitution to non-PFAS alternatives is available to the Dossier Submitters. E.2.2.5. Summary of cost and benefit assessment E.2.2.5.1. Home textiles Table E.29 summarises the outcomes of the assessment of costs and benefits for home textiles. More detailed information c an be found in the accompanying text following the table. 86 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.29. Home textiles - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s Sufficiently strong evidence that technically feasible alternatives exist, with five of seven alternative substance groups being identified as relevant for home textiles, i.e.: Dendrimers; Hybrid (Silicone/hydrocarbon); Hydrocarbons; Polyurethanes; and Silicones. Sufficiently strong evidence (in the form of practical examples of completed substitution) pointing to the economic feasibility of alternatives is available, e.g. from SAIC M (2021). No evidence pointing to a shortage in supply of alternatives is available to the Dossier Submitters. As a result, there is sufficiently strong evidence to conclude that the substitution potential is high E nv ir o nme nta l impact Based on the available evidence, which is considered to be sufficiently strong (i.e. based on verifiable tonnage estimates for sub-uses and PFAS groups and reasonable assumptions about environmental release, a full ban of PFAS use in TULAC will contribute to reducing emissions (PFAAs and PFAA precursors, fluoropolymers and PFPEs) in comparison to the baseline. The expected emission reduction during the use phase for all TULAC sub-sectors, except automotive uses for insulation purposes (for which no volume data is available), together equals around 95% of baseline emissions for a 30-year period (20252055). As the environmental Cost impact Other aspects Low producer surplus losses n/a as a result of business closures [sufficiently strong evidence] due to (i) a low share of business closures [sufficiently strong evidence], (ii) low producer surplus losses at company level due to low margins [sufficiently strong evidence], (iii) a medium offsetting potential, i.e. potential producer surplus losses are balanced out to some extent by producer surplus gains by producers of alternative-based products [sufficiently strong evidence] and (iv) low producer surplus losses in the wider supply chain [sufficiently strong evidence] High producer surplus losses as a result of substitution [sufficiently strong evidence], despite comparatively low costs at company level [sufficiently strong evidence], due to (i) a medium number of companies being affected [sufficiently strong evidence], (ii) a high share of substitution [sufficiently 87 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s at EIF. E nv ir o nme nta l impact impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. Cost impact strong evidence] and (iii) partial internalization of costs [sufficiently strong evidence] Other aspects High consumer surplus losses resulting from price changes associated with substitution [sufficiently strong evidence] despite comparatively low price changes [sufficiently strong evidence] resulting from medium (and comparatively low) substitution costs at company level [sufficiently strong evidence] which are only partially passed on to customers [sufficiently strong evidence], due to (i) the high annual sales volume [sufficiently strong evidence] and (ii) an exacerbation of consumer surplus losses due to a high price elasticity of demand [sufficiently strong evidence] Some welfare losses or additional costs as a result of lower functionality , e.g. in relation to oil and dirt repellence [sufficiently strong evidence] Low level of employment losses due to low share of 88 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Ban use-specific derogations Conclusion Duration of derogation A lte r na tiv e s E nv ir o nme nta l impact Cost impact business closures [sufficiently strong evidence] 5 years n/a n/a n/a 12 years n/a n/a n/a A full ban of PFASs in home textiles with a transition period of 18 months is proposed. Other aspects n/a n/a 89 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in Section E.2.2.2.4, the Dossier Submitters consider based on the available evidence that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives for home textiles. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters conclude by default that technically and ec onomic ally feasible alternatives exist in suffic ient quantities for use in home textiles. As a result, the Dossier Submitters c onsider that there is sufficiently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months. The assessment of costs in relation to home textiles for a full ban with a transition period of 18 months is based on evidence from Annex A on uses and functions, the assessment of alternatives and the substitution potential and: Literature and public databases, e.g. a document produced by industry providing quantitative information on the number of ac tive c ompanies in the te xtile and c lothing industry in the EU as well as the share of different sub-sectors in total EU production, a study summarising information on voluntary industry commitments in different sectors, the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances and the PRODCOM database; Princ iples relating to margins, the pric e elastic ity of demand and offsetting potential; Information from a limited number of stakeholder interviews, e.g. on differences in applying alternative textile finishes and changes in operating costs; The CfE, e.g. information on the sub-sectors with the highest use volumes of PFASs, c hanges in operating c osts and differences in func tionality; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) the timeframe required for substitution, (ii) annual sales losses of individual c ompanies in the TULAC industry in the c ase of a restriction, (iii) differences in the c osts of alternatives in c omparison to PFASs, and (iv) the total c osts associated with substitution at company level. For home textiles, the Dossier Submitters assessed (i) producer surplus losses resulting from c ompany c losures and substitution, as well as produc er surplus losses in the supply chain , (ii) consumer surplus losses resulting from price changes, (iii) welfare losses and/or costs resulting from changes in the characteristics of the good, i.e. its quality and lifetime and (iv) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of c ompanies affected by the restric tion, (ii) the most likely reac tion of affected companies, (iii) the costs that companies face as a result of substitution or a stop of production and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indicator of the number of companies active in the relevant sub-sector, i.e. that all sectors are assumed to be constituted by companies with a comparative production volume. This assumption leads to the plausible result that a comparatively high number of companies is active in sectors with lower barriers to entry, e.g. lower specialisation and certification requirements, such as the consumer apparel industry. Around 20 200 companies are estimated to be ac tive in the home textile industry (whic h is only exc eeded by the c onsumer apparel industry and c omparable in magnitude to the tec hnical textile industry). The number of companies producing articles containing PFASs could not be estimated due to a lack of quantitative information on the share of companies using PFASs. Evidence from the CfE suggests, however, that the home textile indust ry is one of the three biggest users within the TULAC industry. The Dossier Submitters conclude based on this evidence, which is considered to be sufficiently strong, that the number of companies affected by the proposed restriction 90 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) in the home textile industry (in comparison to other TULAC sub-sectors) is medium (and only exc eeded by the c onsumer apparel industry - due to the bigger estimated size of the sector and the technical textile industry - due to the lower market penetration of alternatives given the more limited availability of technically feasible alternatives). As only one stakeholder provided information on the economic and social impacts of a restriction pro for the home textile industry in the 2nd stakeholder consultation, no conclusion on the most likely reaction of affected companies, i.e. the share of companies in the home textile sector opting for substitution in comparison to stopping production, could be drawn based on stakeholder information. The Dossier Submitters therefore relied on the c onclusions concerning the substitution potential in combination with stakeholder information of the timeframe required for substitution. The Dossier Submitters also used information from literature on voluntary industry commitments51 suggesting that the market penetration of alternatives in the home textile industry is lower than in the consumer apparel industry , which makes substitution a more beneficial endeavour due to less established competition. Based on this evidence, which is considered to be sufficiently strong, the Dossier Submitters conclude that the expected share of business closures is low (and exceeded by the share of business closures in the consumer apparel industry) under a full ban with a transition period of 18 months. Producer surplus losses associated with a stop of production are assessed based on a consideration of (i) information on typical annual sales losses reported by a limited and nonrepresentative sample of companies in the 2nd stakeholder consultation, and (ii) margins in each sub-sector. Data on sales losses did not point to significant differences in annual sales values between different TULAC sub-sectors. Specific data on annual sales losses in relation to home textiles was not provided in the 2nd stakeholder c onsultation. The extent of producer surplus losses as a result of production stops in comparison to other TULAC industries has therefore solely been determined based on a consideration of margins (with low margins being associated with lower producer surplus losses). Due to a lack of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and price elasticity of demand with margins. The size of the margin in relation to home textiles is found to be low (as for consumer apparel, leather applications, home fabric treatments, outdoor technical textiles and medical applications). The offsetting potential is determined based on a consideration of principles on the interlinkage between the offsetting potential of other actors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU competition in comparison to international competition. These principles are well-grounded and have a robust foundation in the SEAC guidance on assessing changes in produc er surplus, i.e. ECHA (2021b). In relation to home textiles, the offsetting potential is found to be medium (and therefore only exceeded by the offsetting potential in the consumer apparel industry due to higher market share of affected actors in comparison to the consumer apparel industry). Given the low share of company closures and medium offsetting potential, the extent of producer surplus losses in the wider supply chain are found to be low. The Dossier Submitters consider based on the assessment of alternatives and aforementioned principles pointing to a low share of company closures, low producer surplus losses due to low margins, a medium offsetting potential and low impacts on the wider supply chain that there is sufficiently strong evidence to conclude that the socio-economic costs to industry in the form of producer surplus losses from business closures are low under a full ban with a transition period of 18 months. Producer surplus losses resulting from substitution are assessed on the basis of considerations 51 Information on voluntary industry commitments for eliminating PFASs compiled by the Natural Resources Defense C ouncil in a study supported by the United Nations Environment Programme reports that voluntary industry commitments are dominated by apparel brands, while the home textile sector is reported to be another sector making significant progress with phasing -out PFASs (SAIC M, 2021). 91 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) of the extent to which companies will pass on higher costs to customers and considerations of R&D costs, capital costs for new equipment, changes in operating costs and re -certification c osts. The extent to which c ompanies are expected to pass on substitution costs to customers in the form of higher prices is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding margins and the pric e elastic ity of demand. The extent to whic h c ompanies pass on c osts to c ustomers is found to be low (partial) in the home textiles industry (as for companies in the consumer apparel industry and leather industry as well as producers of home fabric treatments, outdoor technical textiles and medical applications) due to low margins and a high price elasticity of demand. Due to very limited quantitative information on substitution costs across TULAC subsectors, the assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applications (which is deemed to affect R&D costs) and the relevance of re-certification/validation costs. The substitution cost in relation to home textiles is found to be medium (as for consumer apparel, professional sportswear and footwear, outdoor technical textiles, medical applications and leather applications) and therefore more limited than in relation to other technical textile applications, PPE and textiles for the use in engine bays due to the lower complexity of products which limits R&D costs and (in all cases except medical applications) the absence of re-certification costs. The Dossier Submitters consider based on the aforementioned principles pointing to a high (partial) internalization of costs and medium substitution costs, the medium number of companies being affected and the high share of substitution that there is sufficiently strong evidence to conclude that socio-economic costs to industry in the form of produc er surplus losses from substitution are high under a full ban with a transition period of 18 months. Consumer surplus losses resulting from price changes associated with substitution are assessed comparatively based on consideration of (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into account the extent to which this volume will be replaced by alternative-based products (based on a consideration of the substitution share). The volume of goods sold in TULAC sub-sectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading industry association as a basis for concluding on the magnitude of the volume of goods containing PFASs in each sub-sector. Based on medium substitution costs (which are lower in magnitude than substitution costs for PPE, high performance membranes and textiles for the use in engine bays) and a low (partial) extent to whic h c osts are passed on to customers, price changes in relation to home textiles are found to be low (as for c onsumer apparel, outdoor technical textiles, medic al applic ations and leather products). Due to the high pric e elasticity of demand, consumer surplus losses will be exacerbated by changes in the quantity demanded resulting from the price change. Demand in other sectors, for which higher pric e inc reases are expected, is deemed less sensitive to pric e c hanges than for home textiles. As such, the annual volume of goods sold to EU customers are deemed to be the main determinant of differences in the magnitude of consumer surplus losses for different sub-uses. With over three million tonnes, the estimated annual sales volume for home textiles (including PFAS-free and PFAS-containing products) is the second highest of all assessed subsectors. Data gaps exist for most TULAC sub-sectors resulting in a likely underestimation of volumes for these sectors. As this affects all apart from one sub-sector, comparative conclusions on the magnitude of sales volumes are however deemed to be robust. The annual sales volume of goods containing PFASs is deemed high (despite some market penetration of alternatives) and the entire volume is deemed to likely be replaced by PFAS-free products given the high share of substitution. The Dossier Submitters c onsider based on that evidence that there is suffic iently strong evidence to c onclude that socio-economic c osts to c ustomers in the form of consumer surplus losses from price changes associated with substitution are high under a ban with a transition period of 18 months (and only exceeded by consumer surplus losses in the consumer apparel industry). 92 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) With respec t to c hanges in the c haracteristics of goods, evidence from the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances, the CfE and 2nd stakeholder c onsultation suggests that the difference between PFASs and alternatives is their c apacity to provide several functionalities simultaneously. While reaching broadly comparable levels of water repellence tends not to be a concern, identified alternatives reach lower levels of performance for other functionalities such as oil and dirt repellence, which might also impact the lifetime of the good. The Dossier Submitters consider based on that evidence that there is suffic iently strong evidence to conclude that socio-economic c osts to customers in the form of welfare losses (resulting from inferior aesthetic appearance of home textiles) and/or additional c osts for c ounteracting c hanges in func tionality, e.g. purc hasing washable c overs, are likely to occur under a full ban with a transition period of 18 months. The Dossier Submitters consider, furthermore, based on sufficiently strong evidence from mainly the assessment of the substitution potential pointing towards a low share of business closures in the home textile sector that there is sufficiently strong evidence to conclude that the socio-economic costs to society in the form of employment losses will be low under a full ban. E.2.2.5.2. Consumer apparel Table E.30 summarises the outcomes of the assessment of costs and benefits for consumer apparel. More detailed information can be found in the accompanying text following the table. 93 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.30. Consumer apparel - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Full ban Duration of derogation Not applicable A lternatives Environmental impact Cost impact Other aspects Sufficie ntly strong e vidence that Base d on the available Low producer surplus losses as a n/a te chnically feasible alternatives e vide nce, which is result of business closures e x ist, with six of seven considered to be [sufficiently strong evidence] de spite alte rnative substance groups sufficiently strong (i.e. a m e dium share of business closure s be ing identified as re levant for based on verifiable [sufficiently strong e vidence], due to (i) consumer apparel, i.e.: tonnage estimates for sub- low producer surplus losses at company De ndrimers; Hybrid (Silico n e/hydro carbon ); Hydrocarbons; Polyurethanes; Silicone s; and use s and PFAS groups and re asonable assumptions about environmental re le ase, a full ban of PFAS use in TULAC will contribute to reducing e m issions (PFAAs and le ve l due to low m argins [sufficiently strong e vidence], (ii) a high offsetting pote ntial, i.e. producer surplus losses are balanced out to some extent by produce r surplus gains by producers of alternativebased products [sufficiently strong e vide nce] and (iv) lo w pro duce r surplus Alte rnative technologies. PFAA pre cursors, losses in the wider supply chain fluoropolymers and PFPEs) [sufficiently strong e vidence] Sufficie ntly strong e vidence (in the form of practical e xamples of com pleted substitution) pointing to the e conomic fe asibility of alte rnatives, is available, e.g. from SAICM (2021)52 a nd the 2nd stak eholder consultation. No e vide nce pointing to a shortage in supply of alternatives is available to the Dossier Subm itters. in com parison to the baseline. The expected e m ission re duction during the use phase for all TULAC sub-sectors, e xcept automotive uses for insulation purposes (for which no volume data is available), together e quals around 95% of baseline e m issions for a 30-year pe riod (2025-2055). High producer surplus losses as a result of substitution [sufficiently strong evidence], de spite comparatively low substitution costs at company level [sufficiently strong e vidence], due to (i) a high number of companies being affected [sufficiently strong e vidence], (ii) a m e dium share of substitution [sufficiently strong e vidence], and (iii) partial inte rnalization of cots [sufficiently strong e vide nce] As a re sult, there is sufficiently strong e vidence to conclude that the substitution potential is high at EIF. As the e nvironmental im pact assessment does not cove r the waste phase, e m issions under the baseline as we ll as High consumer surplus losses resulting from price changes associated with substitution [sufficiently strong evidence] de spite 52 See also: https://www.ehn.org/pfas-clothing-2656587709.html and https://www.greenpeace.org/international/press-release/17739/greenpeace-reportclothing-industry-shows-progress-in-cutting-hazardous-chemicals/, both accessed: 2023-01-11. 94 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact e m issions avoided as a re sult of the re striction are lik e ly undere stimated. Cost impact com paratively low price changes [sufficiently strong e vidence] resulting from m e dium (and comparatively low) substitution costs at company level [sufficiently strong e vidence] which are only partially passed on to customers [sufficiently strong e vidence], due to (i) the high annual sales volume [sufficiently strong e vidence] and (ii) an e xacerbation of consumer surplus losses due to a high price e lasticity of demand [sufficiently strong e vidence] Other aspects Some welfare losses or additional costs as a result of lower functionality, e .g. in re lation to oil re pe llence, which is deemed to be an im portant functionality in re lation to sportswe ar and footwe ar, and additional costs re sulting from high re placement fre quencies or m ore frequent re im pre gnation due to the lowe r ability of alte rnatives to withstand household laundering [sufficiently strong e vidence] Some employment losses due to m e dium share of business closures [sufficiently strong e vidence] Ban with use-specific 5 ye ars n/a n/a n/a n/a derogations 12 ye ars n/a n/a n/a n/a Conclusion A full ban of PFASs in consumer apparel with a transition period of 18 months is proposed. 95 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in Section E.2.2.2.4, the Dossier Submitters consider based on the available evidence that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives for consumer apparel. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters c onc lude by default that technically feasible alternatives exist in suffic ient quantities for use in consumer apparel. As a result, the Dossier Submitters consider that there is sufficiently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months. The assessment of costs in relation to consumer apparel for a full ban with a transition period of 18 months is based on evidence from Annex A on uses and functions, the assessment of alternatives and the substitution potential and: Literature and public databases, e.g. a document produced by industry providing quantitative information on the number of ac tive c ompanies in the textile and c lothing industry in the EU as well as the share of different sub-sectors in total EU production, the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances and the PRODCOM database; Principles relating to margins, the price elasticity of demand and offsetting potential; Information from a limited number of stakeholder interviews, e.g. on differences in applying alternative textile finishes and changes in operating costs; The CfE, e.g. information on the sub-sectors with the highest use volumes of PFASs, c hanges in operating c osts and differences in func tionality; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) the timeframe required for substitution, (ii) annual sales losses of individual c ompanies in the TULAC industry in the c ase of a restriction, (iii) differences in the c osts of alternatives in c omparison to PFASs, and (iv) the total c osts associated with substitution at company level. For consumer apparel, the Dossier Submitters assessed (i) producer surplus losses resulting from company closures and substitution, as well as producer surplus losses in the supply chain, (ii) consumer surplus losses resulting from price changes, (iii) welfare lo sses and/or costs resulting from changes in the characteristics of the good, i.e. its quality and lifetime and (iv) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of c ompanies affected by the restric tion, (ii) the most likely reac tion of affected companies, (iii) the costs that companies face as a result of substitution or a stop of production and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indic ator of the number of c ompanies active in the relevant sub-sector. This assumption leads to the plausible result that a comparatively high number of c ompanies is ac tive in sectors with lower barriers to entry, e.g. lower specialisation and certification requirements, such as the consumer apparel industry. Around 59 300 companies are estimated to be active in the consumer apparel industry (which is more than twice as much as the number of companies estimated to be active in technical textile industry - the sector with the second highest number of affected companies). As mentioned in section E.2.2.4.1, this is also deemed to inc lude c ompanies producing professional sportswear and footwear. The number of companies producing articles containing PFASs could not be estimated due to a lack of quantitative information on the share of companies using PFASs. Evidence from the CfE suggests, however, that the consumer apparel industry is the biggest user of PFASs within the TULAC industry. The Dossier Submitters c onclude based on this evidenc e, which is c onsidered to be sufficiently strong, that the number of companies affected by the restriction in the consumer apparel industry (in comparison to other TULAC sub-sectors) is high (despite the high market 96 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) penetration of alternatives due to big size of the sector). For determining the most likely reaction of affected companies in relation to consumer apparel, the Dossier Submitters relied on conclusions concerning the substitution potential in combination with information from the 2nd stakeholder consultation on the economic and social impacts of a restriction proposal and the timeframe required for substitution. While the substitution potential is considered to be high (as described above) , information from the 2nd stakeholder consultation suggests a mix of reactions with a rather equal split between companies indicating that they do not need to take action, and companies implementing an alternative or c losing business. The timeframe available for substitution is not found to be of c onc ern based on information from the 2nd stakeholder c onsultation. The Dossier Submitters also consider - based on information from literature on voluntary industry commitments 53 suggesting that the market penetration of alternatives in consumer apparel industry is c omparatively high - that substitution is a less promising endeavour for affected c ompanies in the consumer apparel industry due to more established competition and more price pressure. Based on this evidence, which is considered to be sufficiently strong, the Dossier Submitters conclude that the expected share of business closures is medium (and therefore higher than in the home textile and leather industries as well as in relation to home fabric treatments and outdoor technical textiles) under a full ban with a transition period of 18 months. Producer surplus losses associated with a stop of production are, as mentioned in section E.2.2.5.1, solely determined based on a consideration of margins (with low margins being associated with lower producer surplus losses) as data on annual sales losses reported by a limited and non-representative sample of companies in the 2nd stakeholder consultation did not point to differences in annual sales values between different TULAC sub-sectors. Specific data on annual sales losses in relation to consumer apparel was not provided in the 2nd stakeholder c onsultation. Due to a lac k of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and the pric e elasticity of demand with margins. The size of the margin in relation to consumer apparel is found to be low (as for home textiles, leather applic ations, home fabric treatments, outdoor technical textiles and medical applications). The offsetting potential is determined based on a consideration of princ iples on the interlinkage between the offsetting potential of other actors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU c ompetition in c omparison to international competition. These princ iples are wellgrounded and have a robust foundation in the SEAC guidance on a ssessing changes in produc er surplus, i.e. ECHA (2021b). In relation to c onsumer apparel, the offsetting potential is found to be high especially due to the high market penetration of alternative-based products (and as a result the comparatively low market share of affected companies). Given the medium share of company closures but high offsetting potential, the extent of producer surplus losses in the wider supply chain are found to be low. The Dossier S ubmitters consider based on the assessment of alternatives, stakeholder information and aforementioned principles pointing to a medium share of company closures, low producer surplus losses due to low margins, a high offsetting potential and low impacts on the wider supply chain that there is suffic iently strong evidence to c onclude that the soc io-economic c osts to industry in the form of producer surplus losses from business closures are low under a full ban with a transition period of 18 months. Producer surplus losses resulting from substitution are, as mentioned in section E.2.2.5.1, assessed on the basis of considerations of the extent to which companies will pass on higher 53 Information on voluntary industry commitments for eliminating PFASs compiled by the Natural Resources Defense C ouncil in a study supported by the United Nations Environment Programme reports that voluntary industry commitments are dominated by apparel brands, while the home textile sector is reported to be another sector making significant progress with phasing -out PFASs (SAIC M, 2021). 97 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) costs to customers and considerations of R&D costs, capital costs for new equipment, changes in operating costs and re-certification costs. The extent to which companies are expected to pass on substitution c osts to customers in the form of higher pric es is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of ec onomic s) surrounding margins and the pric e elastic ity of demand. The extent to which companies pass on costs to customers is found to be low (partial) in the consumer apparel industry (as for companies in the home textile and leather industries as well as producers of home fabric treatments, outdoor technical textiles and medical applications) due to low margins and a high price elasticity of demand. In relation to consumer apparel, the ability to pass on costs to customers is deemed to be further limited by competition with c ompanies that have already substituted, as there c ompanies will likely be able to offer their products at lower prices, e.g. due to having competed the amortization of R&D and capital costs. Due to very limited quantitative information on substitution costs across TULAC subsectors, the assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applications (which is deemed to affect R&D costs) and the relevance of re-certification/validation costs. The substitution cost in relation to consumer apparel is found to be medium (as for home textiles, professional sportswear and footwear, outdoor technical textiles, medic al applic ations and leather applications) and therefore more limited than in relation to other technical textile applic ations, PPE and automotive applic ations due to the lower c omplexity of produc ts which limits R&D c osts and (in all c ases exc ept medic al applic ations) the absence of re- certification costs. The Dossier Submitters consider based on the aforementioned principles pointing to a high (partial) internalization of costs and medium substitution costs, t he high number of companies being affected and the medium share of substitution that the re is sufficiently strong evidence to conclude that socio-economic costs to industry in the form of producer surplus losses from substitution are high under a full ban with a transition period of 18 months. As mentioned in Section E.2.2.5.1, consumer surplus losses resulting from price changes associated with substitution for TULAC sub-sectors are determined based on consideration of (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into account the extent to which this volume will be replaced by alternative-based products (based on a c onsideration of the substitution share). The volume of goods sold in TULAC subsectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading industry association as a basis for concluding on the magnitude of the volume of goods containing PFASs in each sub-sector. Based on medium substitution costs (which are lower in magnitude than substitution costs for PPE, high performance membranes and textiles for the use in engine bays), and a low (partial) extent to which costs are passed on to customers, price changes in relation to consumer apparel are found to be low (as for home textiles, outdoor technical textiles , medical applications and leather products). Due to the high price elasticity of demand, consumer surplus losses will be exacerbated by changes in the quantity demanded resulting from the price change. As explained in Section E.2.2.4.2, the annual volume of goods sold to EU c ustomers is deemed to be the main determinant of differences in the magnitude of consumer surplus losses for different sub-uses. With over four million tonnes, the estimated annual sales volume for consumer apparel (including PFAS-free and PFAS-containing products) is the highest of all assessed sub-sectors. Data gaps exist for most TULAC sub-sectors, including consumer apparel for which the estimate is only based on information on indoor and outdoor wear (and does not cover footwear, accessories and sportswear), resulting in a likely underestimation of volumes for these sectors. As this affects all apart from one sub-sector, comparative conclusions on the magnitude of sales volumes are however deemed to be robust. The annual sales volume of goods c ontaining PFASs is deemed high, despite the high market penetration of alternative-based products (in c omparison to other TULAC sub-sectors) due to big size of the sector in terms of sales volumes. The entire volume will likely be replaced 98 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) by PFAS-free products given the medium share of substitution and the potential of substituting companies to take over market shares from companies ceasing production. The Dossier Submitters consider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of consumer surplus losses from price changes associated with substitution are high (in comparison to other TULAC subsectors) under a ban with a transition period of 18 months. With respec t to c hanges in the c haracteristics of goods, evidence from the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances, the CfE and 2nd stakeholder c onsultation suggests that the difference between PFASs and alternatives is their c apacity to provide several functionalities simultaneously. While reaching broadly comparable levels of water repellence tends not to be a concern, identified alternatives reach lower levels of performance for other functionalities such as oil and dirt repellence. As mentioned in section A.3.3.1 and Table E.14, functions other than water repellence are not deemed to be critical for consumer apparel, especially in relation to outdoor and indoor wear as well as accessories. For sportswear and footwear, oil repellence is (as for home text iles and leather applications) deemed to be important as mentioned in sec tion A.3.3.1. Overall, quality losses in relation to consumer apparel are thus deemed to be more limited for consumer apparel than for all other TULAC applications. Changes in the lifetime of goods and associated costs due to changes in the durability of the functionality are however likely according to (i) stakeholder information from the 2nd stakeholder consultation pointing to a difference in the durability of PFASs and alternatives and (i) information from the CfE pointing to a high replacement frequency or increased re-impregnation due to the lower ability of alternatives to withstand household laundering. The lower performance level with respect to additional functionalities, e.g oil repellence, is not deemed to contribute to the shortened lifetime and associated costs despite being mentioned in Wood (2020a) and ECHA (2021a) as an additional factor that could theoretically impact the lifetime of articles due to leading to a lower protection against staining and therefore earlier disposal. A study on PFAS coatings of school uniforms, referred to in the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances (see ECHA (2021a)), c oncluded that the use of stain-resistant textile finishes is not associated with a lower washing or replacement frequency. Based on t his study, the Dossier Submitter for the restriction of PFHxA concluded, that these functionalities might not be as important to customers as claimed by industry (ECHA, 2021a). The Dossier Submitters consider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to c ustomers in the form of welfare losses (e.g. small c hanges in produc t quality with respect to water repellence potentially leading to c hallenges under severe c onditions, and differences in oil repellenc e for sportswear and footwear) and additional c ost from higher replac ement frequenc ies or inc reased re-impregnation, are likely to occur under a full ban with a transition period of 18 months. As mentioned in sec tion E.2.2.4, the magnitude of employment losses in different sub-sectors c ould not be estimated due to the significant uncertainty about the number of c ompanies that would c ease operation and a lac k of representative data on the average number of employees in relevant companies (which might differ between sub-sectors depending on how labourintensive the associated production process is). The Dossier Submitters consider based on the suffic iently strong evidence pointing towards a medium share of business c losures in the consumer apparel industry that some socio-economic costs to society in the form of employment losses will occur under a full ban with a transition period of 18 months. E.2.2.5.3. Professional apparel Table E.31 summarises the outcomes of the assessment of c osts and benefits for professional apparel. More detailed information can be found in the accompanying text following the table. 99 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.31. Professional apparel - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lternatives Sufficie ntly strong e vidence that te chnically feasible alternatives exist, with five of seven alternative (substance) groups being identified as re le vant for professional sportswear and footwear, i.e .: De ndrimers; Hydrocarbons; Polyurethane; Silicone s; and Alte rnative technologies. Sufficie ntly strong e vidence that te chnically feasible alternatives exist for se ven of 13 assessed categories of PPE; four of seven alternative (substance) groups are identified as re le vant for PPE, i.e.: Hydrocarbons; Polyurethane; Silicone s; and Alte rnative technologies. Sufficie ntly strong e vidence that alte rnatives are economically feasible, e .g. based on information pointing to the proven use of alternatives for Environmental impact Base d on the available e vide nce, which is considered to be sufficiently strong (i.e. based on verifiable tonnage estimates for sub-uses and PFAS groups and re asonable assumptions about e nvironmental re lease, a full ban of PFAS use in TULAC will contribute to re ducing emissions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in comparison to the baseline. The e x pected e mission re duction during the use phase for all TULAC subse ctors, except automotive uses for insulation purposes (for which no volume data is available), together e quals around 95% of baseline emissions for a 30-ye ar period (2025- Cost impact High producer surplus losses as a result of business closures [sufficiently strong evidence] de spite lo w number o f a ffected com panies [sufficiently strong e vide nce] due to (i) a high share of business closure s [sufficiently strong e vide nce], (ii) high produce r surplus losses a t company level due to high54 m argins [sufficiently strong e vidence], (iii) a low55 offsetting potential [sufficiently strong e vidence] and (iv) high producer surplus losses in the wide r supply chain [sufficiently strong e vide nce] Low producer surplus losses as a result of substitution [sufficiently strong evidence], de spite medium to high costs at company level [sufficiently strong e vidence] due to (i) a low num ber of companies being affe cted [sufficiently strong e vidence], (ii) the lo w share o f substitution [sufficiently strong e vidence] and, e specially, (iii) low internalization of costs [sufficiently strong e vidence] Low consumer surplus losses resulting from price changes Other aspects n/a 54 The margin for professional sportswear and footwear is deemed to be high given that this is deemed to be a niche sector with a limited number of competitors and the lower price elasticity of demand. (Professional athletes are considered to base their purchasing decisions on quality and performance rath er than price.) The margin for PPE is deemed to be high given the comparatively small target market, the low level of competition r esulting from high barriers to entry and higher up-front costs for suppliers, which they will likely aim to recoup through higher margins. 55 The offsetting potential is deemed to be low for both professional sportswear and footwear and PPE due to: (i) the low extent of competition in both market segments, (ii) the low market penetration of alternatives, (iii) the high degree of specialisation, (iv) the existence of bar riers to entry, i.e. long-standing customer relationships for professional sportswear and certification requirements for PPE. 100 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation Ban with use-specific derogations: Derogation for (i) PPE protecting against risks specified in Risk Category III (a) and (c), (ii) PPE in prof essional firefighting activities 5 ye ars A lternatives profe ssional sportswe ar and footwe ar and strong e vidence for consumer appare l applications (which are de e med to be comparable to some e x te nt). No e vide nce pointing to a shortage in supply of alternatives is available to the Dossier Submitters. As a re sult, there is sufficiently strong e vide nce to conclude that the substitution potential at EiF is high for profe ssional sportswe ar and footwe ar and seven of 13 types of PPE and low for the other PPE applications. Environmental impact 2055). As the e nvironmental im pact assessment does not cove r the waste phase, e missions under the baseline as we ll as e m issions avoided as a re sult of the re striction are lik ely unde restimated. Cost impact associated with substitution [sufficiently strong evidence], m ainly in re lation to professional sportswe ar and some types of PPE, de spite medium to high price changes [sufficiently strong e vidence] resulting from m e dium to high substitution costs at com pany level [sufficiently strong e vide nce], which are passed on to customers to a high e xtent [sufficiently strong e vidence], due to (i) the low annual sales volume [sufficiently stro ng e vidence] a nd (ii) the lo w price e lasticity of demand which limits im pacts on the quantity demanded [sufficiently strong e vidence] Other aspects High welfare losses or additional costs m ainly as a re sult of (i) the absence of ce rtain types of PPE due to no te chnically feasible alternatives be ing k nown and (ii) earlier disposal of PPE as a result of the unavailability of im pre gnation agents [sufficiently strong e vidence] Sufficie ntly strong e vidence that alte rnatives do not exist and that the substitution potential is low fo r six o f 13 PPE applications: Base d on curre nt knowle dge, PFASs are de emed to be re quired to achieve pe rformance standards for six of 13 PPE applications. As no potential Some employment losses as a result of high share of business closures [sufficiently strong e vidence] A 5-ye ar derogation of Sam e as under full ban n/a PFAAs and PFAA pre cursors would cause additional emissions of about 1 260 t, and of about 2 700 t assuming a 12-ye ar derogation. Total maximum additional emissions of a 101 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option protecting against risks specified in Risk Category III (a) - (m), and (iii) impregnation agents for re-impregnation of aforementioned articles Duration of derogation 12 ye ars A lternatives alte rnatives are identified as of now, it is lik e ly that they will not become available in the near future . Stak e holder information presented in Se ction E.2.2.4.1 suggests furthe rmore that betwe en 12 and 36 m onths might be needed to complete substitution once a suitable alternative has been identified due to time re quirements for product development, te sting and approval in the supply chain and certificatio n. Unk nown, depending on R&D progress, but continued R &D incre ases the chance that an alternative will be ide ntified Environmental impact 5-ye ar derogation of fluoropolymers including PFPEs would a ccount of about 3 860 t, and of about 5 370 t assuming a 12-ye ar derogation, re spe ctively.While the fraction of PPE use for risk cate gory III in the EEA is sm all (about 20%), PFAS releases from te xtile tre atment can be assumed to be high (ER C 5, 50% total re le ase). There is sufficiently strong evidence that a de rogation of PFAS use in PPE will cause substantial additional e m issions, but below e m ission levels which would occur under a full de rogation of PFAS use in PPE. Sam e as for a five-year de rogation, but the total e m issions can be e x pected to be higher. Cost impact Assuming that an alternative will be ide ntified: Low producer surplus losses as a result of business closures [weak evidence] due to (i) a low share o f business closure s [we ak evidence], a nd (ii) low pro ducer surplus losses in the wide r supply chain [we ak e vide nce] Other aspects n/a Low producer surplus losses as a result of substitution [sufficiently 102 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Conclusion Duration of derogation A lternatives Environmental impact Cost impact strong evidence], de spite (i) high share of substitution [we ak evidence] and (ii) medium to high costs at com pany le vel [sufficiently strong e vide nce], due to (i) the low num ber of com panies being affected [sufficiently strong e vidence] and (ii) low inte rnalization of costs [sufficiently strong e vidence] Other aspects Low consumer surplus losses from price changes associated with substitution [sufficiently strong evidence] de spite medium to high price changes [sufficiently strong e vide nce] re sulting from medium to high substitution costs at company le ve l [sufficiently strong e vidence], which are passed on to customers to a high e xtent [sufficiently strong e vide nce], due to (i) the low a nnual sale s volume [sufficiently strong e vide nce] and (ii) the low price e lasticity of demand which limits im pacts on the quantity demanded [sufficiently strong e vidence] Some additional costs, as a re sult of e arlie r disposal of PPE as a re sult of the unavailability of impre gnation age nts for some types of P PE [sufficiently strong e vidence] Low level of employment losses due to low sha re of business closures [we ak e vidence] A ban with a transition period of 18 months and a 12 -year derogation is proposed for:Personal protective e quipment (PPE) intended to protect use rs against risks as specified in R egulation (EU) 2016/425, Annex I, Risk C ategory III (a) and (c); 103 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Pe rsonal protective e quipment (PPE) in professional firefighting activities intended to protect users against risks as specified in Regulation (EU) 2016/425, Annex I, R isk Category III (a) - (m); and Im pregnation agents for re -impregnating of articles re ferred to above. 104 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in section E.2.2.2.4, the Dossier Submitters consider that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives for professional sportswear and footwear. For PPE, the Dossier Submitters consider based on the evidence that there is sufficiently strong evidence to conclude that technically feasible alternatives exist for seven of 13 applications but do not exist for the other six applications. Based on evidence from other TULAC sub-sectors, e.g. c onsumer apparel, listed alternatives are also deemed to be ec onomically feasible for PPE. As no evidence pointing to a shortage in supply of alternatives is available to the Dossier Submitters, the Dossier Submitters conclude by default that relevant alternatives exist in sufficient quantities for relevant professional apparel applications. As a result, the Dossier Submitters consider that there is suffic iently strong evidence to c onclude that the substitution potential is high for professional sportswear and footwear and seven of 13 PPE applic ations under a full ban with a transition period of 18 months, while the substitution potential is low for the other PPE applications. The assessment of costs in relation to professional apparel for a full ban with a transition period of 18 months is based on evidence from the assessment of alternatives and the substitution potential and: Literature and public databases, e.g. a document produced by industry providing quantitative information on the number of ac tive c ompanies in the textile and c lothing industry in the EU as well as the share of different sub-sectors in total EU production and the PRODCOM database; Principles relating to margins, the price elasticity of demand and offsetting potential; Information from a limited number of stakeholder interviews, e.g. on differenc es in applying alternative textile finishes and changes in operating costs; The CfE, e.g. changes in operating costs; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) the timeframe required for substitution, (ii) annual sales losses of individual companies in the case of a restriction, (iii) differences in the costs of alternatives in comparison to PFASs, and (iv) the total costs associated with substitution at company level. For professional apparel, the Dossier Submitters assessed (i) producer surplus losses resulting from company closures and substitution, as well as producer surplus losses in the supply chain, (ii) consumer surplus losses resulting from price changes, (iii) welfare losses and/or costs resulting from changes in the characteristics of the good, i.e. its quality and lifetime , or the absence of the product and (iv) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of companies affected by the restriction, (ii) the most likely reaction of affected companies, (iii) the costs that companies face as a result of substitution or a stop of production and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indic ator of the number of c ompanies active in the relevant sub-sector. This assumption leads to the plausible result that a comparatively high number of c ompanies is ac tive in sectors with lower barriers to entry, e.g. lower specialisation and certification requirements, such as the c onsumer apparel industry. Around 2 900 c ompanies are estimated to be active (which is the lowest number among any of the sub-sectors) based on data from the industry association relating to workwear. As the data is related to workwear, the estimated number is deemed to cover PPE, while companies producing professional sportswear and footwear are deemed to be covered by the estimate for consumer apparel (presented in Section E.2.2.5.2), which is based on data for clothing and accessories, knitwear and underwear. The number of companies producing articles containing PFASs could not be estimated due to a lack of quantitative information on the share of companies using PFASs. The Dossier Submitters 105 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) conclude based on this evidence, which is considered to be sufficiently strong, that the number of companies affected by the proposed restriction in the professional apparel industry (in comparison to other TULAC sub-sectors) is low. The Dossier Submitters consider this conclusion to be robust despite the exclusion of professional apparel and sportswear. Given the c omparatively small c ustomer base for these goods, the number of relevant companies is deemed to be small and deemed to not affect the comparative conclusions on the sizes of different TULAC sub-sectors. For determining the most likely reaction of affected companies in relation to professional apparel, the Dossier Submitters relied on conclusions concerning the substitution potential in combination with information from the 2nd stakeholder consultation on the economic and social impacts of a restriction and the timeframe required for substitution (with stakeholder information on the required timeframe solely relating to PPE). Based on this evidence, which is considered to be sufficiently strong, the Dossier Submitters conclude that the expected share of business closures in relation to professional apparel is high (especially as a result of the low substitution potential for PPE) under a full ban with a transition period of 18 months. Producer surplus losses associated with a stop of production are, as mentioned in Section E.2.2.5.1, solely determined based on a consideration of margins (with low margins being associated with lower producer surplus losses) as data on annual sales losses reported by a limited and non-representative sample of companies in the 2nd stakeholder consultation did not point to differences in annual sales values between different TULAC sub-sectors. Data on annual sales losses at company level in relation to professional apparel (provided in the 2nd stakeholder c onsultation by a non-representative sample c onsisting of six c ompanies) ranges from 1.2 million to 200 million. Due to a lack of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and price elasticity of demand with margins. The size of the margin in relation to professional apparel, both professional sportswear and footwear and PPE, is found to be high (as for high performance membranes and textiles for use in engine bays). The offsetting potential is determined based on a c onsideration of princ iples on the interlinkage between the offsetting potential of other act ors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU competition in comparison to international competition. These principles are well-grounded and have a robust foundation in the SEAC guidance on assessing changes in producer surplus, i.e. ECHA (2021b). In relation to professional apparel (both professional sportswear and footwear and PPE), the offsetting potential is found to be low mainly due to the high market share of affected actors. Given the high share of company c losures and low offsetting potential, the extent of producer surplus losses in the wider supply chain are found to be high. The Dossier Submitters consider based on the assessment of alternatives, stakeholder information and aforementioned principles pointing to a high share of company closures, high producer surplus losses due to high margins, a low offsetting potential and high impacts on the wider supply chain, that there is sufficiently strong evidence to conclude that the socio-economic costs to industry in the form of producer surplus losses from business closures are high under a full ban with a transition period of 18 months. Producer surplus losses resulting from substitution are, as mentioned in Section E.2.2.5.1, assessed on the basis of considerations of the extent to which companies will pa ss on higher costs to customers and considerations of R&D costs, capital costs for new equipment, changes in operating c osts and re-certification c osts. The extent to whic h c ompanies are expec ted to pass on substitution c osts to customers in the form of higher pric es is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of ec onomic s) surrounding margins and the pric e elastic ity of demand. The extent to which companies pass on costs to customers is found to be high for both professional sportswear and footwear as well as PPE (as for high performance membranes and textiles for use in engine bays) due to high margins and a low price elasticity of demand. Due to very limited quantitative information on substitution costs across TULAC sub-sectors, the 106 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applic ations (which is deemed to affect R&D costs) and the relevance of re-certification/validation costs. The substitution cost in relation to professional apparel is found to be medium to high. The substitution cost for professional sportswear and footwear is found to be medium (as for home textiles, consumer apparel, outdoor technical textiles, medical applications and leather applications) due to the lower complexity of products which limits R&D costs and (in all cases except medic al applic ations) the absence of re-certification costs. Due to higher R&D c osts and costs for re-certification, substitution costs in relation to PPE are deemed to be high. The Dossier Submitters consider based on the aforementioned principles and information from the 2nd stakeholder consultation pointing to a low internalization of costs and medium to high substitution costs that there is sufficiently strong evidence to conclude that socio-economic c osts to industry in the form of produc er surplus losses from substitution are low under a full ban with a transition period of 18 months. As mentioned in Section E.2.2.5.1, consumer surplus losses resulting from price changes associated with substitution for TULAC sub-sectors are determined based on consideration of (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with pric e and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into account the extent to which this volume will be replaced by alternative-based products (based on a c onsideration of the substitution share). The volume of goods sold in TULAC subsectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading industry association as a basis for concluding on the magnitude of the volume of goods containing PFASs in each sub-sector. Based on medium to high substitution costs and a high extent to which costs are passed on to customers, price changes in relation to professional apparel are found to be medium to high (whereby high price changes are also expected high performance membranes and in relation to textiles for use in engine bays). Due to the low price elasticity of demand, consumer surplus losses will not be exacerbated by changes in the quantity demanded resulting from the price change. As explained in Section E.2.2.4.2, the annual volume of goods sold to EU c ustomers is deemed to be the main determinant of differences in the magnitude of consumer surplus losses for different sub-uses. With around 100 000 t (of PPE), the estimated annual sales volume for professional apparel (including PFAS-free and PFAS-containing products) is the lowest of all assessed sub-sectors. Data gaps exist for most TULAC sub-sectors, including professional apparel for which the estimate is only based on information on PPE, resulting in a likely underestimation of volumes for these sectors. As this affects all apart from one subsec tor, c omparative c onclusions on the magnitude of sales volumes are however deemed to be robust. The annual sales volume of goods containing PFASs is deemed low and given that substitution is only an option for some types of PPE, consumer surplus losses from price changes will likely only be incurred in relation of a share of the estimated volume of around 100 000 t. As substitution is also expected to take place in relation to professional sportswear and footwear, the estimated annual sales volume is however deemed to be a good basis for estimating the magnitude of consumer surplus losses. The Dossier Submitters c onsider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of consumer surplus losses from price changes associated with substitution are low (in comparison to other TULAC sub-sectors) under a ban with a transition period of 18 months. Changes in the characteristics of goods are of less relevance in relation to professional apparel, especially PPE. As revealed by the assessment of alternatives, PFASs are deemed to be required for several types of PPE. As the provision of products of lower quality (below the set standard) is not acceptable for such products, a complete restriction of PFASs would result in the complete unavailability of suitable PPE for these types instead of changes to the quality of PPE on the market. For types of PPE, for whic h alternatives are able to reac h performance levels presc ribed by legal standards, some quality changes c ould however occur, e.g. c hanges 107 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) in water vapour permeability and tear strengths. Information from the 2nd stakeholder consultation furthermore suggests that downstream users of PPE would incur additional costs for replacing PPE earlier than planned given that PPE that is already on the market relies on re-impregnation to provide its protective function. The Dossier Submitters c onsider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of welfare losses and costs resulting especially from the absence of c ertain types of PPE and the associated impac ts on industrial produc tion proc esses as well as earlier disposal of PPE would be high under a full ban with a transition period of 18 months. As mentioned in sec tion E.2.2.4, the magnitude of employment losses in different sub-sectors c ould not be estimated due to the significant uncertainty about the number of c ompanies that would c ease operation and a lac k of representative data on the average number of employees in relevant companies (which might differ between sub-sectors depending on how labourintensive the associated production process is). The Dossier Submitters consider based on sufficiently strong evidence pointing towards a high share of business closures in the professional apparel industry (especially in relation to PPE) that some socio-economic costs to society in the form of employment losses will occur under a full ban with a transition period of 18 months. While all types of PPE that are already on the market rely on re-impregnation to provide its protec tive function, a derogation of impregnation agents for re -impregnating all types of PPE (and not only the articles referred to in the derogations mentioned in Table E.31) is not proposed as it is not deemed to significantly improve the balance between the costs and benefits of a full ban with a transition period of 18 months for the following reasons: The benefits of the full ban (in terms of reduced emissions) and consequently the effectiveness of the restriction would be lowered in exchange for avoiding negative environmental impacts from increased resource use resulting from earlier disposal. Given the challenges and significant costs associated with remediation of PFASs once emitted, the benefit of preventing PFASs emissions is deemed to be greater than the benefit of limiting resource use through a derogation. The cost to industry for replacing PPE before the end of its life cycle is deemed c omparatively low. E.2.2.5.4. Technical textiles Table E.32 summarises the outcomes of the assessment of costs and benefits for technical textiles. More detailed information c an be found in the accompanying text following the table. 108 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.32. Technical textiles - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s Sufficiently strong evidence that technically feasible alternatives exist for outdoor technical textiles, with at least one of seven alternative substance groups being identified as relevant, i.e. Polyurethane. Inconclusive evidence on whether technically feasible alternatives exist for all medical textile applications, with one of seven alternative substance groups being a possible alternative for membranes employed in medical textile applications, i.e.: Polyurethane. Sufficiently strong evidence that technically feasible alternatives do not exist for all types of high performance membranes, with one of the seven alternative substance groups potentially being a relevant alternative for some applications, i.e. E nv ir o nme nta l impact Based on the available evidence, which is considered to be sufficiently strong (i.e. based on verifiable tonnage estimates for sub-uses and PFAS groups and reasonable assumptions about environmental release, a full ban of PFAS use in TULAC will contribute to reducing emissions (PFAAs and PFAA precursors, fluoropolymers and PFPEs) in comparison to the baseline. The expected emission reduction during the use phase for all TULAC sub-sectors, except automotive uses for insulation purposes (for which no volume data is available), together equals around 95% of baseline emissions for a 30-year period (20252055). As the environmental impact assessment Cost impact High producer surplus losses as a result of business closures [sufficiently strong evidence] due to (i) a high number of affected companies [sufficiently strong evidence], (ii) a high share of business closures (especially in relation to high performance membranes) [sufficiently strong evidence], (iii) high producer surplus losses at company level due to high margins (for high performance membranes) [sufficiently strong evidence], (iv) a low offsetting potential [sufficiently strong evidence] and (iv) high producer surplus losses in the wider supply chain [sufficiently strong evidence] Medium producer surplus losses as a result of substitution [sufficiently strong evidence], despite medium (and therefore comparatively low) substitution costs (for outdoor technical textiles) due to (i) the high share of substitution in relation to outdoor technical textiles [sufficiently strong evidence], Other aspects A derogation for filtration and separation media used in high performance air and liquid applications that require a combination of water-and oil repellence properties is proposed for the REAC H restriction on PFHxA, its salts and related substances 109 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s Polyurethane. Sufficiently strong evidence that alternatives are economically feasible for outdoor technical textiles, e.g. based on stakeholder information on the proven use of alternative membranes and strong evidence for consumer apparel applications (which are deemed to be comparable to some extent) No evidence pointing to a shortage in supply of alternatives is available to the Dossier Submitters. As a result, there is sufficiently strong evidence to conclude that the substitution potential is high for outdoor technical textiles at EiF and low for high performance membranes. The substitution potential for medical applications at EiF is unclear. E nv ir o nme nta l impact does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. Cost impact (ii) the likely considerable number of substituting companies [sufficiently strong evidence], (iii) partial internalization of costs [sufficiently strong evidence] and (iv) information on annual sold production volumes (of outdoor technical textiles) of EU producers of > 1 million tonnes [sufficiently strong evidence], which are classified as medium in comparison to other TULAC sub-sectors Other aspects Medium consumer surplus losses resulting from price changes associated with substitution [sufficiently strong evidence], mainly in relation to outdoor technical textiles, despite comparatively low price changes [sufficiently strong evidence] resulting from medium (and comparatively low) substitution costs at company level [sufficiently strong evidence] which are only partially passed on to customers [sufficiently strong evidence], due to (i) the medium annual sales volume [sufficiently strong evidence] and (ii) an exacerbation of consumer 110 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s E nv ir o nme nta l impact Cost impact surplus losses due to a high price elasticity of demand [sufficiently strong evidence] Other aspects High welfare losses or additional costs as a result of (i) the non-existence of technically feasible alternatives for some filtration applications, with impacts the lifetime of industrial equipment, (ii) changes in filtration efficiencies for other filtration applications, (iii) higher energy use in relation to these applications, (iv) more frequent replacement (and associated higher process downtimes) due to shorter lifetimes of filters, (v) some welfare losses as a result of lower functionality leading to inferior aesthetic appearance for outdoor technical textiles (or additional costs for counteracting changes in functionality), and (vi) additional costs in relation to outdoor technical textiles due to changes in the lifetime of goods [sufficiently strong evidence] Some employment losses as a result of high share of business closures [sufficiently strong evidence] 111 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Ban with usespecific derogations: Derogation for textiles for the use in filtration and separation media used in high performance air and liquid applications in industrial or professional settings that require a combination of water- and oil repellence Duration of derogation 5 years A lte r na tiv e s Sufficiently strong evidence (based on stakeholder information and the Annex XV dossier for PFHxA) pointing to a high substitution potential for high performance membranes given that alternatives are already in the R&D stage and that available information on the timeframe required for approval and commercialization is in line with the available timeframe: As mentioned in Section E.2.2.4.2, the Dossier Submitter of the Annex XV dossier for PFHxA, its salts and related substances suggests the same derogation as this dossier, despite acknowledging that some alternatives might already be available or will become so in the near future. Stakeholder information (described in section E.2.2.2.1) suggests that alternatives to PTFE membranes and PFAS-coated products are produced but that PFASs are used for the E nv ir o nme nta l impact Filters/membranes are likely to cause emissions to a lesser extent compared to professional apparel applicationsfor which a derogation is proposed, for example due to an assumed lower release factor (ERC 12a, low release). If wear occurs under a high mechanical impact (ERC 12b) emissions would be higher (ERC 20% instead of 2.5%) and may then not be considered negligible. There is sufficiently strong evidence that additional emissions of a time-limited derogation can be expected to be significantly below additional emissions under maximum additional emission scenarios. As the environmental impact assessment does not cover the waste phase, additional emissions as a result of Cost impact If trials and approval processes for alternatives in the R&D stage are successful, substitution will be encouraged by the high margins and low price elasticity of demand allowing affected companies in the filtration industry to pass on substitution costs to their customers: Low producer surplus losses as a result of business closures [sufficiently strong evidence], despite the high number of affected companies in the technical textile industry [sufficiently strong evidence] and high producer surplus losses at company level due to high margins (for high performance membranes) [sufficiently strong evidence] and a low offsetting potential [sufficiently strong evidence], due to (i) a low share of business closures [sufficiently strong evidence], and (ii) low producer surplus losses in the wider supply chain [sufficiently strong evidence] Medium producer surplus losses as a result of substitution [sufficiently strong evidence], despite low Other aspects n/a 112 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s production process. While filter media can also be produced without PFASs, such alternatives still need to be trialled, tested and validated. E nv ir o nme nta l impact the derogation are likely underestimated. Stakeholder information presented in Section E.2.2.4.1 suggests furthermore that between three and 36 months might be needed for testing and approval, while a supplier of filters for mist and dust removal suggests that at least three years are required for commercializing an alternative technology and receiving customer validation and approval. Cost impact internalization of high substitution costs in relation to high performance membranes [sufficiently strong evidence], due to (i) the high number of affected companies [sufficiently strong evidence] (ii) the high share of substitution for both applications [sufficiently strong evidence], and (iii) medium substitution costs in relation to outdoor technical textiles, which are partially internalized [sufficiently strong evidence] Other aspects Medium (possibly high56) consumer surplus losses resulting from price changes associated with substitution [sufficiently strong evidence], due to (i) the medium sales volume for outdoor technical textiles alone, and the exacerbation of consumer surplus losses resulting from comparatively low price changes due to a high price elasticity of demand [sufficiently strong evidence], and (ii) additional consumer surplus 56 Sales volumes are deemed to be the main determinant of the magnitude of consumer surplus losses as mentioned in Section E.2.2.4.2. Due to a lack of data on sales volumes of high performance membranes, no definite conclusion on whether consumer surplus losses will be medium or high in comparison to other TULAC sub-sectors can be drawn as it is not clear whether the sales volume of high performance membranes results in a total sales volume of technical textiles that is comparable in magnitude to consumer apparel and home textiles, for which consumer surplus losses are found t o be high. 113 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s E nv ir o nme nta l impact Cost impact losses in relation to high performance membranes resulting from high price changes caused by high substitution costs, which are fully passed on to customers [sufficiently strong evidence] Other aspects Some welfare losses or additional costs as a result of (i) changes in filtration efficiencies for some filtration applications, (ii) higher energy use in relation to these applications, (iii) more frequent replacement (and associated higher process downtimes) due to shorter lifetimes of such filters, (iv) some welfare losses as a result of lower functionality leading to inferior aesthetic appearance for outdoor technical textiles (or additional costs for counteracting changes in functionality), and (vi) additional costs in relation to outdoor technical textiles due to changes in the lifetime of goods [sufficiently strong evidence] Low level of employment losses due to low share of business closures [sufficiently strong evidence] 114 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Conclusion Duration of derogation 12 years A lte r na tiv e s n/a E nv ir o nme nta l impact n/a Cost impact n/a Other aspects n/a A ban with a transition period of 18 months and a 5-year derogation is proposed for:Textiles for the use in filtration and separation media used in high performance air and liquid applications in industrial or professional settings that require a combination of water- and oil repellence. 115 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in Section E.2.2.2.4, the Dossier Submitters consider based on the available evidence for outdoor technical textiles (and evidence underlying the assessment of alternatives for other TULAC applications) that there is sufficiently strong evidence for the existenc e of technically and ec onomic ally feasible alternatives. As no evidenc e is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters conclude by default that technically feasible alternatives exist in sufficient quantities. As a result, the Dossier Submitters consider that there is sufficiently strong evidenc e to c onclude that the substitution potential is high under a full ban with a transition period of 18 months. With respect to medical textile applications, the Dossier Submitters consider based on the available evidence that the evidence on the technical feasibility of alternatives for relevant applic ations is inc onclusive. No c onc lusion on the substitution potential under a full ban with a transition period of 18 months can thus be drawn, but conclusions relating to the substitution potential for home textiles might be relevant to some extent given that medical applic ations inc lude articles such as mattress protectors and c urtains around beds. With respect to high performance membranes, the Dossier Submitters consider based on the available evidence that there is sufficiently strong evidence that technically feasible alternatives do not exist for all types of high performance membranes, and that the substitution potential is low under a full ban with a transition period of 18 months. The assessment of costs in relation to technical textiles for a full ban with a transition period of 18 months is based on evidence from the assessment of alternatives and the substitution potential and: Literature and public databases, e.g. a document produced by industry providing quantitative information on the number of ac tive c ompanies in the textile and c lothing industry in the EU as well as the share of different sub-sectors in total EU production, an industry Risk Management Option Analysis (RMOA), the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances, and the PRODCOM database; Princ iples relating to margins, the pric e elastic ity of demand and offsetting potential; Information from a limited number of stakeholder interviews, e.g. on differences in applying alternative textile finishes and changes in operating costs; The CfE, e.g. information on the sub-sectors with the highest use volumes of PFASs, the timeframe required for substitution and changes in operating costs; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) the timeframe required for substitution, (ii) annual sales losses of individual companies in the case of a restriction, (iii) differences in the costs of alternatives in comparison to PFASs, (iv) the total costs associated with substitution at c ompany level and (v) c hanges in the quality of artic les, e.g. its lifetime. For technical textiles, the Dossier Submitters assessed (i) producer surplus losses resulting from company closures and substitution, as well as producer surplus losses in the supply chain, (ii) consumer surplus losses resulting from price changes, (iii) welfare losses and/or costs resulting from changes in the characteristics of the good, i.e. its quality and lifetime and (iv) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of c ompanies affected by the restric tion, (ii) the most likely reac tion of affected companies, (iii) the costs that companies face as a result of substitution or a stop of production and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indic ator of the number of c ompanies active in the relevant sub-sector. This assumption leads to the plausible result that a comparatively high number of c ompanies is ac tive in sectors with 116 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) lower barriers to entry, e.g. lower specialisation and certification requirements, such as the consumer apparel industry. Around 24 500 companies are estimated to be active in the technical textile industry (which is only exceeded by the consumer apparel industry and comparable in magnitude to the home textile industry). Given the high barriers to entry in relation to some types of technical textiles, e.g. high performanc e membranes, the estimated number of c ompanies might be deemed comparatively high but given that the technical textile sector is composed of several specialised sub-sectors, including sectors with likely less barriers to entry such as the market for outdoor technical textiles, the existence of a high number of companies cannot be ruled out. The number of companies producing articles containing PFASs could not be estimated due to a lack of quantitative information on the share of companies using PFASs. Evidence from the CfE suggests, however, that the technical textile industry is one of the three biggest users within the TULAC industry. The Dossier Submitters conclude based on this evidence, which is considered to be sufficiently strong, that the number of companies affected by the proposed restriction in the technical textile industry (in comparison to other TULAC sub-sectors) is high (as for consumer apparel, and thereby higher than for the home textile industry due to the more limited market penet ration of alternativebased products). For determining the most likely reaction of affected companies in relation to technical textiles, the Dossier Submitters relied on: Conclusions concerning the existence of technically feasible alternatives and the substitution potential (summarised at the beginning of this section); Information from the 2nd stakeholder consultation on the economic and social impacts of a restriction (which is dominated by information relating to high performance membranes); and Information from the CfE and 2nd stakeholder consultation on the timeframe required for substitution (with stakeholder information on the required timeframe relating to medic al applic ations and high-performanc e membranes). Information (from a small and non-representative sample of less than 10 stakeholders) on the ec onomic and social impac ts of the restriction at c ompany level suggests a c lear tendency towards business closures. With respect to the timeframe required for substitution, no clear conclusion on the required timeframe could be drawn for technical textiles for medical applic ations due to the large variations in the timeframe reported to be required for approval alone (with reported timeframes ranging from days to ten years). In relation to filtration applic ations, reported timeframes for testing and approval range from three months to three years, while reported timeframes for the entire substitution process range from at least three years up to ten years, whereby the estimate of up to ten years is based on past experience with substitution from C8 to C6 substances. Substitution might thus be feasible in the timeframe available until the restriction takes full effect, but some uncertainty prevails - especially based on practical experiences from the past. Based on this evidenc e, which is c onsidered to be suffic iently strong, the Dossier Submitters c onc lude that the expected share of business c losures in relation to technical textiles is high for high performance membranes under a full ban with a transition period of 18 months, due to the limited implementation of alternatives on the market, information pointing to challenges with the replication of the multitude of functionalities provided by PFAS, information on economic and social impacts from the 2nd stakeholder consultation pointing to a high share of business closures, as well as the potentially long timeframe that is required for substitution. With respect to outdoor technical textiles, the Dossier Submitters conclude based on the available evidence, which is considered to be sufficiently strong, that the expected share of business c losures is low, due to the high substitution potential, only limited and weak evidence from the 2nd stakeholder consultation pointing to business closures and the abse nce of evidence pointing to challenges with respect to the timeframe required for substitution. No conclusion on the share of business closures can be drawn for technical textiles for medical 117 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) applications due to the unclear substitution potential, only limited and weak evidence from the 2nd stakeholder consultation pointing to business closures and the unclarity on the timeframe required for substitution. Producer surplus losses associated with a stop of production are, as mentioned in Section E.2.2.5.1, solely determined based on a consideration of margins (with low margins being associated with lower producer surplus losses) as data on annual sales losses reported by a limited and non-representative sample of c ompanies in the 2nd stakeholder consultation did not point to differences in annual sales values between different TULAC sub-sectors. Data on annual sales losses at company level in relation to technical textiles (provided in the 2nd stakeholder consultation by a non-representative sample c onsisting of five companies) ranges from 10 million and 50 million. Due to a lack of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and pric e elasticity of demand with margins. In relation to tec hnical textiles, the size of the margin differs across applications. It is found to be high for high performance membranes (as for professional apparel and textiles for use in engine bays) and low for outdoor technical textiles and medical applications (as for home textiles, consumer apparel, leather applications and home fabric treatments). The offsetting potential is determined based on a consideration of principles on the interlinkage between the offsetting potential of other actors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU c ompetition in c omparison to international competition. These princ iples are wellgrounded and have a robust foundation in the SEAC guidance on assessing changes in producer surplus, i.e. ECHA (2021b). In relation to technical textiles, the offsetting potential is found to be low, mainly due to the high market share of affected companies. Given the high share of company closures (for at least some applications) and low offsetting potential, the extent of producer surplus losses in the wider supply chain are found to be high. The Dossier Submitters consider based on the assessment of alternatives, stakeholder information and aforementioned principles pointing to a high number of affected companies, a high share of company closures (especially in relation to high performance membranes), high producer surplus losses due to high margins (for high performance membranes), a low off setting potential and high impac ts on the wider supply c hain that there is sufficiently strong evidence to conclude that the socio-economic costs to industry in the form of producer surplus losses from business closures are high under a full ban with a transition period of 18 months. Producer surplus losses resulting from substitution are, as mentioned in Section E.2.2.5.1, assessed on the basis of considerations of the extent to which companies will pass on hig her costs to customers and considerations of R&D costs, capital costs for new equipment, changes in operating costs and re-certification costs. The extent to which companies are expected to pass on substitution costs to customers in the form of higher pric es is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of ec onomic s) surrounding margins and the pric e elastic ity of demand. The extent to which companies pass on costs to customers is found to be high for high performance membranes (as for professional apparel and textiles for use in engine bays) due to high margins and a low price elasticity of demand. For outdoor technical textiles and medical applications the extent to which companies pass on costs to customers is found to be low (partial) (as for companies in the home textile, consumer apparel and leather industries as well as producers of home fabric treatments) due to low margins and a high price elasticity of demand. Due to very limited quantitative information on substitution costs across TULAC sub-sectors, the assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applications (whic h is deemed to affect R&D costs) and the relevance of rec ertification/validation c osts. The substitution c ost in relation to tec hnical textiles is found to be medium to high, with the substitution cost for outdoor technical textiles deemed to be medium (as for home textiles, consumer apparel, professional sportswear and footwear and leather applications) and thereby lower than for other technical textile applications. The 118 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) substitution cost for outdoor technical textiles is found to be medium due to the low er complexity of products which limits R&D costs and the absence of re-certification costs. The Dossier Submitters consider based on the high share of substitution for outdoor technical textiles, the likely considerable number57 of substituting companies, the aforementioned principles and information from consultations pointing to a high (partial) internalization of c osts and medium substitution c osts as well as an annual sales volume of >1 million tonnes (which is classified as medium in comparison to other TULAC sub-sectors) that there is suffic iently strong evidence to c onclude that soc io-economic c osts to industry in the form of producer surplus losses from substitution are medium under a full ban with a transition period of 18 months. As mentioned in Sec tion E.2.2.5.1, consumer surplus losses resulting from price changes associated with substitution for TULAC sub-sectors are determined based on consideration of (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into account the extent to which this volume will be replaced by alternative-based products (based on a c onsideration of the substitution share). The volume of goods sold in TULAC subsectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading industry association as a basis for c onc luding on the magnitude of the volume of goods c ontaining PFASs in eac h sub -sector. As mentioned above, substitution is mainly of relevanc e in relation to outdoor tec hnical textiles under a full ban with a transition period of 18 months. Based on medium substitution costs in relation to outdoor technical textiles (which are lower in magnitude than substitution costs for PPE, other types of technical textiles and textiles for the use in engine bays) and a low (partial) extent to which costs are passed on to customers, price changes in relation to technical textiles (more specifically outdoor tec hnical textiles) are found to be low (as for home textiles, consumer apparel and leather products). Due to the high price elasticity of demand for outdoor technical textiles, consumer surplus losses will be exacerbated by c hanges in the quantity demanded resulting from the pric e c hange. As explained in Sec tion E.2.2.4.2, the annual volume of goods sold to EU customers is deemed to be the main determinant of differences in the magnitude of consumer surplus losses for different subuses. With around 1.3 million tonnes, the estimated annual sales volume for technical textiles (including PFAS-free and PFAS-containing products), which only covers outdoor technical textiles and imports of textiles for medical applications (accounting for around 125 000 t), is medium and exceeded by home textiles and consumer apparel. The annual sales volume of goods containing PFAS is also deemed to be medium (in comparison to other TULAC subsec tors). The entire volume will likely be replac ed by PFAS-free products given the high share of substitution in relation to outdoor technical textiles and the potential of substituting companies to take over market shares from companies ceasing production. The Dossier Submitters consider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of consumer surplus losses from price changes associated with substitution in the outdoor technical textile industry are medium (in comparison to other TULAC sub-sectors) under a ban with a transition period of 18 months. With respect to changes in the characteristics of goods, evidence from stakeholders from the 2nd stakeholder consultation, Drohmann et al. (2021) and the Annex XV dossier proposing a restric tion for PFHxA, its salts and related substances points to possible negative impac ts on the lifetime of outdoor tec hnical textiles(ECHA, 2021a). In relation to PTFE membranes used in outdoor technical textiles, for which polyurethane-and polyester-based membranes are, for example, reported as a proven alternative, no information on differences in the quality and 57 Due to the high number of affected companies in the technical textile industry and the low barriers to entry in the outdoor technical textile industry, the number of substituting companies might be considerable. 119 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) lifetime is available. In relation to textile finishes, e.g. PFAS-based top coat finishes for applic ations such as outdoor upholstery and tents, stakeholder information however points to significant changes in the lifetime of products. The lifetime of articles is reported to be around three to five times shorter if the PFAS-based top coat finish is not applied on the PVC-coated fabrics. The PFAS-based coatings themselves are furthermore reported to be significantly more durable than other coating technologies (Drohmann et al., 2021). A reduced lifetime of outdoor technical textiles, such as outdoor cushions and seating, was also mentioned in stakeholder responses to the Annex XV report consultation conducted in relation to the restriction on PFHxA as a result of the lower dirt, oil and soil repellence of alternatives and the resulting visual impairments (ECHA, 2021a). The Dossier Submitters consider based on that evidence (and the evidence for home textiles) that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of welfare losses (resulting from inferior aesthetic appearance) and additional costs for counteracting changes in functionality and durability, e.g. purchasing washable covers and more frequent re -coating, or more frequent replacement are likely to occur under a full ban with a transition period of 18 months. In relation to high performance membranes, available evidence (based on stakeholder information) points to the non-existence of alternatives for some applic ations, e.g. c oalescing filers as well as membranes for the filtration of very fine particles. For coalescing filters, the absence of such filters is reported to lead to the failure or shortened lifetime of industrial equipment, with wide-ranging economic consequences due to the widespread use of such filter in nearly all industry sectors. The proven use of polyurethane (as well as polyesterbased membranes) in high performance membranes is however also reported. While the overall substitution potential is thus low, as described in Section E.2.2.2.4, some substitution might be feasible. Changes in quality and lifetime are however likely under a full ban with transition period of 18 months. Stakeholder information points to possible changes in pressure properties (porosity), filtration efficiency (e.g. in relation to the removal of microbiological contaminants from air and process fluids and the removal of dusts and mists in industrial processes). Due to higher drops in pressure across f ilters, the use of alternatives is also reported to increase energy use. Stakeholder information also points to changes in the lifetime of filters and possible degradation of filters leading to contamination downstream. The lower lifetime of alternative filtration solutions is reported to lead to increased costs to industrial end users due to higher proc ess downtimes. The Dossier Submitters c onsider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of welfare losses (e.g. changes in filtration efficiency) and additional costs, including increased energy costs as well as costs resulting from higher replacement frequencies of filters, higher process downtimes and shortened lifetimes of industrial equipment would be high under a full ban with a transition period of 18 months. As mentioned in sec tion E.2.2.4, the magnitude of employment losses in different sub-sectors c ould not be estimated due to the significant uncertainty about the number of c ompanies that would c ease operation and a lac k of representative data on the average number of employees in relevant companies (which might differ between sub-sectors depending on how labourintensive the associated production process is). The Dossier Submitters consider based on the suffic iently strong evidence pointing towards a high share of business c losures in relation to high performance membranes that some socio-economic costs to society in the form of employment losses will occur under a full ban with a transition period of 18 months. E.2.2.5.5. Leather Table E.33 summarises the outcomes of the assessment of costs and benefits for leather applications. More detailed information c an be found in the accompanying text following the table. 120 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.33. Leather - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Full ban Duration of derogation Not applicable A lternatives Sufficie ntly strong e vidence that te chnically feasible alternatives e x ist, with four of seven alte rnative substance groups be ing identified as re levant for le ather applications, i.e.: Hybrid (Silico n e/hydro carbon ); Hydrocarbons; Polyurethanes; and Silicone s. No practical e xamples of com pleted substitution are available but the sufficiently strong e vidence for consumer appare l, which includes practical e x amples of completed substitution, suggests that listed alte rnatives are economically fe asible. No e vide nce pointing to a shortage in supply of alternatives is available to the Dossier Subm itters. As a re sult, there is sufficiently strong e vidence to conclude that the substitution potential is high at EiF. Environmental impact Base d on the available e vide nce, which is considered to be sufficiently strong (i.e. based on verifiable tonnage estimates for subuse s and PFAS groups and re asonable assumptions about environmental re le ase, a full ban of P FAS use in TULAC will contribute to reducing e m issions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in com parison to the baseline. The expected e m ission re duction during the use phase for all TULAC sub-sectors, e xcept automotive uses for insulation purposes (for which no volume data is available), together e quals around 95% of baseline e m issions for a 30-year pe riod (2025-2055). As the e nvironmental im pact assessment does not cove r the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are lik e ly undere stimated. Cost impact Low producer surplus losses as a result of business closures [sufficiently strong evidence], de spite lo w o ffsetting po tential [sufficiently strong e vidence], due to (i) a lo w sha re o f business clo sures [sufficiently strong e vidence], (ii) low producer surplus losses at company le ve l due to low m argins [sufficiently strong e vidence] and (iii) low producer surplus losses in the wider supply chain [sufficiently strong e vide nce] Medium producer surplus losses as a result of substitution [sufficiently strong evidence], de spite co mparatively low co sts a t com pany le vel [sufficiently strong e vide nce], due (i) a high share of substitution [sufficiently strong e vide nce], (ii) partial internalization of costs [sufficiently strong evidence] and (iii) information on annual sold production volumes of EU producers of around 900 000 t [sufficiently strong e vidence] Medium consumer surplus losses resulting from price changes associated with substitution [sufficiently strong evidence] de spite co mparatively low price changes [sufficiently strong e vide nce] re sulting from medium (and comparatively low) substitution costs at company level [sufficiently strong e vidence] which are only Other aspects n/a 121 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact partially passed on to customers [sufficiently strong e vidence], due to (i) the m edium annual sales volume [sufficiently strong e vidence] and (ii) an e x acerbation of consumer surplus losses due to a high price elasticity of de mand [sufficiently strong e vide nce] Other aspects Some welfare losses or additional costs as a result of lower functionality, e .g. in re lation to oil and dirt re pellence [sufficiently strong e vidence] Ban with use-specific derogations Conclusion Low level of employment losses due to low sha re of business closures [sufficiently strong e vidence] 5 ye ars n/a n/a n/a n/a 12 ye ars n/a n/a n/a n/a A full ban of PFASs in leather applications with a transition period of 18 months is proposed. 122 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in Section E.2.2.2.4, the Dossier Submitters consider based on the available evidence for leather applications and the evidence for consumer apparel pointing to the economic feasibility of named alternatives that there is sufficiently strong evidence for the existence of technically and economically feasible alternatives for leather applications. The evidence is, however, considered to be somewhat weaker than for home textiles and c onsumer apparel due the existence of some c onflic ting evidence. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters conclude by default that technically and economically feasible alternatives exist in suffic ient quantities for use in leather applic ations and that the substitution potential is high under a full ban with a transition period of 18 months. The assessment of costs in relation leather applications for a full ban with a transition period of 18 months is based on evidence from Annex A on uses and functions, the assessment of alternatives and the substitution potential and: Literature and public databases, e.g, the Annex XV dossier proposing a restric tion for PFHxA, its salts and related substance, the PRODCOM database and an industry RMOA; Principles relating to margins, the price elasticity of demand and offsetting potential; Information from a limited number of stakeholder interviews, e.g. on differences in applying alternative textile finishes and changes in operating costs; The CfE, e.g. c hanges in operating c osts and differences in func tionality; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) the timeframe required for substitution, (ii) annual sales losses of individual companies in the TULAC indust ry in the case of a restriction, (iii) differences in the c osts of alternatives in c omparison to PFASs, and (iv) the total c osts associated with substitution at company level. For leather applications, the Dossier Submitters looked into assessing (i) producer surplus losses resulting from c ompany c losures and substitution, as well as produc er surplus losses in the supply chain, (ii) consumer surplus losses resulting from price changes, (iii) welfare losses and/or c osts resulting from c hanges in the c haracteristics of the good, i.e. its quality and lifetime and (iv) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of companies affected by the restriction, (ii) the most likely reaction o f affected companies, (iii) the costs that companies face as a result of substitution or a stop of production and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indicator of the number of companies active in the relevant sub-sector. As data for leather applications was not covered by this set of data, the number of companies active in this industry branc h has not been est imated. Quantitative information on the share of c ompanies using PFASs is not available but the share is deemed to be comparatively high as cases of completed substitution do not seem to be as widespread as for home textiles, for which evidence points to voluntary industry commitments. As a result, the Dossier Submitters conclude that there is no evidence on the magnitude of companies (in comparison to other TULAC sub-sectors) that is affected by the restriction. As no c onclusion on the most likely reaction of affected companies, i.e. the share of companies in the leather industry opting for substitution in c omparison to stopping produc tion, c ould be drawn based on stakeholder information, the Dossier Submitters relied solely on conclusions concerning the substitution potential in combination with information from the 2nd stakeholder consultation on the timeframe required for substitution. The Dossier Submitters consider that there is sufficiently strong evidence that the substitution potential is high under a full ban with a transition period of 18 months. As between two and three years are reported as being required for completing substitution in relation to leather-based apparel after identification of 123 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) a relevant alternative, the timeframe available is not found to be of concern. Based on this evidence, which is considered to be sufficiently strong, the Dossier Submitters conclude that the expected share of business closures is low under a full ban with a transition period of 18 months (as for home textiles, outdoor technical textiles and home fabric treatments). Producer surplus losses associated with a stop of production are, as mentioned in Section E.2.2.5.1, solely determined based on a consideration of margins (with low margins being associated with lower producer surplus losses) as data on annual sales losses reported by a limited and non-representative sample of companies in the 2nd stakeholder consultation did not point to differences in annual sales values between different TULAC sub-sectors. Specific data on annual sales losses in relation to leather applications was not provided in the 2nd stakeholder c onsultation. Due to a lac k of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and the pric e elasticity of demand with margins. The size of the margin in relation to leather applications is found to be low (as for home textiles, consumer apparel, home fabric treatments, outdoor technical textiles and medical applications). The offsetting potential is determined based on a consideration of principles on the interlinkage betwe en the offsetting potential of other actors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU competition in comparison to international competition. These principles are well-grounded and have a robust foundation in the SEAC guidance on assessing changes in producer surplus, i.e. ECHA (2021b). In relation to leather applications, the offsetting potential is found to be low especially due to the high market share of affected companies. Given the low share of company closures, the extent of producer surplus losses in the wider supply chain are found to be low. The Dossier Submitters consider based on the assessment of alternatives and aforementioned principles pointing to a low share of company closures, low producer surplus losses due to low margins, a low offsetting potential and low impac ts on the wider supply c hain that there is suffic iently strong evidence to c onclude that the socio-economic costs to industry in the form of producer surplus losses from business closures are low under a full ban with a transition period of 18 months. Producer surplus losses result ing from substitution are, as mentioned in Section E.2.2.5.1, assessed on the basis of considerations of the extent to which companies will pass on higher costs to customers and considerations of R&D costs, capital costs for new equipment, changes in operating c osts and re-certification c osts. The extent to whic h c ompanies are expec ted to pass on substitution c osts to customers in the form of higher pric es is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of ec onomic s) surrounding margins and the pric e elastic ity of demand. The extent to which companies pass on costs to customers is found to be low (partial) in relation to leather applic ations (as for c ompanies in the home textile and c onsumer apparel industry as well as produc ers of home fabric treatments, outdoor technical textiles and medic al applic ations) due to low margins and a high price elasticity of demand. Due to very limited quantitative information on substitution costs across TULAC sub-sectors, the assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applications (which is deemed to affect R&D costs) and the relevance of re-certification/validation costs. The substitution cost in relation to leather applications is found to be medium (as for home textiles, consumer apparel, professional sportswear and footwear, and outdoor technical textiles and medical applications) and therefore more limited than in relation to other technical textile applications, PPE and textiles for the use in engine bays due to the lower complexity of products which limits R&D costs and (in all cases except medical applications) the absence of re-certification costs. The Dossier Submitters consider based on the aforementioned principles pointing to a high (partial) internalization of c osts, medium substitution costs, no evidence on the number of c ompanies being affected, but a medium annual sales volume described in Section E.2.2.4.2, and the high share of substitution that there is sufficiently strong evidence to conclude that socioeconomic costs to industry in the form of producer surplus losses from substitution (in 124 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) comparison to other TULAC sub-sectors) are medium under a full ban with a transition period of 18 months. As mentioned in Section E.2.2.5.1, consumer surplus losses resulting from price changes associated with substitution for TULAC subs-sectors are determined based on consideration of (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into ac count the extent to which this volume will be replac ed by alternative-based products (based on a consideration of the substitution share). The volume of goods sold in TULAC sub-sectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading industry association as a basis for c onc luding on the magnitude of the volume of goods c ontaining PFASs in eac h sub-sector. Based on medium substitution costs (which are lower in magnitude than substitution costs for PPE, high performance membranes and textiles for the use in engine bays), and a low (partial) extent to which costs are passed on to customers, price changes in relation to leather-based products are found to be low (as for home textiles, consumer apparel, outdoor technical textiles and medical applications). Due to the high price elasticity of demand, c onsumer surplus losses will be exac erbated by c hanges in the quantity demanded resulting from the pric e c hange. As explained in Sec tion E.2.2.4.2, the annual volume of goods sold to EU customers is deemed to be the main determinant of differences in the magnitude of consumer surplus losses for different sub-uses. With around 900 000 t, the estimated annual sales volume (estimated without consideration of imports and exports due to a lack of information) for leather- based products (inc luding PFAS-free and PFAS-containing products) is the second lowest of all assessed sub-sectors. Data gaps exist for most TULAC sub-sectors including leather-based products for which the estimate is only based on only three of four relevant product categories (as no data was available for professional sportswear and footwear), resulting in a likely underestimation of volumes for these sectors. As this affects all apart from one sub-sector, comparative conclusions on the magnitude of sales volumes are however deemed to be robust. The annual sales volume of goods containing PFASs is deemed medium. The entire volume will likely be replaced by PFAS-free products given the high share of substitution. The Dossier Submitters consider based on that evidence that there is suffic iently strong evidence to conclude that socio-economic c osts to customers in the form of consumer surplus losses from price changes associated with substitution are medium (in comparison to other TULAC sub-sectors) under a ban with a transition period of 18 months. With respec t to c hanges in the c haracteristics of goods, evidence from the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances, the CfE and 2nd stakeholder c onsultation suggests that the difference between PFASs and alternatives is their c apacity to provide several functionalities simultaneously. While reaching broadly c omparable levels of water repellence tends not to be a concern, identified alternatives reach lower levels of performanc e for other func tionalities suc h as oil and dirt repellenc e, which might also impact the lifetime of the good. As mentioned in Section A.3.3.1,oil repellenc e is (as for home textiles as well as sportswear and footwear) deemed to be important for leather-based products. As suc h, some c hanges to the quality are likely. This is also c onfirmed by information from one stakeholder submitting information relating to leather to the 2nd stakeholder consultation reporting that they have been able to identify an alternative whose oil and soil repellence properties are close enough, and not identical. In relation to the use of fluoropolymers (for anti-soiling purposes) in the manufacture of leather products, silicone-based products are furthermore reported by Drohmann et al. (2021) to be an alternative that could provide a comparable performance with respect to soil repellence with resistance to coffee being the sole exception. The Dossier Submitters consider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of welfare losses (resulting from inferior aesthetic appearance) and/or additional costs for counteracting changes in functionality, e.g. more frequent replacement, are likely to occur under a full ban with a transition period of 18 months. 125 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider, furthermore, based on sufficiently strong evidence from the assessment of alternatives pointing towards a low share of business closures in relation to leather applications that there is sufficiently strong evidence to conclude that the socioeconomic costs to society in the form of employment losses will be low under a full ban. E.2.2.5.6. Other: Home fabric treatments (sprays) Table E.34 summarises the outcomes of the assessment of c osts and benefits for home fabric treatments (sprays). More detailed information can be found in the accompanying text following the table. 126 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.34. Home fabric treatments (sprays) - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lternatives Sufficie ntly strong e vidence that te chnically feasible alternatives e x ist, with one of seven alte rnative substance groups be ing identified as re levant for hom e fabric tre atments, i.e.: Silicone s. Sufficie ntly strong e vidence that ide ntified alternatives are also e conomically feasible based on inform ation from other T ULAC s u b -secto rs No e vide nce pointing to a shortage in supply of alternatives is available to the Dossier Subm itters. As a re sult, there is sufficiently strong e vidence to conclude that the substitution potential is high at EiF. Environmental impact Base d on the available e vide nce, which is considered to be sufficiently strong (i.e. based on verifiable tonnage estimates for subuse s and PFAS groups and re asonable assumptions about environmental re le ase, a full ban of PFAS use in TULAC will contribute to reducing e m issions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in com parison to the baseline. The expected e m ission re duction during the use phase for all TULAC sub-sectors, e xcept automotive uses for insulation purposes (for which no volume data is available), together e quals around 95% of baseline e m issions for a 30-year pe riod (2025-2055). As the e nvironmental im pact assessment does not cove r the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are lik e ly undere stimated. Cost impact Low producer surplus losses as a result of business closures [sufficiently strong evidence] due to (i) a lo w share of business closure s [sufficiently strong e vide nce], (ii) low pro ducer surplus losses at company level due to low m argins [sufficiently strong e vide nce], a nd (iii) lo w pro ducer surplus losses in the wider supply chain [sufficiently strong e vidence] No evidence on the magnitude of producer surplus losses as a result of substitution, due to no e vide nce on the number of affected com panies and the m agnitude of substitution costs No evidence on the magnitude of consumer surplus losses resulting from price changes associated with substitution, due to no e vidence on magnitude of price changes and no e vidence on annual sales volumes Some welfare losses or additional costs as a result of lower functionality, e .g. in re lation to oil and dirt re pellence [sufficiently strong e vidence] Low level of employment losses due to low sha re of business closures [sufficiently strong e vidence] Other aspects n/a 127 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Ban with use-specific derogations Conclusion 5 ye ars n/a n/a n/a 12 ye ars n/a n/a n/a A full ban of PFASs in home fabric tre atments with a transition period of 18 months is proposed. Other aspects n/a n/a 128 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in Section E.2.2.2.4, the Dossier Submitters consider based on the available evidence resulting from an extensive literature review taking into account information from a variety of actors, no contradictory evidence from consultation with stakeholders (and evidence relating to home textiles and consumer apparel) that there is sufficiently strong evidence for the existence of technically feasible alternatives for home fabric treatments. No information on the economic feasibility of alternatives for this specific application is available. Based on strong evidenc e for home textiles and c onsumer apparel pointing to the ec onomic feasibility of the named alternative group, the Dossier Submitters however consider that alternatives are also economically feasible. As no evidence is available to the Dossier Submitters that points to a shortage in supply of alternatives, the Dossier Submitters c onclude by default that tec hnically and economic ally feasible alternatives exist in sufficient quantities for use in home fabric treatments. As a result, the Dossier Submitters c onsider that there is sufficiently strong evidenc e to c onclude that the substitution potential is high under a full ban with a transition period of 18 months. The assessment of costs in relation to home fabric treatments for a full ban with a transition period of 18 months is based on evidenc e from the assessment of alternatives and the substitution potential and: Literature, e.g, the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances; Principles relating to margins, the price elasticity of demand and offsetting potential; The CfE, e.g. information on differences in functionality; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) annual sales losses of individual companies in the TULAC industry in the case of a restriction, and (ii) the total costs associated with substitution at company level. For home fabric treatments, the Dossier Submitters looked into assessing (i) producer surplus losses resulting from c ompany c losures and substitution, as well as produc er surplus losses in the supply chain, (ii) consumer surplus losses resulting from price changes, (iii) welfare losses and/or c osts resulting from c hanges in the c haracteristics of the good, i.e. its quality and lifetime and (iv) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of c ompanies affected by the restric tion, (ii) the most likely rea c tion of affected companies, (iii) the costs that companies face as a result of substitution or a stop of production and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indicator of the number of companies active in the relevant sub-sector. As data for home fabric treatments was not c overed by this set of data, the number of c ompanies ac tive in this industry branch has not been estimated. No information on the market penetration of alternative-based products and c onsequently the share of relevant c ompanies manufacturing produc ts containing PFASs is available. As a result, the Dossier Submitters conclude that there is no evidence on the magnitude of companies (in comparison to other TULAC sub-sectors) that is affected by the restriction. For determining the most likely reaction of affected companies in relation to home fabric treatments, the Dossier Submitters relied solely on the conclusions concerning the substitution potential (summarised at the beginning of this section) as no sub-sector-specific information on the economic and social impacts of a restriction and the timeframe required for substitution was available from consultations. Based on this evidence, which is considered to be suffic iently strong, the Dossier Submitters c onclude that the expected share of business closures in relation to home fabric treatments is low (as for home textiles, outdoor technical textiles and leather applications) under a full ban with a transition period of 18 months. 129 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Producer surplus losses associated with a stop of production are, as mentioned in Section E.2.2.5.1, solely determined based on a consideration of margins (with low margins being associated with lower producer surplus losses) as data on annual sales losses reported by a limited and non-representative sample of companies in the 2nd stakeholder consultation did not point to differences in annual sales values between different TULAC sub-sectors. Specific data on annual sales losses in relation to home fabric treatments was not provided in the 2 nd stakeholder c onsultation. Due to a lac k of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and price elasticity of demand with margins. The size of the margin in relation to home fabric treatments is found to be low (as for home textiles, c onsumer apparel, leather applic ations, outdoor technical textiles and medical applications). The offsetting potential is determined based on a consideration of princ iples on the interlinkage between the offsetting potential of other actors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU c ompetition in c omparison to international competition. These princ iples are wellgrounded and have a robust foundation in the SEAC guidance on assessing changes in producer surplus, i.e. ECHA (2021b). In relation to home fabric treatments, no conclusion on the offsetting potential could be drawn due to a lack of evidence on the market penetration of alternative-based products and consequently the market share of affected actors. Given the low share of c ompany c losures, the extent of produc er surplus losses in the wider supply chain are found to be low. The Dossier Submitters consider based on the assessment of alternatives and aforementioned principles pointing to a low share of company closures, low producer surplus losses due to low margins, and low impacts on the wider supply chain that there is suffic iently strong evidence to c onclude that the soc io-economic c osts to industry in the form of producer surplus losses from business closures are low under a full ban with a transition period of 18 months. Producer surplus losses resulting from substitution are, as mentioned in Section E.2.2.5.1, assessed based on considerations of the extent to which companie s will pass on higher costs to customers and considerations of R&D costs, capital costs for new equipment , changes in operating costs and re-certification costs. The extent to which companies are expected to pass on substitution c osts to customers in the form of higher pric es is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of ec onomic s) surrounding margins and the pric e elastic ity of demand. The extent to which companies pass on costs t o customers is found to be low (partial) in relation to home fabric treatments (as for companies in the home textile, consumer apparel and leather industries as well as producers of outdoor technical textiles and medical applications) due to low margins and the high price elasticity of demand. Due to very limited quantitative information on substitution costs across TULAC sub-sectors, the assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applications (which is deemed to affect R&D costs) and the relevance of re-certification/validation costs. Information from consultations on the magnitude of capital costs and changes in operating costs associated with substitution are not deemed of relevance for home fabric treatments as available information refers to the application of textile finishes. The magnitude of substitution costs in relation to home fabric treatments is therefore unknown. As a result, the Dossier Submitters c onsider based on the aforementioned princ iples pointing to a high (partial) internalization of c osts, the high share of substitution, no evidenc e on the number of c ompanies being affected and no evidenc e on the magnitude of substitution c osts (in c omparison to other TULAC sub-sectors), that there is no evidence on the magnitude of soc io-economic c osts to industry in the form of producer surplus losses from substitution (in c omparison to other TULAC sub-sectors) under a full ban with a transition period of 18 months. As mentioned in Section E.2.2.5.1, consumer surplus losses resulting from price changes associated with substitution for TULAC sub-sectors are determined based on consideration of 130 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods (containing PFASs) sold to EU customers per year, also taking into account the extent to which this volume will be replaced by alternative-based products (based on a c onsideration of the substitution share). The volume of goods sold in TULAC subsectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading industry association as a basis for c onc luding on the magnitude of the volume of goods c ontaining PFASs in eac h sub-sector. As data for home fabric treatments was not covered by this set of data, annual sales volumes c ould not be estimated. As the magnitude of substitution c osts for home fabric treatments is unknown, the magnitude of pric e changes for home fabric treatments (in c omparison to other TULAC sub-sectors) is also unknown. As a result, the Dossier Submitters consider that there is no evidence on the magnitude of socio-economic costs to customers in the form of consumer surplus losses from price changes associated with substitution (in comparison to other TULAC sub-sectors). With respec t to c hanges in the c haracteristics of goods, evidence from the Annex XV dossier proposing a restriction for PFHxA, its salts and related substances, the CfE and 2nd stakeholder c onsultation suggests that the difference between PFASs and alternatives is their c apacity to provide several functionalities simultaneously. While reaching broadly comparable levels of water repellence tends not to be a concern, identified alternatives reach lower levels of performance for other functionalities such as oil and dirt repellence. The Dossier Submitters consider based on that evidence that there is sufficiently strong evidence to conclude that socio-economic costs to customers in the form of welfare losses (resulting from inferior performance of home fabric treatment sprays) and/or additional costs for counteracting changes in functionality, e.g. purchasing washable covers, are likely to occur under a full ba n with a transition period of 18 months. The Dossier Submitters consider, furthermore, based on sufficiently strong evidence from the assessment of the substitution potential pointing towards a low share of business closures in relation to home fabric treatments that there is sufficiently strong evidence to conclude that the socio-economic costs to society in the form of employment losses will be low under a full ban. E.2.2.5.7. Other: Automotive use - Noise and vibration insulation Table E.35 summarises the outcomes of the assessment of costs and benefits for textiles used in engine bays in automotives for the purpose of noise and vibration insulation. More detailed information can be found in the accompanying text following t he table. 131 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.35. Automotive use (Noise and vibration insulation) - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lternatives W e ak evidence that te chnically feasible alte rnatives do not exist and that the substitution pote ntial is low a t EiF. Environmental impact Base d on the available e vide nce, which is considered to be sufficiently strong (i.e. based on verifiable tonnage estimates for sub-uses and PFAS groups and re asonable assumptions about e nvironmental re lease, a full ban of PFAS use in TULAC will contribute to re ducing emissions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in com parison to the baseline. The expected e m ission re duction during the use phase for all TULAC sub-sectors, except automotive uses for insulation purposes (for which no volume data is available), together equals around 95% of baseline e m issions for a 30-year pe riod (2025-2055). As the e nvironmental im pact assessment does not cove r the waste phase, e missions under the baseline as we ll as e m issions avoided as a re sult of the re striction are lik ely unde restimated. Cost impact High producer surplus losses as a result of business closures [weak evidence] due to (i) a high share of business closure s [we ak e vide nce], (ii) high producer surplus losses at com pany le vel due to high m argins [sufficiently strong e vidence], (iii) a low offsetting potential, i.e . producer surplus losses are not balanced out by producer surplus gains by producers of alte rnative-based products [we ak e vidence] and (iv) high producer surplus losses in the wider supply chain [we ak evidence ] No producer surplus losses as a result of substitution, due to no substitution taking place as re sult of the lack of te chnically feasible alte rnatives [we ak e vide nce] High socio-economic costs to customers due to the unavailability of te x tiles for use in e ngine bays for insulation Other aspects n/a 132 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact purposes [we ak evidence] Other aspects Ban with use-specific derogations: Derogation for textiles for the use in engine bays for noise and vibration insulation used in the automotive industry 5 ye ars 12 ye ars W e ak evidence that the substitution potential is low due to the inability of com panies to complete substitution before the full ban takes e ffect after the tim e -limited derogation: Information from one stak eholder submitting inform ation to the 2nd stak eholder consultation suggests that a minimum of 10 to 15 years would be re quired for developing and e valuating com ponents once an alte rnative is identified. W e ak evidence that the substitution potential m ight be high: The timeframe for the tim e -limited derogation is highe r than the minimum tim e frame re ported to be re quire d for substitution. The re is no e vidence on the e x pected e nvironmental impacts of the potential derogation (that is mark ed for re consideration). The re is no e vidence on the e x pected e nvironmental impacts of the potential derogation (that is mark ed for re consideration). Some employment losses as a re sult of high share of business closures [we ak e vidence] Sam e as under full ban n/a If alte rnatives are n/a ide ntified, substitution will be e ncouraged by the high m argins and low price e lasticity of demand allowing affected com panies in the automotive industry to pass on substitution costs to the ir customers: Low producer surplus losses as a result of business closures due to low share of business closure s as a re sult of the 133 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact high substitution potential [we ak e vidence] Other aspects Low producer surplus losses as a result of substitution [weak evidence], de spite high share of substitution [we ak e vidence] and com paratively high costs at com pany level [sufficiently strong e vide nce] due to low inte rnalization of costs [sufficiently strong e vide nce] Consumer surplus losses resulting from price changes associated with substitution [weak evidence] re sulting from high share of substitution [we ak e vidence], com paratively high substitution costs at com pany le vel [sufficiently strong e vidence], which are fully passed on to customers [sufficiently strong e vidence] Conclusion Low level of employment losses due to lo w sha re of business closure s [we ak e vidence] In light of the we ak e vidence pointing to the unavailability of technically feasible alternatives at EiF, a 12-year derogation is not proposed at this point, but marked for re consideration for: 134 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects [Te x tiles for the use in engine bays for noise and vibration insulation used in the automotive industry] A de rogation might be proposed at a later stage if additional information on alternatives becomes available, e .g. information on the e xistence of te chnically feasible alternatives and the R &D efforts that have been undertaken in this field so far. 135 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As mentioned in Section E.2.2.2.4, the Dossier Submitters consider based on the available evidence that the evidence is weak that technically feasible alternatives do not exist for textiles for the use in engine bays and that the substitution potential is low under a full ban with a transition period of 18 months. The evidence is considered to be weak due to only being based on one source type, i.e. the 2nd stakeholder consultation, and due to being based on information from one stakeholder only. The assessment of costs in relation to textiles for the use in engine bays for a full ban with a transition period of 18 months is based on evidence from the assessment of alternatives and: Principles relating to margins and offsetting potential; and Information (from a non-representative sample) from the 2nd stakeholder consultation on, for example, (i) the timeframe required for substitution, and (ii) annual sales losses of individual companies in the TULAC industry in the case of a restriction. For textiles for the use in engine bays, the Dossier Submitters looked into assessing (i) producer surplus losses to companies directly affected by a full ban with a transition period of 18 months as well as producer surplus losses in the supply chain, (ii) impac ts on customers, and (iii) employment losses. Producer surplus losses for TULAC sub-sectors are determined based on an assessment of (i) the number of companies affected by the restriction, (ii) the most likely reaction of affected companies, (iii) the costs that a company faces as a result of substitution or a stop of produc tion and (iv) the ability of companies that substitute to pass on higher costs to their c ustomers. The number of c ompanies active in TULAC sub-sectors has, where available, been estimated based on industry data from a leading industry association on the number of c ompanies ac tive in the textile and c lothing industry as well as the assumption that the share of the sub-sector in total EU production, provided by the same source, is a representative indicator of the number of companies active in the relevant sub-sector. As data for textiles used in engine bays was not covered by this set of data, the number of companies active in this industry branch has not been estimated. As a result, the Dossier Submitters conclude that there is no evidenc e on the magnitude of companies (in c omparison to other TULAC subsectors) that is affected by the restriction. For determining the most likely reaction of affected companies in relation to textiles for use in engine bays, the Dossier Submitters relied on the conclusion concerning the existence of technically feasible alternatives reached in the assessment of alternatives. As a result, the Dossier Submitters c onclude based on this weak evidence that the expected share of business closures is high under a full ban with a transition period of 18 months. Producer surplus losses associated with a stop of production are, as mentioned in Section E.2.2.5.1, solely determined based on a consideration of margins (with low margins being associated with lower producer surplus losses) as data on annual sales losses reported by a limited and non-representative sample of companies in the 2nd stakeholder consultation did not point to differences in annual sales values between different TULAC sub-sectors. Specific data on annual sales losses in relation to textile for use in engine bays was not provided in the 2nd stakeholder consultation. Due to a lack of quantitative information, margins were determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding the relation of the level of competition, market sizes and price elasticity of demand with margins. The size of the margin in relation to textiles for use in engine bays is found to be high (as for professional apparel and highperformance membranes). The offsetting potential is determined based on a consideration of principles on the interlinkage between the offsetting potential of other actors in the market and (i) the extent of competition, (ii) the market share of affected companies, (iii) the degree of specialization and (iv) other barriers to entry as well as (v) the extent of EU competition in comparison to international competition. These principles are well-grounded and have a robust foundation in the SEAC guidanc e on assessing c hanges in produc er surplus, i.e. ECHA 136 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (2021b). In relation to textiles for use in engine bays, the offsetting potential is found to be low. Given the high share of company closures and low offsetting potential, the extent of produc er surplus losses in the wider supply chain are found to be high. The Dossier Submitters consider, based on the assessment of alternatives and aforementioned principles pointing to a high share of company closures, high producer surplus losses due to high margins, a low offsetting potential and high impac ts on the wider supply c hain that the evidence is weak that the socio-economic costs to industry in the form of producer surplus losses from business c losures are high under a full ban with a transition period of 18 months. The main shortcoming of the evidenc e base is the weak evidenc e underlying the assessment of alternatives (which is used to estimate the share of business c losures and has implic ations on the c onclusions on the offsetting potential and the magnitude of producer surplus losses in the wider supply c hain). The Dossier Submitters consider based on evidence from the assessment of alternatives that the evidence is weak that the socio-economic costs to customers will be high under a full ban with a transition period of 18 months due to the non-existence of technically feasible alternatives which would lead to the unavailability of textiles for use in engine bays. As mentioned in sec tion E.2.2.4, the magnitude of employment losses in different sub-sectors c ould not be estimated due to the significant uncertainty about the number of c ompanies that would c ease operation and a lac k of representative data on the average number of employees in relevant companies (which might differ between sub-sectors depending on how labourintensive the associated production process is). The Dossier Submitters consider based on weak evidence from the assessment of alternatives pointing towards a high share of business closures that some socio-economic costs to society in the form of employment losses will occur under a full ban with a transition period of 18 months. The assessment of alternatives in relation to textiles for the use in engine bays in relation to a ban with (a transition period of 18 months and) a time-limited derogation of a duration of five years is, as the evidence for the assessment in relation to a full ban, based on evidenc e from: The 2nd stakeholder c onsultation, during whic h three stakeholders reported the use of PFASs in relation to textiles used in engine bays for insulation purposes. Information on alternatives was only provided by one of these stakeholders. The stakeholder reports that once alternatives are identified, a minimum of 10 to 15 years would be required for substitution given the significant amount of time required for developing and evaluating c omponents and vehicles meeting type approval requirements. The Dossier Submitters c onsider based on the above evidence that the evidence is weak that the substitution potential is low under a ban with (a transition period of 18 months and) a time-limited derogation of a duration of five years due to the inability of companies to complete substitution before the full ban takes effect after the time-limited derogation. The Dossier Submitters consider based on the evidence underlying the assessment of alternatives that the evidence is weak that the socio-economic costs to industry, customers and society are high under a ban with (a transition period of 18 months and) a time-limited derogation of a duration of five years (as under a ban with a transition period of 18 months). The assessment of alternatives in relation to textiles for the use in engine bays in relation to a ban with (a transition period of 18 months and) a time-limited derogation of a duration of 12 years is, as the evidenc e for the assessment in relation to a full ban with (a transition period of 18 months and) a time-limited derogation of five years, based on evidence from: The 2nd stakeholder c onsultation, during whic h three stakeholders reported the use of PFASs in relation to textiles used in engine bays for insulation purposes. Information 137 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) on alternatives was only provided by one of these stakeholders. The Dossier Submitters consider based on the evidence that a minimum of 10 to 15 years would be required for substitution after an alternative is identified that the evidence is weak that the substitution potential is high due to the duration of the time -limited derogation being higher than the minimum timeframe reported to be required for substitution. The assessment of costs in relation to textiles for the use in engine bays for a full ban with (a transition period of 18 months and) a time-limited derogation of 12 years is based on evidence from the assessment of alternatives and: Principles relating to margins and the price elasticity of demand, Information from the 2nd stakeholder consultation on re-validation requirements for new products. For textiles for the use in engine bays, the Dossier Submitters looked into assessing (i) producer surplus losses resulting from company closures and substitution, as well as producer surplus losses in the supply chain, (ii) consumer surplus losses resulting from price changes, and (iii) employment losses. As mentioned under the assessment of a full ban, producer surplus losses for TULAC subsectors are determined based on an assessment of (i) the number of companies affected by the restriction, (ii) the most likely reaction of affected companies, (iii) the costs that a company faces as a result of substitution or a stop of produc tion and (iv) the ability of c ompanies that substitute to pass on higher costs to their c ustomers. As mentioned in relation to the assessment of a full ban with a transition period of 18 months, no information on the number of companies affected by a ban is available in relation to t extiles for use in engine bays. For determining the most likely reaction of affected companies under a full ban with (a transition period of 18 months and) a time-limited derogation of 12 years, the Dossier Submitters have relied on the conclusion concerning the substitution potential reached in the assessment of alternatives. The Dossier Submitters consider based on weak evidence pointing to a high substitution potential that the expected share of business closures is low under a full ban with a transition period of 12 years, and that the vast majority of affected companies substitute. Producer surplus losses from business closures are thus expected to be limited, as are producer surplus losses in the wider supply chain. Producer surplus losses resulting from substitution are, as mentioned in Section E.2.2.5.1, assessed on the basis of considerations of the extent to which companies will pass on higher costs to customers and considerations of R&D c osts, capital costs for new equipment, c hanges in operating costs and re-certification c osts. The extent to which c ompanies are expected to pass on substitution costs to customers in the form of higher prices is determined based on a consideration of well-grounded principles (considered to have robust foundations in the theory of economics) surrounding margins and the pric e elastic ity of demand. The extent to whic h c ompanies pass on c osts to c ustomers is found to be high (as for professional apparel and high-performance membranes) due to high margins and low-price elasticity of demand. Due to very limited quantitative information on substitution costs across TULAC sub-sectors, the assessment of substitution costs has focussed on assessing differences across sub-sectors, e.g. based on a consideration of differences in the complexity of applications (which is deemed to affect R&D costs) and the relevance of re-certification/validation costs. The substitution costs in relation to textiles in engine bays is found to be high (as for PPE and high-performance membranes) due to the higher complexity of products which heightens R&D costs and information from the 2nd stakeholder consultation pointing to re-validation requirements. The Dossier Submitters consider based on the aforementioned principles and information from the 2nd stakeholder c onsultation pointing to a limited internalization of c osts and high substitution c osts that the evidence is weak that socio-economic costs to industry in the form of producer surplus losses from substitution are low under a full ban with (a transition period of 18 months and) a time limited derogation of 12 years. The main shortcoming of the evidence base is the weak 138 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) evidenc e underlying the assessment of alternatives (which is used to determine the share of substitution). As mentioned in Section E.2.2.5.1, consumer surplus losses resulting from price changes associated with substitution for TULAC sub-sectors are determined based on consideration of (i) the magnitude of additional costs associated with substitution in each sub-sector, and the extent to which companies are expected to pass on such costs to customers, (ii) the extent to which the demand for goods produced in each sub-sector is deemed to vary with price and (iii) the total volume of goods sold to EU customers per year. The volume of goods sold in TULAC sub-sectors has, where available, been estimated based on public data from the PRODCOM database and import and export data from a leading indust ry association. As data for textiles used in engine bays was not covered by this set of data, annual sales volumes could not be estimated. As explained in Section E.2.2.4.2, the annual volume of goods sold to EU customers is deemed to be the main determinant of differences in the magnitude of consumer surplus losses for different sub-uses. The Dossier Submitters consider based on that evidence that the evidence is weak that socio-economic costs to customers in t he form of consumer surplus losses from price changes will occur under a ban with (a transition period of 18 months and) a time-limited derogation of 12 years. Due to a lack volume data, the magnitude of these losses (in c omparison other sub-sectors) c annot be determined. The Dossier Submitters consider, furthermore, based on weak evidence from the assessment of alternatives pointing towards a low share of business closures that the evidence is weak that the socio-economic to society in the form of employment losses will be low under a ban with (a transition period of 18 months and) a time-limited derogation of 12 years. 139 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.3. Food contact materials and packaging This sec tion addresses the use of PFAS in food c ontact materials and packaging, covering the following uses: Food contact packaging and packaging more generally where PFAS are largely used to confer oil and grease resistance. This includes baking papers whether they are for commercial or domestic use. The use of PFAS as processing aids in the production of plastic film. Consumer c ookware where PFAS primarily provide non-stick surfaces Industrial food and feed produc tion where PFAS are used for non-stick surfaces, inert pipes and seals, provision of oil and grease resistance and as polymer processing additives such as emulsifiers to enable poorly soluble monomers to be made available for polymerisation More detailed information on uses and tonnages of PFAS is provided in Annex A.3.4. Information presented here c overs the manufacture of goods in eac h sector and use of those goods. Production of PFAS and management of materials at end of life are addressed in Section E.2.1 respectively. Each sector breaks down to several subsectors. For example, PFAS used in indust rial food and feed production ranges from non-stick surface coatings used in industrial bakeries and baking papers to fluoropolymer pipes and seals in machinery. Packaging includes paper and plastic products, and various items for holding fresh and cooked food for human consumption and pet food. The possibility that there are nic he applic ations in the broad areas c onsidered that have not been addressed is recognised, though the assessment has accounted for information received through a major consultation exercise to which all affected parties were invited to c ont ribute. E.2.3.1. Baseline Paper and board use in packaging has been relatively steady in the EU since 2015 (Cepi, 2020). In 2015, 38.95 million tonnes of paper were consumed in the EU by packaging, w hilst in 2019, it had risen to 41.4 million tonnes, representing a compound annual growth rate of 1.5%/y. The Circular Economy could affect the use of PFAS in paper and board packaging in a number of ways. For example, increased recycling may lead to further cross contamination with PFAS. Overall, 64.4% of packaging waste was recycled in 2020 in the EU58. Data show that 82% of paper and board packaging is recycled (EURACTIV, 2022) but that rates for plastic packaging are lower, around 41% in 201959. It is anticipated that recycling rates for packaging (as well as for other sectors) will continue to increase because of the Green Deal and Circular Economy agenda. The potential for cross-contamination is illustrated by recent work demonstrating the presence of PFAS in drinking straws (Timshina et al., 2021) at subfunctional concentrations that are more likely to have arisen through cross -contamination than deliberate addition. A trend towards the use of less laminated packaging (packaging containing several bonded layers, which may be difficult to recycle) could promote the use of PFAS (Trier et al., 2018). Based on inc reased demand for plastics packaging (Geijer, 2019) (see Annex A) PFAS volumes 58 https://ec.europa.eu/eurostat/statisticsexplained/index.php?title=Packaging_waste_statistics&oldid=580504#Recycling_and_recovery_target s_and_rates, date of access: 2023-01-11. 59 https://ec.europa.eu/eurostat/web/products-eurostat-news/-/ddn-20211027-2, date of access: 2023-01-11. 140 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) for plastic packaging can be assumed to increase as well. The total demand for plastic in the EU-28 in 2018 was 51.2 million tonnes, of which 40% (20.4 million tonnes) was used in pac kaging (Plastics Europe, 2019). Of this, 8.2 million tonnes is estimated to have been used in food packaging Geijer (2019). Across the EU-28 in 2017 42% of plastic packaging was recycled (Eurostat, 2019). Increased awareness of the problems of plastics in the environment are expected to lead to a reduction in their use for packaging, linked for example to the EU's Single Use Plastic s Direc tive (EC, 2019). This will, naturally, feed through into the quantity of PFAS used in plastic packaging, with possible consequences also for PFAS use in paper and board. However, moves away from plastic packaging c ould lead to inc reased use of PFAS in paper pac kaging. A possible c onsequence of the EU's Single Use Plastics Direc tive (2019/904) is the use of more moulded fibre products (e.g. plates, bowls, cup holders) for food service applications. Nearly 100% of packaging made up of moulded fibre products for heat and grease resistance is understood to contain PFAS. With regard to consumer cookware it is estimated that 3 500 t of fluoropolymers were sold in the EU28 in 2015, representing sales of 60 million to the fluoropolymer industry and with associated goods generating a production value of 2 billion. The figure of 60 million represented just under 8% of the fluoropolymer market in the EU for the year 2015 (Plastics Europe, 2017). The global non-stick cookware market is expected to continue to grow, with growth rates being between 5% and 7%/y. At the same time, the demand for alternative non-stick solutions (particularly ceramics) that could substitute PFAS based cookware is expected to grow as well (Grand View Research, 2021a). For industrial applications of PFAS in the sector some growth in the market for PFASs can be expected, particularly on the component side (rather than coatings) given stricter legislation on food quality and the use of more severe conditions for cleaning and sterilisation of food processing equipment. Estimates of growth rates range from 10 to 20% by the year 2025 relative to the year 2015. A growth rate of 1 - 2% seems appropriate in future years. According to stakeholders, growth is also expected in the industrial bakeware segment. Applied to the 3 000 t/y usage for the EU28 in the year 2015 (Plastic s Europe, 2017) demand would increase between 3 300 and 3 700 t/y (noting that this range covers both food and pharmaceutical operations, and that it has not been possible to disaggregate the quantities for each application). Table E.36 summarizes available information about economic growth rates for relevant subsec tors. Table E.36. Assumptions for projecting tonnage volumes and emissions for food contact materials and packaging. PFAS substance Packaging (food and non-food) Consumer cookware Industrial food and feed processing and transport equipment Assumption about annual growth rate (2020 - 2070) 1.5% 6% 1-2% For assessing the time path of PFAS use (tonnage) and emissions in food contact materials and pac kaging, using the information disc ussed above, a mean real growth rate of 4%/y was assumed. This growth rate was derived from information about market growth rates in specific sub-sectors as shown in the table below. Emissions represent releases during the use phase only and do not cover emissions occurring at the end-of-life (waste) stage of food contact materials. Table E.37 provides a projection of the yearly PFAS use and emissions during the use phase of food c ontact materials. The start year of the projection is 2020. 141 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.37. Projected yearly PFAS use and emissions in the food contact materials and packaging sector of the EEA between 2020 and 2070 in tonnes (mean values based on market data). PFA S substance group 2020 2025 2030 2035 2040 2045 2050 2060 2070 PFA S use 20 725 25 215 30 677 37 325 45 411 55 248 67 218 99 499 147 282 PFA S emissions 606 737 896 1 091 1 327 1 614 1 914 2 907 4 303 Source: Own calculations based on market data from (Cepi, 2020; Plastics Europe, 2019; Trier et al., 2018) (FoodDrinkEurope, 2019; Geijer, 2019; IndustryARC, 2020; ReportLinker, 2019) as well as the CfE. The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). Based on the assumptions set out in Table E.37 above, PFAS use and emissions in the sector food contact materials and packaging are expected to grow considerably under the baseline scenario. By 2040 PFAS use and emissions will have broadly doubled. Though market growth beyond 2050 is highly unc ertain, and PFAS use and emission estimates have therefore to be treated with care, it is likely that PFAS use (and, in turn, emissions) will continue to grow in the long term without a restriction. This growth is largely caused by continued demand for fluoropolymers used for beverage can coatings, in consumer cook and bakeware, and for car wrapping. Figure E.3 shows expected PFAS use and emissions for the sector as a whole, b ased on market data documented in section E.2.3.4, and assumptions on growth rates shown in Table E.36. Since emission estimates are derived from PFAS uses (applying ERCs), emission tre nds, therefore, mirror the trends for PFAS use. Figure E.3. Expected PFAS use and emissions in EEA under the baseline in the food contact materials and packaging sector (mean values) [tonnes]. Source: Own assessment based on market data reported in (Cepi, 2020; FoodDrinkEurope, 2019; FoodDrinkEurope, 2020; Geijer, 2019; IndustryARC, 2020; Plastic s Europe, 2019; ReportLinker, 2019; Trier et al., 2018) as well as information from the CfE. 142 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.3.2. Alternatives The existence of technically feasible non-PFAS alternatives is one key fac tor determining the impact of the proposed restriction of PFASs on society as it determines the options available to companies to achieve compliance. Where technically feasible alternatives exist, substitution is a possible option for affected companies. Whether substitution is chosen as the preferred reaction to the proposed restriction depends - amongst other factors - on whether individual c ompanies c onsider it ec onomic ally viable for them to substitute. Where technically feasible alternatives do not exist, company closures could occur as a result of the proposed restriction. Given the importance of the most likely behavioural reaction of companies to understand t he costs associated with the restriction, the extent to which technically feasible alternatives are available for different sub-uses is desc ribed below. E.2.3.2.1. Packaging In the 2nd stakeholder consultation, 62 out of 110 respondents (56%) mentioned they were actively work on finding alternatives. 47 responses (43%) were not actively looking for alternatives. One response was blank. The primary role of PFAS in packaging for both food and non-food items is for moisture, oil and grease repellence, to prevent the product from sticking to the packaging and also to provide a moisture barrier and to prevent leakage (Maffini, 2020). PFAS are used for hot and cold foods, pet food, animal feed and packaging more generally. The non-stick qualities of PFAS are also important in some food pac kaging applic ations (e.g. baked goods). Alternatives to PFAS-paper and board are broadly divided into two categories to achieve the same performance: physical or chemical barriers. Physical barriers are where the paper itself serves as barrier, by means of its physical manufacture (e.g. refining paper to make cellulose fibres very fine). Chemical barriers are achieved by either adding chemicals during paper production (internal sizing) or adding them as a surface treatment (external sizing) (OECD, 2020). Some additional functionalities have been identified through discussion with stakeholders, including for some packaging, the improved flow of cans coated with PFAS through processing and vending systems and the creation of a more luxurious feel or appearance for packaging. A recent study by the Washington State Department of Ecology (Department of Ecology, 2021a) provides a systematic analysis for food pac kaging for freshly prepared food, c overing a range of packaging forms. This included evaluation of chemical hazards, exposure, performance, cost, and availability. The assessment considered alternatives to PFAS in food pac kaging that are intended for direc t food c ontact and are c omprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibres. Almost 90 stakeholders contributed to the assessment representing government, industry, NGOs, c onsumers and waste handlers. Ten food pac kaging applic ations designed to hold and serve freshly prepared food were selected: Food contact paper: o Wraps & liners o Bags & sleeves. Dinnerware: o Plates o Bowls o Food boats o Trays. Take-out Containers: 143 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) o Pizza boxes o French fry cartons o Clamshells o Interloc king folded c ontainers (also c alled food c artons or food pails). Assessment of cost and availability considered whether alternatives were currently used for the application of interest, and whether they were available in sufficient quantity to meet demand. Options were found for all of the applications considered, with PFAS free options available for some already. Alternatives of comparable price were also present on the market for some applic ations. A c onstraint on the assessment c oncerned a lac k of data on the exact chemical composition of alternatives. In particular, many alternative products are la belled as `poly-coated', a term that includes substances such as PE, PET, polyvinyl alcohol (PVOH), ethylene vinyl alc ohol (EVOH), polypropylene, polyacrylate, or c ombinations thereof. A problem encountered in the assessment for moulded fibre products concerned the use of PFAS as mould release agents: for this application the PFAS is intended to enable faster processing times through faster and more reliable release of moulded packaging at the point of manufacture, though some PFAS inevitably transfers from the mould to the packaging. PFAS in this case is intentionally added to the system but is present in quantities too low to provide the necessary level of performance to confer properties such as moisture or grease resistance. Some alternatives were not c onsidered by the study: single use plastics, polystyrene produc ts, and substitution of one form of food wrapping by another. Assessment of alternatives was c arried out as follows: The hazard assessment used the online system Greenscreen which evaluates 18 hazards including carcinogenicity endocrine activity, neurotoxicity, eye irritation, chronic and acute aquatic toxicity, persistence, bioaccumulation and physical risks 60 Exposure assessment focused on persistence, bioaccumulation and toxicity (PBT) characteristics and whether there were substantive differences between the comparator and the possible alternatives that are likely to increase exposure concerns for the any of the alternatives. Performance was assessed relative to oil and grease resistance (OGR) and leak resistance. Cost and availability were assessed through investigation of the availability and price of goods on the market. To be readily available in sufficient quantity, an alternative product must meet one of the following criteria: o The perc entage of PFAS-free alternative products in a specific food packaging application is above 50% and at least two manufacturers (or one large manufac turer), make a PFAS-free version of this alternative product, OR o The percentage of PFAS-free alternative products in a specific food packaging application is at or below 50% and at least three manufacturers (or one large manufac turer), make a PFAS-free version of this alternative product. o Alternatives were considered cost comparable when data suggested the price of a PFAS- free alternative would not be more than 10% greater than the cost of a c omparable PFAS-containing product. Inspection of the results of the study demonstrated that in cases where cost was considered comparable, there was not a systematic pric e difference between products c ontaining PFAS and those that did not. Table E.38 contains a summary of the assessment for alternative substances for various food contact applications. 60 https://www.greenscreenchemicals.org/learn/full-greenscreen-method, date of access: 2023-01-11. 144 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.38. Assessment summary for alternative substances for various food contact applications (Department of Ecology, 2021a). Uncoated paper Hazard Exposure Low concern Low concern Performance Good 1 A v a ila bility 4 Yes Cost4 Yes/No Waxes (petroleum- or Low concern Low concern Good Yes Yes bio-based) Kaolin C lay Low concern Low concern Good Yes Yes Polyvinyl alcohol (PVOH) Low concern Low concern Good Insufficient data Insufficient data Siloxanes (by analogy to Vinyl dimethylsiloxyterminated polydimethylsiloxane) 5 Avoid - C hemical of High C oncern vPvB Good Insufficient data Insufficient data Polylactic acid (PLA) (by analogy to the monomer lactide [C AS Nos. 4511-42-6; 61595-2]) Use but still opportunity for improvement Low concern Good 2 Yes/No Yes/No Polypropylene (PE) Insufficient data Insufficient data Good 3 Insufficient data Insufficient data Polyethylene terephthalate (PET) Insufficient data Insufficient data Good Insufficient data Insufficient data Ethylene vinyl alcohol Insufficient Insufficient Good Insufficient Insufficient (EVOH) copolymers data data data data Notes: 1) Moulded fibre products may not perform well under high heat and very oily c onditions. 2) PLA plastics not suitable for high heat applications (>40 C) due to low melting point. 3) PE coated products performed well except for interlocking folded containers. 4) In some c ases there was insufficient data available to assess performance on cost or availability. The ratings of `Yes' or `No' reflec t data across a several produc t types, hence `Yes/No' reflects the result where availability or cost was comparable with PFAS containing goods in some cases (`Yes') but not in others (`No'). 5) D4, D5, D6 siloxanes which could be present as residues, are classified as substances of very high concern may need to be authorised under REACH in the future (ECHA, 2019). A further assessment was performed of the cost-comparability of re-usable plates, bowls, trays and food boats (Department of Ecology, 2021a), covering 12 different types of establishments serving food (pizza shop, gelateria, restaurant, elementary school, etc.) based on a series of case studies from 2014 to 2019. Analysis found payback periods typically under 1 year (for all exc ept the elementary school where payback took 3.5 years) with annual cost savings after the payback period in the order of several thousand USD or greater, and large reduc tions in waste generation. The alternatives to PFAS in food and feed contact and generic packaging applications as o il, grease and moisture barriers in paper that have been identified for further consideration are presented in Table E.39 drawing information from various sources (Mokwena and Tang, 2012; OECD, 2020; Singh et al., 2021). They c over physical alternatives, c hemic al alternatives and alternatives which constitute a different technological approach or material. Precise functionality and suitability for use in different applications as substitutes for PFAS will vary between the alternatives listed. 145 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.39. Summary of the Identified Alternatives to PFAS Barrier Coatings in Packaging. Baking paper, liners, bag Heat resistant packaging Pet food and feed packaging Nonpaper based food packaging Generic paper and board packaging Generic nonpaper packaging 1. Natural greaseproof paper 2. Vegetable parchment 3. C lay coatings 4. Silicone 5. Biopolymers (e.g. chitosan, starch, cellulose, polyvinyl alcohol, bioplastics such as polylactic acid (PLA), biowaxes) 6. Synthetic plastics (e.g. low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), high density polyethylene (HDPE), polypropylene (PE), ethylene vinyl alcohol (EVOH), polyvinyl alcohol (PVOH), polyvinylidene chloride (PVDC ), polyethylene terephthalate (PET)) 7. Microfibrillar cellulose (MFC ), cellulose nanofibrils (C NFs), cellulose nanocrystals (C NC s) 8. Aqueous dispersions of co-polymers (e.g. styrene acrylic emulsion (SAE)) 9. Aqueous dispersions of waxes (e.g. TopScreen) 10. Water soluble hydroxyethylcellulose (HEC ) 11. Alkyl succinic anhydride (ASA), alkyl ketene dimer (AKD) 12. Aluminium foil 13. Lamination using impermeable barriers 14. Other plant fibres (miscanthus, etc.) 146 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Baking paper, liners, bag Heat resistant packaging Pet food and feed packaging Nonpaper based food packaging Generic paper and board packaging Generic nonpaper packaging 15. Bitumen coating 16. Re-usable materials (Trier, Taxvig, Rosenmai, & Pedersen, 2017) The OECD reported that the key reason for the current lack of market share of non-fluorinated alternatives for paper and board is their higher cost. Their study indicated that PFAS-free paper and board for food packaging is 11-32% more expensive than food packaging using short chain PFAS (OECD, 2020). However, the analysis suggests that costs of switching away from PBT substance to alternatives in the food pac kaging market is proportionate to the reduc tion in risk, based on comparison with the indicative benchmarks (1 000/kg of substance) that have been used previously in REACH. This is supported by evidence of growing investment in PFAS free packaging, for example in moulded fibre products61. Alternatives are also available for use as polymer processing aids (PPAs) in the production of plastic films for packaging62. PPAs were reported by stakeholders (2nd stakeholder consultation) as having the following specific functions: Smoothing flow of extruded parts in film production, injection moulding, tubes manufacturing, etc. enabling faster and less energy efficient production of goods. Their use also facilitates production of thinner and lighter packaging. Improving hydrophobic qualities of plastic goods, including in blister packaging for pharmac eut icals Strengthening plastic packaging of plant protection products to improve barrier properties The stakeholders concerned were a mix of masterbatch producers and manufacturers of plastic goods and components. Examples of both fluorinated and non-fluorinated options are cited by e.g. Kulikov (2005) and as presented in the footnote63. One example of a PFAS free option is boron nitride. On their website, Saint Gobain64 reports that research (e.g. (Kazatchkov et al., 2000; Rathod and Hatzikiriakos, 2004)) revealed boron nitride to be a highly effective polymer process aid. Dispersing boron nitride powder into molten polymers can increase the threshold shear rate at which distortions in plastic films appear by several orders of magnitude, enabling much higher throughput during production without distortions and instabilities appearing in the polymer. Boron nitride powder has been shown to be effective in the production of films used 61 https://www.paperfirst.info/kemira-joins-4evergreen-alliance-for-the-fibre-based-packaging-value- chain/ and https://www.papnews.com/stora-enso-starts-the-production-of-new-generation-formed- fiber-products-free-from-plastic-and-pfas/, both accessed: 2023-01-11. 62 http://www.plastemart.com/plastic-technical-articles/polymeric-processing-aid-performs-better- than-conventional-waxes/1592, date of access: 2023-01-11. 63 See also: http://www.plastemart.com/plastic-technical-articles/polymeric-processing-aid-performsbetter-than-conventional-waxes/1592#, date of access: 2023-01-11. 64 https://www.bn.saint-gobain.com/blog/how-boron-nitride-polymer-processing-aids-enable-pfas- free-food-packaging#, date of access: 2023-01-11. 147 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) for food packaging including polyethylene and m-LLDPE films. However, one respondent to the 2nd stakeholder consultation regarded boron nitride as not suitable for pipe manufacture as hard `foreign' particles could lead to premature pipe failure. Despite the identification of alternatives, 7 out of 8 respondents to the 2nd stakeholder consultation considered that alternatives to PFAS were not technically feasible as substitutes. Reasons provided included that halogen-free polymers do not provide the same level of moisture protec tion. The use of boron nitride as an alternative was specifically c riticised as hard `foreign' partic les c ould lead to premature pipe failure, though it was not stated whether this applied to all grades of boron nitride. For thin film plastic extrusion, production without PFAS processing aids was said in the CfE to be possible but to lead to (much) lower yield and lower product quality. Alternatives were also criticised in the 2nd stakeholder consultation on economic grounds due to: Whilst the substances identified for the consultation process were generally cheaper than PFAS they do not impart the same properties as PFAS and don't fulfill all roles of the PFAS PPAs. These lower costs for alternative PPAs were offset by additional costs due to the higher material consumption for the alternative coextruded barrier layer during production and additional costs due to the taxes on non-recyclable packaging envisaged in the EU. The use of other polymers (e.g. polyamide) in addition to polyethylene results in multilayer pac kaging, whic h unfortunately is c urrently difficult to recycle , leading to further additional costs. Metal packaging as an alternative to packaging produced using PPAs is more expensive than plastic packaging. Alternatives that are technically feasible appear to be available already for many applic ations, though not all, where PPAs are used. However, no data on t he costs of these alternatives relative to PFAS has been identified. No data has been identified to establish the availability of alternatives of the appropriate quality in suffic ient quantities for the EU plastic s market at the present time. Whilst alternatives are available little is known if non PFAS processing aids are available to keep high yields and good produc t quality without PFAS being used. 5 c ompanies stated that they were actively working on alternatives, 2 were not and 1 did not reply to the question. A total of 11 US states have introduc ed legislation to ban or restric t the use of PFAS in food packaging using a definition of PFAS similar to that used here with legislation becoming active at various dates in the next 2 years (up to 31/12/2024) (Baughan et al., 2022). Different provisions apply in different States. California, for example, includes provision not only for PFAS added intentionally to food packaging but also for food packaging containing PFAS at or above 100 ppm as measured in total organic fluorine. Rhode Island states that intentional introduction of PFAS covers use as a processing agent, mould release agent or intermediate. Variability in legislation between States is clear, making assessment of compliance for individual companies more complex. E.2.3.2.2. Consumer cookware A wide range of alternatives for PFAS is available including: Ceramic, silicone coatings Stainless steel Silicone bakeware (not just coated) Anodised aluminium Other options (e.g. copper) have little penetration into the market or are not yet widely available/tested (e.g. superhydrophobic coatings). 148 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Some of these alternatives to the use of fluoropolymer-coated cookware have significant market share already. There is little evidence for systematic differences in price between these options. Comparative assessments of produc ts with different c oatings have been made, especially for frying pans. However, the results of these studies must be treated with caution for several reasons: They may not be up to date. Given the focus of the non-stick cookware industry for many years on fluoropolymer-based coatings, it is to be expected that tests of a few years ago would favour fluoropolymer-based pans disproportionately over ceramic pans simply bec ause of the extent of research on the two materials. Whilst results may be interesting, they do not necessarily provide robust guidance at the present time. A life cycle analysis available from Tefal compares fluoropolymer-based and ceramic frying pans but is dated 2011 (Tefal, 2011): both types of coating have developed signific antly in the intervening years and there is evidence65 that good quality c eramic pans c an c ompete with fluoropolymer pans. Comparisons may not be made on a like-for-like basis. Whilst a good quality pan with a fluoropolymer-based coating will outperform a bad quality pan with a ceramic coating on tests for non-stick, durability, evenness of cooking, etc., the same applies in reverse with good quality ceramic pans outperforming bad quality fluoropolymer-coated pans, as demonstrated by results of recent consumer analysis in the UK72. It is often not clear what coatings are made from. The phrase `PFOA free' is widely used on pans, reference to PFASs or fluoropolymers is not. Consumer testers have also found a lack of clarity, applying to pans also made from alternative materials 66. Reports from different manufacturers c an provide c onflicting results 67. Test conditions inevitably differ from consumer behaviour. This may be particularly true with respect to the lifetime of products. The manufacturers' view may be that consumers will replace their pans once non-stick performance has degraded to an apprec iable degree. The view of consumers may be different - some using pans indefinitely. This may lead to significant loss of the coating during use. Some respondents to the CfE cited extremely short service lifetimes for ceramic coated pans, though these views were not substantiated through the review. It is possible that such views were developed for earlier versions of the ceramic pans and that current models are c onsiderably more durable. Some alternatives, such as stainless steel are c onsiderably more durable than any coated pan and may be better suited to some applications (e.g. saucepans rather than frying pans). E.2.3.2.3. Industrial applications The use of fluoropolymers in the industrial food and feed sectors is complicated by a wide variety of applications from baking tin coatings to pipes, pipe coatings and various types of seal in large and small machines, with differing potential for PFAS release and population exposure. The ease of substituting alternatives will be similarly variable. The selection of alternatives needs to c onsider operating c onditions whic h may inc lude: High temperatures and thermal cycling as components are heated and cooled High pressures Use of strong cleaning agents High material throughput Automated production 65 https://www.which.co.uk/reviews/cookware/article/best-non-stick-frying-pans-aS2U36a9dld8, date of access: 2023-01-11. 66 https://thecookwareadvisor.com/whats-that-pan-made-of/, date of access: 2023-01-11. 67 https://www.asa.org.uk/rulings/imperial-international-ltd.html, date of access: 2023-01-11. 149 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The broad range of applications of PFAS in the food and feed industry leads to a range of possible alternatives for replacement including: Ceramic , silic one c oatings (e.g. industrial c ookware) Stainless steel (e.g. industrial cookware, production line components) Silic one bakeware (e.g. industrial c ookware, lubric ants, seals) Synthetic rubbers (e.g. seals, gaskets, pipes, tubes for liquid proc essing) The list is not exhaustive: there are likely to be (possibly many) niche applications where further alternatives are possible. These options are applied for different uses, e.g. c eramic or silicone coatings to bakeware, or synthetic rubbers for components such as gaskets and tubing. Different views have been expressed regarding alternatives to the use of fluoropolymers in the industrial baking sector. A number of companies manufacturing equipment for the food and drink sec tor specialise in fluoropolymers and do not supply alternatives. Responses to the stakeholder consultation indicated that a number of these companies do not appear t o have investigated alternatives to a significant extent and would thus be highly exposed to a wideranging restriction. In contrast, some companies market a range of options. The Weilburger Greblon range for example68 includes different coatings made from silicone, PFA, PEEK, PTFE, FEP and SolGel (c eramic ). The different options provide different characteristics (the following information is taken from the Weilburger website): Silic one: Offers durability of the end produc ts through their flexible surfac e and good resistance to chemicals. Particularly suited for pastry with sugar content. SolGel: Abrasion resistance, very good non-stick properties and easy end product c leaning. PTFE: Non-stick properties, very good resistance to chemicals, easy to clean and durable. Some products are ceramically reinforced to improve abrasion and corrosion resistance. PFA: Resistant to chemicals (in particular, alkaline solutions) and good release performances. Easy to clean (by virtue of the non-stick properties). High corrosion resistance and good durability. PEEK: Abrasion resistance and non-stick, in particular for lye rolls (pretzels, etc.). Resistant to alkali and chemicals (in particular, lye). FEP: Non-stick and resistant to c hemic als, particularly well-suited to baking and c ake trays. It is notable that different surfaces are recommended for different bakery products (pastry with sugar content, lye rolls, etc.). The views of companies that market a range of options are typically that each option has its place in the market (according to information received in the CfE in 2020). Several respondents to the consultation process have indicated that fluoropolymers are more expensive than the alternatives listed above, and hence are used in cases for various application-dependent reasons where it is felt that alternatives do not perform so well. Common responses concerned improved durability, non-stick qualities, ease of cleaning, c hemic al resistance and thermal stability, in addition to complianc e for use of materials in the production of food and feed. Some parts of the market (e.g. some industrial bakeries) are already using alternatives to fluoropolymer coatings in bakeware. Analysis has been presented by one company 68 https://www.weilburger.com/en/products/coatings/non-stick-industrial-bakery-coatings, date of access: 2023-01-11. 150 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) demonstrating that whilst the coatings do not last as long as fluoropolymer coatings, and henc e need more frequent re-coating, the overall c ost of re-coating operations is signific antly cheaper. Another company providing a similar service, however, claims that the use of fluoropolymer coatings is essential. There are several possible reasons for this difference in opinion, for example: Differences in the products manufactured in different parts of Europe or in different parts of the baked goods market, with varying fat or sugar content Differenc es in c ooking temperatures and times Difficulties for SMEs to transition to the use of alternatives where additional investment and R&D is required Reluctance of customers to move away from a trusted product. E.2.3.2.4. Other uses For PTFE (wax) c oated beverage cans specific alternatives have not been identified. Likely an alternative is to leave out the PTFE (wax) as cans were also on the market before PTFE (wax) was applied. This may slow down production, or prompt investigation of non-PFAS alternatives. Recent research (EPA-US, 2022) highlights the potential for PFAS leakage from f-HDPE (fluorinated high-density polyethylene, a sturdier version of HDPE) containers. These are used, for example, to safely transport pesticides and chemicals; most use is industrial, though there is some possibility of consumer use as well. Traditional alternatives t o f-HDPE incude stainless steel, though these may be heavier, more expensive or involve other compromises suc h as a worse c arbon footprint. One produc er also mentioned it has a fluorination process in which no PFAS are formed. This is currently under investigating at US EPA level. US EPA mentioned that the creation of PFAS during fluorination is not universal: "It is during certain types of fluorination (e.g. the presence of oxygen) that the manufacture of PFAS has oc c urred". Alternatives are available such as PE, PVC, polyester, PET and polyurethane for plastic coating in the form of a temporary protective layer applied to new c ars. E.2.3.2.5. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. In relation to food contact material and packaging, the list of alternatives contained 20 unique CAS numbers. Seven (7) of the substances with unique CAS were classified according to CLP (harmonised c lassification or self-classification). For none of the substances with unique CAS number, data on PBT or vPvB properties were available. No other hazard properties were mentioned. The list contained an additional 21 substances with unique substance names for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. Two of these 21 substances may contain residues of D4, D5 and D6, cyclic siloxanes. D4, D5 and D6, and cyclic siloxanes are considered to be PBT/vPvB substances and D4 is considered to be an endocrine disruptor. These substances were: Silic one c oating and Silic one c ookware. Appendix E.2. c ontains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. 151 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.3.2.6. Substitution potential As mentioned above, the existence of technically feasible alternatives determines the options available to affected companies to achieve compliance, e.g. substitution or c losure of business (or business unit). Whether substitution takes place depends - amongst other factors such as the availability of alternatives - on whether individual companies consider that it is ec onomic ally viable for them to substitute. Like other sec tors, the substitution potential for food contact materials and packaging is thus dependent on the technical and economic feasibility of alternatives and their availability in suffic ient quantities. With a view of informing the assessment of the impac ts of the restric tion, whic h are heavily determined by the extent to which companies substitute, this section draws overall c onc lusions on the information provided above, based on the evidence from: Literature; Legislation outside of Europe; The CfE, supplemented with information from stakeholder interviews; and The 2nd stakeholder consultation, more specifically answers (from a non-representative sample of stakeholders) to the question whether the listed alternatives known to the Dossier Submitters are tec hnically feasible in the product/process of the responding stakeholder. It is noted that there is a likely bias in response towards those companies that are dependent on PFAS, rather than suppliers of alternatives. With respect to paper and board packaging, a range of alternatives have been identified across various applications. The Department of Ecology (2021b) study demonstrates that technically and economically feasible alternatives are on the market for food contact pac kaging. No evidenc e has been found to indic ate that there would be a shortage of supply in the event of a restriction. As a result, the Dossier Submitters consider that there is suffic iently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months, and no derogation is considered and further assessed for paper and board packaging. With respect to plastic packaging, PFAS are used as polymer processing aids (PPAs) to assist in the extrusion of plastic sheet and other forms, and also to provide improved moisture protection. A number of alternatives that are already on the market have been identified. However, most respondents for this use in the 2nd stakeholder consultation considered that alternatives were not technically feasible on grounds including provision of inferior moisture, reduced processing speed and limits on the quality and thickness of thin plastic film. Precise details, and information on the performance of alternatives were, however, lacking. T he Dossier Submitters consider that there is weak evidence to conclude that the substitution potential is low under a full ban with a transition period of 18 months. As a result, a derogation is c onsidered for the use of PFAS-PPAs in the produc tion of plastic packaging. In relation to consumer cookware, for example frying pans, saucepans and baking trays, the Dossier Submitters c onsider that there is suffic iently strong evidence f or the existence of technically and economically feasible alternatives on the market for non-stick products. The market for alternative c oatings has expanded in rec ent years, and there is no indic ation that the supply of alternatives would be problematic following a restriction. As a result, the Dossier Submitters consider that there is sufficiently strong evidence to conclude that the substitution potential is high under a full ban with a transition period of 18 months. As a result, no derogation is considered and further assessed for consumer cookware. For industrial applications (excluding non-stick c oatings on bakeware, see below), such as the use of fluoropolymers in seals, tubing etc. in production equipment where components need to address stresses from, for example, high temperatures and pressures and strong c leaning agents, it is c oncluded that there is suffic iently strong evidence for low substitution potential, and a derogation is therefore c onsidered. 152 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) With respect to non-stickcoatings in industrial and professional bakeware, alternatives are available on the market. However, they may not be suitable for all produc ts or production systems. Based on limited and c ontrasting responses from stakeholders, it is c oncluded that there is weak evidence for low substitution potential, and a derogation is therefore considered. E.2.3.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.3.3., assuming business-as-usual and, thus, on-going PFAS use and emissions. The analysis of environmental impac ts focuses on two restriction options: 1. RO1, adopting a ban of all PFAS groups used in food contact materials and packaging; 2. RO2, adopting a ban on PFAS in c ombination with use-specific derogations. Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation. Environmental impacts of RO1 are analysed quantitatively. In contrast, for the use-specific derogations emission data were largely lac king. Therefore, environmental impac ts of RO2 are evaluated qualitatively in relation to a worst -case additional emission scenario, assuming a full derogation of the relevant PFAS group. Note that this reference scenario does not represent a restriction option but is used for comparative purposes only. Table E.40 below summarizes the characteristics of the restriction options. Table E.40. Characteristics of restriction options benchmark scenarios. Restriction option a bbr e v ia tio n RO1 RO2 Maximum additional emission scenario Maximum additional emission scenario Short description Full ban Ban with use-specific derogations Ban with use-specific derogations Ban with use-specific derogations Derogations --- (i) Proposed derogation: Food contact materials for the purpose of industrial and professional food and feed production - 5 years (ii) Potential derogation marked for reconsideration: Nonstick coatings in industrial and professional bakeware - no specific derogation mentioned period Derogations of all fluoropolymers Transition period after entry into force 18 months 18 months 18 months 18 months Duration of derogation --- 5 years, 12 years 5 years 12 years For calculating the expected emission reduction, the assumed ent ry-into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. The assessment of environmental impacts under the baseline and the restriction scenarios is conducted at sector level and covers 153 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) tonnage and use estimates during manufacture and the use phase (thus not the waste stage). Table E.41 shows mean emissions and the expected emission reduction for the baseline, RO1 and maximum additional emission sc enarios. All emission estimates represent mean values. Table E.41. Total mean emissions and emission reduction of RO1 and maximum additional emission scenarios (food contact materials and packaging sector, in tonnes). Restriction option Mean total Mean total Mean total emissions [t] emission emission reduction [t] reduction [%] 2025-2055 Baseline 43 708 --- --- RO1 1 563 42 145 96 Maximum additional emission 2 822 40 887 94 scenario `5-year derogation of fluoropolymers incl. PFPEs'* 2025-2070 Baseline 93 468 --- --- RO1 1 563 91 905 98 Maximum additional emission 2 822 90 646 97 scenario `5-year derogation of fluoropolymers incl. PFPEs'* *Maximum additional emission scenarios denote worst-case emission scenarios (assuming a full derogation of a particular PFAS group) against which emissions of proposed use -specific derogations are evaluated qualitatively. They do not represent restriction options. Source: Own calculations based on data reported in (C epi, 2020; FoodDrinkEurope, 2019; FoodDrinkEurope, 2020; Geijer, 2019; IndustryARC , 2020; Plastics Europe, 2019; ReportLinker, 2019; Trier et al., 2018) as well as information from the C fE. Based on available data, results underline that the expected emission reduction is highest (about 96%) under a full ban of PFAS use (RO1). Under RO2, a ban on PFAS use is combined with the following use-specific derogation: (i) Proposed derogation: Food contact materials for the purpose of industrial and professional food and feed production A 5-year derogation is proposed. The derogation affects the use of fluoropolymers. Emission data for quantifying expected additional emissions are not available at the level of the proposed derogation. No evidenc e is available about the prec ise amount of additional emissions for this spec ific derogation. However, maximum additional emissions assuming a full derogation of fluoropolymers can be estimated and account of 2 822 t (30-year period, see Table E.41). In relation to this reference scenario, additional emissions of the proposed derogation are considered to be small. (ii) Potential derogation marked for reconsideration: Non-stick coatings in industrial and professional bakeware A 5-year derogation is proposed. No evidence is available about the precise amount of additional emissions for this specific derogation. However, maximum additional emissions assuming a full derogation of fluoropolymers can be estimated and account of 2 822 t (30year period, see Table E.41). In relation to this reference scenario, additional emissions of the proposed derogation are considered to be small. Figure E.4 shows the time path of mean emissions of the baseline, RO1 and of maximum additional emission scenarios. 154 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.4. Time path of mean emissions under the baseline, RO1, and maximum additional emission scenarios ( food contact materials and packaging sector, in tonnes) . Source: Own assessment based on data reported in (C epi, 2020; FoodDrinkEurope, 2019; FoodDrinkEurope, 2020; Geijer, 2019; IndustryARC , 2020; Plastics Europe, 2019; ReportLinker, 2019; Trier et al., 2018) as well as information from the C fE. E.2.3.4. Economic and other impacts E.2.3.4.1. Food contact packaging and packaging more generally Impacts on industry It has been concluded in a study for the Nordic Council that alternatives to the use of fluorinated materials are available and functional for almost all uses of paper and board Food Contact Materials (FCMs) intended for various foods, and close to cost-neutral for retailers, and hence likely also for manufacturers (Trier et al., 2018). These conclusions are reflected also in the findings of the Washington State study (Department of Ecology, 2021a), where food contact packaging materials with and without PFAS and available on the market were compared for functionality, safety and cost. As noted already, given the breadth of the packaging market there may be nic he applic ations where products using PFAS have an advantage over alternatives that could justify their continued use, but data for their evaluation has not been identified. Possible examples of such niche applications relevant to some extent to packaging and food contact applications that were identified in the CfE and the 2nd stakeholder consultation are as follows: Application of PTFE to the outside of drinks cans to reduce friction on t he production line and speed processing. Use in inks for packaging to improve wear and rub resistance, and to avoid blockages in ink jet nozzles. Use in packaging for extreme environments (e.g. space) A further use identified by stakeholders concerned machinery manufacturing corrugated card, where greases need to withstand high temperatures to maintain performance of machinery 155 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and reduce maintenance frequency. Similar uses are considered under Lubricants ( section E.2.14). Quantification of the economic impacts of a ban on PFAS in the food and feed packaging sector has several elements, of which the following are likely to be of most concern: The costs of input materials and processing for producing packaging that protect against grease, water and water vapour in different ways. The c osts of R&D for new produc ts and adaptation of produc tion facilities. Redistribution of sales and revenues between businesses currently manufacturing packaging with and without PFAS. In c ases where packaging failure is made more likely as a result of the substitution of PFAS or the elimination of PFAS use, the associated loss of goods prior to sale. An OECD study (OECD, 2020) reports that the key reason for the c urrent lack of market share of non-fluorinated alternatives is their higher cost. The study indicated that PFAS-free paper and board for food packaging is 11-32% more expensive than food packaging using short chain PFAS estimate. This range is supported by evidence submitt ed to the Call for Evidence where a cost difference between PFAS treated papers and natural greaseproof paper of approximately 10-30% was provided, resulting mainly from differences in the speed of processing during manufacture. Table E.42. Comparison of the Costs of Alternatives Used in Paper and Board Food Packaging. Paper/board product Average* cost and treatment (/t paper) Base paper 1 250 Short-chain PFAS 1 400 C hemical 1 550 alternative Physical 1 850 alternative Source: (OECD, 2020) Average cost differential between base paper and PF A S- tr e a te d and nonfluorinated paper (/t paper) Not applicable +150 +300 +600 Average difference between base paper and PFAS- treated and nonfluorinated paper (%) Not applicable +12 +24 +48 Average difference between PFAStreated and non-fluorinated paper (%) Not applicable +11 to +32 +11 +32 A conclusion from the OECD study (OECD, 2020) was that whilst PFAS formulations used for food packaging paper are usually significantly more expensive than competitor chemical alternatives on a kilogramme for kilogramme basis, after producing the paper for food packaging this cost differential is reversed resulting in the costs/tonne of paper produced described in Table E.42. This position is challenged by data elsewhere that indicat ed that packaging materials for fresh food at least were of a similar price whether they contained PFAS or not (Department of Ecology, 2021a). However, the data shown in Table E.42 are used below in a proportionality assessment to test the implications of this level of additional c ost . The OECD data in Table E.42 can be used to provide an indicative cost-effectiveness assessment for greaseproof paper. In addition to the information provided in Table E.42 it is necessary to know how much PFAS is loaded into paper to provide the necessary level of protection. Data from stakeholders indicated a maximum loading of 4% with reference to regulatory positive lists such as (BfR, 2020) and the Inventory of Effective Food Contact 156 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Notifications69 (see Overview Module, page 7). However, data identified from these positive lists indicates maximum permitted concentrations of PFAS in a range of 0.4 - 1.2% (dry weight). Taking this range permits quantification of the mass of PFAS per tonne of paper (Table E.43). Substitution costs per tonne of paper from Table E.42 are 150 for the chemical alternative and 450 for the physic al alternative (calculated as the cost of each alternative subtracted by the cost of the PFAS treated paper). Dividing these figures by the estimated mass of PFAS per tonne of paper generates est imates of the substitution costs per kg PFAS to be substituted. This indicates a range for the substitution cost per kg of 37.5 to 112.5/kg for a PFAS content of the paper of 0.4%, and 12.5 to 37.5/kg for a PFAS content of the paper of 1.2%. These estimates are well below the figure of 1 000 per kilogram PBT substance observed by Oosterhuis et al. (2017) in a study designed to assess benchmark indicator for cost effectiveness. This suggests that costs of switching away from the PBT substance to alternatives in the food packaging market (for greaseproof paper at least) is proportionate to the reduction in risk based on comparison with the indicative benchmarks that have been used previously in REACH, assuming these are appropriate to the quantity of material used. Table E.43. Assessment of substitution costs per kg for PF AS used in greaseproof paper based on OECD (2020). PFAS content of paper (A) 0.4% 1.2% Mass per tonne of paper (kg) (B)=(A)x1000kg 4 12 Substitution cost per tonne of paper (), low (C) 150 150 (industry estimate) Substitution cost per tonne of paper (), high (D) 450 450 (industry estimate) Substitution cost per kg PFAS used () low (E)=(C )/(B) to producers 37.5 12.5 Minimum % emission for substitution cost per kg PFAS released not to exceed 1 000/kg PFAS (lower bound) 3.75% 1.25% Substitution cost per kg PFAS used () high (F)=(D)/B) to producers 112.5 37.5 Minimum % emission for substitution cost per kg PFAS released not to exceed 1 000/kg PFAS (upper bound) 11.3% 3.75% Note: Date for cost data not specified but assumed to be representative of costs at the time of the OECD report. Analysis to this point does not take account of the amount of PFAS released as a result of its inclusion in packaging, which as noted elsewhere is subject to significant uncertainty. A minimum figure of a release of 0.3% to 0.6% was obtained considering only the use phase. Accounting for emissions during the manufacture of paper containing PFAS provided a larger estimate, of the order of 12%. indic ates that the minimum quantity of PFAS released to not to exceed the 1 000/kg benchmark of Oosterhuis et al. (2017) would be between 1.25% and 11.3%, higher than the release estimated from use alone, but lower than the estimate for emissions during manufacture. These release figures do not account for emissions at the waste phase. 69 https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contactsubstance-fcs-notifications, date of access: 2023-01-13. 157 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The costs of a restriction to companies currently marketing PFAS for use in packaging were provided by several companies during the consultation process. Given that the companies involved: Are part of a large sector Operate at different steps of production (e.g. polymer processing aids, surface treatments for different types of packaging) Operate in different parts of the market (food, pharmaceutical, industrial (etc.) pac kaging) Do not represent companies already successful at providing alternatives Are not a randomised sample across affected subsectors, and hence may not provide a representative view of effects It is not possible to use the responses provided to give a reliable overvall estimate of the costs to EU manufacturers of a restriction. Whilst data are available to indicate the overall size of some relevant industry sectors (e.g. paper and pulp), information to indicate the extent of companies that use or don't use PFAS in the production of packaging, and the extent to which their products were reliant on PFAS, was not identified. However, from the responses provided, several similar issues are observed as for other sectors involved in PFAS use, for example: Several companies state that they consider that there are no alternatives to the use of PFAS, or likely to be in the coming years, Amongst those companies considering a transition may be possible, that it would be necessary to transition over a period of between 2 and 10 years That costs to each of these companies would be in the order of 1 million to seve ral million. Some c ompanies have a large range of produc ts that would eac h need to go through the R&D and product development cycle. Costs linked to the failure of food packaging could be substantial and it is possible that PFAS are tec hnically the most effective solution. However, the marginal benefit of using PFAS may be small given the efficiency of modern systems for managing what is known as the `coldchain', whereby food is protected through the maintenance of appropriate temperatures throughout its movement from production to processing to sale to consumers. No detailed information was collected to be able to make a judgement on this point. 158 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.44. Comments from the stakeholder consultation for packaging applications on the costs, etc. of a transition to alternative non-PFAS-products (PFAS manufacturers). Company Activity Time Cost Status 1 Polymer processing If an alternative non-fluoro R&D: ca. 1.6 Not started aids for production substance is to be developed, million of food packaging it is expected to take at least EFSA application materials two years to obtain EU EFSA process: 0.8 and/or US FDA permits. At million least 5 years is also foreseen C apital for production investment: 0.4 process/technologies changes million at downstream users 2 Surface treatments About 3.5 Early stage for water Find alternative providing million resistance or similar product performance & (EU aggregated grease-repellence production proof (12 months) value) C ertification (food contact & About 7 million compostability) (12 months) (EU aggregated value) 3 Surface treatments More than 5-10 years 4-5 million for Process not for water covering the processes of one location: started; resistance or finding substitute, testing, large number of chance of a grease-repellence, purchase of new lab products would good production of equipment to be able to need alternative colourants and inks evaluate the new substances, development, considered and low friction providing samples for certification, very low coatings customers to test and adjustment of evaluate, FDA regulations etc. production lines, promotion to customers 4 Surface treatments 2-5 years 0.5 to 1 million Early stage for water of process resistance or with no grease-repellence alternative and use as yet polymer processing identified aids 5 Various niche C ompanies applications do not believe that there is an alternative for their niche in the market From information provided by industry (Table E.44), at least some companies that are currently dedicated to working with FPs would have difficulties if the introduction of a restric tion took plac e on a short time sc ale (e.g. 2 years) because they do not c urrently have alternatives identified for substitution of PFAS. The substitution process would involve several activities, for example finding one or more substitutes, testing substitutes, purchasing new 159 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) laboratory equipment to be able to evaluate the new substances, providing samples for customers to test and evaluate, gaining approval from regulatory bodies, modifying production lines and marketing new product to customers. The situation is of increasing complexity the more products that a company produces. These companies would therefore find a restric tion more prac ticable if there was a delay in its implementation, though the time period suggested by some businesses, of up to 10 years or possibly longer, may be considered too long by other stakeholders considering the disbenefit of continued emission of PFAS. With respect to distributional impacts, companies that have yet to investigate the use of alternatives would be vulnerable to a loss of market share, whilst others already producing alternatives would be able to profit from a restric tion. One producer of PFAS commented during the consultation process that discontinuing certain FPs would impact the overall profitability of manufacturing operations and direc tly impac t the manufacturing c osts of other FPs as well - due to the capital-intensive nature of FP manufacturing and high break-even points. A restriction would also discourage future investments in other FP products by the company and downstream industries. It is also possible that a restriction could lead to further innovation in packaging for European companies which may be of benefit to those trading in other parts of the world. One c hallenge to the practicability of a restric tion c oncerns the import of goods from outside the EU in packaging that would not conform to the restriction. This potentially creates a problem downstream through the addition of packaging contaminated with PFAS into recycling systems, leading to the spread of PFAS through the paper market. Monitorability may be problematic for several reasons including: The high volume of packaging involved The number of companies working in the manufacture and use of food packaging Monitoring effort would clearly need to be targeted to ensure that it is properly focused on areas where risk is most likely to be present. As noted above, there may be specific niches for which switching to alternatives is either difficult or not possible. Impacts on consumers Any cost of the proposed restriction to EU and non-EU businesses could be passed down through the supply chain, although an increase in cost is not guaranteed across the sector (Department of Ecology, 2021b). For most articles, the cost of packaging will be a small component of the cost of the goods bought and impacts on price (assuming that additional costs are incurred) may not be evident to consumers, though the aggregate cost across all consumers may be large. The ability of companies to pass an increase in cost down through the supply chain is of course dependent on the relative strength of the companies involved during negotiation on price. More significant may be costs associated with the failure of packaging. However, these are mitigated for consumers by the `cold chain' that exists in Europe, keeping food fresh by keeping it refrigerated as it moves from producer to processor to retailer to customer. For non-food goods, consumer protection legislation should ensure that damage to goods through the failure of packaging is not borne by customers but by the suppliers. Impacts on society Social impacts associated with a restriction may relate to impacts on employment within the 160 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) sec tor; either an increase in employment through the development of innovative product lines or reduced employment through loss of market share for EU companies as companies find it difficult to adapt. It has not been possible here to estimate the number of workers that could be affected by a restriction on the use of PFAS in the packaging sector. A portion of those directly employed in the European fluoropolymer industry (2 200 in 2015, (Amec Foster Wheeler, 2017)) would be affected by a restriction on the sector. However, the size of this impact is dependent on the overall scope of the PFAS restriction proposal. Downstream of the FP producers, impacts on employment seem most likely to be experienced by those working in c ompanies manufac turing c oatings, sizing agents, etc. rather than either producers of paper and board or the companies fabricating packaging. Most (>90%) of the paper and board in Europe is produced in Europe (Cepi, 2020), and this situation is extremely unlikely to be affected by decisions on permissible substances for treatment of packaging and board to provide it with the qualities required for food (etc.) packaging. Some of the companies that are manufacturing coatings, sizing agents, etc. are understood to be very specialised and focus entirely on produc ts associated with FPs. These companies would be more exposed to the effects of a restriction. Negative impacts on employment can be mitigated by allowing companies more time before a restriction comes into effect. Such a decision would of course involve e mission of PFAS over a longer period. Further soc ial impac ts could arise for c onsumers through a loss of func tionality in pac kaging, perhaps leading to a loss of product shelf life. This effect will vary from product to product. Effects will be very limited for the fast-food market, given the nature of the product (once sold it is almost always consumed immediately). Such impacts are considered here to be of limited signific ance given the effectiveness of the c old c hain in Europe and the near-universal availability of refrigeration. E.2.3.4.2. Consumer cookware Impacts on industry Quantification of the impacts of a ban on PFAS in the production of consumer cookware has several elements, as the following information shows, taking the example of non-stick c ookware: Changes in the cost of input materials. Additional investments in R&D and new, or adapted production lines. Distributional impacts on suppliers of different types of coating and alternative cookware options. Impacts on manufacturers of FP-coated cookware such as costs of R&D, capital costs, operating costs, changes in market share. Economic impacts on consumers from changes in non-stick properties, and the durability and the cost of cooking equipment. Information on several of these elements is unavailable. It has been estimated that 3 500 t of fluoropolymers were sold into the cookware market of the EU28 in 2015, representing sales of 60 million to the fluoropolymer industry and with associated goods generating a production value of 2 billion (Amec Foster Wheeler, 2017). The figure of 60 million represented just under 8% of the FP market in the EU for 2015 (Amec Foster Wheeler, 2017). Market analysis for the European FP sector found a lack of publicly available EU-wide statistics that were specific to the sector (Amec Foster Wheeler, 2017). The report identified 20 EU companies involved in the manufacturing or distribution of PTFE coatings for use in the manufacturing of cookware and other goods in 2015, though acknowledged that these were 161 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) likely to represent only a small fraction of the total number of companies involved. Reference to the same source used in the AFW report (EuroPages, 2021) now lists 20 suppliers in the EU27, 16 of which are in Germany, 2 in Austria and 1 each in Belgium and France. Outside of the EU the same source identifies 13 Chinese companies, 11 in the UK and 2 each in Ukraine and Turkey. Many of the companies listed are SMEs (Small and Medium Enterprises) in terms of the number of employees (<250). However, inspection of the companies listed shows an absence of the major cookware manufacturers. It also shows that the companies listed are not restricted to coating of kitchen goods. Responding to the CfE, FEC (the Federation of European manufacturers of Cookware and cutlery) referred to 40 members producing cookware and manufacturing raw materials and commented that this covered most of the main European producers. At the other extreme, APPLIA (representing European home appliance businesses, some of whom will manufacture products using FPs though they are unlikely to cover the whole domestic cookware market) referred to its membership of 22 direct members (large companies and national associations), 3 337 enterprises, 927 400 direct and indirect employees and 72 billion valued added. It was acknowledged that only part of this would be affected by a PFAS restriction. Given the lack of data on the number of companies involved in the produc tion of FP-cookware and the share of their produc tion that involves FP-coatings, it is not possible to provide quantitative estimates of the companies that would be affected by a full or partial restriction, or of the number of staff working for them. The above data are summarised in Table E.45. They do not provide a complete overview of the use of fluoropolymers in the sector but do provide some useful insight, particularly: Numbers of c oating suppliers and the quantity and value of fluoropolymer sales to the sec tor Production value of fluoropolymer treated goods An indication of the number of large companies involved, and an order of magnitude estimate of the number of smaller companies involved. Table E.45. Business data on the European market. Results are not limited to cookware. Source (Plastics Europe, 2017) (EuroPages, 2021) FEC APPLIA Data 20 PTFE coating suppliers in EU 3 500 t of fluoropolymer sold into the EU28 cookware market in 2015 valued at 60 million Production value of related goods = 2 billion 20 PTFE coating suppliers in EU 28 coating suppliers outside EU but selling to EU 40 companies producing cookware and raw materials 22 large companies and national associations serving the home appliance market 3 337 enterprises 927 400 direct and indirect employees 72 billion value added Several companies have production sites spread around the globe. One stakeholder commented that goods for the European market tend to be manufactured in Europe, with a smaller amount made in Asia. No responses were received from retailers selling unbranded or own-branded goods, which may be more likely to be produced outside of Europe, particularly in Asia. Information provided to the CfE suggested that European production was focused on more high-end products, with the lower end serviced mainly by non-European produc ers. 162 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The businesses at most risk from a restriction are expected to be the suppliers of coatings, especially if their work is focused on the production of coatings made from PFAS. Those offering a broader range of coat ings and other products will, naturally be at lower risk. The same applies to the producers of cookware. Information from the 2nd stakeholder consultation indic ates that many have diversified in rec ent years to provide goods with a range of coatings. However, the extent of diversification is variable, leaving some more vulnerable to the impacts of a restriction than others. One respondent to the 2nd stakeholder consultation remarked that ceramic technology (SolGel) is already oc cupying a signific ant share of the non-stick market without signific ant costimpact for cookware producers or for consumers following 14 years of production. They considered that a restriction would not lead to supply or economic constraints, noting the number of companies already offering such cookware products. With respect to the coating process, they added that Sol-Gel is cured in a shorter time at lower curing temperatures, improving productivity and process economics. They stated that there is no price difference between fluoropolymer and Sol-Gel on housewares, which has largely been confirmed through our own observations on the market (see below). Given the number of c ompanies involved in the c ookware market it is to be expec ted that the sec tor is highly c ompetitive. Branding is one tool for helping c ompanies stand out from their c ompetitors and will influenc e the extent to which c ompanies are able to rec oup the c osts of substitution where they are present. One supplier of fluoropolymers stated that it would take at least 5 years for R&D on a new product, with investment required in the region of 2.4 million for the company concerned. Others have not provided data on costs of adaptation to a restriction. Though several have expressed concern that their businesses would be significantly impacted given the extent of existing commitment to the use of fluoropolymers, no further information was provided on the costs of transition to alternatives. Another producer commented that their company makes more than 100 different materials from fluoropolymers, each with its own specifications and properties. For each of these it would be nec essary to identify an alternative, investigate its properties, investigate whether it is acceptable under EU and FDA food compliance regulations, change ma nufacturing proc esses within the company and then c onvince c ustomers to use the alternative. Stakeholders have stressed the high price of the fluoropolymers, stating that they are used spec ifically where operating c onditions justify their use, and that the y would use alternatives if they were c onsidered able to provide a similar level of servic e. New entrants to the market (noting that there are a number of new companies marketing ceramic and other alternatives) naturally regard alternatives muc h more favourably. Impacts on consumers Given widespread availability of non-PFAS non-stick products, final price on the market for goods provides a partial basis for evaluation of the economic impacts of a restriction as this will reflect many of the issues listed above. A review of the price of 24cm frying pans on Amazon UK in March 2021 found most pans costing between 10 and 35, with PFAS and non-PFAS options spread throughout this range. Stainless steel pans start from approximately the mid-point of this range and extend beyond it. A lack of clarity in the description of the materials used prevents conclusions being drawn on the price brackets for silic one-coated and anodised aluminium pans. Similarly, review of internet pric es for products such as muffin tins or frying pans indicates that there is no clear difference in price to consumers of products made with and without PFAS. Brand, design, quality and appearance of goods appear to be far more important in determination of price than the option selected for achieving non-stick properties. One important issue that is not evident at the time of purchase is of course the durability of products. 163 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Consumer reviews of products are useful for assessing whether there is any effect, positive or negative, of alternatives on consumer surplus. Information from various websites e.g. (BBC, 2020) indic ates that users find little difference between the produc ts. Given that most reviews, whether by individuals or consumer groups, tend to focus on new products, issues of durability may not be adequately reflected in results. T his may lead to a disadvantage for fluoropolymer-coated pans relative to those using other, potentially less durable non-stick coatings for the price comparison. However, it would favour fluoropolymer-coated pans relative to more durable options such as stainless steel. Little difference was found in the price of alternative pans, though this could change if differences in produc t lifespan were taken into account. Some alternatives, especially lowquality options, may have a short product lifespan and hence may need to be replaced more frequently than the fluoropolymer alternative in order to retain the non-stick performance. This is of course dependent on the quality of the articles considered (again, noting that some FP treated articles are low quality72. Several fac tors have been highlighted for the benefits to c onsumers of fluoropo lymer c oated pans: Potential for low-fat or fat free cooking Better control over cooking, potentially improving the flavour and quality of food Reduced time and effort spent in cleaning cookware Durability Price. The first three elements are all user-dependent: some will derive these benefits others will not. Increasingly, of course, these benefits are not restricted to those using fluoropolymertreated pans, given the availability of alternatives. The durability of fluoropolymer coatings has been mentioned as a clear benefit by several stakeholders that are still using fluoropolymers. However, alternative non-stick c oatings have improved in durability over time, as indicated by recent test data72. Another factor relating to consumer behaviour concerns differing views on the lifetime of c ookware. Whilst some may dispose of it as soon as non-stick properties start to deteriorate, others will continue to use it with little concern for either the non-stick performanc e or risks linked to the shedding of PFAS (Figure E.5). This problem is likely to be particularly important with respect to low quality fluoropolymer coatings. Unfortunately, variation in quality is not apparent at point of sale. 164 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.5. Bun tin with severely degraded coating during prolonged use. With respect to health impacts for consumers, the use of pans with FP -based non-stick coatings will increase PFAS exposure to some degree, whilst the use of pans with less efficient non-stick properties (noting that it is not accepted here that this applies to all alternatives) may lead to inc reased use of oil or burning of food, both of which may have consequences for health. Again, there is a link to product quality, with low-quality FP pans unlikely to retain their potential health advantages for long. An additional impact for consumers is linked to the amenity value of a good quality non-stick surface through: Better control over cooking, potentially improving the flavour and quality of food Reduced time and effort spent in cleaning cookware. Both elements are user-dependent. Some will derive value from the non-stick qualities, whereas others will not. Increasingly, of course, these benefits are not re stricted to those using fluoropolymer-treated pans, given the availability of alternatives. Impacts on society The main soc ial impac t to c onsider c oncerns employment in the sec tor: Increased employment in some companies through the development of innovative product lines that do not use FPs, leading to increased market share. Reduced employment through loss of market share for some EU companies as they find it difficult to adapt sufficiently quickly to a restriction. The two effects may coexist, and if so, would clearly counteract one another. Overall demand for cookware may not be affected, so the impact on business overall may be small, though there would be winners and losers in the market. For reasons discussed earlier, it is not possible to estimate the number of workers that could be affected by a restriction, given a lack of data disaggregated sufficiently to describe those working in relevant parts of cookware manufac turing. The fact that several c ompanies already offer a range of produc ts using PFAS 165 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and non-PFAS coatings indicates that it is possible to make the switch, though this could mean that some lose their current position in the market. Several respondents to the stakeholder c onsultation c ommented that there was a risk of job losses linked to a restriction. However, the responses overall were largely from companies using or making FPs. Companies providing alternatives are likely to take the opposite view. Overall, given that the restriction would not affect demand for cooking and baking servic es, effects on employment are forecast to be small at the EU level. Cost -effectiveness Assessment of the cost-effectiveness of alternatives should capture all elements of cost associated with a possible restriction, including R&D, changes to production sit es, costs of launching new products, differences in material costs, impacts on consumers, public health and the environment, and so on. A problem for the present analysis is that data are unavailable for several elements, including the size of the sector in terms of companies and workers that could be affected. Another issue is that the market is mixed, with some manufacturers selling only fluoropolymer based non-stick products, others selling only ceramic coated products, others selling both, and yet more others selling further alternatives. In each case the R&D etc. required to launch alternative products onto the market will vary significantly from zero through to several perhaps many, millions of Euro. Extrapolation from the data that have been collected to the full market is thus prone to substantial uncertainty, even for those elements where data are available. The approach taken here is therefore to consider what level of cost increase for cookware could be justified against the change in emission of fluoropolymer to the environment using an indic ative benchmark c ost per unit of PBT of 1 000 per kilogramme provided by Oosterhuis et al. (2017). This change in cost can then be compared with market data. Analysis presented in this section focuses on frying pans, intended to be representative of the broader market for non-stick c ookware. Analysis is best focused on emissions of substance rather than use, as this is clearly more relevant to human and environmental risk. The exposure assessment indicates in-use release of 0.2 t of fluoropolymer per year, which is equivalent to <0.01% of the 3 500 t of FP sold onto the consumer cook and bakeware market annually. However, this is potentially a significant underestimate given observations of the state of some pans at end of life (s ee, for example Figure E.5). Also, other parts of the lifecycle are relevant to the case for or against restric tion, most notably end-of-life. Two positions are c onsidered here. Both take account of the release of material from the use phase. The second extends analysis to the waste phase and assumes complete release. A first step is to quantify the mass of fluoropolymer used per pan. Industry sources during the 2nd stakeholder consultation provided an estimate of 6-10 g fluoropolymer for a 26 cm frying pan (equivalent to 7 to 11 g for a 28 cm pan), though this was not referenced. Further calculations were therefore undertaken as a check on this range. Analysis is shown in Table E.46 for an illustrative pan measuring 28 c m in diameter with a 5 c m sidewall. The thic kness of the coating is variable, depending on how many coats are applied. A range of 35 to 100 microns is adopted in the table70. Table E.46. Quantification of the mass of a fluoropolymer coating on a 28 cm diameter frying pan with 5 cm deep walls. PTFE density g/m3 Thickness of coating Low 2 200 000 High 70 http://www.ptfecoatings.com/what-we-do/faq.php, date of access: 2023-01-13. 166 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Surface area of pan Thickness of PTFE coating Volume of PTFE coating Mass of PTFE coating/pan estimated here Pans per kg coating Mass of PTFE coating/pan estimated by industry Pans per kg coating m m3 g Number g Number Thickness of coating Low High 616 + 440 = 1 056 cm2 = 0.11 m2 35 100 3.69E-06 1.06E-05 8.1 23.2 123 43 7 11 142 90 Results indicate that 1 kg of coating could be used to produce between 43 and 123 frying pans of this size, with thick and thin coating depths respectively. The data provided by industry during the consultation is used to generate a second estimate of between 90 and 142 frying pans. Acknowledging uncert ainties, analysis continues with the extremes from the two ranges (43 to 142 pan/kg of fluoropolymer). The next stage is to consider what this means in terms of an ac ceptable price differential per pan, taking the figure of 1 000/kg where controls are usually accepted). This is calculated by dividing 1 000 by the number of pans per kg of c oating shown in Table E.47. Two sets of calculations are presented in Table E.47. The first assumes that over the lifecycle all fluoropolymer is lost to the environment, the second assumes that only 1% of fluoropolymer is emitted. Results scale linearly in proportion to the assumed percentage loss of fluoropolymer, so alternative positions can easily be calculated. The v ery broad ranges that result reflec t uncertainty in emissions, particularly linked to emissions at end-of-life. As noted earlier, these are addressed elsewhere. Table E.47. Estimates of the price increase per pan required for costs to equal the indicative benchmarks of 1 000 and 50 000 per kg PBT substance, assuming equal durability. Assume release of all (100%) fluoropolymer to environment over the lifecycle (3,500 t/y) Pans per kg of fluoropolymer released Acceptable price increase per pan at substitution cost of 1 000/kg Acceptable price increase per pan at substitution cost of 50 000/kg Assume release of 1% of fluoropolymer to environment over the lifecycle (34.2 t/y) Pans per kg of fluoropolymer released Acceptable price increase per pan at substitution cost of 1 000/kg Acceptable price increase per pan at substitution cost of 50 000/kg Thickness of coating Low High 142 7.04 352 43 23.26 1 162 14 200 0.07 3.52 4 300 0.23 11.62 These results mean that, in the case that a benchmark of 1 000/kg emission is considered appropriate, and that all fluoropolymer is lost to the environment over the product lifecycle, a pric e inc rease per pan of between 7.04 and 23.26 between the fluoropolymer option and the alternative could be considered proportional. If only 1% of the fluoropolymer is released, this range falls to between 0.07 and 0.23 per pan. Assuming equal service life of the pans, a negligible (0.07) to high (23.26) increase in the price of a pan could be justified, the 167 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) range reflecting differences in the quantity of material used per pan and the amount of that material that is released. If it is assumed that ceramic pans have a shorter lifetime than fluoropolymer pans the situation c hanges. Assuming that a fluoropolymer pan lasts twic e as long as a c eramic pan71 any possible price differential is likely to disappear given the range identified earlier for the pric e of pans of between 10 and 35 (this range only exceeding the case where it is assumed a thic k c oating of fluoropolymer is used, and all is lost to the environment over the lifecycle). However, there are several caveats to the view that fluoropolymer PFAS coatings are more durable than ceramic: There is a lack of reliable information on the durability of the latest formulations of non-fluoropolymer coatings. Poor quality fluoropolymer c oatings will not outlast good quality c eramic s 72. There may be more potential for significant improvement in ceramic coatings than for fluoropolymer c oatings, given the difference in maturity of the two technologies. Some of the alternatives, such as those made of stainless steel, have a longer lifespan than the fluoropolymer coated pans. Although more expensive initially, the costs of these pans over their lifespan will be lower than for fluoropolymer coated equivalents (assuming that the latter are replaced periodically when the coating ceases to function adequately). The differenc e in pric e is also reduc ed through a willingness to pay for some people to avoid PBT exposure. Practicability and monitorability Given the existence on the market of alternatives to consumer cooking products containing PFAS, a restriction on these products is clearly feasible. The practicability of the restriction would be largely dependent on the time frame for compliance, noting that a short timeframe could be problematic for some producers as they would need to research new solutions, adapt or replace production lines and promote new lines to their customers. Monitorability for the cookware sector may be problematic, given a lack of clarity on the materials used in coatings. E.2.3.4.3. Industrial food and feed production Economic Impacts Table E.48 provides an overview of the European food and drink industry. Whilst the industry contains a number of major global companies in the food and drinks market, SMEs provide a large share of both employment and turnover. Table E.48. Statistics for the European food and drink industry 73. Number of companies Employment Turnover Value added 289 000 99% SMEs 4.5 million 58% SMEs 1.1 trillion 43% SMEs 222 billion 71 https://prudentreviews.com/how-long-do-non-stick-pans-last/, date of access: 2022-12-20. 72 https://www.which.co.uk/, date of access: 2023-01-13. 73 https://www.fooddrinkeurope.eu/, date of access: 2023-01-11. 168 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) As noted above, fluoropolymers are very widely used in the industry. No examples of companies that do not use fluoropolymers at some point in their processing facilities have been identified. Many standard components for handling food and drink are made from, or coated, with fluoropolymers, including pipes, valve linings, seals and gaskets, tanks and conveyor belts. A restriction that targeted use of fluoropolymers in existing equipment would clearly have a substantial impact on the industry and affect supply of food and drink. Phasing out fluoropolymers from new equipment will also take some time, given the extent to which the industry has become reliant upon them and hence the need for R&D and certification of alternatives. Most of the responses rec eived in the 2nd stakeholder c onsultation for food c ontact materials came from companies linked to the production of equipment for the food and drink sector. European production of food processing equipment market was estimated to be worth 13 billion in 201474, with Italian and German producers accounting for about half this figure. Standardisation of hygiene requirements has been introduced to the sector through EHEDG (European Hygienic & Design Group) c ertification and the 3-A sanitary standards. This part of the market in food and drink production seems very likely to be more sensitive to a PFAS restriction, even allowing for potential for derogation on Entry Into Force, than the production of food and beverages. Another part of the sector c oncerns maintenance of equipment. One sub-sector that c ould be significantly affected by restriction concerns the recoating of industrial bakeware. This is of particular interest given the potential for significant emission of fluoropolymers when bakeware is c leaned and existing c oating removed, in preparation for rec oating. There were limited responses from this subsector to the 2nd stakeholder consultation, with mixed views: (i) One provider, supplying both silicone and fluoropolymer non-stick coatings, provided case study data drawing on work carried out over 20 years. Their business recoats bakeware to maintain non-stick performance and has developed a database covering over 1 million baking trays at 500 bakeries, recording the lifespan of coatings. About 1/3 of the trays are coated with fluoropolymers, the remainder with silicone. The fluoropolymer coating has a 30% longer lifetime than the silic one equivalent but a higher pric e. Over the lifecycle, the cost of the silicone option is 30% cheaper. The company has tested other parameters also including contact angle (a measure of non-stick properties), temperature durability, steam durability and strength of the aluminium base material of baking trays. For the latter it was noted that the high curing temperatures required for fluoropolymers lead to a rapid weakening of aluminium, leading in turn to reduced lifetime and higher costs. (ii) A sec ond re-coater took the opposite view, that the performance of fluoropolymers was far superior, and that switching away from them would be highly problematic, likely leading to the closure of the company. (iii) A third stakeholder concluded that both positions may be true. The second business, favouring fluoropolymers, was likely to be an SME that has developed its business over several years. The reinvestment needed to switch to alternatives may be unaffordable for the company on a short -medium timescale. Noting the information presented by Weilburger in 202168 on how the c hoice of baked product can affect the choice of coating, it is also possible that the second company may be dealing with bakers produc ing different types of baked good, for whic h silic one c oatings may not be so well suited. Most food and drink produc ers would opt for substitution when alternatives became available. An immediate ban of all PFAS use in the sector would not be practicable given the extent to 74 https://www.cbi.eu/market-information/metal-parts-components/metal-parts-food-processingequipment, date of access: 2023-01-11. 169 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) which PFAS are embedded in the machinery and production processes. Alternatives need to be identified and machinery and operating processes (maintenance, speed of production, frequenc y of c leaning, etc.) adapted as nec essary. As in other sec tors, the longer the period permitted for transition, the lower the costs to business and the risk of business c losure. The high proportion of food and drink producers that are SMEs may increase the risk of business closure, but quantification of this risk is not possible from the information available. The Dossier Submitters expect the proposed restriction to be implemented in 2025 with an entry into force in 2027. Therefore, the expected job losses do not take place before 2027, and depending on the position taken regarding derogations could be delayed a further 5 or 12 years. Table E.49 applies a discount rate of 3% to estimate the NPV (2020) of societal c osts due to job losses of the proposed restric tion for c omponent manufac turers responding to the consultation for the food contact and packaging sector with a view that business closure was a likely response to the proposed restriction. Table E.49. Estimated cost of job losses for some component manufacturers for the food and drink industry that consider themselves at risk of closure in response to a PFAS restrict ion (NPV, 2020 assuming that they are unable to introduce alternatives or otherwise adapt their businesses). Company A B C D E Totals Turnover (EUR million) 120 75 320 15 - 20 11.5 544 Jobs 750 360 2 000 40 - 50 400 3 555 Value (EUR million) for derogations of 0 years 5 years 12 years 79 38 211 5 42 376 68 33 182 4 36 324 56 27 148 3 30 264 Interpretation of these results is not straightforward. The following should be noted: The decline in NPV between the 0 and 12 year derogation periods only reflects the impact of discounting. The table assumes that c ompanies are so dependent on the use of fluoropolymers that they are unable to develop and market alternatives or otherwise adapt: this position is increasingly unrealistic as the derogation period increases given the extra time available for R&D. Results for the 5 and 12 year derogations are therefore biased to overestimation. During consultation, questions were raised on the benefits to businesses of delaying the introduction of t he restriction by 3 and 10 years. However, the question was widely misinterpreted, with respondents typically providing an estimate of lost turnover over 3 and 10 years respectively assuming closure at the start of the period, giving the impression that c osts to industry would be higher if the introduction of the restriction was delayed. The extent to which impacts on business would be reduc ed by delayed implementation c annot therefore be estimated. The extent to which results reflect the impact for the whole sector is not known. Results are based only on information from companies that responded to the consultation proc ess. This may bias to underestimation of impac ts if other c ompanies are similarly at risk. However, the component manufacturers are not limited to supplying the food and drink sector, but also work in fields such as transportation and medical devices. This biases to overestimation of impact for the food and drink sector. The likelihood of business c losure may be exaggerated simply bec ause there has been to date an absence of drivers to encourage research into alternatives. 170 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Food and drink produc tion will not c ease as a result of the restriction. Job losses at the companies providing fluoropolymer seals, tubing, etc. are therefore likely to be compensated by increased employment elsewhere, though this may be outside of the EU. Given their knowledge of the food and drink market the c ompanies c oncerned have at least some competitive advantage over competitors for the development of alternatives. Results are therefore intended only to be indicative, but some general conclusions can be reached based on the analysis presented in Table E.49: There is potential for significant impacts on component suppliers and their employees, particularly if a restriction was introduced on a short timescale. This could have consequences for the food drink producers downstream if alternatives matching the performance of fluoropolymers are not available, for example through reduced speed of production or increased rejection of product. In considering cost issues, the question of the time permitted for manufacturers to switch to alternatives is of key importanc e, along with the issue of whether replacement articles would be permitted for placing on the market for the servicing of existing equipment. Stakeholders expressing a view cited a minimum estimate of 5 years for a transition away from fluoropolymers once satisfactory alternatives had been identified, based in part on experienc e with chromium (VI). One producer provided the following timeline (Table E.50): Table E.50. Indicative estimate of time for transition away from fluoropolymers in production of equipment for the food and drink sector. R&D for new polymer at suppliers Develop new rubber/plastic compounds Develop new products e.g. seals Test products in house Obtain food approval Test products with customers Total 5 years 2 years 1 year 6 months 6 months 1 - 2 years 10 - 11 years There was significant variation in estimates of the time taken to obtain approval from stakeholders identifying as supplying goods to the food and drink market ( 2nd stakeholder consultation), from one month to several years. However, some of the suppliers were providing goods (seals, hoses, pipes, valve linings, etc.) across a range of sectors including medic al and automotive. The estimate of 6 months shown in Table E.50 is c onsidered here to be appropriate for the food and drink sector. A key fac tor in determining the time taken to develop alternatives c oncerns the identification of options that provide an acceptable level of performance. In some areas this may be straightforward, such as alternative coatings for baking pans (though some in the industry would dispute this). In other areas where there is no current alternative on the market, it may take considerably longer to either identify an alternative that provides the necessary level of service, or one that comes closest to it. Non-fluoropolymer options are c learly available on the market to perform the same general functions as items containing or made from fluoropolymers (pipes, seals, etc.). However, several respondents to the CfE and the 2nd stakeholder consultation indicated that the price differential between fluoropolymer products and alternatives provided an effective disincentive to fluoropolymer use in cases where they did not provide a significant benefit. Particular c oncerns for alternatives related to hygiene and durability, which would affect the c osts of food and drink produc ers. 171 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A detailed breakdown of the costs of developing alternatives and introducing them to the market has not been provided by stakeholders. The cost calculation made by manufacturers of equipment and food and feed produc ts and the c ompanies using this equipment fac tors in several elements, such as those listed below. Respondents were mainly from companies providing or using fluoropolymers, rather than producers and users of alternatives, or food and drink produc ers. The following summarises the limited c ost data obtained going through the c hain from identific ation of alternative polymers through to the generation of wastes: The costs of R&D to develop new solutions for (e.g.) a series of different coatings used for different jobs, such as bakeware for different types of foodstuffs. One stakeholder reported producing more than 100 different PFAS based substances, each with its own specifications and properties, each of which would require its own R&D process. One manufacturer of seals, O-rings and gaskets estimated R&D costs of 4 million with annual recurring costs (e.g. for testing) of 50 000, though it is not clear whether the latter should be considered additional as presumably the testing would be required for any produc t. Other stakeholders supported the view that the costs of R&D for their companies would be in the order of EUR millions. The c osts of validation of alternatives for use with foodstuffs for both the c omponent/ solution manufacturer and their customers were raised, but further details were not given. Some data on the cost of components made of different materials was provided by (Amec Foster Wheeler, 2017), indicating a cost for PTFE in the region of 17 000 to 20 000/t and of fluoropolymer more generally averaging around 15 000/t. This was said to lead to a fac tor 3 inc rease in the c osts of some c omponents (specifically, pipes and tubing were identified, though noting that the cost of the alternativ e materials was not given) relative to the use of non-PFAS alternatives. The additional c ost of the PFAS option is c onsidered justified because of lower maintenance costs and improved durability (see below). Consideration was given to adaptation to machinery to facilitate use of alternatives, possibly leading to differences in proc essing times and produc tivity. One stakeholder likened the necessary transition to starting a new company, requiring investment for one site in the region of 4 to 5 million. This could be repeated at many locations across the EU. Another highlighted practical issues on retrofitting alternatives, giving the example of the use of stainless steel expansion joints which could be extremely problematic given a lack of space at some facilities. One company estimated that the use of fluoropolymers reduced downtime linked to cleaning by 50-70%. Alternatives would likely generate additional cost for replacement of parts when they are no longer functioning as required, as they were considered by stakeholder respondents to have a shorter service life than fluoropolymers. There could also be potential impacts linked to increased wastage of product, for example through poor performanc e of non-stick c oatings. Detailed analysis providing suffic ient information to estimate additional c apital and operating costs is not available, preventing estimation of costs of a restriction to the sector for more than specific elements, even then limited to information from a few companies. The above listed issues provided by stakeholders through the consultation process demonstrate why c ompanies c ontinue to use fluoropolymers, despite the higher c ost of purc hase. In the event of business closure, it may be possible to rec oup some c osts through the sale of assets. The businesses most likely to be affected are suppliers of seals, tubing, valve linings and so on whose entire business is currently dependent on PFAS (typically PTFE). The most likely market for these assets would be outside the EU, where controls on PFAS were not so stringent. Again, it is not possible to estimate the extent to whic h costs c ould be rec ouped, if at all. Several stakeholders commented that the use of fluropolymers increased productivity. This will feed through into prices for consumers, though it is not possible to estimate the size of 172 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) this impact. Major food and drink producers operate in a competitive marketplace, though significant market power is held by a limited number of food c ompanies and supermarkets (Van Dam et al., 2021). The power of the supermarkets reduc es the margins of the produc ers, limiting the extent to which producers are able to pass costs onto consumers. This level of competition partly explains the importance of branding in the industry. For the smaller producers (noting that SMEs account for 99% of EU food and drink companies) competition is in many cases less related to price than it is to quality (ECSIP, 2016). Companies competing successfully on quality will be in a better position to pass costs onto retailers and/or consumers. The ECSIP Consortium report concludes that the European food and drink industry is able to compete internationally bec ause of the high quality of produc e. Ac ross the industry as a whole in the EU, pric e c ompetitiveness therefore varies from high to low, depending on the produc ts and precise market segment targeted by producers. Exports outside the EU account for 10% of the turnover of the food and drink sector (120 billion out of a total turnover of 1.2 trillion/y) (FoodDrinkEurope, 2019). Increased c osts for the sector bec ause of reduc ed productivity linked to a PFAS restriction may have an impact on these sales. In both c ases, impac ts of a restric tion may not be long-term, given an inevitable inc rease in the research on alternatives to FP use. However, several stakeholders considered the likelihood of finding replac ements for FPs that performed to a similar level to be low. There is evidenc e to support this view from the fac t that FPs have a high pric e and henc e tend to be used only when considered necessary. However, the current status of alternatives is in part a function of a market where there has not been a legislated barrier to FP use. E.2.3.4.4. Economic impacts on consumers It is not possible to estimate the change in consumer surplus from available data. However, it is useful to consider possible scenarios: 1. Alternatives that match the performance of fluoropolymers are available by the time that the sector is affected by the restriction. In this situation the impacts on consumers would likely be zero, bearing in mind the high price of the fluoropolymers that they would replace. 2. Alternatives are available but do not quite match the performance of fluoropolymers. This may lead to some inc rease in food pric es arising from the need to increase the frequency of cleaning and maintenance. Food quality (from a hygiene perspective) would be unchanged given legislation on food safety. Impacts on those on moderate and high inc omes would likely be small. Impac ts for those on low incomes could be more signific ant, exacerbating inequalities, rec ognising that they will tend to spend a higher proportion of their income on food. 3. Alternatives are available but their use significantly reduces capacity in the food and drink industry. In this situation food prices could increase significantly leading to added financial costs for consumers. Food safety should again not be affected given existing legislation. Consumers may experienc e a reduction in food quality as they switch to alternatives that are c heaper than they would otherwise buy, leading to some welfare loss. There would of course again be higher impacts for those on low incomes. Imports to the EU from regions where fluoropolymers are not restricted would likely increase, leading to some distortion in trade. 4. Alternatives are not available at all. This situation is not considered realistic: alternatives are available at the moment but do not meet the performance of fluoropolymers. [3] is anticipated to represent the worst case. According to this analysis there is some potential for significant impacts on consumers, including concern over affordability for those on low incomes. It is therefore appropriate to consider potential for mitigating such risk, for example by considering a derogation that would 173 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) give time for adaptation. E.2.3.4.5. Other impacts on society From the 2nd stakeholder consultation it was noted that several producers of equipment for the production of food and drink are very specialised in the use of fluoropolymers. In several cases, PFAS accounted for a large share of company production (up to 100%). These businesses consider themselves to be at significant risk of closure as a result of the restriction, leading to a loss in turnover for those companies that responded and provided data of between 11 and 320 million per year (Table E.51) and job losses of between 40 and 2 000 workers per c ompany. The monetisation of the social costs due of unemployment follows the approach set out by Dubourg (2016). In this approach the loss of unemployment is estimated considering the following impacts: The value of output/wages lost during the period of unemployment The c osts of job searc h, hiring and firing employees The scarring effect, i.e. the impact of being made unemployed of future employment and earnings The value of leisure time during the period of unemployment. The discounted net present value (in 2014) of the social costs of losing one job in the EU-28 was estimated at 87 000, equal to 2.7 times the average annual gross wage. This ratio varies across different member states, mainly driven by the country specific average duration of unemployment. The supply chain is here assumed to be distributed across Europe, supporting the use of an EU-average ratio. The average duration of unemployment dec reased from 18 to 16 months sinc e the approach was published by Dubourg. The Dossier Submitters c onsider this change in unemployment duration not substantial enough to redo ECHA's as sessment and takes the ratio of 2.7 as representative for the calculation of the societal costs of unemployment. The EU-27 average annual gross wage for the manufacturing of chemicals is estimated at ~47 000 in 2019/2020 prices based on Eurostat sector data (CfE). The NPV in 2020 of the social costs of losing one job in the manufacturing of chemicals sector is estimated at 130 000 by multiplying the average annual gross wage by 2.7. This figure is likely an upper bound, given higher wages in the chemical sector than the average across the economy, which would give a figure around 102 000. The Dossier Submitters expect the proposed restriction to be implemented in 2025 with an entry into force in 2027. Therefore, the expected job losses do not take place before 2027, and depending on the position taken regarding derogations could be delayed a further 5 or 12 years. Table E.51 applies a discount rate of 3% to estimate the NPV (2020) of societal c osts due to job losses of the proposed restric tion for c omponent manufac turers responding to the consultation for the food contact and packaging sector with a view that business closure was a likely response to the proposed restriction. 174 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.51. Estimated cost of job losses for some component manufacturers for the food and drink industry that consider themselves at risk of closure in response to a PFAS restriction (NPV, 2020 assuming that they are unable to introduce alternatives or otherwise adapt their businesses). Value (EUR million) for derogations of Company Turnover (EUR million) Jobs 0 years 5 years 12 years A 120 750 79 68 56 B 75 360 38 33 27 C 320 2 000 211 182 148 D 15 - 20 40 - 50 5 4 3 E 11.5 400 42 36 30 Totals 544 3 555 376 324 264 Interpretation of these results is not straightforward. The following should be noted: The dec line in NPV between the 0 and 12 year derogation periods only reflec ts the impact of discounting. The table assumes that companies are so dependent on the use of fluoropolymers that they are unable to develop and market alternatives or otherwise adapt: this position is inc reasingly unrealistic as the derogation period increases given the extra time available for R&D. Results for the 5 and 12 year derogations are therefore biased to overestimation. During c onsultation, questions were raised on the benefits to businesses of delaying the introduction of the restriction by 3 and 10 years. However, the question was widely misinterpreted, with respondents typically providing an estimate of lost turnover over 3 and 10 years respectively assuming c losure at the start of the period, giving the impression that costs to industry would be higher if the introduc tion of the restriction was delayed. The extent to which impacts on business would be reduced by delayed implementation cannot therefore be estimated. The extent to which results reflect the impact for the whole sector is not known. Results are based only on information from companies that responded to the consultation process. This may bias to underestimation of impacts if other companies are similarly at risk. However, the component manufacturers are not limited to supplying the food and drink sector, but also work in fields such as transportation and medical devices. This biases to overestimation of impact for the food and drink sector. The likelihood of business closure may be exaggerated simply because there has been to date an absence of drivers to enc ourage research into alternatives. Food and drink produc tion will not c ease as a result of the restric tion. Job losses at the c ompanies providing fluoropolymer seals, tubing, etc. are therefore likely to be compensated by increased employment elsewhere, though this may be outside of the EU. 175 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Given their knowledge of the food and drink market the c ompanies c oncerned have at least some competitive advantage over competitors for the development of alternatives. Results are therefore intended only to be indicative, and it is not possible to quantify the magnitude of these impacts for the sector as a whole but it can be concluded that there is potential for significant impacts on component suppliers and their employees, particularly if a restric tion was introduced on a short timesc ale. This c ould have c onsequences for the food drink producers downstream if alternatives matching the performance of fluoropolymers are not available, for example through reduced speed of production or increased rejection of produc t . Wider Economic Impacts Several stakeholders commented that the use of fluropolymers increased productivity. This will feed through into prices for consumers, though it is not possible to estimate the size of this impact. Major food and drink producers operat e in a competitive marketplace, though significant market power is held by a limited number of food c ompanies and supermarkets (Van Dam et al., 2021). The power of the supermarkets, reduces the margins of the producers, limiting the extent to which producers are able to pass costs onto consumers. This level of c ompetition partly explains the importance of branding in the industry. For the smaller producers (noting that SMEs account for 99% of EU food and drink companies, Table E.48) competition is in many cases less related to price than it is to quality (ECSIP, 2016). Companies competing successfully on quality will be in a better position to pass costs onto retailers and/or consumers. The ECSIP Consortium report concludes that the European food and drink industry is able to c ompete internationally bec ause of the high quality of produc e. Ac ross the industry as a whole in the EU, pric e c ompetitiveness therefore varies from high to lo w, depending on the produc ts and prec ise market segment targeted by produc ers. Exports outside the EU account for 10% of the turnover of the food and drink sector (120 billion out of a total turnover of 1.2 trillion/y) (FoodDrinkEurope, 2019). Increased c osts for the sector bec ause of reduc ed productivity linked to a PFAS restriction may have an impact on these sales. In both cases, impacts may not be long-term, given an inevitable increase in the research on alternatives to FP use. However, several stakeholders considered the likelihood of finding replac ements for FPs that performed to a similar level to be low. There is evidenc e to support this view from the fact that FPs have a high price and hence tend to be used only when considered necessary. However, the current status of alternatives is in part a function of a market where there has not been a legislated barrier to FP use. E.2.3.5. Summary of cost and benefit assessment T he information described above has been brought together to consider the costs and benefits (in terms of changed emissions) of a general transition period of 18 months after Entry into Force of a restriction. Derogations are also considered for periods of 5 years and 12 years additional to the 18 month transition period. Information is presented for the following subsec tors: Consumer cookware (Table E.52) Industrial food, drink and feed processing (Table E.53) Non-stick c oatings in industrial and professional bakeware (Table E.54) Paper and board packaging (Table E.55) Plastic packaging (Table E.56) Other pac kaging applic ations (Table E.57) 176 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.52. Consumer cookware and home kitchen appliances - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of derogation A lternatives Health and environmental impact Cost impact Other aspects Full ban No t a p p licable The re is suf f icient ly strong evidence that te chnically and e conomically fe asible alte rnative nonstick coatings are available for the domestic m ark et, and alre ady have s ig n if icant m ark et share. Base d on available e vide nce which is considered to be sufficiently strong (i.e. based on ve rifiable tonnage e stimates for PFAS and re asonable assumptions about e nvironmental re lease), a full ban of PFAS use in food contact m ate rials and pack aging will contribute to re ducing e m issions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in comparison to the base line. The e x pected e mission re duction under a full ban (R O 1) e quals around 96% of baseline e missions for a 30ye ar pe riod (2025-2055). Note that this e stim ate m ay be an ove re stimation as e m issions from the was te phase of products could not be included in the a s s es smen t. Im pacts will vary be twe e n companies depending on the extent to which the y have adopted or re se arched the available alte rnatives to PFAS coatings for the non-stick m arket. Those that are alre ady advanced in the transition to PFAS-free options are lik ely to see improved prod ucer surplus, whilst those that are not could lose market share and producer surplus. [sufficiently strong evidence]. Manufacturers of fluoropolymer coated pans have claimed that alte rnative coatings do not last as long, le ading to im pacts on consumers. Howe ver, ste ady im provements in the quality of ce ram ic coatings have been noted. Also the fact that there are poor quality fluoropolymer coated pans on the market that have a short se rvice life. There are also othe r alternatives on the m ark et that are we ll suited to some applications. Im pacts on consumer surplus are considere d lik e ly to be small. [sufficiently strong evidence]. Social im pacts are unclear, given that there will be winners and lose rs in the market. Some companies may expand whilst others m ay shrink. Additional mark ets may open up in other countries as othe r re gions m ove away from PFAS. The overall impact on jobs is unce rtain, but considered lik ely to be sm all. [weak evidence]. Ban with 5 ye ars n/a n/a n/a n/a use -specif ic derogations 12 ye ars n/a n/a n/a n/a Conclusion A full ban after a derogation period of 18 months is concluded as feasible for the consumer non-stick coatings market. Some companies are likely to increase consumer surplus whilst others will lose out, depending on their re adiness to move to the alternatives by the e nd of the transition period. Impacts on consumers are considered likely to be small given advances in re cent ye ars in the quality of the alternatives to fluoropolymers. The si tuation for the consumer appliances m ark et is le ss ce rtain and further information is desirable from the stakeholder consultation. Howe ver, no clear basis for de laying the re striction for this part of the m arket has been identified. 177 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The conclusions of the Dossier submitters are based on evidence/knowledge from the: Literature; A limited number of stakeholder interviews; Information from the CfE; and The 2nd stakeholder consultation. The responses to the consultation exercises, whilst useful, are biased to the companies that are most dependent on PFAS. Little response was received from companies focused on alternatives. It is concluded that the evidence is sufficiently strong that technically and economically feasible alternatives are available in the quantities required for use in the home cook- and bakeware markets and that the substitution potential is high under RO1, such that a derogation is not required. It is noted that a number of companies already provide nonfluoropolymer non-stick options either throughout their range or for part of it. Several stakeholders expressed concern over the durability of ceramic coatings, though there is evidence of improved durability well in excess of the figures cited by some stakeholders. At the same time, it is noted that the market for fluoropolymer coated goods shows significant variation in quality, with some products losing their non-stick property in a short time, and shedding fluoropolymer. Some manufacturers have started to produce appliances such as sandwich toasters with non-stick surfaces made from alternatives to fluoropolymers. Less information has been identified regarding fluoropolymers used in the mechanisms of kitchen applianc es (for seals, gaskets, pipes, etc.), though again there are alternatives on the market. It is considered that the time between publication of this dossier and the date at which the provision of a restriction would come into effect provides time for companies to adapt to a rest ric tion. Evidenc e is considered sufficiently strong that the socio-economic benefits in terms of avoided emissions from the use phase will be in the region of 96% for the food contact materials and packaging sector overall. Information at the sub-sector level is not available. A large share of PFAS used in the sub-sector will not be emitted during use, but will be passed through to the waste phase. With respect to costs, again, information to the CfE and 2nd stakeholder consultation was primarily from companies that work with fluoropolymers. For producers, there is sufficiently strong evidenc e that there will be winners and losers in the market, with those companies that are already marketing alternatives being likely to consolidate their market position, whilst those that have remained specialised in fluoropolymer use may lose ground. Impacts on consumer surplus are considered likely to be small, given observations on the price and performance of pans using and not using PFAS. It is acknowledged that there is variability in the quality of coatings, but this applies equally to the market for go ods coated with fluoropolymers as it does t o goods with ceramic coatings. There are then further alternatives, including uncoated kitchenware, that perform well. Social impacts via job losses are considered likely to be small at the level of the EU, noting that some companies are likely to do better after a restriction and may increase staffing levels, whilst those that are slower to adapt or unable to adapt will do worse potentially leading to job losses. Evidence on these social impacts is considered weak. 178 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.53. Industrial food, drink and feed processing - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban Not applicable Alte rnatives e xist for som e use s of fluoropolymers but m ay not cove r the full range of applications in the food, drink and feed se ctor. Further R&D will be ne e ded to assess pe rformance of alte rnative polym ers under conditions varying in (e .g.) te m perature , pre ssure and che m ical e nvironment (including cle aning age nts) [suf f icient ly strong evidence]. Base d on available e vide nce which is considered to be sufficiently strong (i.e. based on ve rifiable tonnage e stimates for PFAS and re asonable assumptions about e nvironmental re lease), a full ban of PFAS use in food contact m ate rials and pack aging will contribute to re ducing e m issions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in com parison to the base line. The e x pected e m ission re duction during the use phase for food contact m ate rials e quals around 96% of baseline e m issions for a 30-ye ar pe riod ( 2 0 2 5 - 205 5). As the e nvironmental im pact assessment doe s not cover the waste phase, emissions unde r the base line as we ll as e m issions avoided as a re sult of the re striction are lik e ly undere stimated. Producer surplus losses as a re sult of business closures, particularly for com panies that have spe cialised in the m anufacture of fluoropolymer co mponents (seals, pipes, etc) to supply the industry [sufficiently strong evidence]. Producer surplus losses could also arise for the com panies buying m achinery for food and drink production, for example through re duce d throughput rate s. Consumer surplus losses arise for customers for food, drink and fe ed products, in the e ve nt of price incre ases (with adde d costs be ing passed on to consumers) or a deterioration in quality. Producer and consumer losses from disruption to the food, drink and fe ed m arket is possible if a re striction was applied to the sector with only a lim ite d transition period in place given the extent of R&D needed to introduce alternatives. [sufficiently strong evidence]. Pote ntial for social costs through job losses e specially in those com panies that have specialised in working with fluoropolymers. [sufficiently strong evidence]. Ban with use- specif ic derogation s: Food co n ta ct m ate rials for the purpose of industrial and profe ssional food and feed p ro d u ction 5 ye ars An additional 5 ye a rs would e nable com panies m anufacturing e quipment for food, drink and feed p ro d u ction to e valuate e x isting alte rnatives and som e new polymers and carry out the ne ce ssary R &D for a s s ociated m odifications of e x isting e quipment de signs. [suf f icient ly No evidence is available about the pre cise amount of additional e missions for this spe cific de rogations. Howe ver, maximum additional emissions assuming a full de rogation of fluoropolymers can be e stimated and account of 2 822 t (30-ye ar pe riod, see Table E.41). In re lation to this re fe rence sce nario, additional e m issions of the proposed de rogation are considered to be sm all. An additional 5 ye ars would e nable a smoother transition from fluoropolymers to alte rnatives and provide opportunity for dive rsification for companies that are currently specialised in the use of fluoropolymers. It is the re fore probable that producer, consumer and social impacts would be re duce d compare d to the position with no de rogation be yond the 18-m onth transition pe riod. Howe ver, it is unlikely that impacts would be eliminated altogether. [sufficiently strong evidence]. 179 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects strong evidence] 12 ye ars An additional 12 n/a ye ars p ro vides gre ater opportunity for de ve lopment of ne w polym ers to m e e t the ne e ds of the se ctor. [suf f icient ly strong evidence] The additional time would permit m ore opportunity to re search and introduce cost-effective alternatives whilst lim iting loss of producer and consumer surplus and we lfare losses from use of le ss e ffective polymers. Performance to m atch fluoropolymers cannot, howe ver, be guaranteed, le ading to some risk, albeit re duce d, of producer and consumer surplus losses. [sufficiently strong evidence] Conclusion A full ban after a derogation period of 18 months would cause disruption to the food and drink market with the lik elihood of some business closures and impacts on producers, consumers and work ers. Risks are mitigated by introducing derogation periods. Given the reliance of the industry on fluoropolymers in rece nt years, the e x tent to which alte rnatives can be re adily substituted to the m arket is unknown: detailed information on the performance of alternative polymers, and the conse quences of using those polymers, has not been presented. There is therefore unce rtainty over the period re quired for the industry to m ake a full transition away from the use of fluoropolymers, and the optimal derogation period taking account of both costs and benefiis. 180 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The conclusions of the DS expert team are based on evidence/knowledge from the: Literature; A limited number of stakeholder interviews; Information from the CfE; and The 2nd stakeholder consultation. The responses to the consultation exercises, whilst useful, are biased to the companies that are most dependent on PFAS. Little response was received from companies focused on alternatives. This sub-sector deals with a diverse range of components used in machinery for production of food, drink and feed, such as seals, O-rings gaskets, pipes and tubing. It is concluded that the evidence is sufficiently strong that technically and economically feasible alternatives are not available for all applic ations in sub- sector. Whilst it is possible that substitution potential is high for some components it is low for others t hat may be operating in harsh environments subject to significant temperature and pressure variation and the use of strong chemicals. A clear timeline for the development of alternatives has not been identified during the assessment. Progress could be made under a 5 year derogation though the chance of success, for example in developing new non-PFAS polymers would naturally increase with a longer derogation. Evidenc e is considered sufficiently strong that the socio-economic benefits in terms of avoided emissions from the use phase will be in the region of 96% for the food contact materials and packaging sector overall. Information at the sub-sector level is not available. A large share of PFAS used in the sub-sector will not be emitted during use, but will be passed through to the waste phase. With respect to costs, information to the CfE and 2nd Stakeholder Consultation was primarily from companies that work with fluoropolymers for example to produce components for the companies that manufacture machinery for the sub-sector. A number of these companies have specialised in fluoropolymers and there is sufficiently strong evidence that they could be at significant risk of closure if they are unable to adapt to the restriction. Closures would lead on to job losses with further cost impacts. Consumer surplus losses arise for customers for food, drink and feed products, in the event of price increases (with added costs being passed on to consumers) or a deterioration in quality. 181 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.54. Non-stick coatings in industrial and professional bakeware - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of A lternatives derogation Environmental impact Cost impact Other aspects Full ban Not applicable Alte rnatives (e.g. silicone) are available and alre ady use d in the m ark et. [strong evidence]. It is not cle ar that the se are available for all re le vant b akery p ro d u cts g iven variation in (e .g.) sugar and fat content, n o tin g re com mendations from one company for diffe rent options for diffe rent type s of bre ad and cake. [weak evidence]. Base d on available e vidence which is considered to be sufficiently strong (i.e . based on ve rifiable tonnage e stimates for PFAS and re asonable assumptions about e nvironmental re le ase), a full ban of PFAS use in food contact m ate rials and pack aging will contribute to re ducing e missions (PFAAs a nd P FAA precursors, fluoropolymers and PFPEs) in comparison to the baseline. The e x pected e m ission re duction during the use phase for food contact m aterials e quals around 96% of baseline e m issions for a 30-ye ar period (2025-2055). As the e nvironmental im pact assessment does not cove r the waste phase, emissions under the baseline as we ll as emissions avoided as a result of the re striction are likely underestimated. The companies at most risk of producer surplus loss are those providing bakeware or re coating se rvices who have spe cialised in use of fluoropolymers. These com panies m ay be at risk of closure, with accom panying job losses, if they are unable to adapt to alte rnatives fast e nough, for e x ample if the y cannot finance changes to the ir production lines (re cognising that m any re -coaters will be SMEs). [sufficiently strong evidence]. Such im pacts would lik e ly be partially offset by com panies already work ing with alternatives. Manufacturers of baked products could be at risk of producer surplus loss if alte rnative coatings are not suitable for the ir specific product range. Added costs would fe ed through to a re duction in consumer surplus. [inconclusive evidence] Ban with usespecif ic derogation s: Potential de rogation m ark ed for re considerati on: Nons tick coatings in in d u s trial and profe ssional bak eware 5 ye ars 12 ye ars Give n that alte rnatives already have som e m arket share it is considered that this would be sufficient tim e for alte rnatives to be de ve loped for use across the range of bak ery p ro d ucts. [sufficiently strong evidence] No evidence is available about the pre cise am ount of additional e m issions for this spe cific de rogations. Howe ver, maximum additional emissions assuming a full de rogation of fluoropolymers can be e stimated and account of 2 822 t (30-ye ar pe riod, se e Table E.41). In re la tion to this re fe re nce sce nario, additional e m issions of the proposed de rogation are considered to be small. Im pacts on producer and consumer surplus would fall re lative to a full ban. [sufficiently strong evidence]. n/a n/a n/a n/a Conclusion A full ban after a derogation period of 18 months could cause disruption to the food m arket with the likelihood of some business closures and impacts on producers, consumers and work ers. Given the e xisting availability of alternatives for some bakery products, it is concluded that a 5 ye ar derogation may be appropriate for the se ctor, though this will m e an that e missions to the e nvironment during the use phase will incre ase. The derogation will also cause additional e missions during the waste phase of food contact materials, though given the finite life of coatings in industrial and professional use this is not expected to c ontinue beyond a ye ar or two 182 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects afte r the re striction becomes effectivce for the sector. In light of we ak e vidence re garding the potential for transitioning to alternatives for some businesses/product line s, such a de rogation is not proposed at this point but m arked for re consideration. A de rogation m ight be proposed at a la te r stage if additional information on alte rnatives becomes available, e .g. re garding performance of curre nt coatings with different types of baked good and other barriers to alternatives . 183 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The conclusions of the DS expert team are based on evidence/knowledge from the: Literature; Information from the CfE; and the 2nd stakeholder c onsultation. Whilst there was sufficiently strong evidence that technically and economically feasible alternatives are available for coatings for the production of a wide range of baked goods, there was also some (weak) evidenc e that they are not suitable for all. It was not c lear if this reflec ted real differences in the suitability of different coatings or the ability of some companies to adapt to the restriction. However, it was noted that a produc er of a range of different bakeware pro duc ts that varied according to the coatings applied provided guidance as to what products were best suited to each pan type, suggesting that variation in baked goods according to criteria such as fat and sugar content or baking times could affect the preference for different coatings. Further information on this issue would be useful for deciding whether or not a derogation is appropriate for the sub-sector. Evidenc e is considered sufficiently strong that the socio-economic benefits in terms of avoided emissions from the use phase will be in the region of 96% for the food contact materials and packaging sector overall. Information at the sub-sector level is not available. A large share of PFAS used in the sub-sector will not be emitted during use, but will be passed through to the waste phase. There was suffic iently strong evidence that some c ompanies c ould inc ur signific ant producer surplus losses in the event of a restriction, certainly in the short term but also possibly in the longer term given the extent to which they have specialised their services. This c ould lead to the closure of some businesses with associated job losses. On the other hand, some c ompanies appear to have made the transition already and c ould inc rease their market share in the event of a restriction on the sector. 184 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.55. Paper and board packaging - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban No t a p p licable The re is sufficiently strong evidence that te chnically and e conomically fe asible alternatives to PFAS use are available for the paper and board pack aging m arkets in the EU. Base d on available e vidence which is considered to be sufficiently strong (i.e . based on ve rifiable tonnage e stimates for PFAS and re asonable assumptions about e nvironmental re le ase), a full ban of PFAS use in food contact m ate rials and pack aging will contribute to re ducing e missions (P FAAs a nd P FAA precursors, fluoropolymers and PFPEs) in comparison to the baseline. The e x pected e m ission re duction during the use phase for food contact materials e quals around 96% of baseline e m issions for a 30-ye ar period (2025-2055). As the e nvironmental im pact assessment does not cove r the waste phase, emissions under the baseline as we ll as emissions avoided as a result of the re striction are likely underestimated. C om panies alre ady selling alternatives will be ne fit from the re striction, whilst those curre ntly dependent on PFAS may incur losses. Howe ve r, re ported transition tim e s we re typically short e nough to be met e ven with only an 18 month transition, given the time taken for preparation of the Annex XV Do ssier and its e valuation. C onsumer surplus losses are the re fore anticipated to be lim ite d. [sufficiently strong evidence] The re m ay be some loss of produce r surplus due to price rise s, for e x ample of natural gre aseproof paper, as this re quire s longe r proce ssing than PFAS tre ate d paper. Howe ve r, again, the se are e x pected to be lim ited. [sufficiently strong evidence]. No evidence has be en provided indicating that the re may be job losses as a re sult of a re striction on PFAS use in paper and board packaging. Ban with 5 ye ars n/a n/a n/a n/a use- specif ic 12 ye ars n/a n/a n/a n/a derogation s Conclusion A full ban after a derogation period of 18 m onths is concluded as feasible for paper and board packaging. Some companies are likely to increase co nsumer surplus whilst othe rs will lose out, depending on how advanced they are in moving away from PFAS, though e vidence has been provided t hat transition times can be short. Im pacts on consumers are considere d likely to be small given the extent to which alternatives already have mark et share at competitive prices. 185 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The conclusions of the DS expert team are based on evidence/knowledge from the: Literature; Information from the CfE; and The 2nd stakeholder consultation. There was sufficiently strong evidence that technically and economically feasible alternatives are available to replace the use of PFAS in paper and board packaging. This is demonstrated by substantial research that has demonstrated not only are alternatives available but they also perform well. Evidenc e is considered sufficiently strong that the socio-economic benefits in terms of avoided emissions from the use phase will be in the region of 96% for the food contact materials and packaging sector overall. Information at the sub-sector level is not available. A large share of PFAS used in the sub-sector will not be emitted during use, but will be passed through to the waste phase. Overall impacts on businesses operating in the sector are considered likely to be low, based on sufficiently strong evidence. It is true that there would likely be a mix of winners and losers, with some companies in a better position to respond to a restriction than others. However there was no evidence that there were likely to be job losses as a result of a restriction on this sub-sector. 186 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.56. Plastic packaging - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban No t a p p licable Sufficie ntly strong evidence that alte rnatives e x ist to re place polym eric PFASs use d as pro ce ssing a ids in the pro duction of plastic film to im prove flow be haviour, spe ed up production rate s, also e nabling the production of thinner films. Se ve ral alternatives (e .g. boron nitride , polyethylene waxes) are available on the market. C onclusion: High pote ntial at EiF strong e vidence] s u b s titution [ s u f f iciently Base d on available e vidence which is considered to be sufficiently strong (i.e . based on verifiable tonnage e stim ates for PFAS and re asonable assumptions about e nvironmental re lease), a full ban of PFAS use in food contact m aterial use will contribute to re ducing e m issions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in com parison to the baseline. The expected emission reduction during the use phase for food contact m aterials and packaging e quals around 96% of baseline e missions for a 30ye ar pe riod (2025-2055). As the e nvironmental im pact assessment does not cove r the waste phase, e missions under the baseline as we ll as e m issions avoided as a re sult of the re striction are likely undere stimated. The potential for cost impacts hinges on the e x te nt to which alte rnatives are able to re plicate the pe rformance of fluoropolymers with re spe ct to the speed and quality of production. Stak eholders have commented that fluoropolymers are e x pensive com pared to alte rnatives and he nce would not be used if the y did not conve y significant advantages for production or product pe rformance. The occurre nce of some functional losses is thus lik e ly. Produce r losses, e .g. as a re sult of costs associated with the ne e d to adapt e x isting e quipment, m ight occur but there is we ak e vidence on the e x tent to which e x isting syste ms using polymeric PFASs would ne ed to be adapted. Ban with 5 ye ars n/a n/a use- specif ic 12 ye ars n/a n/a derogation s Conclusion n/a n/a n/a n/a 187 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The conclusions of the DS expert team are based on evidence/knowledge from the: Literature; Information from the CfE; and The 2nd stakeholder consultation. There was sufficiently strong evidence that technically and economically feasible alternatives are available to replace the use of polymeric PFASs used as proc essing aids in the production of plastic film. The spec ific role of these additives in the plastic packaging market is to speed produc tion and enable manufacture of very thin films whilst maintaining a high quality of film. However, it is not clear to what extent the alternatives are able to fully replicate the performance of PFAS, for example with respect to the thickness of plastic films. Evidenc e is considered sufficiently strong that the socio-economic benefits in terms of avoided emissions from the use phase will be in the region of 96% for the food contact materials and packaging sector overall. Information at the sub-sector level is not available. A large share of PFAS used in the sub-sector will not be emitted during use, but will be passed through to the waste phase. Stakeholders maintain that PFAS are used although they are more expensive than alternatives because they produce a higher quality product and avoid wastage, leading to improved producer surplus. The implication is that this would be eroded through the use of alternatives. However, detailed comparative data on the performance of alternatives and PFAS has not been provided. Evidenc e on this point is thus c onsidered weak. 188 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.57. Other packaging applications - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of A lternatives derogation Environmental impact Cost impact Other aspects Full ban Not applicable The re is sufficiently strong e vidence of the availability of te chnically and e conomically fe asible alternatives for: Pack aging uses of f-HDPE (fluorinated high de nsity polyethylene) Use of PTFE wax on the outer surface of drink s cans Te m porary wrapping of ne w ve hicles for de live ry C onclusion: High substitution potential at EiF [sufficiently strong evidence] Base d on available e vidence which is considered to be sufficiently strong (i.e . based on ve rifiable tonnage e stim ates for PFAS and re asonable assumptions about e nvironmental re le ase), a full ban of PFAS use in food contact m ate rials and pack aging will contribute to re ducing e m issions (PFAAs and PFAA pre cursors, fluoropolymers and PFPEs) in comparison to the baseline. The e xpecte d emission re duction during the use phase for food contact m aterials e quals around 96% of baseline e m issions for a 30-year period (2025-2055). As the e nvironmental im pact assessment does not cover the waste phase, emissions under the baseline as well as e m issions avoided as a re sult of the re striction are likely unde restimated. C om parative cost data have not been ide ntified to pe rmit com parison of PFAS and n o n -PFAS alte rnatives. Ban with 5 ye ars n/a n/a use- specif ic 12 ye ars n/a n/a derogation s Conclusion n/a n/a n/a n/a 189 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The conclusions of the DS expert team are based on evidence/knowledge from the: Literature; Information from the CfE; and The 2nd stakeholder consultation. Limited information was available from these sourc es. However it was c oncluded that there was sufficiently strong evidence that technically and economically feasible alternatives are available to replac e the use of PFASs in a range of diverse pac kaging applic ations Evidenc e is considered sufficiently strong that the socio-economic benefits in terms of avoided emissions from the use phase will be in the region of 96% for the food contact materials and packaging sector overall. Information at the sub-sector level is not available. A large share of PFAS used in the sub-sector will not be emitted during use, but will be passed through to the waste phase. 190 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.4. Metal plating and manufacture of metal products Chrome plating, both functional and decorative, is the dominant application of PFAS in the plating market. PFAS are also used for plating substrates with other metals, such as nickel, copper and tin. However, only limited information is available on the use of fluorinated substances in metal plating processes, other than chrome plating. The subcategory of `metal products' is extremely broad. Fluoropolymers are used widely in the treatment of metal products used in construction, from roofing to door components, in various applications in transport, in the energy industries and so on. The following applications are dealt with explicitly elsewhere in this proposal: Coil coating of metals: Construction (E.2.13). Cover gases for use in magnesium casting: fluorinated gases (E.2.8). Oils and lubric ants: Lubric ants (E.2.14). During primary aluminium production tetrafluoromethane (CF 4) and hexafluoroethane (C2F6) are formed and released to the environment. This results from the reaction of the carbon anode with the fluorine from the c ryolite melt during a proc ess upset c ondition. The "anode effect" occurs when the concentration of alumina in the electrolyte is too low to support the standard reaction (Marks J., 2006). These releases are outside the scope of this restriction as they are not associated with the deliberate manufacture, use and placing on the market of PFAS. They are addressed through the Industrial Emissions Directive (2010/75/EU) and the BAT Reference (BREF) note on Non-Ferrous Metals Industries (JRC, 2017), which describes PFC emissions from the aluminium industry as being regulated to a benchmark performance under the EU's Emissions Trading Sc heme (ETS) for greenhouse gases. E.2.4.1. Baseline Information about market growth rates could not be retrieved. Therefore, for assessing the time path of PFAS use (tonnage) and emissions in metal plating a zero growth rate per year was assumed. Considering that economic growth in this sector is plausible in the medium and long-term, PFAS use and emission estimates may be largely underestimated. The start year of the projection of tonnage and emission estimates is 2020 as presented in Table E.58. Note that tonnage estimates includes both chrome plating and the manufacture of metal products. Emission estimates denote emissions from hard chrome plating only. Information about emissions was provided by industry (no reference available). For the manufac ture of metal produc ts emission estimates are lac king. Table E.58. Projected yearly PFAS use, emissions and waste in the metal plating sector of the EEA and use of PFAS for manufacture of metal products not covered elsewhere in this proposal between 2020 and 2070 in tonnes (mean values based on market data). 2020 2025 2030 2035 2040 2045 2050 2060 2070 PFAS use 990 990 990 990 990 990 990 990 990 PFAS emissions 6 6 6 6 6 6 6 6 6 PFAS to waste 984 984 984 984 984 984 984 984 984 191 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Emission estimates were provided by industry (i.e. not derived from use volumes using ERCs) and cover emissions from hard chrome plating only. Based on the assumptions set out in Table E.58 above, Figure E.6 shows PFAS use and emissions at sector level. Figure E.6. Expected PFAS use and emissions in EEA under the baseline in the metal plating sector (mean values) [tonnes]. E.2.4.2. Alternatives E.2.4.2.1. Metal Plating Technical feasibility Fluorine-free alternatives (substances as well as technologies) are available and already in use (Table E.59). Non-fluorinated surfactants seem feasible for func tional (hard) as well as dec orative c hrome plating (UNEP, 2019b). However, they are not c onsidered equally effective as fluorinated surfactants. Furthermore, additional risks connected to the use of nonfluorinated surfactants with respect to occupational safety, process stability and device preservation have been mentioned previously by the German electroplating industry association (UNEP, 2018a). Nevertheless, these substances have been used successfully in bright (decorative) chrome electrolytes (UBA, 2017). The use in functional chrome plating is also possible, but ac cording to the c urrent state of knowledge the substances should be used on a case-by-case basis. Furthermore, fluorine-free surfactants oxidatively decompose very rapidly in the proc ess solutions and Cr(III) c ompounds are formed. This impairs the functional efficiency of the process solution (UBA, 2017). Information on health and environmental hazards of the alternatives is presented in Table E.59, and summarized in the next sec tion. 192 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.59. Information on non-fluorinated alternatives for chrome plating. Key: F = Functional or `Hard' chrome plating, D = Decorative chrome plating, P= plastic etching. Sources: Blepp M. et al. (2017); Mller et al. (2020); UBA (2022); UNEP (2015b); UNEP (2018a); UNEP (2019b). A lte r na tiv e F D P Information on performance/feasibility Alkane sulfonates x x Disadvantages: not resistant to functional chrome plating; less effective in decorative chrome plating Amines, C 12-C 14 alkyl, ethoxylated (C AS-No. x x 61791-14-8) Oleo amine ethoxylates (e.g. mixtures with x x x (Z)-octadec-9-enylamine, ethoxylated C AS-No. 26635-93-8) 3-[dodecyl(dimethyl) ammonio]propan-1- x sulfonate (C AS-No. 14933-08-5) (mixture with 3-hydroxypropane-1-sulfonic acid (C AS-No. 15909-83-8) and amines, coco alkyldimethyl, N-oxides (C AS-No. 61788-90-7)) paraffin oils, sulfochlorinated, saponified (C AS - x x No. 68188-18-1) Isodecanol, ethoxylated (C AS-No. 61827-42-7) x C hromium (III) plating (x) x Advantages: Problems with colour deviations have been largely solved Disadvantages: potential for conversion of C r(III) to C r(VI) during plating process is unclear; potential contamination with other metals; potential formation of complexing agent Physical barriers e.g. mesh or blankets x x Advantage: high efficiency in removing chromium (VI) aerosols (>98%) (composite mesh pads) placed on top of bath Disadvantage: PTFE coated balls will not reduce chromium emission from the bath or add-on air pollution control devices (packed (on the contrary: increasing chromium emission compared to using no mist bed scrubbers) suppressant); not fluorine-free Add-on air pollution control devices, e.g. x x packed bed scrubbers Thermal spraying, e.g. HVOF (high velocity x x Advantages: process is globally available and is considered effective (high oxygen fuel) process deposition efficiency and good quality finish); extremely thin layers with high corrosion resistance, wear resistance and high dimensional accuracy Disadvantages: requiring high temperature application; partly complex preparation of components; geometric restrictions (only rotationally symmetric parts can be coated); interior machining not possible Physical vapour deposition (PVD) x (x) Advantages: high wear-resistance 193 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A lte r na tiv e F D P Information on performance/feasibility Disadvantages: limited areas of application because of application in vacuum chambers and therefore limitation to the size of the components and required relative hardness of the base materials; low corrosion resistance C ase hardening process, e.g. plasma x nitriding[1] In the field of automotive tools this process has already completely replaced functional chrome plating; closed system process. Laser metal deposition (LMD), Extreme high- x Advantages: no processing chemicals or solvents are used (only the applied metal speed LMD alloys); process is more economical than functional chrome plating; Depending on material composition a higher corrosion and wear resistance than for chrome plating can be achieved (e.g. for off-shore applications); possible applications in automotive industry and mechanical engineering Disadvantages: productivity, process stability and automation have to be further optimized Anhydrous ionic liquids based on C r(III) salts x Still in development C losed coating reactors x x Advantages: no surfactants (either fluorine-free or fluorinated) are necessary; limited aerosol emission to room air. Due to highly diversified chrome plating processes it is impossible to describe a universal closed loop process technology for all of the various uses and process combinations Nickel-based coatings x Disadvantages: possible nickel emission from the surface (not suitable for food and pharmaceutical industries) Sulfonation of plastics with sulfur trioxide in x Advantages: e.g. in terms of flexibility, energy costs or wastewater treatment the gas phase Acidic permanganate solutions, nitric acid and x Disadvantages: problems with wastewater treatment due to organohalogen trichloroacetic acid mixtures. compounds; problems when searching for suitable rack insulation; risk of formation of nitrous gases during the use of nitric acid; and problems with the formation of manganese dioxide and fire safety issues when using permanganate solutions 1 Salt bath nitriding and nitroc arburising are other c ase hardening proc esses as tec hnical alternatives for func tional c hrome plating (Mller et al. 2020) Because of a high risk for the professional user (i.e. physical hazards, use of acute toxic substances, use in open systems), these alternatives are not considered further. 194 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluorine-free wetting agents c ontain higher c oncentrations of active substances (fluorine-free 1 - 50%; 6:2 FTS 1 - 10%). Reasons for this are, for example: Higher dosage of the alternatives is needed to achieve comparable surfac e tensions Higher c onsumption of the alternatives occurs because of oxidation. In c ontrast to fluorinated products the fluorine-free products often have to be diluted before adding and have to be applied more often throughout the day. Despite the need for higher dosage for these reasons, fluorine-free wetting agents are expected to have a lower impact on the aquatic environment than PFAS, due to rapid oxidation and biodegradation (UBA, 2022). From a technical perspective there is no single solution for all cases. For some industrial applications closed reactors, which are used without surfactants, will be an option whereas others will have to switch to non-fluorinated wetting agents or mist suppressants. Some surface treatments will have to even switch to a completely different process such as laser metal deposition or plasma processes. This all requires further intensive research and development work, but approaches show that PFAS-free alternatives will be available for all applic ations whic h today require the use of PFAS. One stakeholder reported that he is a developer of a hard-chrome Cr(III) plating processes. He reports that they assume that a wetting agent is also needed for Cr(III) based hard chrome plating. They are currently evaluating whether non-fluorinated wetting agents are technically feasible and have partial success with it, but have not found a 100% working alternative yet. The following conclusions were reached on the availability of alternatives for chrome plating in the summary report for the sector: Hard Chrome Plating: within 5 years (medium uncertainty). Users will face very varying c osts, mainly depending on c haracteristics of the c urrent ma nufacturing sites (high uncertainty); Decorative plating: Regarding Cr(VI) the shift to Cr(III) is affordable (certain). For some applications the switch to Cr(III) is uncertain. Costs and availability of other alternatives are not clear (high uncertainty). Plastic Electroplating: Regarding Cr(VI) there is an ongoing substitution process to Cr(III) whic h suggests affordability. Human health and environmental hazards of alternatives For the chemical alternatives relevant for this use sector, information on c lassification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) were assessed. Additionally, it is assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. Non-chemical alternatives are also listed in the table. In relation to metal plating and manufacture of metal products, 4 of the alternatives were non-chemical in nature. The list of alternatives contained seven unique CAS numbers. All of the substances with unique CAS were classified according CLP (harmonised classification or self-classification). Three of the substances with unique CAS number did, according to their registration dossier, not fulfil the PBT or vPvB criteria and for the remaining substances no data was found or PBT/vPvB properties were not applicable, meaning that none of these substances were known to fulfil the PBT or vPvB criteria. No other hazard properties were mentioned. The list contained an additional four substances with unique substance names for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. Appendix E.2. contains a table presenting this 195 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) information along with further data on alternatives for the various uses assessed in this dossier. E.2.4.2.2. Manufacture of metal products This sub-sector includes a wide range of met al products from mechanical components for vehicles and other machinery to construction materials. It is therefore to be expected that there will be significant variation within the sub-sector with respect to the availability of alternatives. It is noted that a key property of PFAS listed in Table E.59 for several applications was c ontrol of surface tension during produc tion. To the extent that this is also key property for PFAS used in plating processes (Table E.58) it may be anticipated that alternatives are similarly available. However, there are other applic ations where other properties of PFAS are important, for example durability, resistance to chemical attack, thermal properties and sealing properties. Stakeholders did not identify alternatives that fulfil the performance of fluoropolymers e.g. for chemical and temperature resistance. Alternatives such as polyester and silicone-modified polyester are available at a lower cost point and are already used in c oatings. Galvanization and anodization are effective and cost efficient alternatives for some applications. Based on literature review and feedback from stakeholders, however, it has not been possible to develop a c omprehensive overview of the availability of alternatives for the subsector of manufac ture of metal produc ts. E.2.4.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.2.3, assuming business-as-usual and, thus, on-going PFAS use and emissions. The analysis of environmental impac ts focuses on two restriction options: RO1, adopting a ban of all PFAS used in the metal plating sector; RO2, adopting a ban on PFAS in combinat ion with use-specific derogations. The potential derogation is marked for consideration for a 5-year period. Environmental impacts of RO1 are analysed quantitatively. In contrast, for the potential usespecific derogation emission data were lacking. There is information about the PFAS c omposition of emissions (mainly PFAA precursors). Therefore, environmental impac ts of RO2 are evaluated qualitatively in relation to a maximum additional emission scenario, i.e. a full derogation of the relevant PFAS group. Note that this maximum additional emission scenario does not represent a restriction option but is used for comparative purposes only. Table E.60 summarizes the characteristics of the restriction options in the metal plating sector, and the maximum additional emission scenarios. Table E.60. Characteristics of restriction options and maximum additional emission scenario. Restriction option a bbr e v ia tio n Short description Derogations Transition period after entry into force Duration of derogation RO1 Full ban --- 18 months --- Potential derogation of PFAS use in hard chrome RO2 Ban with use-specific derogation plating (mainly PFAA precursors, further 18 months 5 years possible PFAS: PFSA, PFPiAs see also Annex A) Maximum additional emission scenario Ban with full derogation of entire PFAS groups PFAAs (incl. side-chain polymers) 18 months 5 years 196 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) For calculating the expected emission reduction of RO1 the assumed entry into force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. Environmental impacts are expressed in relation to the baseline scenario discussed in section E.2.4.1. All emission estimates represent mean values. Table E.61 shows emissions and the expected emission reduction for time paths of 30 and 45 years (starting in 2025). Table E.61. Total mean emissions and emission reduction of RO-1 and maximum additional emission scenario (metal plating sector, in tonnes). Restriction option Mean total emissions [t] Baseline RO1 Maximum additional emission scenario `5-year derogation of all PFAAs incl. PFAA precursors'* Baseline RO1 Maximum additional emission scenario `5-year derogation of all PFAAs incl. PFAA precursors'* 2025-2055 183 12 41 2025-2070 271 12 41 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 171 94 142 77 --- --- 260 96 230 95 *Maximum additional emission scenarios assuming a full derogation of a particular PFAS group against which emissions of proposed use-specific derogations are evaluated qualitatively. They do not represent restriction options. The expected emission reduction is highest under RO1 (full ban of all PFAS after the transition period). RO1 achieves a total PFAS emission reduction of about 94% of baseline emissions. Moreover, RO1 is the only option leading to a full stop of emissions (arising during the use phase) after the 18-month transition period. Environmental impacts of RO2 are discussed qualitatively below. Potential derogation marked for consideration: Hard chrome plating The derogation is marked for consideration for a duration of until 5 years after EIF and covers mainly PFAA precursors, and further possible PFAS such as PFSA and PFPiAs. Since PFAAs used in the metal plating sector are predominantly used for hard chrome plating and considering the available weak evidence on emissions from hard chrome plating, expected additional emissions resulting from the derogation can be expected to be very close or even equivalent to emissions of the maximum additional emission scenario assuming a derogation (see Table E.61). The derogation can, therefore, be expected to reduce the effectiveness of the restriction to about 77%. There is no evidence available with regard to emissions from the manufacture of metal products. Hence, no indication about the fraction of additional emissions under RO2 in comparison to total emissions at sector level can be provided. Figure E.7, shows the time path of mean emissions (present values) for the baseline, RO1 and the relevant maximum additional emission scenario. 197 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.7. Time path of mean emissions under the baseline, RO1, and the maximum additional emission scenario (metal plating sector, in tonnes). E.2.4.4. Economic and other impacts E.2.4.4.1. Metal plating sector Economic impacts on industry Size of the sector Variable estimates have been identified for the size of the plating sector. As of 30/06/2022, ECHA reports that there are 1 724 total authorised uses for Cr(III), including 102 uses for which companies hold their own authorisation and 1 622 notified downstream uses. This includes companies of varying sizes, from small specialist platers to major manufacturers. According to the German central association for surface technology (Zentralverband Oberflchentechnik e.V. - ZVO), about 200 companies are working in the sector of functional chrome plating, about 800 in the sector of decorative chrome plating and about 30 in the sec tor of plastic products chrome plating in Germany alone (evaluation from 2018/2019 (UBA, 2022). Extrapolating the number of German companies to the EU, gives around 5 000 companies (extrapolation based on either population or GDP giving broadly similar figures). Boog and Kwaak (2016) indicated an average of 17 workers per plant in the Cr(VI) sector. Applying this to the 5 000 companies just estimated implies a total of 85 000 workers in the sector in the EU. Boog and Kwaak (2016) estimated a much higher number of companies (12 600) and workers (214 000) for Cr(VI) applicators in the EU. Figures increased to 42 000 companies and 736 000 workers when clients of the applicators w ere included. The European automotive c hromium finishing market was estimated to be worth more than USD 1 billion in 2020 (Graphical Research, 2021), with growth in the period 2021 to 2027 estimated at 2.9% annually. No information has been identified for the size of the chrome plating market for kitchens and bathrooms, expected to be another significant part of t he market, or for sectors with smaller demand for chrome plating. Similarly, no information has been identified regarding the size of the market for plating with metals other than chromium. Boog and Kwaak (2016) indicates a much higher level of economic activity in the EU than identified by Graphical Research with annual turnover of 153 billion and value added of 47 198 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) billion. It is to be noted that the data from ECHA, above, are for authorised Cr(III) users as of 2022, rather than Cr(VI) in 2013 as considered by Boog and Kwaak (2016), but the disparity between the two sets of data for c hrome plating is extreme. Uptake of alternatives given other regulatory drivers For metal plating processes mainly C6 PFAS are used. There is little information available on the use of other PFAS for metal plating. Several C6 PFAS (e.g. 6:2 FTS) are already in the scope of the PFHxA restriction proposal and it is most likely that no other PFAS alternatives are available. Therefore, substitution will take place when the restriction on PFHxA and related substances enters into force within the next years and in that case no further economic impacts are expected to result from the PFAS restriction. It is concluded that no additional transitional periods are needed for decorative chrome plating and plastic electroplating as alternatives are available. For hard chrome plating a longer transitional period seems necessary to limit risks to business and high economic costs. Cost data Despite the efforts taken to engage with stakeholders only limited and fragmentary data on c osts has been obt ained. According to stakeholders the alternatives to PFAS are more expensive. Viewed as an individual process, costs may increase by several orders of magnitude. In relation to the manufactured product, cost increases in the low double-digit percentage range are to be expec ted. It is unc ertain how c ustomers reac t to pric e inc reases. However, given the requirement for Authorisation for Cr(VI) use, and the potential impact of the PFHxA dossier, it is possible that the present proposed restriction would have no additional impac t if introduc ed on the same timesc ale as the PFHxA dossier. On this basis the restriction would have no consequences for either businesses or consumers. This seemed to be confirmed by one stakeholder who commented that the ban on the use of Cr(VI) compounds by REACH forces his company to change the affected processes in the next few years. The stakeholder is working on replacing the pre-treatment process for plating on plastics. Then no Cr(VI) and consequently no PFAS is needed: this implies zero cost to the business concerned of the PFAS restriction. It is not, however, clear that this is the case for all plating operations, given limited data for specialist platers, and for plating with metals other than c hromium. Information from industry (Hauzenberger I., 2016) suggests that `the costs of phasing-in alternatives varies per company. Tests with alternative products may cost a company 50 000 to 150 000 per test and a test cycle has a minimum length of at least 1 year. However, the representatives indicate that the costs are mainly related to the costs of phasing in the alternative in practice and not in the costs of testing. Most relevant for the cost is whether the alternative is a drop-in alternative or that new installations (tanks, baths, etc.) are required'. If an alternative is used where the goods to be plated have to be dipped into the surfac tant liquid, an additional bath has to be installed at the produc tion facility. This means additional costs for the procurement of equipment as well as costs related to a reorganization of the production facilities for some companies. For decorative plating a shift to other elec trolytes that are Cr(III), rather than Cr(VI) based is an available alternative. This would mean that the demand on surfactants and process fluids is considerably lower, and that PFAS are not required. The Norwegian association of electroplaters (NGLF) has estimated the cost of replacing Cr(VI) in plating baths with Cr(III) to be approximately NKR 100 000 (10 000) per bath (UNEP, 2013). In the event that this change was made in response to the PFHxA restric tion there is no c ost attributable to the UPFAS restriction. The c ost estimate from the Norwegian association of electroplaters suggests that substitution of Cr(VI) with Cr(III) is 199 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) affordable. Substitution costs mainly consist of one-time replacement costs that amount to less than 1 000/y (750-800/y/bath). It is not possible to estimate overall costs given a lack of data on the numbe r/size of chrome baths in EU/EEC, variance/distribution of size of manufacturing sites, uncertainty on the impact of earlier legislation and so on. It is not possible to define a `typical' enterprise in the sector given that the chrome/metal plating indust ry is characterized by heterogeneity and a large share of small and medium enterprises. Large production facilities might use c onsiderably more than 100 baths of different sizes. Small and medium enterprises might use single to double digit number of baths. A study by the Danish Ministry of Environment from 2011 focussing on PFOS "suggests that the price of the PFOS products used as mist suppressant for non-decorative hard chrome plating is around DKK 100 to 200 (13 to 27) per kg/L. The price is dependent on the concentration of PFOS in the chemical. [... ] The price [of alternatives] is not fully comparable as no information was received on the amounts to be used compared to a PFOS product. [...] Other information about the price of the non-PFOS alternatives was sparse. One supplier informed that their non-PFOS alternative is more expensive than PFOS (but not how much more expensive)" (UNEP, 2013). The consultation process for the present dossier did not obtain further data on this issue. In contrast to fluorinated products, t he fluorine-free products often have to be added diluted and in smaller dosages throughout the day. To ac hieve c omparable surface tensions, higher amounts of wetting agents are necessary (UBA, 2022). Therefore, it is possible that produc tion proc esses need to be c hanged whic h may entail additional equipment and labour c ost s. The potential for recouping losses from premature retirement of assets seems negligible, given the nature of the changes involved - i.e. there is no major asset to be disposed of, and if there was, it would be spec ific to the c hromium plating industry. It is likely that there would be recertification costs for substitution relating to production of some components, for example for the aviation industry. However, the extent of the need for recertification is unknown and will vary widely across the different products of the plating sec tor. Overall, available information suggests general affordability, though it is possible that some manufac turing sites would fac e difficulties with regard to substitution. T imelines The association of the German plastic electroplating companies (FGK Fachverband galvanisierte Kunststoffe e.V.) reports that members "plan the partly extensive modifications of the plating lines and to schedule them. This will take some years to complete depending on the company and the individual complexity and size of the machinery, but will be completed until 2024". The restriction proposed here would not come into effect until after 2024, taking account of the time required for it to pass through the REACH Committees and European Commission, and a minimum 18 month transition period. Answers provided by respondents to the stakeholder consultation for the proposed PFAS restriction were contradictory, with several citing substantially higher losses for introduction of a ban after 10 years than after 3 years (the same has been observed in responses in some other sectors also). This position is not accepted here, given that the 10 year period provides a much longer time horizon for development of alternatives. The Boog and Kwaak (2016) report provided more coherent information on the impacts of authorisation for Cr(VI) plating operations over different timescales. An immediate ban at the time that their report was written was estimated to lead to a 60% reduction in turnover, 200 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) employment, etc . in the industry in the Netherlands. A ban after 4 years was estimated likely to lead to a 40% reduction, whilst a ban after 7 years was estimated as likely to lead to a 9% reduc tion. Results therefore indic ate a signific ant decline in c osts for longer transition periods for the plating sector. It is to be remembered that the Boog and Kwaak (2016) report addressed the situation leading up to 2016: legislation since then on Cr(VI) and use of PFHxA will cause some limiting of the specific impact of the proposed restriction on the sector. Several stakeholders commented that approval by downstream users in some sectors is required and therefore extended transition periods are needed. Sometimes this approval is c onnected to industry and/or legal standards. No details are available but stakeholders c laim that industry specific approval times can take months to several years (automotive, aviation, defence, food, medical equipment etc.). The extent of the need for recertification and assoc iated c osts is unknown. The restriction would not affect demand for chrome plating as such, and where alternatives are available it is anticipated that few companies would stop operating. However, some industry stakeholders c onsidered that a restric tion could have signific ant impac ts, specifically in the areas of hard c hrome and blac k c hrome plating, one c laiming that it c ould lose 90% of its staff in the event of a restriction on a timeline of 3 years, with a large loss of turnover. Some others considered risks to business to be present, but of a much lower level, a few percent of turnover. Risks were dependent on the specific activities being carried out by c ompanies. Also, those with a diverse portfolio of produc ts and activities were naturally likely to be less affected overall as they had other work to fall bac k on. Table E.62 summarises the information collected for the chrome plating sector. No information is presented for plating with other metals. 201 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.62. Conclusions on total economic impacts on directly affected companies resulting from a PFAS restriction on the chrome plating sector. Decorative chrome plating Hard chrome plating NUMBER OF AFFECTED COMPANIES Number of companies 5 000 - 12 600 estimated to be active in the sector Share of companies affected by Low High the restriction due to using PF A S MOST LIKELY REACTION OF AFFECTED COMPANIES Most Based on Substitution Some substitution, some likely information on business closure. reaction impacts at company level from 2ndstakeholder consultation Based on Substitution Dependent on transition period information on but with potential for business technical closure feasibility of a lte r na tiv e s Conclusion: Expected share of Negligible Low, but dependent on business closures transition period COSTS AT COMPANY LEVEL Business Sales value per Likely negligible given Sales losses are deemed to closure: company availability of alternatives range from nothing to a few Cost per million EUR per company company Producer surplus Low given availability of Variable: response ranged active in losses alternatives from low impact to accounting the sector for 90% of turnover. Costs for C losure not considered likely Unknown dismantling plants Substituti Research & Undertaken in relation to other Significant given difficulties on: Cost Development legislation (C r(VI), PFHxA) experienced so far in per (R&D) costs identifying satisfactory company alternatives active in Capital costs As above Unknown the sector Operating costs As above Unknown Certification costs As above Unknown Total cost As above Likely significant ABILITY TO PASS ON COSTS TO CUSTOMERS Expected extent to which Variable depending on end-product and position of plater in the companies can pass on costs to supply chain customers TOTAL ECONOMIC IMPACTS ON AFFECTED COMPANIES AT SECTOR LEVEL Conclusions Total producer Low, given impacts of other Potentially high if short on total surplus loss: legislation and availability of transition period is adopted economic Company alternatives impacts on closures affected Total producer Low, given impacts of other Potentially high if a short companies surplus loss: legislation and availability of transition period is adopted in the sector alternatives 202 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Economic impacts on consumers Fluorine-free substances/products are not considered equally effective to fluorinated surfac tants. Furthermore, additional risks with respec t to safety, process stability and device preservation are mentioned by the German electroplating industry association (UNEP, 2018a). Nevertheless, these substances have been used successfully in bright (decorative) chrome elec trolytes (UBA, 2017), indic ating that in some areas there is no loss in quality. The use in hard chrome plating is also possible but still under development. To the extent that PFAS are being phased out of the industry because of other regulatory ac tion (Cr(VI) authorisation, PFHxA restriction), any impac ts on consumers are a consequence of other legislation and are not relevant here. No information has been gathered relevant to the impact on consumers of metal products where production currently involves use of PFAS (other than for plating operations). Other impacts on society One stakeholder reported that outside Europe the use of Cr(VI) will continue and there for there will be an unequal playing field. According to this stakeholder some Dutch companies already are moving their production to other countries, such as India. There are, however, many reasons why a company may choose to relocate operations, not least the differences in labour costs. No further information is available in this regard. But the Dossier Submitters assume that if there is an ongoing relocation of production facilities linked to increased regulation, it is mainly caused by the authorization requirement for Cr(VI) and not by antic ipated future regulation of PFAS in mist suppressants. Several respondents to the CfE considered job losses likely if a restriction was introduced within 3 years. It is not possible to make an accurate estimate of the impact given limited response in the CfE and the 2nd stakeholder consultation and the wide variation in the estimated numbers working in the sector (85 000 to 736 000 with clients of plating applicators included). Following from the conclusions of Boog and Kwaak (2016) in relation to authorisation requirements for Cr(VI), the implementation of a transition period of a few years could lead to a marked reduction in risk of business closure and risks to employment. The longer that period, the lower the risk. E.2.4.4.2. Manufacture of metal products As noted above, the sector `manufacture of metal products' is extremely diverse, covering many activities including engineering, transport by all modes and industrial processing equipment. It is therefore not possible to provide a clear indication of the overall size of the sector beyond saying that it is broad and restriction has potential to affect many parts of the economy. Some specific applications are dealt wit h in other sections of this annex, for example, under E.2.13. Additional regulatory drivers ranging from building standards to energy efficiency and safety, for example in the aerospace industry will affect both the availability of alternatives and the speed with which they can be introduced, noting, for example, the need for recertification in some areas. Again, given the broad scope of the sector, detailed review is not possible. Data on costs for the sector was not obtained f rom the literature review, the CfE or the second stakeholder consultation at a scale that would permit provision of estimates giving an adequate overview of the impac t of a restric tion. The complexity of the sector also prevents detailed consideration of t he impacts of a restric tion on c onsumers. Impac ts in some areas will be small or non-existent, whilst in others the loss of func tionality of metal produc ts c ould be signific ant. Likewise, the potential for the c losure of businesses and subsequent impac ts on unemployment. 203 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.4.5. Summary of cost and benefit assessment E.2.4.5.1. Hard chrome plating Table E.63 summarises the outcomes of the assessment of costs and benefits for hard chrome plating. More detailed information can be found in the accompany ing text following the table. 204 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.63. Hard chrome plating - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of derogation A lte r na tiv e s Environmental impact Cost impact Other aspects Full ban Not applicable Evidence on the availability of alternatives for the hard chrome plating sector is mixed, with some reporting satisfactory performance of alternatives and others not. Responses to the C fE and 2nd stakeholder consultation from industry are concluded to reflect the precise specifications of product lines provided by different companies, and these specifications causing some to be more advanced in transition than others. High substitution potential at EiF for the sector as a whole [sufficiently strong evidence] but low substitution potential at EiF in relation to some goods [weak evidence]. There is weak evidence provided by industry about emissions from hard chrome plating. No evidence is available about emissions from the manufacture of metal products. Based on available evidence about emissions from hard chrome plating, a ban can be expected to reduce emissions by about 94%. As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. High producer surplus losses due to a significant share of business closures [weak evidence]. Some producer surplus losses as a result of substitution, due to additional expenditure on R&D and additional capital costs [sufficiently strong evidence]. High socio-economic costs to customers [weak evidence] due to the unavailability of, or reduced quality of, hard chrome plating, though this may be negated by import of plated goods from outside of the EU where the restriction would not apply [weak evidence]. High employment losses as a result of significant share of business closures [weak evidence]. Ban with use-specific derogations 5 years Alternatives still being sought for example for hard- and black-chrome plating though there has been some success, indicating that a derogation beyond the 18-month transition period may be beneficial for the industry C onsidering the available weak evidence on emissions arising from hard chrome plating, additional emissions resulting from the derogation can be expected to be very close or even equivalent to A 5-year derogation would permit a longer period for R&D and would reduce costs for producers whilst maintaining production rates and quality. This would also limit potential impacts on It is considered that the use of PFAS in the sector will shortly be legislated against through 205 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s [sufficiently strong evidence]. Environmental impact Cost impact Other aspects emissions of the maximum additional emission scenario (41 t). This reduces the effectiveness of the restriction for the metal plating sector to about 77%. As the environmental impact assessment does not cover the waste phase, additional emissions as a result of the derogation are likely underestimated. consumers and the risk of job losses. [sufficiently strong evidence] the PFHxA dossier. On this basis the proposed restriction would have no cost impact for the sector if conditions were similar to those of the PFHxA restriction [sufficiently strong evidence]. C onclusion 12 years n/a n/a n/a n/a It is concluded that there is evidence of problems for industry to substitute in the hard chrome sub -sector requiring further R&D for some manufacturers. It is unclear whether this is linke d to specific product lines and associated technical parameters or other factors specific to individual companies. A derogation might be proposed at a later stage if additional information on alternatives b ecomes available. Given the REAC H C ommittees conclusions on the PFHxA dossier it is concluded that there would be no additional economic impact of the proposed restriction if similar conditions on timing for the sub -sector apply. Still, a 5-year derogation in addition to the 18-month transition period for hard chrome plating coincides with significant additional emissions of PFAAs. 206 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The views of the Dossier Submitters are based on evidence from the CfE, 2nd Stakeholder Consultation, literature and the precedence provided by the PFHxA restric tion. It is co nsidered unlikely that the sample of businesses that responded to the CfE and 2nd stakeholder consultation are truly representative of the sector, given a greater tendency for those with concerns about potential regulation being more likely to respond than those that would be less affected or not affected at all. It is concluded that the evidence is weak that technically feasible and economically feasible alternatives are available in the quantities required for use in hard/func tional c hrome plating where a number of consultees cited difficulty in transitioning away from the use of PFAS. This is recognised in the conclusions reached previously for a restriction on the use of PFHxA, where a time-limited derogation is proposed for hard chrome plating. This is highly relevant to the current proposal as the PFAS identified as being used for hard chrome plating at present are all covered already under the PFHxA proposal. However, it is also recognised that some operators have introduced alternatives already. On this basis it is concluded that the evidence is weak that it is tec hnically and ec onomic ally infeasible to introduc e alternatives ac ross the hard chrome plating sector under RO1 (restriction after an 18-month transition period after Entry into Force). If a derogation is to be investigated, it would be appropriate to consider the timelines of the PFHxA restriction. Evidence on emissions is weak and focused on hard chrome plating. No data were found to enable quantification of emissions from manufacture of metal products. It is concluded that there is sufficiently strong evidence for producer losses via added R&D c osts through the need to c arry out further research on alternatives on a short timesc ale for RO1. There are also potentially added capital costs for t he same reason. Some respondents to the CfE and 2nd stakeholder consultation considered that there was a significant risk of business closures that would lead to high producer surplus loss and associated job losses. This is acknowledged as a risk, but evidence on the scale of losses is considered weak, given the progress made by some bard chrome platers it is concluded that the evidence is given variation in progress across the sector. The Dossier Submitters acknowledge that there is potential for impac ts on c onsumers from a restric tion that affects hard c hrome plating, given that a number of businesses working in the sector have expressed difficulty in identifying alternatives that provide satisfactory performance. E.2.4.5.2. Decorative chrome plating, plating on plastic and plating with other metals Table E.64 summarises the outcomes of the assessment of costs and benefits for metal plating. More detailed information can be found in the accompanying text following the table. 207 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.64. Decorative chrome plating, plating on plastic and plating with other metals - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of Alternatives derogation Environmental impact Cost impact Other aspects Full ban Not applicable Technically feasible alternatives exist for decorative and plastic chrome plating and are already in commercial use [sufficiently strong evidence]. No information obtained on plating with other metals though there is some similarity with decorative plating in the mechanism of PFAS action via controls on surface tension. It is therefore concluded that alternatives exist for plating with other metals [weak evidence].. No evidence is available about emissions from the manufacture of metal products. Based on available evidence about emissions from hard chrome plating, a ban can be expected to reduce emissions by about 94%. As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated C ost impacts for industry and consumers for the decorative chrome plating and plastics plating sectors are concluded to be negligible given the availability and take-up of alternatives that has already occurred. On this basis, it is not expected that there would be job losses in the sector linked to RO1. It is also concluded that there are no functional losses associated with this substitution [sufficiently strong evidence]. The situation for plating with other metals (primarily nickel, copper and tin) is less clear given a lack of information beyond the observation that the role of PFASs appears to be similar to decorative chrome plating for these metals. On this basis, it is expected that there will be negligible cost impacts for industry and consumers and negligible job losses [weak evidence]. Ban with 5 years n/a use-specific derogations n/a n/a 12 years n/a n/a n/a n/a C onclusion It is concluded that no derogation is required for decorative and plastic chrome plating. No information on plating with othe r metals was reported during the consultation process or identified in literature review, a nd so the position adopted is that no information is available to justify a derogation. 208 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The views of the Dossier Submitters are based on evidence from the CfE, 2nd Stakeholder Consultation and the literature. It is concluded that the evidence is strong that technically feasible and economically feasible alternatives are available in the quantities required for use in decorative chrome plating and plastic electroplating and that the substitution potential is high under RO1 (no derogation but an 18-month transition period after Entry into Force). It is also concluded that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available in the quantities required for use in plating with other metals (nickel, copper, tin). The logic for this conclusion is that the required properties of PFAS for these activities appear similar to those for decorative chrome plating (control of surface tension), although available literature is limited and no substantive information was obtained from the CfE and 2nd stakeholder consultation. Following from the c onc lusion reached for decorative chrome plating it is concluded that the substitution potential is high under RO1 (no derogation but an 18-month transition period after Entry into Force). No evidence was identified to permit quantification of emissions from the sub -sectors dec orative c hrome plating, plating on plastic and plating with other metals. Given the availability of alternatives for decorative c hrome plating and plating on plastic, the Dossier Submitters c onsider that there is suffic iently strong evidence that ec onomic impacts of RO1 for the sector would be negligible. The Dossier Submitters also consider that economic effects on the part of the sector that deals with plating with other metals is also negligible, but evidenc e for this is weak. E.2.4.5.3. Manufacture of metal products Table E.65 summarises the outcomes of the assessment of costs manufacture of metal products. More detailed information can be found in the accompanying text following the table. 209 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.65. Manufacture of metal products - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restrictio Duration of Alternatives n option derogation E nv ir o nme nta l impact Cost impact Other aspects Metal plating Full ban Not applicable It is not possible to provide a breakdown of areas where alternatives are available for the sector as a whole given the diversity of metal products that are likely to be affected. However, given similarity in the function of PFAS for a number of products it is anticipated that alternatives will be available for at least some applications immediately [weak evidence] No data were obtained on emissions related to manufacture of metal products and their use, beyond information presented for other sectors. PFAS use is estimated at 960 t/y for the EU. [no evidence] No evidence was obtained to demonstrate that RO1 would be problematic for the manufacture of metal products other than those addressed specifically under other sectors (e.g. transport and construction products]. There is overlap with other sectors covered in this restriction, for example transport and construction. Precedence should be given to conclusions reached on specific metal products from those other sectors where available, rather than the generalised conclusions provided here. Ban with 5 years n/a n/a use- specific 12 years n/a n/a derogation s C onclusion Whilst some manufacturers of metal products are likely to be able to eliminate use of PFAS on a short time scale, it is not c lear that this would apply in all areas, for example in the production of vehicles and other machinery, where sig nificant additional research could be required, perhaps involving redesign of components. However, those uses are addressed elsewhere (transportation). Any risks would clearly be at least partially mitigated by allowing an additional derogation period. How ever, given limited feedback from stakeholders the need for and benefits of a derogation are unclear, so no derogation is proposed. 210 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Very limited information was identified through literature review with respect to the use of PFAS in the manufacture of metal products. Information from the CfE and 2nd Stakeholder Consultation in this area addressed uses linked to other sectors described in this proposal (eg. construction and transportation) and so is not repeated here. It is concluded by reference to the plating sector that there is some (albeit weak) evidence that technically and economically feasible alternatives are available in the quantities required for use in the manufacture of metal products not covered elsewhere in this proposal and hence it is not possible to conclude that the substitution potential under RO1 would be problematic. No evidenc e was provided or identified on c osts or emissions. 211 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.5. Consumer mixtures (and musical instruments) E.2.5.1. Baseline For consumer mixtures information about market growth rates could not be retrieved. Therefore, a growth rate of 0% was applied in the assessment of the time path of PFAS use (tonnage) and emissions. No further information on historic tonnages and future (expected) tonnages is available. In the 2nd stakeholder consultation (during the preparation of this dossier) one company indicated that they were planning to phase out the use of PFAS from c leaning agents, polishes and waxes by 2025. Another c ompany stated that the use of PFAS in c leaning agents, polishes and waxes will remain c onstant, and a third c ompany estimated that the use of PFAS in cleaning agents will decrease but use in waxes will increase. No generalised trends c ould be derived from this information (see Table E.66). The start year of the projection is 2020. Table E.66. Projected yearly PFAS use and emissions in the consumer mixtures sector of the EEA between 2020 and 2070 in tonnes (mean values based on market data) . PFAS use PFAS emissions 2020 1.2 1.2 2025 1.2 1.2 2030 1.2 1.2 2035 1.2 1.2 2040 1.2 1.2 2045 1.2 1.2 2050 1.2 1.2 2060 1.2 1.2 2070 1.2 1.2 The assessment of environmental impacts under the baseline and the restriction scenarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). It is assumed that PFAS use, consisting predominantly of non-polymeric PFAS, leads to an equivalent amount of emissions. Information about lower and higher bounds of use and emission estimates at sector level, or for specific PFAS applications, are not available. A graphic al illustration of use and emission trends is therefore not possible. E.2.5.2. Alternatives E.2.5.2.1. Technical feasibility Cleaners It is not clear whether the drastic reduction of static surface tension which can be achieved by using PFAS is really necessary for consumer c leaning products or whether other surfactants (e.g. hydrocarbon or silicone based surfactants) could also be employed. For example, the surface energy of metal and glass is rather large; therefore, PFAS are not really necessary for use as a surfactant to achieve a drastic reduction in surface tension of the formulation. For example, the most recognised glass cleaner brand in the USA apparently does not use PFAS in their glass c leaners but claims to leave the treated surface streak free (S. C. Johnson & Son, 2020). Jensen et al. (2008) also states that fluorinated products do not seem to be used in ordinary glass cleaners. It is not known whether alternative substances can match the repellence for water and re-soiling of the PFAS-containing metal and ceramic cleaners. Furthermore, extremely low surface tensions can also be achieved by siloxane Gemini surfactants that achieve a surface tension of 21 mN/m (stakeholder information). For carpet spot cleaners, caprylyl/myristyl glucoside (CAS 68515-73-1 and CAS 110615-47-9) has been used as alternative for PFAS (ECOS, 2021; Glge et al., 2022). Alternatives for PFAScontaining surfactants in laundry detergents are e.g. C12-C16 pareth-7, potassium cocoate, dec yl gluc oside (Ec over, 2021a; Glge et al., 2022). 212 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Waxes Regarding PFAS in waxes, a document of the Stockholm Convention (UNEP, 2012) describes that softer waxes (which are more or entirely biodegradable) may eliminate the need for fluorinated compounds. Instead, non-ionic or anionic surfactants can be used, which have good wetting properties. Floor polishes Alternatives to the use of fluorinated components in floor polishes are available in principle. One patent claims to have developed a non-fluorinated water-based floor wax, which maintains the same gloss and similar or even better levelling properties compared to C8-PFAS (Wang, 2008). Fluorinated wetting agents were replaced by silicone, alkynediol-based hydroc arbons, oleoalkylene oxide block c opolymer wetting agents and others. Another patent (CN101293999) describes the use of a fluorine wetting agent (Glge et al., 2022; Wang, 2008). It was also found that products are on the market that are based on Gemini struc tures using the substance (poly(oxy-1,2-ethanediyl),,-[1,4-dimethyl-1,4-bis(3-methylbutyl)-2butyne-1,4-diyl]bis[-hydroxy-S3,(9CI,ACI)) (CAS 169117-72-0) which is advertised as a cost-effective alternative to traditional fluorosurfactants with even better performance (Air Products, 2014; Glge et al., 2022). Aftermarket carpet care Alternatives to PFAS employed in aftermarket carpet care to achieve stain and dirt resistance exist and are on the market. One c hemic al alternative for fabric protectors in general is based on silicon dioxide (Start Bio-Solutions, 2020; Washington State Department of Ecology, 2020). Another alternative is the use of proprietary anionic non-fluorinated polymers in the cleaning products (Bridgepoint Systems, 2020; Washington State Department of Ecology, 2020). Finally, the use of inherently stain-resistant fibres like wool, polypropylene, polyethyleneterephthalate, and polytrimethyleneterephthalate (Washington State Department of Ecology, 2020) is feasible. Dry c leaning produc ts for metals, glass, c eramic s etc. No information available. Dishwashing products/rinse aid For dishwashing produc ts alternatives exist, for example sodium lauryl sulfate (CAS 151-213) and lauryl glucoside (CAS 27836-64-2) (Glge et al., 2022), (Ecover, 2021c). Moreover, rinse aids for dishwasher products that do not contain PFAS in a functional role are on the market (Borg and Ivarsson, 2017). Alternatives are e.g. sophorolipids (Glge et al., 2022), (Ec over, 2021b). Windsc reen treatments and windsc reen wiper fluids An alternative for PFAS in car windscreen treatments is on the market (e.g. (Ctra. Urnieta, 2020)). The company uses polydimethylsiloxanes in their products to achieve water and stain repellence. The non-polar methyl groups result in a similar hydrophobic surface as the one achieved by the fluorinated alkyl chain of fluoroalkylsilanes (Ctra. Urnieta, 2020; Justo, 2010). Since the silicones used in this product are not chemically bound to the glass surface, the effect is not as long-lasting and the product may have to be applied more frequently (Acton Media Inc., 2019). Windscreen wiper fluids without fluorinated compounds are also available with alternatives such as silicone-based substances (e.g. non-ionic amino-modified silicone-polyalkyl copolymer (Patent US 7585828 B2) achieving similar results to PFAS. Non-fluorinated 213 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) surfactants which are also used for windscreen wiper fluids are well established (e.g. sodium dioctylsulfosuccinate). US patent US5922665A also covers the use of a branched or linear primary alc ohol ethoxylate75, a secondary alcohol ethoxylate, a branc hed decyltridecylalcohol ethoxylate, a branched or linear alkylphenol ethoxylate, a branched or linear alkylamine ethoxylate, an alkyletheramine ethoxylate, a linear alc ohol alkoxylate, and a mixture thereof as non-ionic surfactants. Polyols including a fluorinated polyether diol can be added, but the addition of glycols is possible instead as well. (Patent US 7,585,828 B2). The additions of polyols inc reases the flash point and thus the safety of the product (Patent CA2216888C). Car care Alternatives for PTFE-containing polishes and waxes used for cars are also available on the market. In these products, c arnauba wax (a natural wax obtained from carnauba palm trees, (CAS: 8015-86-9) is often used to achieve protection of the car's surface and water repellenc e. It ac hieves the same effect of c losing pores in the c ar's varnish and is also stable under UV radiation (Krendlinger et al., 2015). Musical instruments Alternative materials for the fabric ation of strings are readily available: a high number of strings is made from nylon or wound metal but strings from gut are available as well. The difference between those different materials is mostly in the sound produced by the resulting strings. One company supplied information that they are currently inv estigating one other alternative (c onfidential information) for c oating guitar strings. However, it is not c lear yet, whether this alternative will indeed turn out to be a feasible alternative. The company estimated that the cost of this work would be <1 million per year for the next 3 5 years and could become four times as high in case the proposed alternative is found to be no suitable alternative and further research is required (c onfidential stakeholder information) Most lubric ants for guitar strings is based on mineral oil (for example white mineral oil (ECnumber: 8042- 47- 5) is used (Thomann GmbH, 2020a)). As an alternative for PTFE micropowder or grease, graphite powder can also be used for minimising the friction between strings and the nut (Thomann GmbH, 2020b). E.2.5.2.2. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alt ernatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. In relation to c onsumer mixtures, the list of alternatives c ontained 14 unique CAS numbers. Seven (7) of the substances with unique CAS were classified according CLP (selfclassification). Four (4) of the substances with unique CAS number did, according to their registration dossier, not fulfil the PBT or vPvB criteria and for the remaining substances no data was found or PBT/vPvB properties were not applicable, meaning that none of these substances were known to fulfil the PBT or vPvB criteria. No other hazard properties were mentioned. The list contained an additional 20 substances with unique substance names for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. 75 Nonylphenol ethoxylate and octylphenol ethoxylate are heavily regulated. 214 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.5.3. Environmental impacts The analysis of environmental impacts of restriction options adopted on PFAS use in consumer mixtures is conducted for restriction option RO1, i.e. a complete ban of all PFAS uses in this sec tor. No derogations are proposed. For calculating the expected emission reduction the assumed entry into force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months , RO1 is expected to be implemented in 2027. Environmental impacts of RO1 are expressed in relation to the baseline scenario discussed in section E.2.5.1. All emission estimates represent mean values. Table E.67 shows mean emissions and the expected mean emission reduc tion for time path of 30 years (starting in 2025). Table E.67. Total mean emissions and emission reduction of RO1 (consumer mixtures sector, in tonnes). Restriction option Baseline RO1 Mean total emissions [t] 2025-2055 55 2 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 53 96 As illustrated in Table E.67, a ban on PFAS use in consumer mixtures leads to a mean emission reduction between of about 96% compared to the baseline. Emissions will fully cease after the 18 months transition period. Figure E.8 shows the time path of mean emissions for the baseline scenario and for RO1. Figure E.8. Time path of mean emissions under the baseline and RO1 (consumer mixtures sector, in tonnes). E.2.5.4. Economic and other impacts No detailed information on economic impacts is available for consumer mixtures. No information in this regard has been submitted by stakeholders. The Dossier Submitters point out that also during the two Annex XV report consultations on the PFHxA restriction proposals and SEACs opinion no information was submitted on PFAS use in consumer mixtures by 215 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) stakeholders. Regarding the global wax market, it is assumed to have valued 9.1 billion US-Dollar in 2019, with an annual growth rate of 4.2% between 2020-2026 (DataIntelo, 2022). This information is very uncertain. Information on PFAS use in this market is unavailable. For the 2nd stakeholder consultation during the preparation of this dossier, one company indicated that they were planning to phase out the use of PFAS from cleaning agents, polishes and waxes by 2025. Another company estimated that the use of PFAS in cleaning agents, polishes and waxes will remain c onstant, and a third c ompany estimated that the use of PFAS in cleaning agents will decrease but use in waxes will inc rease. No generalised trends could be derived from this information. No information on costs associated with substitution was submitted. One supplier of guitar strings estimated that the annual average market value for guitar strings containing PFAS is 10 - 30 million, and that the market would grow in proportion to the general market for musical instruments with a compound annual growth rate of 1.6% Stakeholder organization The International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) is not aware of market estimates for their membership as a whole. PFAS are used only in niche professional applications and available data are limited. One member company (manufacturer of professional cleaning solutions) indicated annual usage of less than 1 t, of which 60% is in commercial laundry (impregnation of protective clothing/equipment) and the remainder in long-life floor polish and floor strippers/cleaners. This is associated with a high value (1 - 10 million turnover) due to highly specialised applic ations. Extrapolation would suggest usage of no more than a few tonnes per year across the entire A.I.S.E. membership. Very low quantities are required, e.g. 0.01% or less in a concentrated solution, to achieve a significant effect. Comparable information for consumer uses is not available. Regarding the global wax market, it is assumed to have valued 9.1 billion US-Dollar in 2019, with an annual growth rate of 4.2% between 2020-2026 (DataIntelo, 2022). This information is very uncertain. For the 2nd stakeholder consultation, it was explicitly stated in the accompanying information that the Dossier Submitters interpret the available information as indication that alternatives are available and technically and economically feasible for all uses. The only input in relation to this statement came from a stakeholder organization representing the manufac turers of soaps, detergents and maintenanc e products. This stakeholder pointed out that functional losses might be associated with the use of the alternatives in some of the produc ts. They also stated that in their view c osts are not an issue when c onsidering possible impac ts from a restric tion on all PFAS. This mirrors the situation faced by Dossier Submitter Germany and the RAC and SEAC rapporteurs in regard to the restriction proposal for PFHxA, where no manufacturers or other relevant stakeholders commented on the background document or the SEAC -opinion. Therefore, no further information, e.g. on market price, market development and manufac ture for PFAS-containing mixtures/articles in this sec tor, is available. SEAC concluded in its opinion on the restriction proposal for PFHxA: `Whilst SEAC notes a lack of information on the magnitude of emissions/emission reduction (benefits), information on restriction-related costs and ongoing substitution activities indicate somewhat limited socioec onomic impac ts. SEAC c oncludes that restricting this use is likely not disproportionate (...) SEAC finds that sufficient information to demonstrate the necessity of a derogation was not provided.' The Dossier Submitters are not aware of any additional products or product groups that can be classified as consumer mixtures that were not already within the scope of the 216 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PFHxA restriction proposal. One company considers that the use of fluorosurfactants can lower the total amount of surfactants necessary in consumer mixtures and therefore lower the costs for surfactants three- to tenfold (Chemours, 2017). It is not known whether this significantly alters overall produc tion costs or not. In general, alternatives exist, and until now no information has been submitted to convincingly show a substantial extent of increasing costs, or lowered quality, or reduced lifetime for these alternatives. On the basis of the available information and the fact that the available PFAS-free products seem to be generally available, the Dossier Submitters infer that a complete ban of PFAS in consumer mixtures will have no significant economic effects. No additional information is available in regard to the impact of a restriction on small and medium companies. However, the stakeholder organization representing the manufacturers of soaps, detergents and maintenance products indicated that it asked its members for information for the 2nd stakeholder consultation. More than 800 members of this industry association are small and medium-sized enterprises. The Dossier Submitters in general have insufficient information to judge the overall ec onomic impact of a PFAS restriction proposal regarding musical instruments. For many applications alternatives exist, but the extent of inc reasing c osts or lowered quality or reduc ed lifetime (if existent at all) cannot be concluded on. No information has been submitted to convincingly show a substantial extent of inc reasing costs, or lowered quality, or reduced lifetime for these alternatives. E.2.5.5. Summary of cost and benefit assessment Table E.68 summarises the outcomes of the assessment of costs and benefits for consumer mixtures and musical instruments. 217 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.68. Consumer mixtures (and musical instruments) - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s C leaners (for glass, metal, ceramic, carpet and upholstery): Sufficiently strong evidence that technically feasible alternatives exist, i.e. silicones, as well as sufficiently strong evidence (in the form of practical examples of completed substitution for glass cleaners) pointing to the economic feasibility of alternative. Waxes and polishes (for e.g. furniture, floors and cars): Sufficiently strong evidence that technically feasible alternatives exist (e.g. carnauba wax for car polishing), i.e. in the form of patent information, as well as sufficiently strong evidence (in the form of practical examples of completed substitution) pointing to the economic feasibility of alternative. Dishwashing products (as rinse aid): Sufficiently strong evidence that technically feasible alternatives exist, i.e. silicones, as well as sufficiently strong evidence (in the form of practical examples of completed substitution for rinse aids) pointing to the economic feasibility of alternative. Windscreen treatments for automobiles and also windscreen wiper fluids: Sufficiently strong evidence that technically feasible E nv ir o nme nta l impact C ompared to the baseline, a full ban of PFAS use in consumer mixtures and musical instruments will contribute to reducing emissions (PFAAs and PFAA precursors, fluoropolymers and PFPEs). The expected emission reduction for all sub-sectors together equals around 96% of baseline emissions. As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. Cost impact Consumer mixtures: No further evidence available. Musical Instruments: Other aspects n/a Moderate producer surplus losses as a result of substitution, due to cost for research on additional alternatives (weak evidence, information on guitar strings based on confidential information from one stakeholder). No further information available. 218 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Ban with usespecific derogation s Conclusion Duration of derogation 5 years 12 years A lte r na tiv e s alternatives exist, i.e. patents, as well as sufficiently strong evidence (in the form of practical examples of completed substitution for windscreen treatments) pointing to the economic feasibility of alternative. Guitar strings: Sufficiently strong evidence that technically feasible alternatives exist, i.e. strings from nylon, gut, metal, lubricants based on mineral oil, as well as sufficiently strong evidence (in the form of practical examples of completed substitution) pointing to the economic feasibility of alternatives. Use in pianos: No information available, including no evidence to the contrary on technically and economic feasibility of alternatives. n/a n/a E nv ir o nme nta l impact n/a n/a Cost impact n/a n/a Other aspects n/a n/a No evidence available for PFAS use in pianos [no evidence]. High substitution potential at EiF for all other uses in consumer mixtures and musical instruments [sufficiently strong evidence]. Given the sufficiently strong evidence pointing to the existence of technically and economically feasible alternatives at EiF, no derogation is proposed. 219 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) No information has been provided on the impact of different transitional periods. Considering that alternatives for all uses seem to be available the Dossier Submitters assume that substitution is technically and economically feasible within 18 months. 220 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.6. Cosmetics E.2.6.1. Baseline A 0% growth rate was assumed for assessing the time path of PFAS use (tonnage) and emissions. This is in line with market data indicating no growth in cosmetic retail value for a three-year period ending in 2019 (KEMI, 2021). The start year of the projection is 2020. Note that information about lower and higher bounds of use and emission estimates at sector level, or for specific PFAS applications, was not available for the cosmetics sector, see Table E.69. Table E.69. Projected yearly PFAS use and emissions in the cosmetics sector of the EEA between 2020 and 2070 in tonnes (mean values based on market data). PFAS use PFAS emissions 2020 32 32 2025 32 32 2030 32 32 2035 32 32 2040 32 32 2045 32 32 2050 32 32 2060 32 32 2070 32 32 The assessment of environmental impacts under the baseline and the restriction s cenarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). As discussed in section E.2.6.2, several companies had declared their PFAS phase out in cosmetic products in 2021. However, information about the implications on PFAS use volumes in the cosmetics sector, and emissions, have not become available. Furthermore, the precise timing of the planned phase-out is unclear. The projected time path for PFAS use and corresponding emissions, therefore, does not incorporate reductions of PFAS use and emissions due to the voluntary phase-out measures. E.2.6.2. Alternatives E.2.6.2.1. Technical and economic feasibility For further details and referenc es related to this section, see KEMI (2021). For this report, we applied information from several databases or platforms, of which three are European cosmetic databases based on consumer data collected via smartphone applic ations (apps), i.e. CosmEthic s (Finnish), Kemiluppen (Danish), ToxFox (German). With these apps, consumers scan cosmetic product barcodes and receive information on ingredients and their potential hazards to make conscious purchase choices or submit new products and product information to the databases. Of these databases, the Dossier Submitters c onsider CosmEthics to be the one most representative of the EEA market, given the wide geographical spread of their data and the large number of products included. The same conclusion was reached in the REACH restriction proposal for D4, D5 and D6 (ECHA, 2019). The share of PFAS containing cosmetic products is below 10% in all the 108 cosmetic product subcategories included in the the CosmEthics database (extracted in August 2020)76. In absenc e of new information to the c ontrary, our assumption is that PFAS c an be replac ed by other ingredients and do not have critical functions in cosmetics. To this conclusion comes also the POPFREE stage two project and it was also confirmed in an interview with a cosmetics produc er. Experienc e from the c osmetic product sampling c onducted as part of the dossier preparation 76 The highest share of PFAS containing products were reported in shaving foam, shaving gel followed by various subcategories of make-up (e.g. pressed powder and foundation). 221 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) showed that several products that in the databases (mentioned above) were indicated as containing PFAS did not list any PFAS as an ingredient in the declaration of content on the product packaging. The Dossier Submitters assume that a substitution of PFAS or reformulation of the product has happened in these cases. Additionally, we noticed at least for these products that c ompanies did not c hange the product name after reformulation. By September 2021, at least 57 different brands (54 global) of nine different companies had declared their PFAS phase out in cosmetic products. PFAS phase out declaration of companies/brands might indicate that at least some have already actively found new formulations without PFAS that still work for the functionality of their products . All the above indicates that PFASs can be replaced by other ingredients and do not have critical functions in cosmetic products. Sinc e the share of PFAS c ontaining c osmetic produc ts is low (less than 10 perc ent) in all the 108 cosmetic product subcategories included in the CosmEthics database, the Dossier Submitters assume that there are economically feasible alternatives available for all uses of PFAS in cosmetic products. The Dossier Submitters conclude that the evidence is sufficiently strong that technically and ec onomic ally feasible alternatives are available for the quantities required for use in c osmetic products and that the substitution potential is high. E.2.6.2.2. Human health and environmental hazards A few specific alternatives to PFAS in cosmetics have been identified (see Table E.70). Table E.70. Examples of non-PFAS used in cosmetics. Substance Synthetic waxes (e.g. magnesium stearate) (Perfluorononyl dimethicone) silicones Fats Synthetic waxes (e.g. sodium myristate) CAS number 91031-63-9 259725-95-6 EC number 292-967-2 Subcategory use For pressed powders (PTFE) For lip pencils 822-12-8 212-487-9 For lip pencils For pressed powders (PTFE) Reference https://echa.europa.eu/substance information//substanceinfo/100.084.484 (EPA-DK, 2018) https://echa.europa.eu/substance information//substanceinfo/100.011.352 For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. In relation to cosmetics, t he list of alternatives contained 2 unique CAS numbers. Both substances were not classified. No data on PBT/vPvB properties were found. One substance without CAS number was listed. For this substance, no information on classification or PBT and vPvB assessments were available. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses 222 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) assessed in this dossier. E.2.6.3. Environmental impacts The analysis of environmental impacts of restriction options adopted on PFAS use in cosmetics is conducted for restriction option RO1, i.e. a complete ban of all PFAS uses in this sector. Sinc e no derogations are proposed, an analysis of further restric tion options is redundant. For calculating the expected emission reduction, the assumed entry into force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, RO1 is expected to be implemented in 2027. Environmental impacts of RO1 are expressed in relation to the baseline scenario discussed in section E.2.6.1. All emission estimates represent mean values. Table E.71 shows emissions and the expected emission reduction for time paths of 30 and 45 years (starting in 2025). Table E.71. Total mean emissions and emission reduction of RO1 (cosmetics sector, in tonnes). Restriction option Baseline RO1 Baseline RO1 Mean total emissions [t] 2025-2055 995 64 2025-2070 1 467 64 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 931 94 --- --- 1 412 96 As illustrated in Table E.71, a ban on PFAS use in cosmetics leads to a mean emission reduction of at least 94% compared to the baseline. Figure E.9 shows the time path of mean emissions for the baseline and for RO1. Under RO1, emissions are expected fully cease after the transition period of 18 months. Figure E.9. Time path of mean emissions under the baseline scenario and RO1 (cosmetics sector, in tonnes). 223 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.6.4. Economic and other impacts E.2.6.4.1. Market overview In 2019, the EEA market for cosmetics had a revenue at retail sales prices of about 67 billion. The market shares and EEA market value per cosmetic product category is presented in Table E.72. Table E.72. EEA cosmetic products market 2019, Retail Sales Prices (RSP including VAT) and market share by product category (Cosmetics Europe, 2020). Market share 2019 by product category Product category Skin C are Toiletries Percent (%) 27.1 24.8 Hair C are 18.7 Perfumes and Fragrances 15.4 Decorative C osmetics 14.0 Total EEA market* all product categories 100.0 *EU27 and Norway (EEA without Lichtenstein and Iceland) Retail Sales Price (bn Euro) 18.22 16.67 12.57 10.35 9.41 67.22 There was no growth in market value in real terms in three-year period ending in 2019. There are some regional differences, with growth in market value in some Eastern European countries and declining market value in some Western European countries. The Dossier Submitters assume that this trend will continue, at least in the short term, and that there will be no growth in real terms in the next few years. The market for the manufac ture of c osmetic products is a high margin business. According to Eurostat the value added at factor c osts is around 30% of produc tion value 77. The European Commission impact assessment on simplification of the Cosmetics Directive in 2008 estimated that there were 300 000 cosmetic product formulations on the EEA market (EC, 2008). This estimate has been updated for the purposes of this assessment based on information from Cosmetics Europe78 and results in an estimate of 520 000 formulations79. Only a small share of these formulations contains PFAS. The share of PFAS containing products, i.e. the percentage of total cosmetic products that contain PFAS in the CosmEthics database was 1.4% (extracted in August 2020)80. According to Eurostat there are around 10 000 enterprises involved in the manufacture of soap and detergents, cleaning and polishing preparations, perfumes and toilet preparations81. Cosmetics Europe states that there are 7 000 SMEs involved in manufacturing of cosmetic products78. The Dossier Submitters have no information on the number of companies that currently have cosmetic products containing PFAS. However, as indicated above, PFAS is present in a fraction of the cosmetic products on the market, and it is therefore likely that only a limited share of all the c ompanies active in the manufacture of cosmetic products have 77 The production value and value added at factor cost for 'Manufacture of soap and detergents, cleaning and polishing preparations, perfumes and toilet preparations' (C .20.4 in NAC E Rev. 2) were 58 billion and 17 billion, respectively, in 2017 (the latest year with non-confidential data available, at the time of writing). Eurostat, Annual detailed enterprise statistics for industry (NA C E Rev. 2, B-E) (sbs_na_ind_r2), extracted 2022-06-26. 78 https://cosmeticseurope.eu/cosmetics-industry/, date of access: 2023-01-13. 79 Assuming 100 000 formulations from `larger companies', 60 formulations per `SME' and 7000 `SMEs'. 80 This is a slight overestimate, since it also includes products containing the non -PFAS F-gas HFC -152a. 81 C .20.4 in NAC E Rev. 2. Eurostat, Annual detailed enterprise statistics for industry (NAC E Rev. 2, B - E) (sbs_na_ind_r2), extracted 2022-06-29. 224 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) produc ts that inc lude PFAS. E.2.6.4.2. Impacts on users of cosmetic products Consumer c osts associated with performance loss In the alternatives section above, the Dossier Submitters concluded that PFASs can be replaced by other ingredients and do not have critical functions in cosmetic products. Substitution away from PFAS could still - in theory - lead to some loss product performance, even if this performance loss would not be critical. The Dossier Submitters have no information available indicating that any such losses will occur as a result of a restriction of PFAS in cosmetic products, and therefore assumes that the associated consumer losses are non-existent or negligible. E.2.6.4.3. Impacts on producers of cosmetic products Substance substitution c osts Substitution costs have not been quantified in this study. The Dossier Submitters have no information that indicates that these costs would be a barrier to implementation of the proposed restriction. The Dossier Submitters assume that these costs are negligible. The assumption is primarily based on the information that the share of PFAS containing cosmetic produc ts is very low (less than 10%) in all the 108 c osmetic product subc ategories inc luded in the CosmEthic s database, which indic ates that there are ec onomic ally feasible alternat ives available for all uses of PFAS in cosmetics. Product reformulation costs The proposed restriction prevents the use of PFAS in cosmetic products. Companies producing PFAS containing cosmetics will have to reformulate their products to remove PFAS if t hey want to c ontinue plac ing them on the market. The key assumptions for reformulation costs are described below. The method and assumptions for the estimation largely follows the approach taken for the D4, D5 and D6 restriction proposal (ECHA, 2019)82, which has already been considered and agreed by SEAC. Total number of c osmetic formulations on the EEA market The European Commission impact assessment on simplification of the Cosmetics Directive in estimated that there were 300 000 c osmetic product formulations on the EEA market in 2008 (EC, 2008). This estimate has been updated for the purposes of this assessment based on information from Cosmetics Europe78 and results in an estimate of 520 000 formulations, of which 100 000 from large companies and 420 000 from small and medium sized enterprises (SMEs)83. Number of cosmetic formulations on the EEA market containing PFAS For this report, we applied information from several databases or platforms, of which three are European cosmetic databases based on consumer data collected via smartphone applications (apps), i.e. CosmEthics (Finish), Kemiluppen (Danish), ToxFox (German). With these apps, consumers scan cosmetic product barcodes and receive information on ingredients and their potential hazards to make conscious purchase choices or submit new products and product information to the databases. Of these databases, the Dossier Submitters c onsider CosmEthics to be the one most representative of the EEA market, given 82 Also, the approach taken for the D4, D5 and D6 proposal closely followed the approach for the preceding D4 and D5 restriction proposal. 83 Assuming 60 formulations per `SME' and 7000 `SMEs'. 225 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) the wide geographical spread of their data and the large number of products included. The market share of PFAS c ontaining products, i.e. the percentage of total c osmetic products that contain PFAS in the CosmEthics database was 1.4% (extracted in August 2020) 84. The Dossier Submitters note that a substantial share of the PFAS-containing products in the three cosmetic product databases consulted for this study contain PFASs that are or a re about to be restricted85. In the CosmEthics database this share was 33% (550 out of 1 658 products with PFAS)86. These c osmetic produc ts need to be reformulated in the baseline sc enario, i.e. even in the absenc e of the restriction proposed in this report. The number of cosmetic formulations on the EEA market containing PFAS by the time the restriction will be implemented is estimated to be 4 878 (520 000*1.4%*(100-33)%), of which 938 are in large companies and 3 940 in SMEs. Number of reformulations expected due to a restriction of PFAS in cosmetics The Dossier Submitters assume that 5% of the relevant products are reformulated. The assumption follows on the restriction proposal for D4, D5 and D6 which argued that for subcategories where products containing the substances proposed to be restricted represent less than 30% of the market, the alternatives are expected to take over their market share and very few of these products are expec ted to be reformulated (assumed 5%). The reasoning behind this assumption is that the lower the proportion of products that c ontain the substances to be restric ted within a subc ategory, the lower the proportion of produc ts within a subc ategory that will ac tually be reformulated in the event of a restric tion. If there are many products within a category that do not contain PFAS then it is likely that these already offer c omparable product performanc e to products that c ontain PFAS. In this sc enario c ompanies (particularly large ones, whic h are also likely to produc e alternative formulations within the same category) will accept that customers will switch to an existing alternative produc t rather than invest in reformulation. The Dossier Submitters note that the assumption that 5% of the PFAS-containing products will be reformulated c ould be c onsidered an overestimation, since the assumption in the restric tion proposal for D4, D5 and D6 was based on shares below 30% while the share of formulations with PFAS is substantially lower than that for all subc ategories of c osmetics in the CosmEthics database. The number of reformulations expected as a result of this restriction proposal are (5%*4 878=) 244, of which 47 belong to large companies and 197 to SMEs. The expected number of reformulations per cosmetic product category is presented in Table E.73. 84 This estimate includes cosmetic products containing the non-PFAS F-gas HFC -152a, which implies that it is a slight overestimation. The calculations of the number of reformulations required and, consequentially, the expected reformulated costs, does not take this into account and ca n therefore also be considered to be slightly overestimated. 85 Primarily C 9-15 fluoroalcohol phosphate, Perfluorooctyl triethoxysilane and Perfluorononyl dimethicone. 86 This does not consider the pending restriction on intended use of microplastics. PTFE i s the most common PFAS in all three of the cosmetic product databases consulted. In the C osmEthics database PTFE was present in 33 % of the products. If PTFE is in both particulate and solid form (<5 mm particle size) it is covered by the proposed microplastics restriction. This includes if it is present as a coating around another `inorganic material'. Liquid particles (colloids) would be excluded. 226 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.73. Summary of estimated number of formulations containing PFAS and expected number of reformulations due to the proposed restriction, per cosmetic product category Product category Decorative Hair care Perfumes & Fragrances Skin C are Toiletries Total Estimated number of formulations containing PFAS 3 297 430 10 959 181 4 878 Expected number of reformulations due to restriction 165 21 1 48 9 244 Number of reformulations per year The assumed share of formulations per year over the assessment perio d 2025-2055 is presented in Table E.74. Table E.74. Assumed share of reformulations per year in the baseline scenario and in the restriction scenario. Year 2025 2026 2027-2044 2045 2046 2047-2055 Baseline 5% 5% 5% 5% 5% 5% Restriction 67% 33% 0% 67% 33% 0% As in the D4, D5, D6 proposal the Dossier Submitters assume that, in the baseline sc enario, 5% of the cosmetic products undergo a major reformulation every year. The implication of the proposed restriction is that the 244 expected reformulations instead will need to occur during the 18-month transition period. The expected year of the adoption of the restriction proposal is 2025. The Dossier Submitters assume that two thirds of the reformulations take place in 2025 and the remaining third in 2026. These formulations are assumed to require a new round reformulation after 20 years, i.e. two thirds in 2045 and one third in 2046. Cost per reformulation In the D4, D5, D6 restriction proposal the cost (in 2017) per major reformulation done by large companies in the cosmetics industry was assumed to be 365 000, while a major reformulation by an SME was assumed to c ost 42 000. Adjusting these c osts for inflation to 2021 values implies that a major reformulation costs 391 000 for large companies and 45 000 for SMEs. The Dossier Submitters assume that all reformulation required due to this restriction proposal c an be c onsidered as major reformulations. The Dossier Submitters note that this c ould imply an overestimation of the true reformulation c osts since all expec ted reformulations might not be major. Total net product reformulation costs Based on the assumptions described above, the proposed restriction leads to major 227 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) reformulations of 244 c osmetic products, of whic h 47 belong to large c ompanies and 197 to SMEs. These reformulations are expected to cost (undiscounted) 27.2 million (of which 18.4 million affect large companies and 8.9 million SMEs) in 2025 and 2026. Over the assessment period of 2025-2055 these products are expected to go through another round of major reformulations in 2045 and 2046. The present value (in 2023, 3% discount rate) of the costs of these two rounds of reformulations is estimated at 39.5 million. In the baseline scenario, 5% of these products are assumed to go through a major reformulation per year. The present value (in 2023, 3% discount rate) of these reformulation c osts over the assessment period of 2025-2055 is estimated to be 26.4 million. Consequently, the present value of the net reformulation costs due to the proposed restriction is estimated to be 13.1 million. The costs per cosmetic product category is presented in Table E.75. Table E.75. Estimated net reformulation costs due to restriction over the period 2025-2055 (million , present value 2023, 3% discount rate). Product category Decorative Hair care Perfumes & Fragrances Skin C are Toiletries Total Reformulation costs in baseline scenario (million , 2023) 17.9 2.3 0.1 5.2 1.0 26.4 Reformulation costs in restriction scenario (million , 2023) 26.7 3.5 0.1 7.8 1.5 39.5 Net reformulation costs due to restriction (million , 2023) 8.8 1.2 0.0 2.6 0.5 13.1 Over the extended assessment period of 2025-2070, the present value of the net reformulation c osts is estimated to be 14.5 million. The Dossier Submitters note that the estimated cost assumes that it is feasible to complete all the required reformulations in 18 months. One argument for the feasibility of this is that the R&D resources required for the product reformulations due to the proposed restriction is a small fraction of the annual R&D budget of the cosmetics industry. Cosmetics Europe assumes that the total expenditure on R&D in Europe was approximately 2.35 billion in 201778. Since the profit margins in the market for manufacture of cosmetic products are relatively high, the Dossier Submitters assume that the product reformulation costs primarily will be borne by the c osmetics produc ers in the form of lower produc er surplus. E.2.6.5. Summary of cost and benefit assessment Table E.76 summarises the outcomes of the assessment of costs and benefits for cosmetic produc t s. 228 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.76. Cosmetics - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Full ban Ban with use-specific derogations Conclusion Duration of derogation Not applicable A lte r na tiv e s Sufficiently strong evidence that technically and economically feasible alternatives are available. No evidence pointing to a shortage in supply of alternatives is available to the Dossier Submitters. Environmental impact Emissions of PFAS to the environment is estimated to be reduced by 931 t (94% compared to the baseline, 30-year period). As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. As a result, the evidence is sufficiently strong that the substitution potential is high. 5 years n/a n/a 12 years n/a n/a Cost impact Other aspects Net product reformulation costs of 13.1 million over the time period 20252055. Over the extended assessment period 2025-2070 the net reformulation costs are estimated to be 14.5 million. Substance substitution costs have not been quantified, but the Dossier Submitters have no information that indicates that these costs would be a barrier to implementation of the proposed restriction. The Dossier Submitters assume that these costs are negligible. Substitution away from PFAS could - in theory - lead to some loss product performance. The Dossier Submitters have no information available indicating that any such losses will occur as a result of a ban, and therefore assume that the associated consumer losses are nonexistent or negligible. n/a n/a Assuming that all other costs than those associated with product reformulation are negligible, the cost per emission reduction is approximately 14 000 /t over the period 20252055. Over the extended assessment period of 2025-2070 the estimated cost per expected emission reduction is 10 300 /t. n/a n/a A full ban of PFASs in cosmetics with a transition period of 18 months is proposed. 229 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The net reformulation costs over the assessment period 2025-2055 is estimated at 13.1 million. Other costs are assumed to be negligible. The expected emiss ion reduction over the assessment period is 931 t. Consequently, the cost per emission reduction is approximately 14 000 /t. Over the extended assessment period of 2025-2070 the estimated cost per expected emission reduction is 10 300 /t. These cost-effectiveness estimates are c lose to the lower end of equivalent estimates of other recent REACH restrictions (Table E.77). Therefore, a full ban on the use of PFAS in cosmetics can be considered cost-effective and proportionate. Table E.77. Cost-effectiveness of recent REACH restrictions . Restriction under REAC H Lead in shot in wetlands D4, D5 in wash-off cosmetics DecaBDE Phenylmercury compounds PFOA-related substances PFOA /kg, central value 9 415 464 649 734 1 649 The annual retail value of the cosmetics sector is 67 billion (see E.2.6.4.1). The estimated c osts from a full ban on PFAS is less than 1/10 000 of the retail value, whic h implies that a ban is affordable. 230 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.7. Ski wax E.2.7.1. Baseline The forecasted market growth of ski wax in general indic ates growth in the c oming years due to the expected increase of the number of skiers and snowboarders, and of the expected increasing number of ski resorts. In contrast, based on existing market data, a negative real growth rate of -8%/y until 2030, and of -1%/y until 2040 was applied for assessing the time path of PFAS use (tonnage) and emissions. After 2040, the market for PFAS containing ski waxes is assumed not to decline any further. The start year of the projection is 2020 (Table E.78). Table E.78. Projected yearly PFAS use and emissions in the ski wax sector of the EEA between 2020 and 2070 in tonnes (mean values based market data). 2020 2025 2030 2035 2040 2045 2050 2060 2070 PFAS use 1.64 1.08 0.71 0.7 0.64 0.64 0.64 0.64 0.64 PFAS emissions 0.95 0.62 0.41 0.39 0.37 0.37 0.37 0.37 0.37 Source: Own calculations based on market data provided by NEA (2021b) assuming a PFAS content of 7.6% in ski wax products. The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). PFAS emissions arising from ski wax use consist of polymeric and non-polymeric PFAS. Due to the shrinking of the market for PFAS containing ski wax, both PFAS use, and emissions are expected to decline in the coming years. However, without a restriction, emissions may stabilize at a c onstant level, and being a sourc e of on-going PFAS release to the environment (see also Figure E.10). Figure E.10. Expected PFAS use and emissions in EEA under the baseline in the ski wax sector (mean values) [tonnes]. E.2.7.2. Alternatives E.2.7.2.1. Technical feasibility Due to increasing concern and publicity regarding the potential human health and 231 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) environmental effects caused using PFAS in ski wax treatments, there is a concerted move within this sector towards phasing out the use of PFAS and moving towards safer alternatives. Most users of ski waxes already use fluorine-free ski waxes, in particular amateur skiers and to some degree athletes during training. However, there is a segment of active amateurs training to and participating in non-FIS events where fluorine waxes have been frequently used. It is estimated that fluorine-free ski waxes account for 70% of the market, the remaining 30% is divided between products that are completely and partially fluorinated. The following alternatives have been identified: Fluorine-free ski waxes have always been in use and widely commercially available87. A number of c ompanies88 have developed alternative fluorine-free ski wax products. In almost all cases a mixture of substances is used in various percentage c ombinations for each of the fluorine-free alternatives to attain the necessary functions of the wax. The available alternatives are mainly based on hydrocarbons and paraffins, where paraffin waxes make up the majority. Siloxanes are another option, but they are subjec t to environmental concerns. New nanoparticles are also being developed as alternatives (Table E.79). A non-exhaustive list of fluorine free ski waxes is included in Appendix A.3.8. Alterations to the ski itself can also be used to improve the performance of the ski and therefore "replac e" some of the func tionality of the wax. These inc lude: o Modifying the microstructure of the ski base89. The thin layer of water that forms between the ski base and the snow must be monomolec ular, as too much water would c ause too muc h fric tion. Researchers are c urrently looking for an optimal microstructure of the ski that helps limit the amount of water under the ski. o Fluorinated ski base89. There are already ski bases which include side chain fluorinated polymers. It is important to note that the effect of having a thin layer of PFAS-based wax on the ski is bigger than having it in the plastic base of the ski90. o Improve the performance of the polyethylene of the ski91. Research is ongoing through a c ollaboration between polyethylene producers. o Heating the base to obtain a better glide which requires energy 87. o Methods to minimise friction by controlling the vibrations of the ski are also being researched. It is estimated that 5-10 years or longer will be required for such products to be developed and available87. Table E.79 provides an overview of the technical feasibility (i.e., ability to provide the required functionality) and economic feasibility (e.g. unit and operational costs associated with its use) of the possible alternatives compared with the PFAS-based waxes. Table E.79. Non-fluorinated ski wax alternatives. Broad assessment of technical and economic feasibility . Product type Manufacturer Hydrocarbon and paraffin waxes Multiple - including Swix, DPS, Mountain Flow, Nordic Waxes, Holmenkol, Green Ice Wax, Purl, Wend, Dominator, Start, Maplus, Toko, Rode, Rex, Vauhti, Star, Fast Wax and Ulla. 87 Interview with Swix. 88 Manufacturers that offer fluorine-free products include Swix, DPS, Mountain Flow, Nordic Waxes, Holmenkol, Green Ice Wax, Purl, Wend, Dominator, Start, Maplus, Toko, Rode, Rex, Vauhti, Star, Fast Wax and Ulla. 89 Interview with NILU. 90 Interview with FIS. 91 Interview with Rodewax. 232 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product type Hydrocarbon and paraffin waxes C hemical composition Substances listed in safety data sheets: Hydrocarbon and paraffin waxes Technical feasibility Application areas (as specified in technical specification) Multiple ski waxes are available for all the different application types and temperature/weather conditions C ompliance with N/A international performance standards Examples of use experience and performance compared to PFAS-containing waxes The key property that PFASs provide in this application is a high-water repellence (hydrophobicity) thus allowing a suitably low surface tension for the skis on snow. The relative performance (speed) of the alternatives is slightly lower especially in weather conditions with high temperatures and humidity. It has been shown that the use of high fluorinated waxes can result, on average, in a 4% increase in performance of the skis (Breitschdel et al., 2014). C ritical uses/applications where product do not meet (fully or partially) the required performance standard and why None Need for changes in equipment No change necessary. Same equipment can be used in manufacture of waxes and application to the skis Economic feasibility: Unit price Unit price as compared with PFAS-containing wax for same application Often less expensive to buy than PFAS waxes Often less expensive to buy than PFAS waxes Relative volume required to achieve comparable/best possible performance Depends on product type and application method but similar to PFAS waxes. For hot wax - 10-15 g per set. For liquid wax - 0.5 g per set Storage, shelf-life ~3 years Frequency of wax replacement No different to PFAS waxes. Depends on the amount of skiing performed by the user. Availability: Volume manufactured, sold and used in the EU Data on volume considered confidential by manufacturers. No issues with supply identified Production capacity in the EU No data but no issues with supply identified Risks: C MR properties Substances not classified with C MR properties Other potential human health concern No data PBT of vPvB properties Substances in the product do not meet the PBT/vPvB 233 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product type Other environmental risk concern C onclusion on risks Hydrocarbon and paraffin waxes criteria No data As the constituents are not classified with C MR properties and do not meet the PBT/vPvB criteria, the overall risks with hydrocarbon and paraffin waxes are considered lower than the risks of PFASbased products. The Dossier Submitters conclude that the evidence is sufficiently strong that technically and ec onomic ally feasible alternatives are available for the quantities required for use in ski wax and that the substitution potential is high. E.2.7.2.2. Human health and environmental hazards For the alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. No information was available on the c lassification of these substance or whether or not these substances fulfil the PBT or vPvB c riteria. No other c oncerns were mentioned. Appendix E.2. contains a table presenting this information along with furt her data on alternatives for the various uses assessed in this dossier. E.2.7.3. Environmental impacts The analysis of environmental impac ts of restric tion options adopted on PFAS use in ski wax is conducted for restriction option RO1, i.e. a complete ban of all PF AS uses in this sector. Sinc e no derogations are proposed, an analysis of further restric tion options is redundant. For calculating the expected emission reduction the assumed entry into force year of the restriction is 2025. Assuming in this case a transition period of 18 months, RO1 is expected to be implemented in 2025. Environmental impacts of RO1 are expressed in relation to the baseline scenario discussed in section E.2.7.1. Emission estimates represent mean values derived from available market data. Table E.80 shows emissions and the expected emission reduction for time paths of 30 years (starting in 2025). Table E.80. Total mean emissions and emission reduction of RO1 (ski wax sector, in tonnes). Restriction option Baseline RO1 (18 months transition period) Mean total emissions [t] 2025-2055 13 1,2 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 11.8 91 As illustrated in Table E.80, a ban on PFAS use in ski wax leads to an emission reduction of 90%. Figure E.11, showing the time path of emissions for the baseline scenario and for RO1, illustrates that emissions from PFAS use in ski wax are expected to decline due to the negative market growth rate for PFAS in this sector, which, in turn, results from an increasing substitution of PFAS in ski waxes. Considering that the av ailable evidence on (avoided) 234 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) emissions in this sec tor c an be c onsidered sufficiently strong it c an be c oncluded that RO1 will lead to a full cessation of emissions by the end of 2027. Figure E.11. Time path of mean emissions under the baseline and RO1 (ski wax sector, in tonnes). E.2.7.4. Economic and other impacts E.2.7.4.1. Market overview Information obtained from stakeholders suggests that the total ski wax market is split approximately 50/50 between c onsumer and professional sales. Fluorinated waxes tend to be used primarily during competitions, and first of all by elite athletes, who may also use fluorine free waxes during training. However, there is also a segment of active amateurs training to and participating in non-FIS events where fluorine waxes have been frequently used in the past. Lists of PFAS-based ski waxes and fluorine free alternatives and their prices are included in Appendix A.3.8. The pric e data is based on reviews of literature and retailers' websites as well as information submitted in the CfE. Desc riptive pric e data of these articles are presented in Table E.81 below. The price of PFAS-based ski waxes is in most cases higher than prices of fluorine-free alternatives. Table E.81. Price ranges and averages of ski waxes reviewed in 2020. Average Minimum Maximum PFAS-based ski waxes 2.35 /g 0.23 /g 6.33 /g F luo r ine - fr ee a lte r na tiv e s 0.23 /g 0.07 /g 1.13 /g Note: The average values are simply an average ac ross all of the listed produc ts; the values are not weighted according to market share (due to lack of data). Based on the average prices (see Table E.81) for PFAS-based and fluorine-free alternatives respectively, and the tonnage estimates provided in A.3.8.2., the market value of ski wax used in the EEA is approximately 62 million per year (Table E.82). Note that this is an unc ertain estimate since the pric es vary considerably, and the averages used are not weighted 235 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) according to market share92. Table E.82. Estimated market value of ski wax used in the EEA . PFAS products Non-PFAS products Total Annual tonnage 22 50 72 Average retail price (/g) 2.35 0.23 Market value (m/y) 51 12 62 E.2.7.4.2. Impacts on users of ski wax As mentioned above, stakeholder interviews indicate that PFAS-based ski waxes are mainly used for competitions, while recreational skiers and athletes during training already mostly use fluorine-free alternatives. A phase out of PFAS-based waxes in the top tier of c ompetitive skiing is ongoing. In 2019 the International Ski Federation (FIS) set to introduce a full ban on all PFAS in waxes in all competitive ski disciplines from their 2020-2021 season, a move that follows national-level bans imposed, for example by the Norwegian Ski Association in 2017. However, enforcement of the FIS ban has been postponed until they have successfully developed a Fluorine Tracker, an instrument that would instantly detect the presence of PFAS on the ski, that would make the competitions fair. This ongoing phase-out in the top tier of competitive skiing suggests that a substantial share of the use of PFAS-based ski waxes will likely be eliminated regardless of the proposed restriction. A REACH restriction on the manufacture and placing on the market of PFAS-based ski wax would also increase the chances that such ski wax is phased out completely and not used illegally in competitions. It is, however, important to note that there are non-FIS events with thousands of participants where the FIS-ban would not apply (e.g. Vasaloppet in Sweden). In stakeholder interviews, Rodewax and NILU suggested that the cost of alternatives is lower than PFAS-based waxes, while Swix suggested that the prices are similar. It was also suggested by Swix that the cost of ski waxes has never been closely linked to cost of raw materials, but rather wax performance, as there are many options available at a wide range of prices, despite similar raw materials. To further elaborate on the potential magnitude of the pric e difference a review of pric es from manufac turers websites for a wide range of ski waxes has been undertaken. The ranges of prices per gram of PFAS -based ski waxes and fluorine-free alternatives are very wide and overlap, but the average pric e of the fluorine-free ski waxes in this review was significantly lower (by a factor of 10) than the average price of the PFAS-based ski waxes (see Table E.81). This clearly suggests that fluorine-free alternatives are typically (but not necessarily always) cheaper than PFAS-based ski waxes, whic h is c onsistent with the suggestions from interviewed ski wax manufac turers. A phaseout of PFAS-based ski waxes would therefore imply lower consumer expenditure on ski wax. The alternatives can provide the required functionality, but in certain situations the use of alternatives can result in slightly lower performance. The importance of such functionality loss depends among other things on the type of ski sport and on the snow c ondition. According to stakeholder information, the loss could be up to 4% reduction of speed/glide. The Dossier Submitters make the following assumptions on the impacts of this reduction in performance 92 The Dossier Submitters note that a market research repor t by Industry Growth Insights estimates that the global market for ski waxes is substantially larger, around USD 800 million annually and growing at 4.5%/y. The Dossier Submitters have not assessed the credibility of this estimate as to whether it covers the same range of articles, or whether it also includes the value of other associated articles and services (Industry Growth Insights, 2021). 236 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) on consumer surplus: In FIS-based c ompetitive skiing, the Dossier Submitters assume that c reating a level playing field and equal c ompetition is most important. The impac t on consumer surplus would therefore be negligible as long as all c ompetitors are treated equally. For ordinary amateurs, the Dossier Submitters assume that the difference in performanc e will barely be notic eable, thus they will probably not experienc e a loss of consumer surplus. For the subset of active amateurs participating in non-FIS events and using PFASbased waxes, the loss in performance can be assumed to have a negative impact on consumer surplus. The extent of this loss is not obvious. Some active amateurs have a revealed preference for PFAS based ski waxes, even though it comes at an additional c ost. This implies that these users would suffer a net loss in c onsumer surplus if PFASbased waxes were no longer available. However, it can also be argued that this is primarily a case of conspicuous consumption or a case of buying the highest performing product available even if the actual relative benefits of using the product are small compared to the alternatives, and that the consumer losses resulting from a restriction are negligible also for this group of users. Overall, the Dossier Submitters assume that the net loss in consumer surplus due to a ban on PFAS-based ski waxes is negligible. E.2.7.4.3. Exposure to PFAS A restriction of PFAS in ski wax would eliminate the direct human exposure, and the related health risks, associated with its use. Direct human exposure to PFAS can occur when applying ski wax treatments, as the applic ation often includes heating, melting, brushing and sanding of mixtures c ontaining PFAS close to the airways, meaning users can be exposed to high concentrations of PFAS. PFASbased ski wax may contain up to 100% PFAS, although the concentrations depend on the formulation. Personal protective equipment is rec ommended, but not always used, especially among amateur skiers. No specific information was provided regarding PFAS exposure during production of ski waxes, but producers suggested that the main potential for exposure is during application of the wax to the ski. Prior to application, the sole of the skis is usually cleaned with a liquid non-fluorinated base c leaner and a c loth. The traditional high-end ski wax is then plac ed on the sole of the ski as a powder, melted with an iron and distributed evenly on the ski sole. Upon cooling the wax becomes solid again and much of the wax is removed from the ski base by scraping, and brushing, leaving a thin layer of wax on the ski sole. This has led to several concerns: The range between melting point and boiling point of the compound is very narrow, so fumes c an be released even when the boiling point is not reac hed. As a result PFAS has been found in the blood of people applying ski wax. It should be noted however that emissions of fumes from the application of fluorine-free alternatives may also have health concerns. A proportion of the wax applied will fall to the floor. Scraping and brushing can lead to formation of dust that could be inhaled. Professional ski technicians use protection equipment to shield themselves from potential exposure, inc luding gas masks, fume hoods, gloves and protec tive c lothing. However, this is not as common for non-professionals. Often, especially with non-professionals, the contained wax is disposed of in general waste or even in the snow/outside, but some ski wax producers and EEA countries (e.g. Norway) have recommendations in place for waste wax to be disposed of by waste handling c ompanies (e.g. through inc ineration). 237 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Another formulation of PFAS-containing ski wax is as a liquid with the fluorinated ingredients as a suspension. Applications of these will result in much lower exposure as they do not require melting with an iron or the same level of sc raping and brushing. The waste generated is also c onsiderably less. However, the performance of liquid wax during skiing does not match the best powder waxes. There have been studies which document a direct correlation between y ears exposed as a ski waxer and c oncentration of several different perfluoroalkyl c arboxylate (PFCA) c ompounds in blood, with one study showing that Swedish wax technicians' median blood level of PFOA is 112 ng/mL compared to 2.5 ng/mL in the general population (Freberg et al., 2010; Nilsson et al., 2010). Nowadays, professional ski technicians are usually using proper personal protective equipment. However, amateurs that are using fluorine- based waxes for rec reational skiing or for 'hobby competitions' may suffer considerable exposure during application of wax due to insufficient protection against exposure. The total number of people involved in the waxing of skis with PFAS-based ski waxes is highly uncertain, bec ause at lower or amateur level skiing competitions, skiers will likely manage their equipment themselves (or their parents will, in the c ase of junior c ompetitors). In some c ases, sports shops offer to wax skis, but it is assumed that a minor part of skis is prepared in this way. For higher level competitions, the number of professionals involved in applying PFAS based ski waxes c an be estimated, based on interviews with ski wax manufac turers, to be around a few hundreds. The Dossier Submitters conclude that human exposure to PFAS during application when preparing skis, may be very high, possibly the highest human exposure level that is documented for any consumer use of PFAS. E.2.7.4.4. Impacts on manufacturers of ski wax Ac c ording to interviews with some of the main ski wax produc ers, around 100-200 people are employed by at least 20-25 ski wax producers (many of which are small companies) in the EEA93. This inc ludes the production of both PFAS-based and fluorine-free ski waxes. Fluorinefree ski waxes account for some 70% of the market (by tonnage), the remaining 30% is PFAS-based waxes (see Annex A.3.8.2). Considering that most producers offer both, it is not possible to distinguish workers relating to only PFAS-based ski waxes. Despite the niche nature of this use, stakeholder interviews suggested that some small ski wax manufac turers exist that only offer PFAS-based ski waxes and are likely not yet ready to transition to fluorinefree alternatives. For these manufacturers the impac t of a restriction will be c onside rable and could potentially lead to business closures. PFAS-based waxes have a substantially higher retail price than the alternative waxes. On average, the pric es differ by a factor of 10 (Table E.81). A phase-out of PFAS-based ski waxes would therefore imply lower revenues for manufacturers of ski wax. Input from one major manufacturer (Swix) indicate that the prices of ski waxes are not closely linked to the cost of the raw materials. The producer surplus from sales of PFAS-based ski waxes c ould therefore be higher than the surplus from sales of alternative waxes and a restriction of PFAS could therefore lead to an overall reduction in producer surplus. To some extent the producers could compensate for this loss by increased sales (and potentially higher margins) of the highest performing alternative waxes. This is dependent on the consumers price elasticity. Considering the large variety in prices, it is likely that a large fraction of consumers, professionals and enthusiastic amateurs, have an inelastic demand, and thus creates room for the producers to have reasonable margins. In conclusion, a ban on PFAS in ski waxes is likely to lead to a reduction in total consumer expenditure on ski waxes and could lead to a 93 Interviews with Rodewax and Swix. 238 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) reduction in producer surplus, the extent of the latter is however unclear. E.2.7.4.5. Costs relating to testing, equipment, occupational safety measures and product development Most suppliers, professional users (service providers offering ski waxing) and end users (skiers) already offer/use fluorine-free alternatives. Therefore, no additional testing, new equipment or training in occupational safety measures would be required to enable the use of alternatives. Costs to regulators to enforce the restriction on this niche use would likely be small. It is therefore expected that the rest of the supply chain (i.e. distributors and service providers offering waxing of skis) would also simply switch to fluorine -free alternatives. There is ongoing research and development to further improve the performance of skis without PFAS-based waxes. However, it is not clear that the associated cost could be considered a necessary cost of the proposed restriction, given that most skiers already use fluorine-free alternatives and athletes in competitions would all be subject to the same potential ban on PFAS-based waxes. Given the potential advantage athletes would have in illegally using PFAS-based waxes, it is necessary to develop a testing methodology to verify the presence of PFAS before the competition, which would come as a development cost. However, testing for ensuring a fair c ompetition is the responsibility of the sports organisations, and development costs would not be a direct cost of a REACH restriction. While waiting for t he testing technology, FIS, the main international ski federation, has already decided to ban fluorinated waxes from competitions. For enforc ement of the REACH PFAS restric tion, authorities may rely on c ollec tion on ski wax samples and sending them to an analytical laboratory for the quantification of PFAS. E.2.7.5. Summary of cost and benefit assessment Table E.83 summarises the outcomes of the assessment of costs and benefits for ski wax. 239 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.83. Ski wax - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restrictio n option Full ban 18month transition period Duration of derogation Not applicable A lte r na tiv e s Sufficiently strong evidence technically and economically feasible alternatives are available. No evidence pointing to a shortage in supply of alternatives is available to the Dossier Submitters. As a result, the evidence is sufficiently strong that the substitution potential is high. Environmental impact Emissions of PFAS to the environment would be reduced by 11 t over the assessment period 20252055. As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. Cost impact Lower consumer expenditure on ski wax is likely. This reduction in expenditure could lead to a reduction in producer surplus, the extent of the latter is however unclear. Loss in consumer surplus expected to be negligible. No evidence of costs relating to testing, equipment, occupational safety measures and product development available to the Dossier Submitters. Other aspects A full ban would eliminate the direct human PFAS exposure and the associated health risks. Human exposure to PFAS during application when preparing skis, may be very high, possibly the highest human exposure level that is documented for any consumer use of PFAS. Ban with 5 years n/a n/a n/a n/a use- 12 years n/a n/a n/a n/a specific derogatio ns Conclusio A full ban of PFASs in ski wax with an 18 month transition period is proposed. n 240 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Based on evidenc e gathered in the CfE, stakeholder interviews and reviews of literature and market data, the Dossier submitt ers note: - that human exposure to PFAS during application when preparing skis, may be very high, possibly the highest human exposure level that is documented for any consumer use of PFAS, - that a phase-out of PFAS-based ski waxes is already on-going, - that the fluorine-free alternatives generally c ome at a lower c ost than the PFAS-based ski waxes, and - that any losses of functionality will primarily affec t competitive skiing but there would still be a level playing field because all athletes would equally be forced to use fluorinefree alternatives therefore limiting potential consumer surplus losses. The Dossier Submitters conclude that there is sufficiently strong evidence that a restriction on PFAS in ski waxes is very likely to have negligible socioeconomic costs. 241 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.8. Applications of fluorinated gases The term fluorinated gases are in this dossier understood to cover any gaseous substance that meets the definition of PFAS according to section 1.1.1. of the main report. It is not limited to those gases legislated under the F-gas Regulation of the EU (517/2014). A desc ription of the different applic ations of fluorinated gases may be found in Annex A.3.9. Industry stakeholders underlined the importance of HFO and fluoroketone (FK) alternatives during the development of this dossier via the CfE and 2nd stakeholder consultation. These substances can substitute the function provided by other fluorinated gases alone or in blends, whilst at the same time having significantly lower global warming potentials (GWP), one of the objec tives of the F-Gas Regulation. However, the F-Gas Regulation does not address the problem of persistence. The use of fluorinated gases in transportation systems for mobile air conditioning (MAC) and refrigeration, and in military applic ations are addressed separately in Annex E.2.10. E.2.8.1. Baseline For spec ific applic ations of fluorinated gases, the market is assumed to grow c onsiderably in the coming 30 years. For instance, for commercial refrigeration a yearly real growth rate of 3% is assumed. Furthermore, the EU market for air conditioning has seen strong growth over the last 25 years, originally in the commercial sector but now also in the domestic sector. Demand is forecast to roughly double in Europe in both the residential and commercial sec tors over the next 30 years (IEA, 2018). Improved efficiency at data centres has prevented significant growth in cooling demand for the sector. It is, however, unclear for how long efficiency will continue to offset increased internet traffic. Market data for fire supressing agents (Research and Markets, 2019) suggest a strong growth over the period 2018 to 2025 at a compound annual growth rate of 5.9%, with the fire detection and suppression market valued at USD3.27 billion in 2018. Growth is anticipated to be driven by increased safety measures including tighter building codes. However, these figures reflect growth across the whole market, and are not specific to sectors that use fluorinated gases a s opposed to other fire suppressants. Projecting market growth at sector level is not possible with sufficient reliability. However, taking available information about market growth in different sub-sectors into account, a yearly real growth rate of 2% is assumed. For the start year of the projection (2020), emission estimates during the use phase comprise emissions from manufacture of fluorinated gases, and from gases in technical stocks. Tonnage (use) data and emission for these two applications are also accounted for in the environmental impac t assessment of the transportation sector (Table E.84). Table E.84. Projected yearly PFAS use and emissions in the fluorinated gases sector of the EEA in tonnes (mean values based on market data). 2020 2025 2030 2035 2040 2045 2050 2060 2070 PFAS use 542 194 598 626 660 931 729 722 805 672 889 527 982 109 1 197 186 1 459 363 P FAS 41 511 45 841 50 602 55 868 61 683 68 103 75 191 91 658 111 731 e m issions 1 Tonnage and emission estimates also inc lude applic ations of fluorinated gases in mobile air c onditioning and in transport refrigeration. The EIA of derogations proposed for these applic ations are also analysed in the transportation sector. The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). Two approaches were considered for either generating or identifying emission estimates: 242 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 1) REACH Guidance (R.16) default methodology (ECHA, 2016) 2) United Nations (UN) methodology. The first methodology is that most often used in REACH restrictions that are concerned with PFAS and is set out in ECHA's R.16 Guidance (ECHA, 2016). This allows for the generation of emissions from market quantity data but is generic and applied to any use sector. The second approach is that used by EU/EEA Governments (EEA, 2022)for the purposes of providing information annually to the United Nations Framework Convention on Climate Change (UNFCCC) according to the methodology and guidance set out by the Intergovernmental Panel on Climate Change (IPCC). The European Environment Agency, together with various EU institutions and the EU Member States, prepares an annual inventory of greenhouse gas emissions, trends and the underpinning drivers in the European Union. The European Environment Agency refers to the inventory as the `EU Greenhouse Gas (GHG) Inventory' and it is reported to the UNFCCC annually. After detailed consideration, the UN Methodology was c hosen bec ause the emissions have already been c alc ulated and these are done so using a well-established and use-specific approach. The geographical scope of the EU GHG Inventory data for 2018 is EU-28 plus Iceland (IS). Norway (NO) reports separately to the UNFCCC process, so for the purposes of this project the Norwegian data has been added to the EU GHG Inventory data to provide a geographical c overage of EU-28 & IS & NO geographic al sc ope. No data was available for Liec htenstein. The European Environment Agency also collects and publishes data reported by industry according to the obligations under the F-Gas Regulation. The most recent report referred to in this projec t, the `F- Gas Report' (EU, 2020c ), provides EU-28 data up to and inc luding 2019 and covers fluorinated gas activity (production, reclamation, imports, exports, destruction and feedstock use), supply of gases (trends in supply) and progress of phasing down the use of HFCs. It is updated annually and is a source of data that industry stakeholders have consistently pointed to as a `definitive reference' during the 2nd stakeholder consultation for this project. Importantly though, the data presented do not include emissions data but conversely data are included for unsaturated hydro(chloro)fluorocarbons (although aggregated for confidentiality reasons), these are primarily HFOs, because FKs are not required to be reported according to the list of substances in Annex II of the F-Gas Regulation. For these reasons the use of the F-Gas Report data was limited to trend information and information on HFOs for the purposes of the current report. The use of fluorinated gases, and emissions during the use phase at sector level, are shown in Figure E.12. Considering the assumptions about the expected market growth as discussed above, emissions are expec ted to inc rease c ontinuously. The prec ise amount of this inc rease is difficult to project with sufficient reliability due to lacking information about the market growth in the different areas of applications of fluorinated gases. Projections of long-term emissions must, therefore, be treated with care. Under current market conditions, emissions of fluorinated gases originate particularly from applications in the HVACR sector (heating, ventilation, air conditioning and refrigeration), in particular from commercial and industrial refrigeration, and from existing technical stocks of stationary air conditioning and heat pumps, see also Annex A). 243 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.12. Expected PFAS use and emissions in EEA under the baseline in the fluorinated gas sector (mean values) [tonnes]. E.2.8.2. Alternatives E.2.8.2.1. General consideration of the availability of alternatives Alternatives need to be identified at the specific application level. In some cases more or less the exact same performance may be provided with an alternative non-PFAS substance, or a different technical solution. In other c ases a slightly different functionality may be provided, whic h is still suffic ient to cover the needs. It is more about seeing the possibilities rather than the ghosts when selecting the optimal refrigerant for the project or a product. No single fluorinated gas can cover all applications, and the same applies for the different non-PFAS alternatives. Some parts of the market have already switched away from the use of fluorinated gases to alternative substances or solutions. However, in certain specific cases, finding alternatives may be more challenging. Information gathering via stakeholder input shows that there are often strong opinions with different views on the suitability and availability of non-PFAS alternatives for the current applications of fluorinated gases. Stakeholders often argue either that fluorine -free alternatives are available for essentially every applic ations, or that fluorine-free alternatives are generally unsuitable due to the properties like high flammability (hydrocarbons), toxicity (ammonia) or the requirement for high operating pressures (CO2). However, in many cases the technical and safety issues may be solved in the design of equipment. In the present assessment the evaluation of availability of alternatives has been performed at the specific subapplic ation level, while weight has been put on the demonstrated availability of alternative solutions. The introduction of a certification scheme for personnel and companies that work with HFO and natural refrigerants has been suggested to secure c ompetence to work safely with these substances, in the same way as what applies in the F -gas regulation for technicians handling HFCs. This appears to be an important step forward to reduce emissions during service and sec ure safe handling. Under the Montreal Protocol the Technology and Economic Assessment Panel (TEAP) is regularly assessing the availability of alternatives to HFCs in various applic ations. Their latest working group report (UNEP, 2022) contains valuable, detailed information on the availability of non-HFC alternatives for specific applications divided into the following main uses: foam blowing agents, fire suppressing agents, medic al and c hemic al uses, as well as refrigeration, 244 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) air conditioning and heat pumps. However, TEAP primarily considers global warming and ozone depleting potential for the potential alternatives, and not e.g. the degradation to persistent TFA in the atmosphere and the environmental impacts that follow from that. Hence, HFOs are in the report considered viable alternatives to HFCs (which is not in line with the assessment in this dossier). Some stakeholders have noted that the use of fluorinated gases within military applications, like refrigeration, fire suppression and air conditioning, is important as the different alternatives are not viable options in military applications due to safety considerations. Refrigeration in military `transport' equipment (ships, submarines) faces several barriers to substitution due to some strong operating and safety conditions: sizing, compactness (and impact on armament equipment), sea motions, shocks, vibrations, noise, closed c ompartments, pressure conditions, toxicity issues of some natural fluids (NH3 c annot be used on a Navy ship; CO2 c omes with limits suc h as toxic ity and c ompactness). However, for many of these applications alternatives are available, just like for the same applications within a civil setting. Several stakeholders have pointed at HFC-32 (CH2F2) as a viable alternative for multiple applications. HFC-32 is an F-gas according to the F-gas regulation, but it is not a PFAS according to the scope definition of this restriction proposal. Its GWP is 675, and as such it has a considerable contribution to climate effects. HFC-32 has an atmospheric lifetime of 5.4 years and forms CO2 and HF as degradation products. Importantly, HFO-1234ze has been found to be a highly flammable gas in combustion experiments, and CO2 and HF together with toxic carbonyl fluoride were identified as combustion products (Schwabedissen et al., 2020). This will need to be taken into c onsideration when the flammability of hydroc arbon alternatives is evaluated. Elasto-caloric cooling is a completely different technique to refrigeration that has developed fast over the last years. An elasto-caloric c ooling system uses the shape memory effect of c ertain metals to induc e a reversible temperature c hange through the applic ation of force. In elasto-caloric materials, mechanical pressure causes a crystalline phase transformation, which heats up the material from the initial temperature T0 to T0+T. The heat generated is transferred to a heat sink and the temperature of the material drops back to the initial temperature T0. When the mec hanical stress is removed, the material c ools to a temperature below the initial level (T0-T)94. Elasto-caloric cooling is considered completely harmless to people and the environment and regarded as one of the most promising alternatives to vapour compression cooling (Kabirifar et al., 2019). In the following, the availability of alternatives for the different sub-applic ations of fluorinated gases is examined. E.2.8.2.2. HVACR applications Several stakeholders have pointed out that natural refrigerants have always been considered as alternatives to the use of fluorinated gases. They are effective, energy efficient and safe in all segments and sub-sectors of HVACR industries. Natural refrigerants are substances that exist naturally in the environment (hydrocarbons, ammonia, CO2, air, water etc.), whose properties and drawbacks are clear and well-understood. Given the progress in technology and engineering processes, natural refrigerants are technically feasible in all applicat ions. When higher loads of hydrocarbons are needed in the equipment (up tp 1.2 kg), dissipating air flows are required in the premises. Price parity has already been achieved for natural refrigerants in the commercial and industrial sector, and it will be achieved within a decade 94 https://www.ipm.fraunhofer.de/content/dam/ipm/en/PDFs/productinformation/TE/KAS/Elastocaloric-Systems-cooling-refrigerant-free.pdf, date of access: 2023-01-13. 245 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) in the heat pumps and air conditioning. Ac c ording to one stakeholder research demonstrates that hydrocarbons c an be used safely in a much wider range of refrigeration and heat pump applications than what is normally expected today. The thermodynamic properties of hydrocarbons are very good and they often outperform fluorinated gases in terms of energy efficiency. Equipment with very low refrigerant charges of hydrocarbons has been developed by component miniaturization (reducing the refrigerant loading). For HVACR applications, Hafner and Ciconkow (2021) investigated the current state and market trends in technologies with natural refrigerants and concluded that all temperature levels and most applications can be cooled by applying natural refrigerants. There is no technical barrier to replace currently used synthetic fluorinated gas refrigerants with natural working fluids. None of the fluorinated gases can go as low in temperature or as high as the natural refrigerants, they only cover the most profitable markets in the middle temperature range. Several stakeholders confirm that natural refrigerants are available for domestic/commercial/industrial applications. The 2018 UNEP assessment report of the refrigeration, air conditioning and heat pumps tec hnical options c ommittee explores the options for different refrigerants within the different sectors (UNEP, 2019a). The availability of both fluorinated gases and fluorine-free alternatives are assessed. For refrigerants, the "Pathway to net-zero c ooling produc t list"95 provides an overview of the availability of energy efficient and ultra-low GWP (<5) natural refrigerants that are used for various refrigeration purposes as alternatives to fluorinated gases. The domestic refrigeration sector has moved from near total reliance on fluorinated gases at the time that the Montreal Protocol came into effect to almost total reliance on hydrocarbon alternatives now. There are signs that a similar approach is also being taken in the clothes dryer heat pump market, with many manufacturers opting for hydrocarbon refrigerants in preferenc e to fluorinated gases. However, there is also strong resistance in other areas: the mobile air conditioning market seems particularly averse to a switch to non-PFAS alternatives, citing concerns on the grounds of safety (for hydrocarbons) and cost (for CO2). In the EU project Life Front, it was looked at barriers that established regulations and standards impose on the introduction of flammable refrigerants (A3 c lassified) 96. The authors concluded that current application of safety standards limits on flammable refrigerants charges are too restrictive for the application of propane (R-290) in most HVACR applications. Furthermore, it was suggested that the safe application of higher charge limits is possible, and that future applications of safety measures will result in charge limits that enable a far greater and wider application of hydrocarbon refrigerants without resulting in a significant risk increase for users. In certain countries building codes prohibit the use of flammable refrigerants in public buildings (e.g. Italy). This could limit the use of hydrocarbons as non-PFAS alternatives in HVACR applications in these countries. However, a relaxation in the limitations would be in line with the development of equipment over the last years as modern technology offers safer solutions as compared to some years ago. Water and air are additional non-PFAS alternative refrigerants that are currently being developed for several applications. The energy efficiency of air systems at higher temperatures is quite poor, and the refrigerant is not suitable for all applications. However, water/air are used for c ertain nic he applic ations, e.g. air in very low temperature rheumatism 95 https://cooltechnologies.org/pathway-to-net-zero/, date of access: 2023-01-13. 96 http://lifefront.eu/portfolio-posts/impact-standards-hydrocarbon-refrigerants-europe-report-2/, date of access: 2023-01-13. 246 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) c hambers. Domestic refrigeration Cost effective non-PFAS alternatives are already widely used. Domestic air conditioning and heat pumps Hydrocarbon based alternatives are already on the market for smaller systems. Calls for relaxation of the limits on charge size have been made. Specific situations may continue to be more challenging, e.g. use in high rise buildings, where the risks of accidents may be considered to exceed the risks from emissions of fluorinated gases. For domestic and commercial air conditioning and heat pumps, the refrigeration circuit can be put outside. It is claimed that the widespread use of natural refrigerants as an alternative in heat pumps cannot c urrently replace the use of HFOs for tec hnical reasons due to safety (inc luding flammability) requirements and the desired effic iency requirements. The availability of natural refrigerants for heat pumps was assessed by Infinitus Energy Solutions and Entropy Cooling Solutions on behalf of the Netherlands Enterprise Agency for the Energy Top Sec tor97. It was c oncluded that suitable natural refrigerants are available for many heat pump applications. These refrigerants have a low environmental impact and perform c omparably to or better than synthetic alternatives, with acceptable and stable costs. The three most common natural refrigerants are hydrocarbons, carbon dioxide and ammonia. Hydrocarbons are particularly suitable for smaller heat pumps, monoblocks and single-split ACs. They are suitable for c ollective systems (bloc ks of houses and apartment buildings) and industrial applications, if adequate risk management measures can be put in place. Hydrocarbons are less suitable for larger multi-split and VRF systems due to the high costs and the constraints of the required safety measures. Carbon dioxide is particularly suitable for higher supply temperatures in both small and large heat pumps. Ammonia is mainly suitable for industrial heat pumps. In the future it may be used in high-tech hybrid domestic heat pumps fueled with natural gas. Existing heat pumps generally cannot be converted for use with natural refrigerants. David et al. (2017) explored the availability of natural refrigerants for use in large-scale electrical heat pumps in district heating. Ammonia was found to be a viable option in large scale systems and is also used already in several cases. However, safety precautions are required as ammonia is moderately flammable and toxic. CO2 is also a suitable alternative, although high pressures are required, making it less suitable for systems larger than 1-2 MW. Today HFC-32 (CH2F2) is frequently used in stationary airconditioning and chillers, while the heat pump segment is introduc ing CO2. It is also already used in split air c onditioners in small data centres and in domestic heat pumps. However, one stakeholder claimed that fluorinated gas solutions are unavoidable for domestic air conditioning and for heat pumps with higher heating capacities where more than 5 kg of propane are needed. One stakeholder indicated that elastocaloric cooling could be commercialised within 5 years for heat pumps and mobile air conditioning. Industrial heat pumps Heat pumps will have to produce steam at a temperature of about 160 C or higher if fossil steam boilers are to be phased out as this is a kind of standard in c urrent steam systems. Even 250 C is used in some drying processes where dry saturated steam is needed because of its hygroscopicity. No universal non-PFAS refrigerant is suitable for all applications up to about 230 C. However, the hydrocarbons butane (R600), iso-butane (R600a), pentane 97 http://infinitus-energy.com/, date of access: 2023-01-11. 247 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (R601) and heptane (R603) are applicable solutions. For temperatures in the range 230 to 250 C, steam (R718) is an option98. Domestic clothes dryers Cost effective non-PFAS alternatives are already widely used. Commercial and industrial refrigeration There is growing acceptance of the use of alternatives, particularly CO2 or hydrocarbons, in the commercial sector. However, the sector is still dominated using fluorinated gases, and the assumption that the sector is fully ready to replace them with alternatives may be premature. Further research is being conducted in several areas. In some cases of commercial refrigeration, a secondary/indirect loop (glycol or water) can be used to reduce risk with flammable alternatives - however this will be less energy efficient and more expensive. For commercial refrigeration isobutane and propane is currently only used for very small equipment due to its A3 high flammability, as safety laws say 150 g is the limitation. Alternatively, the safety laws may be relaxed if the technical state allows. For CO2 high working pressures and poor performance in hot climates makes its uses in small/mid-size c ommerc ial c hillers/refrigerators less efficient. However, CO2 multipac k or rac k systems have become more common. CO2 has gained a lot of attention as a refrigerant over the recent years and currently the 4th generation of supermarket CO2 units are entering the stage. CO2 is also used in cascade systems with other natural working fluids, such as ammonia. Cascade systems are widely used in warehouses and for industrial refrigeration and heat pump systems (Hafner and Cic onkow, 2021). However, it has been noted by stakeholders that drawbacks with CO2 as a refrigerant include high working pressures that require solid equipment design and lower energy effic iency in warm c limate. Efficient systems based on ammonia have been in place for many yea rs in industrial refrigeration. Other alternatives to fluorinated gases are also practicable for some applications. For industrial heat pumps the main market is using fluorinated gases, but this could easily be replaced with natural refrigerant alternatives that provide higher efficiency. There may potentially be situations or processes, however, where the continued use of fluorinated gases is required. It is claimed that for new installations within commercial and industrial refrigeration, a c omplete transition to natural refrigerants is already taking plac e. Training is the only barrier to transition to natural alternatives in commercial refrigeration. It is foreseen that within the next dec ade the same will apply to the air c onditioning and heat-pump sector. Air and waterbased systems will also develop. According to stakeholder information it is technically possible to remove fluorinated gases today within domestic and commercial refrigeration and heat pumps. Commercial and industrial applications using CO2 as refrigerant is already available and in use. However, flammability when using hydrocarbons and costs may be barriers for full substitution of fluorinated gases. Within commercial and industrial refrigeration, low temperature refrigeration below -50 C in large capacities is expected to still depend on fluorinated gases in 10 years. Such low temperatures are often required to store material for medical (e.g. vaccines) or biochemical use. One stakeholder noted that atmospheric air can be used in a special loop to create temperatures from -40 C down to -130 C, but even -160 C is possible to reach. Hydrocarbons (e.g. ethane (R-170) and ethylene (R-1270)) are used in ultra-low temperature 98 https://ntnuopen.ntnu.no/ntnu-xmlui/handle/11250/2827404, date of access: 2023-01-13. 248 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) applications, including in processing plants at temperatures as low as -80 to -100 C. In refrigerated equipment within industrial and laboratory/medical uses, as well as test and measurements, fluorinated gases offer a highly dynamic and precise temperature control in the whole range of -100 C to +300 C. Although the whole temperature range may be achieved with non-PFAS alternatives, no single non-PFAS refrigerant seem to have the same broad operating interval. Hence, fluorinated gases may have an advantage in equipment where temperatures are frequently changed over the entire temperature range. Such equipment may be designed with hermetically sealed systems verified to not leak in normal use. Refrigerated centrifuges are critical in medical laboratories and e.g. sample separation (e.g. blood separation for transfusion centers) and cannot, on a larger system utilize hydrocarbons or high-pressure system (CO2) as a rotor failure (classified by EN 61010-2-020 as a maximum credible accident) may result in a ruptured refrigerant system and therefore a hazard to the area where flammable refrigerants or high-pressure systems are used. VFR systems in commercial air conditioning and heat pumps may be challenging to build with natural refrigerants due to flammability. The option is to use chillers which normally have a somewhat higher energy consumption. Larger propane chillers for industrial applications are readily available in Europe. Wineries, greenhouses, food processing factories and life sc iences industries currently rely on fluorinated gases for refrigeration. However, it is possible to use non-PFAS alternatives in most but not all of those applications according to stakeholder input. Transport refrigeration Some non-PFAS alternatives are already in use in truc ks, in trawlers and in reefer c ontainers. However, they are not c urrently widespread. Alternatives may have lower energy effic iency, and safety is of c onc ern as people are c arried together with the goods to be c ooled. Specific barriers affect the sector, for example, size limitations are problematic for the use of active CO2 systems given the layout of existing trucks. Further design work would be needed to provide viable alternatives that are widely applic able across the market. Refrigeration systems used under transport especially need high energy efficiency to travel long distances. Trucks drive from the Arctic Circle to southern Spain and are exposed to great fluctuations in outside temperature, while safety of the refrigeration system is also crucial as it carries people and various materials. There is no non-PFAS alternatives yet available to meet the required performanc e, energy efficiency and safety. CO2 systems are c urrently not reliable systems due to restrictions in available space and increase in energy consumption. Therefore, continued need for fluorinated gases is expected in the transport of refrigerated goods over long distances and variable operating conditions between warm and cold climate. However, the 'Pathway to net -zero cooling product list' contains a range of examples of natural refrigerant-based equipment already in use in transport refrigeration and suggests that focus in this sector is now focused on natural alternatives including CO2, ammonia, liquid nitrogen and hydrocarbons99. The main barriers that need to be overcome in order to allow for an inc reased uptake of natural refrigerant alternatives to fluorinated gases in the sector is proper training and competence, high costs (CO2), safety standards (propane), production and availability of parts (compressors) and technology/design development for some applications. Transport over long distances and variable operating conditions between warm and cold climate represent a spec ial c hallenge that need to be addressed for transport refrigeration. Time to address those barriers is estimated to 5-10 years by some stakeholders. 99 https://cooltechnologies.org/pathway-to-net-zero/, date of access: 2023-01-13. 249 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) One stakeholder noted that the applicability of alternatives in transport refrigeration is limited due to safety c oncerns, for example in ferries or tunnels. For marine applications, due to safety, care must be taken with equipment with flammable refrigerants. However, ammonia and CO2 refrigerants are often used either alone or in cascade systems in new ships. Mobile air conditioning (MAC) In mobile air conditioning CO2 can be used in place of fluorinated gases in electric vehicles and combustion engine vehicles with electric compressors (hybrid and plug-in hybrid cars). CO2 is unsuitable for combustion engine vehicles with mechanical compressors, as the compressor's leak resistance durability is challenging due to high pressures. CO2 can also be used for buses under the same conditions as described for passenger cars. For trucks CO2 reliability/durability has not yet been proven. Extensive field testing c overing different aspects of operation should be fulfilled prior to introduction. Volkswagen has develped a car with CO2 -based air conditioning, which is used by e.g. the German Environmental Protection Agency, UBA100. The CO2 system c ools the vehicle interior very fast and is energy -efficient. The new mobile air c onditioning system with CO2 uses even less energy than the serially produced system with the fluorinated gas HFC-134a. However, in the future due to best energy efficiency, propane should be used according to stakeholder input, although research and development is still needed for implementation. An estimate has been provided of an additional cost of 300/vehicle for adoption of CO2 MAC systems. The motor industry regards this as too expensive for adoption other than as an option. Assuming leakage of the full quantity of fluorinated gas used in a s ystem over its lifetime, a restriction would cost less than 1 000/kg gas which is the lower indicative benc hmark of proportionality derived by Oosterhuis et al. (2017). Secondary loop systems (SL-MAC) based on HFC-152a as refrigerant have been shown to be efficient and safe, see Section A.3.8. HFC-152a (CHF2-CH3) is not a PFAS and is outside of the scope of the restriction proposal. Its GWP is 138 (Chen et al., 2020). SL-MAC systems with propane (HC-290) as an efficient refrigerant are also currently being explored. Air is already in use as refrigerant in air conditioning in trains and aircraft (Hafner and Ciconkow, 2021). One stakeholder indicated that elastocaloric cooling could be commercialised within 5 years for heat pumps and mobile air conditioning. Electronics cooling, heat exchanger part with fluorinated gases or other refrigerants Large, isolated data centres may be able to use alternative refrigerants such as ammonia without problems for cooling. Small systems may be cooled using basic ventilation or smallscale AC systems for which hydrocarbon charge size would not be problematic. Water is also an alternative refrigerant for the safe and efficient c ooling of data c entres. E.2.8.2.3. Foam blowing agents The availability of natural foam blowing agents as alternatives to fluorinated gas es is described in detail in the report "Natural Foam Blowing Agents - Sustainable Ozone- and Climate-Friendly Alternatives to HCFCs" by Deutsche Gesellschaft fr Internationale 100 https://www.umweltbundesamt.de/en/topics/climate-energy/fluorinated-greenhouse-gases-fullyhalogenated-cfcs/application-domains-emission-reduction/moble-air-conditioning-in-cars-busesrailway/mobile-air-conditioning-climate-friendly, date of access: 2023-01-13. 250 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Zusammenarbeit (GIZ), 2009101. In the report it is explained that hydrocarbons are the preferred blowing agent in the manufacturing of refrigeration appliances in many regions and are entering other applications as well. Pentane offers long-term environmental benefits (no ODP and very low GWP) at comparably low costs; it has good ageing characteristics and thermal insulation properties and is readily available in most regions. Safety risks associated with pentane, such as flammability, have been successfully controlled by implementing safety procedures and installing sound safety systems within companies. CO2 is also used as a blowing agent in many applic ations. Already in 2009 it was stressed that pentane or CO2 can be used as blowing agents in all types of rigid XPS foam, rigid PUR foams and flexible PUR foams, and the technology has been successfully used by several large manufacturers for many years to produce high-quality products. Isobutane (with co-blowing agents) is also a major alternative to blowing agent for XPS. Cyclopentane is a viable alternative blowing agent for materials used in domestic appliances. However, several stakeholders have claimed that non-PFAS alternatives to fluorinated gas blowing agents are unsuitable due to fire performanc e, energy efficiency and durability. HFOs/HCFOs have been estimated by stakeholders t o provide best-in-class insulation improving by up to 20% the values achieved by hydrocarbons. In applications with space constraints, having excellent insulation values is a must to achieve the required levels of insulation. Another stakeholder c laimed that non-PFAS blowing agents exist, but they do not provide the same level of thermal performance and can therefore be detrimental to energy saving goals within the built environment. It may be argued that the insulating properties of foam blown with natural gases are slightly reduced, and therefore that in order to reach the same insulating effect, a thicker layer of foam will need to be used with the alternatives. In certain cases with volume or area limitations, this may be a relevant factor. Proper insulation of buildings is one of the most effective ways to reduce CO2 emissions and is considered an important means to achieving more energy-efficient design for commercial and domestic buildings in the future. One-component caulking foam cannot expand on release from the can without a blowing agent. However, the blowing agent does not support the insulating effect of the foam. Most of it is emitted during applic ation. The propellant gas in canned PU foam, which was previously often fluorinated gases, has now been replaced by hydrocarbons. For PU spray foam the major challenge relates to the safe processing of these systems under in-situ conditions within a building. The potential for the accumulation of blowing agent in `pockets' creates the risk of fire or explosion if flammable materials are used. Water-blown foam is also used, but there are challenges with dimensional stability (including density which increases costs) and insulating capability (UNEP, 2018a). On this basis some stakeholders c laim that low-pressure spray polyurethane foams in self-contained cylinders is a nic he reliant on fluorinated gases as blowing agents in a 10 years' perspec tive. Galden SV110 is also a PFAS used as foam blowing agent in PU insulation foam, however, this is a perfluoropolyether (PFPE) substance and is not considered a fluorinated gas. E.2.8.2.4. Solvents Some of the fluorinated gas type substances exist in the liquid form at ambient conditions - at least long enough for use as solvents. The applications of fluorinated solvents are very diverse as solvents are used widely due to their spec ific properties. Alternatives will need to be assessed on a case-by-case basis. In general, there are many potential non-PFAS alternatives to fluorinated solvents. Solvent selection is based on effectiveness, compatibility, stability, toxicity, environmental properties and physical properties. No single solvent is likely 101 https://www.ctc-n.org/resources/natural-foam-blowing-agents-sustainable-ozone-and-climatefriendly-alternatives-hcfcs, date of access: 2023-01-12. 251 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) to fit all uses, but for a given application often a suitable alternative can be found. In some cases a completely different solution/technology can be used that provides the service that the fluorinated solvent delivers. In the present assessment no alternatives have been identified for the use of fluorinated gases/solvents as industrial precision cleaning fluids and cleaning fluids for use in oxygenenriched environments, or for the use of such substances in solvent-based debinding systems in 3D printing, and as a smoothing agents for polymer 3D printing applications. Information about potential alternatives for such uses is in general difficult to find without first -hand knowledge of the specific applications. E.2.8.2.5. Propellants In general, non-PFAS alternatives to fluorinated gas propellants are widely available. However, no single alternative will work for all applic ations and different solutions may need to be selected for different applications. Nitrous oxide is used in some food applic ations (spray cream) but its use as a propellant is limited because of potential for misuse as a recreational drug with serious side effects. The c ompressed gases generally have lower c apacity per can than other options. The liquefied gases that have been identified are all hydrocarbons with flammability risks. Despite these risks they are used widely and safely in the domestic market. Not-in-kind alternatives such as trigger sprays are also widely used but typically have an inferior quality of spray (inconsistent particle size and spray rate) which is limiting for some applications. Bag-on-valve alternatives overcome a number of these issues (the propellant has the properties of the compressed gases but remains inside the can). However, they are not appropriate for applications where the propellant also acts as a solvent for the payload (for example, products where the can needs to be shaken before use), or the propellant is the payload (e.g. air dusters). E.2.8.2.6. Cover gases Alternatives to fluorinated gases used as cover gases include sulphur dioxide and argon, as well as salt fluxes and powdered sulphur as a not -in-kind alternative. The most likely option is SO2 for which there is a long history of successful use in the magnesium casting industry. SO2 is toxic and c orrosive, but systems have been developed to c ope with these risks. E.2.8.2.7. Fire suppressants There are several alternatives that may be used for different applications within the sector when considering technical function. However, with several of the alternatives there are certain drawbacks, so the fire suppressant must be selected carefully for a given applica tion. For example, for blends containing CO2, there is a risk of serious human health effects of progressive severity as CO2 concentration increases above 4%. Water mist technologies may not be used where water-sensitive equipment requires protection. For some parts of the market there appears to be a lack of alternatives to the use of fluorinated gases that are clean (not leaving residues), of limited toxicity and fast acting. For example, for total flooding agents, stakeholders claim that there are no drop in alternatives available that are considered clean. There is also no indication that a non-PFAS solution will be available in the near future. E.2.8.2.8. Other Insulation gas in electrical equipment Clean air technology has been introduced to replace both SF 6 and fluorinated gases as insulating gas in electrical equipment, together with dry air (mix of nitrogen and oxygen) and vacuum. However, for high voltage switchgear the technology is still in development. A full fluorinated gas free portfolio up to 145 kV is already available and in operation. Some products e.g. instrument transformers up to 420 kV are also available. By 2026 high-voltage electricity products up to 420 kV may start to be replaced with non-PFAS alternatives. However, it is 252 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) expected that some time beyond 2026 will be needed before a full transition to clean air tec hnology for high voltage applic ations is applic able. Semiconductor manufacture No substitutes for the use of fluorinated gases for plasma etching and chamber cleaning in semiconductor manufacturing processes has been identified. However, information about potential alternatives for such uses is in general difficult to find without first-hand knowledge of the specific applications. IT hardware immersion cooling Alternatives to immersion c ooling of electronics include different not -in-kind technical solutions that have been in use for many years. Preservation of cultural paper-based materials Alternatives to the technologies for preservation cultural heritage materials based on fluorinated solvents must be completely chemically inert to protect sensitive objects. However, no such alternative approach has been identified. E.2.8.2.9. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classif ication, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. Non-chemical alternatives are also listed in the table. In relation to fluorinated gases, various alternatives were non-chemic al in nature. The list of alternatives contained 29 unique CAS numbers. Twenty-seven (27) of the substances with unique CAS were classified according to CLP (harmonised classification or self -classification). Twenty-two of the substances with unique CAS number did, according to t heir registration dossier, not fulfil the PBT or vPvB criteria and for 3 of them, no data was found or PBT/vPvB properties were not applicable, meaning that none of these substances were known to fulfil the PBT or vPvB criteria. No other hazard properties were mentioned. The list contained an additional 2 substances for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.8.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.8.1, assuming business-as-usual and, consequently, on-going PFAS use and emissions. The analysis of environmental impacts focuses on two restriction options: RO1, adopting a ban of all PFASs used in HVACR and other fluorinated gas applic at ions; RO2, adopting a ban on PFAS in combination with use-specific derogations. Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation. Environmental impacts of RO1 are analysed quantitatively. In contrast, for the use-specific derogations emission data were lacking except for two derogations. There is, however, 253 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) information whic h PFASs are c overed by a particular derogation. Where use-specific emission data are lacking, environmental impacts of RO2 are, therefore, evaluated qualitatively in relation to maximum additional emission scenario assuming a full derogation of all fluorinated gases. Note that this maximum additional emission worst -case scenario does not represent a restriction option but is used for better anchoring a proposed derogation. Table E.85 below summarizes the characteristics of the restriction options, and of the maximum additional emission scenarios. Table E.85 Characteristics of restriction options benchmark scenarios. Restriction option a bbr e v ia tio n RO1 RO2 (5 years) RO2 (12 years) Maximum additional emission scenario Maximum additional emission scenario Short description Full ban Ban with specific derogations use- Ban with specific derogations use- Ban with full derogation of entire PFAS groups Ban with full derogation of entire PFAS groups Derogations --- Derogations for defined uses of fluorinated gases All fluorinated gases All fluorinated gases Transition period after entry into force 18 months 18 months 18 months 18 months 18 months Duration of derogation --5 years 12 years 5 years 12 years Note that the assessment of environmental impacts excludes environmental impacts arising from fluorinated gases used in mobile air c onditioning and transport refrigeration as they are assessed in the transportation sector. For calculating the expected emission reduction, the assumed entry-into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restric tion options are expec ted to be implemented in 2027. All emission estimates represent mean values. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.86 shows mean emissions and the expected mean emission reduction for time paths of 30 and 45 years (starting in 2025). Table E.86. Total mean emissions and emission RO1 and of maximum additional emission scenarios (fluorinated gas sector, in tonnes). Restriction option Baseline RO1 Maximum additional emission scenario `5-year derogation of all fluorinated gases'* Maximum additional emission scenario `12-year derogation of all fluorinated gases'* Mean total emissions [t] 2025-2055 1 942 313 92 580 340 724 732 110 Mean total emission reduction [t] --1 849 734 1 601 589 1 210 204 Mean total emission reduction [%] --95 83 62 254 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Baseline RO1 Maximum additional emission scenario `5-year derogation of all fluorinated gases'* Maximum additional emission scenario `12-year derogation of all fluorinated gases'* Mean total emissions [t] 2025-2070 3 406 681 92 580 340 724 732 110 Mean total emission reduction [t] --3 314 102 3 065 957 2 674 572 Mean total emission reduction [%] --97 90 79 *Maximum additional emission scenarios denote worst-case emission scenarios (assuming a full derogation of a particular PFAS group) against which emissions of proposed use -specific derogations are evaluated qualitatively. They do not represent restriction optio ns. Refrigeration: (i) Proposed derogation: Refrigerants in low temperature refrigeration below -50C The derogation is proposed for a time period of 5 years after EiF of the restriction and the 18 months transition period. Alternatives for the use are available and technically feasible. However, according to stakeholder input alternatives may be less flexible with regards to operating temperature ranges. Compared to a ban (RO1), a derogation will cause additional emissions. A 5-year derogation of all fluorinated gases use for industrial refrigeration causes additional emissions of 111 705 t. There is no evidence available about the precise amount of additional fluorinated gases emissions from this spec ific derogation, or the prec ise fraction of emissions c ompared to a full derogation of fluorinated gases use for industrial refrigeration. However, they can be expected to be small compared to a derogation of fluorinated gases uses for industrial refrigeration (about 10% as a worst case estimate) as only a limited number of industrial and commercial applications exist (e.g. storage of material for medical or biochemical use, such as vaccine preservation). Compared to a maximum additional emission scenario (i.e. a derogation of all fluorinated gases use, see Table E.86), additional emissions from the proposed derogation would account of <1%. (ii) Proposed derogation: Refrigerants in laboratory test and measurement equipment The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Alternatives for the use are available and technically feasible. However, according to stakeholder input alternatives may be less flexible with regards to operating temperature ranges. Compared to a ban (RO1), a derogation will cause additional emissions. A 12-year derogation of all fluorinated gases use for industrial refrigeration causes additional emissions of 136 680 t. There is no evidence available about the precise amount of additional fluorinated gases emissions from this specific derogation, or the precise fraction of emissions compared to a full derogation of fluorinated gases use for industrial refrigeration. However, additional fluorinated gases emissions from this derogation can be expected to be very small (<10% compared to a derogation of all fluorinated gases use for industrial refrigeration) as the use of fluorinated gases is limited to laboratories only and comprises very small volumes compared to the other applications, in particular fluorinated refrigerants. Compared to a maximum additional emission scenario (i.e. a derogation of all fluorinated gases use, see Table E.86), additional emissions from the proposed derogation would account of <1%. (iii) Proposed derogation: Refrigerants in refrigerated centrifuges The derogation is proposed for a duration of 12 years after EiF of the restriction and the 18 255 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) months transition period as no alternatives have become known so far that may be operated safely. The availability of non-PFAS alternatives is limited as a rotor failure would risk a ruptured refrigerant system and a hazard to the area where flammable refrigerants or highpressure systems are used. However, safe alternatives may be developed over time. A derogation of all fluorinated gases use for industrial refrigeration c auses additional emissions of 136 680 t. There is no evidence available about the precise amount of additional fluorinated gases emissions from this specific derogation, or the precise fraction of emissions compared to a full derogation of fluorinated gases use for industrial refrigeration. However, emissions can be expected to be small (about 1% as a worst case estimate) as the application is limited to uses in laboratories and small-scale preparations. Compared to a maximum additional emission scenario (i.e. a derogation of all fluorinated gases use, see Table E.86), additional emissions from the proposed derogation are considered to be marginal (<0.01%). Air conditioning and heat pumps: (iv) Proposed derogation: Maintenance and refilling of existing HVACR equipment put on the market before [18 months after EiF] and for whic h no drop-in alternatives exist The derogation is proposed for a time period of 12 years after EiF of the restric tion and the 18 months transition period. HVACR equipment based on fluorinated gases is widespread nowadays and comprises both professional and consumer applications (e.g. domestic, commercial and industrial refrigeration, mobile and stationary air conditioning, and heat pumps). Therefore, a derogation of the use of fluorinated gases in existing HVACR equipment can be expected to cause additional emissions which are substantial compared to a full ban (RO1). As a starting point reference, a 12-year derogation of all fluorinated gases use in c ommerc ial and industrial refrigeration (the relevant use c ategory for this derogation), mobile and stationary air conditioning will lead to additional emissions of 349 889 t, which is more than 3 times higher than emissions under a ban of fluorinated gases (RO1) and would be about 50% of a maximum additional emission scenario (i.e. a derogation of all fluorinated gases use, see Table E.86).No evidence is available about the precise amount of addit ional fluorinated gases emissions from this specific derogation. It is, however, plausible to assume that fluorinated gases emissions will gradually decrease over time as new equipment based on non-PFAS refrigerants will be introduced, which will make refilling redundant. The time period required to achieve a significant substitution is not known. If the gradual replacement occurs to be slow, high additional emissions can be expected for several years or even decades to come. At the same time, terminating c urrent HVACR equipment with many years of service life left will likely also cause environmental impacts, as energy and other resources would be needed to replace functional equipment. (v) Proposed derogation: refrigerants in HVACR-equipment in buildings where national safety standards and building c odes prohibit the use of alternatives A time-unlimited derogation is proposed which is justified by existing national safety standards which limit the use of hydrocarbons, ammonia or CO2 as alternatives. So far, national safety standards and codes limiting the use of non-PFAS alternative refrigerants still apply to some EU c ountries, but there is progress to amend the standards and allow for the use of some flammable alternative refrigerants. Therefore, it is expect ed that equipment based on alternatives become safer and more widely used. The time period required to achieve a significant substitution is, however, not known. A time-unlimited derogation of the use of fluorinated gases for refrigerants in HVACR equipment can be expected to cause additional emissions which are substantial compared to a full ban (RO1). As a starting point reference, and based on available data, a 30-year derogation of all fluorinated gases use in stationary air conditioning and heat pumps (the relevant use category for this derogation) will lead to additional emissions of 429 022 t, which is more than 4 times higher than emissions under a ban of fluorinated gases (RO1) and would be about 60% of a maximum additional emission scenario (see Table E.86). No evidence is available for evaluating the precise 256 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) amount of emissions of this derogation. It can, however, be assumed that, additional fluorinated gases emissions are medium (50% as worst-case estimate) and will decline over time. The latter depends on the speed of substitution. If the gradual replacement occurs to be slow, additional emissions can be expected for several years or even decades to come. Foam blowing agents: (vi) Potential derogation marked for reconsideration: Foam blowing agents in expanded foam sprayed on site for building insulation The derogation is considered for derogation for a time period of 5-years. While, technically, non-PFAS alternatives exist, further development is needed in order to identify prac tical and safe operation conditions. In particular, the safe processing of PU spray foam under in-situ conditions within a building is difficult due to a high risk of fire in the cases where hydroc arbons are used as alternatives. While water-blown foam c an also be used, there are challenges with dimensional stability and insulating capability. Spray foam represents a minor part of the emissions from the foam blowing agent segment. Most of the quantified emission should be for fac tory production of boardstock and insulation for spec ific produc ts given that this dominates the market . For the latter emission estimates are available, whic h ac count of approximately 10% of total emissions of fluorinated gases (all applic ations). A derogation of the use of fluorinated gases in foam blowing agents can be expected to c ause additional emissions c ompared to a full ban (RO1). As a starting point reference, a 5-year derogation of all fluorinated gases use in closed cell foam blowing will lead to additional emissions of 108 047 t, which is slightly higher than emissions under a ban of fluorinated gases (RO1). Though evidence on the precise amount of emissions resulting from this use -specific derogation is lacking, it is expected that additional emissions of the derogation correspond to approximately 10% compared to the maximum additional emission scenario scenario(i.e. a full derogation of fluorinated gases use). Solvents (vii) Proposed derogation: Industrial precision cleaning fluids The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. According to limited information available no suitable alternatives are known as yet. The applications of fluorinated gases as solvents are very diverse as the gases are used widely due to their specific properties. Alternatives will need to be assessed on a case-by-case basis, and the necessary information is not yet available. A derogation of the use of fluorinated gases in solvents can be expected to cause additional emissions compared to a full ban (RO1). As a starting point reference, a 12-year derogation of all fluorinated gases use in solvents will lead to additional emissions of 92 730 t, whic h is slightly higher than emissions under a ban of fluorinated gases (RO1). Evidence for a qualitative evaluation of expected additional fluorinated gases emissions in this application is lacking, but they are expected to be small compared to the maximum additional emission scenario scenario (i.e. a full derogation of fluorinated gases use). (viii) Proposed derogation: Cleaning fluids for use in oxygen-enriched environments The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. According to limited information available no suitable alternatives are known as yet. The applications of fluorinated gases as solvents are very diverse as the gases are used widely due to their specific properties. Alternatives will need to be assessed on a case-by-case basis, and the necessary information is not yet available. A derogation of the use of fluorinated gases in solvents can be expected to cause additional emissions compared to a full ban (RO1). As a starting point reference, a 12-year derogation of all fluorinated gases use in solvents will lead to additional emissions of 92 730 t, whic h is slightly higher than emissions under a ban of fluorinated gases (RO1). Evidence for a precise evaluation of expected additional fluorinated gases emissions in this application is lacking, 257 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) but they are expected to be small. (ix) Potential derogation marked for reconsideration: Industrial and professional use of solvent-based debinding systems in 3D printing= 12 years The derogation is proposed for a time period of 12 years after EiF of the res triction and the 18 months transition period. According to limited information available no suitable alternatives are known as yet. A derogation of the use of fluorinated gases in solvents can be expected to cause additional emissions compared to a full ban (RO1). As a starting point referenc e, a 12-year derogation of all fluorinated gases use in solvents will lead to additional emissions of 92 730 t, which is slightly higher than emissions under a ban of fluorinated gases (RO1). Evidence for a precise evaluation of expected additional fluorinated gases emissions in this application is lacking, but they are expected to be small. (x) Potential derogation marked for reconsideration: Industrial and professional use of smoothing agents for polymer 3D printing applications The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. According to limited information available no suitable alternatives are known as yet. A derogation of the use of fluorinated gases in solvents can be expected to cause additional emissions compared to a full ban (RO1). As a starting point referenc e, a 12-year derogation of all fluorinated gases use in solvents will lead to additional emissions of 92 730 t, which is slightly higher than emissions under a ban of fluorinated gases (RO1). Evidence for a precise evaluation of expected additional fluorinated gases emissions in this application is lacking, but they are expected to be small. Propellants (xi) Potential derogation marked for reconsideration: Propellants for technical aerosols for applic ations where non-flammability and high tec hnical performance of spray quality are required A derogation of the use of fluorinated gases in propellants will cause additional emissions compared to a full ban (RO1). As a starting point reference, a 12-year derogation of all fluorinated gases use in propellants will lead to additional emissions of 102 142 t, which is slightly higher than emissions under a ban of fluorinated gases (RO1). Evidence for a precise evaluation of expected additional fluorinated gases emissions in this application is lacking, but they are expected to be small. Fire suppressants (xii) Proposed derogation: Clean fire suppressing agents where current alternatives damage the assets to be protected or pose a risk to human health The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Potential alternatives are available, however, there are drawbacks (e.g. they can cause health effects, or may destroy equipment, or are not considered clean) and therefore fluorinated gases used as fire suppressants are not easily replaceable in the short -term. For this application emission data are available. There is therefore sufficiently strong evidence to evaluate expected emissions in case of a derogation. A 12-year derogation of all fluorinated gases use in fire suppressants will lead to additional emissions of 102 183 t, which is slightly higher than emissions under a ban of fluorinated gases (RO1). Given this evidence it can be concluded that additional emissions of the proposed derogation will account of about 14% of emissions under the maximum additional emission scenario (i.e. a derogation of all fluorinated gases, see Table E.86). 258 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Preservation of cultural paper-based materials (xiii) Potential derogation marked for reconsideration: Preservation of cultural paper -based materials The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Potential alternatives need to be chemically inert in order to protect the sensitive objects. No such alternatives are known as yet. The application covers very low amounts, for which only limited information is available. Evidence for a qualitative evaluation of expected additional emissions is lacking. Still, considering the marginal use of PFAS in this applic ation, additional emissions are likely very small to marginal. Insulated gas in electrical equipment: (xiv) Proposed derogation: Insulating gases in high-voltage switchgear (above 145kV) The derogation is proposed for a time period of 5 years after EiF of the restriction and the 18 months transition period. The main reason is that alternatives are considered not yet ready for all voltage ranges but are in the process of being developed. Fluorinated gases were introduced to replace SF6 as insulating gas in electrical switchgear due to their high climate impac t. Rec ently, alternatives to fluorinated gases in these applic ations have been introduced and are in development for the full voltage range. Hence, even fluorinated gases may be replac ed when technology is ready. Spec ifically, c lean air tec hnology has been introduced to replace both SF6 and fluorinated gases as insulating gas in electrical equipment, together with dry air (mix of nitrogen and oxygen) and vacuum. The required time for substituting fluorinated gases in this application is not known. The amount of fluorinated ga ses in this application is considered significant use but small in comparison to other main applications such as refrigeration and foam blowing agents. Evidence for a qualitative evaluation of additional emissions is, however, not available. It can be expected that a derogation will cause limited emissions due to low leakage rates. Figure E.13 displays the time path of mean emissions for the different calculated scenarios. Figure E.13. Time path of mean emissions under the baseline, RO1, and maximum additional emission scenario (fluorinated gases sector, in tonnes). Source: Own calculations based on data collated by the Dossier Submitters. 259 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.8.4. Economic impacts E.2.8.4.1. HVACR in the domestic sector Refrigeration No economic (or other) impact is expected as a result of a restriction on the use of fluorinated gases in the domestic refrigeration sector given that the market has switched away from fluorinated gases already. Models of all sizes up to larger `American-style' refrigerators were identified that operate with hydrocarbons as alternatives to F -gases. Air Conditioning and Heat Pumps The use of air conditioning and heat pumps are both significant to meeting European carbon reduction objectives though for different reasons. The use of heat pumps reduces demand on fossil fuels and their widespread adoption is seen as an essential measure for moving to net zero emissions of greenhouse gases. The growing use of air c onditioning, however, linked to inc reased affluence and a warming c limate, places additional demands on the energy system. The most likely alternatives for domestic air conditioning and heat pumps are hydrocarbons such as pentane. However, several stakeholders that responded to the consultation expressed concern over the safety implic ations of using hydrocarbons for air c onditioning and heat pumps in the domestic sector. Concern has also been raised in relation to the sale of split air conditioning systems using propane refrigerant for installation by non-professionals some of whom will inevitably lac k the appropriate tools, skills and knowledge to ensure safe fitting of the equipment102. The European Commission has investigated barriers arising from codes, standards and legislation to using climate-friendly technologies in the refrigeration, air conditioning, heat pump and foam sectors (EC, 2016b) indicating the need for update of standards, improved data collection on risk management for flammable refrigerants and review by Member States of restrictive national codes, standards or other legislation102. The later report (EC, 2020b) concluded that standards and codes were unnecessarily restrictive to the use of A3 refrigerants for new single split ACs (air conditioners) with a cooling capacity <7 kW. The report c oncluded that it was still nec essary to use fluorinated gases in single split ACs with a cooling capacity >7 kW, but this conclusion seems to reflect the limited availability of propane based ACs of this size on the market. It was, however, noted that at a global level there is some adoption of systems with larger charge sizes., indicating that they can compete on the market with equipment using fluorinated gases. There is strong aversion from some stakeholders to the use of systems charged with propane in some situations, particularly in high rise buildings, and indeed this may be prevented by national or local building codes. Some stakeholders went so far as to say that there is no alternative to HFOs (specifically R-1234yf) for the heat pump market because of concerns over the safety of using hydrocarbons (referred to both in the CfE and 2nd stakeholder consultation, though this position is not supported by the European Commission's conclusions on use of hydrocarbons in AC systems (EC, 2020b). It is noted that there is c lear overlap in the analysis of alternatives in this area between the review of the F-gas regulation and the development of the universal PFAS restriction. Domestic Use of Heat Pumps in Clothes Dryers Many models of clothes dryer are already using hydrocarbons rather than fluorinated gases 102 https://www.coolingpost.com/uk-news/sales-of-r290-splits-to-diyers-is-irresponsible/ and https://www.coolingpost.com/world-news/ec-report-creates-f-gas-confusion/, date of access for both: 2023-01-13. 260 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Review of price data online indicated that heat pump tumble dryers tended to be more expensive, though this would be mitigated through lower energy costs when in use. Available information suggests that there is no clear economic impact of a restriction on producers of heat pump clothes dryers or consumers. Some manufacturers may need to adapt to the use of hydroc arbons, and c ould inc ur R&D and retooling c osts, but many have already made this switch. Similarly, there are unlikely to be significant environmental, health or social c onsequences of a restric tion, given that it would have little impac t on the market. A summary of information on the cost elements identified at the start of this section is provided in Table E.87. 261 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.87. Summary of Information on the Costs of Alternative Options for Refrigeration, AC, Heat Pumps for Space and Water Heating and Heat Pumps for Clothes Drying for the Domestic Sector Relative to the Costs of Continued Use of fluorinated gases. Cost element Commentary 1. R&D costs of designing equipment to utilise alternative refrigerants. R&D costs for using hydrocarbons have already been incurred by manufacturers of heat pump clothes dryers and refrigerators, and some manufacturers of AC systems. 2. C osts for certification of new Unknown, but costs would be spread across bulk sales in the product in some markets. domestic marketplace. 3. Difference in the cost of equipment using fluorinated gases and equipment using alternatives. Based on information regarding the costs of AC s using different refrigerants, there may be an increase in equipment costs (6-10%), but data may simply reflect the current state of the market, before economies of scale come into play. There would be no effect on the cost of refrigerators as these are already almost entirely reliant on the use of propane. Review of market data on the cost of heat pump clothes dryers indicated no systematic difference in price between propane and fluorinated gas models. 4. Variation in the costs of Propane is cheaper than the fluorinated gases that it would alternative refrigerants. replace, offsetting any price differences. 5. Variation in running costs. Running costs appear similar for fluorinated gas and propane options. 6. In the event of increased energy losses through the use of technologies that are less energy efficient, additional costs of abatement for greenhouse gas emissions elsewhere in the economy to ensure that climate goals and targets are met. Efficiency data suggest similar energy usage. 7. Potential for PFAS-dependent Manufacturers of refrigerators and European heat pump operations to cease leading to clothes dryers are unlikely to be affected given their current reduced market share and models. Manufacturers of AC and heat pumps for space and possible closure of businesses. water heating may be less prepared for change and could be exposed. E.2.8.4.2. HVACR in the commercial sector The c ommerc ial sec tor ranges in sc ale from small venues, suc h as individual shops, to large shopping malls and office buildings. Refrigeration Commercial refrigeration utilises different systems according to situation. Where there is limited need for refrigeration, small units similar to domestic refrigerators and freezers may be used, with hydrocarbons a typical and growing choice as refrigerant and also CO2. Hydrocarbon charge is typically around half of the fluorinated gas charge (UNEP, 2019a). 262 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Medium-sized systems with refrigerating capacities between 1 kW and 20 kW can use condensing units, featuring several display cases linked to a small machine room. Fluorinated gases are commonly used as the refrigerant. The transition from high GWP refrigerants in this part of the sector is mainly towards low GWP HFCs, HFC/HFO blends and HFOs. Use of propane is growing more slowly, but safety standards are improving, with better leak protection and technical improvements that reduce charge size. There is research on the use of CO2 but so far these have not extended beyond the trial stage. (UNEP, 2019a). Larger c entralised and distributed systems are used in supermarkets, operating with rac ks of compressors either in a machine room or on the rooftop linked to cooling coils in the display cabinets or cold rooms. Refrigerant charges of these systems can be large, between 100 kg and 3 t depending on the size of the supermarket. All parts of the system are linked, leading to the potential for very high loss through leakage. Since 2000 there has been increased interest in using propane, propene, ammonia and CO2 in this part of the commercial refrigeration sector, and they have started to penetrate the market. CO2 based systems have been installed in supermarkets up to 7 000 m2 in size (sheccoBase, 2020). Trans-critical CO2 systems have been built in most European c ountries inc luding c ountries with hotter c limates previously considered unsuitable for the technology. Another option, `indirect' centralised systems is available featuring cascading systems that transfer heat from circuit to circuit, providing an optimised system by combining the use of different refrigerants such as CO2 or glyc ol inside stores with refrigerants suc h as hydrocarbons, ammonia, or HFO/HFO blends in the outer machine room loop (the `primary refrigeration circuit') (EC, 2017). Targeted legislation in Luxembourg and Sweden has particularly favoured their introduction. Trans-critical CO2 (Ma et al., 2013) and small stand-alone systems are c ited by the European Commission as being cost-competitive with conventional fluorinated gas systems. In Spain, stand-alone systems based on hydrocarbons and CO2 have demonstrated energy savings of 20% compared to stand alone systems using HFCs (EC, 2017). It should, however, be noted that comparisons of different systems are not always reliable, for example comparing the latest technology for one refrigerant with yesterday's technology for an alternative. From the stakeholder consultation information was gathered to indicate that the lifetime of medium and large equipment is in the order of 15 to 25 years, and that it would take 10 to 12 years to develop new products and take them to market. On this basis, there is a significant lifetime remaining, in the order of decades, for equipment that is already in place. Commercial Air Conditioning and Heat Pumps Smaller systems, stand-alone ACs and single split ACs, were discussed above under the domestic sector. This section considers larger systems (UNEP, 2019a), acknowledging that some may also be used outside of the commercial sector: Multi-split ACs with capacities of 10 kW to 150 kW and typical charge levels of fluorinated gases of 0.30 to 0.70 kg/kW of cooling Split ducted ACs with capacities of 7 kW to 1 100 kW and typical charge levels of fluorinated gases of 0.26 to 0.35 kg/kW of cooling Ducted commercial packaged ACs with capacities of 7 kW to >700 kW and typical charge levels of fluorinated gases of 0.30 to 0.50 kg/kW of cooling Most systems are based on fluorinated gases. Propane is c urrently mostly restric ted to small applic ations because building c odes and other regulations limit c harge size. It is used in some bigger systems including split and rooftop ducted systems (UNEP, 2019a). Air cooled CO2 AC systems are available in capacities from 3 kW to 300 kW, though systems become inefficient at high ambient temperatures. Available data, and information gained through the CfE and the 2nd stakeholder consultation, indicate limited options for commercial AC systems at the present time, though research on the use of CO2, especially in cooler climates, is continuing. Another category of AC systems is chillers, that provide indirect cooling by using a primary 263 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) coolant that chills a secondary coolant, which is then distributed and used to cool air or another substance. These chillers are used in a wide range of applic ations from sc hools and commercial buildings to pharmaceuticals and mining to data centre cooling. Chillers tend to operate for many years and have been reported to last worldwide `not uncommonly for over 40 years' (UNEP, 2019a). Most applications use fluorinated gases though there are some `less common' cases where propane, ammonia, CO2 and water are used as the coolant. Across Europe there is some penetration of options into the chillers market using alternatives to Fgases. UNEP (2019a) refers to a number of applic ations of ammonia, hydroc arbons and CO2 in Europe, though these do not extend to the full range of chiller sizes, and other `emerging' refrigerants include HFOs, HCFOs and lower GWP HFCs. The use of water as a refrigerant involves niche markets, for example, desalination plants, deep mines and ice and snow making. For heat pumps, as in other sectors, the main alternatives to fluorinated gases are propane and CO2. Propane is identified for water heaters and space heaters using air source and water/ground source heat pumps, whilst CO2 is listed for water heaters and combined water and space heaters using air source and water/ground source heat pumps (UNEP, 2019a). Ammonia is a further possibility for large systems. Barriers to deployment in the commercial sector as elsewhere are flammability for propane, the high pressure of CO2 systems and the toxicity of ammonia. These factors become increasingly important as the size of equipment increases. However, the presence of alternatives on the market indicates that they are available at a price that is competing with equipment based around the use of fluorinated gases. Summary for HVACR Use in the Commercial Market A summary of information on the cost elements identified at the start of this section is provided in Table E.88. Table E.88. Summary of Information on the Costs of Alternative Options for Refrigeration, AC, Heat Pumps for Space and Water Heating and Heat Pumps for Clothes Drying for the Commerical Sector Relative to the Costs of Continued Use of F -gases. Cost element Commentary 1. R&D costs of designing equipment to utilise alternative refrigerants. R&D costs for using hydrocarbons, CO2 and NH3 have already been incurred by some manufac turers of c ommerc ial equipment. 2. Costs for certification of new product in some markets. Products using alternatives are already in the marketplace. Certification may be required in some instances. 3. Difference in the cost of equipment using fluorinated gases and equipment using alternatives. 4. Variation in the costs of alternative refrigerants. Evidence has been cited that systems using alternatives are cost-competitive, which matches their emergence in the market in recent years. 5. Variation in running costs. 6. In the event of increased energy losses through the use of technologies that are less energy efficient, additional costs of For c ost-competitive alternatives there is no evidenc e of a loss in effic iency. 264 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Cost element Commentary abatement for greenhouse gas emissions elsewhere in the economy to ensure that climate goals and targets are met. 7. Potential for PFAS-dependent operations to cease leading to reduced market share and possible closure of businesses. For fluorinated gas manufacturers impacts will be dependent in part on the way that maintenance of existing equipment is handled in the restriction (see text below table). Equipment manufacturers that have not investigated alternatives could face problems if a restriction were rapidly int roduc ed. Larger systems need regular maintenance to ensure that they are running effic iently and that any leaks are detected early. In the event that a restriction prevented maintenance activities suc h as topping up equipment where leaks had occurred, equipment would become redundant and require replacement. This would generate significant costs to operators, depending on the anticipated remaining lifespan of equipment, given that drop-in alternatives that are not PFAS are unavailable. There may also be issues relating to the availability of engineers to replace units, given the number of installations involved and the fact that there is a majo r roll-out of heat pumps for domestic and other markets at the present time. Premature retirement of equipment would also incur environmental costs, for example through generation of waste. Industrial refrigeration There are many applications of refrigeration in the industrial sector, for example: 1. Elec tricity production 2. Oil and gas industries 3. Chemicals and petrochemical industry 4. Pharmaceutical industry 5. Food and drink industry (accounting for about 75% of the sector) There is not a clear boundary between industrial and (partic ularly) commercial applications: ice rinks, food storage and electronics cooling are examples that could fit into other sectors. Hence, a restriction on use of fluorinated gases in `industrial refrigeration' could vary in scope from country to country according to local interpretation of the term. Refrigerant charges range from a few kg to 80 t and charges over 100 kg are said to be typical (Schwarz et al., 2011). Data included in the exposure assessment (see Exposure Assessment Module) show little change in demand for fluorinated gases for industrial refrigeration in the last decade. However, some respondents to the CfE considered that the use of fluorinated gases is nearing phase-out in the industry sector, with usage representing less than 10% of the industrial refrigeration market and declining further. The dominant refrigerant for the sector is ammonia, selected on the grounds of cost as well as performance, often used in cascade systems with CO2. Indeed, there has been significant uptake of NH3-based systems bec ause they are c ost-competitive with other options. Data on purchase, maintenance and electricity costs (Schwarz et al., 2011) demonstrate reasonably short pay back times compared to HFC use for examples of both small/medium (270 kW cooling) and large (5 MW cooling) systems in the region of 1 to 6 years. Higher capital costs 265 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and some additional maintenance costs were offset by lower energy demand. A potential penetration rate in Europe of 95% was estimated (Schwarz et al., 2011). Concerns over the toxicity of ammonia are reduced for the industrial sector because the industrial setting provides a more controllable environment than commercial settings and because of the separation of systems from members of the public. Ammonia has been the most common option for industries transitioning from HCFCs and HFCs. Other natural refrigerants, CO2, hydrocarbons, water and air also have a role in the industrial refrigerat ion market. The large c harge sizes required in industrial settings are a barrier to the use of hydroc arbons on safety grounds (Schwarz et al., 2011). Given the ready availability of alternatives for the industrial sector it may be co nsidered that industrial refrigeration is an appropriate area for restriction. However, there may be applic ations where alternatives are not appropriate because of the loc ation of the industry or specific operating conditions. This has previously been recognised by commentators on HFC c ontrols (EIA, 2012). The following specific applic ations have been identified through the CfE and 2nd stakeholder consultation: Low temperature refrigeration below -50 C, Laboratory test and measurement equipment Refrigerated c entrifuges, where rotor c rash failure would result in a hazard from both a high pressure system (CO2) or flammable hydrocarbons A number of constraints have been noted for such equipment, relating to precision control, the temperature ranges addressed and in the case of refrigerated centrifuges potential for rotor failure which could compromise high pressure CO2 systems or lead to the release of a significant hydrocarbon charge. For these applications it does not appear that satisfactory alternatives are available on the market. A maximum penetration rate for equipment not based on fluorinated gases of 95% by 2030 was provided by Schwarz et al. (2011), though a further update would be useful. As was the case for commercial HVACR systems, there is a lack of options for retrofitting existing equipment using fluorinated gases to an alternative refrigerant (UNEP, 2019a). Performance can be improved by following proper maintenance regimes and ensuring that leaks are minimised. This is encouraged in part by the increasing prices of F -gas refrigerants stimulated by the phase down of HFCs under the F -gas regulation (EC, 2020a). Electronics Cooling (e.g. at Data Centres) Consideration here has been limited to the fluorinated gases used in the cooling systems. The use of PFAS as immersion fluids on the other side of the heat exchanger has not been considered though it is noted that there are a number of alternative immersion fluids available. Data centres vary in size from small systems generating in the region of 10 kW of heat to systems generating many MW. Some are located in separate buildings whilst many are integrated with the office or other buildings that they serve. Cooling systems vary from basic ventilation and air conditioning for the smallest systems to industrial cooling for the largest. The same issues on alternatives apply to the data centre market as others, relating to the flammability of hydrocarbon systems operating with anything but low charge sizes and the toxic ity of ammonia. In both c ases there are links to restrictive building c odes that would limit applic ation of these options. Overall, addressing c oncerns over safety seems to be the key for a complete move to alternative refrigerants. On time scales, stakeholders commented that the existing stock would need to rely on HFOs and HFCs for the next 20 years at least. Accepting that existing alternatives are not compatible 266 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) with these systems, this time sc ale does not look unrealistic . HVACR sector: Social impacts Soc ial impac ts of the restric tion can arise in several ways. Considering first, employment, the following could occur: 1. Inc reased employment through the development of innovative product lines 2. Reduced employment through loss of market share for EU companies 3. Downstream effects on society through changes in the quality of goods and the price for attaining an equivalent level of service No evidence has been collected to indicate that these effects would be significant for most parts of the HVACR sector. Distributional impacts are a function of the time over which a restriction would be introduced. Companies currently focused on systems based on fluorinated gases would need to adapt to alternatives, whilst those that have already made the transition would benefit. A rapid transition could cause disruption to parts of the market whilst a slow transition would likely not. The number of organisations that would be affected at different parts of the value chain is indicated in Table E.89. The ubiquitous demands for heating and cooling mean that the number of organisations and facilities that could potentially be affected is very large. For some there could be a loss of business (e.g. manufacturers of fluorinated gases), for others there would be a need for retraining and retooling (e.g. installers and service agents). For some downstream users (e.g. many private households) there might be no direct impact. Key to the effects on these groups are the questions of when a restriction would be introduced and how it would be applied to existing facilities, in particular for how long they would be permitted to c ontinue using fluorinated gases. 267 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.89. Value Chain for HVACR in the EU. Refrigerant manufacturer, Fluorinated gas incumbents in Europe: 1 450 blender, importer OEMs: >200 Equipment manufacturers Major components: ~50 Minor components: hundreds Installers of equipment HVACR For buildings: >200 000 businesses Vehicle dealers and repairers: 336 720103 Shops with refrigeration, air conditioning: ~2.7 to 5.4 million104 Cold stores: >1 200105 Downstream operations and end-users Food and drink companies: 286 000 (FoodDrinkEurope, 2019) Public facilities (governance, schools, hospitals, etc.): ~1 million Data centres: >2 000 Residential buildings: 215 million106 Number of motor vehicles: >280 million (AC EA, 2021) HVACR sector: Summary A detailed economic analysis of the HVACR sector is not possible. However, drawing on the information presented above, the following c onclusions are reac hed (see Table E.90). 103 https://www.cecra.eu/, date of access: 2023-01-13. 104 https://www.eurocommerce.eu/about-retail-wholesale/, date of access: 2023-01-13. 105 https://ecsla.eu/, date of access: 2023-01-13. 106 https://ec.europa.eu/energy/eu-buildings-database_en, date of access: 2023-01-13. 268 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.90. Summary of economic effects on the use of fluorinated gases in new HVACR s y s te ms . Area New Products Domestic refrigeration C ost effective alternatives already widely used. No concerns on proportionality. Domestic AC and heat pumps Hydrocarbon based alternatives already on the market for smaller systems. C alls for relaxation of the limits on charge size. Specific situations may continue to be problematic, e.g. use in high rise buildings, where the risks of accidents may be considered to exceed the risks from exposure to fluorinated gases and their degradation products. Domestic clothes dryers (tumble dryers) C ost effective alternatives already widely used. No concerns on proportionality. C ommercial HVAC R1 There is growing acceptance of the use of alternatives using particularly C O2 and hydrocarbons in the commercial sector. However, the sector is still dominated by using fluorinated gases, and the assumption that alternatives are ready to replace them is premature. Further research is being conducted in several areas. Industrial heating and cooling 1 Efficient systems based on ammonia have been in place for many years. Other alternatives to F-gases are also practicable for some industrial applications. 3 specific types of equipment where identification of alternatives is problematic were identified (low temperature refrigeration, laboratory test and measurement equipme nt and refrigerated centrifuges). Electronics cooling Large, isolated data centres may be able to use alternative refrigerants such as ammonia without problems. Very small systems may be cooled using basic ventilation or small-scale AC systems for which hydrocarbon charge size would not be problematic. For existing systems, the rapid introduc tion of a restric tion would be problematic bec ause of the lack of drop-in alternatives, leading to significant economic impacts. The introduction of a restriction requiring large scale retrofitting of cooling systems or replacement of existing appliances seems infeasible. A further generic issue is the existence of building codes at local and national levels that may limit the type of alternatives that can be selected. Review of these c odes would be useful to assess whether they reflect the c urrent state of technology. E.2.8.4.3. Foam blowing agents Ec onomic impac ts to soc iety of a restric tion on the use of fluorinated gases as foam blowing agents arise in several possible ways: 1. R&D costs of developing new foam-blowing agents and of reformulation for different product lines 2. Costs for certification of new product in some markets 3. Costs of re-equipping manufacturing plant to allow the use of alternatives 4. Variation in the c osts of input materials for new formulations 5. Variation in energy usage and associated costs linked to the use of different blowing agents in insulation 6. In the event of increased energy losses through the use of less efficient insulation additional c osts of abatement for greenhouse gas emissions elsewhere in the economy to ensure that climate goals and targets are met 269 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 7. Costs to consumers from changes to insulation quality through increased heating bills 8. Costs to companies operating with the cold chain (food, liquids, pharmaceuticals, etc) from changes to cold storage during transport 9. Potential for PFAS-dependent operations to c ease. Hydroc arbons, particularly pentane, are favoured for a number of applic ations and are already widely used. The market share of hydrocarbons in the foam-blowing sector has increased from almost zero in 1990 to over 50% in the early 2000s and now to close to 60% (UNEP, 2015a). For XPS foams, one company stated that 75% of their XPS is CO2 blown, the remainder is blown using an HFO. Switching to hydrocarbons has also occurred in the phenolic foam sector, where hydrocarbon blown foams are used in less demanding applic ations where there is scope for increased thicknesses of insulation to compensate for the reduced thermal performance and where fire performance is less critical. Fluorinated gas blowing agents are more expensive than the alternatives. A cost differential of a factor 10 has been provided between for HFOs relative to CO2 mixes. The cost of HFO in XPS can be as much as 55% of the total raw material cost, providing a strong rationale for switching to alternatives. The constraint is superior technical quality with respect to insulation, durability, transformation ability and non-flammability. The view of the industry stated several times in the CfE and 2nd stakeholder consultation is that continued use of fluorinated gases is limited to applications where they convey specific advantages that alternatives do not, for example with respect to non-flammability and their performance as an insulator. Indeed, there was some information provided in the CfE indicating that for the switch from HFC-134a there was an initial move to hydroc arbons on the grounds of pric e and GWP performance, but that the same customers were moving back to HFOs because of superior performance on insulation, by up to 20%, than either hydroc arbons or CO2 (water) systems. The price differential to hydrocarbons and CO2 systems means that there has been a move from the use of F-gases in many parts of the foam market. Estimates were provided to indicate that around 10% of the thermal insulation market in Europe is served by PUR/PIR insulation produc ts used primarily in buildings, c onstruction and the c old c hain, whilst a further 8-10% of the thermal insulation market in Europe is served by XPS insulation products, used primarily in construction sector and to a lesser degree, in the industrial sector (e .g. refrigerated transport, RV vans, etc). Key factors cited by stakeholders in the retention of market share for F-gases as blowing agents reflected the issues made above: For discontinuous board/block PU foam the use of pentane would not satisfy the demands of customers seeking better fire-rated products, and significant investment would have to be made to make those alternative production lines c ompliant with the safety regulations. For spray or dispensed foam, the alternative is to go to polyurethane op en-cell products (with CO2 or water blown system). This would not meet the needs of customers looking for better energy efficiency, insulating performance, strength, rigidity and water absorption resistance. There are also concerns over safety in the application of spray foams, particularly. Where foam is formed in-situ typically on building sites, the use of a flammable blowing agent is largely prohibited on safety grounds, recognising the potential exposure of fumes to naked flames and sparks. A further issue raised on this point is that the production of discontinuous board for cold room panels, refrigerated trucks, etc. is often carried out by SMEs for whom switching to pentane or other hydrocarbons is not possible, either bec ause of a large required investment in explosion proof produc tion lines or, more simply, because their operating permit does not allow the storage of highly flammable substances in quantity, providing a further regulatory barrier to the 270 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) adoption of alternatives. For continuous lamination of PU boards and panels as well as XPS foam boards the use of pentane and CO2 would offer poorer insulation resulting in higher energy consumption, in particular, where space is constrained (e.g. building renovation projec ts). It also forces the use of thicker insulation (and higher use of raw materials) to c ompensate the extra insulation required. Furthermore, to use these alternatives, the design of systems in which PUR/PIR foam is integrated, from district heating pipes to water boilers, will have to be fully reengineered (greater thickness of virtually all the alternative thermal insulation produc ts, with higher density and poorer c ompressive strength). This will lead also to missed energy savings when thickness is a fixed parameter or when the alternative insulation product is burdensome to apply, with a likelihood of increased GHG emissions. There was no evidence in either the CfE or 2nd stakeholder consultation that industry has taken steps to make a transition from HFOs for high spec ification applic ations, whic h should not be considered surprising given that the migration from HFCs to HFOs is ongoing and there is no regulatory pressure to go further, although there is pressure linked to the high pric e of HFOs. A major manufacturer cited a period of 7-10 years for developing future alternatives, similar to the time taken to develop HFOs. A number of steps would need to be taken: Chemical re-formulation of PU/PIR systems and XPS boards Development of production lines for manufac ture of the new substance and adaptation of production lines for manufacture of foam products Re-testing and technical validation of the end-use application to meet its requirements Re-testing and obtaining approvals of European and national construction standards that they must comply with. Other views on time frame indicated 15 years to identify an alternative to HFOs, 5 years to carry out all of the steps around reformulation once an alternative became available and 2 years to change moulds. Whilst these estimates can only be considered approximate, being based on a hypothetical substitution with as yet unidentified substances, they indicate that the process of making the transition to an alternative is not straightforward for the markets that would be affected. Estimated c osts of adaption to production lines based on responses to the CfE and 2nd stakeholder consultation provided estimates of 3 million (based on earlier c osts of converting back to F-gases from having used hydrocarbons) to 100 million. It is not possible to extrapolate these figures to derive an overall total for the sector as there is no information of how representative they are of the wider market. However, it is clear that costs would be substantial for some producers. Several regulatory barriers have been identified that could conflict with the introduction of a rest ric tion: Permitting of the storage of flammable substances by SMEs Use of flammable substances on building sites Building c odes that set standards for insulation quality and flammability International rules on the performanc e of insulated truck bodies Requirements for carbon emission controls under the EU Green Deal. The issue of international rules on the performance of insulated truck bodies provides an interesting case where several regulat ory factors come together. Vehicle size is, naturally, a func tion of the road network and other infrastructure. The maximum width of a truc k body is 271 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 2600 mm. The internal width of a truck typically corresponds to the size of two palettes to be transported side by side. Palette size is standardised (to facilitate trade), with the most common size being 1200 x 800 mm. The ATP agreement (agreement on the International Carriage of Perishable Foodstuffs and on the special equipment to be used for such carriage), drawn up by the Inland Transport Committee of the United Nations Economic Committee for Europe sets standards for insulation, requiring heavily insulated, mechanically refrigerated containers to have a K coefficient (for insulation) of <0.4 W.m2/C. this certifies vehicles to refrigerate down to -20 C (Refrigerated Vehicles Test Centre, 2020). The ATP agreement provides confidence through the cold chain that product leaving e.g. a storage facility or a food proc essing site will reac h its destination in good condition. Insulation of the walls of these truc ks has moved to the use of HFO blown XPS. The use of c heaper alternatives would require thic ker insulation to meet the ATP standard, and this would affect the number of palettes that could be loaded. Companies could be affected in different ways: a reduction in the carrying c apacity of vehicles would drive up transport c osts, acceptance of lower insulation standards could reduce the shelf life of foods and other goods. Given that foams are intended to be used for the lifetime of a product there are no problems associated with a restriction on those foams in respect of equipment that is already in use. This is not the case for the use of PFAS as refrigerants (as opposed to foam-blowing agents) for commercial refrigeration, where systems tend to be topped up periodically: in that case a restriction could lead to the premature retirement of existing equipment. Most of the applications identified are for buildings, white goods (particularly refrigerators and freezers) and vehicles, though there are some exceptions such as use in shoes. Many of the foams have a closed structure that retains the blowing agent over the product lifetime. These characteristics may facilitate the collection of foams at end of life (10-20 years for vehicles, decades or centuries for building applications) for recycling. However, the low density and correspondingly high volume of the foams may be a deterrent to establishment of an efficient c ollec tion network for low value rec yclate. The data collected from the literature and stakeholders does not permit a full economic analysis of the impacts of a restriction. A negative impact arising from the restriction would be a reduction in the qualit y of insulation, in terms of both cell structure and the insulating quality of the gas trapped in closed-cell foams. This would lead either to an increase in greenhouse gas emissions or the use of thicker insulation. In some cases, the thicker insulation may be acceptable, though this will not always be the case. Given the life expectancy of foams used in c onstruction and facilities such as distric t heating plant, there would be long-term c onsequences of a restriction for energy effic iency. Table E.91 demonstrates that c yclopentane has roughly a 25-30% higher thermal conductivity than alternative HFOs and HCFOs. Its global warming potential is higher than two of the F-gases shown in table below and lower than one of them. 272 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.91. Comparison of Insulation properties of HFO and HCFO foam-blowing agents with cyclopentane (EFCTC, 2020). HF O1336mzz(Z) HF O1336mzz(E) HCF O1233zd(E) Cy c lo pe nta ne GWP 2 7 1 5 Thermal 10.7 11.5 10 13 conductivity [mW/m.K] The use and release of hydrocarbon blowing agents will inc rease atmospheric volatile organic compound levels, promoting the formation of ground level ozone that is linked to damage to crops, forest, materials and human health. The use of closed foams will limit these releases in the short to medium term through to the end of the service life of the foams. Information on the thic kness of alternatives required to matc h the insulating properties of Fgas blown-foam was provided by some stakeholders. Mineral wool and fibreglass need to be applied in layers approximately twice as thick as for F -gas foams. A better comparison on a like-for-like basis, however, is with cyclopentane where data in Table E.91 suggest that a thickness inc rease by about 25-30% would be needed to match insulation performance. In addition to the effects described above, social impac ts c an arise in several ways: 1. Inc reased employment through the development of innovative product lines 2. Reduced employment through loss of market share for EU companies 3. Job losses through the closure of firms 4. Legacy burdens Neither [1] or [2] seem likely to have a significant impact. Under the existing market there is a diversity of products, some F-gas based and others based on alternatives, depending on what the market will accept. It is unclear how a restriction would foster further product innovation. Information from the CfE indicated that there is limited import of foam-based produc ts into the EU, making loss of market share unlikely for EU c ompanies. A restriction could have a significant effect [3] on SMEs that are less able to adopt alternatives, noting that they may not gain a permit for the handling of signific ant quantities of flammable hydroc arbons. They c ould move to the use of CO2 based systems, though these have limited application given differences in the quality of foam. Market share would then move to companies that were able to use these substances. The magnitude of this effect cannot be estimated from the data collected. Legac y burdens [4] arise through the use of materials that will need to be managed over long (inter- generational) periods. This applies particularly to construction materials where lifetimes are commonly in the order of decades. Low leakage rates from closed-cell foams mean that the blowing agents used will be present in significant quantity when they are no longer needed (either as a result of building renovation or demolition). It has not been possible to provide a detailed economic assessment of the effects of a 273 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) restric tion on the use of F-gases for foam-blowing. The following should be noted: 1. There has been a shift away from the use of F-gases since the 1980s in the PU, phenolic and XPS foam markets, with increased use of alternatives including particularly CO2 based options and hydrocarbons. 2. There remains demand for the use of F-gases in areas where insulation quality, durability and fire protection are critical, and alternative blowing agents do not meet the performance required by downstream users and in some cases by regulation. 3. The higher pric e of F- gas blowing agents (as muc h as a fac tor 10, with blowing agents making up a significant part of the raw material cost of foams) provides a clear economic driver for the use of cheaper alternatives. T his in itself provides some validation that the additional cost of using F-gases is outweighed by the value placed on their performance in specific applications. 4. The F-gases that are currently preferred for the remaining applic ations are increasingly HFOs, following the path laid down by the F-gas regulation. A restriction based on PFAS persistence should thus consider specifically the characteristics of HFOs, HCFOs and their degradation products relative to PFAS more generally as defined under the rest ric tion. 5. One applic ation where particular c oncerns have been noted concerns the use of spray foams on building sites (as distinct from the use of pre-formed boardstock). The use of hydrocarbons is considered to pose a significant fire hazard in this case. This is not to deny that there are other areas (e.g. truck insulation) where concerns have been raised. There is no indication that alternatives that provide the same level of service as the F -gases relative to the key c riteria disc ussed above are c urrently av ailable. This means that the time taken to develop and market an alternative or alternatives that provide a similar level of servic e is highly unc ertain, but it is c lear that the necessary work would take several years to complete. The rapid introduction of a restriction would be problematic with respect to the time that businesses would need to adapt and the consequences for other regulation. The specialist nature of some applic ations creates difficulty for the introduction of alternatives, rec ognising use in nic he applic ations such as truck refrigeration systems, insulation of district heating pipes and insulation of cryogenic gas (LNG) where the use of hydrocarbon blowing agents would be unac ceptable due to interference with leak detection devices. E.2.8.4.4. Solvents Given limited response to the CfE and 2nd stakeholder consultation and limited data on specific applications of F-gas based solvents elsewhere, it is not possible to provide a detailed economic analysis of the effects of a restriction on businesses involved in the production of F-gases, or solvents or solvent -based products based on them, or on the users of those products. The information gathered indicates that these solvents are used in niche applications where there are a number of constraints that make the identification of alternative solvents or approac hes difficult, at best. The applications that have been identified via the CfE and 2nd stakeholder consultation are: Industrial precision cleaning fluids Cleaning fluids for use in oxygen-enriched environments Solvent-based debinding systems in 3D printing for industrial and professional applic at ions Smoothing agents for polymer 3D printing applications for industrial and professional applic at ions. 274 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Impacts could arise in the following ways: Costs of developing new substances for the market R&D cost of reformulating products downstream of the bulk suppliers of F -gases Costs of changing production systems to factor in alternative cleaning methods. Costs of switching from F-gases to alternative solvents Loss of performance associated with switching to existing alternatives Inc reased c osts of other regulation These are discussed below: Costs of developing new substances for the market Industry estimates indicate that the past transitions to new molecules have cost individual companies developing new fluorocarbons in the region of USD 1 billion. An estimate has also been provided based on past experienc e that the development of new substances has taken in the order of 7 to 10 years. A number of activities need to be undertaken before such a substance c ould be plac ed on the market: Produc t development, product testing, production feasibility, building necessary production plant, certification and commercialisation. A complete switch from the use of fluorinated substances could take longer and be more expensive given that the expertise of those currently involved in the manufacture of the substances of concern here is strongly associated with fluorine-based compounds. Discussion with stakeholders revealed no advanced plans for moving on to a next generation of substances. Theoretical possibilities for complying with a restriction and other legislation are: Development of a completely different chemistry that is not based on fluorine but provides similar technical properties regarding solvent strength, non-flammability, low toxicity etc., or Development of F-gases that provide similar performance to the current options but are not persistent in the environment and do not generate persistent breakdown produc t s. The c osts and timesc ales for moving to either of these theoretical possibilities are unknown, but are c learly dependent on the time taken to identify suitable alternatives that are not yet on the market. The estimate of USD 1 billion is understood to cover the costs of R&D. An additional cost has been given by the same respondent to say that the price of developing a new solvent and production facility would run to USD billions, though no further information was supplied to validate this figure. Whilst these costs are considerable, past experience with the F -gases suggests that they would be used across many product groups. Development costs could also be spread over the global market. It may be expected that newly developed propellants meeting the necessary characteristics would be more expensive than the substances that they replac e. However, it is not possible to estimate future prices of such alternatives with any confidence. R&D cost of reformulating products downstream of the bulk suppliers of F -gases One supplier estimated c osts of reformulation in the order of 10 million to whic h should be added any cost-differential between existing chemicals and the alternatives. Another, 275 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) providing pharmaceutical packaging, indicated that transition would take at least 5 years if the alternative material already existed. Associated costs could range from a few 10 000s to several 100 000. Cost would rise further through the need for requalification of product and submission of evidenc e to other regulatory proc esses. It is to be antic ipated that there would be signific ant variation ac ross the solvents sec tor given the different c onstraints applying to different applications. Costs of changing production systems to factor in alternative cleaning methods The introduction of techniques such as plasma cleaning, use of ultrasound, use of supercritical fluids and use of no-clean fluxes would require purchase of new equipment. Costs of switching from F-gases to alternative solvents Available information from companies involved in the sector indicates that the F -gas solvents are a more expensive c hoice than others on the market. This indic ates that the added service benefits of using the more expensive solvents are valued highly by c ustomers. The introduction of the quota system under the 2014 F -gas regulation introduced additional price pressures into the market. Between 2014 and the end of 2016 there was a modest increase in the price of some commonly used HFCs in the refrigeration market, but a very sharp increase through 2017 into 2018 of between a factor 6 and 13 (depending on substance) compared to prices at the end of 2014. Prices have declined since then, but by the end of 2019 were still between roughly 4 and 6 times more expensive than in 2014. The effect on lower GWP alternatives was much smaller, with some seeing prices fall af ter 2017, presumably in response to increased production as companies moved out of the market for the higher GWP substances that were targeted by the F -gas regulation (Kleinsc hmidt, 2020). Loss of performance associated with switching to existing alternatives This has effects at different parts of the value chain depending on application and the extent to which alternatives are able to substitute for the restricted substance. There are several possibilities: a. In the event that a satisfactory alternative is already available, providing exactly equivalent service compared to the substituted substance, end-users would not be affected. Producers of F-gas would be affected through lost sales, though these would be replaced by sales of other substances, either by the original supplier or a competitor. b. In the event that the alternative that is adopted is not as good as the currently used F- gases, impac ts occur at several points in the value c hain: i. Producers of F-gases, who would lose sales, whilst producers of substitute produc ts would benefit. ii. Producers of existing options, who would lose business if they were unable to offer a substitute produc t. Impac ts to these produc ers would be balanced to a greater or lesser degree by those gaining market share. iii. Downstream users who would experience reduced quality of service from the product supplied. This may have several consequences, for example increased maintenance schedules for equipment, reduced equipment lifetime, an increase in interruptions to operations, or inc reased wastage of produc t. c. It is considered unlikely that a replacement for F-gases would provide superior service, partly because alternative solvents are often less expensive than the F-gas equivalent, and partly because of restrictions or the requirement for 276 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) authorisation for other popular industrial solvents in recent years. In time, superior solvents may be developed, but they do not appear to be available at the present time. It has not been possible here to place a value on the difference in performance, as this will vary extensively from user to user. Inc reased c osts of other regulation One respondent noted that most users of trans-1,2 dichloroethylene, nPB and F-gases affected through the F-gas regulation intended to switch to PFAS-based solvents. A restriction that shut off this possibility would mean that the cost estimates used in previous impact assessments could be unreliable. Potential for PFAS-dependent operations to c ease Several respondents to the consultation reported that they would not be able to continue operations in the markets for which they currently provide aerosols if a full restriction on the use of F-gases as propellants was introduced. For some, it was reported that this was likely to lead to company closure. Effec ts through the value c hain are summarised in Table E.92. No attempt has been made to provide an overall cost as insufficient data are available, including on the size of the F -gas solvent sector. The areas likely to be most negatively affected by a restriction would be specialist niche markets where current expertise is focused on continued use of F -gases and alternatives have not yet been identified. Table E.92 lists a number of potential positive impacts. Whilst these cannot currently be ruled out, at the present time they are considerably more speculative than the negative impacts. Few alternatives have been identified that could fit into this category: the most likely options appear to be supercritical fluids, ultrasonics and plasma cleaning for the precision cleaning market (NASA, 2016), though they do not cover all current uses relevant here and have not been subject to detailed assessment for current applic at ions. 277 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.92. Potential Effects Through the Value Chain. Potential negative impacts Potential positive impacts C urrent producers, formulators and distributors of solvents based on F-gases Abandonment of the F-gas solvent marketplace for some producers R&D for development of new substances (potentially shared across a range of applications) Increased market opportunity for producers of alternative solvents Development of new production lines (potentially shared across a range of applications) C losure for companies that are highly dependent on the use of F-gases Producers of products based on carrier solvents (lubricants, etc.) Reformulation costs Recertification costs C losure for companies that are highly dependent on the use of F-gases Increased market opportunity for producers of alternative cleaning systems and lubricants Product manufacturers: Electronics production Electronics maintenance Aerospace Automotive Pharma- ceutical Etc Price increases in solvents and associated products C osts of changes in production systems to facilitate new approaches for precision and other cleaning (e.g. use of ultrasound, plasma cleaning) Possible development of alternatives through research that are: C heaper Technically superior Recertification costs Increased costs of compliance with other regulations relative to estimates made in prior impact assessments End users: Electronics production Electronics maintenance Aerospace Automotive Pharmaceutic al Etc Price increases passed on through the value chain Use of alternatives through research that are: Increased maintenance requirements Increased product wastage Increased downtime of electronic equipment either through component failure or increased time taken for cleaning operations C heaper Technically superior leading to provision of improved service, lower wastage, etc. Social impacts could arise in several ways: 1. Inc reased employment through the development of innovative product lines 2. Reduced employment through loss of market share for EU companies, including in t he event of business closure 3. Downstream effects on society through changes in the quality of goods and the price 278 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) for attaining an equivalent level of service Quantific ation of any of these effects at the present time would be spec ulative, given the lack of specific information on the availability of alternatives for niche applications, and, for example, the extent that they would affect existing participants in the market and new suppliers. However, it is noted that some respondents to the consultations carried out for this assessment are highly dependent on the use of F -gases, and have built their businesses around them. If these businesses are unable to adapt to the new restriction there is a significant risk that they may close leading to loss of employment in the manufacturing sector. Whilst it has not been possible to quantify economic effects, the following observations can be made with confidence: 1. Affected sectors in addition to chemicals include aeronautics, automotive and elec t ronics. 2. Alternatives have been identified for some cleaning applications, though it is not clear how widely these alternatives may be used ac ross the range of c urrent applic ations of fluorinated solvents. Existing applications of fluorinated gases are typically in niches where solvents are required to meet very spec ific c haracteristics, limiting potential to identify alternatives. 3. Alternatives have not been identified for carrier solvents in particular. Options are limited by the specific requirements for solvents and increasing regulation on alternatives such as nPB and trichloroethylene. 4. A restriction that affected all solvent uses would be problematic to the wider industries that are dependent on them if brought in over a short time period. Development of a new class of solvents would likely take many years, at least a decade, to move from the identification and testing of options through to manufacture and certification. E.2.8.4.5. Propellants Industry estimates indicate that the costs of bringing new product to market for past transitions to new molec ules have c ost individual c ompanies developing new fluorocarbons in the region of USD 1 billion. The relevance of this cost estimate is questionable given that future transitions in response to a restriction on PFAS would almost certainly not lead to adoption of other fluorinated gases. More relevant is the estimate provided based on past experience that the development of new substances has taken in the order of 7 to 10 years. A number of activities need to be undertaken before such a substance could be placed on the market: Product development, product testing, production feasibility, building necessary production plant, certification and commercialisation. Development costs could be spread over the global market. It may be expected that newly developed propellants meeting the necessary characteristics would be more expensive than the substances that they replac e. However, it is not possible to estimate future prices of such alternatives with any confidence. Downstream c osts of re-equipping manufacturing plant to allow the use of alternatives also need to be considered. Alternatives with similar properties to the existing propellants (low toxicity, non-flammability, boiling points close to ambient temperatures, etc.) may take the form of drop-in alternatives where little or no modific ation to existing proc esses is needed. In the event that some manufacturers moved from non-flammable to flammable propellants (e.g. butane and propane) there could be added cost at manufacturing and storage f acilities, to the extent that these had previously not handled flammable substances. However, any suc h c osts would be offset by the cheaper pric e of the alternative propellant. The development of production lines for manufacture of BOV systems will require further investment. However, suc h systems are already present on the market, so muc h of the necessary development work has been carried out. 279 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Finally, there is potential for PFAS-dependent operations to cease. Several respondents to the consultation reported that they would not be able to continue operations in the markets for which they currently provide aerosols if a full restriction on the use of fluorinated gases as propellants was introduced. For some, it was reported that this was likely to lead to c ompany c losure. Social impacts can arise in several ways: Inc reased employment through the development of innovative product lines Reduced employment through loss of market share for EU companies Downstream effects on society through changes in the quality of goods and the price for attaining an equivalent level of service A restriction targeting products where alternatives are already widely used would seem likely to have very little impact: affected companies would most likely switch to the same propellants being used by others. A restriction against use of all fluorinated gas propellants would have some significant effects. The largest potential for impac ts appears to be in nic he industries, for example supplying air dusting equipment, or propellant /solvents for applying specific finishes, lubricants, etc. in industrial settings. A small number of companies responding to the CfE reported that they would be vulnerable to restriction on fluorinated gases in their sector given the extent to which they have specialised their product lines. With this in mind, particular consideration should be given to propellants for tec hnical aerosols for applic ations where non- flammability and high tec hnical performanc e of spray quality are required. Changes in the quality of goods are possible in some areas under a restriction on all uses. Inferior cleaning of electronic equipment may lead to increased failure rates during manufacture or reduced service lifetimes. Inability to use some lubricants could also reduce service lifetimes of products or lead to a requirement for more frequent maintenance, for example in the automotive sector. Effec ts of a restric tion are traced trough the value c hain in Table E.93. 280 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.93. Value chain for fluorinated aerosol propellants. Fluorinated gas producers: Small number of chemical companies Impact likely to be small given that use of fluorinated gases for propellants is now not widespread, hence production volumes would be little affected. Stimulus to research alternatives that provide the same service as fluorinated gases but are not persistent. Aerosol companies: 350 SMEs and multinationals in Europe (excluding manufacturers of medical and veterinary aerosols) Small number still using fluorinated gases. Some of these could be seriously impacted by a restriction as their product portfolios are heavily based around use of fluorinated gases. Downstream business users: Aerospace, automotive and electronic sectors Reduced reliability of some equipment. More rapid deterioration of goods leading to reduced reliability of products (e.g. lubricants in the auto and aerospace industries). C ustomers for downstream products: Business and general public Reduced reliability of some equipment. More rapid deterioration of goods leading to more frequent maintenance, replacement or inferior service. E.2.8.4.6. Cover gases Table E.94 provides an overview of the value chain for the magnesium casting sector with respect to suppliers of cover gases and downstream uses of cast magnesium products. A relatively limited number of companies are involved in the production and distribution of HFC134a. Foundry products can be used across a range of sectors, including some of the most economically important European manufacturing sectors. 281 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.94. Value Chain for Cover Gases Used for Magnesium Casting. Stage 1 NOVECTM 612 HF C- 134a SO2 Production and distribution of cover gas 1 manufacturer has registered this substance under REAC H in the 1 000 t range. 29 legal entities have registered this substance under REAC H in the 10 000 to <100 000 t/y range. Amount used as cover gas not known. Widely available Foundries Die casting (EU) Sand casting (EU) ~ 23 companies ~ 0 companies 2 ~ 30 companies ~ 0 companies2 Value of production Foundry customers Automobile assembly and engine production plants (EU) ~200 Motorcycle companies (EU) 3 Major aerospace companies (EU) Others >10 >17 Unknown, but large number of companies Table notes: 1) Different stages do not always involve different companies: a producer of cover gas may also be a distributor, and a foundry may be located inside an automotive or aerospace factory.2) It is understood that SF6 is the dominant cover gas for sand casting. 3) The figure given for motorcycle companies reflects those based in Europe and excludes non -European companies such as Yamaha, Kawasaki and Harley Davidson. Many European motorcycle companies, such as Ducati and Moto Guzzi, are small in global terms, but leaders in the performance machine field and may thus use lightweight components such as those made from magnesium. Information on the costs of cover gas systems for use in magnesium smelting is provided in the 2005 BREF (BAT - Best Available Techniques REFerence note) from the European IPPC Bureau (EC, 2005). As noted above, the purpose of the cover gas is to control oxidation of the surface of the magnesium. At the time that the BREF was written, three options were available to industry: Sulphur hexafluoride, SF6 at a typical concentration of 0.3% in air or nitrogen Sulphur dioxide, SO2 at a typical concentration of 1-2% in air or nitrogen Per- and polyfluoroalkyl substances (PFAS) such as HFC-134a and perfluoroketone (C3F7C(O)C2F5) which had been developed and successfully tested but not deployed in industry at the time the BREF was released. The BREF provides data on the annual c osts of gas and the c ost of c over gas systems, using 282 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) SO2 or SF6, both for spec ific plant. To assess the c osts of switching from HFC-134a to SO2 c alc ulations have been rerun as follows (the BREF c ompares costs for SO2 and SF6 rather than SO2 and HFC-134a, so the c alculations presented there need some adaptation): It is assumed that HFC-134a can be used as a drop-in substitute for SF6 without significant adjustment. It is assumed that the mass dosage of HFC-134a is 30% greater than for SF6 (3M, 2011) based on differences in starting concentration. It is assumed that the original c ost data are from 2000 (no date is spec ified by (EC, 2005)). Current (19th November 2020) pric es for SO2 and HFC- 134a, ex. VAT, are taken from the BOC Ltd website, based on use of 65 kg cylinders. Equipment costs are adjusted from 2000 to 2020 using a GDP deflator of 38%. Results are presented in the following tables (Table E.95 and Table E.96). Table E.95. Cost Comparison for Consumption of SO2 and HFC-134a Used as Cover Gas. Source: (EC, 2005). Units HF C- 134a SO2 C oncentration of gas Price 2 % /kg 0.4 28.95 0.7 7.45 Inverted density (at 0 C and 1 atmosphere) L/kg 153 350 Yearly consumption of gas kg/y 441 259 C ost/year EUR 12 758 1 930 Table notes: 1. Data are for 3 die-casting machines run for 300 d/y, 24 h/d with a flowrate to each machine of 10 L/min. 2. C osts for HFC -134a and SO2 are based on current prices (see text). Significant volatility is noted in the costs of HFC -134a that is linked to the phase down under the F-gas regulation (Kleinschmidt et al., 2020). Table E.96. Operational and Cost Data for Use of Cover Gases for a New Die-casting Plant of 1000 t/y Mg output. Source: (EC, 2005). General Casting Data Net weight of the Mg parts Surface of the Mg baths Gas (carrier+cover gas)/m2 of surface 1 000 t/y 6 m2 300 L/h, constant Extra dosage while charging 25% Gas Data HF C- 134a SO2 C arrier gas nitrogen nitrogen 283 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) C over gas concentration in carrier gas 0.2% volume 1.5% volume C over gas dosage per hour 61.0 g 154.2 g C over gas dosage per year 668 kg 1 688 kg C over gas/t Mg output 0.66 kg/t 1.69 kg/t Cost Data HF C- 134a SO2 1 kg cover gas 1 m3 carrier gas (nitrogen) 28.95 0.28 7.45 0.28 Investment cost of new gas equipment 32 424 97 273 Discount rate per year 10% 10% Depreciation period (years) 10 years 10 years Annualised investment cost of equipment 5 276 15 830 Operating cost of cover gas 19 339 2 12 575 Annual running cost (without nitrogen) 24 615 28 405 Additional total cost of using SO2 3 791 Reduction cost/kg HFC -134a consumed 5.68 Emission factor for HFC -134a per unit of HFC 134a consumption Substitution cost/kg HFC -134a emitted Table notes: Illustrative 10% to 90%1 6.3 - 57 1 1. No data have been identified to quantify the degradation of HFC -134a in use as the MgF2 layer is formed. An illustrative range of 10-90% is applied, although for SF6 many experts consider the level of degradation to be negligible (Schwarz;, 2005). The purpose of adopting this range is to test whether uncertainty regarding degradation rate could affect the conclusion of the proportionality assessment (see text). 2. C osts for HFC -134a and SO2 are based on current prices (see text). Significant volatility is noted in the costs of HFC -134a that is linked to the phase down under the F-gas regulation (Kleinschmidt et al., 2020). Table E.95 indicates a significant saving in the costs of cover gas from switching to SO2, reduc ed by over 80% for the c ase c onsidered. Table E.96 shows a muc h smaller reduc tion in the c osts of the c over gas and an overall inc rease in the c ost when additional investment in machinery required for handling SO2 is accounted for. The additional cost for using SO2 ac c ording to c alculations in Table E.96 equates to 5.68/kg HFC-134a c onsumed. Conversion of this figure to an estimate of cost per unit HFC-134a emitted is problematic given a lack of emission factors equating use to emission. There is a lack of such information even for SF6, 284 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) which has been studied in more detail. Different views have been reported, that SF6 undergoes minimal c onversion (and hence use and emissions are broadly equivalent), whilst some have argued that there is extensive degradation (UBA, 2005). It seems reasonable to assume that levels of degradation for SF6 and HFC-134a are broadly equivalent, given that they are applied in similar quantities. An illustrative range is given at the foot of Table E.96, assuming a very high level of degradation (emission = 10% of use) or a low level of degradation (emission = 90% of use). Neither figure should be regarded as a robust indication of the emission factor, but the broad range is useful for the purpose of testing whether c onclusions reac hed on the proportionality of a restriction are sensitive to this assumption. Noting that one respondent to the consultation considered PFAS to be `inert', the most robust estimate of the substitution cost seems most likely to be the lower end of the estimates made, between 6.3 and 57/kg HFC- 134a. Costs of switching for die-casters have been estimated at between 0% and 0.5% of the turnover from magnesium c asting parts (Sc hwarz and Gsc hrey, 2009). Given the low costs of switching as a fraction of turnover, it is anticipated that the costs to consumers will be insignificant. No social impacts have been identified. It is unlikely that the introduction of a restriction would significantly affect operations in the sector, given the availability of alternatives that are well tested and already widely used. The low impact on turnover makes it unlikely that there would be job losses arising from a switch to SO2 (Schwarz and Gschrey, 2009). There is also considered to be no potential for an increase in employment, given that additional investments are slight. No wider economic impacts have been identified. It is unlikely that the introduction of a restriction would significantly affect competition in the sector, given the availability of alternatives that are well tested and already widely used. The adoption of SO2 as a cover gas should be easily implementable for magnesium recycling and die-casting activities. Costs seem low as a fraction of turnover, and conversion of plants, where it is needed, should not take long. E.2.8.4.7. Fire suppressants There has been a signific ant switch from the use of fluorinated gases to alternatives in the fire suppressant market, driven by price (UNEP, 2018c). One stakeholder estimated that Fgases comprised 5-10% by volume of all fire-fighting products including foams, though a higher percentage of revenues given the higher cost of the substances relative to other options. Residual use of F-gases occurs where it is c oncluded that alternatives are either less efficient or would cause damage to the staff, facilities, installations and goods that they are supposed to protect. This includes risks of asphyxiation from exposure to CO2 and damage to electronics, paper goods and artworks from the use of water or salt solutions. Examples where efficiency is key include the use of fire suppressants in aviation and in military applications, where the size and weight of equipment is a major factor in determining applicability of options. In the event that existing options are not suitable, new substances would need to be developed. With respect to time scale, one industry stakeholder reported that it would take a minimum of 4-7 years to transition to new molecule once it was identified, a position supported by the Halons Technical Options Committee under the Montreal Protocol (UNEP, 2018c). The bigger challenge concerns identifying substitute molecules in the first place (noting that it is unlikely that a single substance would be able to meet the requirements of all applications), that meet the requirements of a possible PFAS restriction while delivering 285 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) the performanc e and safety the market expec ts for HFC and HFO produc ts. On this basis the time needed to transition to a new substance where the available alternatives are c onsidered not appropriate c ould be well in exc ess of 10 years. Once a molecular target is identified, there is significant R&D required to complete the process and produc t development R&D in order to produc e a business case worthy of investment with manageable risks. The process development involves scouting possible synthetic routes, piloting reaction steps and developing thermodynamic and kinetic models. Product development requires property measurements, modelling and customer sampling to determine if the development product has the expected value proposition with the c ustomer. Once these activities have been carried out and customers have validated demand for the product, an investment decision can be made by manufacturers. A commercial scale plant can often take 2 years or more from authorisation to start-up. In parallel, any new molecule would need to complete a full battery of toxicity and safety testing to support a global registration effort. It is reported that it is not uncommon for the global registration process including testing to take 3-4 years. One stakeholder reported that the total R&D investment can exceed USD50 million to bring the molecule from concept to commercial scale. Follow up application development and product extensions, the total R&D investment can exceed USD250 million. Capital investment is direc tly related to c apacity. A stakeholder tha t provided information to this project has previously acknowledged its recent investment in HFO-1234yf capacity exceeded USD300 million. However, for fire suppressants for which market size is limited, c osts c ould be signific antly lower. One manufacturer has reported that it would withdraw from the market in the event that current substances were restricted: the low volume of sales would not justify product development expenses. Data was also provided by industry stakeholders for the fixed costs associated with plant operation and manufacturing technical support, ranging from USD10-100 million annually depending on the c omplexity and c apacity of the operation. However, it is assumed here that these costs are similar to those currently incurred, so would not be an additional cost to the industry. Wider economic impacts would be linked to differences in the efficacy of alternatives in c omparison to the F-gases that they displace. Assuming that alternatives are less effective to a degree that is c ritic al for some applic ations, there would be inc reased fire damage leading to, for example: Inc reased downtime at data centres with knoc k-on impac ts through a business Possible loss of data (though the risk of this should be minimised through effective backup systems) Loss of cultural heritage through damage to museums and associated warehouses Increased risks for military personnel and equipment through using less efficient fire suppressants These costs are not quantified here, but have potential to be substantial. E.2.8.4.8. Other Preservation of cultural paper-based materials The preservation systems use fluorofluids to stop acid corrosion of paper-based cultural heritage materials. Alternatives have not been identified for preservation of cultural paperbased materials that provide specific optical, physical, mechanical, and cultural objectives 286 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) that are defined by customers. In the absence of even potential alternatives the following costs would arise from a restriction applied on a short time scale, recognising that new approaches would need extensive testing before reaching the market: Loss of business for the preservation companies, with potential for some social impacts via job losses Loss of opportunity to treat cultural paper-based materials in the EU (assuming that there are not other companies carrying out this work with alternatives), leading to the work potentially being undertaken outside of the EU. Possible damage to cultural materials if treatment is unavailable, which could generate significant consumer surplus losses. Insulating gases It is understood that the substitution of both SF6 and fluorinated gases as insulating gas in electrical equipment is ongoing, using dry air (mix of nitrogen and oxygen) and vacuum. Switching is currently possible up to 145 kV and further work is being undertaken to deal with higher voltage switchgear. Information provided in the 2nd stakeholder consultation suggests that by 2026 high-voltage electricity products up to 420 kV may start to be replaced with non-PFAS alternatives. However, it is expected that time beyond 2026 will be needed before a full transition to clean air technology for high voltage applications is carried out. It is, however, unclear, whether this work c overs the whole of th EU or only one or some c ountries. The major cost impacts of a restriction would likely arise from socio-economic costs due to delayed power grid expansions, inadequate electricity transmission and increased risk of outages. E.2.8.5. Summary of cost and benefit assessment The preceding text demonstrates that there is widespread use of fluorinated gases. The following tables summarises the outcomes of qualitative assessment of costs and benefits for the fluorinated gas use drawing on information submitted to the CfE, 2nd stakeholder consultation and the literature. Further information can be found in the accompanying text following each table. Reference throughout this section to possible 5- and 12-year derogations is additional to the general transition period of 18 months. Uses considered in the tables below are as follows: Refrigeration (Table E.97) Air conditioning and heat pumps (Table E.98) Maintenance of HVACR equipment and national/local limitations on use of natural refrigerants (Table E.99) Foam blowing agents (Table E.100) Solvents (Table E.101) Propellants (Table E.102) Magnesium c asting (Table E.103) Fire suppressants (Table E.104) Preservation of cultural paper-based materials (Table E.105) Insulating gas in electrical equipment (Table E.106) Table E.97, Table E.98 and Table E.99 and the accompanying text summarise the outcomes of the assessment of costs and benefits for refrigeration, air conditioning and heat pumps, maintenance of existing equipment and response to local regulations on permissible refrigerants (e.g. bans on flammable refrigerants in high rise buildings). Discussion of the quality of evidence for all three tables is provided below Table E.99. 287 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 288 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.97. Refrigeration - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Duration of derogation No t a p p licable A lternatives Dom estic re frigeration: Te chnically and e conomically fe asible alternatives exist for all type s of domestic re frige ration. [sufficiently strong evidence] C om mercial and industrial re frige ration: The re is growing acce ptance of the use of natural re frige rants in the com m ercial and industrial m ark ets across the range of e nvironmental conditions e x perience d in Europe. [sufficiently strong evidence] Spe cialist applications: Thre e specialist applications have been identified whe re alte rnatives are not currently a va ilab le. R e frigerants in low te m perature refrigeration be low -50 C R e frigerants in laboratory te st and measurement e quipment R e frigerants in re frigerated ce ntrifuges used for e xample in m e dical laboratories whe re natural refrigerants pose hazards due to flammability or the use of high pressures as rotor failure, which is unde rstood to not be uncommon, could Environmental impact It is e stimated that RO1 would re duce e m issions across all uses of fluorinated gases by 95% compared to the b a s eline. Cost impact Dom estic re frigeration: No cost im pacts given that equipment using fluorinated gases is no longer place d on the market given the price and performance of alternatives. [sufficiently strong evidence] C om mercial and industrial re frige ration: The re is growing acce ptance of alte rnatives, indicating that they are cost-competitive with fluorinated gas syste ms. Ne gative cost impacts under R O 1 are likely to focus on m anufacture rs that are slow to transition to the use of alternative re frige rants with significant loss of producer surplus and risk of business closure . [sufficiently strong evidence] Spe cialist applications: The lack of availability of alternatives would be problematic for both producers and consumers. R O1 would cause loss of producer surplus from the lik ely withdrawal of some product line s with some risk of business closure and loss of consumer surplus through the lack of availability of alte rnatives that are e ither safe to use or provide the necessary le vel of pe rformance . [sufficiently strong evidence] W ith re spect to the m aintenance of e x isting e quipment there are problems given a lack of drop-in alte rnatives. There are a limited num ber of trained and ce rtified pe rsonnel for commercial and Other aspects C om mercial and industrial re frige ration units will need m aintenance over their se rvice life. This issue is addre ssed in Table E.99. In some locations the use of certain re frige rants may be b a n n ed th ro u g h conve rn over (for e x ample) flam mability. This issue is a ls o addre ssed in Table E.99. 289 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Ban with usespe cific de rogations: (i) R e frigerants in low te m perature re frige ration be low -50C (ii) R e frigerants in laboratory test and m e asurement e quipment (iii) R e frigerants in re frige rated ce ntrifuges Duration of derogation 5 ye ars A lternatives com promise the re frigerant s ys te m. [sufficiently strong e vidence] O ve rall it is considere d that the re is high substitution pote ntial at EiF for domestic, com m ercial and industrial re frige ration [sufficiently strong evidence] Lo w substitution potential at EiF for the thre e specialist applications identified [sufficiently strong evidence] Base d on stakeholder fe e dback, there is some pote ntial though not certainty for alte rnatives to be feasible for low te m perature re frige ration below - 50 C in large capacities following a 5 year derogation on top of the 18 month transition period [sufficiently strong evidence base]. The situation for re frigerants in laboratory te st and m e asurement e quipment and in re frige rated ce ntrifuges is m ore uncertain given that no pote ntial alternatives are ide ntified a s o f now a nd it is unlik ely that they become available in the near future [sufficiently strong evidence base]. Environmental impact For (i): A 5-ye ar derogation of all fluorinated gases use for industrial re frige ration causes additional e m issions of 111 705 t. No evidence is available about the precise amount of additional fluorinated gases e m issions from this specific de rogation. Howe ver, emissions can be e x pected to be small compared to a de rogation of fluorinated gases use for industrial refrigeration (about 10% as a worst case e stimate). C ompared to a m ax imum additional emission scenario (i.e . a derogation of all fluorinated gases use) additional emissions from the proposed derogation account of <1%. 12 ye ars The probability of alte rnatives re aching the For (ii) : A 12-year derogation of all fluorinated gases use for industrial Cost impact industrial refrigeration e quipment for m aintaining e xisting systems, including maintenance of e quipment whe re le aks have occurre d. Application of R O1 leading to an inability for maintenance of systems would ge nerate significant added costs and associated environmental im pacts through the early re tirement of e x isting e quipment. [sufficiently strong evidence] For low te m perature refrigeration b e lo w -50 C , a 5 year de rogation would permit a longer pe riod for R&D and would re duce costs for producers whilst maintaining production rates and quality. This would also limit potential impacts on consumers and the risk of job losses. For laboratory te st and measurement e quipment and refrigerated ce ntrifuges the lack of potential alte rnatives at the present time indicates a likelihood that alternatives would not be on the market e ven afte r a 5 year derogation, leading to producer and consumer surplus losses. Some job losses would also se e m likely as some products would no longer be produced. Information on the ability of the companies supplying this market to continue in business if this equipment could not be m ark eted has not been identified. [sufficiently strong evidence] A 12 ye ar derogation would permit m ore opportunity to re search and Other aspects 290 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives m ark et across the range o f spe cialised uses naturally incre ases with further tim e allowe d for the necessary R &D. [sufficiently strong evidence] Environmental impact re frige ration causes additional e m issions of 136 680 t. The re is no evidence available about the precise am ount of additional fluorinated gases e m issions from this specific de rogation. Howe ver, additional fluorinated gases e m issions from this de rogation can be e xpected to be ve ry sm all (<10% compare d to a de rogation of all fluorinated gases use for industrial re frigeration). Compare d to a m aximum additional emission sce nario (i.e. a derogation of all fluorinated gases use) additional e m issions from the proposed de rogation would account of <1%. Cost impact introduce cost-effective alternatives whilst lim iting loss of produce r and consumer surplus and we lfare losses, particularly in re lation to laboratory te st and measurement e quipment and re frige rated ce ntrifuges. [sufficiently strong evidence] Other aspects C onclusion For (iii): A de rogation of all fluorinated gases use for industrial re frigeration cause s additional e missions of 136 680 t. No evidence is available about the precise amount of additional fluorinated gases emissions from this spe cific derogation. Howe ver, e m issions can be expected to be small (about 1% as a worst case e stimate) C om pared to a maximum additional e m ission scenario (i.e. a derogation of all fluorinated gases use) additional e m issions from the proposed de rogation are considered to be m arginal (< 0.01%). For m any applications it is apparent that there are alre ady viable alternatives on the market and hence that transition to alternatives is feasible on a lim ite d time base. Difficulties have been identified for some specialist applications re garding low te m peratures and laboratory e quipment and for these a de rogation appears necessary if producer and consumer surplus losses are to be limited. It is not possible to forecast with ce rtainty how m uch time would be needed for substitution in these are as. Howe ver, challenges appear greater for laboratory e quipment, for e xample give n the potential for failure of rotors in refrigerated ce ntrifuges. 291 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.98. Air conditioning and heat pumps - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Duration of derogation No t a p p licable A lternatives Dom estic air conditioning: Te chnically and e conomically feasible alte rnatives exist for smaller (singlehousehold) facilities, via use of hydrocarbons. Safe ty concerns have limited the application of hydrocarbons as an option in s ome dom estic settings, for e xample share d re sidential space whe re re frigerant charge size s m ay be large and high-rise buildings whe re the re is heightened concern over fire risk s linked to the flammability of natural re frige rants. In both cases local or national building codes may limit the use of hydrocarbon re frigerants. C om mercial air conditioning: The re is growing acce ptance of the use of alte rnatives in this sector, particularly CO2 and hydrocarbons, or C O2 in cascade systems with othe r gases such as ammonia. Industrial air conditioning: Efficie nt systems based on ammonia have be e n in place for many years in industrial re frige ration and air conditioning. This is one possible solution for large data ce ntres, though others exist. Sm all systems could be coole d using natural re frigerants or small air conditioning systems whe re re frigerant charge size is not problematic. Dom estic tumble driers: He at pumps using hydrocarbons for heat transfer have alre ady gained a significant m ark et share in the tumble drier market. O ve rall, there is high substitution potential at EiF for m ost stationary applications [sufficiently strong evidence]. Howe ve r, the re is low substitution potential a t EiF for use s whe re (particularly fire) re gulations Environmental impact It is e stimated that R O 1 would re duce emissions across all uses of fluorinated gases by 95% com pared to b a s eline. Cost impact Dom estic, industrial and commercial air conditioning and heat pumps: It is noted from consultation that some m anufacture rs have expre ssed conce rn over safe ty issues related to the use of alte rnative re frigerants, whilst some others consider that alternative systems can ope rate safely. Risks to producer surplus and of business closure under R O1 for the dom estic, industrial and commercial markets would be present for manufacturers that are slo w to tra nsition to the use o f a lternative re frige rants. Howe ver, business that are able to re spond rapidly to a re striction or are alre ady supplying products that would be com pliant with it would be likely to gain additional business. It is not possible to e stim ate the e xtent to which these two e ffe cts would counteract one another. The sam e applies to the potential for job losses through the closure of businesses or business units: losses in one geographic are a may be balanced by gains in another. [sufficiently strong evidence] Dom estic tumble driers: C ost impacts linked to the domestic tumble drie r m arket are likely negligible given wide spre ad use of alternatives to fluorinated gases already, combined with the e xperience of the same companies in the domestic re frige ration m arket. [sufficiently strong evidence] Other aspects C om mercial and in d u s trial re frige ration units will need m aintenance over their se rvice life. This issue is addre ssed in Table E.99. In some locations the use of ce rtain re frige rants may be b a n n ed th ro u g h conve rn over (for e x ample) flam mability. This issue is a ls o addre ssed in Table E.99. 292 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Ban with use -specific de rogations C onclusion Duration of derogation 5 ye ars 12 ye ars A lternatives prohibit use of hydrocarbons [sufficiently strong evidence]. n/a n/a Environmental impact Cost impact n/a n/a Other aspects Air conditioning systems and heat pumps are available on the m arket already for a wide range of applications, leading to the conclusion that they are both te chnically and e conomically feasible. On this basis there appears no need for a derogation for new goods. Maintenance of e xisting equipm ent, and case s whe re national or local regulations limit the choice of re frigerant are considered in Table E.99. Table E.99. Maintenance of HVACR equipment and national/local limitations on use of natural refrigerants - Summary table on assessment of costs and benefits, based on a general transition period of 18 m onths. R e striction o p tio n Full ban - 18 m onth tra n s ition pe riod Ban with usespe cific Du ra tio n of de rogation No t a p p licable 5 ye ars Alte rnatives Maintenance of e xisting equipment le ading to the need to top up or re fill HVAC R e quipment would re quire use of re frigerants with similar properties to those used originally. Non-PFAS alte rnatives would not provide drop-in re placements as they would be incom patible with the e quipment alre ady in place, for e xample with re spe ct to operating pre ssure s. In some cases there are local or national re gulations or building codes in force that limit the use of some m ate rials, such as flammable re frige rants whe re charge sizes are gre ater than those used, for example, in dom estic re frigerators. In both cases potential alternatives are considered te chnically not feasible. [sufficiently strong e vidence] Unde r the re striction, the number of HVAC R installations using fluorinated Environm ental im pact It is e stimated that R O 1 would re duce e m issions across all use s of fluorinated gases by 95% com pared to b a s eline. C ost impact An inability to maintain existing equipment would le ad to premature redundancy of e quipment with associated environmental burdens and significant added costs to consumers. Given limited resource in te rm s of e ngineers and a lack of drop-in alte rnatives, a re striction with no or a short de rogation would lead to losses to both business using re frigeration equipment and their customers. It m ay also interfere with the roll out of heat pumps as a clim ate mitigation measure by diverting available e ngineers from the installation of new he at pumps to other systems. A re striction that affected uses subje ct to local re strictions would impact the businesses that provide re frigeration e quipment, businesses using re frige ration and their customers. [sufficiently strong e vidence] O ther a s p ects C osts to businesses and consumers would be lowe r than under a full ban, but given (e.g.) the expecte d 293 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) R e striction o p tio n de rogations: (iv) M a in ten ance and re filling of e x isting HVAC R e quipment put on the m arket before [18 m onths afte r EiF] and for which no d ro p -in alte rnatives e x is t C onclusion Du ra tio n of de rogation Alte rnatives Environm ental im pact C ost impact O ther a s p ects gases will decline over time as they a re re placed by new e quipment. Building codes m ay also be changed through re cognition of safe operation by alte rnatives. Howe ver, a 5-year de rogation seems insufficient for these changes to occur to a significant e x te nt. [sufficiently strong e vidence] life span of equipment, these costs are e xpected to re m ain high. [sufficiently strong evidence] 12 ye ars The tre nds identified under a 5 year de rogation would strengthen under a 12 ye ar derogation, with fe we r e xisting HVAC R installations using fluorinated gases and wider acceptance of the safe ty of alternatives. [sufficiently strong e vidence] For (iv): No evidence is available about the pre cise amount of a d d itional fluorinated gases e m issions from this spe cific derogation. A 12-ye ar de rogation of all fluorinated gases use in commercial and industrial re frige ration, mobile and stationary air conditioning will lead to additional e m issions of 349 889 t, which is m ore than 3 times highe r than e m issions under a ban of fluorinated gases (RO1) and would be about 50% of a m aximum additional emission sce nario (i.e. a de rogation of all fluorinated gases use). Unde r a 12 year derogation there wo uld be a furthe r decline in costs to businesses and consumers as older equipment re aches the end of its se rvice life and as building codes and other re gula tions adapt to new te chnologies. Issues concerning m aintenance and building codes/regulations are re levant to a restriction on the use of fluorinated gases. The high cost and e nvironmental impact of premature re tirement of HVACR e quipment need to be re cognised. Whilst a 5 year derogation seems too l ittle time for 294 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) R e striction o p tio n Du ra tio n of de rogation Alte rnatives Environm ental im pact C ost impact O ther a s p ects sufficiently significant change in either the stock of HVACR equipment or building codes, it is possible, though not ce rtain that this may change within 12 ye ars. 295 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on evidence/knowledge from the literature, CfE and 2nd stakeholder consultation that the evidence is: Sufficiently strong that technically and economically feasible alternatives are available in the quantities required for use in domestic, commercial and industrial refrigeration and air conditioning and heat pumps and that the substitution potential is high under RO1. Sufficiently strong that that technically and economically feasible alternatives are not available in the quantities required for use as refrigerants in low temperature refrigeration below -50 C, laboratory test and measurement equipment and refrigerated centrifuges, and hence substitution potential is low under RO1. Evidence is considered strong that alternatives will become available with a 5 year derogation for low temperature refrigeration, though a longer period, 12 years, is considered more reasonable for laboratory test and measurement equipment and refrigerated c ent rifuges. Sufficiently strong that technically and economically feasible alternatives are not available in the quantities required for use for maintenance and refilling of HVACR equipment or for use in locations where the use of flammable or toxic refrigerants is banned under local or national regulations or building codes under RO1. Evidence is strong that the stock of equipment dependent on fluorinated gases will remain in servic e for many years in the absence of regulation to force its shut down. Evidence is also strong that national regulations and building codes designed to reduce the risk of fire or release of toxic substances will take many years to change. This suggests in both c ases a lengthy derogation c ould be appropriate. RO1 would naturally provide the greatest benefit in the form of reduced emissions. There is strong evidence supporting the quantification of emissions given submissions made under the F-gas regulation and the UNFCCC (UN Framework Convention on Climate Change). Evidence on the savings made under 5- and 12-year derogations is weaker given uncertainty on the precise time-schedule for the introduction of alternative systems, and t he precise scope of derogations, but they would naturally lead to increased emissions. Given the availability on the market of alternatives for domestic, commercial and industrial refrigeration, evidence is sufficiently strong that cost-effective alternatives are available. Impacts on companies operating in the sector will, however, be variable, depending on the speed with which they can transition to alternatives if they are not already working with them. There may be some possibility of c losure of businesses or business units, and associated loss of jobs. Loss of consumer surplus is not expected to be large. The situation is different for the spec ialist applic ations (refrigerated c entrifuges, etc.) where alternatives are not already on the market. For these applic ations there is suffic iently strong evidenc e of significant loss of both producer and consumer surplus under RO1. This is reduced under RO2 as the probability of development of equipment that is not dependent on fluorinated gases increases. There is sufficiently strong evidence that costs would be high under RO1 if it were applied to the maintenance of existing HVACR equipment. The lack of drop-in alternatives means that equipment that would currently need servicing including some top up of refrige rant levels could not be repaired. Added costs would arise from the premature retirement of existing equipment, the early purchase of replacement equipment and added environmental burdens from disposal of equipment. To further complic ate matters it is also likely that there would be insufficient engineers available to do the work. There is also sufficiently strong evidence of high costs in cases where national or local regulations and building codes limit the use of alternatives, where businesses manufacturing or using HVACR equipment and their customers would all be impacted. Table E.100 and the accompanying text summarise the outcomes of the assessment of costs and benefits for foam blowing agents. 296 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.100. Foam blowing agents - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Duration of derogation No t a p p licable A lternatives The m ajor use that has commonly use d fluorinated gases as blowing age nts relates to foams used for insulation in buildings and ve hicles. The re has been some shift away from the use of fluorinated gases in some parts of the m arket. Alternatives are available but have performance constraints linked to fire performance, e ne rgy efficiency and durability. Hydrofluoroolefins (HFOs) provide the be st le vel of insulation (the gases contained within the foam themselves providing an effective barrier to heat transfer). To provide a similar level of insulation alternatives would need to be applied in a thick er layer, which m ay or m ay not be feasible, de pending on location. In some applications (e.g. spraying on-site) the use of hydrocarbons would not be pe rm itted given the risk of flam mability. Some stakeholders indicate that low-pressure spray polyure thane foams in self-contained cylinde rs is a niche reliant on fluorinated gases as blowing agents. Environmental impact It is e stimated that R O 1 would re duce e m issions across all use s of fluorinated gases by 95% com pared to b a s eline. Cost impact Loss of producer surplus through loss of market for high value fluorinated gases that are significantly more e x pensive than alternatives (by as much as a factor of te n). Howe ver, there is also a likelihood of some loss of consumer surplus through lowe r performance of alte rnatives in some insulation applications. This may le ad to increased heat loss (conflicting with climate m itigation actions) or the need for thicker insulation which m ay be problematic whe re space is limited or value d (e.g. cargo space in vehicles) The re could also be we lfare losses linked to increased risk s of flammability in some applications, notably onsite spraying. [sufficiently strong e vidence]. Other aspects Ban with use -specific de rogations: (vi) [Foam 5 ye ars O ve rall it is concluded that there is high substitution potential at EiF for m ost applications [sufficiently strong e vide nce] but low substitution pote ntial at EiF for foam blowing age nts in PU spray foam [we ak e vide nce]. A 5 ye ar de rogation would provide opportunity to develop alternatives whe re curre nt options are not considered viable. This is considered For (vi): A 5-ye ar de rogation of all fluorinated gases use in closed ce ll Additional time would permit more opportunity to re se arch and introduce cost-effective alternatives whilst lim iting loss of produce r and consumer surplus 297 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option b lo win g age nts in e x panded foam spraye d on site for b u ild ing in s u lation] C onclusion Duration of derogation A lternatives he re to apply particularly to foams spraye d on site for building insulation, whe re othe r activities on site lead to a significant risk of fire. [we ak e vidence] Environmental impact foam blowing will le ad to additional e m issions of 108 047 t, which is slightly higher than e m issions under a ban of fluorinated gases (RO1). Though evidence on the precise am ount of e m issions re sulting from this usespe cific derogation is lacking, it is e x pected that additional emissions of the derogation corre spond to approximately 10% com pared to the m ax imum additional emission sce nario scenario (i.e . a full de rogation of fluorinated gases use). Cost impact and we lfare losses from use of less e ffective or m ore hazardous foam blowing agents. [we ak evidence] Other aspects 12 ye ars The likelihood of identifying more e fficie nt alternatives will incre ase over tim e . [we ak e vidence] Furthe r tim e would permit more gradual adaptation in the m ark et to possible alternatives, re ducing cost im pacts to both producers and consumers. [we ak e vide nce] It is noted that there has already been a shift away from the use of fluorinated gases for foam blowing, linked in part to an increase in price as new gases have been introduced to the m arket to meet the re quirements of the F gas regulation. The view from the industry is that the more e xpensive gases are only used whe re alternatives do not provide a sufficient level of performance or pose additional risks such as flammability. Whilst alternatives are available, they do not have the same insulating properties as fluorinated gases and hence would e ither provide a lowe r le vel of insulation or need to be applied in a thick er layer to match performance . The most likely area whe re a derogation could be justified is concluded t o be use for foams blown on site for building insulation, whe re there may be a significant risk of f ire linked to the use of hydrocarbon blowing agents. Howe ver, in light of uncertainty re garding the precise circumstances under which alternatives would be unavailable , such a derogation is not proposed at this point but marked for re consideration. A derogation might be proposed at a later stage if additional information on alternatives becomes available. 298 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on information from the literature, the CfE and the 2nd stakeholder consultation that there is sufficiently strong evidence that technically and economically feasible alternatives are available in the quantities required for use as foam blowing agents for a range of applications where fluorinated gases may currently be used. An exception concerns foam blowing agents in PU spray foam, where fire hazards linked to use of hydrocarbons may be a significant concern, and substitution potential is considered low. A precise date by which alternatives may become available for this use is not known, though the probability of identifying and c ommerc ialising an alternative will inc rease over time. RO1 would provide the greatest benefit in the form of reduced emissions. 5- and 12-year derogations under RO2 would naturally lead to increased emissions. There is suffic iently strong evidence that the use of alternatives would lead to some level of compromise in performance. The fluorinated gases provide a higher contribution to the insulation properties of foam than alternatives such as hydrocarbons. This means either that the foam will be less insulating when alternatives are used leading to higher energy costs and greater c arbon emissions, or that it will need to be applied more thic kly to ac hieve the same performance. In some cases it will not be problematic to apply a thicker layer of foam, whereas in others it will be. For some installations thicker foams will lead to reduced storage c apacity, adding a further burden. Whilst derogations will lead to higher emissions, they may also permit identification of further alternatives to those considered here that are able to address some of these compromises. Table E.101 and the accompanying text summarise the outc omes of the assessment of c osts and benefits for solvents. 299 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.101. Solvents - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Ban with use -specific de rogations: Duration of derogation No t a p p licable 5 ye ars A lternatives This is a ve ry diverse sector with solve nts used for a wide variety of applications. In many cases, there are alte rnatives. Howe ver, in addition to the lite rature search, stakeholders have re ported that there are no alte rnatives to fluorinated gases for: Industrial precision cle aning fluids C le aning fluids for use in oxygene nriche d environments For 3D printing, limited information has been submitted by industry to indicate alternatives do not e xist for som e specific applications: Solve nt-based debinding systems in 3D printing for industrial and profe ssional applications Sm oothing agents for polymer 3D printing applications for industrial and profe ssional applications. A case has been made for 3D printing of m e tals and medical devices though not for other parts of the 3D printing m ark et. C omparative evidence of the pe rformance of alternatives is lacking. It is concluded that there is high substitution potential at EiF across a dive rse range of applications [sufficiently strong evidence] and low substitution potential at EiF for spe cialist cleaning fluid applications [sufficiently strong evidence] and for 3D printing [weak evidence]. Applications identified here whe re substitution appears m ost difficult conce rn: Industrial precision cle aning fluids Environmental impact It is e stimated that R O 1 would re duce e m issions across all use s of fluorinated gases by 95% com pared to b a s eline. Cost impact Use of fluorinated gases as solvents is limited to niche parts of the solvents m arket, typically whe re cheaper alte rnatives have yet to be identified. With this in m ind, it is likely that there would be consumer surplus losses for European manufacturers of products curre ntly using fluorinated gas solvents. For precision cle aning uses linked to production of goods this could place EU producers at a disadvantage internationally as the re striction would not apply to goods brought into the EU that had been manufactured using PFAS but did not themselves contain PFAS. For industrial precision cle aning fluids there are further pote ntial impacts on consumers through flammability of alte rnatives, incre ased drying times, inability of solve nt to penetrate confined spaces leading to re duce d performance, incompatibility with e lectronic syste ms, etc. These may feed through to impacts on the durability of systems. [Sufficiently strong evidence] It is no t cle ar how bro adly the 3D printing sector would be affected by a re striction - whe ther difficulties a re re stricted to a few pro ducers o f 3D printed metals and m edical devices, or all, or whe ther they affect othe r products as we ll. This clearly affects the scale of producer and consumer surplus losses linked to a re striction. W ith 3D printing finding new m arkets it is possible that a restriction could have a significant im pact on innovation in EU m anufacturing. [W e ak e vidence] Additional time would permit more opportunity to re se arch and introduce cost-effective alternatives whilst lim iting loss of produce r and consumer surplus and we lfare losses from use of less e ffective solvents. Other aspects 300 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option (vii) I n d u strial pre cision cle aning fluids (viii) C le a ning fluids for use in ox ygene nriche d e nvironments (ix ) [ I n d u strial and profe ssional use of solve ntb a s ed de binding systems in 3D printing] (x) [ I n d u strial and profe ssional use of sm oothing age nts for polym er 3D p rin tin g a p p lications] Duration of derogation 12 ye ars A lternatives C le aning fluids for use in oxygene nriche d environments Industrial and professional use of solve nt-based debinding systems in 3D printing Additional time is considere d ne ce ssary for development of alte rnatives for these applications. It is considered doubtful that a 5 year de rogation on top of the 18 month transition period would be sufficient for the applications listed here. The re is weak evidence that alte rnatives will not be available in the short-medium term for: Industrial precision cle aning fluids C le aning fluids for use in oxygene nriche d environments Industrial and professional use of solve nt-based debinding systems in 3D printing O n this basis, a 12 ye ar derogation m ay be appropriate for these a p p lications. Environmental impact Cost impact It has not been possible to quantify these economic e ffe cts given uncertainty in the time required to de ve lop alternatives that are able to adequately re plicate the functions of fluorinated gases. For ((vii), (viii), (ix) e n (x ): A 12-year de rogation of all fluorinated gases use in solvents will le ad to additional e m issions of 92 730 t, which is slightly higher than e m issions under a ban of fluorinated gases (RO1). Evidence for a q u a litative e valuation of e x pected additional fluorinated gases e m issions in this application is lacking, but the y are e x pected to be sm all compared to the m aximum additional emission sce nario scenario. Other aspects C onclusion The use of fluorinated gases in the solvents market addresses a number of niche applications. For some of these, notably industrial precision cle aning fluids, cle aning fluids for use in oxygen rich environments and some profession and industrial 3D printing applications, info rmation has been identified to 301 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects indicate that alternatives are not likely to be available on the short to medium te rm. An inability to use these solvents could have a significant impact on innovative industries within the EU, leading to significant loss of both producer and consumer surplus, though quantification of impacts is not possible. A de rogation for these applications may therefore be considered appropriate. Improved characterisation of applications that could benefit from a de rogation would be beneficial. Howe ver, in light of uncertainty re garding the necessary scope for a derogation for industrial precision cle aning fluids, cle aning fluids for use in oxygen-enriched e nvironments and 3D printing, such a derogation is not proposed at this point but marked for re consideration. A de rogation might be proposed at a later stage if additional information to clarify the scope becomes available. 302 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on information from the literature, the CfE and the 2nd stakeholder consultation that there is sufficiently strong evidence that technically and economically feasible alternatives are available in the quantities required for use as solvents for a range of applic ations where fluorinated gases may c urrently be used. However, there is also evidence od applications where alternatives are not considered feasible at the present time: Industrial precision cleaning fluids Cleaning fluids for use in oxygen-enriched environments Industrial and professional use of solvent-based debinding systems in 3D printing It is concluded that there is sufficiently strong evidence that alternatives are unlikely to become available by the time that RO1 would be effective for this set of applications. No evidenc e has been identified to suggest that other applic ations would be in a similar position. There is no information available suggesting a specific time by which alternatives could become available, though there is weak evidence that it would take longer than a 5 year derogation on top of the 18 month transition time. RO1 would provide the greatest benefit in the form of reduced emissions. 5- and 12-year derogations under RO2 would naturally lead to increased emissions. It is difficult to draw conclusions on the potential economic impacts of a restriction applying at different times in the future. There is potential for significant producer and consumer surplus losses if the introduction of alternatives compromised manufacturing processes for tec hnical produc ts to any signific ant degree. The view of the industry is that the high price of fluorinated gases means that they are only used where there is a sound economic case for their use, which itself indicates potential for socio-economic costs at some level. A restriction could also generate scope for advantage for competitors outside of the EU, given that they would remain free to use fluorinated gas propellants in the production of goods destined for the EU as the propellants would not remain on those goods after production. Table E.102 and the ac companying text summarise the outc omes of the assessment of c osts and benefits for propellants. 303 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.102. Propellants - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Ban with use -specific de rogations: (x i) [P ro p ellants for te chnical Duration of derogation No t a p p licable 5 ye ars A lternatives The re has been a substantial le vel of switching away from fluorinated gases to alte rnatives in the propellants m ark et in re cent decades. A variety of options are available on the market in the form of alternative propellants and delivery systems (e.g. bag-onvalve ) though in some applications tox icity and flammability of alte rnatives are a conce rn. Limitations apply, for e xample, whe re the prope llant is the payload (air dusters) or the propellant is a solvent for the payload (cans that need to be shaken be fore use). A small number of com panies in niche industries (e.g. supplying air dusting equipment, or prope llant/solvents for applying spe cific finishes, lubricants, e tc. in industrial settings), indicated that the y would not be able to continue ope rations in the mark ets for which the y curre ntly provide aerosols given the e x tent to which they have spe cialised their product lines. It is concluded that there may still be high substitution potential at EiF across a dive rse range of applications [sufficiently strong evidence] but low substitution potential at EiF in niche industries [weak evidence]. A de rogation may be particularly use ful for propellants for technical ae rosols for applications whe re nonflam mability and high te chnical pe rformance of spray quality are re quire d. Better characterisation of such applications would be beneficial Environmental impact It is e stimated that R O 1 would re duce e m issions across all use s of fluorinated gases by 95% com pared to b a s eline. Cost impact The increasing price of fluorinated gas propellants via the m ove from HFCs to HFOs already provides e ncouragement to switch to alternatives. Acceptance of this added cost has been cite d by several in industry as strongly indicative of the added value of using fluorinated gases, though there appears to remain som e use in personal and household care products whe re any added benefit cannot be significant. Howe ve r, safety and performance constraints for some te chnical aerosols should be recognised as these could le ad to significant consumer surplus losses [sufficiently strong e vidence for some applications]. W hilst additional time would assist in the development of alte rnatives, a 5 ye ar derogation does not appear sufficient on curre nt e vidence to both identify alte rnatives and bring them to m arket. This would lead to producer losses for propellant m anufacture rs and the ir customers. A re striction could put EU m anufacturing at a disadvantage given that Other aspects 304 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option ae rosols for a p p lications whe re nonflam mability and high te chnical pe rformance of spray quality are re quire d] C onclusion Duration of derogation A lternatives to focus a derogation appropriately [weak evidence]. Environmental impact Cost impact com petitors would still be able to use fluorinated gases in the production of goods intended for the EU. Other aspects 12 ye ars Give n the lack of potential alte rnatives at the present time for the m ark et for technical aerosols for applications whe re non-flammability and high technical performance of spray quality are re quired, a longer de rogation may be required to ide ntify suitable alternatives and bring the m to m arket [weak evidence] For (x i): A 12-year de rogation of all fluorinated gases use in propellants will le ad to additional emissions of 102 142 t, which is slightly highe r than e m issions under a ban of fluorinated gases (RO1). Evidence for a pre cise evaluation of e x pected a d d itional fluorinated gases e m issions in this application is lacking, but the y are e x pected to be sm all. Additional time would permit more opportunity to re se arch and introduce cost-effective alternatives whilst lim iting loss of produce r and consumer surplus and we lfare losses from use of less e ffective or m ore hazardous propellants. W hilst alternatives to fluorinated gases have m ade major inroads to the market in re cent decades there remain some niches whe re fluorinated gases re m ain as the leading option as propellants, in particular for technical aerosols for applications whe re non -flammability and high technical performance of spray quality are re quired. Improved characte risation of the specific applications whe re fluorinated gases confer significant advantage would be useful if a de rogation is to be developed for them. The introduction of a restriction with no derogation beyond the 18 month transition time would affect m anufacture rs of the propellants and aerosols, and could place parts of EU manufacturing at a disadvantage to international competitors who would re m ain free to use them in the manufacture of goods destined for the EU m arket. A pre cise time frame for development of alternatives is not possibl e, but the lack of potential alternatives at the present time indicates that a longer derogation may be appropriate. 305 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on information from the literature, the CfE and the 2nd stakeholder consultation that there is sufficiently strong evidence that technically and ec onomic ally feasible alternatives are available in the quantities required for use as propellant gases for a range of applications. However, the extent of substitution may be limited given the extent to which the aerosol industry has switched away from the use of fluorinated gases in rec ent decades. Potential for alternatives is considered low for some nic he applications such as supplying air dusting equipment, or propellant/solvents for applying specific finishes, lubricants, etc. in industrial settings. Fluorinated gases have a number of properties that favour their use in such applications, including low conductivity, good and consistent spray quality and non-flammability. Evidence regarding the time at which alternatives providing adequate performanc e will be available on the market was lac king. RO1 would provide the greatest benefit in the form of reduced emissions. 5- and 12-year derogations under RO2 would naturally lead to increased emissions. Without a clearer understanding of the scale of usage of fluorinated gas propellants it is difficult to draw conclusions on the potential economic impacts of a restriction applying at different times in the future. There is potential for significant producer and consumer surplus losses if the introduction of alternatives compromised manufacturing processes for technical products to any significant degree. The view of the industry is that the high price of fluorinated gases means that they are only used where there is a sound economic case for their use, whic h itself indic ates potential for socio-economic c osts at some level. A restriction c ould also generate scope for advantage for c ompetitors outside of the EU, given that they would remain free to use fluorinated gas propellants in the production of goods destined for the EU as the propellants would not remain on those goods after production. Table E.103 and the accompanying text summarise the outcomes of the assessment of costs and benefits for the use of fluorinated gases in magnesium c asting. 306 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.103. Magnesium casting - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Ban with usespe cific de rogations C onclusion Duration of derogation No t a p p licable 5 ye ars 12 ye ars A lternatives It is k nown that alternatives are alre ady wide ly used already to act as cove r gases in magnesium diecasting to pre ve nt oxidation at the metal/air inte rface, and it is concluded that the re is high substitution potential at EiF [sufficiently strong evidence] In contrast, no information specific to sand casting has been identified. Howe ve r, no re spondents to the CfeE or 2nd sta k eholder consultation raised conce rns over this activity and hence it is concluded that alternatives are also available for that part of the se ctor. n/a n/a Environmental impact It is e stimated that R O 1 would re duce e m issions across all use s of fluorinated gases by 95%. n/a n/a Cost impact SO 2 has been identified as a cost-effective alternative to HFC 134a for die casting operations, with a substitution cost in the order of 6 to 60/kg of HFC 134a e mitted. Very limited data has been ide ntified for sand casting operations, but there is no indication that a restriction without derogation would not be proportionate [sufficiently strong evidence]. n/a n/a Other aspects n/a n/a Alte rnatives are already available and wide ly used in the sector. Substitution costs are estimated in the range of 6 to 60/kg of PFAS emitted. It is concluded that a full ban following an 18 month transition period is appropriate. 307 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on evidence/knowledge from the literature that the evidence is sufficiently strong that technically and economically feasible alternatives are available in the quantities required for use in magnesium casting and that the substitution potential is high under RO1. No evidenc e has been submitted or identified to indic ate that a derogation would be nec essary or benefic ial. Table E.104 summarises the outcomes of the assessment of costs and benefits for fire suppressants. More detailed information c an be found in the ac companying text following the table. 308 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.104. Fire suppressants - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban 18 m onth tra n s ition pe riod Ban with use -specific de rogations: (x ii) C le an fire s u p p ress in g age nts whe re curre nt alte rnatives dam age the assets to be prote cte d or pose a risk to hum an h e a lth Duration of derogation No t a p p licable 5 ye ars 12 ye ars A lternatives Alte rnatives are available and already use d in m any fire suppre ssant applications. Howe ver, for some applications these alternatives have a range of drawbacks, for e xample risk of asphyxiation (e.g. CO2), potential to damage protected assets (e.g. wate r), slowe r speed of action than fluorinated gases. Ex amples of applications whe re these characte ristics are important include aviation, m ilitary vehicles some data ce ntre s and historical archives and m useums. High substitution potential at EiF for some uses [sufficiently strong evidence] and low substitution potential at EiF for other applications [sufficiently strong evidence]. Alte rnatives are yet to be identified for critical applications, making it unlik ely that they would be available for adoption on a timescale of 5 ye ars. [sufficiently strong evidence] A 12 ye ar derogation may provide sufficient time for the development of alte rnatives that can provide the ne ce ssary level of protection in the critical applications identified. Howe ve r, the curre nt lack of alte rnatives, long-term experiences in se e king alternatives (driven by the Montre al Protocol and F-gas re gulation indicate that there is no ce rtainty that alternatives will become available on this timescale. Curre nt re se arch on alternatives seems to focus on alternative fluorinated gases Environmental impact It is e stimated that R O 1 in all fluorinated gas applications would re duce emissions of fluorinated gases by 95% com pared to the baseline. A 12-ye ar de rogation of all fluorinated gases use in fire suppressants will le ad to additional e m issions of 102 183 t, which is slightly higher than e m issions under a ban of fluorinated gases (RO1). Given this e vidence additional emissions Cost impact Price alre ady provides a mechanism favouring alte rnatives to fluorinated gases and has le d to a significant shift in the market whe re they are not considered necessary. R emaining uses which include safe ty critical applications and protection of cultural assets, consider the benefits of fluorinated gases sufficient to accept higher prices indicating potential for significant consumer surplus losses, including through potential for loss of life and cultural and other assets, in the event that a full ban is adopted. [sufficiently strong e vidence] As RO1 In the e vent that alternatives are identified that sufficiently re plicate the performance of fluorinated gases, cost impacts of the restriction with a 12 ye ar de rogation could be small. Howe ver, as noted e lse where , the development of alternatives e ven on the 12 ye ar time scale cannot be guaranteed. In this case there would be potential for significant consumer surplus losses, including through potential for loss of life and cultural and other assets after the derogation had e xpired. Other aspects 309 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option C onclusion Duration of derogation A lternatives Environmental impact Cost impact Other aspects rathe r than non-PFAS groups [weak evidence] of the proposed de rogation will account of about 14% of e missions under the m ax imum additional emission sce nario (i.e. a de rogation of all fluorinated gases). A de rogation is nece ssary given the lack of alternatives to avoid significant risk to human life and cultural and other asset s. Given the failure of past re se arch into alternatives it is likely that a 5 year derogation would be insufficient and a longer derogation would be neede d. [sufficiently strong evidence] 310 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on evidence/knowledge from the literature, CfE and 2nd Stakeholder consultation that the evidence is sufficiently strong that technically and economically feasible alternatives are available in the quantities required for use for some applications of fire suppressants. However, these applications may constitute only a small part of the current market for fluorinated gases in the sector. These are most likely to be used in applications subject to constraints regarding the toxicity of fire suppressants, their speed of action and the need for `clean action' whereby the fire suppression agent does not damage the assets to be protected (e.g. data centres or cultural artefacts that would be damaged by the use of water). For applic ations in aviation, museums, the military and some data centres, there is sufficiently strong evidence that the substitution potential is low under RO1. It is noted that this is an area that has been investigated for many years under the Montreal Protocol and F-gas regulation, without acceptable fire suppression agents that are not fluorinated gases being identified. RO1 would naturally provide the greatest benefit in the form of reduced emissions. There is strong evidence supporting the quantification of emissions given submissions made under the F-gas regulation and t he UNFCCC (UN Framework Convention on Climate Change). Evidence on the savings made under 5- and 12-year derogations is weaker given uncertainty on the precise time-schedule for the introduction of alternatives, but they would naturally lead to increased emissions. Given the lack of alternatives for fire suppression in sensitive situations such as those identified above, evidence is sufficiently strong that cost-effective alternatives are not available at the present time. As a result, there is sufficiently strong evidence of significant loss of both producer and consumer surplus under RO1. This is reduced under RO2 as the probability of development of systems that are not dependent on fluorinated gases inc reases, though the historically slow rate of development of alternatives in this field indicates that producer and consumer loss could still be significant under RO2. Indeed, no evidence was identified to indic ate that a 5 year derogation would be muc h more benefic ial than RO1. Table E.105 summarises the outcomes of the assessment of costs and benefits for preservation of paper-based cultural materials. Further information can be found in the accompanying text following the table. 311 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.105. Preservation of cultural paper-based materials - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Ban with use -specific de rogations: (x iii) [Pre servation of cultural p a p er-bas ed m ate rials] C onclusion Duration of derogation A lternatives Environmental impact Cost impact Other aspects No t a p p licable This process involves suspending magnesium ox ide (MgO) in a fluorinated gas solvent for tre atm ent of paper m aterials to stop acid corrosion hence pre serving artefacts. Fluorinated gas solvents have the ability to de live r the alkaline buffer without degrading ink , binding materials, glue or discolour the paper. Alternative approaches have not been de scribed. Ne w a pproaches wo uld need e x te nsive testing to e nsure that they are safe to use on irre placeable materials. From the inform ation that is available it is concluded tha t the re is low substitution po tential a t EiF, but this is based on feedback from a small num ber of stakeholders [weak evidence]. It is e stimated that RO1 in all fluorinated gas applications would re duce emissions of fluorinated gases by 95% com pared to the b a s eline. The re would be some loss of produce r surplus through the loss of market opportunity, though associated use volum es may be small. It is not cle ar to what e x te nt businesses have specialised in this activity: those that have specialised spe cifically in preservation of paper m ate rials could be significantly affected le ading to some job losses. C onsumer surplus losses are likely more important, with pote ntial long-term consequences for the pre servation of cultural materials if inappropriate alternatives are adopted [sufficiently strong evidence]. 5 ye ars 12 ye ars Acce pting that alternatives are not available and given the re search that is needed to e stablish safe alternatives, a 5 ye ar de rogation would likely be insufficient [weak evidence]. Information obtained here suggests that new approaches would need extensive R&D and te sting, which m ay be feasible under a 12 ye a r de rogation. Howe ver, only limited re sponses we re re ceived re lative to this activity. [weak evidence]. Evidence for a qualitative evaluation of e x pected additional e m issions is lacking. Still, considering the m arginal use of PFAS in this application, additional emissions are lik e ly very small to m arginal. Sam e as under RO1 Additional time would permit more opportunity to research and introduce cost-e ffective alternatives whilst limiting loss of producer and consumer surplus and we lfare losses from an incre ased risk of damage to cultural assets. A de rogation appears nece ssary to bring alternatives to the market. Howe ver, the evidence informing this position is only weak, re flecting limited fe e dback from stakeholders to the CfE and 2nd stakeholder consultation and limited information identified in the literature. A derogation is therefore not proposed at this time, with m ore information being re quired from the consultation proce ss. 312 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters c onsider based on evidence from the 2nd Stakeholder c onsultation that there is weak evidence that technically and economically feasible alternatives are not available in the quantities required for preservation of cultural paper-based materials and that substitution potential under RO1 is low. The `weak' rating arises because the evidence is from a small number of stakeholders, and it is not known how representative they are of the overall market for preservation of cultural paper-based materials. RO1 would provide the greatest benefit in the form of reduced emissions. 5- and 12-year derogations under RO2 would naturally lead to increased emissions. Accounting for the current lack of alternatives for at least some companies working in the field, evidence is sufficiently strong that there would be some loss of producer and consumer surplus under RO1. Consumer surplus losses may be more significant given the nature of the goods being preserved and potential for long term damage to them. No evidence was identified to indic ate that a 5 year derogation would be muc h more beneficial than RO1, given the c urrent lac k of c andidates for alternatives. Table E.106 summarises the outc omes of the assessment of c osts and benefits for the use of insulating gas in electrical equipment. Further information can be found in the accompanying text following the table. 313 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.106. Insulating gas in electrical equipment - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban - 18 m onth tra n s ition pe riod Duration of derogation No t a p p licable A lternatives C le an air te chnology has been introduced to re place both SF6 and fluorinated gases as insulating gas in e le ctrical equipment, together with dry air (m ix of nitrogen and oxygen) and vacuum. Howe ver, for highvoltage switchgear the te chnology is still in de velopment. A full fluorinatedgas-free portfolio up to 145 kV is alre ady available and in operation. For high-voltage switchgear >145 k V, alte rnatives are not yet on the m ark et. [sufficiently strong evidence]. Environmental impact It is e stimated that R O 1 would re duce e m issions across all use s of fluorinated gases by 95% o ver the pe riod 2025 to 2055 compared to the baseline. Cost impact The m ajor cost impacts are likely to arise from socioe conomic costs due to delayed powe r grid expansions, inadequate electricity transmission and increased risk of outages. Other aspects Ban with use -specific de rogations: (x iv) I n s u lating gases in h ig h - voltage switchge ar (a b o ve 145 kV) 5 ye ars Information provided in the 2nd stak eholder consultation suggests that by 2026 high-voltage e lectricity products up to 420 kV may start to be re placed with non-PFAS alternatives. Howe ve r, it is e xpected that time be yond 2026 will be needed before a full transition to clean air te chnology for high voltage applications is applicable [sufficiently strong evidence]. Evidence for a q u a litative e valuation of additional emissions is, howe ve r, not available. It can be e x pected that a de rogation will cause limited e m issions due to low le akage rates. Additional time provides manufactures and downstre am users the opportunity to substitute inste ad of ceasing operation thereby limiting producer surplus losses, employment impacts and impacts on customers. Given the direction of travel away from PFAS in the industry it is expected that costs would be ne gligible if sufficient time is given for the transition, and that a 5 year derogation would be sufficient for th is . C onclusion 12 ye ars n/a n/a n/a It is concluded that there is a high substitution potential at EiF for m ost uses but low substitution potential at EiF for high-voltage switchgear (above 145 k V) [sufficiently strong evidence]. A 5 ye ar derogation seems sufficient for the transition for high-voltage switchgear, and associated costs are considered likely to be negligible. Without a derogation, howe ver, there are risks of disruption for electricity transmission that would have potentially significant economic consequences to society. 314 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider based on evidence from the literature and the 2 nd Stakeholder consultation that there is sufficiently strong evidence that technically and economically feasible alternatives are available in the quantities required for use as insulating gases in elec tric al equipment up to 145 kV. However, evidence is also suffic iently strong that alternatives are not currently available for high voltage equipment (>145 kV). Stakeholder information indicates that alternatives are gradually being introduced to higher voltages, but that a full transition will not be achieved until some time after 2026. This provides a sufficiently strong basis for concluding that a 5-year derogation on top of the 18 month transition period would be sufficient. RO1 would provide the greatest benefit in the form of reduced emissions. 5- and 12-year derogations under RO2 would naturally lead to increased emissions. There is sufficiently strong evidence that RO1 could lead to significant socio-economic costs due to delayed power grid expansions, inadequate electricity transmission and increased risk of outages. Given that the power sector in many European countries is currently undergoing signific ant development to expand use of renewable technologies, RO1 may also delay some important climate mitigation actions. The information presented on alternatives indicates that a 5 year derogation on top of the 18 month transition period would be sufficient t ime to permit alternatives to be developed to the point where they are able to fully substitute out the existing use of fluorinated gases. 315 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.9. Medical devices E.2.9.1. Baseline The market for PFAS applications in the medical sector is assumed to grow considerably in the short- and medium term. For instance, the use of prescribed PFAS-pharmaceuticals in the EU in 2019 is estimated to increase with 3.4%/y by the Dossier Submitters. For European anesthesia drugs a growth of 5.5% is expected between 2020 and 2025107. Furthermore, positive growth rates are expected for fluoropolymer invasive use as well as medical packaging (mainly fluoropolymers). For other PFAS applications in this sector, there is no reliable information about market trends. As a conservative approach a y early real growth rate of 5% was assumed at sector level for assessing emissions under the baseline, and under the different restriction options. The start year of the assessment is 2020. Baseline tonnage and emission estimates are projected for a time path of 30 and 45 years (2025-2070) as presented in Table E.107. Table E.107. Projected yearly PFAS use and emissions in the medical devices sector of the EEA in tonnes (mean values based on market data). PFAS use PFAS emissions 2020 43 899 5 674 2025 56 027 7 242 2030 71 507 9 242 2035 91 263 11 796 2040 116 477 15 055 2045 148 658 19 214 2050 189 729 24 523 2060 309 048 39 945 2070 503 407 65 066 The assessment of environmental impac ts under the baseline and the restriction scenarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). Emission estimates were derived from use/tonnage estimates. In c ase of po lymeric PFAS it was assumed that 1% of PFAS use is emitted. For fluorinated gases release fractions between 10% (gases used in industrial processes related to medical applications) and 100% (e.g. propellants, anaesthetics, c ontrast media) were applied. Figure E.14 shows expected low and high PFAS emissions between 2020 and 2070 in tonnes. 107 https://www.mordorintelligence.com/industry-reports/europe-anesthesia-drugs-market, date of access: 2023-01-12. 316 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.14. Expected PFAS use and emissions in the EEA under the baseline for the medical devices sector (mean values) [tonnes]. Based on the assumptions made about market trends for PFAS use in medical applications, emissions can be expected to increase over time. Specifically, between 2025 and 2055 an increase by 400% can be expected. The largest fraction of PFAS emissions are fluorinated gases, followed by fluoropolymers, and non-polymeric PFAS (including PFAA precursors). E.2.9.2. Alternatives E.2.9.2.1. Availability, technical feasibility and economic feasibility Implantable medical devices Fluoropolymers are used in a broad range of implantable medical devices (see Appendix A.3.10. of Annex A). Applic ations where PFASs are used inc lude for example sutures, stents and pacemakers. Meshes, wound treatment products (bandages, surgical tapes, surgical staples), tubes and catheters are covered in separate sections below. As indicated in Appendix A.3.10. of Annex A, various other polymers are used in some of the implants where fluoropolymers are commonly used, but the Dossier Submitters do not have information on the tec hnical and ec onomic feasibility of these alternatives. The general feedback from the second stakeholder consultation on alternatives is that: Material properties like biocompatibility, heat resistance, low friction, chemical inertness of fluoropolymers like PTFE, PFA, FEP and PVDF are unique. Alternative materials available for this type of applications do not cover the whole range of properties. Fluoropolymers are generally relatively costly compared to alternatives. For applic ations where alternatives are technically feasible, substitution of fluoropolymers is already ongoing or finished. The properties of fluoropolymers provide increased lifetime of implants reducing risk of failure and risk of replacement. 317 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) If any alternatives are identified, the lead time for substitution is likely to be several years to assess suitability and to go through the relevant approval processes. The Dossier Submitters conclude that the evidence is [sufficiently strong] that technically and ec onomic ally feasible alternatives are [not generally available] for the quantities required for use in [implantable medical devices] and that the substitution potential is [low]. Hernia meshes Typically, meshes are made of the basic materials polypropylene (PP), polyester, polyvinylidenfluoride, or PTFE. The use of pure PP meshes and polyester meshes are not rec ommended for laparoscopic intraperitoneal onlay mesh, where the mesh is plac ed over the abdominal wall defect and secured from inside the peritoneal cavity. It is accepted t hat PP and polyester meshes are coated either with a protective membrane or a protective film (absorbable or nonabsorbable) or with a titanium layer to protect the viscera. These composite meshes and ePTFE meshes are generally recommended for intraperitone al use. It is assumed that the use of these meshes reduc ed adhesion formation and henc e lowered the risk of intestinal damage and fistula formation (Bittner et al., 2014). No information on alternatives has been received during the CfE or the second stakeholder c onsult ation. The available information indic ates that alternatives to PFAS-based hernia meshes are widely available, but that their functionality is lower and lead to increased risk of adverse health impac ts (intestinal damage and fistula formation) in patients. Therefore, the alternatives are assessed to not be technically feasible. The Dossier Submitters note that this information is based on a public ation from 2014 and that no information has been obtained or rec eived on the eventual development of alternatives in the period after that. Therefore, the Dossier Submitters see a need for further justification for (or against) the assessment (that technically and economically feasible alternatives are not available) in the Annex XV report consultation. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [hernia meshes] and that the substitution potential is [uncertain]. Wound treatment products Regarding wound treatment products (bandages, surgical tapes, surgical staples), submissions from two stakeholders indicate that technically feasible alternatives are not widely available. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [wound treatment products] and that the substitution potential is [low]. Tubes and catheters Tubes and catheters made of fluoropolymers (primarily ePTFE, but FEP, PFA and PVDF were also mentioned in the second stakeholder consultation) are important in minimally invasive procedures. The use of catheters is a cost-effective technique compared to more invasive procedures. Especially the lubricity (smoothness) of the catheters is desired in medical applications (Bates and Campbell, 2015). The insertion of tiny, flexible and very smooth tubes enable small pathways and precision manoeuvring at the treated tissue and accelerate patients rec overy. Some of the main properties of ePTFE tubes are listed in Table E.108, along with the equivalent properties of some of the available alternatives. The example resins shown are all materials that have medical grades available (Teng, 2012). The lubricity (smoothness) is so 318 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) critical to the guiding catheters function that alternatives are insufficient as a catheter liner in many types of procedures (Wagner et al., 2020). Even the chemically most closely related alternative show a significant change is crucial properties. The replacement of only one C-F bond by a C-H bonds leads to a material that is less smooth (as indicated by the coefficient of fric tion) and stiffer (as indic ated by the flex modulus). This c ould lead to more damage and c omplic ations during operat ions. For instance, c atheters that are stiffer are pushed into non- target tissue or through the vessel walls more easily, leading to internal trauma and tissue irritation. Table E.108. Overview of properties of ePFTE tubing compared to alternative materials. Material Test Property being method measured e PT F E Poly e thy le ne (UHMWPE) Po ly e the r etherketone (PEEK) Pebax 7233 (Po ly e the r block amide) C oefficient of Friction ASTM D1894 Lubricity (lower = more slippery 0.050.1 0.12-0.2 0.35-0.5 0.36 Flex Modulus (MPa) ASTM Flexibility/Stiffness 496 606 D790 (higher = stiffer) 4065-4275 518 Tensile strength (MPa) at break ASTM D638 Brittle/Ductile (higher = more brittle) 10-50 40 98-100 56 Elongation at break ASTM D638 How far it can stretch before breaking (higher = further) 200600% 300% 50% >300% It should be emphasized that there are limitations of PTFE that include low tensile strength, wear resistance, creep resistance and radiation resistance. T herefore, FEP is sometimes used since FEP has better impact strength and wear resistance, yet slightly higher frictional properties and lower resistance to thermal stress cracking than PTFE (Teng, 2012). The feedback in the second stakeholder consultation generally supports the assessment above. One respondent note that alternatives are feasible in some proc edures, but it will be more painful for the patient, due to the higher friction coefficient. The Dossier Submitters conclude that the evidence is [sufficiently strong] that technically and ec onomic ally feasible alternatives are [not generally available] for the quantities required for use in [tubes and catheters] and that the substitution potential is [low]. Coatings Regarding coating of metered dose inhalers, several stakeholders in the second stakeholder consultation indicate that alternatives to fluoropolymers are either non-compatible with the medicine, do not resist the corrosive environment or do not have the required non-stick properties that facilitates accurate dosage of the active pharmac eutical ingredients. One respondent in the second stakeholder consultation noted that the bio-inertness of fluoropolymers can be matched by other substances, such as precious metals (e.g. gold, platinum). The Dossier Submitters have not been able to assess whether precious met als are technically feasible alternatives for the relevant coating applications. Regarding economic 319 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) feasibility, the respondent also noted that the price for precious metals is >1 000 times higher than that for fluoropolymers. The Dossier Submitters conclude that the evidence is [sufficiently strong] that technically and ec onomic ally feasible alternatives are [not generally available] for the quantities required for use in [c oatings of Metered Dose Inhalers] and that the substitution potential is [low]. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [other uses of c oatings of medic al devic es] and that the substitution potential is [unc ertain]. Cleaning and heat transfer: engineered fluids Two potential alternatives to perfluorinated engineered fluids are n-propyl bromide (nPB or 1-bromopropane) and trichloroethylene (TCE). These two substances are on Annex XIV of REACH and requires authorisation to be used. ECHA initiated c alls for evidenc e investigating whether to initiate a restriction under REACH Article 69(2) in 2021. In both cases ECHAs conclusion after the calls for evidence was that the information on the use and pres ence of the substances in articles was minimal and that before any further action on the substances it will monitor the presence of the substance in articles via SCIP (Substances of Concern In articles as such or in complex objects) and Substances in Artic les notifications. The Dossier Submitters note that transition towards the two alternatives mentioned above can be considered regrettable substitution. No other information on alternatives to perfluorinated engineered fluids have been obtained or found by the Dossier Submitters. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [engineered fluids] and that the substitution potential is [uncertain]. Sterilization gases Mixtures of ethylene oxide and HFCs are available for use in hospital sterilizers (A. 3.10.). The Medical and Chemicals Technical Options Committee (MCTOC) of the Montreal Protocol reviewed alternatives to HCFCs in sterilization applications and noted that there is a wide range of technical and chemical alternatives available (UNEP, 2018b). The alternatives are categorised in four main groups: heat, radiation, alkylating agents, and oxidising agents. MCTOC c oncluded that many of these alternative technologies provided signific ant advances, such as better safety profiles, turn-around times, and reduced cost per cycle, and that the c omplete phase-out of HCFCs in sterilization uses to meet the Montreal Protocol schedule was readily achievable. The Dossier Submitters note the wide range of alternatives available. The Dossier Submitters assume that some of the alternatives listed in MCTOC report are technically and economically feasible in the relevant applications. No information that contradicts this conclusion was rec eived in the c alls for evidenc e. This c onclusion is an issue for c larific ation in the Annex XV report consultation. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [generally available] for the quantities required for use in [sterilization gases] and that the substitution potential is [high]. Diagnostic laboratory testing The sector organisation Spectaris has provided input regarding these applications during the 2nd stakeholder consultation process. The stakeholder claims that PFAS are used in these applications because of their chemically/biologically stable, unreactive, nature and their 320 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) hydrophobic and oleophobic properties. It is an important feature of PFAS that they do not degrade or dec ay in the presence of chemical or biological agents; if they did, they would not be fit for purpose. In most cases there are no currently identified alternatives with appropriate properties to test and there is a concern that the potential alternatives would also be persistent in the environment due to their nec essary c haracteristics. Input from another stakeholder in the second stakeholder consultation supports this assessment and claims that in the case of laboratory equipment, alternative polymeric materials have been assessed, but they are poorly biocompatible and can lead to the absorption on foreign substances, such as fibrinogen, immunoglobulin G, insulin, histone, and carbonic anhydrase. The Dossier Submitters conclude that the evidence is [sufficiently strong] that technically and ec onomic ally feasible alternatives are [not generally available] for the quantities required for use in [diagnostic laboratory testing] and that the substitution potential is [low]. Vision applications - rigid gas permeable contact lenses and ophthalmic lenses The following information has been obtained during the second stakeholder consultation and through a report submitted by the sector organisation Spectaris (RINA, 2021). For ophthalmic lenses, alternative coatings are available, but they are associated with lower quality (hydrophocity and anti-fouling/anti-fingerprint properties) and shorter durability. Alternative coatings with similar properties are not reported as having been identified to date. For rigid gas permeable (RGP) contact lenses, both technical and chemical alternatives exist. Technical alternatives include glasses and soft hydrogel contact lenses. In most cases these alternatives are more comfortable, softer or cheaper but have not been a useful solution for the user, implying that RGP c ontact lenses have superior c haracteristics. Fluorinated methacrylate monomers have been introduced into the polymer matrix as a complement to the predominantly silicone methacrylate structure of the 1st generation gas permeable products. The silicone/fluorine part of the polymer gives the product its high oxygen transmissibility, while the methac rylate enhances optical quality and stability. Higher amounts of silicone tend to have detrimental effects on lens performance, including poor surface wettability, greater protein deposition, increased flexure and instability, and decreased lens durability. The incorporation of fluorine monomers helps to overcome many of these shortcomings, thus significantly improving the overall performance of the RGP products. In short, the 1st generation is an available alternative, but it has lower technical func tionality in some respec ts. The Dossier Submitters note that alternatives are widely available for both applications, but that stakeholder input indicates that these alternatives lead to articles with lower functionality for (some of) the users. The importance of these differences in functionality needs further justification for a derogation to be considered. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [vision applications] and that the substitution potential is [uncertain]. Propellants in Metered Dose Inhalers (MDIs) According to the consultancy report, MDIs currently use HFC-134a or HFC-227ea as propellants. These substances are within the sc ope of this restric tion proposal. There are mainly two types of alternatives: technical alternatives and non-PFAS propellants. Technical alternatives include alternative ways of administering the active pharmaceutical ingredient in the human body, such as dry powder inhalers (DPIs) or by pill, liquid or intravenous solution. Each administration method has its own benefits and drawbacks, and in 321 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) some countries, DPIs are more popular than MDIs. These technical alternatives are not suitable for all types of patients. MDIs are particularly beneficial to patients with little breathing power or who lack the coordination to handle a DPI, for instance young children, frail elderly or severely weakened or panic king persons. The Medical and Chemic als Technical Options Committee (MCTOC) of the Montreal Protocol notes the exact proportion of these groups depends on the definition of satisfactory use (UNEP, 2018b). It is probably less than 20 perc ent, although there is no real-world data. HFC 152a is a non-PFAS propellant for MDIs with a substantially lower global warming potential (GWP) than HFC- 134a and HFC- 227ea. HFC- 152a would not require any c hange of usage by the patients that are used to the c urrent HFC MDI inhalers, whic h implies that HFC152a can be considered as a "drop-in" alternative. According to the Commissions impact assessment (EC, 2022) for the ongoing review of the F-gas regulation and input in the 2nd stakeholder c onsultation, HFC-152a will be available on the market starting in 2025 after an extensive period of testing, homologation and necessary approval by the European Medicines Agency that is currently ongoing. A production facility for the substance was opened in 2022108. The Commission also notes that research is also currently conducted on the safety of HFC1234ze for use in MDIs. HFC-1234ze has an even lower GWP109 than HFC-152a and is expected to be a favoured alternative for the implementation of the F-gas regulation objectives in the long term (post -2030). But since HFC-1234ze falls within the substance scope of this restriction proposal it is not considered as a viable alternative here. It is, however, important to note that in the absenc e of a regulation of PFAS -propellants in MDIs, HFC-1234ze is expected to be a long-term substitute for both the currently used propellants (HFC- 134a and HFC-227ea) and the non-PFAS alternative HFC-152a. This introduces a tradeoff between the objectives of the F-gas regulation and the objectives of this proposal for restriction of PFAS. The Dossier Submitters conclude that the evidence is [sufficiently st rong] that technically and economically feasible alternatives are [generally available] for the quantities required for use in [propellants in Metered Dose Inhalers] and that the substitution potential is [high]. Membranes used for venting of medical devic es Hydrophobic/oleophobic membranes based on PTFE and PET with fluorinated C6 based side chain coatings are used for (sterile) venting of several medical devices, for example cell culture devices, analytical devices, blood tube systems for dialyzer systems , tube systems for eye surgery (second stakeholder consultation). One stakeholder claims that technically feasible alternatives are not available. The Dossier Submitters have no other information. More information is needed for a derogation to be considered. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [membranes used for venting of medical devices] and that the substitution potential is [unc ert ain]. Packaging of medical devices T he Dossier Submitters note the following information received during the CfE and the second stakeholder consultation: Flash-spun non-woven packaging material for medical devices. One stakeholder claimed that it is not possible to find non-fluorinated alternatives. The 108 https://www.kouraglobal.com/5899/, date of access: 2023-01-11. 109 The GWP of HFC -1234ze is 7, while HFC -152a has a GWP of 124. The currently used HFC -134a and HFC -227ea have GWPs of 1430 and 3220, respectively. 322 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Dossier Submitters note that the use of PFAS as processing aids in thermoplastic packaging is covered in Annex E.2.3. No further assessment of this use in this section. PCTFE-based packaging for medicinal preparations, medical devices and molecular diagnostics. One stakeholder claims that several non-fluorinated alternatives have been tested in the past, in both medical and general packaging applications, without success. Suitable alternatives in terms of performance have not yet been identified. This claim is supported by a submission from another stakeholder. PTFE in ophthalmic solutions packaging. One stakeholder claims that PTFE acts as hydrophobic membrane in certain ophthalmic solutions' packaging, allowing the venting of air, while retaining fluid within the container, preventing leakage. The critical characteristics of PTFE mentioned are chemical inertness and hydrophobicity. The stakeholder has no knowledge of tec hnically feasible alternatives for this use. Packaging of terminally sterilised medical devices. One stakeholder claims that materials based on C6 telomer c hemistry provide a permeable bac terium barrier (to meet the requirements of ISO 11607-1/2) and that this function requires dirt, oil, grease and water repellence properties, which cannot be reached by existing nonfluorinated alternatives. One stakeholder noted that the bio-inertness of fluoropolymers in packaging of pharmaceuticals and medical devices can be matched by other substances, such as precious metals (e.g. gold, platinum). The price for precious metals is >1000 times higher than for fluoropolymers. The information indicates that technically and economically feasible are not av ailable for all uses of packaging of medical devices. The Dossier Submitters note that derogations for some uses in this area could be considered, but also that more information is required before a broad derogation c overing pac kaging of medic al devic es in general c ould be c onsidered. The Dossier Submitters conclude that the evidence is [weak] that technically and economically feasible alternatives are [not generally available] for the quantities required for use in [packaging of medical devices] and that the substitution potential is [uncertain]. Concluding remarks on the availability, technical feasibility and economic feasibility of alternatives The Dossier Submitters conclude based on information from the CfE and the second stakeholder c onsultation, that: 1. the evidence is [sufficiently strong] that technically and economically feasible alternatives are [not generally available] and that the substitution potential is [low] for the following medical device applic ations: a. implantable medical devices (not including meshes and wound treatment proc uc ts), b. tubes and catheters, c. c oatings of Metered Dose Inhalers, and d. diagnostic laboratory testing. 2. the evidence is [weak] that technically and economically feasible alternatives are [not generally available] and that the substitution potential is [uncertain] for the following medical device applications: a. hernia meshes, b. wound treatment products, c. c oatings (other than MDIs), d. engineered fluids, e. membranes used for venting of medical devices, and f. rigid gas permeable contact lenses and ophthalmic lenses. 3. the evidence is [sufficiently strong] that technically and economically feasible alternatives are [generally available] and that the substitution potential is [high] for propellants in metered dose inhalers (MDIs). 323 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 4. the evidence is [weak] that technically and economically feasible alternatives are [generally available] and that the substitution potential is [high] for sterilization gases. Regarding pac kaging of medic al devices, the Dossier Submitters conclude that there is [weak] evidenc e that technically and ec onomic ally feasible alternatives are [not generally available] for the following uses: PCTFE-based packaging for medicinal preparations, medical devices and molecular diagnostics, PTFE in ophthalmic solutions pac kaging, and Packaging of terminally sterilised medical devices. For any other potential uses of PFAS in the packaging of medical devices, no information on alternatives have been provided. The Dossier Submitters note that derogations for some uses in this area could be considered, but also that more information is required before a broad derogation c overing packaging of medic al devic es in general c ould be c onsidered. E.2.9.2.2. Stakeholder input on timeframe for substitution and transition periods A visualisation of the process of finding a technically suitable alternative - provided by a sector organisation - is the so-called "substitution hopper" illustrated in Figure E.15. This sets out the steps required starting from the identification of potential alternatives to the selection of materials/substances through to the final substitution in production (assuming success). Each step is essential and takes time. Should an alternative have sufficient of the desired properties to warrant testing, there is no guarantee that it can make it through the testing and approval loops necessary for the product to reach market. After an alternative is identified, the certification process applicable according to the products use (e.g. the approval proc ess under the Medic al Devic es Regulation), also needs to be undertaken and c an take a considerable amount of additional time, especially for medical and in-vitro medical devices. For a substitution to be successful, it must pass through all the stages successfully. As time goes on, more alternatives are `filtered out' as they do not meet the requirements of each step in the process. 324 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.15. Illustration of the "Substitution Hopper" (RINA, 2021). The timeframes for substitution are highly dependent on the type of art icle in question, as well as the end use of the article. In general, the more stringent the technical requirements applicable to the application concerned and the greater the degree of regulation, the longer the expected implementation timeframe will be. The majority of respondents to the second stakeholder consultation indicated that regulatory approval under the Medical Devices Regulation is expected to take up to 2 years. Some stakeholders noted that the approval time is dependent on the capacity of the regulatory authorities and that a restriction of PFAS could lead to a substantial number of applications for the authorities to proc ess, thus extending the timeline of the approval proc ess. It is also possible that the initial submissions may not be approved by regulatory authorities and in these cases approval times are extended. This approval process would follow a rigorous development proc ess for an additional 2-5 years. Stakeholders indicate that the process prior to approval can also be expected to t ake several years. Most respondents indicate that the complete process from identification of alternative to approved produc t takes at least 5-10 years, if alternatives are identified at all. The Dossier Submitters conclude that in cases where technically and economically feasible alternatives have not already been identified, there is sufficiently strong evidence that identific ation, development and c ertification of alternatives would take more than five years to complete. E.2.9.2.3. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHA's dissemination site. In relation to medic al devic es, t he list of alternatives contained 13 unique CAS numbers. Two of these substances were classified according to CLP (self-classification). One substance (Parylene C) was, according to the registration dossier, a PBT substance. None of the remaining substances were known to fulfil the PBT or vPvB criteria, since they either did, according to their registration dossier, not fulfil the PBT or vPvB criteria or no data was found. For one substance with CAS number (PDMS), it was indicated that it may contain residues of D4, D5 and D6, cyclic siloxanes. D4, D5 and D6, and cyclic siloxanes are PBT/vPvB substances and D4 is an endocrine disruptor. The list contained an additional 8 substances for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. For one substance group (silicones), it was indicated that it may contain residues of D4, D5 and D6, cyclic siloxanes. For one substance group (polyamides), it was indicated that it may c ontain residues of primary aromatic amines (PAA). Appendix E.2. c ontains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. 325 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.9.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.9.1, assuming business-as-usual and, consequently, on-going PFAS use and emissions. The analysis of environmental impacts focuses on two restriction o ptions: RO1, adopting a ban of all PFAS used in medical applications after an 18-month transition period; RO2, adopting a ban on PFAS in combination with use-specific derogations. Regarding the duration of the derogations two variant are distinguished, i.e . a 5- year derogation and a 12-year derogation. Environmental impacts of RO1 are analysed quantitatively. In contrast, for the use-specific derogations emission data were largely lac king. There is information available about the PFAS group which will be affected by a derogation. Therefore, environmental impacts of RO2 are evaluated qualitatively in relation to worst -case (maximum) additional environmental emission sc enarios, i.e. a full derogation of each of the relevant PFAS groups (polymeric PFAS, fluorinated gases, PFAAs in prec ursors, or a c ombination of these). Note that these maximum additional emission worst-case scenarios do not represent restriction options. Table E.109 below summarizes the c haracteristics of the restric tion options, and the maximum additional emission scenarios. 326 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.109. Characteristics of restriction options and maximum additional emission benchmark scenarios. Restriction option a bbr e v ia tio n Short description Derogations Transition period after entry into force Duration of derogation RO1 Full ban --- 18 months --- RO2 Maximum additional emission scenario Ban with use-specific derogations Ban with full derogation of entire PFAS groups (i) Proposed derogation: Implantable medical devices (not including meshes, wound treatment products, and tubes and catheters) (ii) Potential derogation marked for reconsideration: Hernia meshes (iii) Potential derogation marked for reconsideration: Wound treatment products (iv) Proposed derogation: Tubes and catheters (v) Proposed derogation: C oatings of Metered Dose Inhalers (MDIs) (vi) Potential derogation marked for reconsideration: C oating applications for medical devices other than Metered Dose Inhalers (MDIs) (vii) Potential derogation marked for reconsideration: C leaning and heat transfer: engineered fluids for medical devices (viii) Proposed derogation: Diagnostic laboratory testing (ix) Potential derogation marked for reconsideration: Rigid gas permeable (RGP) contact lenses and ophthalmic lenses (x) Potential derogation marked for reconsideration: Membranes used for venting of medical devices (xi) Potential derogation marked for reconsideration: PC TFE-based packaging for medicinal preparations, medical devices and molecular diagnostics (xii) Potential derogation marked for reconsideration: PTFE in ophthalmic solutions packaging (xiii) Potential derogation marked for reconsideration: Packaging of terminally sterilised medical devices Polymeric PFAS; polymeric PFAS + PFAAs (incl. precursors); fluorinated gases; polymeric PFAS + fluorinated gases + PFAAs (incl. precursors) 18 months 18 months 12 years 12 years For calculating the expected emission reduction, the assumed entry -into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.110 shows mean emissions and the expected mean emission reduction for 327 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) time paths of 30 and 45 years (starting in 2025). Table E.110. Total mean emissions and emission reduction of RO1 (medical devices sector, in tonnes). Restriction option Mean total emissions Mean total Mean total emission [t] emission reduction [%] reduction [t] 2025-2055 Baseline 512 432 --- --- RO1 14 845 497 578 97 Maximum additional emission scenario `12-year derogation of polymeric PFAS'* 16 116 496 397 97 Maximum additional emission scenario `12-year derogation of fluorinated gases'* 39 915 472 508 92 Maximum additional emission scenario `12-year derogation of polymeric PFAS and PFAAs (incl. precursors)'* 27 647 484 775 95 Maximum additional emission scenario `12-year derogation of PFAAs and precursors, 50 023 462 400 90 polymeric PFAS and fluorinated gases'* 2025-2070 Baseline 1 221 554 --- --- RO1 14 845 1 206709 99 Maximum additional emission scenario `12-year derogation of polymeric PFAS'* 16 116 1 205 429 99 Maximum additional emission scenario `12-year derogation of fluorinated gases'* 39 915 1 181 639 97 Maximum additional emission scenario `12-year derogation of polymeric PFAS and PFAAs (incl. precursors)'* 27 647 1 193 907 98 Maximum additional emission scenario `12-year derogation of PFAAs and precursors, 50 023 1 171 531 96 polymeric PFAS and fluorinated gases'* *Maximum additional emission sc enarios denote worst-case emission sc enarios (assuming a full derogation of a particular PFAS group) against which emissions of proposed use -specific derogations are evaluated qualitatively. They do not represent restriction options. The assessment of environmental impacts under the baseline and the restriction scenarios is conducted at sector level and covers tonnage and use estimates during manufac ture and the use phase (thus not the waste stage). The expected emission reduc tion is highest under RO1 (full ban of all PFASs after the 18 months transition period). RO1 achieves a total PFAS emission reduction of about 96% of baseline emissions. Environmental impacts of RO2 are discussed qualitatively below for each of the proposed derogations. 328 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (i) Proposed derogation: Implantable medic al devic es (not inc luding meshes, wound treatment products, and tubes and c atheters) The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions. There is no evidence available about the precise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric PFAS in this sector, maximum additional emissions would be 16 116 t (30-year period), which is slightly higher than emissions under RO1. However, it can be expected that additional emissions arising from the proposed derogation will be lower than the (worst-case) reference scenario. (ii) Potential derogation marked for reconsideration: Hernia meshes The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions. There is no evidence available about the precise amount of additional emissions that are to be expected from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric PFAS use in this sector, maximum additional emissions would be 16 116 t (30-year period), which is slightly higher than emissions under RO1. However, considering available information about tonnage levels for medical plastics it can be assumed that additional emissions will be a small frac tion of emissions under the referenc e scenario (=full derogation of polymeric PFAS). (iii) Potential derogation marked for reconsideration: Wound treatment products The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions, and emissions of PFAAs and their precursors. There is no evidence available about the prec ise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric and PFAA PFAS use in this sector, maximum additional emissions would be 27 647 t (30-year period), which is considerably higher than emissions under RO1. (iv) Proposed derogation: Tubes and catheters The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions. There is no evidence available about the precise amount of additional emissions to be expec ted from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric PFAS use in this sector, maximum additional emissions would be 16 116 t (30-year period), which is slightly higher than emissions under RO1. (v) Proposed derogation: Coatings of Metered Dose Inhalers (MDIs) The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions, and emissions of PFAAs and their precursors. There is no evidence available about the prec ise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric and PFAA PFAS use in this sector, maximum additional emissions would be 27 647 t (30-year period), which is considerably higher than emissions under RO1. According to the data available to the Dossier Submitter, the amounts of PFAS use in this applic ation can be c onsidered to be very low (<100 kg), and emissions arising from this derogation are expected to be far below the (worst-case) reference scenario (i.e. a full derogation of polymeric and PFAA PFAS use in this sector). 329 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (vi) Potential derogation marked for reconsideration: Coating applications for medical devices other than Metered Dose Inhalers (MDIs) The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions, and emissions of PFAAs and their precursors. There is no evidence available about the prec ise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric and PFAA PFAS use in this sector, maximum additional emissions would be 27 647 t (30-year period), which is considerably higher than emissions under RO1. (vii) Potential derogation marked for reconsideration: Cleaning and heat transfer: engineered fluids for medical devices The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will c ause additional fluorinated gases emissions. There is no evidence available about the precise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all fluorinates gases' use in this sector, maximum additional emissions would be 39 915 t (30-year period), which is substantially higher than emissions under RO1. This would reduce the overall effectiveness of the restriction in this sector from 97% to about 80%. (viii) Proposed derogation: Diagnostic laboratory testing The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional emissions of PFAAs and PFAA precursors, fluorinated gases, and polymeric PFAS. There is no evidence available about the precise amount of additional emissions from the derogation in this sector. Under the (worst -case) reference scenario, assuming a full derogation of all polymeric PFAS, fluorinated gases and PFAA PFAS in this sector, maximum additional emissions would be 50 032 t (30-year period), which is substantially higher than emissions under RO1. However, considering available information about a use quantity of < 5 t per year, it is assumed that additional emissions arising from a derogation of this applic ation will be a small frac tion of emissions under the reference scenario (=full derogation of PFAAs and PFAA precursors, fluorinated gases, polymeric PFAS, see also Spectaris submission; https://webgate.ec.europa.eu/s-circabc/ui/group/881f9fd7-9e57-4de5-ab1235c e08dbf09b/library/ab4adafa -a315-428c-af1d-ff9bf547b6b8/details). (ix) Potential derogation marked for reconsideration: Rigid gas permeable (RGP) contact lenses and ophthalmic lenses The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions. There is no evidence available about the precise amount of additional emissions from this derogation. However, considering available information about the use quantity of about 1 t/y, it is assumed that additional emissions will be of a small frac tion c ompared to emissions under the referenc e sc enario of 16 116 t (=full derogation of Polymeric PFAS, see also Spectaris submission; https://webgate.ec.europa.eu/s-circabc/ui/group/881f9fd7-9e57-4de5-ab12- 35c e08dbf09b/library/ab4adafa -a315-428c-af1d-ff9bf547b6b8/details). (x) Potential derogation marked for reconsideration: Membranes used for venting of medical devic es 330 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause polymeric PFAS emissions, and emissions from PFAAs. There is no evidence available about the precise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric and PFAA PFAS use in this sector, maximum additional emissions would be 27 647 t (30-year period), which is considerably higher than emissions under RO1. Based on examples mentioned in the second consultation (culture devices, analytical devices, blood tube systems for dialyzer systems, tube systems for eye surgery) it is assumed that addional emissions will be a small fraction of emissions compared to the reference scenario (=full derogation of polymeric PFAS and PFAAs). (xi) Potential derogation marked for reconsideration: PCTFE-based packaging for medicinal preparations, medical devices and molecular diagnostics The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions. There is no evidence available about the precise amount of additional emissions to be expected from this derogation. Under the (worstc ase) reference sc enario, assuming a full derogation of all polymeric PFAS use in this sector, maximum additional emissions would be 16 116 t (30-year period), which is slightly higher than emissions under RO1. Considering available information about tonnage levels for medical plastic s, however, it is assumed that additional emissions will be a small frac tion of emissions under the reference scenario (=full derogation of polymeric PFAS). (xii) Potential derogation marked for reconsideration: PT FE in ophthalmic solutions pac kaging The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional polymeric PFAS emissions. There is no evidence available about the precise amount of additional emissions to be expected from this derogation. Under the (worstc ase) reference sc enario, assuming a full derogation of all polymeric PFAS use in this sector, maximum additional emissions would be 16 116 t (30-year period), which is slightly higher than emissions under RO1. Considering available information about tonnage levels for medical plastics it is assumed that additional emissions will be a small fraction of emissions under the referenc e sc enario (=full derogation of polymeric PFAS). (xiii) Potential derogation marked for reconsideration: Packaging of terminally sterilised medical devices The derogation is marked for consideration for a duration of 12 years after EiF of the restriction and the 18 months transition period. Compared to a ban (RO1), a derogation will cause additional emissions from polymeric PFAS emissions, and emissions from PFAAs. There is no evidence available about the prec ise amount of additional emissions from this derogation. Under the (worst-case) reference scenario, assuming a full derogation of all polymeric and PFAA PFAS use in this sector, maximum additional emissions would be 27 647 t (30-year period), which is substantially higher than emissions under RO1. Considering available information about tonnage levels for medical plastics it is assumed that additional emissions will be a small frac tion of emissions under the reference scenario (=full derogation of polymeric PFAS and PFAAs). Figure E.16 below shows the time paths of mean emissions for the baseline scenario, RO1 and maximum additional emission scenarios for PFAS groups covered by the proposed derogations. 331 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.16. Time path of mean emissions in the medical devices sector under the baseline, RO1 and maximum additional emission scenarios [tonnes]* * The time path for a full ban (RO1) is very close to the time path of a 12 -year derogation of polymeric PFAS. The orance line therefore overlaps with the light green line. Source: Own calculations based on data compiled by the Dossier Submitters. E.2.9.4. Economic and other impacts E.2.9.4.1. Implantable medical devices Tubes and catheters, meshes and wound treatment products are covered in separate sections below. The conclusion from the assessment of alternatives is that there is sufficiently strong evidenc e that technically and ec onomic ally feasible alternatives are not available. The general feedback from the second stakeholder consultation on the impacts of a t ransition to alternatives is that: Fluoropolymers are generally relatively costly compared to alternatives. For applic ations where alternatives are technically feasible, substitution of fluoropolymers is already ongoing or finished. The properties of fluoropolymers provide increased lifetime of implants reducing risk of failure and risk of replacement. Based on this input from stakeholders, the Dossier Submitters conclude that there is [sufficiently strong evidence] that a ban of the use of PFAS in implantable medical devices is 332 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) [likely] to have considerable impacts on the use of implantable medical devices and, c onsequently, on public health and that it would lead to [high soc ioeconomic c osts]. Furthermore, the Dossier Submitters note that the second stakeholder c onsultation indicated that the complete process from identification of alternative to approved product takes at least 5-10 years in this sec tor. This indic ates that a relatively long derogation period is required to avoid these costs. E.2.9.4.2. Hernia meshes The available information indicates that available alternatives are widely available, but that their functionality is lower. In the assessment of alternatives, the Dossier Submitters concluded that further justification for (or against) this assessment is needed in the Annex XV report consultation. The Dossier Submitters note that, if technically feasible alternatives indeed are not available, a ban on PFAS would lead to inc reased risk of adverse health impac ts (intestinal damage and fistula formation) in patients. These impacts are likely to be associated with high socioeconomic costs. The Dossier Submitters c onclude that there is [weak evidence] that a restriction of the use of PFAS in hernia meshes is [likely] to have [high socioeconomic costs]. This conclusion is an issue for c larific ation in the Annex XV report c onsultation. E.2.9.4.3. Wound treatment products Submissions from two stakeholders in the second stakeholder consultation indicate that technically feasible alternatives are not widely available. No further information on the impacts of a potential restriction was provided. The Dossier Submitters conclude that the socio-economic costs of a ban on PFAS in wound treatment products is [unc ertain]. E.2.9.4.4. Tubes and catheters The assessment of alternatives above indicated that technically and economically feasible alternatives are not generally available. One respondent in the second stakeholder c onsultation noted that alternatives are feasible in some procedures, but it will be more painful for the patient, due to the higher friction coefficient. The use of catheters is a cost-effective technique compared to more invasive procedures. Especially the lubricity (smoothness) of the catheters is desired in medical applications (Bates and Campbell, 2015). The insertion of tiny, flexible and very smooth tubes enables small pathways and precision manoeuvring at the treated tissue and accelerate patients' recovery. The Dossier Submitters note that the information obtained indicates that a ban on PFAS in these applic ations would lead to more proc edures that are more invasive and/or more painful for the patient. The socio-economic costs related to these implic ations c an be expected to be substantial. The Dossier Submitters conclude that there is [sufficiently strong evidence] that a ban of the use of PFAS in tubes and catheters is [likely] to have considerable impacts on public health and that it would lead to [high socioeconomic costs]. Furthermore, the Dossier Submitters note that the second stakeholder c onsultation indicated that the complete process from identification of alternative to approved product takes at least 5-10 years in this sector. This indicates that a relatively long derogation period is re quired to avoid these costs. 333 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.9.4.5. Coatings Regarding coating of metered dose inhalers, several stakeholders in the second stakeholder consultation indicate that alternatives to fluoropolymers are either noncompatible with the medicine, do not resist the corrosive environment or do not have the required non-stick properties that facilitates accurate dosage of the active pharmaceutical ingredients. The lack of technically feasible alternatives and the high societal value of the medic inal produc t indic ates that this RO would be associated with substantial socio-economic costs. The Dossier Submitters conclude that there is [sufficiently strong evidence] that a ban of the use of PFAS in coatings of MDIs is [likely] to have considerable impacts on public health and that it would lead to [high socioeconomic costs]. Furthermore, the Dossier Submitters note that the second stakeholder consultation indicated that the complete process from identification of alternative to approved product takes at least 5-10 years in this sector. This indic ates that a relatively long derogation period is required to avoid these c osts for c oatings of MDIs. For other coating applications, no information on the impacts of a proposed restriction was provided and the Dossier Submitters conclude that the socio-economic costs of a ban on PFAS in these applications is [uncertain]. E.2.9.4.6. Cleaning and heat transfer: engineering fluids The Dossier Submitters have no information on feasible alternatives. No information provided on the c ost impac ts of a ban. The Dossier Submitters conclude that the socio-economic costs of a ban on PFAS in these applic ations is [unc ertain]. E.2.9.4.7. Sterilization gases The Dossier Submitters note the wide range of alternatives available and assumes that some of the alternatives listed in the assessment report from The Medical and Chemicals Technical Options Committee (MCTOC) of the Montreal Protocol are technically and economically feasible in the relevant applications. No information that contradicts this conclusion was received in the CfE or in the second stakeholder consultation. The Dossier Submitters c onclude that there is [weak evidence] that a restriction of the use of PFAS as sterilization gases is [likely] to have [low socioeconomic costs]. This conclusion is an issue for c larific ation in the Annex XV report c onsultation. E.2.9.4.8. Diagnostic laboratory testing In the assessment of alternatives above we concluded that there is sufficiently strong evidence that alternatives to PFAS are not generally available in this field of applicatio ns. The Dossier Submitters note that a ban on PFAS could have substantial impacts on the feasibility of diagnostic laboratory testing, which in turn would have severe implications on public health. The Dossier Submitters conclude that there is [sufficiently strong evidence] that a ban of the use of PFAS in diagnostic laboratory equipment is [likely] to have considerable impacts on public health and that it would lead to [high socioeconomic costs]. Furthermore, the Dossier Submitters note that the second stakeholder c onsultation indicated that the complete process from identification of alternative to approved product takes at least 5-10 years in this sec tor. This indic ates that a relatively long derogation period is required to avoid these costs. 334 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.9.4.9. Vision applications - rigid gas permeable contact lenses and ophthalmic lenses PFPE-coatings of ophthalmic lenses are applied make them easy to clean, hydrophobic, oleophobic and scratch resistant. The assessment of alternatives indicates that (unspecified) alternatives have lower quality and shorter durability. One stakeholder c laims that this could imply lower quality of life for eyeglass users as well as increasing costs due to higher replac ement frequency of eyeglasses. The Dossier Submitters note that these types of socioeconomic impacts are not unlikely but does not have information to conclude on the magnitude of the impacts. For rigid gas permeable (RGP) contact lenses, the assessment of alternatives indicates that both technical and chemical alternatives are widely available. According to information provided by the sec tor organisation Spectaris the technical alternatives (inc luding eyeglasses and soft hydrogel c ontact lenses) are generally more c omfortable or c heaper, but users still prefer RGP contact lenses, which indicates that RGP contact lenses have other superior characteristics (RINA, 2021). Spectaris also claims that the chemical alternative has lower technical functionality in some respects. The Dossier Submitters note that a ban on PFAS could have negative impacts on the quality of life for users of RGP contact lenses, but the severity of these impac ts is unc lear. Ac c ording to the sec tor organisation EUROMCONTACT, a ban on PFAS in RGP c ontact lenses soft contact lenses and ophthalmic solutions packaging would result in job losses in a range of 1 800 to 2 000 across production, packaging and distribution operations for the affected produc ts sold within the EU, assuming that no alternatives are available ( second stakeholder c onsult ation). The Dossier Submitters note that alternatives are available, but that a transition away from PFAS could lead to some negative socio-economic impacts. The information provided does not allow for quantification of these impacts. Further justification on the severity of the quality-of-life reductions and the increased costs due to more frequent replacements of eyeglasses is required to c onc lude on the magnitude of the soc io - economic impac ts of a ban on PFAS in these applications. The Dossier Submitters conclude that the socio-economic costs of a ban on PFAS in these applic ations is [unc ertain]. E.2.9.4.10. Propellants in Metered Dose Inhalers (MDIs) Phasing out the use of PFAS propellants in MDIs can be partly met by increased use of technical alternatives, primarily dry powder inhalers (DPIs). As noted in the assessment of alternatives, the technical alternatives are not suitable for all types of patients. So, part of the phasing out of PFAS propellants - in c ase of a restric tion - will need to be met by increased use of the non-PFAS propellant HFC-152a. In the absence of a policy driver, the market uptake of HFC-152a is expected to be rather slow. In the baseline scenario of the Commissions impact assessment for the review of the F-gas regulation, it is assumed that HFC-152a will be used in 1 % of the new MDIs in 2026, increasing to 50% in 2050 (EC, 2022). If the F-gas Regulation is revised in line with the proposal from the Commission (April 2022) the transition to HFC152a is expected to happen more quickly. In the "proportionate action scenario" of an external preparatory study for the Commissions impac t assessment, the penetration rate of HFC-152a increases sooner than in the baseline scenario and is estimated to reach an average of 47% over the period 2024-2036 (ko-Institut et al., 2022). One stakeholder in the 2nd stakeholder consultation claims that ongoing trials indicate that most (by volume), if not all, MDI treatments can be reformulated and approved to use HFC 152a, but the time needed for a complete transition away from the current propellants is unc lear. 335 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The expected year of the adoption of this restriction proposal is 2025. This will be followed by a transition period. The default transition period in this proposal is 18 months. Whether this period will be enough to facilitate a complete transition away from the currently used propellants is unclear. It is also unclear to what extent a transition that is faster than expected in the baseline scenario will lead to additional one-off capital costs or other transitional costs. These issues will need to be c larified in the Annex XV report c onsultation. Apart from potential transitional c osts, the c osts of substituting to HFC- 152a are likely to be very small. The price of HFC-152a is equivalent with the price of the currently used propellants in MDIs and the price of the gas is only a very small part of the price of the overall MDI product (less than 1%) which is mostly determined by the medicinal agent (ko-Institut et al., 2022). The pharmaceutical sector is a high margin industry. This implies that potential costs of substitution are likely to be internalized by the producers (in the form of lower profit margins) rather than passed on to consumers. Since the approval process of HFC-152a in MDI applications is already ongoing, the Dossier Submitters assume that a ban on PFAS in these applications will not lead to any additional administrative c osts for industry or authorities. A long-term (post 2030) impac t of a ban on PFAS-propellants in MDIs is that the low-GWP propellant HFC-1234ze is not a viable alternative. Unless alternative non-PFAS propellants with similar, or lower, GWP properties (or alternative technologies) are developed, a ban on PFAS propellants will make it more challenging (and probably more c ostly) to fulfil the objec tives of the F-gas regulation. This implies that there is a trade-off between the objectives of the F-gas regulation and the objec tives of this proposal for restric tion of PFAS. The Dossier Submitters conclude that the evidence is [sufficiently strong] that a restriction on PFAS as propellants in MDIs is [likely] to have [low socioeconomic costs]. The main unc ertainty that needs to be c larified in the Annex XV report c onsultation is whether the 18month transition period will be enough to facilitate a complete transition away from the currently used propellants and to what extent the transition will lead to additional one -off capital costs or other transitional costs. E.2.9.4.11. Membranes used for venting of medical devices The assessment of alternatives above c oncluded that there is weak evidenc e that technically feasible alternatives are not generally available. The Dossier Submitters have no information on the socio-economic implications of a ban on PFAS in these applications, if feasible alternatives indeed are not available. The Dossier Submitters conclude that the socioeconomic costs of a ban on PFAS in these applications is [uncertain]. E.2.9.4.12. Packaging of medical devices The assessment of alternatives above concluded that there is weak evide nce that feasible alternatives are not generally available for the following packaging applications: PCTFE-based packaging for medicinal preparations, medical devices and molecular diagnostics. PTFE in ophthalmic solutions packaging. Packaging of terminally sterilised medical devices. For other pac kaging of medic al devices there was no evidence on the availability or feasibility of alternatives. The Dossier Submitters note that packaging in some instances is of high importance for the functionality and safety of medical devices and that changes in packaging require renewed 336 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) quality assessments and regulatory authorisations. The Dossier Submitters c onc lude that in applic ations where pac kaging is of high importance for functionality and safety, and where there are no available alternatives that meets the technical requirements, there is [sufficiently strong] evidence that a ban on PFAS is [likely] to have [high socioeconomic costs]. The Dossier Submitters do not have the information available to identify these applications. Further information is requested in the Annex XV report consultation. In applic ations where pac kaging is not of high importanc e for the func tionality and safety of the medical devices or where available alternatives can meet the technical requirements for func tionality and safety, the Dossier Submitters assume that a ban on PFAS would have [low socioeconomic costs]. 337 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.9.5. Summary of cost and benefit assessment Table E.111 summarises the outcomes of the assessment of costs and benefits for medical devices. For further information on cost impacts, see section E.2.9.4. Table E.111. Medical devices - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction Duration of option derogation Medical devices Full ban Not applicable A lte r na tiv e s Sufficiently strong evidence that technically and economically feasible alternatives are generally available, and that the substitution potential is high for propellants in metered dose inhalers (MDIs). Weak evidence that technically and economically feasible alternatives are generally available, and that the substitution potential is high for sterilization gases. Sufficiently strong evidence that technically and economically feasible alternatives are not generally available, and that the substitution potential is low for implantable medical devices (not including meshes and wound treatment products), tubes and catheters, coatings of MDIs, and diagnostic laboratory testing equipment. E nv ir o nme ntal impact According to available evidence, which is considered sufficiently strong, the expected emission reduction from the restriction is 497 578 t for a 30-year period (2025-2055), and 1 206 709 t for a 45-year period (20252070). As the environmental impact assessment does not cover the waste phase, emissions under the baseline as Cost impact Sufficiently strong evidence that a ban in propellants in MDIs is likely to have low socioeconomic costs. Weak evidence that a ban in sterilization gases is likely to have low socioeconomic costs. Sufficiently strong evidence that a ban in implantable medical devices (not including hernia meshes and wound treatment products), tubes and catheters, coatings of MDIs, and diagnostic laboratory testing equipment is likely to have considerable impacts on public health and would consequently lead to high socioeconomic costs. Weak evidence that a ban in hernia meshes would have high socio-economic costs. The cost impacts of a ban on wound treatment products, coatings (other than coating of MDIs), engineered fluids, rigid gas permeable contact lenses and ophthalmic lenses and membranes used for venting of medical devices are unknown. Packaging. In applications where packaging is of high importance for the functionality and safety of Other aspects 338 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s Weak evidence that technically and economically feasible alternatives are not generally available, and that the substitution potential is uncertain for wound treatment products, coatings (other than coating of MDIs), engineered fluids, rigid gas permeable contact lenses and ophthalmic lenses, hernia meshes, membranes used for venting of medical devices and the following packaging of medical of devices: PCTFEbased packaging for medicinal preparations, medical devices and molecular diagnostics, PTFE in ophthalmic solutions packaging, and packaging of terminally sterilised medical devices. E nv ir o nme ntal impact well as emissions avoided as a result of the restriction are likely underestimated. Cost impact the medical devices, and where there are no available alternatives that meets the technical requirements, there is sufficiently strong evidence that a ban would have high socioeconomic costs. The Dossier Submitters do not have the information available to identify these applications. In applications where packaging is of now or low importance for the functionality and safety of the medical devices or where available alternatives can meet the technical requirements for functionality and safety, the Dossier Submitters assume that a ban would have low socioeconomic costs. Other aspects Ban with usespecific derogation s: Derogation for (i) implantable 5 years For other packaging of medical devices, there is no evidence on alternatives available. Sufficiently strong evidence that the substitution potential is low for implantable medical devices (not including meshes and wound treatment products), tubes and catheters, coatings of MDIs, and diagnostic laboratory testing C ompared to a 12-year derogation, expected additional emissions will be lower, but the same Same or similar as under a full ban. 339 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option medical devices, (ii) hernia meshes, (iii) wound treatment products (iv) tubes and catheters, , (v )c oa tings of MDIs,, (vi) coating application s for medical devices, (v ii) cleaning and heat transfer (v iii) diagnostic laboratory testing equipement , and (ix) rigid gas permeable contact lenses and ophthalmic lenses (x) membranes Duration of derogation 12 years A lte r na tiv e s equipment. Sufficiently strong evidence that technically and economically feasible alternatives are not generally available for these uses and sufficiently strong evidence that identification, development and certification of alternatives would take more than five years to complete. Weak evidence that technically and economically feasible alternatives are not generally available for the other usespecific derogations. Unknown, depending on R&D progress, but continued R&D increases the chance that alternatives for the relevant applications will be identified. E nv ir o nme ntal impact conclusions can be drawn in relation to a full ban (RO1). Cost impact No evidence available about the precise amount of additional emissions from this derogation. For (i), (ii), (iv), (ix), (xi), (xii): Under the (worst-case) reference scenario, assuming a full derogation of all polymeric PFAS in this sector, maximum additional If feasible alternatives are identified, developed and approved, the public health concerns (and their related socio-economic costs) due to reduced functionality of the medical devices where derogations are considered would be avoided. The process of identifying and developing alternatives will be associated with considerable costs. If feasible alternatives are not identified (or not approved) then the socio-economic costs after the end of the derogation period would be equivalent with the costs outlined in the full ban scenario above. Other aspects 340 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option for venting of medical devices (xi) PCTFEbased packaging for medicinal preparation s, medical devices and molecular diagnostics , (xii) PTFE in ophthalmic solutions packaging, (xiii) packaging of terminally sterilised medical devices. Duration of derogation A lte r na tiv e s E nv ir o nme ntal impact emissions would be 16 116 t (30-year period), which is slightly higher than emissions under RO1. Additional emissions arising from the proposed derogation are expected to be be lower than the (worstcase) reference scenario. For (iii), (v), (vi), (x), (xiii): Under the (worstcase) reference scenario, assuming a full derogation of all polymeric and PFAA PFAS use in this sector, maximum additional emissions would be 27 647 t (30-year period), which is considerably Cost impact Other aspects 341 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s E nv ir o nme ntal impact higher than emissions under RO1. Additional emissions from these derogations can be expected to me a small fraction of emissions compared to the reference scenario. For (vii): Under the (worst-case) reference scenario (= full derogation of all fluorinates gases' use in this sector) maximum additional emissions would be 39 915 t (30-year period), which is substantially higher than emissions under RO1. This would reduce the overall effectiveness of Cost impact Other aspects 342 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Conclusion Duration of derogation A lte r na tiv e s E nv ir o nme ntal Cost impact impact the restriction in this sector from 97% to about 92%. For (viii): Under the (worst-case) reference scenario, assuming a full derogation of all polymeric PFAS, fluorinated gases and PFAA PFAS in this sector, maximum additional emissions would be 50 023 t (30-year period), which is substantially higher than emissions under RO1. Factual emissions from this derogations are assumed to be a small fraction of emissions under the reference scenario. A full ban of PFAS with a transition period of 18 months is proposed for: Other aspects 343 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s E nv ir o nme ntal Cost impact impact propellants in Metered Dose Inhalers, sterilization gases, and packaging of medical devices, excluding: o PC TFE-based packaging for medicinal preparations, medical devices and molecular diagnostics, o PTFE in ophthalmic solutions packaging, and o packaging of terminally sterilised medical devices. Other aspects A full ban of PFAS with a time-limited derogation period of 12 years (after the 18 months transition period) is proposed for: implantable medical devices (not including meshes and wound treatment products), tubes and catheters, coatings of Metered Dose Inhalers, and diagnostic laboratory equipment. A full ban of PFAS with a time-limited derogation period of 12 years (after the 18 month transition period) is under consideration, but further justification is needed, for: hernia meshes, wound treatment products, coatings applications for medical devices (other than coating of Metered Dose Inhalers), engineered fluids for medical devices, membranes used for venting of medical devices, rigid gas permeable contact lenses and ophthalmic lenses, and the following packaging of medical of devices: o PC TFE-based packaging for medicinal preparations, medical devices and molecular diagnostics, o PTFE in ophthalmic solutions packaging, and o packaging of terminally sterilised medical devices. In light of the weak evidence that technically and economically feasible alternatives are not available for these applications is not proposed at this point but marked for reconsideration. A derogation might be proposed at a later stage if additional informat ion on the (lack of) availability of feasible alternatives is provided. 344 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A full ban with a transition period of 18 months is proposed for uses where the Dossier Submitters have identified that technically and economic ally feasible alternatives are available (propellants in MDIs and sterilization gases), or where there is no information explicitly indicating that technically and economically feasible alternatives are not available (packaging of medic al devic es, with some exc eptions). A 12-year derogation, after the 18 months transition period, is proposed for uses where there is a sufficiently strong evidence base showing that significant R&D efforts did not identify PFAS-free alternatives and it is likely that they will not become available in the near future and/or that there is sufficiently strong evidence provided that certification of PFAS-free alternatives cannot be achieved within a five-year derogation period. The Dossier Submitters note that the second stakeholder consultation indicated that the complete process from identification of alternative to approved product takes at least 5-10 years in this sector. All uses where the Dossier Submitters have assessed that the evidence is sufficiently strong that tec hnically and economic ally feasible alternatives are not generally available, are proposed to get a 12-year derogation. A 12-year derogation after the 18 months transition period is under consideration for uses where the justification of a derogation (i.e. non-availability of technically and economically feasible alternatives) is based on a weak evidenc e base. 345 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.10. Transport The transportation sector covers all modes of transport, by road, rail, air and sea. PFAS are used in a wide range of functions in the transport ation sector, listed in Annex A.3.11. This sec tion c oncerns use of PFAS in: 1. Sealing applic ations, suc h as o-rings, seals in valves, gaskets, pistons, draft shafts to prevent loss of fluids and to protect components 2. Other uses in drive systems such as lines and hoses, use in gas turbine engines for improving effic iency and reduc ing emissions, lubric ation free bearings 3. Other uses relevant to vehicle safety, such as in seat belt mec hanisms and brake pads 4. Corrosion inhibitors in hydraulic fluids 5. Mobile air conditioning (MAC) systems 6. Refrigeration systems Other uses with relevanc e to transport are c overed elsewhere in the dossier, inc luding: TULAC: Annex E.2.2 Metal plating and manufacture of metal products: Annex E.2.4 Electronics and semiconductors: Annex E.2.11 Energy (Batteries and fuel cells): Annex E.2.12 Lubricants: Annex E.2.14 Such uses are not discussed further in this section, but the conclusions reached in other sections apply equally to transport. There are a wide range of functions and characteristics of PFAS in the transport ation sector, inc luding: - Durability - Flexibility - Resistance to chemical attack - Resistance to UV - Electrical properties - Heat transfer properties - Performance over a range of operating conditions - Low weight - Low or non-flammability - Non-stick properties E.2.10.1. Baseline For assessing the time path of PFAS use (tonnage) and emissions in the transport ation sector a mean real growth rate of 1%/y was assumed110. Though information about market trends is neither available at sector level, nor for specific PFAS uses within this sector, it seems likely that the market will further expand in the future. The start year of the assessment is 2020. Baseline tonnage and emission estimates are projected for a time path of 30 and 45 years (2025-2070) as presented in Table E.112. 110 https://www.acea.auto/figure/vehicle-sales-mirror-economic-growth-2006-2019-trend/, date of access: 2023-01-11. 346 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.112. Projected yearly PFAS use and emissions in the transportation sector of the EEA in tonnes (mean values based on available market data). PFA S use PFA S emissions 2020 285 391 6 723 2025 299 949 7 066 2030 315 249 7 426 2035 331 330 7 805 2040 348 231 8 203 2045 365 994 8 622 2050 348 664 9 062 2060 424 908 10 010 2070 469 363 11 057 The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). Based on the assumptions discussed above, PFAS use and emissions in the transport ation sector are expected to grow considerably under the baseline scenario. Since the assumed market growth rate is uncertain, especially in the long run (beyond 2050), PFAS use, and emission estimates have to be treated with care. Still, considering the continued expansion of E-documented in Annex, it is likely that PFAS use (and, in turn, emissions) will continue to grow in the long term without a restriction. This growth is predominantly caused by continued demand for fluoropolymers used in sealing applications, and by the use of fluorinated gases for mobile refrigeration and air conditioning. Figure E.17 shows expected PFAS use and emissions for the sector, based on available market data documented in Annex A, and assumptions on growth rates explained above. Emissions during the use phase occur from the use of PFASs used in HVACR-systems and fluoropolymers and are c alc ulated from PFAS use estimates and relevant ERCs. Therefore, emission trends mirror the trends for PFAS use. Despite the large tonnage of PFAS used in the transportation sector, emissions account for less than 1% of PFAS use. This low fraction can be explained by the assumed very low emissions from fluoropolymer use. The start year of the projection of tonnage and emission estimates is 2020 as presented in Table E.112. Figure E.17. Expected PFAS use and emissions in EEA under the baseline in the transport sector (mean values) [tonnes] Source: Own calculations based on market data collated by the Dossier Submitters. 347 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.10.2. Alternatives E.2.10.2.1. Technical feasibility Information on alternatives is only available for a few applications. The applications where information on alternatives is provided are presented below. If provided, also information on legal approval schemes and possible timelines for transitions to alternatives are described for the different applications. Also, some general information on the availability of alternatives and legal approval schemes was provided by stakeholders during the CfE and 2nd stakeholder consultation. This will briefly be presented below. The information presented in the next chapters is summarized in Table E.113. The manufacturers of transportation vehicles usually do not prescribe the use of individual substances to their suppliers but rather stipulate performance requirements that the individual parts have to meet. Performance requirements are laid down for example in industrial standards (e.g. DIN, EN, ISO), or individual company standards, but may also be dictated by legal frameworks (e.g. Regulation (EU) 2018/858 or 2013/168). In an economically driven and competitive sector, such as the manufacture of transportation vehic les, suppliers are inc ited to provide the most c ost-effective solutions that still meet the performance requirements. Since the production of fluorine containing materials usually is more expensive compared to most other materials (e.g. PE 1/kg and PTFE 12.75 /kg, information received from stakeholder) it could be assumed that fluorinated materials are used only where performance requirements leave no other option. Yet, it should be c arefully considered whether this holds true for all transportation applications. Performance or safety requirements are most likely not relevant for the application of PFAS in e.g. the coating of trim materials to achieve stain protection and give surfaces a valuable feel and look. Similarly, the treatment of textiles e.g. for seats, carpets, roof linings, to give the textiles water and dirt repellent properties. This indicates that PFAS are used if it is considered that there is a quality improvement that customers are willing to pay for. One stakeholder provided information, that in automotive and aerospace applic ations silicones are usually banned due to the high risk of contamination, without specifying what kind of contamination this refers to, or legal texts or standards where this is fixed. A different stakeholder presented information regarding transition times for road vehicles. It was stated that, if alternatives were available and suitable for the dedicated applications, a transition can be estimated to take 5 - 10 years taking into account the time for new material development, manufacturing process adaptations or set -up of new manufacturing tec hnologies and alternative product designs. New vehic les whose development begins today would be on the market in 6 - 7 years (for trucks 10 - 12 years). For already developed vehicles, it was stated that a transitional period of 15 years is needed until the end of the production of these vehicles. 348 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.113. Alternatives for PFAS substances used in transportation products and articles. Empty cells indicate that no information was received. The estimate of time needed for substitution is taken from estimates provided by stakeholders and accounts only for the tim e needed for substitution once an alternative has been identified. A pplication Body-, hull-, and fuse lage construction Se aling applications C om bustion engine syste m (lines and hose s) Hydraulic fluids C oating and finishes Non PFA S alternative No inform ation identified or submitted to the consultation process Non-fluorinated polymers (e.g. NBR , ACM, CR), m e chanical seals made of ce ramics Nylon All-m e tal fuel lines None available (for aviation sector) Hydrophobic coatings for windshields: Varnishes (e.g. poly acrylates) Silicon based materials Polypropylated aromatics Fatty alcohols Fatty acids Alk ylsilanes Nano-particles Substitution potential Suitable for some specific applications but ove rall disadvantages compared to fluorinated polym ers (e.g. reduced lifetime, emissions, f rictio n ) Nylon fails to fulfil the emission re quirements All-m e tal fuel lines do not m eet crash te st s ta n d ards scratch se nsitive se nsitve to hydrolysis no grafting function we ak adsorbance to glass se nsitve to hydrolysis low re sistance to UV-B supe rhydrophobicity could not be observed in p ra ctice Estimate of time needed for substitution 2-3 ye ars >5 ye ars >10 ye ars >2 ye ars For sliding element applications UHMW -PE only if no special re quirements re garding se rvice temperature or chemical resistance >10 ye ars PTFE coated tubes PEX (irradiation crosslinked Polyethylene) only if no special re quirements re garding se rvice temperature or chemical resistance m ust still contain some PTFE filler to meet the gliding properties >10 ye ars C ontrol cable liners Non-PFAS based polymers alte rnatives are missing one or two of the key re quirements: e ither low frictio n, low stiffness o r high te m perature resistance Lubrication fre e bearings: 349 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A pplication Non PFA S alternative Substitution potential Polyamid (PA) Polybutylene Terephthalate (PBT) Polye theretherk etone (PEEK) Polypropylene (PP) Silicone none -available Estimate of time needed for substitution HVAC R -systems in transport ve hicles pave ment markings and re flective s heetings Air W ater Ethyle ne glycol Mine ral oils Silicone oils Alcohols Natural gases: HC-600 (n-butane), R-717 (Ammonia), R -744 (CO2) R152a Alte rnatives are not drop-in re placements but re quire adaptation of e quipment. Dis a d vantages: a) Ele ctrically conductive b) C re ate corrosion c) More e nergy necessary to re ach low te m perature s d) Flam mable and/or explosive e) Highe r levels of toxicity f) Highe r global warming potential (GWP) le ve ls g) Not the rm ally stable h) High work ing pressure i) W ate r re active j) R e quire periodic re placement and need to be disposed of 3 m onths - 4 ye ars (de pending on the co u n try) 5-11 ye ars Ad va n tages : (i) Air, wate r, C O 2 e tc. are wide ly available, che a p, have non to low GW P and are e asier to handle during service and e nd of life. (ii) Mode rn HVAC-solutions with natural alte rnatives may e ven be more e nergy e fficie nt than the use of fluorinated g a s es . 350 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Body-, hull and fuselage construction No information on alternatives for this application was received during the CfE and 2nd stakeholder consultation. Legal approval sc hemes and timelines for transition Stakeholders mentioned two specific standards regarding the manufacture of parts for automotive vehicles: ASTM2000, ISO/TS16949. Additionally, there are individual manufacturers specifications. Transition times where alternatives are available, were predicted to be 2-3 years to run function tests and give sufficient time for approval. Sealing applications Currently, fluorinated polymers are used to produce various seals for transportation vehicles. They provide important functions such as protection from dust and aggressive chemicals (lubricants, fuels, diesel) to ensure functionality and reduce service intervals. Furthermore, they prevent leakage and are therefore important for emission reduction. Alternatives to fluorinated polymers for sealing applications in transportation vehicles need to meet various requirements. They need to have a durability against lubricants, fuels, diesel, cooling agents and/or other fluids and have to provide good sealing properties over wide range of temperatures. In the following Table E.114 potential alternatives and their suitability for different sealing applic ations (if spec ified) are summarized. Table E.114. Alternatives for sealing applications. A lte r na tiv e Non-fluorinated polymers (e.g. nitrilie butadiene rubber (NBR or HNBR), acrylate rubber (AC M or AEM), silicone rubber, mechanical seals (ceramics) Application General sealing applications Tribo-modified Polyurethane NBR or neoprene rubber (C R) Sealing piston rings at high pressure water-lubricated bearings in stern tube seals for marine vessels Suitability Provide good properties over a wide range of temperatures (ca. -30 - +150 C ) but significant disadvantages concerning overall performance and emissions Nitril rubber has approx. 10% of the lifetime of fluorocarbon and above 100 C even lower Generally suitable but are inferior in friction and wear characteristics compared to PTFE Legal approval schemes and transition times One stakeholder informed about specifications BS EN 14432 & BS EN 14433 for lined valves used in the transportation of dangerous goods suitable for liquid and gas. BS EN 14433 is currently under review by the technical committee which has to be performed not more than 5 years after public ation. Thus, these approval sc hemes c ould be revised within a timeframe of 5 years. However, the simultaneous revision of many standards would take longer because of limited availability of qualified and experienced personnel, possibly a decade. One stakeholder informed the c onsultation that stern tube sealing devic es on marine vessels have to be approved by the Ship Classification Society. Accordingly, it is necessary to re- 351 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) acquire all ship class approvals when the seal is changed to a substitute material. The time required for a transition was estimated to be >5 years for R&D activities. Timelines for the approval of new materials for existing standards were not mentioned. Combustion engine system PFAS-containing materials are used in c ombustion engine systems bec ause of their durability and resistance against heat, pressure and corrosive chemicals. Further, these materials are much lighter than e.g. metal-based materials. The main use of PFAS-containing materials in combustion engines is in sealing and coating applications (see respective sections in Annex A). Non-woven textiles are applied as cover in the engine bay area of many vehicles as acoustic insulation inside the vehicle engine compartment. They are treated with PFAS to ac hieve oil repellenc e and high temperature resistance i.e. to make them non-flammable. Regarding alternative materials for lines and hoses one stakeholder commented that alternatives based on nylon fail to fulfil emission requirements, and all-metal fuel lines do not meet crash test standards, though further details were not provided. Other information on alternatives to the use of fluorinated polymers or non-woven textiles in combustion engine systems were not mentioned. There are alternatives available for the treatment of textiles (see Section E.2.2.2) but it remains unclear to the Dossier Submitters if those alternatives meet the requirements for the application in combustion engine systems. Legal approval sc hemes and timelines for transition Combustion engines need to comply with the current and future European CO2 and other emission legislation. It is particularly notable that the Council and the European Parliament have reached a provisional political agreement on stricter CO2 emission performance standards for new cars and vans for moving towards zero-emission mobility. Pending formal adoption, the following targets have been agreed: - 55% CO2 emission reduction target for new cars and 50% for new vans by 2030 compared to 2021 levels - 100% CO2 emission reduction target for both new cars and vans by 2035. Hydraulic fluids According to stakeholder information the anti-corrosion agent added to hydraulic fluids can contain several fluorinated cyclohexanes and trace amounts of unidentified residual fluorochemicals. These are considered to be a byproduct of the manufac turing process. The information provided only referred to hydraulic fluids in airc rafts but it might also be valid for other transportation vehicles. So far, no acceptable non-PFAS alternatives have been approved for use in the aviation sector, according to stakeholder information. No information for other sectors of transportation was provided during the CfE. One stakeholder provided a non-exhaustive sample list regarding approval schemes for military and industry specifications for hydraulic fluids: Boeing Material Specification (BMS)3-11: Hydraulic Fluid, Fire Resistant MIL-PRF-8328: Hydraulic Fluid, Fire Resistant, synthetic hydrocarbon base, metric, NATO code number H-537 M1L-PRF-87257: Hydraulic Fluid, Fire Resistant, synthetic hydrocarbon base, low temperature, aircraft and missile SAEAS1241: Fire-Resistant Phosphate Ester Aviation Hydraulic Fluid Transition times were estimated by the stakeholder to be at least ten years. Based upon 352 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) previous experience, this is the time needed to develop, qualify and certify alternatives. Coating and finishes Fluorinated polymers are used in c oating applic ations in the transportation sector bec ause of their good performanc e over a wide range of temperatures (anti c rack resistance), abrasion resistance, fire resistanc e and resistance to aggressive chemicals. In some special coating applications fluorinated polymers are used due to their dielectric properties, low thermal c onductivity, non-stick properties and UV-stability. There are some fluorine free materials available which can be used to achieve a protective c oating (e.g. for c oated trim materials) Silicone based chemicals Sulfosuccinates Propylated aromatics Fatty alc ohol polyglycol ether sulphates Alkyl acrylates Polyurethanes and -acrylics According to one stakeholder, a disadvantage of these materials is their higher layer thickness and the likelihood of cracking under high temperatures. Extensive information was provided by one stakeholder regarding alternatives for PFAS-based coatings on windshields. Varnishes, which may contain polyacrylics, alkyl acrylates or polyurethane are not suitable as they are too scratch sensitive. Silic one-based solutions have good hydrophobic ity but low durability (sensitive to hydrolysis) as the grafting on glass is not dense. OH-terminated silicone has also been tested: although such substanes are relatively UV stable they are very sensitive to hydrolysis. Polypropylated aromatics do not have a grafting function. Sulfosuccinates are more suitable for metals. Fatty alcohols are absorbed only by physisorption via their OH func tions. Fatty acids may absorb slightly more strongly to glass but their hydrolytic resistance is low. Different alkylsilanes have been tested with different carbon chain length: long chain alkylsilanes have a very low resistance to UV-B compared to the current substance used. Short chain alkylsilanes have a too low hydrophobicity and intermediate sizes are neither stable nor significantly hydrophobic. Solutions based on nanoparticles and hydrophobic grafting (fluorinated in this c ase) have also been tested. These solutions promise superhydrophobicity but it was not observed in practice. Above all, there is no grafting on glass, so the stability to water (wet heat) is very low. For sliding element applications made from PTFE (such as used in the sliding components of roofs of convertibles) ultra-high molecular weight polyethylene (UHMW-PE) can be used as a non-PFAS alternative as long as there are no special requirements regarding service temperature or chemical resistance (stakeholder information). As a potential alternative for PTFE-tubing, PEX (irradiation crosslinked Polyethylene) was mentioned by one stakeholder. However, this is only applicable in cases where the temperature is low and chemical attacks do not occur. Other polymers can be used for control cable liners, but according to stakeholder input, must still contain some PTFE filler to meet the gliding properties. According to stakeholders, alternatives are not available for coatings for lubrication f ree bearings, failing on one or two of the key requirements: either low friction, low stiffness or high temperature resistance. More rigid materials (e.g. polyamid (PA), Polybutylene Terephthalate (PBT), or Polyetheretherketone (PEEK)) c annot be used as they are not flexible enough. Additionally, they cannot adjust to edge loading. Materials of lower thermal stability (e.g. PE, polypropylene (PP)) do not survive the temperatures which occur during the curing of the paint on the car body or in the exhaust gas stream. High temperature materials (PA, 353 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PEEK, Silicone) do have significantly higher friction (4 to 10 times) (stakeholder information) One stakeholder provided information, that for PTFE waxes no drop-in replacements with equal performance are available. Approval sc hemes and timelines for transition Timelines for approval of new standards were estimated from 1 (automotive) to 7 (aerospace) years (stakeholder information). Regarding the aerospace industry one stakeholder informed that it is regulated by t he FIA and must confirm to ISO AS9100 and follow the NADCAP system for product introduction One stakeholder estimated transition times for non-critical applications in the automotive sector to be around 3 years whilst for the most demanding applications in aeronautics this could be much longer, citing global aero and auto norms (e.g. EN9100, or IATF16949). According to the CS25 (aeronautic standard, by the EASA) aircraft must be equipped with tec hnology allowing a c lear portion of the windshield during rainy c onditions. Modific ation of the certification of these aircraft types, which is a process that can take up to 2 years, to which is added the time needed for the actual modification of all aircraft in service. Transition time to switch to non-PFAS alternatives for tube coatings or sliding element applic ations are estimated by one stakeholder to be at least 10 years. For alternatives for PTFE waxes typical reformulation times can take up to 5-10 years (stakeholder information) Regarding alternatives for interior coatings of public transportation vehicles to achieve fire resistance timelines were estimated to be at least 15 years by one stakeholder: 5 years for the actual paint development and 10 years for qualification and certification. HVACR-systems: Overview This section provides an overview of HVACR (Heating, Ventilation, Air Conditioning and Refrigeration) applications in the transport ation sector. These cover a range of situations including cooling of passenger/operative cabins, regulation of battery t emperature, refrigeration of goods in transit and refrigeration in the fishing industry. Further information on individual sectors within transportation is given below. Refrigerant charges (PFAS or other heat transfer agents) across these uses range from a few hundred grams in light vehicles to several tonnes in fac tory ships. PFAS are commonly used as heat -exchange media in HVACR-systems of transport vehicles due to their technical properties e.g. good thermal capacity, wide range of operating temperatures, low-/non-flammability, and non-corrosivity. Further information on alternatives to PFAS as heat transfer media is provided in section E.2.8.2. A limited number of alternatives to the use of fluorinated gases has been identified for further consideration (Table E.115). Inclusion in the table does not indicate that options identified for the different sectors are alternatives that can be deployed now or in the future, but simply summarises what has been identified from consultation and literature review for further discussion below. 354 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.115. Summary of the identified a lternatives to fluorinated gases in HVACR applications in transport. C O2 refrigerant NH3 refrigerant C O2, N2 as direct coolant Propane R152a Not in-kind refrigeration: Insulation Transport refrigeration Mobile air conditioning R152a is listed in Annex I of the F-gas Regulation (517/2014) and has a global warming potential of 124, though this is below the threshold GWP of 150 specified in the MAC Directive (2006/40/EC). Although an HFC, it has no F-saturated carbon atoms and hence does not meet the criteria for PFAS defined in this proposal. Stakeholders raised a number of disadvantages for non-PFAS heat transfer agents (though not all are relevant in all cases): Lack of drop-in replacements, with alternatives needing systems engineered to cope with different operating c onditions of the alternative heat transfer agents Electrically conductivity Reactiveness, with potential for degradation with the possibilty of periodic replac ement, potential for c reating c orrosion Energy efficiency especially for lower temperatures Added risk of flammability or toxicity Global warming potential (GWP) High working pressure due to a higher boiling point, leading to the need for more robust engineering. However, there are also some advantages associated with the use of non-PFAS alternatives, espec ially regarding the use of "natural" alternatives i.e. air, water, CO2 etc . They are widely available, cheap, have no or only a low GWP (R152a being a partial exception) and are easier to handle during service and end of life. Modern HVACR-solutions with natural alternatives may even be more energy efficient than the use of PFASs. An air-cycle system for a train HVACR-system was reported to render up to 28% of annual energy savings compared to R134a systems (Aigner R., 2019). Another UBA report shows, that the use of R-744 (CO2) instead of R134a can reduce the fuel consumption of a passenger car HVAC-system from 1454%, depending on the ambient temperature (UBA, 2009). Stakeholder provided information, that the use of R-744 (CO2) requires a higher working pressure of the HVAC-system and that it is challenging to contain the refrigerant in the flexible hoses needed to manage vibration during vehicle use (Papasavva and Moomaw, 2014). This may lead to higher leakage rates compared to systems using R-1234yf. Approval sc hemes and timelines for transitions One stakeholder provided input regarding the transition to non-PFAS heat transfer agents for HVACR-systems for road vehicles. According to this information, obtaining legal approval for an alternative to e.g. R-134a and R-1234yf outside the F-gas regulation starts with registration with the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) and is followed by vehicle road-worthy and safety legal approval (type approval). For flammable refrigerants, compliance with ATEX requirements (regulation on protection from explosions) is mandatory. Certain regions or jurisdictions also require a risk assessment to be completed before installation. ASHRAE and ISO817 registration typically 355 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) take between 12-18 months. The vehicle type approval typically takes 24-48 months after ASHRAE registration. A suggestion for a timeframe for a complete transition could be taken from article 6 of Directive 2006/40/EC (mobile air conditioning systems (MAC) directive), where the provision allowed for an overall period of 11 years the retrofitting and refilling of vehic les. Transport refrigeration systems by sector Road Transport Road vehicles vary from small vans to large articulated vehicles, with coolant charge varying from several hundred grams to 10 kg. Refrigeration units for vans (with direct drive from vehicle engine) cost about 3 000; for trucks (diesel engine) 10-20 000 and for trailers approximately 20 000 (Schwarz et al., 2011). Much as in other sectors, the problem of flammability of hydrocarbons is a major concern for transport refrigeration. Trucks would need a significant charge size (1 kg and upw ards) in equipment that has a higher risk of leakage than for example domestic refrigeration given operating environment subject to prolonged vibration and changing environmental conditions. There are further c onstraints regarding the use of CO2 as an ac tive refrigerant relating to the size of refrigeration units and the limited space available in current designs of truck. One option to accommodate CO2 based systems would be to shorten the load space within the trailer unit. This has not been investigated by the industry as it would reduce carrying capacity of vehicles and there is currently no driver for such action given ability to comply with the Fgas regulation. An alternative system is the use of liquefied gases, CO2 or N2. This solution is available on the market already111, using CO2 from industrial processes that would be emitted to air in any case. However, the widespread use of this system is dependent on the availability of an extended network for filling up the refrigerant tank that as yet does not exist at the European level though it is expanding and is extensive within some countries (Norway and the Netherlands). Application in warmer climates may be more challenging through the higher demand placed on refrigeration (and hence greater consumption of refrigerant). There may also be health concerns linked to potential gas leakage in confined spaces, such as tunnels or parking garages. Reefer Containers Reefers are refrigerated containers used for intermodal transport (sea, road, rail). The c ontainer industry generally has foc used on a transition from high GWP gases to lower GWP fluorinated gases, particularly R-513A. However, as of 2018, 3 shipping lines had placed orders for containers refrigerated using CO2 112. A barrier to introduction of CO2 is its lower efficiency at medium to high temperatures, though it performs well at lower temperatures (UNEP, 2019a). Limitations on movement of containers as a consequence of the use of CO2 as a refrigerant can clearly be problematic in an industry that moves goods globally, but less of a problem for goods where movement is more regionalised. There is also research on the use of flammable refrigerants (IIF-IIR, 2016) with safety issues prominent given potential for build-up of gases in enclosed spaces. Fishing Industry Fishing vessels vary from small trawlers to factory ships with fluorinated gas cha rge sizes 111 https://europe.thermoking.com/, date of access: 2023-01-13. 112 https://www.carrier.com/container-refrigeration/en/worldwide/news/newsarticle/largest_ever_order_naturaline_goes_to_msc.html, date of access: 2023-01-13. 356 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) ranging from <100 kg to more than 8 t. The costs of refrigeration units vary from 2 to 6 million for medium to large vessels (Schwarz et al., 2011). It is reported that ammonia has already a significant presence in the fishing industry, and that CO2 is also being used both as cascade and in trans-critical systems regarded as a good choice for small refrigeration systems (UNEP, 2019a). Other Transport Refrigeration There have been some moves in the shipping industry towards adoption of ammonia and CO2 for refrigerated cargo and for cruise ships (Schwarz et al., 2011). However, widespread adoption of ammonia or hydrocarbons seems unlikely at the present time as it would likely require radical redesign of equipment (UNEP, 2019a). Not in-kind alternatives are available in the form of advanced cool boxes that maintain the temperature of goods through the cold chain from producers to end users for some applications including provision of medical supplies. Temperatures down to -65 C can be maintained for several days using some of these boxes113. Whilst such systems might replace some use of fluorinated gases, they will only ever have a niche role, for example when carrying large loads that need to be distributed across a number of sites, leading to regular opening and closing of the refrigerated environment. The more extreme the chilling regime, the smaller the quantity of material that c an be transported using suc h options. Shipment of goods by air involve little use of refrigeration and so is not considered here. Cold chain options for air freight are mainly insulation based. Summary for Transport Refrigeration There is some transition in the transport refrigeration sector to non-fluorinated alternatives, including some use of CO2 in trucking and reefer containers and of ammonia in the fishing industry. However, there are barriers to expansion of the use of alternatives across the sector relating to the range of temperatures that equipment is required to operate in, the size of refrigeration units, the safety of some options in a transport environme nt that can include restricted spaces (e.g. tunnels) etc. The expected lifespan of equipment (roughly 12 to 30 years across applications) makes retrofitting unattractive, particularly at the lower end. Longer lifespans of equipment raise the need for continued supply of spare parts and an appropriate refrigerant. Mobile Air Conditioning and cooling Consideration of alternatives identified two major barriers for the use of alternatives to fluorinated gases in the mobile air conditioning market: Safety c oncerns linked to the use of hydroc arbons or ammonia. Cost concerns relating to the use of CO2 given the need for higher engineering standards to deal with the higher pressures used. As a cooling agent, CO2 is considerably cheaper than the fluorinated gases (Blumberg and Isenstadt, 2019). The higher c ost of CO2 systems arises through: 1. Changes in c omponents to account for higher pressures 2. Differences in materials used to account for the different physical and chemical properties of the refrigerant gases 3. An inability with very low demand to account for economies of scale that would be expected if CO2 systems were adopted more widely. 113 https://pelibiothermal.com/, date of access: 2023-01-13. 357 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) However, of the alternatives that are available, CO2 is the leading contender as a replacement. Positive experience in the use of such a vehicle has been reported by UBA in Germany (UBA, 2009). CO2 based systems are on the market from one OEM (original equipment manufac turer), but at additional c ost (300/vehicle) c ompared to the fluorinated gas option. This is understood to be for a petrol or diesel engine vehic le. The development work on CO 2 based systems may be useful for setting tighter leakage limits for systems based on fluorinated gases, noting the experience reported by UBA (UBA, 2009). Retrofit of existing systems to permit use of alternatives is not feasible. These systems would therefore require availability of fluorinated gases for vehicle servicing if they are to continue operating. Cutting off supplies opens potential for illegal trade, which has been a problem in the historic control of fluorinated gases. A constraint on the applicability of alternatives for the mobile air conditioning sector is the linkage between the AC system and c ooling and heating of trac tion batteries (the batteries used in electric vehicles). These batteries need cooling and heating during operation, recharging and storage. It is possible that the systems so far researched and costed have been for AC serving the passenger cabin of vehicles only, rather than systems that serve also traction batteries. This issue highlights potential for increased demand for fluorinated gases as electric vehicles enter the market in larger numbers. An estimate was made in a submission to the CfE of the need for a 15-year transition from the current R-1234yf based systems to CO2 based systems. Given that one OEM offers this option already, and others have investigated it, this figure seems excessive. In the 2nd stakeholder consultation a major stakeholder for the automotive industry indicated that the transition from fluorinated gases was not a problem for electric and hybrid ve hicles, but some additional time would be needed for combustion-engined vehicles with mechanical c ompressors. Use of R152a has been investigated by industry (Hill, 2003). It has a higher GWP than R1234yf (124 vs <1, though substantially lower than R134a used previously with a GWP of 1 300). It has an ASHRAE rating of A2, indicating low toxicity and low flammability. In contrast, hydrocarbon refrigerants such as propane have an ASHRAE rating of A3, indicating higher flammability, and R1234yf a rating of A2L, indicating that it is weakly flammable. The paper by Hill (2003) makes specific comparisons with R134a given that it was the market leader at the time. As a drop-in replac ement for R134a without system optimisation, R152a showed improved cool-down performance. The system also required a 35% smaller refrigerant charge and was subject to lower leakage rates. The lower system charge meant that additional safety systems c ould be integrated with no penalty on the weight of vehicles. An alternative system designed to separate the low flammability coolant from the passenger cabin of vehicles involved a secondary loop system. The primary loop would cool using R152a, whilst a secondary loop would operate using a non-flammable coolant. Estimates of additional costs were modest and are discussed in more detail below. Hill's findings, t hough now dated, are supported by other more recent reports such as Andersen et al. (2017). One industry stakeholder in the automotive sector c ommented that the use of alternatives for elec tric and hybrid vehic les was not problematic. However, further work would be needed to integrate alternatives with vehicles with combustion engines that used mechanical compressors in the MAC system. A manufacturer of construction equipment raised additional concerns to the CfE in 2020 specific to that market, linked to energy consumption of alternative systems, potential conflict in the use of higher pressures with the Pressure Equipment Directive (EC, 2014) and the Machinery Directive (EC, 2006) and possible issues with visibility linked to an increase in the size of AC units. As construction equipment is a small niche area in the vehicles market, no independent view on these issues has been identified, but as in many other areas investigated for fluorinated gases, the potential for nic he markets to have very specific c oncerns that may affect the practicability of a restric tion should be noted. 358 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Whilst retrofitting existing vehicles is not practicable, it has been noted that there is some sale of R-134a to the do-it-yourself market for topping up MAC units. Andersen et al. (2017) report analysis from the USA indicating that half of service refrigerant emissions occur from the 10% of vehicles that are serviced by the do-it-yourself market. Information on the size of the European do-it-yourself market has not been identified, though seems likely to be smaller than in the US given lower penetration of air c onditioning in the vehicle fleet. However, prevention of sales to non-professionals would generate some possibly significant emission savings. Timelines for transition Hill (2003) reported that a reasonable transition period to convert vehicle MAC systems away from the prevalent PFAS-based option at the time (R134a in 2003) was 2 years to optimise systems and assure refrigerant manufacturing capacity and an additional 2 to 4 years for introduction to global vehicle production. From comments received during the 2nd stakeholder consultation, a longer transition period seems necessary for military vehicles to permit further research on alternatives for use in extreme conditions. Refrigeration in military transport equipment (including ships and submarines) faces several barriers to substitution due to some strong operating and safety conditions: sizing, compactness (and impact on armament equipment), sea motions, shocks, vibrations, noise, closed compartments, pressure conditions and health re lated issues of natural fluids such as NH3 and CO2. Military applications for MAC and refrigeration Comments were provided to the 2nd stakeholder consultation from 3 national defence ministries. Spec ific activities of c oncern were the following uses of fluorinated gases: As refrigerants for the storage of sensitive material (e.g. ammunition, pharmaceuticals, fuels) within the required climate range. Cooling of sensitive military electronics Mobile air conditioning to provide military personnel with a comf ortable environment in a stressed and sometimes dangerous situation. A broad range of military equipment was identified covering land, air and sea, the latter including submarines as well as surface vessels. Further uses identified by stakeholders inc luded fire extinguishing systems, though these are addressed separately (see E.2.8). Specific characteristics of PFAS cited by these stakeholders related to non-toxicity and nonflammability, both heightened by the risks of operating in a hostile military environment. The higher operating pressures of some alternatives (e.g. MACs running on CO2) are also relevant. Stakeholders commented that refrigeration in military transport equipment faces several barriers to substitution due to some strong operating and safety conditions: sizing, c ompac tness, impac t on armament equipment, sea motions, shocks, vibrations, noise, closed compartments, pressure conditions and health related issues of natural fluids such as NH3 and CO2. Whilst it is ac cepted that the military environment will include high risk conditions spec ific to the military, several of these factors apply outside of the military where alternatives are already being used. Also, many activities undertaken by military services (e.g. general proc urement, housing staff and their families) do not involve working in hostile environments. A further barrier identified by stakeholders concerned standards developed specifically for the military, though further details on how these standards af fect the suitability of alternatives beyond the requirements for equipment not specifically designed for military use were not provided. 359 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Several of the responses made to the consultation specific to military applications focused on problems linked to retrofitting existing equipment, noting that the life of these vehicles can extend as long as 30-50 years. It is apparent that the adoption of alternatives in military applications is more complicated than for civilian applications given the need to meet added criteria, particularly the use of equipment in hostile environments. Other uses related to transportation According to stakeholder information, the listed non-PFAS alternatives for pavement marking tape and reflective sheeting: do not provide sufficient t hermodynamic differentiation from the binder which connects the beads to the product to ensure reproducible embedment of the beads. If the beads are embedded too far, they are no longer optically active. If the beads are embedded too little (50% or less), then they will not be durably attached. If they are not durably attached, the pavement markings will then quic kly lose optic al ac tivity. Approval schemes For pavement markings and reflective sheeting's approval times depend on the country: In Germany the typical approval time can be 3 months. In France, typical approval time will be 1-2 years, depending on the expected lifetime of the product. Other jurisdictions vary depending on local regulations. Most countries require road trials, which will tend to ta ke up to 2 years before approval. For AFT (used e.g. to fix wheel weights) no alternate chemistry has been identified that enables the performance needed in foam tape applications. Fluorosurfactants lower the surface tension to a value half of what is attainable by using hydrocarbon surfactants, and fluorosurfactants are more stable and fit for harsh conditions than hydrocarbon surfactants because of the stability of the carbon-fluorine bond. Alternate non-PFAS surfactants, such as silicone and hydrocarbon surfactants, do not perform the stabilizing function to the same degree as PFAS-based surfactants, whic h is nec essary to ac hieve c ustomer requirements. E.2.10.2.2. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHA's dissemination site. In relation to transportation, the list of alternatives contained 4 unique CAS numbers. All of these substances were classified ac cording CLP (harmonised classification or selfclassification). None of the substances were known to fulfil the PBT or vPvB criteria, since they either did, according to their registration dossier, not fulfil the PBT or vPvB criteria or no data on PBT/vPvB properties were found, or PBT/vPvB properties were not applicable. The list c ontained an additional 9 substances with unique substance names for whic h no CAS numbers were available. One of these substances was classified according CLP (selfclassification). No information on PBT and vPvB properties was available. For two substances (Silicone based chemicals, Silicone oils), it was indicated that they may contain residues of D4, D5 and D6, cyclic siloxanes. D4, D5 and D6, and cyclic siloxanes are considered to be PBT/vPvB substances and D4 is considered to be an endocrine disruptor. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. 360 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.10.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.10.1, assuming business-as-usual and, consequently, on-going PFAS use and emissions. The analysis of environmental impacts focuses on two restriction options: RO1, adopting a ban of all PFAS used in the transportation sector; RO2, adopting a ban on PFAS in c ombination with use-specific derogations (see Table E.16 below). Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation . Environmental impacts of RO1 are analysed quantitatively. Likewise, environmental impacts for two of the proposed use-specific derogations (PFAS use in transport refrigeration equipment and mobile air conditioning) relevant for this sector can be assessed quantitatively bec ause emission data are available. Table E.116 below summarizes the c haracteristics of the restriction options. Table E.116. Characteristics of restriction options and maximum additional emission scenarios. Restriction option a bbr e v ia tio n RO1 RO2 (5 years)a Short description Derogations Full ban Ban with use-specific derogations --- (i) Proposed derogation: Refrigerants in mobile air conditioning (MAC )- systems in combustion engine vehicles with mechanical compressors (iii) Proposed derogation: Refrigerants in transport refrigeration other than in marine applications Transition period after entry into force 18 months 18 months Duration of derogation --- 5 years RO2 (12 years) Ban with use-specific derogations (ii) Potential derogation marked for reconsideration: Use as refrigerants and for mobile air conditioning (MAC ) in vehicles in military applications (iv) Potential derogation marked for reconsideration: Applications affecting the proper functioning related to the safety of vehicles, and affecting the safety of operators, passengers or goods (v) Proposed derogation: Additives to hydraulic fluids for anti-erosion/anti- corrosion in hydraulic systems (incl. control valves) in aircraft and aerospace industry 18 months 12 years 361 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option a bbr e v ia tio n Short description Derogations Transition period after entry into force Duration of derogation Maximum additional emission scenarios Ban with full derogation of entire PFAS species groups Polymeric PFAS; fluorinated gases 18 months 5 years, 12 years For calculating the expected emission reduction, the assumed entry -into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.117 shows mean emissions and the expected mean emission reduction for time paths of 30 and 45 years (starting in 2025). Table E.117. Total mean emissions and emission reduction of RO1 and of maximum additional emission scenarios (transportation sector, in tonnes). Restriction option Mean total emissions [t] Baseline RO1 Maximum additional emission scenario `5-year derogation of all fluorinated gases'* Maximum additional emission scenario `12-year derogation of all fluorinated gases'* Maximum additional emission scenario `5-year derogation of all polymeric PFAS'* Maximum additional emission scenario `12-year derogation of all polymeric PFAS'* Baseline RO1 Maximum additional emission scenario `5-year derogation of all fluorinated gases'* Maximum additional emission scenario `12-year derogation of all fluorinated gases'* Maximum additional emission scenario `5-year 2025-2055 508 839** 28 306*** 95 076 195 315 30 568 33 929 2025-2070 817 430 28 306 95 076 195 315 30 568 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 480 533 94 413 763 81 314 524 62 468 271 94 474 910 93 --- --- 789 124 96 722 354 88 623 116 76 423 748 96 362 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Mean total Mean total Mean total emission emissions [t] emission reduction reduction [%] [t] derogation of all polymeric PFAS'* Maximum additional emission scenario `12-year 33 929 427 110 95 derogation of all polymeric PFAS'* * Maximum additional emission sc enarios denote worst-case emission sc enarios (assuming a full derogation of a particular PFAS group) against which emissions of proposed use - spec ific derogations are evaluated qualitatively. They do not represent restriction options. ** The estimate provided in the table inc ludes emissions from fluorinated gases. Emission estimates under the baseline without emissions from fluorinated gasses would be 49 824 t. *** The estimate provided in the table inc ludes emissions from fluorinated gases. Emission estimates under RO1 without emissions from fluorinated gasses would be 14 202 t. RO1 achieves a total PFAS emission reduction of about 94% compared to baseline emissions. Furthermore, RO1 is the only restriction option where emissions arising during the PFAS use phase will cease after the 18 months transition period. Environmental impacts of RO2 are discussed below for the proposed derogations. (i) Proposed derogation: Refrigerants in mobile air conditioning (MAC)-systems in combustion engine vehicles with mechanical compressors (ii) Potential derogation marked for reconsideration: Use as refrigerants and for mobile air conditioning (MAC) in vehicles in military applications For (i) a 5-year derogation is proposed after EiF of the restriction and the 18 months transition period. For (ii) a 12-year derogation is proposed after EiF of the restriction and the 18 months transition period. The proposed restric tions (i) and (ii) address the use of HVCAR fluorinated gases for mobile air conditioning. The discussion of alternatives for this application is included in the section on fluorinated gases (see section E.2.8.2). For the proposed derogation strong evidence of expected maximum emissions is available which is derived from tonnage estimates provided in the HVACR sector. Total additional emissions of a 5-year derogation of fluorinated gas use for MAC are 95 076 t, and 194 315 t for a 12-year derogation. Hence, expected additional emissions of both derogations will be substantially higher compared to emissions under a full ban (RO1, see Table E.117), and close to the maximum additional emission scenario (assuming a full derogation of fluorinated gases in the transportation sector, see Table E.117). No evidence is available of the fraction of emissions of these two derogations compared to maximum additional emission scenarios. For (i) it is assumed that emissions will be up to 90% of emissions expected under a full derogation of fluorinated gases. For (ii) emissions are assumed to be substantially lower considering that for the UK, for instance, military vehicles on land are equivalent to only 0.035% of the vehicle fleet (14 000 vs 41 million). No data were identified for ships. Assuming further that UK data are broadly representative for other European countries, a worst case estimate of additional emissions arising from (ii) is about 1% of fluorinated gas use for MAC. (iii) Proposed derogation: Refrigerants in transport refrigeration other than in marine applic at ions The restriction addresses the use of HVCAR fluorinated gases in transport refrigeration equipment. The derogation is proposed for a time period of 5 years after EiF of the restriction and the 18 months transition period. The discussion of alternatives for this application is 363 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) included in the section on fluorinated gases (see section E.2.8.2). For the proposed derogation strong evidence of expected maximum emissions is available which is derived from emission estimates in the fluorinated gases sector. Total mean additional emissions of a 5year derogation of fluorinated gas use for refrigeration are 95 076 t (30-year period), which is an increase of emissions by 30% compared to a full ban (RO1). Though the precise amount of emissions arising from the derogation is not known, it is assumed that it can be up to 100% (worst -case). (iv) Potential derogation marked for reconsideration: Applications affecting the proper functioning related to the safety of vehicles, and affecting the safety of operators, passengers or goods A 12-year derogation is proposed. The derogation will c ause additional emissions of polymeric PFAS. No evidence is available about the precise amount of additional emissions. Assuming a derogation of all polymeric PFAS use, maximum additional emissions will be 33 929 t (30year period, see Table E.117). This is slightly higher than additional emissions under a full ban (RO1, being 28 306 t). Though the precise fraction of emissions compared to this worstc ase reference scenario is not known, it c an be assumed it is up to 100% c onsidering that the use is indispensable for a proper functioning of all transportation vehicles. (v) Proposed derogation: Additives to hydraulic fluids for anti-erosion/anti-corrosion in hydraulic systems (incl. control valves) in aircraft and aerospace industry A 12-year derogation is proposed. The proposed derogation will likely cause additional emissions of fluoropolymers and probably PFAAs including PFAA precursors. No evidence is available about expected additional emissions arising from this derogation. However, additional emissions are assumed to be small as the PFAS use derogated is limited and has only some applic ations in aviation. Figure E.18 shows the time path of mean emissions in the transportation sector for the baseline, RO1 and the proposed derogations of uses for fluorinated gases. Figure E.18. Time path of mean emissions in the transport sector under the baseline, RO1 and maximum additional emission scenarios (transportation sector, in tonnes)[tonnes]. Source: Own calculations based on market data collated by the Dossier Submitters. E.2.10.4. Economic and other impacts E.2.10.4.1. Impacts on companies The transport sector addressed here covers the production of vehicles for a ll transport by road 364 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (all motor vehicles), rail, air and sea. Market data for Europe are presented in Table E.118, demonstrating the economic importance of the transport sector. A European focus creates some diffic ulty given the global supply chains for the industries covered by the sector. The discussion excludes consideration of aspects of the transportation sector that are covered in other sections, for example TULAC (section E.2.2), electronics (section E.2.11), consumer mixtures (section E.2.5) and metal plating and metal goods (section E.2.4). Table E.118. European transport industry data114. Year for data Employment (jobs) Revenues Exports EU trade data A v ia tio n 2019 405 000 130 billion 109 billion A uto mo tiv e 2021 3.7 million (manufacturing) 14.6 million (total) 76.3 billion trade surplus R&D expenditure 8 billion 62 billion Rail 46% share of global production of rail equipment and services Shipping 2019/2020 Only 5% of European orders are manufactured in the EU Detailed information on economic impacts is scarce and hence a detailed e conomic analysis is not currently possible. However, from the evidence gathered it is possible to draw general conclusions regarding the possible impacts of a restriction introduced over different periods for the sector. The level of response to the 2nd stakeholder consultation is shown in Table E.119 (noting that some responses relevant to transport may have been picked up in other sectors such as TULAC). Table E.119 Levels of response to the 2nd stakeho lder consultation for transportation subsectors. A c tiv ity Respondents Non-electrical components (seals, hoses, tubes, valves, etc.) 54 HVAC R (including MAC ) 16 Respondents covering several kinds of product 11 Electrical components 9 Miscellaneous (windshield treatments, moulds, etc) 9 C oatings 7 Fire suppression 4 Hydraulic fluids 4 Military applications 4 114 https://defence-industry-space.ec.europa.eu/eu-aeronautics-industry_en, https://www.acea.auto/publication/e conomic -and-mark et-report-state -of-the -eu-auto-industry -fullyear-2021/, https://www.acea.auto/figure/key-figures-eu-auto-industry/, (SEA Europe, 2021), date of access: 2023-01-13. 365 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A c tiv ity Respondents Distributors and fluorochemical suppliers 3 Batteries and fuel cells 2 Lubricants 2 No data 11 A particularly high level of response is seen from companies using PFASs to manufacture seals, tubes, pipes, gaskets, valves and similar goods. Several of these companies reported that their business was at the present time wholly dependent on the use of PFASs and so they perceived that a restric tion could represent a major threat to their business. A large majority of respondents considered that identified alternatives to PFAS were not technically feasible for their produc ts or proc esses (107 c ompanies to 4). A number of respondents argued that a restriction on the use of PFASs would lead to complete or almost complete loss of business with some providing estimates for loss of business/profits and loss of jobs for their c ompanies. However, it is not possible to extrapolate from these data to provide an overview of impacts for the sector as a whole. It is worth noting that the 4 respondents who felt that alternatives were technically feasible were from different areas (refrigeration, seals, c oatings and one non- specific). Given the breadth of applic ations of PFAS across transport there will be a significant burden on manufacturers to undertake the necessary R&D activities as they investigate the use of alternatives, rec ognising not only the applic ations c overed in this sec tion, but also transport relevant applic ations c overed in other parts of this dossier (e.g. under TULAC, lubric ants and electronics). The need for vehicle testing and certification further extends timescales. The necessity for decarbonisation already creates pressure on R&D and design for the sector, though may also provide opportunity to design PFAS out of vehicle systems. As the preceding text shows, vehicle manufacturers have developed a high dependence on the use of PFAS across a wide variety of applications within the transport s ector. The manufac turers are therefore all likely to be in a similar position to one another when it c omes to investigating the possible use of alternatives for uses such as seals, gaskets, hoses, pipes, valves, electronics and so on. Based on information gathered in literature review and the responses to the CfE and the 2nd stakeholder consultation it is reasonable to expect that: 1. No vehicle, ship or aircraft manufacturers are currently in a position to make a n immediate rapid switch to alternatives for all PFAS applications. 2. Switching will be easier for some components than others. TULAC is one example where alternatives are available for some applications on a `drop in' basis where modification of mechanics would not be necessary. It is, however, unclear to what extent this will apply in other areas, such as the introduction of alternative polymers for seals and gaskets. 3. It is expected that significant R&D will be required to fully transition away from PFAS. 4. The time taken for alternatives to be fully accepted and pass all necessary certification processes may be long. Transition times reported during consultation ranged from about 1 year to more than 10 years, once a satisfactory alternative had been identified. Consideration must also be given to component suppliers to the major manufacturers. A risk of business closure or reduction in sales, combined with job losses, was highlighted by companies involved in supplying the major automotive, aviation and rolling stock manufac turers with a diverse range of produc ts: Gaskets, seals, hoses and pipes Lubricants 366 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Coatings Friction products Moulded products MAC and refrigeration systems Electronics and electrical insulation Hydraulic fluids Water repellent coatings for windshields used across transport modes. Several companies considered business closure a realistic response to a restriction on PFAS, and lost earnings per company ranged from hundreds of thousands to hundreds of millions of . Few provided evidence to indicate that they expected alternatives to become available on the market in the next 10 years. This may not be surprising given the extent to which PFAS have come to dominate the marketplace in recent decades. Referring back to Table E.118, signific ant disruption to the transport sec tor c ould c ause lost earnings in the order of billions of EURO and job losses in the hundreds of thousands or more. However, disruption at this level is not a c ertainty, and impac ts c ould of c ourse be mitigated through the adoption of derogations providing more time for the sector to adapt. The extent to whic h inc reased c osts for produc ers c an be passed on to c onsumers is unc lear. There will be variation in c apacity to do this between suppliers at different points in the value chain: manufacturers of some components may have limited competition, whereas manufac turers of c ars and goods vehicles aimed at the mass market would likely be prone to higher competitive pressures. A further complication at the moment arises from the economic situation post-COVID, where shortages of components has led to reduced production of vehic les: this may lessen c ompetition between manufacturers, making it easier for them to increase prices to account for additional costs. It is not known how long this situation may persist . One area where cost data have been identified for transitioning away from PFAS concerns mobile air conditioning (MAC) systems. Controls for this sector are important, given that it is the largest emitter of F-gases, generating 29% of F-gas emissions in the EU/Norway/UK region, despite previous legislation. Some commonly used alternative refrigerants such as hydrocarbons have not been considered for this purpose given their flammability and the potential for them to escape into the passenger compartment. However, an estimate of added cost for CO2 MAC systems has been identified based on costs of an option offered by one manufacturer (Table E.120), giving a figure of 300 per vehicle (car or small van). Volkswagen has developed a car with CO2-based air conditioning, which is used by e.g. the German Environmental Protection Agency, UBA (UBA, 2021). As a gas, CO2 is considerably c heaper than the fluorinated gases (Blumberg and Isenstadt, 2019). However, the higher cost of CO2 systems arises through: Changes in c omponents noting that CO2 is unsuitable for c ombustion engine vehicles with mechanical compressors, as the compressor's leak resistance durability is challenging due to high pressures Differences in materials used to account for the different physical and chemical properties of the refrigerant gases Available cost data seem likely to be inflated given that they are t aken from one example where CO2 MAC systems are offered as an option. The resulting low demand suggests that the pric e given does not reflect the pric e if such systems were offered as standard and further economies of scale would apply. Given the estimates of 300 additional cost and 0.6 kg of fluorinated gas per vehicle, a substitution cost of 500/kg gas can be calculated, assuming c omplete release of this quantity of gas over a vehic le lifetime. For very leaky systems where the full amount of gas is replaced several times over the vehicle lifetime, the price per kg of fluorinated gas avoided would fall, making the restriction more attractive. In contrast, for highly engineered and near leakproof 367 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) systems with efficient recovery of fluorinated gas at the end of the vehicle life, the cost per unit of emission would, naturally, be higher. It is assumed that the cost of 300 covers R&D costs, costs of certification and variation in the price of the refrigerant charge. No information on a change in running costs for a CO2 MAC system has been identified, specifically relating to energy efficiency. However, it is noted that the price of CO2 is significantly lower than the price of comparable HFCs and HFOs, and so refilling systems with CO2 would be cheaper than refilling with fluorinated gases. No reason has been identified to indicate that other manufacturers would be unable to switch to new systems. Information from the 2nd Stakeholder Consultation indicates that this is less problematic for hybrid and electric vehicles than for c ombustion engine vehic les with mec hanical c ompressors. Table E.120. Summary of information on the costs of a CO2 based alternative for Mobile Air Conditioning relative to the costs of continued use of fluorinated gases. Cost element R&D costs of designing equipment to utilise alternative refrigerants. C osts for certification of new product in some markets. Difference in the cost of equipment using fluorinated gases and equipment using alternatives. Variation in the costs of alternative refrigerants. Variation in running costs. In the event of increased energy losses through the use of technologies that are less energy efficient, additional costs of abatement for greenhouse gas emissions elsewhere in the economy to ensure that climate goals and targets are met. Potential for PFAS-dependent operations to cease leading to reduced market share and possible closure of businesses. Commentary Assumed to be accounted for in the added price of 300/vehicle. Assumed to be accounted for in the added price of 300/vehicle. A single cost estimate of 300/vehicle is available. It is assumed that this is the added cost of a C O2 based system compared to one using fluorinated gases. Assumed to be accounted for in the added price of 300/vehicle, but the price of C O2 is significantly lower than the price of comparable HFC s and HFOs. Refilling systems with C O2 would thus be cheaper than refilling with fluorinated gases. No data. No data. No reason has been identified to indicate that existing manufacturers would be unable to switch to new systems. Other options may be available. Hill (2003) reported on the possible use of R152a as an alternative refrigerant for use in vehicles. R152a has the disadvantage of mild flammability (ASHRAE rating A2) compared to the use of other fluorinated gases, but is markedly less flammable than hydrocarbon alternatives. It also requires a smaller refrigerant charge. Hill considered two systems, one involving a direct expansion option, similar to those used for the dominant systems currently in use with PFAS refrigerants, and another using a secondary loop system. R152a would provide the cooling power in a system separated fro m the passenger cabin, to which cooling would be delivered through a non-flammable refrigerant c ontained in a sec ondary loop. Inflating the original c ost estimates from Hill (2003) to 2022 prices indicates an added cost for systems based on R152a of around 22 for the direct expansion system inc orporating an additional safety system, and 60 for a sec ondary loop system, compared to systems using refrigerant R134a, equivalent to a cost of 37 to 100/kg PFAS based on a 0.6 kg charge. The price differential could be considerably smaller (or even 368 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) reversed) comparing R152a with HFO R1234yf, given the substantially higher price of the latter, USD 100/g compared to USD 5/kg for automobile OEM bulk wholesale prices (Andersen et al., 2017). There would be some additional costs for manufacturing and servicing for new recovery/recycling equipment and service procedures and additional safety requirements, equipment and training for vehic le assembly plant and service providers. However, the overall costs of the R152a based systems appear, from this evidence, to be significantly che aper than CO2 based systems. The direc t system proved to be on average 10% more energy effic ient than R134a at temperatures ranging from 27 to 46 C. R152a would also be effective in heat pump mode. Use of a sec ondary loop system was estimated to give a similar effic iency to R134a. The conclusions of Hill (2003) are supported in more recent works, for example by Andersen et al. (2017) and IEA (2019). Mobile refrigeration in trucks and reefer (refrigerated) containers has seen businesses switching from refrigerants with high global warming potential t o HFOs in response to the requirements of the F-gas regulation. However, there is little indic ation of switching to other alternatives for this sector: hydrocarbons because of the risk of flammability, ammonia because of toxicity and CO2 because of concerns over cooling efficiency at higher temperatures (e.g. in southern Europe) and increased space required for active CO 2 refrigeration systems. Information provided in the CfE showed how the distance between tractor and trailer units for articulated lorries was optimised for existing refrigeration systems, to the extent that trailer modifications would be needed to fit a CO2 unit into the available space. A reduction in the load capacity of trucks to account for a bulkier refrigeration system was cited by some stakeholders as a significant disincentive for fleet operators given the desire to maximise load capacity. There is some penetration of passive systems using CO2 or other liquefied gases, though there are c onstraints on the use of suc h systems (they requ ire an extensive network of refilling stations for liquefied gases). Overall, it is concluded that there are several options that may be c ost-effective, though further work to design systems based on non-PFAS gases is clearly necessary and this will take t ime. The situation for shipping seems different. As of 2018, 3 shipping lines had placed orders for c ontainers refrigerated using CO2 112. A barrier to introduc tion of CO2 is its lower effic iency at medium to high temperatures, though it performs well at lower temperatures (UNEP, 2019a). Limitations on movement of containers as a consequence of the use of CO2 as a refrigerant can clearly be problematic in an industry that moves goods globally, but less of a problem for goods where movement is more regionalised. There is also research on the use of flammable refrigerants (IIF-IIR, 2016) with safety issues prominent given potential for build-up of gases in enclosed spaces. It is reported that ammonia already has a significant presence in the fishing industry, and also that CO2 is being used both as cascade and in trans-critical systems for small refrigeration systems (UNEP, 2019a). The fact that these technologies are already finding market opportunity indic ates that they are c ost-effective. Overall, the situation for mobile air conditioning and refrigeration with respect to switching from PFAS refrigerants seems promising. Unlike the situation with respect to fluoropolymers there are known alternatives and some already have market share. Spec ific operating c oncerns relating to the use of natural refrigerants in military vehic les were mentioned above, relating to the protection of servic e personnel. For these reasons it c annot be assumed that cost effective alternatives are already available in the market, and further R&D is needed. The need to maintain supplies of spare parts for the transport sector could keep PFAS based products in the supply chain for some years to come, particularly for the military market where vehicle lives of 30-50 years were cited by stakeholders to the 2nd stakeholder consultation. The alternative would seem to be to accelerate the redundancy of vehicles. There c ould be competing effects on pric es in the second-hand market if access to spare parts was restric ted: Concern over the availability of spare parts c ould reduce the value of existing assets. However, a lack of spare parts could also reduce the availability of older vehicles which would tend to increase prices. In the event that satisfactory alternatives that could be used 369 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) on a `drop-in' basis are identified, the effect on the second-hand market could be small, but the existenc e of suc h alternatives across the range of applic ations relevant to the restriction is a matter of speculation The Dossier Submitters have observed the sale of the fluorinated gas R134a to the do-it-yourself (DIY) market for topping up MAC units. It has not been possible to investigate this activity in more detail, but it is noted that DIY repairers are unlikely to be equipped to capture and safely dispose of waste refrigerant. A requirement that only professional and qualified service personnel with access to the correct tools and safe disposal should be permitted to refill MAC units should ensure that leaky systems are repaired and properly maintained. E.2.10.4.2. Impacts on consumers As in other sectors, a view expressed by several stakeholders was that due to their comparatively high price, fluoropolymers would not be used unless they offered significant benefits relative to alternatives that are on the market at the present time. This suggests that there could be significant impacts on consumers if PFAS were to be phased out of transportation. However, without prec ise details and a c lear understanding of alternatives in some areas, suc h impac ts are a matter of spec ulation. There is c learly potential for an inc rease in c ost from manufac turers given the need for R&D on alternatives and potential redesign of equipment. The extent of suc h pric e c hanges is not estimated here given unc ertainty regarding prec isely which alternatives would be introduced and the wider consequences of using those alternatives. Demand for road transport as a func tion of cost ranges from being inelastic (e.g. in relation to c ommuting) to highly elastic (e.g. for rec reation) (Litman, 2022). There is some evidence that demand for purc hasing new vehic les is more elastic than previously, in response to a range of fac tors, inc luding: Inc reased working from home The growth of c ar c lubs (where vehicle hire is muc h simplified) Improved provision of public transport in at least some areas Improved provision of infrastruc ture for walking and c yc ling Financial burdens such as the current cost of living crisis. There may be further impacts on consumers if switching to alternatives reduces the performance of vehicles or vehicle components, for example affecting re liability, comfort, safety features or the overall durability of vehic les. The risk of suc h impac ts should diminish over time given opportunity for further R&D, but c annot be ruled out altogether. Alternatives able to perform at a high level will be available for some applications (the alternatives for MAC c oolants are one example) but this cannot be guaranteed for all of the many applic ations of PFASs ac ross the vehicle industry. The same general view seems likely to hold for other transport modes. There w ill be examples where substitution is straightforward and there will be others where it is not, reflecting the broad range of characteristics of PFASs referred to previously for the sector, such as: Flexibility Resistance to chemical attack Resistance to UV Electrical properties Heat transfer properties Performance over a range of operating conditions Stain resistance Low weight Low risk of flammability Low risk of toxicity Several of these characteristics seem likely to be of higher importance for military applications operating in hostile environments given higher risks to life and the associated need for very 370 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) high reliability of equipment. E.2.10.4.3. Impacts on employment As noted already, there was a widespread view amongst industry respondents to the CfE and 2nd stakeholder consultation that business would reduce in the event of a PFAS restriction leading to job losses. In a number of cases companies are so dependent on PFAS at the present time that they c onsider business closure or shutdown of c ertain business units a likely response to restriction. Of the 133 respondents to the transport related questions in the 2nd stakeholder c onsultation, 37 c ompanies provided estimates of job losses ranging from 4 to 2 500 per company (some included supply chain impacts, some did not), giving a total forecast from respondents of 12 700 jobs lost. This can be translated to an economic estimate of damage from lost employment using a figure per job lost in the order of 100 000 to 130 000, following an approach defined by Dubourg (2016) and used elsewhere in this dossier, to derive an estimate of around 1 billion. This is clearly not a precise estimate for a number of reasons, for example: Not all manufacturers, either of final vehicles or in the supply chain, responded to the consultation exercise, and of those that did, many who considered that there were economic risks to their business did not t ranslate that into lost jobs. Given a lac k of researc h on alternatives, the true severity of the risk to businesses will not be certain for most companies at this point in time. Responses from companies that have alternatives and could benefit from the restriction were limited. For these reasons it would not be appropriate to assume that these figures are a reliable estimate of job losses and their economic impact under a restriction. However, they demonstrate that there is concern for the future amongst companies in the sector, and associated impacts could be in the order of billions of euros. E.2.10.5. Summary of cost and benefit assessment The prec eding text demonstrates that there is widespread use of PFAS in the transport sector. However, it is not possible to provide a quantified estimate of economic impac ts and benefits. The following tables summarise the outcomes of a qualitative assessment of costs and benefits for the transport sector drawing on information submitted to the CfE and 2nd stakeholder consultation and the literature. Further information can be found in the ac c ompanying text following each table. Reference throughout this section to possible 5- and 12-year derogations is additional to the general transition period of 18 months. Uses considered in the tables below are as follows: Use in transport (including automotive, aircraft, rail, marine, and aerospace industries) where the substances are affecting the proper functioning related to the safety of transport vehic les, and affecting the safety of operators, pasengers or goods (Table E.121) Anti-erosion/anti-corrosion purposes in hydraulic systems in the aviation and aerospace industry (Table E.122) Mobile Air Conditioning systems (Table E. 123) Transport refrigeration (Table E.124) MAC and refrigeration in military applications (Table E.125) 371 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.121. PFAS use in transport (including automotive, aircraft, rail, marine, and aerospace industries) - Summary table on assessment of costs and benefits, based on a general transition period of 18 mo nths where the substances are affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, pasengers or goods. Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s The transport sector has an extremely high dependence on PFASs, including use in complex products (e.g. seals, O-rings and gaskets in engines). The properties of PFASs can provide input to the design of such products, with the result that drop-in substitutes will not always be available. Even where they are, testing and certification procedures would need to be followed. It is therefore concluded that a full ban is not feasible for the transport sector and that substitution potential is low [sufficiently strong evidence]. E nv ir o nme nta l impact Based on available evidence which is considered weak (i.e. not based on referenced data or documented assessments) a full ban of PFAS use in the transportation sector is expected to reduce PFAS emissions by about 94% (assuming a 30year assessment period, 20252055). As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a Cost impact In the event of a full ban, there would be significant disruption to the industry leading to very high producer surplus losses including business closures, which would also lead to substantial employment losses. In the event that it is possible to produce vehicles, there is also a strong likelihood of consumer surplus losses through the sale of vehicles with limited capabilities and reduced reliability. Disruption to the market could also affect the transition to electric vehicles, with consequences for climate and air quality policies. [sufficiently strong evidence]. Other aspects 372 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Ban with use spe cific de rogations: Pote ntial de rogation m ark ed for re consideration: Ap p lica tions affe cting the prope r f u n ctio nin g re late d to the safe ty of ve hicle s, and affe cting the safe ty of ope rators, passengers or goods Duration of derogation 5 years 12 years A lte r na tiv e s Given the wide variety of PFAS applications in the sector, the potential need for significant re-design of equipment and recertification requirements, it is concluded that 5 years is unlikely to be sufficient to introduce alternatives to PFAS across the sector [sufficiently strong e v ide nc e ]. Allowing an additional 12 year period for the development, certification, etc. of alternatives would be sufficient for likely many applications, although in many cases the industry is not advanced in its research on alternatives [weak evidence]. E nv ir o nme nta l impact result of the restriction are likely underestimated. For the proposed de rogation total m ax imum additional e m issions of a 5ye ar de rogation of fluorinated gases use for MAC are 95 076 tonnes. Though no evidence is available about the pre cise fraction of e m issions, the fraction of emissions is assumed to be up to 100% (worstcase ). n/a Cost impact Whilst an additional 5 years would permit some transition from PFAS in the industry it is concluded to be insufficient for a significant number of applications. Introduction of a restriction on this basis could generate risk to many companies in the sector, with potential for substantial job losses and also consumer surplus losses. Both would be reduced compared to the position with no derogation. [sufficiently strong evidence]. The extent of impacts on producers is not estimated, and will be dependent for example on the extent to which drop-in alternatives can be identified without the need for redesign of equipment. A long derogation period provides opportunity to mitigate costs by enabling redesign to be factored into product development cycles [weak evidence]. Given vehicle safety standards and an additional 12 years for development, it is anticipated that safety will not be compromised. Vehicle reliability may Other aspects 373 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s E nv ir o nme nta l impact Cost impact Other aspects however be impacted leading to some consumer surplus loss [weak evidence]. Conclusion There is no information on the extent to which different parts of the sector are able to pass on added cost to their customers (both the general public and other parts of the motor industry). [no evidence]. It is often argued by industry that PFASs are only used where absolutely required, given their high cost. However, technical data to prove this point have not been provided. It is accepted that it is likely that there are possibly many applications where PFA Ss are currently used where substitution with alternatives could be problematic at the presen t time given the various properties of fluoropolymers. It is concluded that a 12 year derogation could be appropriate for PFAS use in transport (including automotive, aircraft, rail, marine, and aerospace industries) where the substances are affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, pasengers or goods . Shorter transition periods would not reflect the current state of the industry with respect to PFAS use, with many uses having no satisfactory identified alternatives at the present time. The rapid introduction of alternatives could lead to consumer losses through reduced reliability of equipment as well as added costs to industry being passed through to customers. There is potential that a 12-year derogations would cause additional PFAS emissions which are likely substantial. In light of the broad use scope and the weak evidence base to narrow down the scope for a derogation, such a derogation is not proposed at this point but marked for reconsideration. A derogation might be proposed at a later stage if additional information on (e.g.) the rationale for continued PFAS use in specific applications and the quantities of PFAS used in those applications is pr ovided. 374 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider that the evidence is sufficiently strong that technically and economically feasible alternatives are unavailable in the quantities required for use in transport applic ations (including automotive, airc raft, rail, marine, and aerospac e industries) where the substances are affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, pasengers or goods under a full ban (RO1) subject to an 18 month transition period following EiF. This view is based on evidence from the literature, CfE and 2nd stakeholder consultation. Given the extent to which PFAS are embedded in the design of vehic les in many forms (various seals and gaskets, valves, pipes, tubes, electronics, hydraulic fluids and so on) and in many different c omponents, time will be needed to c arry out the R&D, etc. and obtain necessary c ertifications before alternatives can be introduc ed across the industry. The same also applies to a 5 year derogation, because of the c urrent diversity of PFAS use, and the industry view until now that alternatives were not needed, leaving many alternatives under-researched. There is weak evidenc e that a 12 year derogation would be required. Improvement of the evidence base will be dependent on further R&D to assess the potential for progress on substitution of alternatives. The opportunity for additional research would clearly improve the substitution potential over time. RO1 would naturally provide greater benefit in the form of reduced emissions, though there is only weak evidence to support the quantification of those emissions. It seems unlikely that stakeholders have access to the data needed to provide more robust estimates, so improvement of the data would probably require original data collection. The evidenc e is strong that the socio-economic c osts to both industry and c onsumers under RO1 would be very high given the diversity of uses of PFAS in the transport sector and the fact that the industry has seen little need to develop alternatives for many of t hose applic ations. This creates significant potential for business c losures and job losses, especially where companies are currently 100% dependent on the use of PFAS, as is the case with some suppliers of seals, pipes and other components. Costs, and the likelihood of business closures would fall under a 5-year derogation and then further under a 12-year derogation as more time is permitted for research into alternatives and for their introduction to the market. Whilst a 5 year derogation would likely permit some substitution of PFAS applications, it seems unlikely that it would permit complete removal of PFAS from transport without some level of disruption to the market. Further data to identify precisely which current uses of PFASs are problematic , and the quantities of PFASs used in those applic ations would be benefic ial. The complexity of PFAS use in the sector strongly suggests that a 12-year derogation would be needed in order for the nec essary R&D, c ertification, and other work to be put in place. It is noted that a number of industry commentators to the stakeholder consultation considered even this timescale too short. Several points should be noted.: The conclusions reached here do not apply to specific applications of PFAS in the transport sector that are addressed elsewhere in this dossier, including in the tables that follow. These conclusions are specific to PFAS use in transport (including automotive, airc raft, rail, marine, and aerospace industries) where the substances are affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, pasengers or goods. The c onclusions reached on the benefits of a restric tion do not ac count for c hanges in emissions at the waste phase, whic h is dealt with separately. 375 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.122. Hydraulic fluids for anti-erosion/anti-corrosion purposes in hydraulic systems in the aviation and aerospace industry - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Ban with use-specific derogations: Proposed derogation: Additives to hydraulic fluids for antierosion/anticorrosion in hydraulic systems (incl. control valves) in aircraft and aerospace industry Conclusion Duration of derogation Not applicable 5 years 12 years A lte r na tiv e s No acceptable non-PFAS alternatives have been approved for use in the aviation sector and for aerospace industry, where PFASs are used for example for antierosion/anti-corrosion purposes in hydraulic systems, including landing gear [sufficiently strong evidence]. Alternatives are not available on a short timescale given the need for approval under various specification schemes [sufficiently strong evidence]. Information from industry indicates that 5-years would be insufficient to perform the necessary R&D on alternatives and gain approval for their introduction. [sufficiently strong evidence] Information from the 2nd stakeholder consultation indicates that a 12 year derogation should give sufficeint time for alternatives to be introduced. [sufficiently strong evidence] Environmental impact n/a No evidence is available about expected additional emissions arising from this 12-year derogation. However, additional emissions are assumed to be small as the PFAS use derogated is limited and has only some applications in aviation. Cost impact Other aspects Not feasible for the aviation and aerospace industry under a full ban given the need to develop, test and certify alternatives [sufficiently strong e v ide nc e ]. As RO1 Reduced producer surplus loss compared to RO1 particularly given the need for recertification of components using alternative substances in their hydraulic fluid. [sufficiently strong evidence] Hydraulic fluids are used in safety-critical applications in the aviation sector such as landing gear. Although only limited evidence has been obtained, a sufficiently strong case has been made that transition to alternatives will take several years. On this basis, an d accepting views on the time taken for alternatives to become available and receive the necessary certification, a derogation of 12 -years appears appropriate 376 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation for this use. A lte r na tiv e s Environmental impact Cost impact Other aspects 377 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters c onsider that the evidence is strong that technically and ec onomic ally feasible alternatives would be unavailable in the quantities required for for anti- erosion/antic orrosion purposes in hydraulic systems in the aviation and aerospace industries under a full ban (RO1) subject to an 18 month transition period following EiF. This view is based on a limited number of responses to the 2nd stakeholder consultation. The same position applies to a 5 year derogation, because of the time likely to be needed for R&D on alternatives and certification once an alternative is identified. Substitution potential would increase significantly for a 12-year derogation as this provides sufficient time for testing and c ertification of alternatives once they have been identified. RO1 would provide greater benefit in the form of reduced emissions, though there is no evidence to support the quantification of those emissions. Hydraulic fluids containing synthetic oils should be treated as a controlled waste at the end of their service life. The evidence is sufficiently strong that the socio-economic costs to both indust ry and consumers under RO1 would be very high given the role played by hydraulic fluids in the sec tor, though it has not been possible to estimate the size of these c osts. 378 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E. 123 MAC (Mobile Air Conditioning) systems - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable Ban with usespecific derogation s: Proposed derogation: 5 years A lte r na tiv e s Environmental impact Alternatives are available for electrical and hybrid cars, while not necessarily for combustion engine vehicles with mechanical compressors. Such systems may need to be redesigned by each manufacturer to enable use of alternative refrigerants, for example to address higher pressures of CO2 systems and secondary loop systems for R152a. [sufficiently strong evidence] Based on available evidence which is considered weak (i.e. not based on referenced data or documented assessments) a full ban of PFAS use in the transportation sector is expected to reduce PFAS emissions by about 94% (assuming a 30-year assessment period, 20252055). 5 years would provide opportunity for R&D to bring alternatives to the mass market [sufficiently strong e v ide nc e ]. For the proposed derogation total maximum additional emissions of a 5- year derogation of fluorinated gases use for MAC are 95 076 tonnes. Though no evidence is available about the precise Cost impact Alternatives have been identified for combustion engine vehicles, with an estimated costeffectiveness in the order of 100 to 500/kg PFAS, depending on leakage rates over the service life of vehicles, fate of fluorinated gases at the end of life and the alternative adopted. However, they are not drop-in replacements and systems would need to be redesigned to enable their use [sufficiently strong evidence]. Economic impacts of RO1 related to mobile air conditioning are dependent on the time taken for most manufacturers to design alternative mobile air conditioning systems that can be integrated with existing vehicle designs. This leads to some loss of producer surplus through costs of R&D, capital costs etc. to provide new MAC -systems [sufficiently strong evidence]. There is no reason to expect exports of vehicles from the EU to be affected as systems could be filled with fluorinated gases after export. Lower costs of alternative refrigerants would mitigate costs to consumers in the longer term during servicing. [sufficiently strong evidence]. Lower producer surplus losses than under a full ban given added time to develop alternative systems and phase out of some nonelectric/hybrid models. [sufficiently strong evidence] Other aspects MAC systems in particular are responsible for significant emissions of gaseous PFAS. The decision on whether or not to apply a derogation period thus needs to reflect the practicalities of introducing alternatives across the industry and the associated environmental burden. Low consumer losses, depending on the extent to which manufacturers are able to pass costs 379 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Refrigerants in mobile air conditioning (MAC )systems in combustion engine vehicles with mechanical compressor s Conclusion Duration of derogation A lte r na tiv e s Environmental impact Cost impact Other aspects fraction of emissions, it is onto consumers. [weak evidence] assumed that emissions will be up to 90% of emissions As above, cost effectiveness estimated at 100 expected under a full derogation to 500/kg PFAS, depending on leakage rates, of fluorinated gases. fate of fluorinated gas at end of life. and the alternative adopted [sufficiently strong evidence] 12 years A 12 year derogation n/a n/a would naturally provide additional time for R&D into alternative systems which could provide efficiency and cost advantages [weak evidence]. It is concluded that additional time beyond the 18-month transition period would be needed for alternative systems to be introduced, noting that drop-in alternatives are unavailable. A 5-year derogation seems most appropriate for PFAS use in typical transport MAC and refrigeration systems given the likely availability of alternatives at the present time, with the exception of military applications for wh ich a 12-year derogation seems more appropriate. In some sectors alternatives are already widely used, but in others they are not. It is re cognised that a derogation of PFAS use in MAC and mobile refrigeration will cause substantial additional emissions, which together account for close to 100% of the use of gaseous PFAS in the transportation sector. 380 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider that based on evidence from the literature, CfE and 2nd stakeholder consultation that the evidence is strong that technically and economically feasible alternatives would be unavailable in the quantities required for use in MAC systems for c ombustion engine vehicles using mec hanical c ompressors under RO1. This does not apply to elec tric and hybrid vehic les. Substitution potential is therefore high for some applic ations but low for others under RO1. Drop-in alternatives have not been identified, and so cooling systems would need to be designed around the use of alternative refrigerants. There is sufficiently strong evidence that a 5 year derogation would provide sufficient time for a transition, given that potential alternatives have already been identified, though further work is needed to integrate these alternatives with vehicles. Evidence on the availability of alternatives strengthens again for a 12 year derogation given both knowledge that there are possible alternatives already on the market and the longer period for undertaking necessary R&D and other activities. RO1 would naturally provide the greatest benefit in the form of reduced emissions. There is strong evidence supporting the quantification of emissions given submissions made under the F-gas regulation and the UNFCCC (UN Framework Convention on Climate Change). Evidence on the savings made under different derogation periods is weaker given uncertainty on the precise time-schedule for the introduction of alternative systems, but associated error in estimates seems likely to be modest. 381 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.124. Transport refrigeration - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable Ban with usespecific derogation s: 5 years Proposed derogation: Refrigerants in transport refrigeration other than in marine applications A lte r na tiv e s There is sufficiently strong evidence that alternatives exist for both marine and landbased applications (active and passive C O2 systems and NH3 systems). However, these may require re-design of equipment as alternatives are not drop-in replacements for PFASs. There is evidence that redesign would need to go beyond cooling systems to wider redesign, for example of lorry tractor and trailer units to provide sufficient space for C O2 based systems. Overall, it is concluded that there is high substitution potential at EiF for marine applications [sufficiently strong evidence] and low substitution potential at EiF for other applications [sufficiently strong evidence]. Given that alternatives are already known, a 5 year derogation would provide opportunity for R&D to better optimise systems, particularly in areas where current options could introduce inefficiencies such as reduced load capacity. [sufficiently strong e v ide nc e ]. Environmental impact Based on available evidence which is considered weak (i.e. not based on referenced data or documented assessments) a full ban of PFAS use in the transportation sector is expected to reduce PFAS emissions by about 94% (assuming a 30-year assessment period, 2025-2055). For the proposed derogation total maximum additional emissions of a 5- year derogation of fluorinated gases use for MAC are 194 315 tonnes. Though no evidence is available about the precise fraction of emissions, it is assumed that emissions are substantially lower compared to the maximum emission scenario. Cost impact Alternative systems have some market penetration indicating that they can be cost-competitive but there remain significant barriers to widespread adoption. There is sufficiently strong evidence that for some parts of the transport sector significant re-design of equipment would be needed, raising questions about the feasibility of substitution under an 18-month transition This would then cause loss of both producer and consumer surplus, though costs have not been estimated. [sufficiently strong evidence] Other aspects A 5 year derogation would provide opportunity for further development of systems and integration with other vehicle components for typical uses. This would have economic benefits to both producers and consumers. [sufficiently strong evidence]. 382 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Conclusion Duration of derogation 12 years A lte r na tiv e s A 12 year derogation would naturally provide additional time for R&D into alternative systems which could provide efficiency and cost advantages prior to the introduction of alternative systems [weak evidence]. Environmental impact n/a Cost impact C osts to industry would be reduced compared to the above time limits because of increased potential for identifying and certifying alternatives [sufficiently strong evidence] Other aspects There is also potential for benefits to consumers through reduced costs and systems that are better integrated into vehicle design. [weak evidence]. It is concluded that additional time beyond the 18-month transition period would be needed for alternative system s to be introduced, noting that drop-in alternatives are unavailable, although alternatives are known. A 5-year derogation seems most appropriate for PFAS use in typical transport refrigeration systems other than marine, given the likely availability of co st-effective alternatives at the present time. It is recognised that a derogation of PFAS use in MAC and mobile refrigeration will cause substantial additional emissions, which to gether account for close to 100% of the use of gaseous PFAS in the transporta tion sector. 383 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitter consider based on evidence from the literature, CfE and 2nd stakeholder consultation that the evidence is strong that technically and economically feasible alternatives are unavailable in the quantities required for use in transport refrigeration (including automotive, rail and aerospace industries), and hence that substitution potential is low under RO1. Drop- in alternatives have not been identified, and so c ooling systems would need to be designed around the use of alternative refrigerants. It is, however, concluded that there is high substitution potential for marine applications where alternatives already have market share. Some alternatives are being used in road transport also, but their extension to the full market is not straightforward and other alternatives may be preferable in the longer term. There is sufficiently strong evidence that a 5 year derogation would provide sufficient time for a transition for typical uses, given that potential alternatives have already been identified, though further work is needed to integrate these alternatives with vehic les. Evidence on the availability of alternatives strengthens again for a 12 year derogation given both knowledge that there are possible alternatives already on the market and the longer period for undertaking nec essary R&D and other ac tivities. RO1 would naturally provide the greatest benefit in the form of reduced emissions. There is strong evidence supporting the quantification of emissions given submissions made under the F-gas regulation and the UNFCCC (UN Framework Convention on Climate Change). Evidence on the savings made under 5- and 12-year derogations is weaker given uncertainty on the precise time-schedule for the introduction of alternative systems, but associated error in estimates seems likely to be modest. The evidence is sufficiently strong that the socio-economic costs to both industry and c onsumers under RO1 would be high given the need to introduc e new systems and integrate them into vehic les. Transport operators may bear additional c osts if alternative systems are bulkier than those used c urrently, leading to added weight on vehic les and reduc ed c arrying c apacity (though this could be small). There would be some risk of business c losures and job losses, though this would be mitigated by continued demand for transport refrigeration. Costs, and the likelihood of business closures would fall under a 5 year derogation and then further under a 12 year derogation as more time is permitted for research into alternatives and for their introduc tion to the market. 384 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.125. MAC and refrigeration in military applications - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable Ban with usespecific derogation s: Potential derogation marked for reconsiderat ion: Use as refrigerants and for mobile air conditioning (MAC ) in 5 years 12 years A lte r na tiv e s For specialist military vehicles, including tanks and submarines, concerns have been raised about safety relating to alternatives that are toxic, flammable or require high pressure for operation, recognising that these vehicles can operate under extreme conditions with heightened risk of the failure of MAC and refrigeration systems. Alternative approaches to refrigeration in military transport vehicles may be required, but these are not currently available for the sector. It is concluded that there is low substitution potential [Sufficiently strong evidence]. The lack of clear alternatives at the present time that are capable of providing the performance and safety aspects required for military applications where vehicle users are at high risk makes it unlikely that alternatives could be developed under a 5-year derogation. [Weak evidence]. It is envisaged that a 12 year derogation would provide sufficient time for development of alternatives for military applications, given the emergence of new cooling technologies on a Environmental impact No evidence has been found regarding PFAS use specifically in the military applications covered here. Based on available evidence which is considered weak (i.e. not based on referenced data or documented assessments) a full ban of PFAS use in the transportation sector (not specific to military applications) is expected to reduce PFAS emissions by about 94% (assuming a 30-year assessment period, 2025-2055). No account is taken of emissions from the waste phase. n/a No evidence is available about the precise amount of additional emissions of a 12-year derogation. Assuming a derogation of all polymeric PFAS use, maximum additional Cost impact C osts of existing alternatives for military applications would be similar to those for options applying to civilian applications for many routine goods. However, it is likely that goods that are not to be used in higher risk situations that procurement would follow the civilian market simply on price grounds. However, additional design considerations and further R&D would be required to ensure the protection of service personnel in higher risk activities and these will likely be at an increased cost relative to civilian situations. Increased risks to service personnel, reduced comfort, etc. would lead to consumer surplus loss [Weak evidence]. As it is likely that more time would be needed to develop alternatives, the cost impact is considered similar to the case for a full ban. [Weak evidence] Added time for the derogation provides manufacturers with more opportunity to screen alternative systems to ensure that they can be optimised to the demanding military environment. This is likely to be more cost-efficient for the manufacturers Other aspects 385 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option vehicles in military applications Conclusion Duration of derogation A lte r na tiv e s Environmental impact Cost impact Other aspects similar timescale [Weak emissions will be 33 929 t. This and reduce risks of job losses, though cost e v ide nc e ]. is slightly higher than additional data for alternative systems have not emissions under a full ban (RO1, been identified. It is also likely to facilitate being 28 306 t). a safer on-vehicle environment for service personnel with associated welfare benefits. It is envisaged that price pressures would mean that this derogation is only used where safety considerations for service personnel are a significant issue: for non-critical applications it is likely that goods supplied as standard to the civilian market would be cheaper. [Weak evidence]. The Dossier Submitters accept that military applications need special considera tion given the possible extremes of the working environment. It is therefore concluded that additional time beyond the 18-month transition period may be needed for alternative systems to be introduced for military applications, noting that drop-in alternatives seem to be unavailable. A 12-year derogation appears most appropriate, recognising the added hazards encountered in military operations and the possible need for innovative cooling solutions. This will lead to so me increase in emissions relative to a full ban, but military applications are concluded to be only a small part of the MAC and refrigeration market. In light of the broad use scope and the weak evidence base to narrow down the scope for a derogation, such a derogation is not proposed at this point but marked for reconsideration. A derogation might be proposed at a later stage if additional information on alternatives bec omes available through the Annex XV report consultation, for example concerning the range of applications where a derogation m ay be appropriate and the quantities of PFAS used in those applications. 386 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The Dossier Submitters consider that based on information from the 2nd stakeholder consultation (particularly 3 responses from national defence agencies) that the evidence is strong that technically and economically feasible alternatives are unavailable in the quantities required for use in MAC and refrigeration systems for c ertain military applic ations under RO1, and hence that the substitution potential is low. Particular consideration is given to extreme operating conditions for some military applications and their need to operate in hostile environments, which may increase risks associated with natural refrigerants. Drop -in alternatives have not been identified. RO1 would naturally provide the greatest benefit in the form of reduced emissions. There is limited evidence supporting the quantification of emissions from military applications specifically, though % changes linked to different derogation periods seem likely to be bro adly reliable, especially as use-phase emissions for the transport sector are dominated by fluorinated gases from MAC and refrigeration systems. Given limited time for R&D and certification of alternatives it is likely that there would be significant costs to both producers and consumers under RO1, with potential for business closures and job losses. These would be mitigated through derogations giving additional time for the sector to move to alternatives, increasing the substitution potential. A 5-year derogation is suggested above for MAC and transport refrigeration systems in other transport applic ations. However, given the harsher operating conditions for military equipment, a longer derogation (12-years) may be appropriate for this sector. Further information to support this is desirable, for example to specify more precisely the applications concerned and the quantities of PFAS involved. 387 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.11. Electronics and semiconductor E.2.11.1. Baseline Stakeholders did not provide specific information on a trend in volumes or quantities of PFAS used. It is assumed that in 2022 PTFE is still the dominant fluoropolymer, but PVDF and FEP will have a growing market share. For FEP this is largely because of the growing electronics market (FEP is used extensively in c ables like LAN c ables) as well as solar c ell and fiber optic applic at ions. Stakeholders provided information on expected trend in sales for the next few years. In general, there is no one-to-one relation between sales and the volumes or quantities of PFASs and the data on sales are merely a best guess based on the data at hand. Stakeholders projected increases in annual sales of PFAS containing mixtures and articles in the electronics and semiconductor industry in the EEA to be between 0 and 100 percent. Most stakeholders reported an expec ted inc rease of 10% or less (see Annex A.2.13.3). Additional information from literature and CfE is summarized as follows: Electrical and electronic equipment (EEE): The Urban Mine Platform indicated that a total weight of 12 500 000 t of EEE was placed on the EEA market in 2020. Stakeholders did not provide specific information on a trend in volumes or quantities of PFAS used in the EEE sectors. However, growth in use of PFASs is expected because of their increasing application in electronics and electrical engineering. In general, annual sales (%) of PFAS containing mixtures and artic les in the elec tronics and semic onductor industry in the EEA is expected to increase by more than 3%/y and in some cases to be growing 100%. No information was provided for relative market share of electronics containing PFASs to the total electronics market in the EEA. The growth of PFAS use and emissions depends on the growth in the electronics industry (inc luding semic onduc tors). Precise growth rates are not known. For assessing baseline PFAS use and emissions a mean real growth rate per year of 10% is assumed. To account for the uncertainty of emission estimates, two alternative growth scenarios (5% and 10%/y) are investigated. The start year of the assessment is 2020. Baseline tonnage and emission estimates for industrial uses of PFASs are projected for a time path of 30 and 45 years (2025-2070) as presented in Table E.126. Table E.126. Projected yearly PFAS use and emissions in the electronics and semiconductors sector of the EEA between 2020 and 2070 in tonnes (mean values based on market data)* . 2020 2025 2030 2035 2040 2045 2050 2060 2070 PFAS use 4 860 7 834 12 617 20 319 32 724 52 703 84 878 220 152 571 017 P FAS 738 1 189 1 914 3 083 4 966 7 997 12 880 33 407 86 648 e m issions *Estimates c over industrial and use phase only (thus, not waste phase of produc ts). Source: Own calculations based on market data collated by the Dossier Submitters. Emissions were determined by applying standard environmental release categories as provided by ECHA Guidance documents (ECHA, 2016) to available market data of PFAS use in this sec tor. Hence, emission estimates represent worst c ase PFAS emissions resulting from industrial manufac ture of elec tronics and semic onductors. The results must be c onsidered as a first tentative estimation with considerable uncertainty because many calculation parameters are based on assumptions with limited underpinning fac ts. The approach c an be used for further refinement when better data bec ome available. Figure E.19 shows expected 388 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) mean PFAS emissions between 2020 and 2070 in tonnes. Figure E.19. Expected PFAS use and emissions in EEA under the baseline in the electronics and semiconductor sector (mean values) [tonnes]. Source: Own calculations based on market data collated by the Dossier Submitters. Based on the assumptions made about market trends for PFAS use, emissions can be expected to increase considerably over time. The latter very much depends on assumed growth rates for the sector, which are highly uncertain but may become adjusted as new and reliable information becomes available. Based on current assumptions, an increase by more than 1000% can be expected in the period between 2025 and 2050. The largest fraction of PFAS emissions are fluoropolymers (including PFPEs) and non-polymeric PFAS (including sidechain fluorinated polymers). E.2.11.2. Alternatives E.2.11.2.1. Discussion on availability and quality of information Information on the alternatives for uses disc ussed in this c hapter and the c hapter on energy is difficult to interpret. For a limited number of specific sub-uses information is sufficient to draw conclusions on already available or promising alternatives. The Dossier submitters received a high number of comments from stakeholders. These can be broadly divided into six categories (see Table E.127). For each category stakeholder information is presented. Note that this tabular listing is intended to document the problems the Dossier Submitters are facing in general and does not differentiate between the uses for electronics, semiconductors and energy as the character of the information is very similar for these uses and in some c ases the stakeholder addresses all three uses, and in some c ases, it is diffic ult to understand which specific uses are addressed. 389 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.127 Stakeholder information received in the 2nd stakeholder consultation on availability of alternatives for electronics, semiconductors and energy (all quotes copied directly from stakeholder input). Broad statements that alternatives are not available. The Dossier Submitters cannot derive generalizable information from generic formulations (Dossier Submitters marked examples in bold) Innovative alternatives must be found to restrictions in the choice of materials, which are associated with high development costs. Fluorinated materials, which are quite expensive are only used for the cases, where no technical/safe alternatives (cheaper or same price level) are available. For the majority of uses, EPDMs (or NBRs/HNBRs) are used already. Most of our applications require oleophob coating due to customer requirements and application conditions. In several cases chemical stability in combination with higher temperature stability is requested, especially for battery and fuel cell venting and in automotive field. No other class of polymers do offer such a balance of properties; that is to say replacement of fluoropolymer will degrade cable functionality and portfolio use. Non fluorinated agent can't work. Applications where our PFPE based elastic material is used may be able to be replaced by other PFAS material but we don't think it is technically feasible to replace with non PFAS alternatives, as far as we know. As of today no possible alternative technically suitable is available Maybe in the future ... Maybe with strong drawbacks (Availability) Where possible, applications using PTFE-containing materials are replaced with their alternatives already, due to the cost of the PTFE-based materials. No other material has the same low friction and hea t resistance as PTFE. Non-fluorinated candidate substitutes cannot be substituted for oil barrier applications, where high oil repellence is an essential property, because it is not possible to ensure sufficient properties. Even in conformal coating applications, it is very difficult to provide multiple properties such as oil repellence, heat resistance, and corrosion gas resistance at simultaneously using only non-fluorinated materials, and a significant decrease in properties compared to fluorinated materials is unavoidable. In applications where such multiple properties are required, substitution with non fluorinated materials is not realistic. The proposed solutions are not suitable for all applications. Non-PFAS alternatives are not technically feasible since they do not provide the functionalities (performance) required by these applications as the PFAS products. Fluoropolymers (FP) are chosen when the following combination of properties are required: High thermal stability, Non-flammability and high melting-point. Inertness to chemical attack and permeation, Low coefficient of friction, Electrical properties PFAS is the only material that fulfils the functions required by the market. Most of the applications require heat resistance and chemical resistance. The materials to be applied have those performances. Only PFAS exists as such the material. There is no alternative material that perform high adhesive strength, heat resistance and water resistance for fixing some components to electronics devices. 390 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) There is no alternative material that perform high transpar ency, antistatic property and easy peeling. FAS is only the polymer which has several characteristic performance, the heat resistance, Low dielectric performance, C hemical/UV resistance and others, any other polymer does not have above performance as a unique polymer. It is not easy to replace PFAS polymer to other materials especially Electronic and Energy field, it has wide range application for using PFAS polymer. At present, there are no alternative materials for PFA in terms of releasability, heatresistant adn chemical resistance. We do not have any information on substitutes for PFAS. PFASs can provide several excellent functions that only PFASs can impart, e.g. low dielectric constant, low dielectric loss tangent, low refractive index, oil repellenc e, chemical resistance, corrosion resistance, precursor as very strong organic acid (Photo Acid Generator). These abilities are not in the list and this ability is difficult to be replaced with other materials. Even before we search non-PFAS alternatives, we firstly need to identify the use. PFAS have neither been regulated nor are listed as SVHC s, so their presence and concentration in articles are not subject to communication in the complex supply c hains so far. Alternatives would lead to costly redesign and testing, killing our innovations in the egg. Statements on specific uses. That often are too specific to derive a generalizable need for a derogation. For Photovoltaic standard polyolefines are not applicable to to their lack of UV stability...you would have to exchange photovoltaic panels every 5 years We have yet to find an alternative foil that has similar barrier and antifouling properties whilst not impeding Light transmission with a similar life time (20 year) the dielectric constant of the PTFE (low density PTFE) used for data cable cannot be reached by the listed alternatives or any other cable insulation: None of the listed alternative can provide all the cumulative benefits of PTFE for mo st demanding applications, when space cluttering is limited. Up to now, no alternative material for membranes is known. Likely it will never be found, as the requirements under the highly corrosive conditions and functionality are quite special. If PFAs cannot be used in our process anymore, this would mean for all clients a downgrading of their technology to old diaphragm or amalgam technology (with much higher energy consumption) We have not yet identified a cable insulation material capable of the 200 C operating required "Solid state batteries" have been discussed as a panacea for several years, but, for most applications, they are a speculative technology with no advanced construction For traction batteries, semiconductors and non-semiconductors in vehicles, the proposed substitute materials are not feasible. All-solid-state batteries are still under study and even their material systems have not been disclosed. For example, In the case of a vent filter, it is necessary to achieve both breathability an d waterproofness. The requirements of modern semiconductor manufacturing equipment and electronics and energy products, are so demanding that the only technically feasible alternatives are other fluoropolymers. For instance, seals made out of EPDM are being destroyed quickly in a ozone plasma. Silicone is not considered due to contamination concerns in semiconductor 391 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) manufacturing. Silicone is not competitive for cable insulation in high -speed data communication. A dielectric constant around 2.5 - 3.6 is for the colour copy and the high speed, the melt temperature of toner will be higher. (Alternatives) not competitive to Perfluoropolymers at 1.5 (cellular) Unknown for us but we are only downstream users, and we rely on our suppliers to study an alternative. However, due to our specifications required, the substitution would be complicated. If there are any suitable alternatives, they would first have to be tested, evaluated and qualified for each individual application (design modification, validation and repetition in type test), in some cases also at the customer's site (requires >5 y and resources, outcome uncertain). Potential alternatives must be photoactive. Up to now no feasible non PFAS based alternative has been invented. In addition, most of the SC manufacturing processes have had robust research conducted over the last 15+ years with no feasible non perfluorinated alternatives found that could be used in high volume manufacturing. So, for these processes, it isn't a matter of when it will [be] feasible to substitute but IF industry can substitute. Generally, the technical feasibility will depend on a thorough evaluation process at the different stages of our supply chain. Part validation is key to guarantee a qualitative, durable, safe product on the market, but it is the complete vehicle that ultimately need the final validation (integration of a part into a complex article into an even more complex article). We cannot just rely on a material supplier saying that he found a suitable alternative for a certain substance There are no non-fluorinated alternatives available that can withstand the harsh conditions of the chemical wetting processes, which ensure the durability, efficiency and performance of the products Information that alternatives do not exhibit the required functionalities Non of the alternatives listed can be used as corrosion protection Specific combination of antiadhesive -, electrical- and mechanical behaviour not replaceable. E.g. PEEK is ten times more expensive and less antiadhesive and too hard for comparable usage. The listed alternatives do not comply with the requirements regarding dissipation factor, insulation performance or temperature requirement C an't cope with the required environment to operate. Silicone might cause problems in PWIS free products. Alternatives like EPDM, Silicons and other Elastomers are already used for decades in section insulators. However, for "in contact" applications, the unique combination of hydrophobic, lipophobic, UV & tracking resistance, mechanical properties make fluoropolymers irreplaceable for this kind of application. Synthetic oil seems to be difficult for using boiling cooling. because its viscosity and surface tension strongly depends on temperatures. Especially, at low temperate, oi ls becomes sticky and almost solid. In order for this battery to be used for general purposes, several decades are required for its quality and durability to withstand practical use, and after that, it is believed that review of alternative materials will begin.Several alternative materials for the positive electrode binder have been proposed for current lithium -ion batteries, but both of them are lacking in quality and durability at the R&D stage. 392 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Photolithography: no known polymer-based alternatives In the cryogenic area there is no other material where the remaining elasticity guaranties safe operation. TC E, nPB, PERC , and DC M are the closest alternatives but are extremely toxic and are being phased out. Aqueous cleaning agents are also corrosive to metals, have high energy costs, and require extensive wastewater treatment, and there are irregular water disposal practices across end-users. Organic solvents (HC , alcohols, esters, and ketones) are flammable, some are VOC air pollutants, have limited solvency (low Kb values) and are not suitable for oxygen service cleaning applications. Volatile Methyl Siloxanes are persistent & bioaccumulative. There is no alternative to replace PFAS (PFSA, PTFE) in the H2 industry (both EL and FC ). Research has evaluated the potential of sulfonated hydrocarbon membranes eg. sulphonated polyetheretherketone (sPEEK) or polysulfone (e.g. seminal work on BPSH polymers by J. E. McGrath). While conduction properties and performance of these materials can be reasonably good, mechanical stability and durability are extremely poor, as oxidation by oxygen radicals, occurs. All non-fluorinated membrane concepts are still highly immature against minimum lifetime requirements of >25 000 hours. In a nutshell, they are not even close to meeting any durability requirements in a lab testing environment The listed alternatives are not known to be useful in lithography processes as process chemicals. For electronics bought from external suppliers, it is unclear if the mentioned alternatives would be technically feasible. No, despite ongoing research and market-exploration, we are not aware of any alternative substance, suitable as anti-drip agent in polycarbonate and PC blends. C oils: No substitution materials available which are technically known and tested. High developing costs would be necessary for alternative solution. HVS: No substitution materials available to PTFE that can be used for arc extinguishing. The listed fluorine-free alternatives are not technically feasible, as they do not reach the same performance and safety level as fluorochemicals. General information on non-suitable alternatives C onceivable alternatives have huge impact on product design and negative impact on carbon footprint and device availability: PTFE =>no 1/1 a lternative; PP, PE, POM not temperature resistant; PEEK, PPS, LC P no dielectric performances or no resistance to fluids; FEP/ETFE =>no 1/1 alternative PE and PU don't combine the same performances. Hydrocarbon elastomers are not resistant against minera l oil used in genset diesel engines as lube oil or fuel. Nitrile rubber has been used before fluorocarbon rubber in diesel engines. But as temperatures increased due to emission requirements and customers requested elongation of maintainance periods nitrile rubber has completely substituted with fluorcarbon rubber. To date, their properties like ion coductivity and long term stability is not in the same range. Performance of alternative materials regarding proton conduction not competitive at the moment. PEEK not an alternative for chemical baths/process basins - will be attacked by solvents or anorganic chemicals in our production processes. 393 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Reinforcement of PTFE with glass to reduce the wear has been tried, but it trades off with tracking properties. Silicon material tears easily. It is nearly impossible to make thin wall insulation using silicone C urrently, non-PFAS alternatives are lacking sufficient stability under high potentials as they occur in PEW WES (2) and partly during regular operation of PEM FC (1). High potentials cause an oxidation of hydrocarbon based materials which shorten the lifetime considerably. Moreover, above mentioned PEEK materials which are considered for membrane application (1a, 2a) exhibit a high elatstic modulus, i.e. they are very stiff and therefore show a low mechanical durability over a long operation period. low gas permeability of non-PFAS materials which make non-PFAS not feasible as the polymer component in the electrode. We cannot use silicone alternatives as the cross -contamination is high. it is anticipated that the electric motorization of vehicles in Europe will lag behind other regions by several decades.Even in fuel cells, the proposed alternative materials are not feasible. Substitutes are in the Semiconductor production: alternative gasketing materials have too low temperature resistance, chemical resistance and are not pure enough. PEM membranes: the described non-PFAS membranes can be used in high temperature fuel cells with a much lower efficiency. These HT-fuel cells need an operating temperature of up to 200 C and are not suitable for the use in automotive applications. Using reformer gas to run HT-fuel cells would also cause C O2 emission. R&D phase and lack quality and durability. Because of the poor mechanical and dielectrical properties of Silicone, EPDM and Mica. PEEK is not suitable, because of hardness, stiffness and low flexibility compared to used fluoropolymers Photoresist sensitivity and resolution are strongly dependent on the acidity. PFAS structu re is necessary to have strong acidity in organic acid. Non-PFAS type PAG can't be applicable. PFAS groups in the polymer can control surface coating uniformity. They are also essential to form hydrophobic top layers for advanced photoresist, such as 193 n m immersion lithography. Low surface free energy of the PFAS group is necessary, and Non -PFAS polymers are not technically feasible. The cited NPAs lack necessary durability and features for process chambers and distribution components that contain chemicals in a range of reactivities, temperatures and pressures and so risk failure and process contamination with substances & micro -particles from degradation, cracking and leachates. PEEK is an alternative for fluoropolymers based on temperature resistance b ut has shortcomings when it comes to electrical or chemical resistance, its stiffness and cannot be colored for identification. Fluoropolymers ensure prolonged lifetime of parts. EPDM cannot be used in long lifetime oil and gas applications where (part of) the seal cannot be easily changed, nor where steam and caustic resistance are required. Information on unsuccessful research Research and development 3 - 5 year cycle followed by product qualification and testing. First impression is that alternatives do not fulfill all requirements. More investigation is needed for a detailed answer. All other alternatives that could be considered in the development process do not lead to a reliable function, which ultimately has to reliably protect material goods as wel l as people. 394 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Information on possible alternatives (unspecific) For process liners other materials might be suitable if the process can be adapted accordingly. Some applications can be switched to alternatives, but not all Cable insulation: For some applications an alternative could be possible, for some not. So, the alternative plan in this field is not clear yet, it will be clear depends on the operating environment conditions and the application The alternatives provided in the list, and further down in the questionnaire, are all technically feasible alternatives to PFAS that have a proven record. The proposed solutions are not suitable for all applications Without prior evaluation and listing of all applications an assessment of the substitution possibilities cannot be made accordingly Different approaches to solid-state lithium ion batteries are still explored, so it is not clear yet if this kind of batteries will need PFAS to be sufficiently durable. The trialled lubricant is currently showing promise because the fluoro based liquids immiscibility with all other liquids. There are no other substances that have similar properties. IT&GC : working on a replacement of PTFE components using mentioned alternatives -POM Over a period of 10 years alternative technology is available. A replacement of PTFE for other applications can be developed but a parallel development of the existing products will delay the ongoing development of green products. Hydrocarbon membranes are not competitive to PFAS membranes on e fficiency and lifetime and have not entered the mass market. PEEK is used but cannot substitute all properties. Looking for better solutions is ongoing There are some applications where alternatives may be technically feasible. Sealing with alternatives could be possible when chemical resistance and low friction are not an issue. However, because of the high costs of PFAS they are not used. For wire insulation silicone materials can provide temperature resistance in some applications. However, the lower mechanical strength might require other design changes. Considering the listed information on alternatives the Dossier Submitters c onclude as follows: Only limited information has been submitted on possible alternatives for PFAS uses in the electronics and semiconductors and energy sectors. General or at least broadly applicable alternatives may not be available and stakeholders do not foresee any change in the future. Some stakeholders therefore c onclude that alternatives are not available at all. Other stakeholders reported that substitution is possible for some applications. Limiting factors are R&D costs, time needed for substitution, uncertainty regarding future success in finding suitable alternatives, assessment of functional losses and the resulting assessment of suitability. Some alternatives, notably for uses of polymers, are already available. Nevertheless, stakeholder information on current substitution potential is inconclusive. Some stakeholders agree that users need to analyse all their uses in detail to identify less demanding uses where alternatives suffice. Other stakeholders argue that there is no potential for substitution as PFAS-based materials are more expensive than the available alternatives and therefore are only used when they are indispensable. Regarding the sub-uses electronics and semiconductors more detailed information on 395 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) substitution potential for specific uses is scarce: Elec t ronics In general, there are very few alternatives. The alternatives available might not fulfil the requirements e.g. thermal/chemical resistance or durability. Some stakeholders report that it is likely that alternatives can be found for a lot of smaller components, e.g. gaskets, wires, cables etc. as these components are used in many categories. For so me uses, e.g. of fluorinated polymers, in elec tronics alternatives might be available. Semic onduc tors According to industry stakeholders, no non-PFAS technically feasible alternatives are available that can replace the properties necessary for semiconductor manufacturing process chemistries. No single "drop-in" replacement is possible for all semiconductor applications where substitutes exist. Almost every use has to be re-engineered to see if a replacement material will meet the technology requirements. Moreover, even within the semiconductor industry technologies are not consistent. Alternatives that work for one application or one c ompany, will not nec essarily work for another applic ation or another c ompany. The Dossier Submitters identified only a small number of alternatives that can be linked to spec ific uses, see Table E.128. Table E.128. List of available non-PFAS substances and technics in Electronics, Semiconductor industry . Use Non-PFAS alternatives Electronics industry Semiconductor industry a) Ethylene propylene diene monomer (EPDM) and silicone rubbers as alternatives for fluoroelastomers in sealing. b) Silicone materials, Polyetheretherketone(PEEK), mica, EPDM, Polyvinyl chloride, Polyethylene, ceramic based and one confidential polymer as alternatives for wire insulation. c) Mineral oils, synthetic oils, natural oils, Hydrocarbon fluids as alternatives in heat transfer fluids for immersion cooling (no current but possible future use) d) C yano group instead of C F3 for liquid crystal displays (LC D). e) Aromatic PAG and heteroaromatic PAGs (PAG triphenylsulfonium benzo[b]thiophene-2-sulfonic acid, 4(or 7)-nitro-, ion(1-) (TPS TBNO) for photolithography (photoacid generators). f) Polyetheretherketone (PEEK) for example for chip manufacturing g) For photolithography (hard and not for all applications): hydrocarbon-based greases, Molybdenum disulfide, graphite h) In semiconductor production Atomic Layer Deposition/Atomic Layer Etching technologies may have potential to reduce the number of photolithography process steps but has not achieved necessary manufacturability to support high volume manufacturing. i) Immersion cooling of semiconductor devices: Mineral oils, synthetic oils, natural oils, Hydrocarbon fluids (Patent: WO2012127342). j) For flame retardancy in plastics: Brominated and chlorinated flame retardents k) One additional confidential alternative for semiconductor manufacturing equipment & infrastructure 396 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.11.2.2. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHA's dissemination site. In relation to the electronics and semiconductor industry, t he list of alternatives contained 8 unique CAS numbers. Two of these substances were classified according to CLP (selfclassification). None of the substances were known to fulfil the PBT or vPvB criteria due to the fact that no data on PBT/vPvB properties were found. The list c ontained an additional three substances with unique substance names for which no CAS numbers were available. None of these substances was classified according to CLP. No information on PBT and vPvB properties was available. For one substance (Silic one rubb ers), it was indicated that they may contain residues of D4, D5 and D6, cyclic siloxanes. D4, D5 and D6, and cyclic siloxanes are considered to be PBT/vPvB substances and D4 is considered to be an endoc rine disruptor. Appendix E.2. c ontains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.11.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.11.3., assuming business-as-usual and, consequently, on-going PFAS use and emissions. The analysis of environmental impacts focuses on two restriction options: RO1, adopting a ban of all PFAS used in the electronics and semiconductor industry; RO2, adopting a ban on PFAS in c ombination with use-specific derogations. Regarding the duration of the derogations two scenarios are distinguished, i.e. a 5-year derogation (RO2a) and a 12-year derogation (RO2b). Environmental impac ts of RO1 are analysed quantitatively. Environmental impac ts of RO1 are analysed quantitatively. In contrast, for the use-specific derogations emission data were largely lacking. Still, there is information to which PFAS group emissions will belong. Therefore, environmental impac ts of RO2a and RO2b are evaluated qualitatively in relation to worst-case environmental benchmark scenarios, i.e. a full derogation of the relevant PFAS groups. Note that these benchmark scenarios do not represent restriction options but are used for comparative purposes only. Consequently, the expected emission reduction Table E.129 below summarizes the characteristics of the restriction options, and the worst-case benchmark scenarios. Table E.129 below summarizes the characteristics of the restriction options. Table E.129. Characteristics of restriction options and the worst-case maximum additional emission (benchmark) scenarios. Restriction option a bbr e v ia tio n RO1 Short description Full ban RO2 Ban with use-specific derogations Derogations --(i) Potential derogation marked for reconsideration: The semiconductor manufacturing process - 12 years Transition period after entry into force 18 months Duration of derogation --- 18 months 12 years 397 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Maximum additional emission scenario Ban with full derogation of entire PFAS groups Fluoropolymers incl. PFPEs, fluorinated gases, PFAAs incl. precursors 18 months 12 years For calculating the expected emission reduction, the assumed entry -into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.130 shows mean emissions and the expected mean emission reduction for time paths of 30 and 45 years (starting in 2025). Table E.130. Total mean emissions and emission reduction of RO1 and maximum additional emission (benchmark) (electronics and semiconductor sector, in tonnes). Restriction option Mean total Mean total emission Mean total emission emissions [t] reduction [t] reduction [%] 2020-2055 Baseline 293 248 --- --- RO1 2 496 290 751 99.1 Maximum additional emission scenario scenario `12-year derogation of all fluoropolymers incl. 9 394 283 854 PFPEs, fluorinated gases, PFAAs incl. PFAA precursors'* 2020-2070 Baseline 941 244 --- --- RO1 2 496 938 748 99.7 Maximum additional emission scenario scenario `12-year derogation of all fluoropolymers incl. 9 394 931 850 PFPEs, fluorinated gases, PFAAs incl. PFAA precursors'* *Maximum environmental emission sc enarios denote worst-case sc enarios assuming a full derogation of a particular PFAS group, against which emissions of proposed use-specific derogations are evaluated qualitatively. They do not represent restriction options. Source: Own calculations based on data collated by the Dossier Submitters. A full ban achieves an emission reduction of about 99%. Moreover, as can be seen from Figure E.20, due to the expected market growth in this sector (see section E.2.11.3 for further details), emissions are expected to increase over time, which will increase the PFAS pollution burden in the environment if no ac tion is taken. Environmental impac ts of RO2 are disc ussed below for the proposed derogation. (i) Potential derogation marked for reconsideration: The semiconductor manufacturing process - 12 years The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period and affects emissions from polymeric PFAS, fluorinated gases and PFAAs incl. precursors. Of the uses related to semiconductors that are identified in Annex A all except one would be captured by the derogation. Furthermore, it is the Dossier Submitter's 398 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) understanding that within this potential derogation uses related to semiconductor manufac turing equipment & infrastructure would be derogated. Based on c urrent information (i.e. alternatives are available at least for some uses, e.g. some polymeric PFAS uses) a derogation for these uses would not be justified. Of the PFAS uses reported in tables in A.3.12.2, only a fraction would be derogated (7% of PFAAs and precursors; 45% of polymeric PFAS). No information is available about the amount of fluorinated gases used for the manufacture of semiconductors. The semiconductor production is very technical and requires a controlled environment, where low emissions will occur. As an indication, and based on information on greenhouse gas emissions, the Dossier Submitter assumes that about 5% of PFAS use will be emitted during semiconductor production. An unknown, but (according to stakeholder information) small amount of PFAAs remains in the manufac tured article. No information is available about emissions from polymeric PFAS, but it is expected that a considerably high share of the use quantities remains in the article (i.e. it is not emitted during use). For fluorinated PFAS no information is available about emissions during the use phase of semiconductors, however, only negligible emissions are expected as in general semiconductors are expected to be protected from external stressors. Given these information gaps, it has to be concluded that there is no evidence about the expected additional PFAS emissions arising from this derogation. Assuming a full derogation of all polymeric PFAS, PFAAs incl. precursors, and fluorinated PFAS for a duration of 12 years would cause additional emission of 9 394 t (maximum additional emission scenario, see Table E.125). Given the assumptions and arguments provided above it is reasonable to assume that factual emissions during the production and use phase of semiconductors will be lower. No information is available about expected emissions during the waste phase. In general, the WEEE (Waste from Electrical and Electronic Equipment) directive requires the separate collection and proper treatment of WEEE and sets targets for their collection as well as for their recovery and recycling. However, the Dossier Submitters assume that especially recovery and recycling of small polymeric PFAS parts is difficult to achieve, meaning that they end up in the shredder light fraction, ultimately being landfilled or incinerated. Therefore, it is expected that significant emissions will occur during waste phase resulting from the continued use of polymeric PFAS. Figure E.20 shows the time path of emissions for the baseline sc enario, a full ban of PFAS use in the electronics and semiconductor sector (RO1), and a maximum additional emission sc enario. 399 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.20. Time path of mean emissions in the electronics and semiconductor sector under the baseline, RO1 and the maximum additional emission scenario [tonnes]. Source: Own calculations based on data collated by the Dossier Submitters. E.2.11.4. Economic and other impacts Detailed information on impacts for European industry could not be obtained during the c onsultations or from researc h. Currently, the semiconductor industry does not see an option to substitute the fluorine chemistry from their processes immediately. It is assumed that this process will take more than five years. The industry stakeholder consensus is t hat PFAS alternatives are not available for the electronic industry and if they are available in due time, the expected transition costs on average exceed 100 million and the expected transition times vary but are expected to be considerable (3-15 years). In general, the industry stakeholder consensus in the semiconductor industry is also that PFAS alternatives are not identified and if they are available , in due time the expected transition costs vary from 20-30 million to more than 100 million and the expected transition times vary per use/component but are expected to be considerable (3-10+ years). Respondents (from industry) expect loss of competitiveness and innovation for the EEA. They claim that appropriate transition periods and exemptions are necessary due to the lack of alternatives that could guarantee similar performances of affected products. They have also reported that the restriction would have disrupting effects on many technology produc ts/industries and, in turn, on EEA soc iety. Only five replies (all from the call for evidence) report a precise estimate of the loss in e arnings before interest, taxes (EBIT) for electronics including semiconductor: - 150 million (not clear over which time period because the respondent has not provided the annual turnover); 400 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) - 1 400 million (over 20 years); - 20 billion (over 20 years); - 50-100 million (over 20 years); - 1 000 million (over 1 year). Only two out of these five replies are from companies based in the EEA. None of the other respondents provide any estimated loss in EBIT. Qualitative assessments of further possible impac ts were given by stakeholders as follows: Manufacturers of raw materials used in PFAS and manufacturers of PFASs: The main economic impact of a ban of PFASs is downstream and the employment effects are expected to be of a larger magnitude for the specific sectors. Electronic industry and equipment including semiconductors: FluoroCouncil reports that the industry of electronic applications supports more than 53 000 jobs in Europe. Automotive industry also uses PFAS-based electronic components. FluoroCouncil has previously reported that the use of the fluoro-technology supports more than 72 000 jobs in Europe, though it is not clear how many of these jobs are directly connected to PFAS uses in car-electronics, because fluoro-technology is also used in other automotive solutions (e.g. engines, fuel systems, interiors, transmissions). FluoroCouncil reported that the semiconductor industry involves more than 91 000 jobs in Europe. The information was insufficient to make a reasonable estimate of what share of employees of each of the wide range of diverse downstream user sectors might be affected in the EEA. Wider economic impact: The products are widely used across all industries including IT, government, healthcare, education, entertainment, manufacturing, energy, defense, etc. According to an industry representative "A ban on import of the products would have a severe impac t on the economies of the EEA countries.". Some respondents highlight that competitors outside the EEA will immediately gain world market share and the gains for non-EEA competitors (mostly located in Asia) is due to the fact that they can continue to use a technology (using PFAS) that would be restricted for EEA c ompanies. E.2.11.5. Summary of cost and benefit assessment E.2.11.5.1. Electronics As long as no further information is available, the information suggests that the use of PFAS enhanc es safety and durability of articles and facilitates a more effic ient energy consumption. The Dossier Submitters rec eived limited information on alternatives, however, does not fully understand whether these alternatives have the potential to be use d broadly or c an only be utilized in nic he applic ations. It is the Dossier Submitters' understanding that alternatives are available for some uses in which fluorinated polymers are used currently. No information on c ost -effectiveness and affordability of the alternatives is available, making it impossible to justify a general derogation for all PFAS-uses in electronics. It is also not possible to identify sub-uses for which a derogation is justified as the available information basis is mostly weak or inc onc lusive. 401 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.11.5.2. Semiconductors A c ost-effectiveness estimate cannot be derived considering the scarce information on impacts of a PFAS ban on this sector. The Dossier Submitters conclude that information on the availability of alternatives is insufficient and therefore characterize it as `weak' in the summary table below (in accordance with the discussions presented in section 2.4.1.1. of the main report). But there are some indications that substitution to PFAS free alternatives in semic onduc tors and semic onductor manufacturing across a wide range of applications will not be possible within a transition period of 18 months. Although no quantitative data is available, it is obvious that a potential non-availability of semic onductors would lead to extremely high economic impacts. Semiconductors are used in numerous articles. Not being able to manufac ture, use, import or export these articles would lead to high produc er surplus losses for manufac turers and employment losses due to business closures and to high socio economic c osts to c ustomers due to the unavailability of an unknown number of artic les . However, for some, most likely smaller, applications substitution is possible and research is ongoing to identify further alternatives and further uses to which the available alternatives are applicable. Table E.131 summarises the outcomes of the assessment of costs and benefits for electronics. Additional information can be found in the accompanying text following the table. 402 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.131. Electronics - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s Fluoroelastomers: Inconclusive evidence on whether technically feasible alternatives (i.e. EPDM and silicone) exist for all sealing applications, Wire insulation: Inconclusive evidence whether technically feasible alternatives (e.g. PEEK, EPDM) exist. Heat transfer fluids for immersion cooling: Sufficiently strong evidence that technically feasible alternatives exist. Liquid C rystal Displays: Weak evidence that technically feasible alternatives exist, i.e. cyano group instead of C F3, for liquid crystal displays. Other uses: Inconclusive evidence as several stakeholders point out that alternatives are not available. However other stakeholders confirm that it is likely that alternatives are already available or might be found for a lot of components depending on concrete circumstances for each use. Ban with usespecific derogations: (i) Potential derogation marked for reconsideration: 5 years Given the evidence pointing to the existence of technically and economically feasible alternatives at EiF for heat transfer fluid for immersion cooling and liquid crystal displays, in combination with the inconclusive evidence pointing to the non-existence of technically and Environmental impact There is sufficiently strong evidence that RO1 will lead to a reduction of emissions of about 99%. n/a Cost impact Fluoroelastomers: Sufficiently strong evidence (in the form of stakeholder information) that generally alternatives are cheaper than fluoroelastomer. Wire insulation: Strong evidence that one potential alternative is significantly more expensive (PEEK). Strong evidence that other potential alternatives are cheaper (EPDM, PC ). Heat transfer fluids for immersion cooling: No evidence on the economic feasibility of alternatives. Liquid C rystal Displays: No evidence on the economic feasibility of alternatives. Other uses: Inconclusive or no evidence on the economic feasibility of alternatives. n/a Other aspects C ost impacts are based on limited and very general information provided by stakeholders. n/a 403 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option The semiconductor manufacturing process - 12 years Conclusion Duration of derogation A lte r na tiv e s Environmental impact Cost impact Other aspects economically feasible alternatives at EiF in all other uses, no derogation is proposed. 12 years Given the evidence pointing to the n/a n/a n/a existence of technically and economically feasible alternatives at EiF for heat transfer fluid for immersion cooling and liquid crystal displays, in combination with the inconclusive evidence pointing to the non-existence of technically and economically feasible alternatives at EiF in all other uses, no derogation is proposed. High substitution potential at EiF for heat transfer fluids for immersion cooling [sufficiently strong evidence] and liquid crystal displays [weak evidence]. Unclear substitution potential at EiF for fluoroelastomers in all sealing applications, in wire insulation a nd all other uses [inconclusive evidence]. Given the evidence pointing to the existence of technically and economically feasible alternatives a t EiF for heat transfer fluid for immersion cooling and liquid crystal displays, in combination with the inconclusive evidence poi nting to the non-existence of technically and economically feasible alternatives at EiF in all other uses, no derogation is proposed. 404 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Based on the available limited evidence, no use-specific derogations are proposed for the electronics sector. Several alternatives are available in general, but limited information suggests that users must identify and c hoose suitable alternatives for a large variety of very different applic ations. The Dossier Submitters note that the applic ability of alternatives often depends on specific use conditions. Sometimes it is not clear whether no alternatives are available at all, or whether users argue that for their specific use and the surrounding conditions no alternative is available. Additionally, most stakeholders do not s pecify impacts from using alternatives with reduced functionality, e.g. likelihood of material failure, costs for early replacement of materials, etc. 405 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.132 summarises the outc omes of the assessment of c osts and benefits for semic onductors. Additional information c an be found in the accompanying text following the table. Table E.132. Semiconductors - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s Weak evidence that technically feasible alternatives exist for: Photolithography generators), (photoacid Fluoroelastomers used for chip manufacturing, Immersion cooling of semiconductor devices, and Flame retardancy in plastics Weak evidence (stakeholder information) suggests the nonexistence of alternatives for several uses because of the chemical properties necessary for semiconductor manufacturing process. Weak evidence that alternatives that could be available for one specific use cannot be used for other similar uses. E nv ir o nme nta l impact Sufficiently strong evidence that RO1 will lead to a reduction of emissions of about 99%. Cost impact Low/no cost impacts for uses where alternatives are available Stakeholders report that PFAS-based materials are more expensive than alternatives. Other aspects High producer surplus losses as a result of business closures [strong evidence] due to not being able to manufacture semiconductors (weak evidence) High producer surplus losses as a result of substitution processes, dueto costs associated with R&D (weak evidence). High socio-economic costs to customers due to the unavailability of an unknown number of articlesusing semiconductors (weak evidence). Ban with usespecific derogations: The 5 years Given the weak evidence that 3- n/a 10+ years for transition are needed per component that Employment losses as a result of high share of business closures [weak evidence] In general, same as under full ban. For n/a a limited number of applications alternatives might be available. 406 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option semiconductor manufacturing process Conclusion Duration of derogation A lte r na tiv e s needs to be substituted a 5 year derogation is not considered. E nv ir o nme nta l impact Cost impact Other aspects 12 years Weak evidence that PFAS alternatives will be available in due time (transition times vary per use/component, but are expected to be considerable, i.e. 3-10+ years). No evidence available about the expected additional PFAS emissions arising from the derogation. Assuming a full Weak evidence on cost impacts: n/a the expected transition costs vary from 20-30 million to more than 100 million per manufacturer and per component (weak evidence). In general, added time for the derogation provides manufacturers derogation of all polymeric PFAS, with more opportunity to identify and develop cost-effective alternatives PFAAs incl. whilst limiting loss of producer and precursors, and consumer surplus and welfare losses. fluorinated PFAS for a duration of 12 years would cause additional emission of 9 394 t (maximum additional emission scenario, see Table E.130). Given the assumptions and arguments provided above it is reasonable to assume that factual emissions during the production and use phase of semiconductors will be lower. High substitution potential at EiF in an unknown number of specific uses for photolithography (photoacid generators), fluoroe lastomers 407 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s E nv ir o nme nta l impact Cost impact Other aspects used for chip manufacturing, immersion cooling of semiconductor devices and flame retardancy in plastics [weak evide nce]. Low substitution potential at EiF for the semiconductor manufacturing process [weak evidence] Given the weak evidence pointing to the non-existence of technically and economically feasible alternatives at EiF, a 12-year derogation in addition to the general 18 months transition period is not proposed at this point but marked for reconsideration for: [the semiconductor manufacturing process] In light of the weak evidence base in relation to alternatives, such a derogation is not formally proposed a t this point in the proposed entry text. A derogation might formally be proposed at a later stage if additional information on the availability of alterna tives and their technical feasibility becomes available, e.g. information on the R&D efforts that have been undertaken and planned R&D in the future. 408 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Based on the available information for semiconductors no generally applicable alternatives are available. However, according to stakeholders for an unknown number of applications, substitution is already, or in the near future, possible and research is ongoing to identify further alternatives and further uses for which the already available alternatives are applic able. The Dossier Submitters note that the current wording of the derogation marked for reconsideration, (`the semiconductor manufacturing process') is ambiguous in regard to the precise uses and sub-uses that would be covered by the derogation. The wording needs to be adjusted and refined based on additional information. It is the understanding of the Dossier Submitters that a derogation for most uses related to the manufacturing process might be justified (as covered in Table A.49. of Annex A). For immersion cooling a derogation is not justified. For the uses mentioned in the table, the Dossier Submitters need additional information to better understand the potential for substitution (e.g. advanced packaging, semiconductor manufacturing equipment and infrastructure). Additionally, stakeholders submitted information that it is unavoidable that small amounts of PFAS remain in the manufac tured semic onductor article. Therefore, the placing on the market and use of the article must be covered by a potential derogation as well. 409 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.12. Energy E.2.12.1. Baseline a) Energy sector: Robust information is not available. However, limited information obtained suggests that PFAS use in the energy sector will increase within the next years: The expected inc rease in annual sales of PFAS c ontaining mixtures and articles in and outside the EEA is estimated to be more than 15% and, in some cases, up to 100%. However, based on stakeholder comments there is no one-to-one relation between sales and the volumes or quantities of PFASs. b) The Urban Mine Platform indicated that a total weight of 12 500 000 t of EEE was placed on the EEA market in 2020. Stakeholders did not provide specific information on a trend in volumes or quantities of PFASs used in the EEE sectors. However, growth in use of PFASs is expected because of their increasing application in electronics (see corresponding chapter), fuel cells and hydrogen technology, rechargeable batteries, electroactive (ferro-, pyro-, and piezoelectric) devices, backsheets for photovoltaics et c etera. c) The European Green Deal aims to make the EU's economy sustainable. The EU Chemic als Strategy for Sustainability is part of the European Green Deal and is a first step towards a zero-pollution ambition for a toxic -free environment. According to industry stakeholders, PFASs play an essential role in achieving the EU green deal ambitions of a c limate neutral soc iety by 2050 in several industries. Those industries include, amongst others, the semiconductor and fuel cells industries. If no alternatives become available and if the Green Deal continues an increased demand for PFAS s in the energy sector can be expected. d) Batteries: Asia (China, South Korea, and Japan) remains the worldwide leader in the produc tion of Lithium-ion batteries, with many manufac turers able to produc e several (up to 100) GWh per year. The European production capacity on this front is expected to grow over time. JRC reports that the 2018 EU share in global production of Lithiumion batteries was 3% with a slight expec ted inc rease to approximately 5% for today. The 2023 forecasts for Europe show a 13.9% worldwide market share in production capacity (expected worldwide production of 658 GWh) (JRC, 2018). Benchmark Mineral Intelligence also reports a steep increase for the EU share in global production of Lithium-ion batteries: They estimate that the EU share as of 2020 was 6.8%. and will inc rease to 17.8% in 2030. e) The total number of battery cells placed on the EEA market in 2020 is close to 6 000 000 000. For additional information confirming strong growth until 2040 see Annex A. f) The global fuel cell market is forecasted to grow by a Compound Annual Growth Rate of 18% in the next few years. In particular, the fuel cell market for the automotive industry is expected to grow by 9% by 2021, with increasing demand for fuel cells in material-handling vehic les, light - duty vehicles, buses and the aerospace sector. g) The European production of all the fuel cells systems combined is expected to amount to between 500 million and 4 200 million. The same estimates range between 1 500 million and 10 600 million by 2030, corresponding to a value added of 500 million and 3 500 million, respectively. h) The market for hydrogen-related machinery, equipment, and components could rise to an annual 200 billion USD by 2050. Fuel cells and electrolysers offer the largest opportunities for machinery makers. Only fuel cells add up to potential revenue for machinery makers of USD 21-25 billion annually by 2050. i) Hydrogen Europe estimated the future need for PFASs in PEM electrolysis, based on the following: To reac h the EU's Hydrogen Strategy objective of 40 GW of elec trolysis capacity by 2030, a maximum of 500 t of PFSA ionomer (perfluorinated copolymers containing sulfonic acid moieties) most commonly reinforced by PTFE is needed. The estimated volume is an upper bound because it is assumed that all electrolysers will be PEM technology based and there will be no technological improvements reducing the amount of PFASs. 410 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) j) Photovoltaics: Solar panels are mainly produced in Asia. No data was received on the volume of imports to Europe. k) Immersion cooling (Most likely no PFAS-use in EEA but potentially in the future): Globally, data centre market is expected to grow by 10% in the coming years. Several factors are driving this growth, including the datafication and the increased needs for c omputational power and storage drove up by technological trends such as Internet of Things (IoT), Data & Analytics, Artificial Intelligence (AI) and - particularly - bloc kc hain and video streaming. In 2019, data c entres immersion c ooling market was valued at US$177 million, but the market is expected to grow at a CAGR of 23.2% in the reference period 2019-2024 and reach an estimated market size of US$500 million by 2024. Precise growth rates for the energy sector are not known. For assessing baseline PFAS use and emissions a mean real growth rate per year of 10% is assumed based on information from the second stakeholder consultation. The start year of the projection of tonnage and emission estimates is 2020 as presented in Table E.133. Table E.133. Projected yearly use and PFAS emissions in the energy sector of the EEA between 2020 and 2070 in tonnes (mean values based o n market data)*. 2020 2025 2030 2035 2040 2045 2050 2060 2070 PFAS use 3 049 4 911 7 909 12 738 20 514 33 039 53 209 138 101 357 963 P FAS 56 89 144 232 374 602 969 2 513 6 519 e m issions *Estimates c over industrial and use phase only (thus, not waste phase of produc ts). Source: Own calculations by the Dossier Submitters based on market data provided. The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). Emissions were determined by applying standard environmental release categories as provided by ECHA Guidance documents (ECHA, 2016) to available market data of PFAS use in this sector. Hence, emission estimates represent worst case emissions of industrial products during their formulation phase. The results must be c onsidered as a first tentative estimation with considerable uncertainty because many calculation parameters are based on assumptions with limited underpinning facts. The approach can be used for further refinement when better data become available. Figure E.21 shows expected mean PFAS tonnage and emissions between 2020 and 2070. 411 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.21. Expected PFAS use and emissions in EEA under the baseline in the energy sector (mean values) [tonnes]. Based on the assumptions made about market trends for PFAS use, emissions can be expected to increase c onsiderably over time, comparable to the increase in the electronics and semiconductor sectors, though at a lower absolute level . In particular, in the period between 2020 and 2050 an increase by more than 1 000% can be expected. PFAS emissions consist mainly of fluoropolymers and non-polymeric PFASs. E.2.12.2. Alternatives E.2.12.2.1. Discussion on availability and quality of information Information on the alternatives for uses disc ussed in this c hapter is diffic ult to interpret. For a limited number of spec ific sub-uses information is suffic ient to draw c onclusions on already available or promising alternatives. The Dossier Submitters received a high number of comments from stakeholders. These can be broadly divided in six categories. For each category stakeholder information is presented (see corresponding table in section E.2.11.4 combining information available for electronics, semiconductors and energy). Note that the tabular listing is intended to document the problems the Dossier Submitters are fac ing in general and does not differentiate between the uses for elec tronics, semic onductors and energy as the character of the information is very similar for these uses. Considering the listed information on alternatives the Dossier Submitters c onclude as follows: Only limited information has been submitted on possible alternatives. Generally, or at least broadly applicable alternatives are not available , and stakeholders do not foresee any c hanges in the future. Some stakeholders therefore c onclude that alternatives are not available at all. However, other stakeholders reported that substitution is possible for some applic at ion. Limiting factors are R&D costs, time needed for substitution, uncertainty regarding future success in finding suitable alternatives, assessment of functional losses and the resulting assessment of applicability. Some alternatives, notably for uses of polymers, are already available. Nevertheless, stakeholder information on current substitution potential is inconclusive. Some 412 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) stakeholders agree that users need to analyse all their uses in detail to identify less demanding uses where alternatives suffice. Other stakeholders argue that there is no potential for substitution, citing that PFAS-based materials are more expensive than the available alternatives and therefore are only used when they are indispensable. Based on information submitted in various stakeholder consultations, some specific alternatives have been identified that are available for the energy industry but several of them might have limitations regarding properties such as weather resistance, heat resistance or chemical resistance that may cause a decrease in lifetime and/or instability in the systems (see Table E.134). 413 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.134. List of available non-PFAS substances and technics in Energy sector. Use category Solar collector Photovoltaic cells Sub-use Film/coating Tape Potential non-PFAS alternative No information received Polyolefin, polyethylene terephthalate (PET) and/or ethylene vinyl acetate (EVA). Wind energy Film/coating and cables Lubricant Surface coating on top of front sheets covered under construction products No information received No information received Coal based power plant Nuclear power plant Heat exchanger tubing Filters Infrastructure: Gasket material No information received C onfidential information available PEM fuel cells Membrane electrode assemblies (MEA) (including re-enforcement) Gas Diffusion Layer (GDL) Microporous layers (MPL) Gaskets and seals Polysulfone, electrospun polybenzimidazole-type materials, hydrocarbon membrane, sulphonated polyetheretherketone (PEEK) No information received No information received Fluorine free elastomers, hydrocarbon elastomers Suitability Alternatives are already on the market (OEC D, 2022). One stakeholder stated that alternatives have a lack of weather resistance and water vapour barrier properties leading to defects and/or deterioration of the cell (decrease in service life). See also chapter on construction where coating of windmill blades and towers are covered. See chapter on lubricants. Note that this also covers lubrication of e.g. gears in windmills. Stakeholder reports that the discussed alternatives are less resistant to higher temperatures, they have limited ability to incorporate components to destroy or capture harmful emissions. Lower chemical resistance results in higher article failures, increased emissions, and more frequent replacement. Other potential alternatives are not expected to perform at the same demanding conditions under which fluoropolymer-based articles can provide reliable operation. No instant large-scale availability. A stakeholder mentioned that due to the harsh environment in combination with the sensitivity of the Membrane Electrodes Assembly (MEA) for 414 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use PEM electrolyser/ PEM fuel cells Sealing materials; gaskets Potential non-PFAS alternative Hydrocarbon membrane, sulphonated polyetheretherketone (PEEK), polysulfone (Under development). Ionomers/sulfonated polymers Reinforcement material alternatives: electrospun polybenzimidazole-type materials Hydrocarbon elastomers (seals) One confidential material Suitability contamination, very stable sealing materials are required. Fluorine-free-elastomers are under evaluation but contamination of the MEA - limiting its lifetime - as well as oxidative deterioration of the material itself are issues. Some elastomers without fluorine exist and could potentially be used in the future for this function. Those could be cheaper but are, today, not as chemically stable. As for gas-permeability and cost, the alternatives are superior to fluorinated elastomers thus replacement of these materials is desirable when possible. Another stakeholder pointed out issues when using alternatives: Lack of heat resistance, chemical resistance, water vapour barrier and flame-retardant properties. Failure of the seal material to maintain a tight seal due to deterioration. Further they mentioned lack of durability against load fluctuations during power generation. Lack of durability could cause the car carrying the fuel cell to come to a sudden stop. In their view there is also the possibility of short-circuit and ignition. According to stakeholders, research work has been ongoing for hydrocarbon membrane and sulphonated polyetheretherketone (PEEK) membrane development. Usually, properties and performance of these materials can be reasonably good whereas the durability is often poor, as oxidation by oxygen radicals occurs. It is expected that it will take ten years or more until a validated alternative material is available in volume. As for the reinforcement material, promising approaches are currently made to replace the PTFE by fluorine-free compounds like electrospun polybenzimidazole-type materials. The commercial use of these reinforcements is expected to begin not before five to ten years from now. Another stakeholder argued that alternatives do not 415 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Potential non-PFAS alternative PEM electrolyser Lithium ion batteries Seals, electrode binders, separator films/coatings, electrolyte additives, thermal management pack/module Batteries Battery fluid, C ompounds for separator films, Binder No information received hydrocarbon elastomers (seals). Solid state batteries. Lead acid batteries No information received Suitability fulfil the required functions: Lack of heat resistance, chemical resistance, water vapour barrier and flame retardant properties. Failure of the seal material to maintain a tight seal due to deterioration. C hemical stability, creep resistance, sliding properties, cryogenic properties. It is not clear in which application the "reinforcement" is intended to be used, but if it is intended to be used as a core material in fuel cells, the proposed alternative cannot guarantee the stability, safety and long-term use of the reinforced object. Another stakeholder: While conduction properties and performance of these materials can be reasonably good, mechanical stability and durability are extremely poor, as oxidation by oxygen radicals, occurs. All nonfluorinated membrane concepts are still highly immature against minimum lifetime requirements of >25 000 hours. Although there would be an economic advantage to finding performant fluorine-free materials, there is no alternative today to replace PFASs (PFSA, PTFE) in the hydrogen industry (both electrolyser and fuel cell). One stakeholder stated: Lack of heat resistance, chemical resistance, water vapour barrier and flameretardant properties. Failure of the seal material to maintain a tight seal due to deterioration Stakeholders inform that there may be some non-pfas alternatives for solid state batteries 416 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Flow batteries Sub-use Ionomer membranes Ion exchange membrane Potential non-PFAS alternative Solid state batteries E le c tr o ly s is technologies (not PEM) Equipment: gaskets, tubes, inliner of pipes/tanks C onfidential information on alternatives available Oil and gas application Others Equipment: gaskets, tubes, inliner of pipes/tanks. Wires and capacitors. Switchgears High Voltage DC C onverter Valves No information received Sulfur hexafluoride (SF6) Suitability Alternatives such as solid-state batteries are still investigated, but it might take a while before they can replace flow batteries. Stakeholders inform that there is no viable PFAS alternatives as of this moment. Mentioned alternatives for PTFE-based sealing systems could have satisfactory performance but certainly not at the levels that fluoropolymers provide, particularly in extreme conditions of mechanical strength required, variability of temperatures and chemical conditions. Other elastomers could eventually be used but providing limited mechanical strength and chemical resistance. For this use see also information in C hapter petroleum and mining Stakeholder information: While conduction properties and performance of these materials can be reasonably good, mechanical stability and durability are extremely poor, as oxidation by oxygen radicals, occurs. All nonfluorinated membrane concepts are still highly immature against minimum lifetime requirements of >25 000 hours. 417 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Literature research did not result in the identification of additional alternatives. In sum, it is not clear for which uses alternatives are already or within the next 5-10 years available. Stakeholders stressed the functional losses when non-PFAS materials need to be used in the future, however, did not provide specific information on expecte d impacts regarding direct substitution costs and additional costs for premature failure of articles or additional maintenance. E.2.12.2.2. Human health and environmental hazards Not a separate list; see `Electronics and semiconductors'. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.12.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in sec tion E.2.12.3., assuming business-as-usual and, consequently, on-going PFAS use and emissions. The analysis of environmental impacts focuses on two restriction options: RO1, adopting a ban of all PFASs used in the energy industry; RO2, adopting a ban on PFAS in c ombination with use-specific derogations. Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation. Environmental impacts of RO1 are analysed quantitatively. In contrast, for the use-specific derogations emission data were largely lacking. Still, there is information to which PFAS group emissions will belong. Therefore, environmental impacts of RO2 are evaluated qualitatively in relation to worst-case environmental benchmark scenarios, i.e. a full derogation of the relevant PFAS groups. Note that these benchmark scenarios do not represent restriction options but are used for comparative purposes only. Table E.135 below summarizes the c haracteristics of the restriction options. Table E.135. Characteristics of restriction options and benchmark scenarios. Restriction option abbreviation RO1 RO2 Maximum environmental emission scenario Short description Full ban Ban with specific derogations use- Ban with full derogation of entire PFAS groups Derogations --(i) Proposed derogation: Proton-exchange membrane (PEM) fuel cells Fluoropolymersand PFAAs incl. precursors Transition period after entry into force 18 months 18 months 18 months Duration of derogation --5 years 5 years For calculating the expected emission reduction, the assumed entry -into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.136 shows mean emissions and the expected mean emission reduction for time paths of 30 and 45 years (starting in 2025). 418 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.136. Total mean emissions and emission reduction of RO1 and maximum additional emission scenarios (energy sector, in tonnes). Restriction option Mean total Mean total emission Mean total emission emissions [t] reduction [t] reduction [%] 2020-2055 Baseline 16 272 --- --- RO1 188 16 084 99 Maximum additional emission scenario `5- year derogation of all 607 fluoropolymers incl. 15 661 96 PFPEs and PFAAs incl. precursors'* 2020-2070 Baseline 70 815 --- --- RO1 188 70 672 99.6 Maximum additional emission scenario `5- year derogation of all 607 fluoropolymers incl. 70 204 99 PFPEs and PFAAs incl. precursors'* *Maximum environmental emission scenarios denote worst-case scenarios assuming a full derogation of a particular PFAS group, against which emissions of proposed use-specific derogations are evaluated qualitatively. They do not represent restriction options. Source: Own calculations based on data collated by the Dossier Submitters. As illustrated in Table E.136, a full ban on PFAS use in this sector leads to a mean emission reduction of about 99% compared to the baseline scenario. Environmental impacts of RO2 are discussed below for the proposed derogation. (i) Proposed derogation: Proton-exchange membrane (PEM) fuel cells The derogation is proposed for a time period of 5 years after EiF of the restriction and the 18 months transition period, and affects emissions from PFAAs incl. precursors and fluoropolymers. Emissions resulting from the proposed derogation are difficult to assess as information on c urrent and future use quantities is sc arc e and unc ertain. A best guess would be that emissions resulting from the production phase are expected to be similar to the emissions expected for electronics, i.e. 5%. During use phase emissions should be negligible as PFAAs and polymeric PFAS are used in enc losed articles. Information on emissions at the end of life of products is sparse, but it is the Dossier Submitters understanding that recycling of PEM fuel cells and electrolysers is difficult and currently focused on recovering metal. Therefore it is expected that PFAA and polymeric PFAS parts will be landfilled or incinerated, causing emissions during the end-of-life phase. Evidence about PFAS emissions during the produc tion and use phase is lacking. However, assuming a full derogation of PFAAs and their precursors, and of fluoropolymers used in the energy sector, maximum additional additional emissions will be about 607 t, which is about 3 times higher emissions compared to a full ban (RO1). Figure E.22 shows the time paths of emissions under the baseline, RO1 and the maximum additional emission scenario. 419 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.22. Time path of mean emissions unde r the baseline, RO1 and the maximum additional emission scenario (energy sector, in tonnes). Source: Own calculations based on data collated by the Dossier Submitters. E.2.12.4. Economic and other impacts The majority of the replies for the energy industry overlap with the electronics and semiconductor business: Information is available that a very limited number of non-PFAS alternatives are available, more alternatives will be available within the next 5-15 years. Only qualitative information on transition c osts is available. Some stakeholder replies indic ate the nec essary additional transition period within the range 3-15 years when alternatives become available. Respondents (from industry) expect loss of competitiveness and innovation for the EEA when no equivalent alternatives are available. They claim that appropriate transition periods and exemptions are necessary due to the lack of alternatives that could guarantee similar performance of affected products. They have also reported that the restriction would have disrupting effects on many tec hnology products/industries and, in turn, on EEA soc iety. Only two replies report some estimates of the loss in EBIT for the energy sector (these are the same respondents for the electronics sectors reporting the same expec ted EBIT losses): - 50- 100 million (over 20 years); this c ompany is based outside the EEA; - 1 500 million (over 20 years); this company is based in the EEA. No hints on the EBIT-sales ratio can be derived from these two replies. Overall, the restric tion of PFASs is likely to affect the workforce in the whole EEA. However, suffic ient data was not available to reliably extrapolate impac ts to the whole EEA. Stakeholder input suggests that employment would be impacted in the industries that manufacture energy-related articles. But stakeholders also expect significant employment losses in downstream user sectors where the articles are no longer available. Respondents highlight that competitors outside the EEA will immediately gain market share (on non-EEA-markets) since they can continue to use a technology that would be restricted to EEA companies. 420 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.12.5. Summary of cost and benefit assessment Table E.137 summarises the outc omes of the assessment of c osts and benefits for energy uses. More detailed information c an be found in the accompanying text following the table. Table E.137. Energy - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s Sufficiently strong evidence that technically and economically feasible alternatives exist for: Backsheets for photovoltaic cells (PET, EVA), but also claimed to be less durable. Sufficiently strong evidence for the existence of technically feasible alternatives for membrane applications in PEM fuel cells. Alternatives are reported to be inferior in terms of durability. Evidence points to potential shortages in supply. Sufficiently strong evidence for the existence of alternatives for reinforcement materials for use in PEM fuel cells. Evidence points to alternatives not being commercially available before five to 10 years from 2022. Sufficiently strong evidence that technically and economically feasible alternatives exist for sealing materials used in PEM fuel E nv ir o nme nta l impact There is strong evidence that a ban will lead to an emission reduction of about 99% (assuming a 30year assessment period). Cost impact Not enough information to conclude on costs associated with specific uses. For uses for which substitution is deemed possible, examples of costs that will be incurred include: C osts associated with more frequent replacement, resulting from quicker deterioration and/or more frequent defects, e.g. as a result of the lower weather resistance and inferior vapour barrier properties of alternatives with respect to photovoltaic cells, or lower chemical resistance in the case of nuclear power plants For PEM fuel cells alternatives will not be available in 18 months resulting in closing of business, and resulting producer surplus losses, employment impacts and impacts on customers resulting from the unavailability of PEM fuel cells. Other aspects C ost impacts are based on limited and very general information provided by stakeholders. 421 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s cells These alternatives are claimed to be less durable but available at lower cost. There is weak evidence pointing to lower flame-retardant properties. As such, alternatives might not be technically feasible for applications with particularly high stability, and durability and flame-retardance requirements. E nv ir o nme nta l impact Weak evidence, that alternatives for gasket material for nuclear power plants exist but are less durable. Weak evidence that technically feasible alternatives exist for gaskets, tubes, and inliners of pipes/tanks used in relation to nonPEM electrolysis technologies. Weak evidence that alternative batteries, e.g. PFAS-free solid-state batteries could be used as a substitute for lithium-ion and flow batteries: The feasibility of using such batteries as a replacement for flow batteries is still investigated. Inconclusive evidence for uses not mentioned above: Several stakeholders point out that alternatives are not available. However other stakeholders Cost impact Other aspects 422 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation Ban with usespecific derogations: Derogations on fluoropolymers and perfluoropolyethers in Proton-exchange membrane (PEM) fuel cells 5 years 12 years A lte r na tiv e s confirm that it is likely that alternatives are already available or might be found for several components depending on concrete circumstances for each use. Sufficiently strong evidence available, pointing to problems in relation to the availability of validated alternatives (for fluoropolymers and perfluoropolyethers) in sufficient quantities for membranes and significant time requirements for the commercialization of reinforcement materials, (at least 5-10 years are deemed to be required from 2022). E nv ir o nme nta l impact Evidence about PFAS emissions during the production and use phase is lacking. However, maximum additional emissions (assuming a full derogation of PFAAs and their precursors, and of fluoropolymers used in the energy sector) will be about 607 t, which is about 3 times higher emissions compared to a full ban (RO1). Cost impact Assuming that alternatives will be available in sufficent quantities in time: No producer surplus losses as a result of business closures [weak evidence] No or low producer surplus losses as a result of substitution [weak evidence] as weak evidence points to lower costs for alternatives. Low or no consumer surplus losses from price changes associated with substitution [no evidence] depending on whether potential additional costs will be borne by producers or consumers. producers Some additional costs possible, as a result of the earlier disposal of fuel cells due to less durability of alternatives [weak evidence] Other aspects n/a No employment losses [no evidence] n/a n/a n/a n/a 423 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option C onclusion Duration of derogation A lte r na tiv e s E nv ir o nme nta l impact Cost impact Other aspects A full ban with a transition period of 18 months is proposed for the sector. A use -specific 5-year derogation in addition to the 18 months transition period is proposed for fluoropolymers and perfluoropolyethers in proton -exchange membrane (PEM) fuel cells. 424 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) No derogations are proposed for the majority of uses at this stage. Evidence is inconclusive and therefore not sufficient to justify additional use-specific derogations. A general derogation for all uses is likely to be not justified, as there are alternatives for some uses. A derogation c ould (most likely) be justified for specific uses where alternatives are not technically feasible, but this would rely on more detailed information on the specific uses. No quantitative or more detailed qualitative c ost information is available. It seems likely that a full ban on the use of PFAS in the energy sector would result in disproportionate costs. Stakeholders did not argue that alternatives will not be affordable in general but pointed out the technical shortcomings. Therefore, the Dossier Submitters assume that alternative materials will be affordable if they become available. For some uses alternatives might become available within the next years. No or only limited alternatives will be available within the proposed transition period for an unknown number of sub-uses. The Dossier Submitters do not have enough information to fully assess the impacts of longer transition periods of 5 or 12 years. Considering the information received regarding ongoing R&D and available alternatives, a general transition period of 12 years is likely to be justified (considering the additional emissions). Although uncertainties remain, the Dossier Submitters have no evidence that for the use of PFAS in PEM fuel cells a long transition period of 12 years will result in lower producer or consumer surplus losses and a dec rease in supply shortages. 425 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.13. Construction products This section addresses the use of PFASs in building materials/construction products . Uses and volumes of PFAS-based lubricants is provided in Annex A.3.14 and emission calculations, inc luding assumptions is provided in Annex B.9.14. E.2.13.1. Baseline As described in Annex B.9.14., a basic source-flow model has been developed for assessing emissions from building material/construction products containing PFASs under the baseline scenario. The model makes use of the data gathered from stakeholder consultations or estimations based on literature and substance identification in Annex A.3.14. One key c aveat here is that on a more general level a large number of substances have been identified as being in use or potentially in use with the quality of data available varying signific antly across all substances identified. Therefore, the approach taken has not tried to develop estimates on a substance-by-substance basis, but rather taken a grouping approac h. Where availability of data varies signific antly on a substance-by-substance basis a key benefit of using a grouping approach is that impacts of varying specific substance data are lessened. The trade-off of using suc h an approac h is that it means the estimates provided will have a higher unc ertainty attached to them overall (see Table E.138). However, this approach c an still provide useful data to estimate the orders of magnitude for emissions when comparing PFAS groups and different sectors. The projection of the time path of PFAS use (tonnage) and emissions under the baseline scenario considers expected growth rates for the relevant PFAS groups as shown in Table E.139. Table E.138. Assumptions for projecting tonnage volumes and emissions. PFAS groups Polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) Ethylene tetrafluoroethylene (EFTE) Other fluoropolymers Non-polymeric PFAS Assumption (2020 - 2070) C ontinued growth at 5%/y until 2030, after which growth slows to 2.5% between 2030 and 2040 and slows further to 1%/y between 2040-2050. Growth rate of 8%/y until 2025, after which growth slows to 5% (in line with PTFE) until 2030. The growth pattern then mirrors PTFE as growth of 2.5% annually between 2030 and 2040 and 1%/y thereafter between 2040-2050. Growth rate of 2.5%/y between 2020 and 2040, after which it falls in line with the other fluoropolymers as a rate of 1%/y between 2040 and 2050. Use is assumed to have a flat increase of 1%/y from 2020 to 2050, assuming the market continues to be suppressed by the existing restrictions on a number of PFAS. Based on the information provided in Table E.138, for the baseline scenario of PFASs use and emissions in the building/construction sector a declining growth rate is assumed for all PFAS groups. A yearly real growth rate for all PFASs groups of 5% is applied from 2020-2030, which declines to 2.5% from 2030-2040, and to 1% for the remaining years of the assessment period assuming that the growth rate of 1% will also apply in the period from 2050 to 2070. For non-polymeric PFASs the market growth is 1% during the entire assessment period. The start year of the projection of tonnage and emission est imates is as presented in Table E.139. 426 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.139. Projected yearly PFASs use and emissions in the building /construction sector in the EEA between 2020 and 2070 in tonnes (mean values based on market data) PFA S use PFA S emissions 2020 8 984 2 489 2025 11 465 3 026 2030 14 633 4 055 2035 16 556 4 588 2040 18 732 5 190 2045 19 687 5 455 2050 20 691 5 733 2060 22 856 6 333 2070 25 248 6 996 The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during formulation and the use phase (thus not the waste stage). In Annex B.9.14.2. PFASs emissions from building materials/construction products were determined by applying standard environmental release categories to the range of tonnages (low and high) provided by stakeholders (Annex A.3.14.2.). Emission estimates represent low and high worst case emissions during formulation, application (for mixtures only) and usephase of building material/construction products containing PFASs. The results must be considered as a first tentative estimation with considerable uncertainty because many calculation parameters are based on assumptions with limited underpinning facts. In Annex B.9.14.2. emission estimates of building material/construction products is divided between articles and mixtures. Mixtures (such as architectural paints and coatings, coil coating, wind turbine blade coating and top coating for composite architectural membranes) account for approximately 98% of the emissions and application of mixtures accounting for 90% of the total emissions. The in-use phase for both articles and mixtures, as well as the application phase for mixtures can be split between indoor and outdoor use. Emissions is in the model dominated by the outdoor use and especially by application of mixtures outdoor, as the inuse phase outdoor for articles and mixtures only account for around 1% and 2%, respectively. Primary degradation for the in-use phase outdoor is likely to be through a combination of weathering and abrasion depending on the specific application. For emissions associated with indoor applications, the rate of emission is likely heavily influenced by the specif ic application. For example, architectural membranes used in roof spaces may lie undisturbed many months or years, with a single significant release during maintenance or removal. Conversely, coatings used on flooring may emit on a steady basis over the working life due to abrasion from footfall and cleaning activities. This makes applying emission factors at a high-level (i.e., all indoor articles) challenging. It also means that use itself can be both within public buildings and domestic properties, which also affects the potential rates of emission, pathways, and exposure. No further efforts have been made to try and disaggregate between artic les used in public and private buildings. In terms of substance groups, emission calculations in Annex B.9.14. 2 is dominated by polymeric PFASs (fluoropolymers) that account for approximately 94% whereas nonpolymeric PFASs/PFAAs and precursors (including side-chain fluorinated polymers) only account for approximately 6%. Figure E.23 shows expected PFASs use and emissions (all PFASs) for the construction sector as a whole, based on available market data (Annex A.3.14.2.) and assumptions on growth rates shown in Table E.138. Growth rates adopted for PFAS use were also applied to emission projec t ions. 427 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.23 Expected PFASs use and emissions in EEA under the baseline in the building/construction sector (mean values) [tonnes]. Based on the assumptions made about market trends for PFAS use in construction products, emissions can be expected to increase over time. Under the baseline, PFAS emissions will likely double between 2020 and 2050. E.2.13.2. Alternatives E.2.13.2.1. Description of the use and function of the restricted substance(s) Uses of PFASs in building material/construction products is described in Annex A.3.14. In this sec tion further descriptions are given for uses were evidence on alternatives and/or ec onomic impact has been provided or identified. For other uses, including some of the uses in Annex A.3.14. no evidence on alternatives and/or economic impacts has been provided or identified and there is, as a result, no evidence indicating that a derogation might be needed. These uses will not be discussed any further. Wires and cables used in the building and construction sector are included under the sections on elec tronic and semic onductors (see section E.2.11). The same goes for the foam blowing agents which is included under Heat ing, ventilation, air conditioning and refrigeration (HVACR) and other applic ations of fluorinated gases (see section E.2.8). The section is divided in to three sub-sections: Fluoropolymer and PFPEs, side-chain fluorinated polymers and non-polymeric PFASs. E.2.13.2.2. Fluoropolymers and PFPEs - description of function and use in building materials/construction products Architectural c oatings and paints, coil coating and coating of wind turbine blades A c oating is a c overing that is applied in a thin film to the surfac e of an artic le (substrate) to add specific function(s) to the substrate. Paints (and lacquers) are coatings that are decorative and that can also add function(s) to the substrate. In fluoropolymer coatings, the fluoropolymer is usually considered to be part of the binder. Many fluoropolymer top coatings in protective paint systems are nearly pure fluoropolymers, whereas primers and one-coats are generally blends of high temperature organic polymers or inorganic polymers with fluoropolymers. In coating and paint for building material/construction products, here considered as architectural paint and coating (painting/coating the exteriors and interiors of buildings and other building structures like e.g. bridges), coil coating (coated steel and 428 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) aluminum coils, that can be formed into exterior building panels and roofs) and wind turbine blade coating, fluoropolymer binders can be used for protection against harsh (environmental) c onditions and provides chemic al/corrosion resistance, durability, weather and UV resistance. Especially for the interior use of architectural paint and coating under harsh conditions (e.g. industrial use), fluoropolymers can also provide thermal stability and flame resistance. According to OECD (2022) the most commonly used fluoropolymer (binders) in coating and paint for building material/construction products is PVDF, ECTFE, FEVE, PTFE and FEP. Functionalised PFPEs can also be used as binders in paints and coatings Micro-powder PTFE can be used as additives in coating in low levels to impart fluoropolymer like properties such as reduced wear rate and friction. Architectural membranes (composite membranes with top coating) and architectural membranes (pure fluoropolymers) Architectural membranes/structural membranes/tensile fabrics are used for light weight roofing, facades and building envelops. Fluoropolymers used for this application and are either used as a c omposite or as a pure fluoropolymer membrane. Composites c an e.g. be fiberglass fabric with a topcoat of e.g. PTFE, PFA, FEP or PVDF. Another example is polyester coated with PVC (base coat) and a topcoat of e.g. PVDF or PTFE. Such top coatings are mixtures comparable to the coatings and paints described above. Pure fluoropolymer membranes can be ePTFE, PVDF or ETFE foil/film. Fluoropolymers are used especially for protection against harsh environmental conditions (weathering and UV radiation). They are also durable, chemical resistant, water- and oil/dirt repellant and require low maintenance. In general, they have a long service life. ETFE foil/film for greenhouses Pure ETFE foil/film can be used for covering greenhouses to make them self -cleaning, durable, weather and chemical resistant while allowing the full spectrum of solar light to pass through. PTFE thread sealing tape PTFE tape (100% PTFE film) is self- welding and used to seal applications e.g. pipe connections for liquids and gases. PTFE tapes have high tensile strength and by using PTFE tape the sealings becomes durable, water- and heat resistant. PTFE tape can also be used in the manufacturing and installation of windows, doors etc. Polymeric PFASs used as processing aids for production of non-PFAS polymers/plastics PFAS polymer processing aids (PPAs) (fluoroelastomers, PVDF (and also PFPEs)) are added to resins of non-PFAS thermoplastics (e.g. PE and PP), thermosetting plastics and elastomers used as building materials/construction products. The PPAs is added to eliminate of melt fracture (shark-skin effect), improve wear and abrasion resistance, reduce coefficients of friction (COF), make surfaces easier to clean, increase melt tension and strength, and improve processability and mold release, reduce of die build-up, improve of the surface finish with high gloss levels, increase production start-up, reduce pressure, increase output at constant die pressure and temperature, lower energy consumption. Bridge and building bearings Fluoropolymers (PTFE) are used in bridges and building bearings to lower friction. This allows one end of the bridge to slide when the bridge expands or shrinks due to temperature differenc es. In buildings sliding allows movement in c ase of earthquakes. Window frames 429 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluoropolymers (PVDF) films are used for laminating PVC and high-pressure laminate (HPL) window frames. PVDF is added because it is transparent and for protecting the PVC frame against chemicals, weathering and UV-radiation. E.2.13.2.3. Side-chain fluorinated polymers - description of function and use in building materials/construction products Side-chain fluorinated polymers used for surface protection/sealants PFAS-containing sealants are, as described in Annex A.3.14.1, used to create a water and soil/oil-resistant barrier that protects surfaces of building materials/construction products from stains, mold and physic al damage. Ac rylate-, urethane- and silane/siloxane-based sidechain fluorinated polymers can be used for sealing of porous materials such as stone, grout, unglazed tile, and concrete in e.g. kitchen and bathroom tilework, and stone, tile or concrete flooring. Also used in exterior applications such as patios, staircases, foundatio ns, parking garages, bridges, old buildings, c hurc hes etc. The same substances can (in slightly different formulations) be used for surface protection of non-absorbing subsrates (e.g. glass, enamel, c eramic s, metal, stone, c oncrete and linoleum, laminated plastic floor). E.2.13.2.4. Non-polymeric PFASs - description of function and use in building materials/construction products Fluorosurfactants as wetting/levelling agents in e.g. c oating, paints and adhesives Non-polymeric PFASs (fluorosurfactants) are used at low levels in the formulation of building/construction products such as coatings, paints, lacquers and adhesives. The fluorosurfactants lower the surface tension, improve wetting, levelling and anti-blocking in (especially water-based) paints and coatings. Defoaming and avoidance of surface defects such as cratering and orange peel is also mentioned as important surfactant properties. For adhesives the fluorosurfactants also enhance the penetration in the substrate and thereby increase adhesion strength. Some types of fluorosurfactants also provide water and oil/dirt repellenc y. Non-polymeric PFAS as processing aids: Non-polymeric PFASs are used as processing aids for production of certain types of non-PFAS construction products (articles). The processing aids are not part of the final product (or do not serve a function in the final product). Window film manufacturing Fluorosurfactants are used as coating additives and dispersants to create low resurface energy in window film manufacturing E.2.13.2.5. Availability of alternatives All alternatives considered below have been identified because they are currently marketed produc ts. Very limited spec ific quantitative data on the relative levels of productions, sales or use of alternatives have been provided in this assessment, however. E.2.13.2.6. Identification of potential alternative substances and techniques fulfilling the function This section is divided into three sections: Fluoropolymer and PFPEs, side -chain fluorinated polymers and non-polymeric PFASs. 430 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.13.2.7. Alternatives to fluoropolymers and PFPEs in building/construction mixtures and articles Arc hitectural c oatings and paints According to OECD (2022), the overall global market penetration for PFASs in architectural protec tive c oatings is approximately 1%. In arc hitectural paints and c oatings fluoropolymers are used as top coating for protection against harsh (environmental) conditions and provides chemical/corrosion resistance, durability, weather and UV resistance as well as thermal stability and flame resistance OECD (2022). Similar technical functions are described for func tionalised PFPEs (e.g. urethane ac rylate or amido-silane PFPEs) (Solvay, 2013; Wang et al., 2020). In the 2nd stakeholder consultation, the same technical properties of fluoropolymers as mentioned above and the long service life of especially PVDF and FEVE-based (30 to 50+ years mentioned) coatings were highlighted. Corrosion resistance of non-PFASs-based architectural paints and coatings: Fluoropolymer paints and coatings are said to be corrosion-resistant and can withstand harsh weather c onditions such as on bridges near oc eans where the salt c ontent is high. Ac c ording to OECD (2022) epoxy and polyurethane coatings both provide suitable corrosion resistance due to their stability to various c hemic als. No further information was rec eived on this in the CfE or the 2nd stakeholder consultation. It should be noticed that non-PFASs architectural paints and coating systems are already widely used on bridges across the world (Hempel, 2022a). As an example, Hempadur Avantguard epoxy primer series contains zinc and hollow glass spheres for corrosion resistance (Hempel, 2022c). Durability, weather and UV resistance of non-PFASs-based arc hitectural paints and c oatings: According to OECD (2022) e.g. polyurethane, polyester, polysiloxane, and epoxy coatings are durable and weather resistant. The report also compares efficacy and performance of these c oatings c ompared to PVDF and FEVE-based c oatings used as topcoat. Specifically, the gloss retention (a measure of degradation by UV light) was compared. The conclusion was that FEVE performed slightly better than PVDF and that both these fluoropolymer-based c oatings perform much better (have a higher gloss retention) than acrylic urethane (a type of polyurethane), polyester and polysiloxane. OECD (2022) also refers to a case example where painting of a bridge with a fluoropolymer-based paint (FEVE) is compared to a non-PFAS alternative (polyurethane). For the total c ost c alculations over 100 years, a lifetime of 20-25 years for FEVE-paint seems to be assumed, whereas it is only 5-10 years for the polyurethane paint. The OECD (2022) report states that epoxy coatings degrade in sunlight. It should be noted that the Hempadur Avantguard epoxy primers mentioned above are used in a coating system (often 3-coat system) and that the topcoat is often based on polyurethane. According to Hempel different qualities of polyurethane exist (Hempel, 2022b). Hempel offers paint systems that do not contain fluoropolymers, with a very high estimated service life (>25 years) even at high humidity, aggressive atmosphere and inshore areas of high salinity (Hempel, 2020). In the 2nd stakeholder consultation, a product called Tetrashield (a polyurethane top coating) was also mentioned, and it is stated by the stakeholder that "preliminary studies showcase that Tetrashield resins technically perform comparably to FEVE". Tetrashield is also mentioned in OECD (2022). According to OECD (2022) non-fluoropolymer alternatives used for thermal stability include epoxy-based c oatings. These can resist temperatures up to 200 C, which is lower than fluoropolymer c oatings, which c an resist temperatures up to 230 C (OECD, 2022). However, ac c ording to the produc t data sheet on Hempel Silic one Aluminium 56914 this produc t, that is based on aluminium pigmented polysiloxane, is heat resistant and has a service 431 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) temperature up to 600 C (Hempel, 2022e). The product is intended for painting of hot pipelines, exhaust pipes, smokestacks and other hot surfaces. Non-fluoropolymer alternatives also exist for fire protection. E.g. Hempafire Pro 400 for protection of structural steel against cellulosic fires (Hempel, 2022d) or Hempafire XTR 100 for protection of structural steel against hydrocarbon passive fire (Hempel, 2022g). In the 2nd stakeholder c onsultation, no stakeholders mentioned the use of mic ro-powder PTFE (PTFE wax) as an additive in alternatives to architectural paints and coatings based on fluoropolymer binders. The Hempel produc ts mentioned in this sec tion do not c ontain mic ropowder PTFE (Hempel, 2022b). According to OECD (2022) household paints and coating products are not based on fluoropolymer binders. Coil coating According to OECD (2022), the PFAS-based coil coating market penetration is 3-12% in EU and for paint market penetration is 8% in EU, Asia and North and South America. In the 2nd stakeholder consultation, it is stated that coil coatings can be formulated to give the metal a very attractive surface finish and the coated metals have a long durability (guaranteed for 25 years). One stakeholder state that durability is >30 years and another states that it is >40 years. In the OECD (2022) report it says that the durability of coils coated with PVDF is 25-30 years. In the 2nd stakeholder consultation, it is further stated that the ease of removing and separating pre-painted metal cladding (including PVDF/FEVE coated) from other building waste facilitates very high rates of recycling 89% and reuse 10% with only 1% going to landfill. In the 2nd stakeholder c onsultation, it is stated that general alternatives identified in the CfE and targeted stakeholder consultation for paints and coatings (polyurethane, polyester powder, wax emulsions, silicones/silanes/polysiloxanes, and hydrocarbon polymer tec hnologies) is not suitable replac ements for PVDF c oil c oatings, as they are not as durable (have the same lifetime). According to stakeholder input in OECD (2022) polyester melamine (durability 15 years) is the best alternative to PVDF (durability 25-30 years). No further information was given in the report. On their webpage Wanzhi steel115 compares binders in Polyester, Silicone Modified Polyester (SMP) and High Durability Polyester (HDP) topcoats for c oil c oatings to PVDF binders in terms of hardness, strength, weather resistance corrosion resistance, cost and service life. Polyester has the lowest cost and lowest service life (7-8 years) since UV and corrosion resistance is poor compared to PVDF. SMP and HDP is more expensive than polyester but costs less than PVDF. SMP and HDP is comparable in terms of hardness, strength, weather resistance c orrosion resist ance to PVDF. However, servic e life of SMP (10-12 years) and HDP (up to 15 years) is shorter than the 20-25 years mentioned for PVDF. Other alternatives are available on the EEA market. E.g. one product described in Mder (2021) who claims that their ultra-high durable polyester-based coil coating product Durovern UHD "meets the most stringent requirements in metal construction and can be considered as an alternative to standards PVDF". In the 2nd stakeholder consultation, it was also commented that PTFE waxes (micro-powder PTFE) is used in non-PFAS paint systems for coil coating e.g. polyester and polyurethane paint 115 https://wzppgi.com/what-is-the-best-paint-for-steel/, date of access: 2023-01-13. 432 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) to optimise the formulations for application on the coil coating line and improve the scratch resistance of the end products. Without mentioning specific alternatives, it is stated in one reply to the 2nd stakeholder c onsultation, that: "some alternatives for the PTFE waxes exist; they do not allow for like-for-like substitution. Their performance in forming processes and resistance against scratches will be affected. The use of these alternatives in coil coating paints would require extensive assessments to validate their performance." No other information on alternatives for the use of mic ro-powder PTFE as an additive in c oil coating mixtures was identified. Coating of wind turbine blades Fluoropolymers (FEVE and ETFE) are as described in Annex A.3.14.1 used for protection of wind turbine blades under harsh conditions. The main function is to resist environmental damage such as weathering and rain erosion of the blades. According to Hempel the impact from rain may cause significant coating erosion or even composite damage. In severe cases the erosion may lead to a 2-3% drop in annual energy production (Hempel, 2022f). The CfE and 2nd stakeholder consultation did not provide any information on surface protection of wind turbine blades. Neither on the use of fluoropolymers as binders or on alternative binders. In OECD (2022) epoxy and polyurethane coatings have been identified as alternatives to PFAS formulated coatings. However, three examples given in the report may not be an alternative for wind turbine blades as one of the products seems to contain PFASs and the Hempel produc ts Hempadur 4774D and Hempathane HS 5561 B seems to be for steel c onstructions (including wind turbine towers). Since OECD (2022) did not provide useful information on alternatives, a quick internet search was conducted in order to find out if any non-PFAS coatings for wind turbine blades are available in the EEA market. This search showed that Hempel in 2022 launched non-PFAS top coating based on polyaspartic ester and titanium dioxide for wind turbine blades called Hempablade Edge 171. At the Hempel webpage it is stated that the coating has exceptional rain erosion protection performance and strong UV resistance (Hempel, 2022f). No data have been identified that compares the efficacy of Hempablade Edge 171 with fluoropolymer-based coating for wind turbine blades. In personal communication with Hempel (Hempel, 2022b) they said that to the best of their knowledge fluoropolymers is currently not used for wind turbine blade coating in Denmark. Similar information is available in the Danish press. In a quote the wind turbine producer Siemens Gamesa said: "PFAS is not used in our products" (translated from Danish) (TV2, 2022) and the branch organisation Green Power Denmark is quoted for saying: "We do not have information that shows that PFAS is used in Danish wind turbines" (translated from Danish) (Rnberg, 2022). This information, involving some of the largest wind turbine producers in the world, indicates that non-fluoropolymer-based coating for wind turbine blades is used in EEA. Architectural membranes (composite membranes with top coating) and architectural membranes (pure fluoropolymers) In this section alternatives for composite architectural membranes with a fluoropolymer based top coating and pure fluoropolymer architectural membranes is described together, even though, top coatings for composite membranes are considered to be mixtures and pure fluoropolymer membranes are considered to be articles. Llorens (2015) describes typically used fabrics and coated fabrics for composite architectural 433 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) membranes/structural membranes/tensile fabrics and their technical performance: Cotton and other natural fibres:High UV resistance but in general low technical performance. Feasible only for light -duty applications (service life of 4-5 years). Polyamide (PA or nylon): High strength, stiffness and tenacity and low weight, but not dimensionally stable when wet, poor UV resistance and stretches considerably (therefore not commonly used in architecture). Polyester: Very commonly used in architecture. Good tensile strength and elasticity, but mechanical properties degrade with UV light, and it is subject to ageing. Can be coated or laminated with PVC to provide UV protection. A top coating is commonly applied on top of polyester/PVC. Both fluoropolymer and non-fluoropolymer based top coatings can be used. Fluoropolymers (e.g. PVDF) provide (further) UV resistance, durability and water/dirt resistance. The technical performance of the nonfluoropolymer top coatings is: - Acrylic lacquer: Poor UV resistance - PVF film (fluoropolymer not in sc ope of this restric tion proposal): UV resistance, durability and water/dirt resistance - Titanium dioxide (TiO2): UV resistance, hydrophobic (self-cleaning) and high light reflectance Fiberglass: Very commonly used in architecture. High tensile strength (although decreasing when wet) and long lifetime, but brittle and low elastic strain. Can be coated with silicone to enhance properties such as UV resistance and water protection (not soil resistance). The translucency for silic one c oated fiberglass c an be as high as 25%. Aramid (Kevlar, Twaron): High strength (except compressive strength), low weight, good abrasion/chemical/thermal resistance. Can degrade slowly from UV exposure. Can be coated with PVC or silicone to provide UV protection (only used when other materials are inadequate). Carbon fibers: Less detail provided than on the other materials. Used for high-tech produc ts, low expansion c oefficient, non-combustible. Llorens (2015) also compared the technical performance of some of the above described materials with fluoropolymers (PTFE and PVDF). This is show in Table E.140 below that is a remake of table 3.2 in Llorens (2015). Table E.140. Comparison of fabric performance (table 3.2 in Llorens (2015)). Po ly e s te r Fiberglass fabric PVDF fabric C oating PVC PVC PVC PVC PTFE Uncoat Si ed PVDF Top coating Weldable PVDF merging Nonweldable PVDF merging TiO2 merging C rosslin k PVDF Expected lifetime 15 years >20 years >25 years >25 years >20 years >30 years >25 years Soiling protection Average Good Good Good Very good Average Very good Very good 434 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Po ly e s te r Fiberglass fabric PVDF fabric Tranparency 5-15% 8-14% 8-20% 25-30% 2040% 35% Fire behaviour Flame retardant Flame retardan t Flame retardan t Flame retardan t Noncombus tible Flame retardant Noncombu stible Noncombus tible Tolerance to folding Very good Good Very Very n.a. Little Medium good good Table E.140 does not include performance of polyester/PVC with PVF top coating (film). According to Seaman Corporation (2020) it has a service life of >20 years and resist UV radiation better than PVDF. On other parameters (durability, fire resistance etc.) performance seems to be comparable to PVDF. Questions on the use of non-fluoropolymer based architectural membrane fiber materials mentioned above, cotton and other natural fibers, polyamide, polyester and polyester/PVC, fiberglass and fiberglass/silicone, aramid, aramid/PVC and aramid/silicone, w as included in the 2nd stakeholder consultation. In response to the 2nd stakeholder consultation stakeholders generally stated that none of the mentioned alternatives can provide the unique combination of properties provided by fluoropolymers (thermal resistance, c hemic al resistance, exceptional anti-stick performance, UV- and whether resistance, light weight, shockproof and flame retardancy) and consequently, it lowers significantly environmental impacts over the service life of the membrane (50 years). For the moment, there are no alternatives offering such requested performances. Stakeholders further commented that natural fibers, polyester, nylon and aramid fibers are all degraded by ultraviolet light from outdoor exposure and that fiberglass, aramid, c arbon and fluoropolymer fabrics are substrates to be coated by PTFE or PFA - coating with PVC will not allow for chemical resistance. One stakeholder stated that they, during the last 20 years, have been working in R&D on silic one c oating but without any success to provide similar performanc e as fluoropolymers. Regarding fire safety, one responded to the 2nd stakeholder consultation commented, that cotton and other natural fibers is very flammable whereas another stakeholder commented that c otton, natural fibers, polyester and polyamide do not provide fire resistanc e equivalent to PTFE coated glass fiber fabrics. One stakeholder highlighted that the mono-material solutions ETFE foil/film (100% PFAS), that is frequently used in membrane applic ations for roofs and facades, is fully rec yclable and have a long service life (>40 years). Overall, the responses from the 2nd stakeholder c onsultation are in line with Llorens (2015), however, no specific comments were received f or the materials that has performance characteristics that is comparable to fluoropolymer coated fabrics - polyester/PVC with PVF or TiO2 containing top coating and silicone coated fiberglass fabric. No other alternatives were identified via the 2nd stakeholder consultation. ETFE film/foil for greenhouses One stakeholder mentioned in the 2nd stakeholder c onsultation that ETFE foil/film is used for greenhouses as it is light weight, break/shockproof, flame retardant and anti-stick 435 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) performance (leading to easy cleaning). The stakeholder did not mention any alternatives. However, glass and polyethylene foils are used for the same application in greenhouses. PTFE thread sealing tape Four stakeholders gave input on the use of PTFE tape in the 2nd stakeholder c onsultation. In general, the stakeholders agreed that there are no useful alternatives available that meet the requirement of natural gas fittings and connections and aggressive media such as oxygen and nitric acid). One stakeholder commented that tow, as a potential alternative to PTFE thread sealing tape, is now heavily restricted due to microbial development. Another stakeholder mentioned that hemp sealant will dry out in natural gas service and causes leaks which is a safety risk. Ac c ording to Fernndez et al. (2021), silic one- based thread-seal tapes are available but less c ommon. However, it does not seem like the silic one-based produc ts referred to is ac tually thread sealing tape (like PTFE tape), as LeakSeal Self-Fusing Tape is referred to as: "silicone repair tape that is used for fixing leaky pipes and hoses". PTFE can also be used as a temporary short-term solution to help seal plumbing leaks until further work c an be c arried out. LeakSeal seems to be an alternative for this use. Sharkbite Silicone Wrap is used for "brass fittings that requires the fitting be wrapped in an impermeable material to protect the connection from ground contaminants" and does not seem to be an alternative for PTFE thread sealing tape. Fernndez et al. (2021) also states that "liquid/paste pipe thread sealants without PFAS are available" and that "such products can be stronger and more durable alternatives to PTFE tape and are thus preferred by plumbers for permanent seals". It should, though, be noted that PTFE tape is used for non- permanent seals. Fernndez et al. (2021) refers to a product called Hercules Megaloc that is described as "a multi-purpose thread sealant made with DuPontTM Kevlar for use on metals, inc luding steel, stainless steel, brass, copper, aluminium and plastic.". According to Fernndez et al. (2021) PTFE tape is not only used for sealing applications for e.g. pipe connections, it can also be used in the manufacturing and installation of windows, doors, vents, skylights and other structural openings. The report states "during manufacturing, fluorinated tape is employed to hold PVC frames together and prevent physical deformities during welding". No information on these uses of PTFE tape was received in CfE or 2nd stakeholder consultation. Therefore, for the use of PTFE tape for manufacturing and installation of windows, doors etc. no evidence has been provided or identified to indicate that a derogation is needed. Polymeric PFASs used as processing aids (PPAs) for production of non-PFAS polymers/plastics Polymeric PFASs are used as processing aids (PPAs) in the production of non-PFAS polymers/plastics e.g. such as polyethylene and polypropylene. As the processing aid is added to the resin, it is incorporated into the final building material/construction product. Seven stakeholders gave input on this use in the 2nd stakeholder c onsultation. It is, though, not clear if all uses of non-PFAS polymers/plastics referred to by stakeholders are building material/construction products or industrial equipment like films, pipes and tubing. The types of polymer/plastic mentioned by stakeholders are mostly thermoplastics but also a few that are (or could be, depending on the exact type) thermosets. As described in Annex E.2.3.4.1, on technical feasibility of alternatives to PFASs in thermoplastic packaging film for food packaging, boron nitride is identified as an alternative processing aid. In this section it is described that boron nitride powder has been shown to be effective in the produc tion of films inc luding polyethylene and m-LLDPE films. One stakeholder in the 2nd stakeholder consultation stated that in pipe applications, hard 436 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) foreign particles like boron nitride can result in premature pipe failure due to stress concentrations. No other stakeholders commented on the use of boron nitride. Another stakeholder in the 2nd stakeholder consultation replied that siloxanes might be an alternative. It is, though, not specified in the reply which type of polymer/plastics were siloxanes can be used as processing aids instead of polymeric PFASs. No ot her stakeholders commented on the use of siloxane, but two stakeholders stated that there are no commercially available alternatives that meet the technical requirements. DuPont manufactures the thermoplastics additive series Multibase TM. According to the datasheet (DuPont, 2021) these siloxane-based additives can be used to enhance polymer processing of thermoplastics suc h as polyolefins, thermoplastic polyurethanes, styrenics, polyester, polycarbonate, polyamide and polyoxymethylene. The described properties of using MultibaseTM, e.g. improved processing and flow, mold release, faster throughput, internal lubrication, improved dispersion of fillers, reduced energy demand, improved scratch resistance, surface properties and greater abrasion and mar resistance, is c omparable to the properties described from using polymeric PFASs as PPAs. Bridge and building bearings One stakeholder gave input on the use of PTFE in bridge and building bearings in the 2nd stakeholder consultation. The stakeholder stated that the only known alternative are steel rollers, which require significantly more space in the constructions. The Dossier Submitters identified no other information on this use. Window frames (laminated with fluoropolymers) One stakeholder gave input on the use of PVDF film for laminating PVC and high-pressure laminate (HPL) window frames in the 2nd stakeholder consultation. T he stakeholder states that: "the polymer needs to be transparent and must be UV-stable for >20 years and needs to provide a high c hemic al resistance" and that to their knowledge there is no alternative. As no other stakeholders gave input on this use, the Dossier Submitters do not know if other producers of PVC and HPL window frames also use PVDF (or other fluoropolymers) for laminating the frames. According to a market analysis (MarketResearch, 2020) PVC accounted for 31% of the global market window and door frames market in 2019. Wood, metal and other (e.g. fiberglass, glass and composite) accounted for the remaining part. E.2.13.2.8. Alternatives to side-chain fluorinated polymers in building/construction products Side-chain fluorinated polymers used for surface protection/sealants Side-chain fluorinated polymers are used for making surfaces resistant to water- and soil/oil. According to the 2nd stakeholder consultation surfaces can be protected without c hanging the natural appearance of the substrate. Other functionalities mentioned in the 2nd stakeholder c onsultation are UV durability and breathability. It is further stated that that these substances can be used for anti-graffiti applications. Without mentioning any alternatives it was stated in the 2nd stakeholder consultation that alternatives do not provide the same combination of effects. It is not clear from the three responses received in the 2nd stakeholder consultation on the use of side-chain fluorinated polymers for building material/construction products precisely which types of side-chain fluorinated polymers they refer to in their replies. However, based on these stakeholders' webpages it cannot be excluded that they all refer to side -chain fluorinated polymers based on 6:2 fluorotelomer chemistry (with different types of reactive groups) as they have raw materials with these substances in their portfolio. 437 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 6:2 fluorotelomers are c onsidered to be PFHxA-related substances. According to the RAC and SEAC Opinion on the Annex XV dossier proposing a restric tion on "Undecafluorohexanoic acid (PFHxA), its salts and related substances" (ECHA, 2021a), which is currently under deliberation, no derogation for building materials and construction products is suggested. If the EU commission follows this opinion, it will be the primary reason for substituting 6:2 fluorotelomers in building material/construction products. The non-fluoropolymer alternatives described under architectural paints and coatings, epoxy, polyester, polyurethane etc. does also provide protection of surfaces and can therefore for some applic ations be seen as alternatives to side-chain fluorinated polymers. According to ECHA (2017) non-PFAS side-chain polymers based on silane/siloxane chemistry are commercially available for building protection. In this background report properties of PFAS side-chain polymers based on silane/siloxane is compared to non-PFAS side-chain polymers based on silane/siloxane chemistry. The comparison is from a 2004 technical datasheet from Bayer Silicones who manufactured/formulated some of the alternatives. In the background report it says: "The mixtures containing polyfluorosilanes, are according to the comparison, outstanding as concern stain resistance on concrete, terracotta and claybrick, but have less water repellence than some of the alternatives and are relative expensive. The differences are reflected in the fact that the mixtures containing polyfluorosilane are mainly marketed for applications where oil and stain resistance (including anti-graffiti) is required. Mixtures based on silicones/siloxanes (without fluor) are efficient in water repellence and are today the mixture of choice for applications where water repellence is the main propert y required. For oil-repellence, mixtures based on PFAS-technology (with silane or carbon bac kbone) are the most efficient.". SiSiB Silicones via their webpage offers a range of non-PFAS side-chain polymers based on silane/siloxane chemistry for protection of building material/construction products such as concrete, bricks, ceramics, roof tiles, perlite, vermiculite, gypsum, sand-lime bricks, natural sandstone, mineral plasters etc. The actual formulation (c rme based, water based or solvent based) determines the level of penetration into the substrate. According to SiSiB Silicones, silanes are smaller than the pores of mineral building materials and when applied they react with themselves (e.g. via a sol-gel reaction) and hydroxyl groups within the substrate to create (sidechain) siloxane network. This formation of strong chemical bonds provides the durability c haracteristic of silic one treatments. When cured, external liquid water is kept from entering the pores, while water vapour generated from within the structure can still escape. The structure remains breathable. Because they are inside the pores, water repellent treatments are not affected by UV radiation (SiSiB, 2015). Other companies e.g. Dow Corning and Evonik produce similar products as SiSiB Silicones. Side-chain fluorinated polymers can be used for permanent anti-graffiti coating (coating that usually only has to be applied once). Other permanent anti-graffiti coating on the market are nanoparticles(silica)-based coating, silicon, acrylic-siloxane copolymers, and polyurethanes (including polyurethane acrylate) (Amrutkar et al., 2022). Semi-permanent anti-graffiti coating is also on the market. Semi-permanent anti-graffiti coating is typically based on acrylics or epoxies and can sustain two or three cleaning cycles, after which reapplication is required. Sacrificial anti-graffiti coating (removed during the graffiti removal) that includes waxes, polysaccharides, and polysiloxane have to be re-applied after the cleaning process (Amrutkar et al., 2022). In the paper by Amrutkar et al. (2022) a number of commercially available permanent, semi-permanent and sacrificial anti- graffiti c oatings is identified. Some surface protection products are also available as DIY products for consumers . E.2.13.2.9. Alternatives to non-polymeric PFASs in building/construction products Fluorosurfactants as wetting/levelling agents in e.g. c oating, paints and adhesives Of the six stakeholders providing answers to the 2nd stakeholder consultation three specifically 438 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) mentioned C6, fluorotelomer surfactants and/or C6 fluorotelomers (two manufactures of PFASs and one downstream user). One stakeholder (manufacturer) specifically referred to C4 side-chain polymeric fluorosurfactants. The remaining two stakeholders (downstream users) who responded to the 2nd stakeholder consultation, did not specify the type of fluorosurfactant that they referred to in their responses. To the question in the 2nd stakeholder consultation "Are in your view the listed non-PFAS alternatives technically feasible in your produc t(s)/processes?" the following responses were rec eived: The two PFAS manufactures who referred to C6, fluorotelomer surfactants and/or C6 fluorotelomers: "Fluorotelomer surfactants reduce surface tension while providing excellent wetting and leveling, oil repellency and chemical resistance. No alternative has this combination." and "Different potential alternatives have been tested but do not provide the same level of combined water, oil and stain repellency than C6. Downstream users have reported that only C6 fluorotelomers c an provide a high level of performance to the c onstruction products and a low environmental impact." The downstream user referring to C6, fluorotelomer surfactants and/or C6 fluorotelomers: "The PFAS substances currently used have unique technical properties, however being expensive. Equivalent PFAS-free alternatives still remain to be developed by our raw materials suppliers and would thereafter need to be thoroughly tested by our R&D team on a product-by-product basis, all the way from manufacturing to application in the customer specific production line. There is no readily available alternative that can easily subst itute the fluorinated surfactants, so it will take considerable time for the suppliers to first develop the alternatives and then for us, being the coating formulator, to test and evaluate the alternatives in application uses." The PFAS manufactures referring to C4 side-chain polymeric fluorosurfactants : "silicone or hydrocarbon alternatives do not deliver reduction in surface tension required for wetting and leveling of hard to coat surfaces. Technically feasible alternatives are also PFAS-c ontaining additives" The two downstream users that did not spec ify the type of fluorosurfactants they referred to: "No, reason being that fluorinated material has outstanding properties which allows them to use in small quantities. Alternatives need to be used in much higher concentration consequently leading to jeopardizing other paint properties" and "To my knowledge, there is no alternative chemistry that can provide same level of performances as surfactants (extremely low surface tension/high c ontact angle), and resistance/repellency to water/oil/grease all together" The Alliance for Telomer Chemistry Stewardship (ATCS) in a response to ECHAs consultation on the restriction proposal of Undecafluorohexanoic acid (PFHxA), its salts and related substances, states that: "Paints and varnishes in which C6 fluorosurfactants are used as additives are mainly intended for building materials. These products must display, amongst other properties, high durability. Downstream users have reported that alternatives based on C4 fluorotelomers are available, but that they display a lower performance and raise similar concerns regarding persistence." (ATCS, 2020). Furthermore, in the RAC and SEAC Opinion on the Annex XV dossier proposing a restriction on Undecafluorohexanoic acid (PFHxA), its salts and related substances (ECHA, 2021a), which is currently under deliberation, no derogation for building material/construction products is suggested. If the EU commission follows this opinion, it will be t he primary reason for substituting C6 fluorotelomer surfactants in building material/construction products. The stakeholder that referred to C4 side-chain polymeric fluorosurfactants in the 2nd stakeholder consultation in December 2022 announced that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to disc ontinue use of PFAS ac ross our product portfolio by the end of 2025" (3M, 2022). This announcement can very well be the primary reason for substituting C4 side-chain polymeric fluorosurfactants in building material/construction products. 439 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) No manufac turers of non- PFAS surfactants replied to the 2nd stakeholder c onsultation. Based on responses to the CfE and literature some non-PFAS wetting and levelling agents were identified. Evonik e.g. offers a range of non-PFAS wetting additives for paints and c oatings (Evonik, 2017a) under the trade names such as TEGO, SURFYNOL and DYNOLTM. These wetting and levelling agents are based both on siloxanes ( e.g. polyether siloxane copolymers, siloxane-based gemini surfactant or modified polyet her siloxane) and hydrocarbon surfactants (e.g. non-ionic organic surfactants). Another type of hydrocarbon surfac tants used as wetting and levelling agents that is c ommonly mentioned in the literature (e.g. in OECD (2022) is based on sulfosuccinates like Hydropalat (BASF, 2019). DYNOLTM is by the manufacture Evonik referred to as superwetting surfactants (Evonik, 2017b). The DYNOLTM products is available for a number of different applications related to building material/construction products e.g. adhesives, wood, plastics, industrial and arc hitectural c oatings. Surface tension behavior of the DYNOLTM surfac tants is c laimed to be comparable to fluorosurfactants (DYNOLTM has better dynamic surface tension behav ior whereas fluorosurfactants has slightly better equilibrium surface tension behavior) (Evonik, 2017b). The Evonik products can also be used on difficult to wet substrates like metal and glass (Evonik, 2022). Via their webpage Evonik also offers a Webinar called "Substrate wetting - the future beyond fluorosurfactants". It should also be noted that the solvent-based paints and coatings from Hempel mentioned above under architectural coatings and paints and coating of wind turbine blades does not c ontain fluorosurfactants as wetting and levelling agents. According to OECD (2022) domestic/household paints and coatings usually don't contain fluoropolymer binders, they may, however, c ontain fluorosurfactants as wetting and levelling agents. It should be noted that in the EEA there are Ecolabeled indoor household paints and varnishes are available, labelled with the Nordic Swan. According to the most recent criteria document such products must not contain PFASs (Nordic Ecolabelling, 2022). Non-polymeric PFASs as proc essing aids In the 2nd stakeholder consultation one stakeholder described the use of non-polymeric PFASs as processing aids for production of certain types of non-PFAS architectural membrane-like building material/c onstruction product. The proc essing aids are not part of the final product. The stakeholder described that no non-PFAS processing aids are available for the production of the specific use. However, the stakeholder describes the architectural membrane -like product as niche product in the market, which is dominated by alternatives. Another stakeholder in the 2nd stakeholder consultation described the use of non-polymeric PFASs (fluorosurfactants) as processing aids for production of acrylic foam tape. According to the stakeholder, the fluorosurfactant does not serve a function in the performanc e of the final product. The stakeholder further states that the fluorosurfactant is used because no alternatives have been identified that enables the performanc e needed in these foam tape applications. R&D to identify alternatives is ongoing. The stakeholder in December 2022 announced that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to discontinue use of PFAS across our product portfolio by the end of 2025" (3M, 2022). Therefore, the information on the use of fluorosurfactants as processing aids for production of ac rylic foam tape is c onsidered to be unc ertain, as manufac turing will either have to be stopped or the R&D process to identify, test and re-qualify alternatives is already at an advanced stage. Window film manufacturing In the 2nd stakeholder consultation one stakeholder stated that fluorosurfactants are used as coating additives and dispersants to create low resurface energy in window film manufac turing. According to the stakeholder there are no known PFAS-free alternatives that provide the same performance. No other producers of window film replied to the 2 nd 440 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) stakeholder consultation. The stakeholder that gave input on window film manufacturing in the 2nd stakeholder c onsultation in Dec ember 2022 announc ed that they will "Exit all PFAS manufac turing by the end of 2025" and "Work to discontinue use of PFAS across our product portfolio by the end of 2025" (3M, 2022). Therefore, the information on window film manufac turing is c onsidered to be unc ertain, as manufac turing will either have to be stopped or alternatives will have to be identified within a short timeframe. E.2.13.2.10. Risk reduction, technical and economic feasibility of alternatives This section is divided into three sections: Alternatives to fluoropolymer and PFPEs, alternatives to side-chain fluorinated polymers and alternatives to non-polymeric PFASs. The following section engaged with risk reduction, technical and economic feasibility of alternatives to PFAS-containing products within the c onstruction and building sector. The section has been divided into three sub-sections: Alternatives to fluoropolymer and PFPEs, alternatives to side-chain fluorinated polymers and alternatives to non-polymeric PFASs, as presented below each describing the technical and ec onomic feasibility of alternatives. The section covering technical and economic feasibility alternatives to fluoropolymer and PFPEs are divided into two sub-sections covering respectively alternatives to mixtures containing fluoropolymers or PFPEs, and alternatives to articles consisting of or containing fluoropolymers or PFPEs. The first section, on mixtures, includes architectural paints and coatings, coil coating, wind blade coating, and top coating for composite architectural membranes. The second section on articles, includes architectural membranes (pure fluoropolymers), ETFE film/foil for greenhouses, PFTE thread sealing tape, polymeric PFASs used as processing aids for production of non-PFAS polymers, bridge and building bearings and window frames (laminated with fluoropolymers). Alternatives to mixtures containing fluoropolymers or PFPEs in building material/construction produc t s Technical feasibility of alternatives Architectural paints and coatings, wind turbine blade coating, and coil coating As c an be seen from sec tion E.2.13.2.3 alternative binders for top c oatings are available for arc hitectural paints and coatings, coil c oating and wind turbine blade coating. For architectural paints and coatings and coil coating these alternatives dominate the market. In general alternative binders exist that provides technical properties that are comparable to the fluoropolymers, though, especially for architectural paints and coatings and coil coating stakeholders commented that service life of alternatives will be shorter under harsh (environmental) conditions. Micro-powder PTFE may be used in low levels as additives in coil coating mixtures of alternative-based (non-fluoropolymer) binders. No information on specific alternatives or performance has been provided or identified. Arc hitectural membranes (c omposite membranes with top c oating PVF is in use as top c oating on polyester/PVC c omposite arc hitectural membranes under the 441 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) brandnames suc h as Shelter-Rite with Tedlar film by Seaman Corporation, however, it is not clear to the Dossier Submitters, if PVF is marketed for this use in EEA. According to Seaman Corporation (2020) performance of polyester/PVC with PVF top coating is comparable to polyester/PVC with PVDF in terms of protection against harsh environmental condition (weathering and UV radiation) and it has a service life of >20 years. On other parameters suc h as durability, fire and c hemic al resistance, water- and oil/dirt repellenc y performance of PVF is at least as good or better than PVDF (Seaman Corporation, 2020). PVF as top coating is therefore considered to be technical feasible alternative for composite architectural membranes. However, to the best of the Dossier Submitters' knowledge PVF is still being manufactured with PFAS polymerization aids. By adding T iO2 on top of a polyester/PVC architectural membrane the photocatalytic effect of adding TiO2 can absorb natural sunlight (UV) and decompose organic matter, making the membrane self-cleaning (TiO2 can also be added to PVDF and PTFE). According to Llorens (2015) performance of polyester/PVC membranes with TiO2 is comparable with PVDF in terms of soiling and fire resistance. Llorens (2015) did not provide any information on expected service life and transparency. No other information on expected service life of polyester/PVC membranes with TiO2 was identified. Based on the available information polyester/PVC membranes with TiO2 is, therefore, considered to be a technical feasible alternative for composite architectural membranes, though, service life may be shorter than the 15 years for fluoropolymers as indicated by Llorens (2015) and stakeholders. It should be noted that such polyester/PVC membranes with TiO2 is available on the EEA market (Taiyo Europe, 2021). According to Llorens (2015) silicone is more flexible than PTFE which gives fiberglass fabric coated with silicone a higher tolerance to folding. Furthermore, fiberglass fabric coated with silicone can be made more translucent than fiberglass fabric coated with PTFE. Silicone is water resistant whereas dirt/soil resistance is by Llorens (2015) described as `average' compared to soil resistance of PTFE which is described as `very good'. It seems, though, like there is ongoing research on the use of TiO2 for self-cleaning properties - e.g. the use of the TiO2 in c ombination with silane/siloxane (Khan et al., 2020). Besides self-cleaning properties, laboratory test also showed promising results to maintain the superhydrophobic durability against mechanical abrasion, chemical exposure and UV radiation (Khan et al., 2020). For the key performance parameter `lifetime/service life', that is related to weathering and UV radiation, Llorens (2015) states that it is >25 years for fiberglass fabric coated with PTFE, and >20 years for fiberglass fabric coated with silicone. Stakeholders stated that fluoropolymer coating (PTFE, FEP, PVDF) on top of fiberglass fabric can reach 40-50 years durability and that silicone coating does not provide the same performanc e. It should, though, be noted that fiberglass fabric architectural membranes coated with silicone are available in EEA e.g. under the brand name Atex textile membranes (service life 20 years). Based on the available information fiberglass fabric coated with silicone is considered to be a tec hnical feasible alternative for fiberglass arc hitectural membranes, though, service life may be shorter than fluoropolymer coated fiberglass fabric and dirt/soil resistance will not be as good. Economic feasibility of alternatives Arc hitectural c oatings and paint In the CfE and 2nd stakeholder c onsultations stakeholder input has been rec eived, but it has not been possible to gain quantifiable, economic data on the use of fluoropolymer binders. In a reply to the 2nd stakeholder c onsultation, one stakeholder who uses fluoropolymer based architectural paint and coatings, emphasized that they have not been able to find an alternative to replace the fluoropolymer binders currently used, but they are aware of the high price of fluoropolymers. Though the use of fluoropolymer coatings is rather expensive, and likely significantly more expensive than potential alternatives, the use is, according to 442 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) stakeholders, still favored due to the chemical properties. Three stakeholders reasoned in reply to the 2nd stakeholder consultation how potential alternatives have lower lifetime, and requires higher concentrations of the alternative substances, more frequent reapplication, and/or an increased need for replacement of the coated elements. This would in the end lead to higher costs e.g. increased labour costs, despite the unit price of alternatives being c heaper. According to OECD (2022), the overall global market penetration for PFASs in architectural protec tive c oatings is approximately 1%. A producer of alternatives noted, however, in the 2nd stakeholder consultation, that their alternative, Tetrashield, not only is favorable in terms of cost, but that the technical performanc e is c omparable to FEVE - and even exc eeds FEVE in some ways. Coil coating With respect to coil coating, two stakeholders argue, in the 2nd stakeholder consultation, that PVDF prepainted metal, used for large external surfaces of buildings, is a cost effective, sustainable and recyclable material. They state over 90% of the prepainted metal is recycled at end of life and as such the material is positive for the circular economy. According to these stakeholders, replacing the fluoropolymer top coating with alternatives would lead to significant cost increases, as panels would have to be repainted or replaced to be equivalent to metal painted with PVDF. Additionally, one stakeholder argued that a restriction scenario would lead to decreased quality of European coil coated products and thus reduce the c ompetitiveness in the market. According to OECD (2022) approximately 90% of the coil coatings are used for roofing and building panels in the EU market. In 2011, the EU c oil c oating market shares were distributed with 88-91% being non-fluoropolymer materials, while 3-12 % were estimated as containing fluoropolymers such as PVDF and FEVE (OECD, 2022). The alternative binders for topcoats coil c oating inc ludes Silic one Modified Polyester and High Durability Polyester, where the cost per unit prices, according to the webpage of Wanzhi steel is lower than for PVDF. Wind turbine blade coating For wind turbine blade coating quantitative estimates on comparative unit costs between fluoropolymers and fluorine- free alternatives is generally lac king in the public domain, and no information has been provided by suppliers or downstream users in the 2nd stakeholder consultation. Non-fluoropolymer-based coatings are available on the EEA market from e.g. Hempel. Arc hitectural membranes (c omposite membranes with top c oating) Polyester coated with PVC and TiO2 composite architectural membranes is in use in the EEA and is c laimed to be a c ost-effective alternative to traditional roofing systems (Taiyo Europe, 2021). Fiberglass fabric architectural membranes coated with silicone are available in EEA e.g. under the brand name Atex. According to Llorens (2015), with regards to cost and handling, silicone-coated fiberglass can be positioned somewhere between PVC-coated polyester and PTFE-coated fiberglass. Quantitative estimates on comparative unit costs between composite architectural membranes with a fluoropolymer topcoat and non-PFAS architectural membranes are generally lac king in the public domain. Despite requesting more information from CfE and 2nd stakeholder consultations, it has not been possible to gain quantifiable, economic data on fluoropolymers and fluorine-free architectural membranes. In the 2nd stakeholder consultation four stakeholders have, however, provided their viewpoint on the cost of 443 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) alternatives compared to fluoropolymers within their uses and productions. It has thus been emphasized by the stakeholders how the unit cost of non-PFAS alternative top coating might be cheaper than the costs of fluoropolymer top coating, but as the alternatives among other things require more cleaning and frequent reapplication, the end costs are likely to be higher when applying alternatives. Increased costs of labor, maintenanc e, c omplianc e, qualific ation, and general development and adaptation throughout the supply c hain is also likely to be of significance, though no specific data has been submitted in the 2nd stakeholder consultation. Stakeholders highlighted moreover, that while the unit cost of most fluoropolymers is likely to be higher than other materials, the use is still favored as it ensures functionality, and overall cost saving can be made over the full working life of the product. Therefore, transitioning to alternatives might have potential knock-on implications for the operations where the fluoropolymers are used. Stakeholder input on transition periods Input on transition periods was received via the 2nd stakeholder consultation on architectural coatings and paints, coil coating and composite architectural membranes. No stakeholders commented on wind turbine blade coating. Stakeholder replies can be seen below. Arc hitectural c oatings and paints: o There are no legal requirements, but customers expect coatings to meet certain spec ifications. Approval time 3-4 years. o Flame spread testing (EN ISO 13501) 8-12 months for certain uses and 5-10 years of accelerated real world exposure testing is also mentioned. Coil coating: o Coil coated steels are subjected to extensive weathering studies, to develop the appropriate technical information that is used to satisfy nat ional building regulations and tec hnical ac creditations. Approval will take 5-6 years from the start of weathering studies. o Assessment of alternatives to micro-powder PTFE (PTFE waxes) in coating formulations will have to be followed by extended weathering studies. Composite architectural membranes: o No legal requirements but various approval schemes exist by public authorities, by third parties, and by customers. There are time consuming weathering tests under multiple c onditions and flame retardancy tests whic h need to be c arried out, estimated testing time is 12-24 months. o No suitable alternatives have been found so far. The transition period might vary between 3 and 10 years, depending on the application. Concluding remarks Arc hitectural c oatings and paints Available data indicates that alternative binders in top coatings, such as polyurethane in arc hitectural paints and c oatings, might have a shorter lifetime under harsh (environmental) c onditions than fluoropolymer binders. However, this does not seem to have an impac t on the global market that according to OECD (2022) is dominated heavily by alternatives binders. The Dossier Submitters, therefore, conclude based on information from CfE, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in arc hitectural paints and c oatings and that the substitution potential is high. Coil coating Available data indicates that alternative binders in top coatings, such as high durability 444 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) polyester in coil coatings, might have a shorter lifetime under harsh (environmental) conditions than fluoropolymer binders. This does not seem to have impact on the market, that according to OECD (2022) is heavily dominated by alternative binders. However, two stakeholders state that micro-powder PTFE is used as an additive in coil coating mixtures containing alternative binders. No information on alternatives to the use of micro -powder PTFE was identified. There is hence weak evidence that available alternatives might contain micro-powder PTFE as an additive. The Dossier Submitters conclude based on information from CfE, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in c oil c oatings and that the substitution potential is high. Wind turbine blade coating Information shows that alternative binders to fluoropolymers are available on the EEA market for top coating of wind turbine blades. Available information further indicates that these alternatives already are in use by some of the largest wind turbine producers in the world. The Dossier Submitters, therefore, c onclude based on information from literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in wind turbine blade coatings and that the substitution potential is high. Arc hitectural membranes (c omposite membranes with top c oating) Information shows that alternative top coating of composite architectural membranes is available on the market. PVF is not c onsidered a useful alternative sinc e it is likely still being manufactured with PFAS polymerisation aids. Lifetime of polyester/PVC membranes with TiO2 and fiberglass fabric coated with silicone will likely be shorter, than composite architectural membranes with a fluoropolymer based top coating. Further, fiberglass fabric coated with silicone will be less dirt/soil repellent. No evidence pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. The Dossier Submitters, therefore, conclude based on information from CfE, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in composite architectural membranes and that the substitution potential is high. E.2.13.2.11. Alternatives to articles containing fluoropolymers or PFPEs in building material/construction products Tec hnical feasibility of alternatives Architectural membranes (pure fluoropolymers) Composite architectural membranes (polyester/PVC with TiO2 containing top coating and silicone coated fiberglass fabric) can to some degree be seen as alternatives to pure fluoropolymer architectural membranes of ePTFE, PVDF or ETFE foil/film. It is indicated in Llorens (2015) and by stakeholders in the 2nd stakeholder consultation that the pure fluoropolymer architectural membranes have a (much) longer service life than the alternative c omposite membranes described in the previous section. Furthermore, fiberglass fabric is not flexible and can therefore, in many cases not be used directly for the same applications as the pure fluoropolymer membranes (another design is required). Silicone coated fiberglass fabric is less soil/dirt resistant. It was pointed out by one stakeholder in the 2nd stakeholder consultation that ETFE is fully recyclable. ETFE film/foil for greenhouses As ETFE film/foil in greenhouses in some cases have replaced glass and polyethylene they can be considered as alternatives. Compared to ETFE film/foil in greenhouses polyethylene has a shorter service life before the greenhouse has to be re-sheeted. Glass has a long service 445 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) life but is less flexible and has a weight that is approx. 100 times higher than ETFE. PTFE thread sealing tape Tow, hemp, silicone and liquid/paste pipe thread (based on e.g. Kevlar) is mentioned as potential alternatives to PTFE thread sealing tape. As described in the previous section tow and hemp are by stakeholders considered not to be technical feasibly alternatives. No information has been identified that challenges this. The silicone -based tape LeakSeal, described in the previous section, seems to be a technical feasibly alternative to PTFE tape for fixing leaky pipes until further work c an be c arried out. LeakSeal does not seem to be an alternative to PTFE thread sealing tape. Non-PFAS liquid/paste pipe thread is considered to be a technical feasibly alternative PTFE thread sealing tape. However, liquid/paste pipe thread is used for permanent seals whereas PTFE thread sealing tape is used for nonpermanent seals. Polymeric PFASs used as proc essing aids for production of non-PFAS polymers/plastics Boron nitride and siloxanes were identified as potential drop-in alternatives to the use of polymeric PFASs as processing aids (PPAs) in the production of non-PFAS polymers/plastics. As described in Annex E.2.3.4.1 boron nitride is considered to be a technical feasibly alternative for the production of PE films. However, as indicated by one stakeholder, boron nitride might not be a technical feasibly alternative for all applications exemplified by the stakeholder c omment that: "hard foreign particles like boron nitride c an result in premature pipe failure due to stress c oncentrations". The properties of using siloxanes (MultibaseTM) are comparable to the properties described from using polymeric PFASs as PPAs (DuPont, 2021). However, no information has been identified that describes potential loss of functionality from substituting polymeric PFASs PPAs with siloxanes. Bridge and building bearings Steel rollers are expected to be technical feasible alternatives to PTFE in bridge and building bearings. However, it is the understanding of the Dossier Submitters that the use of steel rollers will require that the bridges and buildings will have to be designed differently as the steel rollers require signific antly more spac e in the c onstructions. Window frames (laminated with fluoropolymers) The stakeholder that gave input on the use of PVDF film for laminating PVC and HPL window frames in the 2nd stakeholder consultation stated that to their knowledge there is no alternative. However, other types of window frames such as wood and metal frames hav e a signific ant market share (MarketResearch, 2020). These alternative materials are c onsidered technical feasible alternatives to PVC and HPL laminated with PVDF. Furthermore, given the limited number of stakeholder input on this use, the Dossier Submitters do not know if it is c ommon for produc ers of PVC and HPL window frames to laminate the frames with PVDF film. Economic feasibility of alternatives Architectural membranes (pure fluoropolymers) No quantitative estimates on comparative unit costs between pure fluoropolymers architectural membranes and non-PFAS composite architectural membranes has been identified. However, polyester c oated with PVC and TiO2 c omposite arc hitectural membranes are in use in EEA, and it is claimed to be a cost-effective alternative to traditional roofing systems (Taiyo Europe, 2021). Fiberglass fabric architectural membranes coated with silicone are available in EEA e.g. under the brand name Atex. According to Llorens (2015), with regards to cost and handling, silic one-coated fiberglass can be positioned somewhere between 446 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PVC-coated polyester and PTFE-coated fiberglass. The unit cost of non-PFAS composite architectural membranes is, therefore expected to be lower than pure fluoropolymers architectural membranes. The comment received in the 2nd stakeholder consultation on economic feasibility of alternatives to composite architectural membranes with a fluoropolymer top c oating in general also applies to pure fluoropolymers architectural membranes. These comments are reflected in the section on economic feasibility of alternatives to mixtures containing fluoropolymers and PFPEs. ETFE film/foil for greenhouses No comment was received in the 2nd stakeholder consultation on the economic feasibility of alternatives to ETFE greenhouses and no quantitative estimates on comparative unit costs have been identified. However, more frequent reapplication must be expected for polyethylene foils as they have a shorter lifetime than ETFE film/foil. Glass is much heavier than ET FE and it therefore requires more material (e.g. wood or metal) for construction. Glass has a long lifetime but is not self-cleaning. Even if ETFE has a higher unit c ost, these things will raise the overall cost of polyethylene and glass. Unit costs of recycling of ETFE compared to polyethylene and glass have not been identified. PTFE thread sealing tape The only comment received in the 2nd stakeholder consultation on the economic feasibility of alternatives to PTFE tape, is that there is no alternative material. PFASs used as processing aids (PPAs) for production of non-PFAS polymers/plastics In a response to the 2nd stakeholder consultation one stakeholder indicated that alternatives are c heaper than polymeric PFAS PPAs. The same stakeholder, however, also states that the alternatives do not live up to the technical requirements. Three other stakeholders also stated that the alternatives do not live up to the technical requirements and that the question of economic feasibility is therefore not relevant. Bridge and building bearings The stakeholder that gave input to the 2nd stakeholder consultation stated that steel rollers as alternative to PTFE containing bridge and building bearings "are economically on a much higher level". Window frames (laminated with fluoropolymers) The stakeholder that gave input to the 2nd stakeholder c onsultation on lamination of PVC and HPL window frames with PVDF film, did not provide information on economic feasibility of alternatives, likely bec ause they stated that to their knowledge no alternatives are available. Stakeholder input on transition periods Pure fluoropolymer architectural membranes In a response to the 2nd stakeholder consultation one stakeholder stated that: "Flammability test and studies have to be performed according to DIN, EN and ASTM standards. Long term test on weathering and durability have to be carried out to prove the suitability of the alternative products." The same stakeholder stated that the average approval time is >10 years for the intended use in roofing. ETFE film/foil for greenhouses 447 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) No information received on transition periods. PTFE thread sealing tape EN751-3 desc ribes the use of PTFE tape in sealing materials for metallic threaded joints used for family gases (fuel gases), natural gases, liquefied petroleum gases and for hot water of heating systems. No information on expected transition period was provided by stakeholders in the 2nd stakeholder consultation. Production of non-PFAS polymers used as building materials/construction products In a response to the 2nd stakeholder consultation one stakeholder mentioned a need for a 35 year transition period without specifying why. Bridge and building bearings No information received on transition periods. Window frames (laminated with fluoropolymers) No information received on transition periods. Concluding remarks Architectural membranes (pure fluoropolymers) Non-PFAS composite architectural membranes are available on the market as alternatives to pure fluoropolymer architectural membranes. The lifetime of polyester/PVC membranes with TiO2 and fiberglass fabric coated with silicone is shorter than pure fluoropolymer architectural membranes. Further, fiberglass fabric coated with silicone is less flexible and less dirt/soil repellent. No evidence is available to t he Dossier Submitters pointing to a shortage in the supply of alternatives. The Dossier Submitters, therefore, conclude based on information from literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in architectural membranes currently made of pure FP a nd that the substitution potential is high. ETFE film/foil for greenhouses Glass and polyethylene are technically feasible alternatives to the use of ETFE in greenhouses. Polyethylene has a shorter lifetime and glass requires more material (e.g. wood or metal) for construction. The alternatives might also require more frequent cleaning. Polyethylene and glass are common materials, and the capacity is expected to be high. The Dossier Submitters, therefore, conclude based on information from stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in greenhouses covered by ETFE and that the substitution potential is high. PTFE thread sealing tape Liquid/paste pipe thread (based on e.g. Kevlar) is an alternative to PTFE thread sealing tape for permanent pipe seals. There is no evidence pointing to a shortage in the supply of alternatives available to t he Dossier Submitters. The Dossier Submitters, therefore, c onclude based on information from CfE, literature review and the 2nd stakeholder consultation that the evidenc e is weak that technically feasible and ec onomic ally feasible alternatives are available for the quantities required for use as PTFE thread sealing tape and that the substitution potential is high. 448 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) For non-permanent pipe seals no alternatives have been identified and technical feasibility is uncertain. The Dossier Submitter, therefore, conclude based on information from CfE, literature review and 2nd stakeholder consultation, that the evidence is inconclusive that technically feasible and economically feasible alternatives are available for the quantities required for use as PTFE thread sealing tape and that the substitution potential is unclear. For the use of PTFE tape for manufacturing and installation of windows, doors etc. no evidence has been provided or identified to indicate that a derogation is needed. Polymeric PFASs used as processing aids (PPAs) for production of non-PFAS polymers/plastics Available data indicates that alternative for polymeric PFASs used as processing aids for production of non-PFAS polymers such as boron nitride and siloxanes is commercially available. However, limited information has been identified that describes potential loss of func tionality of building material/c onstruction products from substituting to alternatives. No evidence is available to the Dossier Submitters pointing to a shortage in the supply of alternatives. The Dossier Submitters, therefore, conclude based on information from CfE, literature review and the 2nd stakeholder consultation that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use as processing aids and that the substitution potential is high. Bridge and building bearings Only one stakeholder gave input in the 2nd stakeholder consultation on PTFE in bridge and building bearings. Steel rollers are expec ted to be technically feasible alternatives, however, they are more expensive and are not considered to be drop-in alternatives as bridges and buildings will have to be designed differently as the steel rollers require significantly more space in the constructions. No evidence is available to the Dossier Submitters pointing to a shortage in the supply of alternatives. The Dossier Submitters, therefore, conclude based on information from stakeholder consultations, that the evidence is weak that technically feasible and economically feasible alternatives are available for the quantities required for use as bridge and building bearings and that the substitution potential is high. Window frames (laminated with fluoropolymers) Only one stakeholder gave input in the 2nd stakeholder consultation on the use of PVDF film for laminating PVC and HPL window frames. Other types of window frames suc h as wood and metal frames have a significant market share and are considered technically feasible alternatives. The Dossier Submitters, therefore, conclude based on information from, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in window frames and that the substitution potential is high. E.2.13.2.12. Alternatives to side-chain fluorinated polymers in building material/construction products Technical feasibility of alternatives Without mentioning any alternatives, it was stated in the 2nd stakeholder consultation, that alternatives do not provide the same combination of effects of side-chain fluorinated polymers when used for surface protection/sealing. As mentioned in the previous section, it cannot be excluded that the three stakeholders that replied to the 2nd stakeholder consultation all refer to side-chain fluorinated polymers based on 6:2 fluorotelomer chemistry. Based on non-exhaustive desktop research non-PFAS side-chain polymers based on silane/siloxane c hemistry for protection of porous surfaces was identified to be c ommerc ially available. The non-PFAS side-chain polymers based on silane/siloxane chemistry for 449 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) protection of porous surfaces provides good water repellence, the structure remains breathable, and the water repellent treatments are not affected by UV radiation. However, oil/dirt repellence is not good compared to side-chain fluorinated polymers. Overall, the nonPFAS side-chain polymers based on silane/siloxane chemistry is considered to be technical feasibly for protection of porous surfaces, though, with loss of functionality in terms of oil/dirt repellence compared to side-chain fluorinated polymers. Ac c ording to Amrutkar et al. (2022) sacrificial (e.g. waxes, polysaccharides), semi-permanent (e.g. acrylics and epoxides applied in several layers) and permanent (e.g. nanoparticles-based coating, silicon/siloxane, and polyurethanes) anti-graffiti coatings are on the market as potential alternatives to side-chain fluorinated polymers. In the review paper by Amrutkar et al. (2022) advantages and disadvantages of the different types of anti-graffiti coatings are given. The described advantages of permanent nanoparticles-based coating (e.g. nano-silica): "corrosion prevention, chemical and thermal stability, hardness, UV resistance, transparency, improved self -cleaning capability and antibacterial efficiency" is comparable to the advantages described for PFAS-based antigraffiti c oatings. Some of the nanoparticles-based c oating in Amrutkar et al. (2022), though, seems to be based on PFAS-based binders. This is, however, not the case in Moura et al. (2014), where the performance of a permanent nano-silica anti-graffiti product is compared to an anti-graffiti product based on side-chain fluorinated polymers. Both products are considered to be suitable for anti-graffiti solutions on inorganic porous materials when comparing water vapour permeability, colour change, hydrophobicity, durability and resistance to weathering (Moura et al., 2014). According to Moura et al. (2014) sacrificial anti-graffiti coatings are generally preferred for historic and heritage buildings where the appearance of the building cannot be altered. Sacrificial coatings based on polysaccharides is compatible with most surfaces, including metals, exterior walls, or painted surfaces (Amrutkar et al., 2022) and is therefore not limited to historic and heritage buildings. The non-fluoropolymer alternatives described under architectural paints and coatings, epoxy, polyester, polyurethane etc. does also provide protection of surfaces and can therefore for some applic ations be seen as alternatives to side-chain fluorinated polymers. Economic feasibility of alternatives Quantitative estimates on c omparative unit c osts between side -chained fluorinated polymers and non-PFAS alternatives are lacking. Despite requesting more information through CfE and 2nd stakeholder c onsultation, it has not been possible to gain quantifiable economic data. Two stakeholders in the 2nd stakeholder consultation refer to the issue of alternatives not providing the same effects, while one finds it possible that alternatives c ould be ec onomic ally feasible, but that this would require totally revised processes. Sac rific ial anti-graffiti c oating is according to Amrutkar et al. (2022) more c ost-effective than another category of anti-graffiti coating products (semi-permanent and permanent). Stakeholder input on transition periods The stakeholders find that an implementation of alternatives will involve elements such as development of products, market launch, and commercialization, which is likely to take approximately 5 years according to one stakeholder, while another expects it to take at least 6 years. A third stakeholder refers to the quality and effectiveness of the process but estimates it to be possible within 1 to 3 years. Concluding remarks Alternatives to side-chain fluorinated polymers used for surface protective coating/sealing are 450 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) available on the market, and there is no evidence available to the Dossier Submitters pointing to a shortage in the supply of alternatives. Many of the alternatives have been on the market for a long time and the Dossier Submitters consider these to be technically feasible, and many can be considered as drop-in alternatives. However, there can be a loss of functionality, as alternatives do not provide the same level of soil/dirt repellence as side -chain fluorinated polymers. The Dossier Submitters, therefore, conclude based on information from literature review, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use in protective coating/ sealants and that the substitution potential is high. E.2.13.2.13. Alternatives to non-polymeric PFASs in building material/construction products Technical feasibility of alternatives Fluorosurfactants as wetting/levelling agents in e.g. c oating, paints and adhesives: The solvent-based paints and coatings from under architectural coatings and paints and coating that do not contain fluorosurfactants may for some applications be considered as drop-in alternatives. According to the six stakeholders that replied to the 2nd stakeholder consultation (three referring C6 and/or fluorotelomer surfactants, one referring to C4 side-chain polymeric fluorosurfactants and two didn't specify the type of fluorosurfactant that they referred to in their responses) no alternatives have the same combination of properties as fluorosurfactants and alternatives cannot match the low surface tension of fluorosurfactants, even at higher doses. Many non-PFAS-based surfactants are available on the market. It has not been possible for the Dossier submitters to prepare a full survey of this market. However, examples of nonPFAS-based surfactants that can be used in building materials/construction products such as water-based c oatings, paints and adhesives are provided in the previous sec tion. These wetting and levelling agents are based both on siloxanes ( e.g. polyether siloxane copolymers, siloxane-based gemini surfactant or modified polyether siloxane) and hydroc arbon surfactants (e.g. non-ionic organic surfactants and sulfosuccinates). Non-PFAS alternatives to fluorosurfactants used in building material/construction products such as TEGO, SURFYNOL and DYNOLTM and Hydropalat is available on the market. The manufacture of DYNOLTM, Evonik, claims that the surface tension behavior of the DYNOLTM superwetting surfactants is c omparable to fluorosurfactants. Furthermore, Evonik also offers a Webinar called "Substrate wetting - the future beyond fluorosurfactants". It is the understanding of the Dossier Submitters that alternatives should in general not be considered as drop-in alternatives to fluorosurfactants but rather that in many cases re formulation will be needed in order for the non-PFAS surfactant system to fulfill properties comparable to the fluorosurfactants, e.g. wetting, levelling, defoaming and anti-cratering. Even if no alternatives on their own have the same combination of properties as fluorosurfactants, as stated by stakeholders, it seems based on information from Evoniks webpage, that it is possible to reformulate and use (combinations of) non-PFAS surfactants to obtain (some of) the properties of the fluorosurfactants. Especially compared to the fluorosurfactants that are restricted in the EU (PFOS, PFOA and their related substances) or those that are about to be restricted (PFHxS, C9-C14 PFCAs (and likely also PFHxA) and their related substances). One property that can likely not be matched by non-PFAS surfactants is oil/dirt repellency that is provided by some spec ific types of fluorosurfactants. 451 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Processing aids According to one stakeholder reply in the 2nd stakeholder consultation no non-PFAS processing aids are available for the production of the specific use. However, the stakeholder describes the architectural membrane-like product as niche product in the market, which is dominated by alternatives. In terms of technical feasibility the stakeholder states that all alternatives have their trade-offs in performance, but that they are able to meet building regulations. It must, therefore, be assumed that downstream users see the alternatives as technically feasible. Another stakeholder in the 2nd stakeholder consultation stated t hat alternatives to fluorosurfactants as processing aids for production of acrylic foam tape are available but that R&D to identify alternatives is ongoing. The stakeholder in December 2022 announced that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to discontinue use of PFAS across our product portfolio by the end of 2025" (3M, 2022). No other producers of ac rylic foam tape replied to the 2nd stakeholder c onsultation and no other information has been identified. Window film manufacturing In the 2nd stakeholder consultation, one stakeholder there are no known PFAS-free alternatives that provide the same performance. The stakeholder in December 2022 announced that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to discontinue use of PFAS across our product portfolio by the end of 2025" (3M, 2022). No other producers of window film replied to the 2nd stakeholder consultation and no other information has been identified. Economic feasibility of alternatives Fluorosurfactants as wetting/levelling agents in e.g. c oating, paints and adhesives Quantitative estimates on comparative unit costs between fluorosurfactants and non-PFAS alternatives are generally lacking. Despite requesting information through CfE and 2nd stakeholder consultation, it has not been possible to gain quantifiable, economic data on fluorosurfactant and non-PFAS alternatives, as several stakeholders note how, due to the lack of alternatives, they cannot comment on whether there are economically feasible ones. It should be noted that no manufacturers of non-PFAS surfactants responded to the 2nd stakeholder consultation. Two stakeholders mention how potential alternatives might require more frequent reapplication and higher concentrations of the alternative substance, which could lead to higher costs. Two stakeholders, who in the 2nd stakeholder consultation specifically mentioned C6 and C6 fluorotelomers in their replies, expect moreover a transitioning to alternatives to be likely to have knock-on effects on the operations where fluorosurfactants traditionally are used, as there will be a need for developing and testing the alternatives. In the 2nd stakeholder consultation, two stakeholders responded that the use of fluorosurfactants is rather expensive, and likely significant ly more expensive than potential alternative surface-active substances, but the use is still favored as it ensures functionality, which stakeholders believe is the reason that paint manufacturers and end-users are willing to pay the higher price. Therefore, according to one stakeholder, the C6 fluorotelomer surfac tants are used only if low surfac e tension and other functional properties are required, which cannot be achieved with a fluorine-free alternative. Another stakeholder, referring to fluorosurfactants in general, further added that fluorosurfactants provide unique properties, there are no technical alternatives, so not so much a question of formulation costs. Paint manufacturers and end-users are ok to pay a higher price as long as this chemistry is the right technical solution. Economically, they state, that they may find some lower cost alternatives but for water repellence only, not allowing to reach overall properties, not matching the most demanding applications. 452 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Processing aids No specific information on economic feasibility of alternative architectural membrane -like produc ts (not produced with non-polymeric PFAS processing aids) was provided or identified. For the use of fluorosurfactants as processing aids for production of acrylic foam tape it was mentioned in the 2nd stakeholder consultation that "Non-fluorinated alternatives' material costs are not significantly different than PFAS-based surfactants used in acrylic foam tape applications; however, non-PFAS alternatives do not meet the technical requirements". Window film manufacturing In the 2nd stakeholder consultation, one stakeholder there are no known PFAS-free alternatives that provide the same performance. The stakeholder in December 2022 announced that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to discontinue use of PFAS across our product portfolio by the end of 2025" (3M, 2022). No other producers of window film replied to the 2nd stakeholder consultation and no other information has been identified. Stakeholder input on transition periods Fluorosurfactants as wetting/levelling agents in e.g. c oating, paints and adhesives In response to the 2nd stakeholder consultation stakeholders stated that there currently are no suitable alternatives available to fluorosurfactants, w ith the same combination of properties. Based on responses from two downstream users the proposed estimations of the necessary time for a transition varies between "up to several years", "3 to 10 years" though stakeholders underline how a fitting alternative is yet to be found. The stakeholder that mentioned "3 to 10 years" specifically referred to C6. Processing aids For the final architectural membrane-like product, where non-polymeric PFASs is used as proc essing aids, one stakeholder states that CE c ertification takes 6-12 months and on top of that national c ertification takes 1-2 years for the testing of one produc t. For the use of fluorosurfactants as proc essing aids for produc tion of ac rylic foam tape one stakeholder mentioned in the 2nd stakeholder consultation that "the R&D timeline to seek another option is five years. It will take an additional three years for product testing, requalification and full-scale operational manufacturing capability across all industries and customers impacted". It should be noted that this stakeholder has announced that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to discontinue use of PFAS across our product portfolio by the end of 2025". Concluding remarks Other factors than this restriction proposal do likely have a big impact on substitution of nonpolymeric PFASs in building materials/construction products. One factor being the 3M announc ement that they will "Exit all PFAS manufacturing by the end of 2025" and "Work to disc ontinue use of PFAS ac ross our product portfolio by the end of 2025" another factor is the restriction proposal on undecafluorohexanoic acid (PFHxA), its salts and related substances which is currently under deliberation. For PFHxA no derogation of building material/construction products is suggested by RAC and SEAC (ECHA, 2021a). Fluorosurfactants as wetting/levelling agents in e.g. c oating, paints and adhesives The solvent-based paints and coatings, mentioned under architectural coatings and paints and coatings that do not contain fluorosurfactants may for some applications be considered 453 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) as drop-in alternatives. For other applications alternatives are available on the market, however not as drop-in alternatives. Re-formulation is likely possible for most applications, however, there may be some loss functionality (no or lower oil/dirt repellency) for some applic ations. No evidenc e is available to the Dossier Submitters pointing to a shortage in the supply of alternatives. The Dossier Submitters, therefore, conclude based on information from CfE, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use of surfactants as wetting/levelling agents in e.g. coating, paints and adhesives and that the substitution potential is high. Non-polymeric PFASs as proc essing aids Technically feasible alternatives are available to architectural membrane-like building materials/construction product s produced by non-polymeric PFAS processing aids (not included in the product). The alternatives dominate the market , and no evidence is available to the Dossier Submitters pointing to a shortage in the supply of alternatives. The Dossier Submitters, therefore, conclude based on information from stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are available for the quantities required for use as processing aids in building material/construction products and that the substitution potential is high. Specifically, for the use of non-polymeric PFAS processing aids for production of acrylic foam tape the evidence on available alternatives is inc onclusive. One stakeholder highlighted in the 2nd stakeholder consultation that no alternatives are available, but that R&D is ongoing for replacing fluorosurfactants as processing aids for production of acrylic foam tape. The stakeholder in December 2022 announced that they will "Work to discontinue use of PFAS across our product portfolio by the end of 2025". Either production will, therefore, have to be stopped or another solution (alternatives) will have to be identified within a short timeframe. The Dossier Submitters, therefore, conclude based on information from 2nd stakeholder consultation, that the evidence is inconclusive that technically feasible and economically feasible alternatives are available for the quantities required for use as [non-polymeric PFAS processing aids for production of acrylic foam tape and that the substitution potential is unc lear. Window film manufacturing There is uncertain evidence for the use of fluorosurfactants for window film manufacturing. One stakeholder highlighted in the 2nd stakeholder consultation that there are no alternatives available for this use. The stakeholder in Dec ember 2022 announc ed that they will "Work to discontinue use of PFAS across our product portfolio by the end of 2025". Either production will, therefore, have to be stopped or another solution (alternatives) will have to be identified within a short timeframe. The Dossier Submitters, therefore, conclude based on information from 2nd stakeholder consultation, that the evidence is inconclusive that technically feasible and economically feasible alternatives are available for the quantities required for use as window film manufacturing and that the substitution potential is unclear. E.2.13.2.14. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHAs dissemination site. Non-chemical alternatives are also listed in the table. In relation to building material/construction products, the list of alternatives contained twenty-eight (28) unique CAS numbers. Twenty of the substances with unique CAS was 454 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) classified according to CLP (harmonised classification or self -classification). One of these substances (fiberglass) is self-classified as Carc. 1B in its fiber/solid state. None of the substances with unique CAS is identified as having PBT or vPvB properties. Sixteen (16) of the substances may contain D4, D5 and/or D6 as residues. D4, D5 and D6 have been identified by ECHA's Member State Committee as SVHC substances with PBT/vPvB properties (ECHA, 2019). The list contained an additional six (6) substances with unique substance names for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.13.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.13.3., assuming baseline and, consequently, on-going PFAS use and emissions. The analysis of environmental impac ts focuses on one restric tion option: RO1, adopting a ban of all PFAS used in the building/construction sector; Environmental impacts of RO1 are analysed quantitatively. Table E.141 below summarizes the characteristics of RO1. Table E.141. Characteristics of RO1. Restriction option abbreviation RO1 Short description Derogations Full ban --- Transition period after entry into force 18 months Duration of derogation --- For calculating the expected emission reduction, the assumed entry-into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, RO1 is expected to be implemented in 2027. All emission estimates represent mean values. Table E.142 shows mean emissions and the expected mean emission reduction for a time path of 30 and 45 years (starting in 2025). Table E.142. Total mean emissions and emission reduction of RO1 (building/construction sector, in tonnes). Restriction option Baseline RO1 Baseline RO1 Mean total emissions [t] 2025-2055 152 555 6 513 2025-2070 250 522 6 513 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 146 042 96 --- --- 244 009 97 As illustrated in Table E.142, a full ban on PFAS use in this sector leads to a mean emission reduction of about 96% compared to the baseline scenario, depending on the length of the timeline. E.2.13.4. Economic and other impacts It has not been possible to identify much information in literature, associated with potential costs related to the substitution of PFASs within the areas of building material/construction products. A brief literature review did, however, reveal some potential alternatives for the 455 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) main uses of PFASs in building material/construction products. To assess more information on the potential effects of a restric tion and ec onomic impac ts, CfE, and targeted stakeholder consultations have been carried out. Despite these efforts, very little specific information to quantify the potential costs of a restriction on the use of PFASs in building material/construction products is available. The collected information on the main types of costs is patchy and covers only some of the many applications of PFASs in building material/construction products. The impacts of a ban on PFASs use in the building/construction sector varies considerably depending on the use and types of PFASs covered. Therefore, the assessment here is separated into fluoropolymers & PFPEs and non-polymeric PFASs, respectively. The section on fluoropolymers and PFPEs is further sub-divided in to building/construction mixtures and building/construction articles. As the side-chained fluorinated polymers degrade to PFAAs, t he economic impacts related to the side-chain fluorinated polymers are included under non-polymeric PFASs. E.2.13.4.1. Fluoropolymers and PFPEs For fluoropolymer and PFPE in building/construction mixtures some alternatives are available. The economic implications for downstream users are summarized in Table E.143 below. Table E.143. Overview of economic impacts of a ban of polymeric PFASs (fluoropolymers and PFPEs) used in mixtures in building/cons truction applications. Product category Architectural coatings and paints Substitution costs No comparison between FP top coating and alternatives (polyurethane, polyester, polysiloxane) has been possible in this assessment. Transitional costs Loss of functionality Likely to be limited, as alternatives are available and dominates the EEA market. Possible negative impacts on the lifetime under harsh environmental conditions (weathering/UV-radiation) when substituting FP top coating with e.g. polyurethane C oil coating Wind turbine blade coating It is indicated that FP top coatings is the most expensive No comparison between FP top coating of coil and alternatives (silicone modified polyester and high durability polyester) has been possible in this assessment. Indicated that FP top coatings are of the highest cost. No comparison between FP top coating of wind turbine blades and alternatives (e.g. coating based on polyaspartic ester and titanium Likely to be limited, as alternatives are available and dominates the EEA market. However, stakeholders state that alternatives may contain micro-powder PTFE as additive. If this is the case reformulation will be needed. Likely to be limited, as alternatives are available on the EEA market. Possible negative impacts on the lifetime harsh environmental conditions (weathering/UVradiation) when substituting FP top coating with different polyester types No loss of functionality identified. It can be speculated if there are possible negative impacts on the lifetime under harsh environmental conditions (weathering/UV radiation and rain erosion) when substituting FP top coating with alternatives 456 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product category Architectural membranes (composite membranes with top coating) Substitution costs dioxide) has been possible in this assessment. No comparison between FP top coating and alternatives (silicone for fiberglass and TiO2 for polyester/PVC ) has been possible in this assessment. Indicated that FP top coatings are the most expensive. Transitional costs Likely to be limited, as alternatives are available and currently on the market. Loss of functionality Possible negative impacts on the lifetime of the polyester/PVC membrane under harsh environmental conditions (weathering/UV-radiation) when substituting FP top coating with TiO2 Possible negative impacts on the lifetime of the fiberglass fabric under harsh environmental conditions (weathering/UVradiation) when substituting FP top coating with silicone Less soil/dirt repellence of the fiberglass fabric when substituting FP top coating with silicone (unless made self-cleaning with TiO2) For architectural coatings and paints and coating of wind turbine blades drop-in alternatives are available. For architectural coatings and paints the alternatives are available at a lower cost, but the alternatives are likely to have a shorter lifetime under harsh environmental conditions. This is also the case for coil coating. However, information from two stakeholders indicate that alternative formulations based on e.g. polyester or polyurethane, contain low levels of micro-powder PTFE. If this is correct for all or most of the alternative formulations, reformulation is required - which will increase the costs. On the other hand, if only a limited number of alternative formulations contains micro-powder PTFE as an additive, transitional costs will be low as no shortage in supply of drop-in alternatives is expected. For composite architectural membranes less expensive alternatives composite membranes with non-PFAS top coating (e.g. silicone for fiberglass fabric and TiO2 for polyester/PVC membranes) are available on the market, though, with some loss of functionality, which might induce higher maintenance costs. As no evidence pointing to a shortage in the supply of alternatives is available to the Dossier Submitters, substitution costs are expected to be limited. For fluoropolymer and PFPE in building/construction articles, there are some available alternatives. The economic implications for downstream users are summarized in Table E.144 below. Table E.144. Overview of economic impacts of a ban of polymeric PFASs (fluoropolymers and PFPEs) used in articles in building/construction applications. Product category Substitution costs Transitional costs Loss of functionality Architectural membranes (pure fluoropolymer) No comparison between pure FP membranes and composite alternatives (silicone for fiberglass and TiO2 for polyester/PVC ) has Likely to be limited, as alternatives are available and currently on the market. Negative impacts on the lifetime when substituting pure FP membranes with composite membranes with non-FP top coating (TiO2 or silicone). 457 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product category Substitution costs Transitional costs Loss of functionality been possible in this assessment. Fiberglass fabric is less flexible than pure FP membranes. Indicated that the cost of pure FP membranes are higher than the cost of alternatives. Less soil/dirt repellence of the fiberglass fabric when substituting FP top coating with silicone (unless made selfcleaning with TiO2). ETFE film/foil for greenhouses No comparison between ETFE and alternatives (glass and polyethylene) has been possible in this assessment. Likely to be limited, as alternatives are available and currently on the market. Negative impacts on the lifetime when substituting ETFE with polyethylene. Glass is less flexible than ETFE film/foil and the weigh is approx. 100 times higher. Alternatives require more cleaning PTFE thread sealing tape No comparison between PTFE thread sealing tape and alternatives (liquid/paste pipe thread) has been possible in this assessment. Uncertain, as liquid/paste pipe thread may only partly be an alternative. If this is the case, some R&D costs may also be expected Liquid/paste pipe thread can (likely) only be used for permanent pipe seals. Polymeric PFASs used as processing aids (PPAs) for production of non-PFAS polymers No comparison between polymeric PFASs and alternatives (boron nitride and siloxane) has been possible in this assessment. Indicated that pure polymeric PFAS processing aids is the most expensive Likely to be limited, as alternatives are available and currently on the market. Uncertain if there are drop-in alternatives. If there are no drop-in alternatives, reformulation and/or adaption of existing systems will be needed. In general, limited information available. Potential premature pipe failure when using boron nitride instead of polymeric PFASs as processing aid for production of pipes Bridge and building bearings No comparison between PTFE bridge and building bearings and alternatives (steel rollers) has been possible in this assessment. Stakeholder state that alternatives are much more expensive Uncertain, as it is unknown if alternatives are available and currently on the market (as drop-in). The use of steel rollers will likely require that the bridges and buildings will have to be designed differently. Steel rollers require significantly more space in the construction Windows frames No comparison between PVDF film for laminating Likely to be limited, as alternatives are available Window frames made of wood 458 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product category Substitution costs Transitional costs Loss of functionality (laminated with fluoropolymers) PVC and HPL window frames and alternatives (other types of window frames like wood or metal) has been possible in this assessment. and currently on the market. may require more maintenance No shortage of supply of alternatives to ETFE film/foil for greenhouses and for PVC and HPL window frames laminated with PVDF are expected, as alternatives already have large share of the market. Substitution costs for these uses are, therefore, expected to be limited. For pure fluoropolymer architectural membranes there are less expensive alternatives, in the shape of architectural composite membranes with non-PFAS top coating, available on the market. But these alternatives entail, however, some loss of functionality. The capacity of alternative top coatings for composite architectural membranes is unclear. No evidence is available to the Dossier Submitters pointing to a shortage in the supply of composite architectural membranes with non-PFAS top coating.This is also the case for polymeric PFASs used as processing aids for production of non-PFAS polymers. If the capacity of alternatives for these two uses is high enough, substitution costs are expected to be limited. For PTFE thread sealing tape, liquid/paste pipe thread is considered a technically feasible alternative for permanent pipe seals, but the technical feasibility is uncertain for nonpermanent seals. There is no evidence pointing to a shortage in the supply of alternatives available to the Dossier Submitters, and the substitution costs are hence expected to be low. According to a stakeholder, using steel rollers as alternatives to bridge and building bearings, will be much more expensive. This alternative might also result in bridges and buildings having to be designed differently. Though thereis no evidence pointing to a shortage in the supply of alternatives available to the Dossier Submitters, there might hence be high socio -economic c osts associated with substitution. E.2.13.4.2. Non-polymeric PFASs For non-polymeric PFASs in building material/c onstruction products, there are some available alternatives. The economic implications for downstream users are summarized in Table E.145 below. 459 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.145. Overview of economic impacts of a ba n of non-polymeric PFASs (PFAAs and PFAA-precusors) in building/construction applications . Product category Substitution costs Transitional costs Loss of functionality Side-chain fluorinated polymers (PFAA- precursors) used for surface protection/seala nts No comparison between SC FP and alternatives (e.g. non-PFAS side-chain polymers) has been possible in this assessment. Indicated that SC FP is the most expensive. Likely to be limited, as alternatives are available and currently on the market. Less soil/dirt repellence when substituting SC FP with alternatives. F luo r o s ur fa cta nt s as we tting/le v e llin g agents in e.g. coating, paints and adhesives No comparison between fluorosurfactants and alternatives (silicone and hydrocarbon surfactants) has been possible in this assessment. Fluorosurfactants are significantly more expensive. In some cases, higher levels of alternatives might be needed. Likely limited, as alternatives are available and currently on the market, but not as drop-in alternatives (apart from products without fluorosurfactants). Reformulation is required for e.g. waterbased paints and coatings using fluorosurfactants as wetting and levelling agents. Reformulation might to some extent be driven by the PFHxA restriction proposal and 3M announcement to end manufacturing and use of PFASs. Possible negative impacts on surface tension substitutin g fluorosurfactants with alternatives. However, superwetting surfactants are claimed to be comparable to fluorosurfactants in terms of surface tension. Less or no soil/dirt repellency when substituting specific types of fluorosurfactants with alternatives. Products (e.g. solvent based architectural paints and coatings) without fluorosurfactants are available on the market. No n- po ly me r ic PF A S as processing aids (not included in the final non- PFAS article) No comparison between final products produced by processing aids and alternative final products has been possible in this assessment. Likely to be limited, as alternative final products (not produced with PFAS processing aids) are available and currently on the market as drop- Stakeholder indicated possible loss of functionality of alternative final products (without further specifications), however this stakeholder also 460 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product category Substitution costs Transitional costs Loss of functionality in alternatives. Alternative final products dominate the market. stated that the alternative final products meet building regulations. There is no evidence pointing to a shortage in supply of alternatives to side-chain fluorinated polymers used for surface protection/sealants are expected, as alternatives have been on market for several years. The socio-economic costs for these uses are, therefore expected to be limited. However, loss of functionality is to be expected for some applications as alternatives provides less soil/dirt repellenc e. For fluorosurfactants used as wetting/levelling agents there are less expensive alternatives available, though these are not drop-in alternatives. Increased concentrations might be required when applying the alternatives, and there might be some loss of functionality. There are however also products (e.g. solvent based architectural paints and coatings) without fluorosurfactants available on the market. No evidence pointing to a shortage in the supply of alternatives is available to the Dossier Submitters, and substitution costs are likely limited. With regards to non-polymeric PFAS processing aids, there are manufactured alternatives to replac e the final produc ts (without PFAS), and as there is no evidenc e pointing to a shortage in the supply of alternative final products available to the Dossier Submitter, the costs are expected to limited. Besides the uses of non-polymeric PFASs listed in Table E.145, uses of fluorosurfactants for window film manufac turing and for the use of fluorosurfactants as processing aids for production of acrylic foam tape were also mentioned by stakeholders: There is uncertain evidence for the use of fluorosurfactants for window film manufacturing and for the use of fluorosurfactants as processing aids for production of ac rylic foam tape. One stakeholder highlighted in the 2nd stakeholder c onsultation that there are no alternatives available for these two uses, but that R&D is ongoing for replacing fluorosurfactants as processing aids for production of acrylic foam tape. The stakeholder in December 2022 announced that they will "Work to discontinue use of PFAS across our product portfolio by the end of 2025". Either production will, therefore, have to be stopped or another solution (alternatives) will have to be identified within a short timeframe. E.2.13.5. Summary of cost and benefit assessment E.2.13.5.1. Fluoropolymers and PFPEs Table E.146 summarises the outcomes of the assessment of costs and benefits f or polymeric PFASs (fluoropolymers and PFPEs) in mixtures used as building materials/construction produc t s. 461 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.146. Polymeric PFASs in mixtures used as building ma terials and construction products - Summary table on assessment of costs and benefits, based on a general transition period of 18 months (fluoropolymers and PFPEs). Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban A rchitectural coatings and paints No t a p p licable Sufficie ntly strong e vidence that te chnically and e conomically feasible alte rnatives exists. No e vide nce points in the dire ction of shortages in the supply of alternatives. C onclusion: High substitution pote ntial at EiF [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a reduction of e m issions of about 96% (30-year pe riod). As the e nvironmental impact assessment does not cover the waste phase, emissions under the baseline as we ll as emissions avoided as a re sult of the re striction are likely unde restimated. Sufficie ntly strong e vidence that substitution costs are e x pected to be limited; alternatives are available and dominating the EEA m arket. No e vide nce on re formulation costs, one-off capital costs or administrative costs re lated to the transition have been identified. The e conomic implications for downstre am users are e x pected to be limited; possibly some loss of functionality (lifetime), under harsh environmental conditions (we athering/UV radiation). The re is sufficiently strong e vidence that a ban on polym eric PFASs in architectural coatings and pa ints is likely to have low so cioeconomic co sts. Not applicable 462 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Coil coating No t a p p licable Sufficie ntly strong e vidence that te chnically and e conomically feasible alte rnatives to replace fluoropolymer binders in coil coating exist. No e vide nce pointing to a shortage in supply of alte rnatives is available to the Dossier Submitters. W e ak evidence that available alte rnative formulations m ight contain micro-powder PTFE as additive. Further information is ne e ded to understand to which e x te nt e xisting alte rnatives contains m icro powde r PTFE as additive. Sufficie ntly strong information that R O 1 leads to a reduction of e m issions of about 96% (30-year pe riod). As the e nvironmental impact assessment does not cover the waste phase, emissions under the baseline as we ll as emissions avoided as a re sult of the re striction are likely unde restimated. The e xistence of alternatives to fluoropolymer binders in coil coating is not doubted, as they dom inate the market (even with some potential changes to the lifetime). Cost impacts are unce rtain as a re sult of the unce rtainty associated with the content of m icro -powder PTFE in (some) alte rnative formulations. The substitution costs depend on the num ber/volume of alternative formulations without m icro-powder PTFE as additive. If this number is high, co sts will be low a s drop -in a lternatives then are available (with some potential changes to the life time). If the number is low, re formulation is ne e ded, a nd new we a thering studies may a lso be ne e ded, and costs will be higher. As a re sult, the socio-economic costs of a full ban are unce rtain. Not applicable C onclusion: High substitution pote ntial at EiF [sufficiently strong e vidence]. 463 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Wind turbine blade coating No t a p p licable Sufficie ntly strong e vidence that te chnically and e conomically feasible alte rnatives exist. No e vidence points in the dire ction of shortages in the supply of alternatives. C onclusion: High substitution pote ntial at EiF [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a reduction of e m issions of about 96% (30-year pe riod). As the e nvironmental impact assessment does not cover the waste phase, emissions under the baseline as we ll as emissions avoided as a re sult of the re striction are likely unde restimated. Sufficie ntly strong e vidence that substitution costs are e x pected to be limited. No e vide nce on re formulation costs, one-off capital costs or administrative costs re lated to the transition have been identified, and the economic im plications for downstream users are expected to be lim ited. The re is sufficiently strong e vidence that a ban on polym eric PFASs in wind turbine blade coating is lik e ly to have lo w so cioeconomic co sts. Not applicable A rchitectural membranes (composite membranes with top coating) No t a p p licable Sufficie ntly strong e vidence that te chnically and e conomically feasible alte rnatives to replace fluoropolymers in composite m e mbrane top coating exists - but with som e loss of functionality (less soil re pe llence for some types) and re ductions in lifetime. No e vide nce pointing to a shortage in the supply of alte rnatives is available to the Dossier Submitters. C onclusion: High substitution pote ntial at EiF [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a reduction of e m issions of about 96% (30-year pe riod). As the e nvironmental impact assessment does not cover the waste phase, emissions under the baseline as we ll as emissions avoided as a re sult of the re striction are likely unde restimated. Som e alternatives are available on the m arket and lik e ly at a lowe r unit cost than fluoropolymer top coating. Substitution costs are e xpected to be lim ite d, if alternatives are available in sufficient q u a n tities. The available alternatives m ight have negative im pacts on the lifetime of polyester/PVC membrane and fiberglass fabric under harsh environmental conditions. Siloxane has less soil/dirt re pellence. As a re sult, higher maintenance costs are expected. As such, there is sufficiently strong e vidence that a ban of PFASs in architectural m embranes (com posite membranes with top coating) will likely be associated with m oderate socio-economic costs. Not applicable 464 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Conclusion A full ban of polymeric PFASs (FPs and PFPEs) in architectural coating and paints with a transition period of 18 months is proposed. A full ban of polymeric PFASs (FPs and PFPEs) in wind turbine blade coating with a transition period of 18 m onths is proposed. A full ban of polymeric PFASs (FPs and PFPEs) in coil coating with a transition period of 18 months is proposed. A full ban of polymeric PFASs (FPs and PFPEs) in architectural membranes (composite membranes with top coating) with a transition period of 18 months is proposed. Table E.147 summarises the outcomes of the assessment of costs and benefits for polymeric PFASs (fluoropolymers and PFPEs) in articles used as building material and construction products. Table E.147. Polymeric PFASs in articles used as building materials and construction products - Summary table on assessment of costs and benefits, based on a general transition period of 18 months (fluoropolymers and PFPEs). Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban A rchitectual membranes (pure Fluoropolym ers) No t a p p licable Sufficie ntly strong e vidence te chnically and e conomically feasible alternatives to replace pure fluoropolymer architectural membranes with non-PFAS composite membranes exists, but with som e loss of functionality (less soil re pe llence for some types) and reductions in life time. No e vide nce pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. C onclusion: High substitution potential at EiF [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment does not cover the waste phase, e missions under the baseline as we ll as e m issions avoided as a result of the re striction are likely unde restimated. Som e alternatives are available on the mark et and likely at a lowe r unit cost than pure fluoropolymer membranes. Substitution costs are likely to be lim ited, if alternatives are available in sufficient quantities. The available alternatives com posite architectural m e mbranes (polyester/PVC m e mbrane with TiO2 and fibe rglass fabric coated with silox ane) will have negative im pacts on the lifetime under harsh e nvironmental conditions, and fiberglass fabric coated with silox ane have less soil/dirt re pe llence. As a re sult, higher No t a p p licabl e 465 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact m aintenance costs are e x pected. As such, there is sufficiently strong e vidence that a ban of PFASs will lik ely be associated with m oderate socio-economic co s ts . Other aspects ETFE film/foil for greenhouses No t a p p licable Sufficie ntly strong e vidence that technically and e conomically feasible alternatives to re place ETFE film/foil in greenhouses e xist. No e vide nce pointing to a shortage in supply of alte rnatives is available to the Dossier Subm itters. C onclusion: High substitution potential [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment does not cover the waste phase, e missions under the baseline as we ll as e m issions avoided as a result of the re striction a re likely unde restimated. Sufficie ntly strong e vidence that substitution costs are likely to be lim ited, following the availability of alternatives (traditional products: glass and polye thylene foil), that likely dom inate the market. The e conomic implications for downstre am users are e xpected to be m oderate, as functional losses and re ductions in lifetime will le ad to higher m aintenance costs (polyethylene foil has a shorte r lifetime and glass is less fle x ible, re quire s more construction material (e.g. wood or m e tal) and not is selfcle aning). Only one s ta kehold er has re sponde d to the re que st for inform ati on The re is sufficiently strong e vide nce that a ban on ETFE film /foil for gre enhouses is lik e ly to have m oderate socioeconomic costs. 466 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects PTFE thread sealing tape No t a p p licable W e ak evidence that te chnically and e conomically feasible alternatives to replace PTFE thre ad sealing tape exist. Liquid/paste pipe thread is considered technically feasible alte rnative for permanent seals but the te chnical feasibility is unce rtain for nonpe rm anent seals. No e vide nce pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. C onclusion: High substitution potential at EiF in re lation to permanent seals [we ak e vide nce] and unclear substitution potential at EiF for non-permanent seals [inconclusive e vide nce]. Sufficie ntly strong information that R O 1 leads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment does not cover the waste phase, e missions under the baseline as we ll as e m issions avoided as a result of the re striction are likely unde restimated. The m agnitude of capital costs associated with substitution is unk nown and liquid/paste pipe thre ad may only partly be an alte rnative. If this is the case, som e R&D costs may also be e x pected. The re is we ak evidence that substitution costs are low, following the availability of alte rnatives and no indication pointing to significant capital costs or significant changes to ope rating costs. No t a p p licabl e Polymeric PFA Ss used as processing aids (PPA s) for production of non-PFA S polymers/pl astics No t a p p licable Sufficie ntly strong e vidence that technically and e conomically feasible alternatives to re place polymeric PFASs as processing aids for the production of thermo- and thermoset plastics in use in the building/construction se ctor e xist. But the re is we ak e vidence on the extent to which e x isting systems would need to be a d a pted . No e vide nce pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. C onclusion: High substitution potential at EiF [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment does not cover the waste phase, e missions under the baseline as we ll as e m issions avoided as a result of the re striction are likely unde restimated. Substitution costs are likely to be lim ited as alternatives (e.g. boron nitride and siloxanes) are available and likely of a lowe r cost. There is howe ver unce rtainty on whe ther alte rnatives can be considered drop-in alternatives or if re form ulation or adaptations to e x isting systems would be ne e ded. No t a p p licabl e The e conomic implication for downstre am users depends on whe the r alternatives can be considered to be drop-in alte rnatives. The re is we ak e vidence that 467 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects substitution costs are low, following the availability of alte rnatives, evidence pointing to lowe r costs of alternatives and no indication pointing to significant capital costs. Bridge and building bearings No t a p p licable W e ak evidence that te chnically and e conomically feasible alternatives are available to re place fluoropolymers (PTFE) in bridge and building bearings e xist. Steel rolle rs are considered technical feasibly but are m ore expensive and will likely re quire re de sign. No e vide nce pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. C onclusion: High substitution p otential at EiF [we ak e vidence]. Sufficie ntly strong information that R O 1 leads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment does not cover the waste phase, e missions under the baseline as we ll as e m issions avoided as a result of the re striction are likely unde restimated. The m agnitude of capital costs associated with substitution is unk nown, as it is unknown if ste e l rollers are available as drop-in alternatives. Steel rolle rs are stated to be significantly more e xpensive by stak eholders. The e conomic implications fo r downstre am users could be high, as alternatives require m ore space in constructions. Bridge s and buildings will the re fore likely have to be de signed differe ntly, which m ight also be associated with additional costs. If the higher costs of alternatives are passed on to downstre am users, downstre am users will also face consumer surplus losses. Only one s ta kehold er has re sponde d to the re que st for inform ati on The re is we ak evidence that a ban of PFASs in bridge and building bearings could be associated with high socioe conomic costs. 468 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects W indows f ram es (laminated with f luoropoly m e rs) No t a p p licable Sufficie ntly strong e vidence that technically and e conomically feasible alternatives to re pla ce P VC and HPL windo w fra mes lam inated with fluoropolymers (PVDF) exist. No e vide nce pointing to a shortage in supply of alte rnatives is available to the Dossier Subm itters. C onclusion: High substitution potential at EiF [sufficiently strong e vidence]. Sufficie ntly strong information that R O 1 leads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment does not cover the waste phase, e missions under the baseline as we ll as e m issions avoided as a result of the re striction are likely unde restimated. Sufficie ntly strong e vidence that substitution costs are likely to be lim ited, following the availability of alternatives. Alte rnatives to PVC and HPL fram es include traditional m ate rials for window frames such as woo d and metal. These alte rnatives have a high m arket share . Only one s ta kehold er has re sponde d to the re que st for inform ati on The e conomic implications for downstre am users are e xpected to be limited. Window fra mes m ade of wood will lik ely require m ore maintenance, but they also have a long lifetime if m aintained properly. The re is sufficiently strong e vide nce that a ban on fluoropolymers (PVDF) for lam inating PVC and HPL window fram es is likely to be associated with lo w so cio eco nomic co sts. Conclusion A full ban of pure fluoropolymer architectural membranes with a transition period of 18 months is proposed. A full ban of ETFE film/foil for greenhouses with a transition period of 18 months is proposed. A full ban of PTFE thread sealing tape with a transition period of 18 months is proposed. A full ban of polym eric PFASs used as processing aids for production of thermo and thermosetting plastics with a transition period of 18 months is proposed. A full ban of fluoropolymers in bridge and building bearings with a transition period of 18 m onths is proposed. A full ban of PVC and HPL windows frames lam inated with fluoropolymers with a transition period of 18 months is proposed. 469 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.13.5.2. Non-polymeric PFASs Table E. 148 summarises the outcomes of the assessment of costs and benefits for non-polymeric PFASs in building materials and c onstruction products. Because the side-chain fluorinated polymers degrade to non-polymeric PFAS (PFAAs) these are included in the table below. Table E. 148 Non-polymeric PFASs in building materials and construction products - Summary table on assessment of costs and benefits, based on a general transition period of 18 months (including PFAA-precursors). Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban Side-chain f luorinat ed polymers (PFA A precursors) used for surf ace protection/s ealants Not applicable Sufficie ntly strong e vidence that te chnically and e conomically fe asible alternatives to re place side -chain fluorinated polymers for surface protection/sealants exist. No e vide nce pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. C onclusion: High substitution pote ntial [sufficiently strong e vide nce]. Sufficie ntly strong information that R O1 le ads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment doe s not cover the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are likely undere stimated. Sufficie ntly strong e vidence that substitution costs are limited, following the availability of (though not always drop -in) alternatives. The alte rnatives are likely of lowe r costs. The economic implications for downstream use rs are expected to be moderate, as functional loss will le ad to higher maintenance costs due to lowe r soil/dirt re pellence which can be re le vant for some applications. The re is sufficiently strong e vidence that a ban on side-chain fluorinated polymers used for surface protection/sealants is likely to have m oderate socioeconomic costs. No t a p p licabl e 470 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects F luorosurf ac tants as wetting/leve lling agents in e.g. coating, paints and adhesives Not applicable Sufficie ntly strong e vidence that te chnically and e conomically fe asible alternatives to re place nonpolym eric PFASs (fluorosurfactants) ex ist. No e vide nce pointing to a shortage in the supply of alternatives is available to the Dossier Submitters. C onclusion: High substitution pote ntial [sufficiently strong e vide nce]. Sufficie ntly strong information that R O1 le ads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment doe s not cover the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are likely undere stimated. Sufficie ntly strong e vidence that substitution costs are likely to be limited, following the availability of alternatives. The alternatives are lik e ly of lowe r costs but might require higher am ounts. There are no drop-in alternatives, e x ce pt products (e.g. solvent based archite ctural paints and coatings) without fluorosurfactants that are available on the m ark et and can be seen as alternatives for ce rta in applications. Reformulation might be re quire d for some uses, howe ver the costs are to some e xtent likely to be absorbed by the PFHx A re striction proposal and the 3M announcement to e nd manufacturing and use of P FASs . No t a p p licabl e Pote ntially some we lfare losses following lowe r functionality, as some specific types of fluorosurfactants provide dirt/soil re pellence, which is not the case for alternatives. The re is sufficiently strong evidence that a ban o n P FAS is likely to have low so cio-eco nomic costs in re lation to fluorosurfactants as we tting/le velling agents in products such as coatings, paints, and adhesives. 471 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Nonpolymeric PFA Ss as processing aids Not applicable Sufficie ntly strong e vidence that te chnically and e conomically fe asible alternatives to re place the final products (architectural m e mbrane-like product) m anufacture d with a non-polymeric PFAS proce ssing aid exist. No e vide nce pointing to a shortage in the supply of alternative final products is available to the Dossier Subm itters. C onclusion: High substitution pote ntial at EiF [sufficiently strong e vide nce] Sufficie ntly strong information that R O1 le ads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment doe s not cover the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are likely undere stimated. Sufficie ntly strong e vidence that substitution costs are limited, following the availability of alte rnative final products (not produced with non-polymeric PFAS processing aids) as dropin. Alte rnative final products dominate the m ark et According to a stakeholder, alternative final products also meet building re gulations (not furthe r specified). The re is sufficiently strong e vidence that a ban o n P FASs is likely to have low so cio-economic costs in re lation to proce ssing aids for production of an architectural membrane-like p ro d u ct. No t a p p licabl e 472 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Not applicable Inconclusive e vidence on whe ther te chnically and e conomically fe asible alternatives exist for re placing non-polymeric PFAS proce ssing aids for production of acrylic foam tape. C onflicting inform ation - one stakeholder state d that no alternatives are available. Howe ver, later the stak eholder announced to e nd m anufacturing and use of PFASs. Sufficie ntly strong information that R O1 le ads to a re duction of emissions of about 96% (30-year period). Not assessed due to unclear substitution pote ntial As the e nvironmental impact assessment doe s not cover the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are likely undere stimated. No t a p p licabl e C onclusion: Unclear substitution pote ntial [inconclusive evidence ]. Window film m anuf act uri ng Not applicable Inconclusive e vidence on whe ther te chnically and e conomically fe asible alternatives exist for re placing non-polymeric PFASs (fluorosurfactants) for m anufacturing of window film . C onflicting information - one stak eholder stated that no alte rnatives are available. However, late r the stakeholder announced to e nd m anufacturing and use of P FASs . Sufficie ntly strong information that R O1 le ads to a re duction of emissions of about 96% (30-year period). As the e nvironmental impact assessment doe s not cover the waste phase, e m issions under the baseline as we ll as e m issions avoided as a re sult of the re striction are likely undere stimated. Not assessed due to conflicting information No t a p p licabl e C onclusion: Unclear substitution pote ntial [inconclusive evidence ]. Conclusion A full ban of side-chain fluorinated polymers used for surface protection/sealants with a transition period of 18 m onths is proposed. A full ban of non-polymeric PFASs (fluorosurfactants) as we tting/levelling agents in e .g. coatings, paints and adhesives with a transition period of 18 months is p ro p o sed. A full ban of non-polymeric PFASs used as processing aids with a transition period of 18 months is proposed. A full ba n of non-polymeric P FASs used for window film manufacturing with a tra nsition period of 18 months is pro posed. 473 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A ban on the use of non-polymeric PFAS in the building materials/construction products are indicated to have limited consequences. 474 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.14. Lubricants This Section addresses the use of PFASs in lubricants. Uses and volumes of PFAS -based lubricants are provided in Annex A.3.15. and emission calculations, including assumptions, are provided in Annex B.9.15. E.2.14.1. Baseline As described in Annex B.9.15.2. a basic source-flow model has been developed for assessing emissions from the use of PFAS-based lubric ants under the baseline scenario. One key caveat here is that 38 different PFASs (both polymeric and non-polymeric) have been identified as being in use or potentially in use with the quality of data available varying signific antly across all substances identified. Therefore, the approach taken did not aim to develop estimates on a substance-by-substance basis, but rather taken a grouping approac h. Where availability of data varies signific antly on a substance-by-substance basis a key benefit of using a grouping approach is that impacts of varying specific substance data are lessened. The trade-off of using suc h an approac h is that it means the estimates provided will have a higher unc ertainty attached to them overall. However, this approach can still provide useful data to estimate the orders of magnitude for emissions when comparing PFAS groups and different sectors. The projection of the time path of PFAS use (tonnage) and emissions under the baseline scenario considers expected growth rates for the relevant PFASs groups as shown in Table E.150. Table E.149. Assumptions for projecting tonnage volumes a nd emissions for PFAS-based lubricants. PFAS groups Pe r fluo r o po ly ethe rs (PF PE s ) Po ly te tr a fluo r o ethy le ne (PT F E ) Other PFAS-based additives than PTFE PFAS-based solvents used as carrier/deposition fluids PFAS-based solvents used as cleaning agents Assumption (2020 - 2070 ) A market research report by Grandview expects the demand for synthetic oils to grow by 5% annually between 2019 and 2025 (Grand View Research, 2021b). Specifically, for PFPEs a market research report by MarketResearch (2019) expects demand to grow by 4.2% annually between 2018 and 2027 driven by the aerospace, chemical sector, electronics sectors and other sectors (e.g. automotive and food sector). Industry feedback from C fE was that demand for fluorinated lubricants is expected to grow by 1 - 15% per annum in the short to medium term (next 10 years). Based on the C fE the sectors that use the highest volume of lubricants containing micro-powder PTFE are automotive, industrial and aerospace. C onsumer use accounts for approximately 7%. According to the definition of synthetic polymer microparticles in the restriction proposal of synthetic polymer microparticles, micropowder PTFEs are synthetic polymer microparticles. At the implementation of the proposed restriction (EC HA, 2020) for synthetic polymer microparticles consumer and professional uses of lubricants containing micro-powder PTFE are expected to be restricted. Uses at industrial sites are expected to be derogateda). The projection assumes that demand for micro-powders PTFE continues to grow slightly in 2021 and 2022 (2% increase in 2021 and further 1% increase in 2022). See text below See text below See text below 475 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PFAS groups before lubrication Assumption (2020 - 2070 ) a) The volume of use at non-industrial sites is not known Based on the information provided in Table E.149, for the baseline scenario of PFAS use and emissions in the lubricants sector a yearly real growth rate of 5% is assumed between 2020 and 2030, after which it is assumed to slow due to market saturation, increasing thereafter at 2.5% annually to 2040 and 1% annually after 2040. The same trends have been applied to PFAS- based solvents and additives in lieu of better data. The same trends have also been applied for PFAS-based solvents used as c leaning agents before lubric ation. Besides market trend data as discussed above, projections of PFAS use and emissions of lubricants considered feedback from industry stakeholders. The future projections do not inc lude any c onsideration of changes in usage (increase, decrease or replac ement) as a result of changes in technology. Likewise, the projections do not consider changes in abatement technology which may affect emissions. The potential effect of a REACH restriction on synthetic polymer microparticles on the future use of micro-powder PTFE has not been accounted for but could have a substantial impact as consumer and professional uses are likely to be banned. The start year of the projection of tonnage and emission estimates is 2020 as presented in Table E.150. Table E.150. Projected yearly PFAS use and emissions in the lubricants sector of the EEA between 2020 and 2070 in tonnes (mean values based on market trend data) . PFAS use PFAS emissions 2020 1 666 219 2025 2 126 279 2030 2 713 357 2035 3 069 403 2040 3 473 457 2045 3 650 480 2050 3 836 504 2060 4 237 557 2070 4 681 615 The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during formulation and the use phase (thus not the waste stage). In Annex B.9.15.2 emissions from PFAS-based lubricants were determined by applying standard environmental release categories to the range of tonnages (low and high) provided by stakeholders (Annex A.3.15.2). Emission estimates represent emissions during the service-life of products containing PFAS and their formulation (including manufac ture of sealed artic les). Table E.150 provides mean values projec tions of these emission estimates. The life-cycle stage with the highest emissions is `in-use' sealed applications (likely from maintenanc e, faults, leaks, etc.). However, proportionately `in-use' open applic ations are far more emissive. In terms of substance groups emissions is dominated by polymeric PFASs (PFPE base oils and micro-powder PTFE) that account for approx. 80%. However, the polymeric PFASs also account for 93% of the tonnage. Proportionately PFAS-based solvents are more emissive as they account for approx. 20% of the emissions, even though, they only account for 7% of the tonnage. Emissions from the use of PFAS-based solvents is dominated by c leaning as the use of cleaning agents before the lubric ation process account of the approx. 80% of the total use of PFAS-based solvents. Other lubricant additives than micro-powder PTFE account for less than 1% of the emissions and tonnages. Based on the assumptions made about market trends for PFAS-based lubricants, emissions can be expected to increase over time. During the assessment period emissions will likely more than double. 476 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.24 shows expected PFAS use and emissions (all PFASs) for the lubricants sector as a whole, based on available market data and assumptions on growth rates shown in Table E.149. Growth rates adopted for PFAS use were also applied to emission projections. Figure E.24. Expected PFAS use and emissions in EEA under the baseline in the lubricants sector (mean values) [tonnes]. E.2.14.2. Alternatives E.2.14.2.1. Description of the use and function of the restricted substance(s) As described in Annex A.3.15.1 PFASs is used in lubricants as base oils in low viscosity lubricants and greases (PFPEs, PCTFE and fluorosilicone oil), and as additives (e.g. micropowder PTFE, PFPEs and surfactants) in low viscosity lubricants, greases and solid/dry -films lubrication with release-agents being a special type of solid/dry-films lubrication. Besides the uses mentioned above, PFAS-based solvents are also used for spec ial applic ations as c arrier and deposition solvent in lubrication and as cleaning agents for precision cleaning before the lubrication process (not part of the lubricant). According to stakeholders, PFAS-based lubricants are used in many sectors in situations where they are superior in terms of technical performance under extreme/harsh conditions c ompared to other lubric ants and/or where other types of lubric ants would not be technically feasible. A description of technical functions of PFAS-based lubricants is given in Annex A.3.15.1. Key functions that are often mentioned are: Temperature resilience (large temperature service range), c hemic al inertness and a very low c oefficient of fric tion. E.2.14.2.2. Availability of alternatives The amounts/volumes of PFAS-based lubric ants account for less than 1% (or even less than 0.1%) of the overall lubric ants market, depending on how exac tly lubric ants are defined. One stakeholder in reply to the 2nd stakeholder consultation estimates that PFPE lubricants account for less than 0.015% of the total lubricant market. Even though there is a large non-PFAS lubric ant market most responses to the CfE state that no or no appropriate alternatives to PFAS-based lubricants are known or available for the 477 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) specific applications for which the PFAS-based lubricants are applied. Several stakeholders note that various alternatives have been researched and tested over the past decades, but without success. This message was generally repeated during the targeted stakeholder consultation and the 2nd stakeholder consultation. E.2.14.2.3. Identification of potential alternative substances and techniques fulfilling the function Alternatives to PFAS-based base oils Some common non-PFAS lubricant base oils on the European market are: Crude oil: Mineral oil available in many different fractions. Synthetic base oils: e.g. poly-alpha-olefins (PAOs), silicone oils (polysiloxanes) and esters of fatty ac ids with alc ohols (inc luding polyols) Natural sources (oils, fats and waxes of vegetable or animal origin) other than crude oil In general, stakeholders agree that it is very difficult to substitute PFPE as base oil in many applic ations, exemplified by the following statement from the 2nd stakeholder c onsultation: "There is currently no alternative which has the same properties as PFPE such as low vapor pressure, amphiphilic, resistance against aggressive media, resistance of oxygen, not being flammable, being inert, clean in the usage of high temperature applications, very long service life time behavior and excellent low temperature properties up [down] to -80 C and radiation resistant.". The temperature service range for the PFPE base oils goes from approx. -80 C to approx. 350 C (depending on the type of PFPE). The type of non-PFAS lubricant base oils mentioned above, that c ome c losest to this, are silic on oils with a temperature servic e range of approx. -70 C to approx. 200 C. Silicone lubricants and greases are used for some specific applic ations for whic h a temperature above 200 C is not required. Ac cording to replies in the 2nd stakeholder consultation they are compatible with most elastomers (except silicone) but they are more affected by radiation than PFPEs and have at worst lubrication behaviour and cause more wear and tend to spread. Breakdown voltage of silicone is poor compared to PFPE formulated lubric ants. Silic one oil is not c onsidered as flammable material but c an burn when it reaches a certain temperature, which is not the case of PFPE formulated lubricants. Furthermore, it is commented in the 2nd stakeholder consultation that: "Silicone alternatives can remain on the finished articles surface and will reduce the technical performance. E.g. silicone on tire surface will reduce grip between tire and road which is relevant for road safety.". For these reasons silicon oil is not considered a proper alternative to PFPE base oil - at least not for all applications, and especially not under harsh conditions. Long service life can also be a key property for safe functioning and safety of equipment exemplified by c irc uit breakers and switchgear that must work reliable when required even if not being used for years. According to the 2nd stakeholder consultation Switchgear can have a lifetime of 40+ years. No information was received on potential alternatives to other PFAS base oils like PCTFE or fluorosilicon oils. However, the technical properties of PCTFE and fluorosilicon base oils is c omparable to the technical properties of PFPE base oils (Annex A.3.15.1). Alternatives to micro-powder PTFE as lubricant additive As described in Annex A.3.15.1 micro-powder PTFE is used as both a friction modifier and grease thickener. Micro-powder PTFE provides one of the lowest coefficients of friction of any solid lubricant on the market. As a grease thickener micro-powder PTFE provides superior chemical inertness in harsh/extreme operating conditions that enables longer grease life in servic e. Many PFPE greases use PTFE as the thickener providing a grease where both base oil 478 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and thickener have superior chemical inertness allowing the finished grease to provide long and effective service in harsh c hemic al environments. Ebnesajjad S. & Morgan R (Eds.) (2019) mention that in addition to fluoropolymers such as micro-powder PTFE, the other solid additives that may typically be used in lubricants are graphite, molybdenum disulphide (MoS2), and boron nitride (BN). For Low Viscosity Lubricants and dry-film lubric ation Ebnesajjad S. & Morgan R (Eds.) (2019) highlights that a mixture of micro-powder PTFE and boron nitride performs better than micro-powder PTFE and boron nitride on their own and also better than graphite and molybdenum disulphide. For grease clays e.g. bentonite may be used in combination with PTFE to thicken synthetic base oils such as polyalphaolefin oils, esters and PFPE oils. Silicon oil (polysiloxane) greases are commonly thickened with a mixture of amorphous fumed silica and PTFE. Molybdenum disulphide, graphite, talc and zinc oxide can also be used as grease additives (Ebnesajjad S. & Morgan R (Eds.), 2019). The solid additives mentioned by Ebnesajjad S. & Morgan R (Eds.) (2019) was also mentioned by stakeholders in the CfE and targeted stakeholder consultation. A few other potential alternatives were identified in literature such as Blac k Phosphorous (BP) (Wang et al., 2018), Tungsten disulphide (WS2), (modified) graphene (Liu et al., 2019), and silicone oil thickened with polyurea as a substitute for a PTFE-thickened silic one oil (ELKALUB, 2020). In the questionnaire for the 2nd stakeholder consultation, stakeholders were asked if the above mentioned non-PFAS alternatives are seen as technically feasible alternatives to micropowder PTFE in their products or processes. A summary of the stakeholder replies is given below. Graphite and molybdenum disulphide are used in combination with PTFE micropowders but c annot be used alone as thic keners for PFPE base oils due to inc ompatibility. They do not provide the same coefficient of friction that PTFE does. They are more beneficial in carrying load rather than providing low friction. Micro-powder PTFE is more chemically resistant than graphite and molybdenum disulphide and allows for clean conditions. Micro-powder PTFE has an excellent plastic/elastomer compatibility were graphite or molybdenum disulphide fail. Graphite and molybdenum disulphide is not inert or water resistant. Graphite needs water to fully activate its low friction properties and some applications may under no circumstances contain water ( e.g. HVACR refrigerant circuits). Modern lubricants are formulated to function at different temperatures - commonly from -40 C (or even lower) to 260 C (the highest heat resistance among organic lubricants). PTFE is an important component to achieve that. Molybdenum disulphide is electrically conductive, PTFE is resistive. It is also highlighted that PTFE is suitable for incidental food contact applications whereas graphite and molybdenum disulphide are not, and that PTFE is white whereas molybdenum disulphide and graphite are blac k. One stakeholder state that this leads to more pollution in the production facilities. Boron nitrides are used in combination with PTFE micropowders but cannot be used alone as thickeners for PFPE base oils due to incompatibility. Boron nitride has a completely different lubrication behavior than PTFE. Modern lubricants are formulated to function at different temperatures - commonly from -40 C (or even lower) to 260 C (the highest heat resistance among organic lubricants). PTFE is an important component to achieve that. One stakeholder also states that their customers do not allow them to use boron nitride, especially the automotive industry does not allow this (not further explained). Other inorganics: Talc is used in combination with PTFE micropowders. Graphene, silica and zinc compounds have a completely different lubrication behavior compared to micro-powder PTFE and that for many applications in the electronic industry it is difficult to use graphene as an alternative to micro-powder PTFE because of its 479 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) hardness, which can damage the mating material, the higher dosage, and the potential for electrical effects when released due to its electrical conductivity. Silica is hard and not low in friction. Silica thickened grease can perform poorly in high s hear applic ations. One stakeholder further state that their c ostumers do not allow them to use silica, especially the automotive industry does not allow this (not further explained). Silicone oil thickened with polyurea: The question in the questionnaire for the 2nd stakeholder consultation on the use of polyurea as a substitute for a PTFE-thickened silicone oil is related to a specific application in a progressive distributor on the central filler carousel in a brewery. This was commented on in the 2nd stakeholder consultation were one stakeholder agreed that "polyurea is a very good option in bearing with a very high-speed application" but that micro-powder PTFE-thickened silicone oil can do the same job and has additional applic ations/benefits as well. It was also stated in the 2nd stakeholder consultation that polyurea thickeners don't perform well in harsh chemical environments and can degrade at elevated temperatures meaning that the lubricant will fail or require more frequent lubrication (if possible). Further it is stated that life span of PFPE-based lubricants much longer than polyurea lubricants (up to 21 times). In the questionnaire for the 2nd stakeholder c onsultation there was also a question on the use of 'water-based phenolic-melamine gold lac quer' as an alternative. However, it does not seem like this is used as a lubricant and is therefore not further discussed. Besides answers on the specific alternatives mentioned in the questionnaire for the 2 nd stakeholder consultation and summarised above, several stakeholders in general stated that the suggested alternatives don't meet requirements for their applications. In fact, only two stakeholders replied that they considered the alternatives to be technically feasible, one NGO and one downstream user in the food industry (without mentioning specific application). The other nine stakeholders that specifically mentioned food industry in their answers generally did not see the alternatives as technically feasible for their applic ations. The replies to the 2nd stakeholder consultation refer to the use of micro-powder PTFE in many different sectors such as food industry, transportation (including aerospace and aircrafts), energy sec tor, electronics industry, chemic al industry etc. (see also Annex A.3.15.1). In most replies stakeholders refer to uses under harsh conditions (very high or low temperatures, very high or low pressure, strong chemical conditions like strong acids/bases or corrosive chemicals, oxidizing or reducing substances, radiation etc.) and safety such as chemical contamination of food, pharma and medical products. Some uses of micro-powder PTFE do, though, not take place under harsh conditions or for safe func tioning and safety of quipment - exemplified by dry-film lubric ation of bike c hains and lubrication of door hinges and noise reduction in automotive. Lubrication of bikes chains is not mentioned in the 2nd stakeholder consultation. However, in the targeted stakeholder consultation, this lubricant use was not considered important by stakeholders. Furthermore, Glge et al. (2022) states for bic ycle lubric ants that: "There are lubricants on the market that do not contain PTFE and perform well according to tests and user experiences". For lubrication of door hinges and for noise reduction in automotives no information was received in the 2nd stakeholder consultation on the applicability of graphite, molybdenum disulphide, boron nitride etc. There are other lubricants on the market than PTFE-based lubricants that can be used for door hinges in automotives such as lithium grease (e.g. WD40 Specialist High Performance White Lithium Grease) or silicone (e.g. WD-40 Specialist High Performance Silicone Lubricant). An alternative marketed for (among other things) reduc tion of friction and noise in automotive c omponents is tungsten disulphide (WS2) (2020 Micro Surface Corp) is also available. It can't be excluded that these alternatives 480 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) require re-lubrication. The availability of alternatives to micro-powder PTFE for lubrication of door hinges and for noise reduction in automotives suggests that there are alternatives on the market applied under conditions that is not considered to be harsh or for safe functioning and safety of quipment. However, it is uncertain if alternatives are available for all these types of applications, as only a limited number of these application has been identified (Table A.58 in Annex A.3.15.1). It should be noted that non-industrial uses of micro-powder PTFE will likely be targeted by the restriction proposal on microplastics, as RAC and SEAC in their opinion on an Annex XV dossier proposing restrictions on intentionally added microplastics (ECHA, 2020) proposes only a derogation on the use of microplastics at industrial sites. It is specifically mentioned in the opinion that: "SEAC considers that insufficient information was provided to assess the need to derogate lubricants". If the EU commission follows this opinion, it will be the driver for substituting the use of mic ro-powder PTFE in lubric ants in non-industrial uses. Alternatives to PFAS-based solvents and additives (other than micro-powder PTFE) As described in Annex A.3.15.1 PFAS-based lubricant additives other than micro-powder PTFE c an be both polymeric PFASs and non-polymeric PFASs. Functionalised PFPEs is used e.g. as corrosion inhibitors for oils and grease based on PFPE base oils (used under harsh conditions) and as lubricants for magnetic media, where high thermal stability is required. Only four of the substances identified as being in use or used at some point in lubricant applications in Annex A.3.15.1 was non-polymeric PFASs. There is limited information on their exact uses, but they all seem to be intended for use at high temperatures. PFAS-additives are the only additives that is compatible with PFPE base oils. In the targeted stakeholder consultation, stakeholders commented that: Fluorinated additives act as strong adsorbing agents for PFPE/PTFE and therefore reduce leakage of PFPE/PTFE into the environment. As long as PFPE-based lubes have to be used, the function of the fluorinated additives -they are polymers- c annot be substituted." In the 2nd stakeholder it was repeated that PFAS-additives cannot be substituted. Given the available information the Dossier Submitters assume that this statement means that they cannot be substituted under harsh c onditions. No further information on additives was identified. In relation to the use of PFAS-based solvents/functional fluids (referred to as fluorinated solvents in Annex E.2.8) as carrier and deposition solvent in lubrication, it was stated in the targeted stakeholder consultation that: "Fluorinated solvents cannot be substituted as long as PFPE/PTFE is to be dissolved for minimum quantity lubrication". This message was repeated in the 2nd stakeholder consultation were one stakeholder added that the solvent that comes closest to the PFAS-based solvents in terms of technical feasibility is the chlorinated and brominated solvent: trichloroethylene, tetrachloroethylene, dichloromethane, and N-propyl bromide. These substances all have a harmonised classification under CLP as CMR and can therefore not be seen as safe and feasible alternatives. The same goes for benzene, D4 and hexane mentioned by another stakeholder in a reply to the 2nd stakeholder c onsultation. The same stakeholder also mentioned trans-1,2-dichloroethylene, isopropyl alcohol and heptane as carrier solvents. trans-1,2-dichloroethylene seems only to be used in combination with PFASs (hydrofluoroethers) (3M, 2021). According to Ebnesajjad S. & Morgan R (Eds.) (2019) solid/dry-film lubricants can contain e.g. water, low-MW hydrocarbons, or a polar organic compound such as isopropanol or acetone as carrier solvent for easy evaporation. These solvents cannot dissolve PFPEs. In the present assessment no alternatives to PFAS-based solvents as carrier and deposition solvents have been identified that c an be used in c ombination with PFPE base oils. 481 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.14.2.4. Risk reduction, technical and economic feasibility of alternatives Tec hnical feasibility of alternatives See previous section. Economic feasibility of alternatives PFAS based lubric ants, in general In response to the 2nd stakeholder consultation one stakeholder noted how PFAS-based grease only is selected when there are no alternatives, due to the high cost. The costs have also been commented upon by a lubricant producer during the targeted stakeholder consultation, who underlined the price difference between respectively PFAS-based and non-PFAS-based lubricants with the comment: "Fluorinated lubricants may cost the end-user 300-600 $/kg. Non-fluorinated lubric ants have a purc hase pric e of perhaps 15-40 $/kg and a little higher if one moves into a basic silicone grease." PFPE base oils It has not been possible to perform any quantitative estimat es on comparative unit costs between PFPE base oils and alternatives. Stakeholders argue how the use of PFAS-based lubricants is of higher price than when applying traditional lubricants, which leads to a natural substitution when possible; this has however been challenged by Rudnic k (2020). Rudnic k (2020) finds the many benefits of PFPE based oils and greases makes these lubricants the most cost-efficient solution, despite the initial pric e being higher. As the lubric ants based on PFPE base oils have a longer lifetime and inc reased load-carrying c apability, the equipment where it is applied is likely to have a longer lifetime whereby costs are reduced. Additionally, these lubricants have a lower need for relubrication, which decrease the labour costs. By regenerating the P FPE base oils, manufactures are moreover able to reuse oils at low costs. Hereby, the total cost of lubrication is not c onsidered, when arguing alternatives are c heaper, why the oils and greases based on PFPE base oils can be used for general-purpose lubrication. Grechin et al. (2018) has also c ommented on the total c osts and how less re-lubrication, when using PFAS-based lubricants, can lead to lowered operation/maintenance costs. This is however only relevant when there are technically available alternatives which just need more re-lubrication. Micro-powder PTFE as lubricant additive In respect to micro-powder PTFE alternatives one stakeholder stated in the 2nd stakeholder consultation how non-PFAS materials are either more expensive or at least not cheaper than PFAS solutions. This was supported by two other stakeholders, who commented on how the alternatives boron nitride and graphene are of higher cost than PTFE, and additionally show reduced performance. More specifically the stakeholder noted how the costs are 2 to 3 times higher when applying the alternatives instead of micro-powder PTFE, while requiring the same dosage rates. It was moreover noted how the alternatives will require to be tailored to the relevant applications. According to data presented by Ebnesajjad S. & Morgan R (Eds.) (2019) the alternative graphite is of lower cost than micro-powder PTFE, while molybdenum disulphide and boron nitride are of higher costs. PFAS-based solvents and additives (other than micro-powder PTFE) Stakeholders have commented that there are no technical nor economic alternatives. According to one stakeholder, t he PFAS-based solvents can cost up to 10 times more than non-fluorine c ontaining materials. Therefore, the PFAS-based solvents are only applied when 482 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) their properties cannot be met by other materials. To replace the costs related to research, development, testing, qualifications, and changes of processes are to be expected. These costs are, according to the stakeholder, likely to be passed on to downstream users. Stakeholder input on transition periods As described in Annex A.3.15.1 PFAS-based lubricants in used in many different sectors. Almost all the described uses are under harsh conditions, which means that uses in many cases are related to safety. For all these different sectors there are different legislation and/or standards. In reply to the 2nd stakeholder consultation, the following was mentioned: Food industry approval (including lubricant that allows for incidental contact with food), drinking water approval, gas contact approval, approval for oxygen contact, Medical Device Regulation, in Vitro Diagnostics Regulation, Low Voltage Directive, Machinery Directive, Pressure Equipment Directive etc. According to stakeholders' approval can take up to 5 years depending on application. According to stakeholders the critical point is to develop alternatives. This will take at least 10 years if at all possible PFPE base oils. Concluding remarks PFAS-based lubric ants are superior in terms of tec hnical performanc e under harsh c onditions (very high or low temperatures, very high or low pressure, strong chemical conditions like strong acids/bases or corrosive chemicals, oxidizing or reducing substances, radiation etc.) c ompared to other lubric ants and/or where other types of lubric ants would not be technically feasible. Further, they are also used for safe functioning and safety in e.g. circuit breakers and switchgear (long lifetime) and according to stakeholders also in food industry (avoid chemical contamination due to inertness). No alternatives to the use of PFAS base oils and micro-powder PTFE under harsh conditions or for safe functioning and safety of quipment have been identified. As PFAS-additives (other than micro-powder PTFE) and PFAS-based solvents are the only additives and solvents that are compatible with PFAS-base oils, they must follow the PFAS base oils in terms of a ban or derogation. The Dossier Submitters, therefore, conclude based on information from CfE, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically feasible and economically feasible alternatives are unavailable for the quantities required for use in lubric ants under harsh c onditions or for safe functioning and safety of equipment and that the substitution potential is low. For PFAS-based lubricants used under other conditions there is an indication that alternatives are available. This is exemplified for the use of micro-powder PTFE for lubrication of dry-film lubrication of bike chains and lubrication of door hinges and noise reduction in automotive. However, it is unclear to the Dossier Submitters, if alternatives are available for all uses PFASbased lubricants not applied under harsh conditions or for safe functioning and safety of equipment. Cleaning agents for precision cleaning before the lubrication process, is covered in the assessment of industrial cleaners in Annex E.2.8 (Application of fluorinated gases). E.2.14.2.5. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) were assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHA's dissemination site. In relation to lubricants, t he list of alternatives contained 20 unique CAS numbers. Fourteen (14) of the substances with unique CAS were classified according to CLP (harmonised 483 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) classification or self-classification). Of these seven substances, as also mentioned in Annex E.2.14.2 has a harmonised classification as CMR. One of the substances with unique CAS number (Octamethylcyclotetrasiloxane (D4)) do, according to the registration dossier, fulfil the PBT or vPvB criteria. For the other substances with unique CAS number, the PBT or vPvB criteria were not fulfilled or were not applicable. Silicon oil may contain D4, D5, and/or D6 as residues. It is noted in ECHA (2019) that under certain conditions (high temperatures, presence of certain types of fillers), silicone polymers can break down resulting in low concentration of D4, D5 and D6 within the polymer matrix. D4, D5 and D6 have been identified by ECHA's Member State Committee as SVHC substances with PBT/vPvB properties (ECHA, 2019). The list c ontained additional substance with a c ommon name for whic h no CAS numbers were available. For thise substance, no information on c lassification or PBT and vPvB assessments were available. Appendix E.2. c ontains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.14.3. Environmental impact Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.14.1, assuming baseline and, consequently, on-going use of PFAS-based lubricants and emissions. The analysis of environmental impacts focuses on two restriction options: RO1, adopting a ban of all PFASs used in the lubricants sector; RO2, adopting a ban on PFASs in combination with use-specific derogations. Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation, both preceded by a transition period of 18 months. Environmental impacts of RO1 are analysed quantitatively. Likewise for the use-specific derogations emission are available, though not in the same way for all PFAS groups affected by the derogation. There is, however, information availale about maximum additional emissions assuming a full derogation of the relevant PFAS groups. Note that this reference scenario does not represent a restriction option but is used for comparative purposes only. Table E.151 below summarizes the characteristics of the restriction options, and the maximum additional emissions scenario. Table E.151. Characteristics of restriction options and of maximum additional emissions scenarios. Restriction option abbreviation RO1 RO2 Maximum additional emission scenarios Short description Full ban Ban with use-specific derogations Ban with full derogation of entire PFAS groups Derogations --- Proposed derogation: Lubricants where the use takes place under harsh conditions or use is for safe functioning and safety of equipment- 12 years PFAAs incl. PFAA precursors; polymeric PFAS, PFPEs, fluorinated gases Transition period after entry into force 18 months 18 months 18 months Duration of derogation --- 12 years 12 years For calculating the expected emission reduction, the assumed entry -into-force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, restriction 484 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) options are expected to be implemented in 2027. All emission estimates represent mean values. Table E.152 shows mean emissions and the expected mean emission reduction for a time path of 30 and 45 years (starting in 2025) for RO1 as well as for the maximum additional emission scenarios. Table E.152. Total mean emissions and emission reduction of RO1 and maximum additional emission scenarios (lubricants sector, in tonnes). Restriction option Baseline RO1 Maximum additional emission scenario `12-year derogation of all fluoropolymers'* Maximum additional emission scenario `12-year derogation of all PFPEs ' * Maximum additional emission scenario `12-year derogation of all PFAAs incl. PFAA precursors'* Maximum additional emission scenario `12-year derogation of all fluorinated gases'* Maximum additional emission scenario `12-year derogation of all fluoropolymers, PFPEs, PFAAs incl. precursors, and fluorinated gases'* Baseline RO1 Maximum additional emission scenario `12-year derogation of all fluoropolymers'* Maximum additional emission scenario `12-year derogation of all PFPEs'* Maximum additional emission scenario `12-year derogation of all PFAAs incl. PFAA precursors'* Maximum additional emission scenario `12-year derogation of all fluorinated gases'* Maximum additional emission scenario `12-year derogation of all fluoropolymers, PFAAs incl. precursors, and fluorinated gases'* Mean total emissions [t] 2025-2055 20 698 884 Mean total emission reduction [t] Mean total emission reduction [%] --- --- 19815 96 2 349 18 349 89 1 833 18 865 91 890 19 809 96 1 808 18 890 91 6 088 14 610 70 2025-2070 33 990 --- --- 884 33 107 97 2 349 31 641 97 1 833 32 157 94 890 33 101 97 1 808 32 182 95 6 088 27 902 82 * Maximum additional emission scenarios denote worst-case emission scenarios (assuming a full derogation of a particular PFAS group) against which emissions of proposed use-specific derogations are evaluated qualitatively. They do not represent restriction options. Source: Own calculations based on emission calculations (Annex B.9.15.2) and estimated market trend data collated by the Dossier Submitters. As illustrated in Table E.152, a full ban (RO1) on PFAS-based lubricants leads to a mean 485 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) emission reduction of about 96% compared to the baseline scenario, depending on the length of the timeline. A generic derogation of fluoropolymers and PFPEs leads to higher emissions and reduc es the effectiveness of the restric tion. Environmental impac ts of RO2 are disc ussed below for the proposed derogation. (i) Proposed derogation: Lubric ants where the use takes plac e under harsh c onditions or use is for safe func tioning and safety of equipment The derogation is proposed for a time period of 12 years after EiF of the restriction and the 18 months transition period. The proposed derogation covers all uses of PFPEs, PFAAs and their precursors, fluorinated gases, and a large fraction of fluoropolymers. While it is not possible to quantify the precise tonnage and amount of emissions of fluoropolymers (mainly micro-powder PTFE) covered by the derogation, it is assumed that the derogation will cover about 96% of fluoropolymer emissions. There is, therefore, sufficiently strong evidence that the proposed derogation will cause substantial additional emissions. Assumung that the derogation causes all emissions from PFPEs, PFAAs and their precursors, and fluorinat ed gases, and 90% of fluoropolymer emissions to continue for 12 years, additional mean emissions can be expected to be about 5 249 t, which is close to the maximum additional emission scenario (= 6 088 t). As a result of the derogation, the effectiveness of the restriction is expec ted to decrease to 70%. Figure E.25 shows the time path of mean emissions from the use of PFAS-based lubricants under the baseline, RO1 and maximum additional emission scenarios. Figure E.25. Time path of mean emissions from the use of PFAS-based lubricants under the baseline, RO1 and maximum additional emission scenarios [tonnes]. Source: Own calculations based on emission calculations (Annex B.9.15.2) and estimated market trend data collated by the Dossier Submitters. 486 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.14.4. Economic and other impacts Lubricants are used in many products and applications, within a broad range of sectors and industries and throughout various supply chains. Less than 1% (some say <0.1%) of all lubricants on the EU market are PFAS-based. No safe alternatives to the use of PFAS-based lubricants under harsh conditions or for safe functioning and safety of equipment has been identified. Therefore, according to industry, substitution of the PFAS-based lubric ants has not been considered up until now. Industry expects that a ban of PFAS-based lubricants will have large impacts on substitution costs, technical and transitional cost related to development and implementation of alternatives, and c osts related to functionality loss. These impac ts will not just be inflicted on the lubricant industry, but also the downstream users of lubricants - and hence the products and sectors where the PFAS-based lubricants are applied. Despite the broad use of lubricants, it has not been possible to identify any information in literature associated to potential costs related to the substitution of PFASs within this industry. To assess some of the effects of a restriction, information has instead been collected though CfE, targeted stakeholder consultation and 2nd stakeholder consultation. In the CfE and stakeholder consultations it was recognised that the industry has not performed any in-depth assessment of the consequences and impacts following a restriction on PFASbased lubricants. According to industry such an assessment will require substantial effort and time, following the complexity of the many affected downstream sectors and uses. The many c omplex and individual produc tions and uses of PFAS-based lubric ants, means that it will not just be challenging to assess economic impacts, but that it also will be difficult to perform substitution and transition to alternatives. E.2.14.4.1. Substituting PFAS-based lubricants PFAS-based lubricants have many properties, especially under harsh conditions, and developing and implementing new types of lubric ants with the same high level of performance is generally c hallenging as there are few or no relevant alternatives available -this is especially the case for PFAS base oils, though there are some exceptions. For (some) applications of micro-powder PTFE under non-harsh conditions and where safe functioning and safety of equipment is not an issue, there are alternatives available. This this for example the c ase for dry-film lubrication of bike chains, lubrication of door hinges, and noise reduction in automotive. As alternatives for these applic ations may require re -lubric ation, it c an have an impac t on downstream users. Following the absence of drop in alternatives or alternatives with similar properties under harsh conditions or for safe function and safety of equipment, substituting PFASs in lubricants will take a long time, which is estimated to take at least 10 years by stakeholders. The Dossier Submitters note that the industry responses seem not to have accounted for an anticipated ban on micro-powder PTFE used at non-industrial sites following the expected restriction on synthetic polymer microparticles (microplastics). During the development of this restriction opinion SEAC received a derogation request for lubricant applications, however SEAC considered insufficient information was provided to assess the need to derogate lubricants (ECHA, 2020). Based on the expected ban on synthetic polymer mic ropartic les, the Dossier Submitters c onsider any c osts related to transitioning away from micro-powder PTFE in lubricants, for the consumer and professional markets, not to be relevant for this restriction proposal on PFASs, as the costs are likely to be absorbed by the restriction on synthetic polymer microparticles. E.2.14.4.2. Costs related to a restriction of PFAS-based lubricants While there c urrently is no known safe drop-in alternative available under harsh c onditions or for safe functioning and safety of equipment, the industry expressed how a possible, future transition to alternatives is likely to be costly, t ake time and not necessarily be safer, additionally, approval for use might (for some sectors) also be a lengthy and costly process. 487 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Despite the lac k of data, stakeholders agree on how the c osts of a ban will be very high, and the impacts likely to be passed on to downstream sectors using the PFAS-based lubricants. It is expected that these users will have to develop new technologies or discontinue their operations following a restriction. Based on the CfE and targeted stakeholder consultations it was possible to define the following expected economic costs of substitution: R&D and reformulation costs o Search for and development and testing of alternatives o Reformulation and industrialisation of alternatives in lubricants o Regulatory approval or certification costs Substitution costs o Raw material c osts (i.e. price difference with PFASs and differences in volumes needed) Costs incurred by downstream users o Changes in equipment/machinery/installations o Training of personnel o Occupational safety measures (?) E.2.14.4.3. Substitution costs Among the anticipated substitution costs were the costs of higher quantities of alternatives compared to the current amounts of applied PFAS-based lubricants. Despite not having much information on the price (differences), higher volumes of alternative substances might indic ate higher c osts in general. Some stakeholders have estimated these c osts c ould range between 50 000 to 5 million, but without any reasoning for the estimates. One stakeholder supported this with the example on how 15-25 times higher quantities of lubric ant are needed when using a premium quality ester-based lubricant as a substitution for the PFPE-based ones. It was also suggested how there in some environments might be a need for more often reapplication of the lubricants, when using alternatives for PFAS-based lubricants. With respect to alternative technologies (without further specification) possible costs were estimated as follows: 50 000 to 200 000 per industrial application, 200 000- 500 000 per automotive application, 500 000 to 1 000 000 per aerospace application. The total substitution costs for an average project duration of 3-5 years per product were estimated to range between 500 000-1 000 000 per product. At least 3 raw materials would be affected for this particular stakeholder, so the costs for them would be in the order of 1.53 million. The estimated substitution costs are presented in the Table E.153 below. Table E.153. Substitution costs as estimated by stakeholders. Substitution costs type Costs of higher substance quantities Estimated costs 50 000 to 5 million Per industrial application A lte r na tiv e Per automotive technologies application Per aerospace application Total substitution cost, for an average project (3-5 years) per product 50 000 to 200 000 200 000 to 500 000 500 000 to 1 000 000 500 000 to 1 000 000 With respect to the development of new alternatives, stakeholders from various sectors 488 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) suggested to need at least a 10-year period to develop and qualify new alternatives. E.2.14.4.4. Other costs According to some stakeholder input, reformulation costs (i.e., costs covering the effort to change the chemical formulation of products when PFASs is replaced with an alternative in that product) could range between some 50 000 and 3 million per lubricant formulation and/or per application. It was, however, also emphasized that it is not possible to put a spec ific estimate on these c osts, as there are no relevant alternatives available. A possible reformulation is likely to impact the design of downstream uses and productions, which creates ground for a requirement of a long transition period, which is likely to be costly in terms of time as well as R&D, laboratory and field tests, screening, impleme ntation, etc. E.2.14.4.5. Functionality loss PFAS-based lubricants are used in many downstream products, installations, and applications within a broad range of sectors/industries such as the food industry, transportation (including aerospace and airc rafts), energy sector, electronics industry, c hemic al industry etc. Some of the uses require high levels of security, safety and certainty, which the PFAS -based lubricants deliver, with their many properties suc h as long service life, non-flammability, stability under low and high temperature as well as pressure, resistance to radiation, and chemic al resistance etc. As no safe alternatives have been identified to the use of PFAS-based lubricants under harsh conditions or for safe functioning and safety of equipment, alternatives used under these conditions are likely to induce functionality losses. As these losses would fall within many categories, they are difficult to estimate and might, according to stakeholders, have unforeseeable effects. Table E.154 below summarizes an overview of the economic impac ts of a ban on PFASs in the lubricants sector. From the supplied data it appears that the impacts of a ban can be expected to be substantial and affect many more sectors and industries than the lubricants sector alone. Table E.154. Economic impacts related to a ban of PFASs in lubricants . Substitution costs Transitional costs Loss of functionality The re are curre ntly no "drop in" alte rnatives available for PFASbased lubricants used under harsh conditions or for safe functioning and safety of equipment. The industry stakeholders e stimated the costs of a ban of PFAS-based lubricants under harsh conditions or whe re safe functioning and safe ty of equipment is an issue, to re ach at least 50 000 per industrial application, and betwe en a m illion to several billion euros for e ach of their individual companies, as a re striction would re quire com plete industry re structuring and alte rnative development. As no specific or justified costs calculations are available, it has not be e n possible to perform a cost calculation or comparison. For use s of PFAS-based lubricants De ve loping, substituting and applying alternative lubricants to be used under harsh conditions or for safe functioning and safety of e quipment m ay require several ye ars of transition time and induce substantial costs for both the production industry as we ll as downstre am users. As the re are many complex supply chain structure s and downstre am use rs of PFAS-based lubricants it is im portant to pay attention to e le ments like safety measures, quality assurance, reliability, and hazard, to assure the functionality of the products whe re lubricants are applied. It has not been possible to m ake spe cific estimates on the transitional costs and possible lowe r le ve ls of performance, which the affected unknown number of e nd-users and industries might PFAS-based lubricants have a broad range of properties. These include s, but are not limited to long se rvice life, non-flammability, sta bility under low a nd high te m perature , stability under low and high pre ssure , re sistance to radiation, and chemical re sistance. For applications whe re (some of) the se properties are required, no safe alternatives have been ide ntified and substitution to the curre ntly available alternatives will lik e ly induce some functionality losses, which are important to consider whe n summarizing the co s ts . For use s of PFAS-based lubricants unde r non-harsh conditions and whe re safe functioning and safety of is not an issue, alternatives m ight for some uses have a shorter life time, which will re quire m ore 489 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substitution costs Transitional costs unde r non-harsh conditions and whe re safe functioning and safety is not an issue, alternatives have be e n identified for some uses. It is uncle ar to the Dossier Submitters if alte rnatives are available for all the se uses. Due to m issing information, it has not be en possible to perform a cost calculation or comparison of these alte rnatives face , due to insufficient info rm ation. For use s of PFAS-based lubricants unde r non-harsh conditions and whe re safe functioning and safety of is not an issue, drop -in alte rnatives have been identified for some uses. It has not been possible to estimate the related co s t. Loss of functionality fre quent re-lubrication. As PFAS-based lubric ants are applied to many products within many sectors, where various properties are required, it is c omplex to define and distinguish feasible alternatives. For many uses functioning lubricants are important in terms of performance and safety, why costs related to e.g. research and development, quality checks, reliability and hazard tests are important to be aware of, in addition to the substitution costs covering alternatives development. Potential functionality loss is also important to pay attention to, as lubricants with dec reased functions might have extended effects to an unknown number of produc ts. Because of the complexity of the use of PFAS-based lubricants, it has not been possible to identify generally technically feasible alternatives to be used under harsh conditions or for safe functioning and safety of equipment. Consequently, a broad restriction on the use of PFAS-based lubric ants is likely to affect various businesses in terms of produc tion c hallenges as well potential c easing. Due to the wide-ranging use of lubric ants is it diffic ult to assess the number of affected users, and how these are to be influenced. The identified costs information is therefore insufficient in several respects, but it is expected that downstream sectors and users would suffer from the economic impacts of a restriction. E.2.14.4.6. Potential effects on employment The Dossier Submitters have no information on how a ban on PFAS use in lubricants would affect unemployment in the lubric ant s sector. Effects on downstream users of lubric ants is expected to be insignificant. E.2.14.5. Summary of cost and benefit assessment Table E.155 summarises the assessment of the costs and benefits for PFAS-containing lubricants. More detailed information can be found in the accompanying text following the table. 490 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.155. PFASs in lubricants - Summary table on assessment of costs and benefits, based on a general transition period of 18 months. Restriction option Duration of derogation A lternatives Environmental impact Cost impact Other aspects Full ban Sufficie ntly strong e vidence that te chnically and e conomically feasible alte rnatives are unavailable for the uses of PFAS-based lubricants under harsh conditions or for safe functioning and safe ty of equipment The re is inconclusive e vidence on the e x istence of te chnically and e conomically fe asible alternatives for PFAS-based lubricants which are not applied under harsh conditions or for safe functioning and safety of equipment. For some uses the y are available, but probably not for a ll. Lo w substitution potential at EiF fo r lubricants applied under harsh conditions or for safety functioning [sufficiently strong e vidence]. Unclear substitution pote ntial at EiF for lubricants not applied unde r harsh conditions or for safe functioning or safety of equipment [inconclusive e vidence]. Sufficie ntly strong information that R O 1 leads to a reduction of e m issions of about 93% (30-ye ar period). As the e nvironmental impact assessment does not cover the waste phase, emissions unde r the baseline as we ll as e m issions avoided as a re sult of the re striction are likely unde restimated. A full ban on PFAS-based lubricants is lik e ly to have high socioeconomic costs, due to the non-existence of alte rnatives. C osts re lated to functionality loss, e .g. pe rformance level and lifetime, are e x pected to affect an unknown number of industries and e nd-users, as e conomic impacts are likely to be passed on to downstream users. There is howe ve r not sufficient data to make a cost e stimate. Econom ic im pacts are likely to be passed on to downstream users. Product re formulation costs are e stim ated within a range of te ns of thousands and several m illion Euros, but it has not been possible to make m ore specific e stimates. R eformulation is, howe ve r, unlikely within the given tim e frame. The basis of the cost im pacts is based on inform ation provided by stak eholders. No e vide nce on the effects on e m ployment losses, but these are e x pected to be insignificant. Banwith usespe cif ic derogations 5 ye ars Te chnically feasible alternatives used unde r harsh conditions or for safe functioning and safety of equipment are lik e ly not available within 5 ye ars; the substitution potential is low. Following the pre sumed unavailability of a lte rnatives, the cost impacts will be sim ilar to the ones mentioned under "full ban" above. 491 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Conclusion Duration of derogation A lternatives Environmental impact Cost impact Other aspects 12 ye ars The substitution potential is unknown and depends on the development within the se ctor. Howe ver, with a transition pe riod of 18 months and a 12-year de rogation the extended time will e nable room for further re search and de ve lopment to identify alternatives, for re le vant uses under harsh conditions and/or for safe functioning and safety of e quipment. The re is sufficiently strong evidence that the proposed de rogation will cause substantial additional e m issions. Assumung that the de rogation causes all e m issions from PFPEs, PFAAs and their precursors, and fluorinated gases, and 90% of fluoropolymer emissions to continue for 12 years, additional mean emissions can be e x pected to be about 5 249 t, which is close to the maximum additional emission scenario (= 6 088 t). As a re sult of the de rogation, the e ffectiveness of the re striction is expected to de cre ase to 70%. If te chnically and e conomically feasible alte rnatives are identified within the 12-ye ar period, functionality losses ide ntified under RO1 are likely avoided, while substitution and re form ulations costs will re m ain, but be spread out over several years. A full ban of PFAS-based lubricants with a transition period of 12 ye ars for uses under harsh conditions or for safe functioning and safety of e quipment is proposed, prece ded by a transition period of 18 months . 492 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Ac c ording to industry stakeholders a ban of PFASs in lubric ants would have signific ant effects on the economy. In the information submitted by stakeholders, it is noted how there are no drop-in alternatives under harsh conditions or for safe functioning and safety of equipment, and therefore produc t reformulation is needed for an extensive number of uses. The product reformulations will not only result in impacts directly related to the development and implementation of the new products, but also impacts related to elements such as quality assurance and safety measures. It is also noted how there are additional potential costs related to product functionality losses resulting in elements suc h as shorter lifetime, potential func tional downtime, inc reased frequency and maintenance uses. These impacts and challenges would mainly be passed on to downstream sectors where impacts could be 100 - 1 000 times more costly than for the lubricant sector itself , if access to PFAS-based lubricants or parts with these lubricants are no longer available. Many downstream sectors would be at risk of significantly reducing efficiency, productivity, competitiveness, and perhaps even have to discontinue their operations. The effects would be seen among many industries inc luding automotive, aviation, medic al, chemic al, renewable energy sec tors etc. For more information on these sectors and affected see section A.3.15.1. The Dossier Submitters consider, based on evidence gathered from CfE, targeted and 2nd stakeholder consultation, that the evidence is sufficiently strong that a ban on PFAS in lubricants is likely to have high socioeconomic costs. The main uncertainty relates to the insufficient data. To some extent there are alternatives to PFAS-based lubricants for some applications, when the lubricants are not applied under conditions that are harsh or f or safe functioning and safety of equipment. Stakeholders have indicated that when it is possible PFAS-free lubricants are applied already, and that PFAS-based lubricants are only used when there are no relevant alternatives. In respects to PFPE base oils and greases this statement is, however, challenged by Rudnick (2020), who find the many benefits of PFPE based oils and greases makes these lubricants the most cost-efficient solution, despite the initial price being higher. As the lubricants based on PFPE base oils have a longer lifetime and increased load-carrying capability, the equipment where it is applied is likely to have a longer lifetime whereby costs are reduced. Additionally, these lubricants have a lower need for re -lubrication, which decrease the labour costs. By regenerating the PFPE base oils, manufacture rs are moreover able to reuse oils at low costs. Hereby, the total c ost of lubric ation is not considered, when arguing alternatives are cheaper, why the oils and greases based on PFPE base oils can be used for general-purpose lubrication. Grechin et al. (2018) has also commented on the total costs and how less re-lubrication, when using PFAS-based lubricants, can lead to lowered operation/maintenance costs. This is however only relevant when there are technically available alternatives which just need more re-lubrication. Stakeholders have stated that a full ban without delay on the use of PFAS in lubricants is likely to have substantial c onsequences for the lubric ants sector, and downstream users of PFAS-based lubricants relying on the specific functionalities of PFASs. The Dossier submitters find that there currently is limited information on the necessary time required for substitution of the PFAS-based lubricants; several stakeholders have, however, indicated that several years are required. Due to the extensive consequences a full ban with an 18-month transition period would impose, a 12-year derogation, preceded by a transition period of 18 months, is instead proposed. Despite alternatives existing for some uses of lubricants, there is evidence that these alternatives are unable to live up to the required functionalities of the PFAS -based lubricants under harsh conditions or for safe functioning and safety of equipment , and therefore, the proposed derogation should only apply under these conditions. The Dossier Submitters c onsider that a long transition period is required to identify, assess and implement alternatives in the many applic ations and use sec tors. 493 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.15. Petroleum and mining E.2.15.1. Baseline Prec ise growth rates for PFAS use in petroleum and mining are not known. Ac cording to a recent report (NEA, 2021a), PFAS use in petroleum and mining can be expected to decline significantly in the coming decades. Furthermore, the oil and gas infrastructure is expected to become increasingly decommissioned, with over 200 platforms to be partially or fully removed, and over 2 500 wells to be decommissioned in the North Sea before 2030. However, input from manufacturers and suppliers has indicated that the demand for PFAS -based tracer and anti-foaming agents is expected to increase in future years, as the industry is likely to explore more `challenging' environments for oil and gas production. In the absence of more detailed information or estimates from industry, an annual growth rate of 1% has been assumed for the three product categories (PFAS-based tracers, antifoaming agents, solid fluoropolymers) (NEA, 2021a). The start year of the projection of tonnage and emission estimates is 2020 as presented in Table E.156. Table E.156. Projected yearly PFAS use and emissions in the petroleum and mining sector of the EEA between 2020 and 2070 in tonnes (mean values based market data) . 2020 2025 2030 2035 2040 2045 PFAS use 5 507 5 788 6 083 6 393 6 719 7 062 PFAS 2 028 2 132 2 240 2 355 2 475 2 601 emissions Source: Own calculations by the Dossier Submitters based on 2050 7 422 2 734 market 2060 8 199 3 020 2070 9 057 3 335 data provided. The assessment of environmental impac ts under the baseline and the restric tion sc enarios is conducted at sector level and covers tonnage and use estimates during manufacture and the use phase (thus not the waste stage). For the assessment of emissions in the baseline sc enario a basic source-flow model has been developed to make use of the data gat hered and collated from the market analysis and substance identification. It should be noted that, while a number of spec ific applic ations and products using PFAS or fluoropolymer have been identified in the petroleum and mining sector, these applications can cover a relatively large number of individual PFAS, with the quality of data available varying significantly across all substances identified. Therefore, the approach taken has not tried to develop estimates on a substance-by-substance basis, but rather taken a grouping approach. Where availability of data varies significantly on a substance-by-substance basis a key benefit of using a grouping approach is that impacts of varying spec ific substance data are lessened. The trade-off of using suc h an approac h is that it means the estimates provided will have a higher uncertainty attached to them overall. However, this approach can still provide useful data to estimate the orders of magnitude for emissions when c omparing PFAS groups and different sectors. The approach c an be used for further refinement when better data become available. Emission estimates for each of the three main PFAS groupings described above (tracers, antifoaming agents, fluoropolymer) were derived using both ECHA environmental release factors (ERCs) as documented in the ECHA Guidance (ECHA, 2016) and, where available, productspec ific information on PFAS use and disc harge. ERCs were applied to annual volumes of use of PFAS in each product category. For a detailed overview of scenarios and assumptions we refer to the report prepared by the NEA (2021a). Figure E.26 shows expected low and high PFAS emissions between 2020 and 2070 in tonnes. 494 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.26. Expected PFAS use and emissions in EEA under the baseline in the petroleum and mining sector (mean values) [tonnes]. Source: Own calculations based on market data collated by the Dossier Submitters (NEA, 2021a). Based on the assumptions made about market trends for PFAS use, emissions can be expected to increase over time. Though emissions increase less than in other sectors (e.g. construction, energy) due to the assumed low market growth, the fraction of emissions to the environment arising from PFAS use is much higher. Fluoropolymers (used in pipelines, seals, gaskets valves and o-rings) account for the by far largest share of total emissions in this sec tor. E.2.15.2. Alternatives E.2.15.2.1. Description of the use and function of the restricted substance(s) Non-polymeric PFAS There are two key current applications for non-polymeric PFAS in the oil and gas sector that have been identified in this assessment: Fluorinated siloxanes used as anti-foaming agents Fluorinated alkanes used as tracers in oil fields The key properties that make these PFAS substances desirable in these application s are summarised in Table E.157 below. 495 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.157. Summary of uses and properties of non-polymeric PFAS in the oil and gas industr y . Use Type of PFAS used Key properties Tracers Perfluorinated alkanes and others Very low limit of detectability, very low background levels] Anti-foaming agents Fluorinated siloxanes [1] Based on industry input; [2] see Shaban (1995). High efficiency, versatile and practical for both aqueous and nonaqueous systems, compatibility for high performance applications[2] Fluoropolymers The uses of fluoropolymers (fluoroplastics and fluoroelastomers) in the petroleum and mining industry and the specific properties provided by these materials that are particularly desirable for these applic ations is disc ussed in detail in Sec tion A.3.16. A brief summary is provided in Table E.158 below. Table E.158. Summary of uses and properties of fluoropolymer in the petroleum and mining industr y . Application Examples Properties Lining of piping, flowmeters and fittings, fluid-handling components, process vessels, tanks, storage and transport containers Seals, liners, valves, Orings, gaskets, packer elements. Cable and wiring insulation Polytetrafluoroethylene (PTFE) Perfluoralkoxy polymer (PFA) Fluorinated ethylene propylene (FEP) Fluoroelastomer (FKM) Perfluoralkoxy polymer (PFA) polyvinyldifluoride (PVDF) Fluorinated ethylene propylene (FEP) Ethylene tetrafluoro- ethylene (ETFE) High temperature resistance Might mechanical strength C hemical resistance C orrosion resistance Inertness Non-adhesive/low friction resistance Low permeation Flexibility/ductility Light weight Non-flammable High temperature resistance Rapid gas decompression resistance Resistance to compression fluids High temperature resistance Flexibility/ductility 496 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.15.2.2. Availability of alternatives All alternatives considered below have been identified because they are products that are currently marketed and sold in Europe, and consultation with industry and national authorities suggest they are in use in signific ant volumes. Very limited spec ific quantitative data on the relative levels of production, sales or use of alternatives have been provided in this assessment, however. E.2.15.2.3. Identification of potential alternative substances and techniques fulfilling the func t ion Non-polymeric PFAS T racers For `injected gas' tracers such as the perfluorinated alkane tracers identified in this assessment, a number of alternative options have been identified (Bjrnstad, 1991). These inc lude: Isotopic radioactive/radiolabelled tracers, e.g. inorganic gases (xenon, krypton) and other (d13C, d18O) labelled trac ers116. Polyhalogenated hydrocarbons (e.g. freon-11, and -12). Fluorinated benzoic acids117. Both halogenated and radioactive tracers could possibly be used in the oil and gas industry in Europe (IAEA, 2003). Radioisotopes have been used to study the in-situ placement and flow of various subsurface processes in the oil and gas sec tor for many dec ades (Abernathy et al., 1994). The tracers emit gamma radiation capable of penetrating the casing and being detected by wireline conveyed instruments,and offer cost-effective means of determining the loc ation and placement of many types of treatments and proc edures frequently performed on wells. The most common types of gamma emitters used in oil and gas tracer are, for example, 46Sc , 140La, 56Mn, 24Na, 124Sb, 192Ir, 99mTc , 131I, 110mAg, 41Ar and 133Xe118. In addition to other halogenated substances, industry has also mentioned noble gas isotopic tracer, xenon, radioac tive tracers, and radiolabelled c ompounds (d13C, d18O) as alternatives. It is noted that a number of fluorinated benzoic acids (FBAs) identified as being used as tracers in this sector do not meet the criteria of PFAS in this restriction proposal. FBAs are becoming increasingly favoured as stable, non-radioactive tracers, commonly being used to investigate flow dynamic s in geothermal, hydrothermal and oil well applic ations119. However, input provided by one supplier suggests FBA tracers are not considered as alternatives to fluoroalkane-based tracers, as their chemical properties are different and their specific use and application may be quite different. For example, FBAs are known to partition within the aqueous phase and are considered as water-based tracers, while the fluoroalkane tracers are highly hydrophobic and considered as gas-tracers. Industry input has suggested loss of functionality for some applications when using alternatives, and loss of information on reservoir outflow if no trac ers are used. Based on the input of one supplier in the CfE, it is expected that industry would tend towards using radio- 116 Identified as being in current use on the basis of input from one supplier of tracers. 117 Identified as being in current use on the basis of data received from national authorities, confirming these substances are actively being used and discharged in offshor e oil and gas installations in Europe. 118 Note that `m' signifies `metastable', see https://www-pub.iaea.org/MTC D/publications/PDF/TC S40_web.pdf, date of access: 2023-01-13. 119 See https://www.perkinelmer.com/labsolutions/resources/docs/APP_Analysis_of_Fluorobenzoic_Acids_for_Water_Tracers_01 3880_01.pdf, date of access: 2023-01-13. 497 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) labelled tracers for the applications where PFAS-based tracers are currently used, in the event of a restric tion on these substances. Anti-foaming agents One specific alternative to fluorinated silicone/siloxane products for use as anti-foaming agents has been suggested to be non-fluorinated silicone/siloxane-based products. It is reported that poly(dimethylsiloxane) (PDMS) oils are the most common chemical foam control agents, and that fluorosilicone fluids are used in some relatively `severe' cases to provide foam c ontrol at small dose levels (Chen et al., 2019). It is known that a number of manufacturers are marketing various non-fluorinated siliconebased anti-foaming agents for use in the oil and gas sector120 and it has been indicated that products containing PDMS are being used in the oil and gas industry in Europe. The level of sales and use of non- PFAS based anti-foaming agents is far greater than that of PFAS-based produc t s. Input from one supplier indicates that fluorinated siloxane products is a relatively niche use in this sector and may be favoured in a small number of installations because relatively small concentrations are required. It was indicated by the same supplier, that the industry considered that, if required, alternatives would be available to provide the same function. Further industry input indic ates that other alternatives inc lude ethyl siloxanes, polypropylene glyc ol, naphthalene/1,2,4-trimethylbenzene based products, dipropylene glyc ol monomethyl ether and 2,6-dimethylheptan-4-one, and that alternatives are often less efficient and need to be used in higher quantities/concentrations, which has implications for cost and storage requirements. Fluoropolymers A wide variety of different fluoropolymer materials (including fluoroplastics and fluoroelastomers) have been identified as being used in the oil and gas sector, and the number of individual products/components manufactured from these materials for ongoing use in the oil and gas sector totals is in the thousands. It has not been possible to conduct an analysis of potential alternatives for all individual uses or components produced from fluoropolymers in this assessment, and relatively limited information on specific alternative materials has been provided during this assessment (as part of the CfE and from further c onsultation with manufactures, suppliers and downstream user associations). It is important to note that, most of the information on alternatives collected for this assessment has been collected from fluoropolymer manufacturers and suppliers. Limited input was received from either the downstream producers of specific products used in the petroleum and mining industry, or operators in the petroleum and mining sec tor using these products. Hence, the below sections should be read with caution, as limited information has been provided from downstream users. During the consultation for this assessment, manufactures and suppliers have emphasised that, in general, it is very challenging for suppliers to replicate the combination of required properties of materials that is required by downstream users for application in the oil and gas sector using non-fluoropolymer materials. It has been noted by several suppliers, that use of fluoropolymer is generally used only when the high-performance functionality, as described 120 https://www.wacker.com/cms/en-us/products/brands/silfoam/silfoam.html, date of access: 2023-01-13. 498 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) above, is required. The oil and gas sector was highlighted by the manufacturers and suppliers consulted, as an area where this high-performance functionality consistently is required, so in general this sector displays a tendency towards opting to use fluoropolymer over other alternatives, despite the overall unit c osts of material often being muc h higher. It is noted that, in some cases, manufacturers consulted indicated that they consider that the most viable alternative for one form of fluoropolymer in oil and gas application, is to use another type of fluoropolymer. For example, one supplier noted that the main alternative to PFA is PTFE. Since this assessment is considering a potential restriction on all types of fluoropolymers and is taking a general approach of considering all fluoropolymer use combined, this aspect is considered in the following discussion. In general terms, the potential alternatives for fluoropolymer materials in the oil and gas sector include the following: Steel and other metal alloys A number of suppliers indicated that, if fluoropolymers (e.g. PTFE) in constructing pipes or the lining of pipes in the oil and gas sector were no longer available or restricted, it is expected that the oil and gas sec tor would most likely revert to using c orrosion-resistance steel pipes as they would be the only alternative that could demonstrate a similar performance. Other corrosion-resistant alloys that do not require the additional lining of fluoropolymer have been suggested, inc luding121: o Copper Base alloys (with Ni, Fe, Mn) o Nickel-based alloys (with Cu, Mo and Cr) However, it is noted that steel is considered less favourable as the pipelines or other c omponents are heavier, less flexible, and more c arbon intensive to produce. Non-metal materials Other potential options considered by industry as possible alternatives to fluoropolymers in this sector include ceramic -based materials and epoxy-based systems, either using glass fibres or carbon fibres. No specific information on the types of components that could be constructed for these materials in the oil and gas sector, or a relative comparison with existing fluoropolymer material has been provided in this assessment. Fluorine-free polymers A number of different non-fluorinated polymers are available for use in this sector, and supplier have highlighted specific examples where they c ould be utilised. However, a number of manufac turers and suppliers have emphasised that these alternatives may not be able to fulfil all technical criteria required to match the performance of fluoropolymers in this sector (see further discussion in section E.2.15.4). Examples include: o Crosslinked polyethylene (XL PE) as a possible alternative to ETFE o Polyamides suc h as ethylene propylene diene monomomer (EPDM) o Hydrogenated Nitrile Rubber (HNBR) as an alternative to fluoroelastomers 121 https://nickelinstitute.org/media/1732/nickel_containingalloypipingforoffshoreoilandgasproduction_10 033_.pdf, date of access: 2023-01-13. 499 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) o Polyether ether ketone (PEEK) Nylon Another non-fluorinated substance cited by industry in the CfE is nylon, which is reportedly used in a number of engineering applications to replace other materials such as aluminium and steel, with desirable properties such as high mechanical strength and wear resistance. However, it is not clear to what extent this material is used in the petroleum or mining sector. E.2.15.2.4. Human health and environmental hazards For the chemical alternatives relevant for this use sector, information on classification, the octanol/water partition coefficient (Log Kow) and bioconcentration factor (BCF) was assessed. Additionally, it was assessed whether the alternatives fulfil PBT or vPvB criteria and/or whether there are additional concerns. The assessment of the PBT/vPvB criteria is taken from the registration dossier that is published on ECHA's dissemination site. In relation to petroleum and mining, the list of alternatives contained 33 unique CAS numbers. Twenty-three (23) of the substances with unique CAS were classified according CLP (harmonised c lassification or self-classification). Seven (7) of the substances with unique CAS number did, according to their registration dossier, not fulfil the PBT or vPvB criteria. For the other substances with unique CAS number, the PBT or vPvB criteria were not applicable or no data were found. For one of the substances (PDMS-based alternatives (poly(dimethylsiloxanes), it was indicated that they may contain residues of the cyclic siloxanes D4, D5 and D6. These are considered to be PBT/vPvB substances and D4 is considered to be an endocrine disruptor. The list contained an additional 41 substances with unique substance names for which no CAS numbers were available. For these substances, no information on classification or PBT and vPvB assessments were available. For 2 substances (silicone polymers, Nylon), it was indicated that they may contain residues of D4, D5 and D6 cyclic siloxanes. Appendix E.2. contains a table presenting this information along with further data on alternatives for the various uses assessed in this dossier. E.2.15.2.5. Risk reduction, technical and economic feasibility of alternatives In this section, a summary of available information on the technical, economic, and health & environmental risks of identified alternatives to the specific PFAS-containing products is presented, based on information gathered during this assessment. Non-polymeric PFAS T racers As discussed above, the principal alternatives identified for the use of PFAS -based tracers in the oil and gas industry are radioisotope-based products. While some isotopes are known to be widely used in the oil and gas industry, it is not clear, based on the input received from the supplier of tracer which specific radiolabelled products or substances are currently available for use in this application in Europe specifically as an alternative to the perfluorinated alkane products. Technical feasibility: It is indicated that radio-labelled tracers are a feasible alternative and have been widely used in the oil and gas industry for many years. Input from one supplier in the CfE in 2020 indicated that these are c onsidered the likely alternative in the presence of a restriction on use of PFAS. 500 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Quantitative information on the comparative level of technical performanc e (e.g. the detection limit, chemical and thermal stability) between different traces was not available in this assessment. It is indicated that one of the desired properties of fluoroalkane tracers is the very low levels of detection (e.g. parts per quadrillion). It is noted that, while there is some indic ative values of detection limits for different types of tracers in Bjrnstad (1991), providing an ac curate c omparison with PFAS-based tracers is c hallenging as different units are used. It is not clear to what extent radiolabelled tracers are able to match this technical performance. Difference in detectability would potentially have knock-on effects on the volume/c oncentration of alternative product needed. Health and environmental risks: An important consideration will be the potential safety aspects relating to the use of radioactive substances for this application. Use of radioactive tracers as an alternative to fluoroalkane trac er, presents a potential safety risk to workers handling these materials, and possibly the wider environment depending on the volumes used. A specific advantage highlighted by the supplier of the fluoroalkane tracer product is the non-toxic , non-radioactive properties. It has not been possible to quantify the significance of the risk posed by radiolabelled tracers, as data is lacking on the specific products used and the volumes and concentrations involved. Economic feasibility: No quantitative comparison has been possible. The overall c osts will be dependent on required dose rate. Stakeholder information in the CfE indicates that PFAS-based tracers are used in low quantities, approximately 1 t/y, due to extremely low (parts per quadrillion) detection levels, so overall cost may ultimately be lower than alternative. It is indicated that fluoroalkane-based tracers are considered very expensive (>600/kg) so alternatives may offer a less expensive option. Information is lacking to be able to carry out a full assessment. It should also be noted that the use of alternative tracers could have implica tions on overall efficiency of extraction/production for operators, which affects economic productivity of an installation. Again, it is not possible to provide a detailed assessment of this aspect due to the overall lac k of data. There has been no information submitted in the call for evidence or in the 2nd stakeholder consultation that indicate that a restriction would lead to considerable economic impacts. Anti-foaming agents The principal alternatives for the use as anti-foaming agents are based on poly(dimethylsiloxane) (PDMS). Relatively limited information has been provided to perform a comprehensive comparison for an in-depth alternatives assessment. Technical feasibility: Stakeholder input in the CfE indicates that PDMS-based anti-foaming agent products are widely available in Europe and can perform with a comparable level of functionality in most cases, although the required dose rate is likely to be much higher. The Dossier Submitters note that the annual quantities of PDMS-based anti-foaming agents are far higher than those of the PFAS-based agents. This is further support to the statement above that PDMS-based agents are technically feasible in most c ases. There may be specific types of installation and characteristics of crude oils where PDM S-based anti-foaming agents may be less effective than PFAS-based siloxanes. It has not been possible 501 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) to assess how many, or what type of installations this applies to, or derive an approximation of the proportion of installations or the volume of petroleum reserves this applies to. Input from one supplier in the CfE indicated that, in the event of a restriction on PFAS-based products, it is expected that alternatives could be obtained that can perform the required func t ion. Health and environmental risks: No spec ific risks have been identified from the use of PDMS- based alternatives c ompared to fluorinated siloxane products. PDMS-based agents are approved for use in the oil and gas sector in OSPAR countries, so it is expec ted that registered produc ts will be assessed for potential health and environmental risks. It is noted in ECHA (2019) that under certain conditions (high temperatures, presence of certain types of fillers), silicone polymers can break down resulting in low concentration of D4, D5 and D6 within the polymer matrix. D4, D5 and D6 have been identified by ECHA's Member State Committee as SVHC substances with PBT/vPvB properties (ECHA, 2019). Economic feasibility: Stakeholder input indicates that PDMS-based alternatives are likely to be marginally less expensive than the PFAS-based products, however no quantitative comparison has been possible. Overall quantities used will be higher as higher dose rates are required for PDMS, mea ning overall costs could be higher than PFAS-based products. However, a quantitative estimate of differenc e in dose rates or volumes used has not been possible. As mentioned above, the quantities of PFAS anti-foams used is relatively minor, far lower than that of PDMS-based anti-foams. There has been no information submitted in the call for evidence or in the 2nd stakeholder consultation that indicates that a restriction would lead to considerable economic impacts. Fluoropolymers Technical feasibility: It is noted that, in general, the fluoropolymer-containing components and products supplied to the oil and gas sector are made to a specific order for downstream users and operators, so the specific functionality (and by design the necessary chemical ingredients) required will be unique to individual produc ts. Given the many hundreds or thousands of individual products likely to be provided to the oil and gas sector, this makes the assessment of technical feasibility for potential alternatives very challenging. As disc ussed in earlier sec tions, it is c lear from the information rec eived in this assessment (in the CfE and further consultation with manufacturers and suppliers) that the petroleum and mining sec tor (particularly the oil and gas industry) require a very high and very specific level of performance from materials in the components/products used, for example to ensure efficiency of operations by preventing failure of components and the leakage of chemicals and/or oil. For fluoropolymers used in oil and gas industry, durability, high temperature resistance (>270 oC) and chemical resistance and high mechanical strength in harsh environments, are highlighted as being an important aspect of their technical function. Several possible fluorine-free alternatives have been identified for fluoropolymers in some 502 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) applications (see section E.2.15.2.3). However, manufacturers and suppliers have noted concerns over different technical aspects that will impact their ability to be used for applications in the oil and gas industry. This is summarised in Table E.159 below. Table E.159 Overview of technical considerations for alternatives to fluoropolymer in the oil and gas industry. Material F luo r o po ly mer to be replaced replace Stainless steel and other metal alloys PTFE and others PEEK PTFE XL PE (crosslinked po ly e thy le ne PTFE HNBR (Hy dr o ge na te d Nitrile Rubber) FKM EPDM (ethylene propylene diene monomomer) FKM Specific application(s) Pipes, other unspecified components Various C ables Seals, gaskets, other components Seals, gaskets, other components Summary of technical considerations C an provide the required temperature, chemical and corrosion resistance performance but is heavier, less flexible and can have higher life-cycle C O2 emissions Provides comparable temperature resistance and better mechanical and tensile strength. Lower chemical resistance (e.g. to H2S and other acids) PEEK also cannot be readily coloured for identification (e.g. cables). Lower chemical resistance, it cannot manage temperature range needed as the maximum temperature it can handle is 150 C for single cables. HNBR can be used in steam and oil and gas applications up to about 150 C but may not be suitable above that temperature EPDM can only work up to 150 C and needs far more gasket changes and production time down Several comparisons between the performance and costs of PEEK, compared to PTFE, have been carried out122. While it is considered that PEEK has excellent mechanical and chemical resistance at high temperature, and is resistant to thermal degradation as well as attack by both organic and aqueous environments, there are concerns regarding potential susceptibility to halogens, strong acids (e.g. sulphuric acid) as well as some halogenated compounds and aliphatic hydrocarbons at high temperatures. PEEK is generally considered more `machinable' than PTFE and can be processed by conventional methods such as injection moulding, extrusion, and compression moulding. PEEK is a much higher unit price polymer but provides value by offering the possibility of manufacturing parts that are lightweight and durable with the ability to survive longer in harsh environments. 122https://fluorocarbon.co.uk/news-and-events/post/55/ptfe-versus-peek, date of access: 2023-01-13. 503 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PEEK offers the possibility of manufacturing parts with several beneficial characteristics123. For these reasons, PEEK is identified in a number of specific products on the market, with specific use in the oil and gas sector, such as: Insulated cable and wiring materials Heat shrinkable material for encapsulation and protection for sensitive components Materials for seals and backup rings, connectors, compressor components, pumps (surfac e and submersible), plugs and packers, c omposites, tubes and pipes, insulating c omponent s. Health and environmental risks: Several manufacturers and suppliers have emphasised that a key functional requirement of the materials used in the oil and gas installations where fluoropolymer is c urrent favoured, is to prevent the failure of c omponents that c an lead to leakage (of either petroleum reserves or chemicals). For example, the lack of either the required resistance to temperature or chemicals has been highlighted by a number of manufacturers as being an aspect that could prevent alternatives being favoured for uses in this sec tor. The use of alternative materials with potential lower levels of functional performance would have potential implications for a greater potential for leakage, which in turn has implications, both for exposure of workers to chemical, or leakage of oil or other components to the environment. There c ould also be a higher risk of exposure of staff to hazardous substances due to more frequent maintenance and more shutdowns. Economic feasibility: Quantitative estimates on comparative unit costs between fluoropolymers and fluorine-free alternatives is generally lacking in the public domain. This level of information, although requested, has not been provided by suppliers or downstream users in the CfE or further consultation with multiple companies. For some alternatives, an indicative comparison is available. PEEK is for example indicated to cost 5-10 times more than PTFE. For most applic ations where produc ts c ontaining these materials are used in the oil and gas industry, manufacturers and suppliers have highlighted that fluoropolymers are typically a more expensive option (per unit) c ompared with most fluorine -free alternatives. It should be emphasised that the economic implications of switching to alternatives for fluoropolymer in this sector are not limited to the differences in unit cost. Several manufacturers and suppliers have noted that, while the unit cost of most fluoropolymers is likely to be higher than other materials, downstream users still favour its use in the petroleum and mining sector as it ensures the required functionality, and overall cost saving can be made over the full working life of the product (e.g. due to avoided downtime and maintenance associated with more frequent failure and replacement of components) so consideration of alternatives need to be viewed with the potential knock-on implications for the efficiency of operations in the oil and gas sector. Stakeholders have also claimed that use of fluorine-free components could reduce future clean-up and waste-handling costs of fluorinated polymers. The general feedback from manufacturers and suppliers (based on CfE responses and further consultation) is that the widespread use of fluoropolymer-containing components in the oil and gas sec tor reflects the need for the func tionality provided by fluoropolymer c ompared to 123 https://omnexus.specialchem.com/selection-guide/polyetheretherketone-peek-thermoplastic, date of access: 2023-01-13. 504 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) alternatives. Where the required performance can be achieved with non-PFAS based materials, this is expected to be already being used in practice. E.2.15.2.6. Stakeholder input on transition periods Non-polymeric PFAS For non-polymeric PFAS uses in tracers and anti-foaming agents, it is indicated based on input from suppliers that alternatives are currently available on the market and can be used in the relatively short-term to ac hieve broadly the same func tionality. In the c ase of anti-foaming agents, one supplier noted that it may take up to four years for users to transition towards using alternatives. Fluoropolymers In the case of fluoropolymers, manufacturers and suppliers have indicated that it could take a relatively long time (several years to several decades) to transition towards using alternatives that can achieve the same level of performance. It has been emphasised that downstream users demand an assured level of high performance and function from the material used in applications for the petroleum and mining sector, and any product based on fluorine-free materials must be thoroughly quality assured. Given the relatively large (up to hundreds or thousands) number of individual products supplied in this sector, all with different specific formulations, this would be a complex undertaking and sufficient timescales would need to be allowed to ensure adequate performanc e in this sec tor. E.2.15.2.7. Concluding remarks Non-polymeric PFAS The Dossier Submitters conclude based on information from CfE, literature review and stakeholder consultations, that the evidence is sufficiently strong that technically and economically feasible alternatives are available for the quantities required for use in oil and gas tracers and anti-foaming agents and that the substitution potential is high. The Dossier Submitters note that one stakeholder claims that a transition period of up to 4 years might be required. The assessment of the Dossier Submitters is that this claim will need further justification (in the Annex XV report consultation) to be considered. Fluoropolymers The Dossier Submitters conclude based on information from CfE and literature review and stakeholder consultations, that the evidence is sufficiently strong that technically and economically feasible alternatives are not generally available for fluoropolymer applications in the petroleum and mining sectors and that the substitution potential is uncertain. E.2.15.3. Environmental impacts Environmental impacts are assessed in comparison to the baseline scenario discussed in section E.2.15.3, assuming baseline and, consequently, on-going PFAS use and emissions. The analysis of environmental impac ts focuses on two restriction options: RO1, adopting a ban of all PFAS used in the petroleum and mining sector RO2, adopting a ban on PFAS in combination with a use-specific derogation for fluoropolymers. Regarding the duration of the derogations two variants are distinguished, i.e. a 5-year derogation and a 12-year derogation. 505 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Environmental impacts of RO1 are analysed quantitatively. The proposed use -specific derogation covers all fluoropolymers used in the sector. Since emission data are available for this derogation, environmental impacts of RO2 could also be quant ified. Table E.160 below summarizes the characteristics of the restriction options, and the maximum additional emission scenarios. Table E.160. Characteristics of restriction options and of maximum additional emissions scenarios. Restriction option a bbr e v ia tio n RO1 RO2 Short description Full ban Ban with use-specific derogations Derogations --Derogation of fluoropolymer applications Transition period after entry into force 18 months 18 months Duration of derogation --5 years 12 years For calculating the expected emission reduction, the assumed entry into force year of the restriction dossier is 2025. Assuming a standard transition period of 18 months, RO1 and RO2 are expected to be implemented in 2027. Environmental impacts of RO1 and RO2 are expressed in relation to the baseline scenario discussed in section E.2.15.3. All emission estimates represent mean values. Table E.161 shows mean emissions and the expected mean emission reduction for time paths of 30 and 45 years (starting in 2025). Table E.161. Total mean emissions and emission reduction under the baseline, RO1 and RO2 (petroleum and mining sector, in tonnes). Restriction option Mean total Mean total emission Mean total emission emissions [t] reduction [t] reduction [%] 2025-2055 Baseline 77 018 --- --- RO1 4 284 72 733 94 RO2 (5-year derogation) 14 726 62 291 80 RO2 (12-year derogation)b 30 246 46 772 60 2025-2070 Baseline 123 726 --- --- RO1 4 284 119 442 97 RO2 (5-year derogation) 14 726 109 000 88 RO2 (12-year derogation)b 30 246 93 480 75 Source: Own calculations based on data collated by the Dossier Submitters. As illustrated in Table E.161,a full ban on PFAS use in this sector leads to a mean emission reduction of at least 94% compared to the baseline scenario. There is strong evidence (i.e. based on referenced quantitative data) that a derogation of all fluoropolymers leads to substantially higher emissions compared to a full ban (RO1). A 5-year derogation causes expected emissions which are more than double as much compared to RO1 (14 726 t compared to 4 284 t under RO1). Expected emissions under a 12-year derogation are more than 4 times higher compared to RO1 (30 246 t compared to 4 284 t under RO1). The amount of emissions avoided of a 12-year derogation is 60% compared to 94% under RO1. 506 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure E.27 shows the time path of mean emissions of the baseline, RO1 and RO2. Figure E.27. Time path of mean emissions under the baseline, RO1 and RO2 (petroleum and mining sector, in tonnes). Source: Own calculations based on data collated by the Dossier Submitters. E.2.15.4. Economic and other impacts The impacts of a ban on PFAS use in the petroleum and mining sector varies considerably depending on the types of PFAS covered. Therefore, the assessment here is separated into non-polymeric PFAS (in tracers and anti-foaming agents) and fluoropolymers, respectively. The impacts of a ban on non-polymeric PFAS are expected to be relatively limited, while a ban on fluoropolymers would be likely to have substantial impacts on the sector. E.2.15.4.1. Market overview An overview of the oil and gas, and mining sectors, based on Eurostat data is provided in Table E.162 and Table E.163 respectively. Table E.162. Number of enterprises, employment, turnover and value added in the oil and gas sector, 2019. Number of enterprises Number of persons employed Turnover ( million) Value added ( million) EU27 207 24 991124 29 951 7 917 Source: Eurostat, Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E) (sbs_na_ind_r2), extracted 2022-09-08. 124 Data from 2018. No data available for later years. 507 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.163. Number of enterprises, employment, turnover and value added in the mining and quarrying sector, 2019. Number of enterprises Number of persons employed Turnover ( million) Value added ( million) EU27 16 932 392 246 86 394 33 055 Source: Eurostat, Annual det ailed enterprise statistics for industry (NACE Rev. 2, B-E) (sbs_na_ind_r2), extracted 2022-09-08. The margins in the petroleum and mining sector are high (value added as share of total turnover is 26% and 38%, respectively, in the tables above), which implies that there is room to internalize potential substitution costs instead of passing them on to consumers. The EEA producers are also likely to be price-takers on global commodity markets which makes it difficult to pass on substitution costs to consumers. The costs of substitution are therefore likely to be borne in full by the producer in the form of reduced producer surplus/profits. Value added as share of total turnover is relatively (26% and 38%, respectively) high in both sec tors, indic ating that the sectors have high margins and that any costs arising in the sectors due to a restriction would primarily result in lower margins in the sectors, rather than in higher prices for consumers. An overview of each of the three categories of use is provided in Table E.164, with an indicative description of the likely relative number of workers and users. Table E.164. Overview of information available on workers and users involved . Number of workers Number of users Tracers Very low One producer/supplier identified Low Expected to be used only at a limited number of installations Anti-foaming agents Low Relatively few producers/suppliers expected[1] Low Expected to be used at a limited number of installations F luo r o po lymers High Large number of manufacturers and suppliers of FP and products in the EEA High Most petroleum and mining installations expected to use fluoropolymer [1] Two suppliers identified in the C fE, no indication given of overall market share or total number of suppliers or locations. It is expected that only a small proportion of the installations in the oil and gas industry and very few if any mining installations are actively handling non-polymeric PFAS-based substances. The number of users of non-polymeric PFAS in the sector is therefore expected to be relatively small. The use of fluoropolymer at oil and gas, and mining facilities is expected to be much more widespread across the sector. In both cases, quantit ative estimates on the numbers of workers producing or using PFAS or fluoropolymer in the petroleum and mining sector are not possible. 508 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.15.4.2. Non-polymeric PFAS For oil and gas tracers it is indicated based on input from suppliers in the CfE that alternatives are currently available on the market and can be used in the relatively short -term to achieve broadly the same functionality. The PFAS-based tracers are generally used in niche applications, and the identified alternatives are much more commonly used. A similar conclusion can be drawn for anti-foaming agents, but one supplier has noted that it may take up to four years for users to transition towards using alternatives. The eventual impacts on anti-foaming agent applications of an implementation period short er than that still need to be c larified. The number of companies supplying PFAS tracers and anti-foaming agents are assumed to be very few (three companies identified). These companies might be affected by a loss of revenue, unless they can compensate the revenue losses by selling substitutes. No information on the number of employees affected have been identified. The revenue generated by these products seem to be quite limited: The quantity of PFAS-based tracers used in the EEA is indicated to be only 1 000 kg/y. The c ost per kg is c laimed to be >600/kg. This indic ates an annual market value of around 0.6 million. The quantities of use for PFAS-based anti-foaming agents is far lower than that of PDMS-based agents. The economic implications for downstream users are summarized in Table E.165 below. Overall, the economic implications for downstream users are expected to be minimal. Substitution costs and transitional costs are expected to be relatively small. No ref ormulation costs, one-off capital costs or administrative costs related to the transition have been identified. Table E.165. Overview of economic impacts of a ban of non-polymeric PFAS in petroleum and mining applications. Product category Tracers Anti-foaming agents Substitution costs Transitional costs Loss of functionality No comparison between PFAS-based tracer and radio-labelled alternatives has been possible in this assessment. It is indicated that PFAS-based tracers are considered relatively expensive so alternatives may offer a less expensive option. No unit cost data has been made available in this assessment, so costs comparison has Likely to be minimal, as alternatives are available and currently on the market. Expected to be relevant in a relatively small number of installations. Likely to be minimal, as alternatives are available and currently on the market. Alternative tracer products (e.g. radiolabelled tracers) can deliver the required functionality. Unclear if alternatives will match the low limits of detection delivered by PFAS-based tracers (implication on dose rate). It is not expected that use of alternative tracers will have a significant impact on the overall production levels of oil and gas in Europe. Fluorinated anti-foams are expected to offer a superior functionality relative to the 509 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product category Substitution costs Transitional costs Loss of functionality not been possible. Indicated that higher dose rate of nonfluorinated product would be required to fulfil the same function and therefore a much higher overall volume of use, and hence overall higher costs can be expected. Expected to be relevant in a relatively small number of installations. alternatives. Non-PFAS based products are more widely used than PFASbased foams, with the latter used only for a relatively small number of `niche' locations. Overall impact of losing this functionality would be relatively minor and would not result in a significant loss of production or revenue. Loss of functionality could prove to be a more important implication, but the consultations with stakeholders indic ate that only a small share of oil and gas installations would be affected and that overall production levels of oil and gas in Europe would not be significantly impacted by a ban. Based on evidence gathered from the CfE, the 2nd stakeholder consultation and literature, the Dossier Submitters c onc lude that there is suffic iently strong evidence that a ban on PFAS in oil and gas tracers and anti-foaming agents is likely to have low socioeconomic costs. The main uncertainty relates to short-term transitional impacts for users of PFAS-based antifoaming agents. E.2.15.4.3. Fluoropolymers It is clear from the information received in this assessment (in the CfE and further consultation with manufacturers and suppliers) that the petroleum and mining sector (particularly the oil and gas industry) require a very high and very spec ific level of performance from materials in the components/products used, for example to ensure efficiency of operations by preventing failure of components and the leakage of chemicals and/or oil. In general, the fluoropolymer-containing components and products supplied to the oil and gas sector are made to a spec ific order for downstream users and operators, so the spec ific functionality required will be unique to individual products. Given the many hundreds or thousands of individual produc ts likely to be provided to the oil and gas sec tor, this makes the assessment of technical feasibility for potential alternatives very challenging. This implies that it could be a relatively long (several years to several decades) and complicated transition towards using alternatives that c an achieve the same level of performanc e. An overview of the economic impacts of a ban on fluoropolymers in the sector is provided in Table E.166. Overall, the impacts of a ban can be expected to be substantial. Table E.166. Overview of economic impacts of a ban of fluoropolymers in petroleum and mining applications. Product category Fluoropolymers Substitution costs Transition to using alternatives to fluoropolymer in Transitional costs Loss of functionality Substitutions of new materials for fluoropolymers could Alternatives need to match the high-performance function delivered by fluoropolymer 510 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product category Substitution costs the oil and gas sector cannot be viewed as a simple `drop in' replacement of one material for another. For product reformulation, costs can range from tens of thousands of Euros to millions of Euros for any single formulation, so the overall costs could be expected to extend (in total) up to several millions of Euros per company. Transitional costs Loss of functionality take substantial time (years if not decades) and costs. The relative complexity in the supply chains is an important factor. Quality assurance, both for the material/formulation supplied by the manufacturer, and of the actual products containing those material supplied to downstream users in the petroleum and mining industry (e.g. need for quality checks to assure adequate performance, efficiency and reliability, as well as a review of potential hazards, toxicology, environmental impacts). (mechanical strength and stability, high resistance to high temperatures and chemical corrosion, found in the harsh environments associated with deep drilling depths). The potential differences in overall costs between using the fluoropolymers and fluorine-free alternative options are therefore likely to cover the following aspects: Differences in operational lifetime of components Overall frequency and costs of maintenance The production efficiency and amount of operational downtime (e.g. to carry out maintenance) Difference in clean-up costs (e.g. due to leakage or leaching) Difference in waste disposal costs For a limited number of applications alternatives are available. For example, PEEK is a feasible alternative to PTFE in some applic ations even if it c omes at a considerable additional c ost (the material cost of PEEK is stated to be 5-10 times that of PTFE). All substitution would also require transitional costs in the form of reformulation costs and extensive quality checks to assure adequate performance, efficiency, and reliability. Quantitative information on substitution c osts and transitional c osts is generally lac king. Due to the complex nature of the market, where fluoropolymer containing articles are often made to a spec ific order for downstream users and operators, the Dossier Submitters have not been able to identify (and c learly define) the fluoropolymer applic ations where technically feasible alternatives are available, and where such alternatives are not available. Therefore, the Dossier Submitters expect that a general ban on fluoropolymers in the sector could lead to business closures or operation disruptions, even though the scale of closures and disruptions has not been clarified. Most petroleum and mining installations are expected to use fluoropolymers, so the number of users and affected employees (see Table E.162 and Table E.163 in section E.2.15.4.1) are potentially high. It has not been possible to derive an estimate for the total number of workers involved in operations where fluoropolymers are used in these sectors, due to a lac k of data and the relatively large number of steps and complexity in the supply chain. Based on evidence gathered from the CfE and the 2nd stakeholder consultation, the Dossier submitters conclude that there is sufficiently strong evidence that a ban on fluoropolymer 511 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) applic ations in the petroleum and mining sec tors is likely to have high soc ioeconomic c osts. The implications of a (time-limited) derogation on economic impacts depends on the suc cessfulness in identifying and developing alternatives. A derogation would allow for more time and, presumably. a higher probability for success in this process. If technically and ec onomic ally feasible are not identified the ec onomic impac ts would be largely unc hanged. If technically and economically feasible alternatives are identified: The c osts related to loss of func tionality would be avoided. The costs related to product reformulation and quality assurance would (at least partly) remain but would be postponed or spread out over a longer period. E.2.15.5. Summary of cost and benefit assessment Table E.167 summarises the outcomes of the assessment of costs and benefits for the petroleum and mining sec tors. More detailed information c an be found in the ac companying text following the table. 512 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.167. Petroleum and mining - Summary table on assessment of costs and benefits, based on a general transition period of 18 months . Restriction option Full ban Duration of derogation Not applicable A lte r na tiv e s No n- po ly me r ic PF A S Sufficiently strong evidence that technically and economically feasible alternatives are available. No evidence pointing to a shortage in supply of alternatives is available to the Dossier Submitters. As a result, the evidence is sufficiently strong that the substitution potential is high. Environmental impact Emissions of PFAS to the environment (relative to baseline) estimated to be reduced by 70 559 t over the period 2025-2055. Over the period 2025-2070 the estimated reduction in emissions is 117 267 t. Emissions reported in this table only account for the use phase. PFAS that are not emitted in this phase will at some point be transferred to waste management in quantities described in Section 1.3.1 (Main text). As the environmental impact assessment does not cover the waste phase, emissions under the baseline as well as emissions avoided as a result of the restriction are likely underestimated. Cost impact The costs of substitution are likely to be borne in full (in the form of reduced producer surplus/profits) by the firms in the sector. Non-polymeric PFAS The economic implications for downstream users are expected to be minimal. Substitution costs and transitional costs are expected to be relatively small. No reformulation costs, one-off capital costs or administrative costs related to the transition have been identified. As a result, there is sufficiently strong evidence that a ban on PFAS in oil and gas tracers and anti-foaming agents is likely to have low socioeconomic costs. Other aspects F luo r o po ly mer s Strong evidence that technically and economically feasible alternatives are not generally available. The substitution potential is low. The main uncertainty relates to short-term transitional impacts for users of PFASbased anti-foaming agents. F luo r o po ly mer s Product reformulation costs can range from tens of thousands of Euros to millions of Euros for any single formulation. Product reformulation will also imply costs relating to quality assurance. 513 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s Environmental impact Cost impact Other aspects Ban with usespecific derogation s: Derogation for fluoropoly mers. 5 years Loss of functionality of products in this sector could have substantial economic implications, including shorter operational lifetime of components, increased frequency and costs of maintenance, and increased operational downtimes. Sufficiently strong Emissions of PFAS to the environment Due to the expected unavailability of n/a evidence that (relative to baseline) estimated to be feasible alternatives, the costs are technically and reduced by 60 117 t over the period expected to be similar to situation with no economically feasible 2025-2055. Over the period 2025-2070 derogation. alternatives will not be the estimated reduction in emissions is generally available, 106 825 t. and that the substitution potential The emissions are estimated to be will be low. 9 632 t higher than if there would be no derogation. 12 years Unknown substitution potential, depending on R&D progress, but continued R&D increases the chance that alternatives for the relevant applications will be identified. As the environmental impact assessment does not cover the waste phase, additional emissions as a result of the derogation are likely underestimated. Emissions of PFAS to the environment (relative to baseline) estimated to be reduced by 44 598 t over the period 2025-2055. Over the period 2025-2070 the estimated reduction in emissions is 91 306 t. The emissions are estimated to be 25 961 t higher than if there would be no derogation. If technically and economically feasible n/a alternatives are identified: The costs related to loss of functionality would be avoided. The costs related to product reformulation and quality assurance would (at least partly) remain but would be postponed or spread out over a longer period of time. 514 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Restriction option Duration of derogation A lte r na tiv e s Environmental impact Relative to the 5-year derogation scenario, the emissions are estimated to increase by 16 329 t. Cost impact As the environmental impact assessment does not cover the waste phase, additional emissions as a result of the derogation are likely underestimated. Other aspects Conclusion A full ban of non-polymeric PFASs in petroleum and mining with a transition period of 18 months is proposed. A full ban of fluoropolymers in petroleum and mining with a transition period of 1 8 months and a 12 year derogation is proposed. 515 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.2.15.5.1. Non-polymeric PFAS A ban on the use of non-polymeric PFAS in the petroleum and mining sec tor are indic ated to have minor consequences and can be considered proportional. For anti-foaming agents, where one stakeholder has claimed that a period of up to four years is needed to transition from PFAS-based agents, a ban could lead to a temporary pause in the niche applications where PFAS-based agents are used. The assessment of the Dossier Submitters is that this claim will need further justification (in the Annex XV report consultation) to be considered. E.2.15.5.2. Fluoropolymers The Dossier Submitters note that, in general, the fluoropolymer- containing c omponents and products supplied to the oil and gas sector are made to a specific order for downstream users and operators, so the specific functionality required will be unique to individual products. Furthermore, it is clear from the information received in this assessment that the petroleum and mining sector (particularly the oil and gas industry) require a very high and very specific level of performance from materials in the components/products used. Given the many hundreds (or thousands) of individual products likely to be provided to the sector, this makes the assessment of technical feasibility for potential alternatives, and the substitution potential, very challenging. Even though several possible fluorine-free alternatives have been identified for fluoropolymers in some applications, manufacturers and suppliers have noted concerns over different technical aspects that will impact their ability to be used for applica tions in the oil and gas industry. The Dossier Submitters note that the information received on cost implications of restricting the use of fluoropolymers in the petroleum and mining sec tors are primarily qualitative, but that several aspects indicate that the costs could be substantial. Stakeholders claim that transition to using alternatives cannot be viewed as a simple `drop in' replacement of one material for another, which implies that more extensive product reformulations are required. Stakeholder input indicates that product reformulation costs can range from tens of thousands of Euros to millions of Euros for any single formulation. Product reformulation will also imply costs relating to quality assurance, both for the material/formulation supplied b y the manufacturer, and of the actual products containing those material supplied to downstream users. The Dossier Submitters also note that loss of functionality of products in this sector c ould have substantial ec onomic and other implic ations, inc luding shorter operational lifetime of components, increased frequency and costs of maintenance, and increased operational downtimes. The Dossier Submitters have limited information on the timelines required for substitution. Manufacturers and suppliers have indicated that it could take a relatively long (several years to several decades) to transition towards using alternatives that can achieve the same level of performance as products containing fluoropolymers. All in all, the above strongly indicates that a full ban, within an 18-month transition period, on the use of fluoropolymers in the petroleum and mining sector is likely to lead to high socioec onomic c osts. Therefore, a time-limited derogation is proposed. A 12-year derogation in addition to the 18 months transition period is proposed. Although the provided information indicates that alternatives seem to be technically and economically feasible in some applications where fluoropolymers are currently used, there is sufficiently strong evidence that alternatives cannot provide the required functionality in many applications in the petroleum and mining industries. Due to the complex nature of the industry, the harsh c onditions the industry is operating under, the need for extensive testing before use and the wide range of fluoropolymer applic ations, the Dossier Submitters note that a long transition period is needed to identify and assess alternatives in all the various applic ations in the sec tor. 516 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.3. Other impacts E.3.1. Human health impacts E.3.1.1. Health impacts of exposure to PFAS The hazard properties of PFAS for human health have been extensively described in section B.5. However, a detailed toxicological assessment for each of the thousands of PFAS is not possible. The available scientific literature on PFAS that has investigated the hazards associated with PFAS exposure through animal and epidemiological studies suggests that numerous PFAS can exert multiple adverse effects in biological systems (for details see sections B.5.2 and B.5.4). Specifically, experimental animal studies demonstrate toxicological effects of PFAA on the liver, kidney, thyroid, immune system, and reproduction. In addition to their ability to accumulate in the environment, some PFAS also have the ability to bioaccumulate in the human body (see section B.5.1.5). Some precursors to PFAAs may be of less direct concern with regard to human health effects but will ultimately add to exposure of PFAAs due to degradation (see section B.4.1. for details ) and henc e, also indirec tly add to the concern. Hence, also fluorinated gases and polymeric PFAS will contribute to the overall exposure to and risks of PFAAs. Epidemiological studies show an association between increased serum levels of various PFCA and PFSA (mostly PFOA and PFOS) and reduction in vaccine antibodies, increased propensity of infections, reduced birth weight , increased serum cholesterol and increased serum alanine transferase (ALT) (section 1.1.4) with immune effects considered as the most sensitive endpoint in humans (see sections B.5.2.5 and B.5.2.1). Increased serum cholesterol is a risk factor for cardiovascular disease and is associated with diabetes. Increased serum alanine transferase could indicate non-alcoholic fatty disease, the most common liver disorder in adolescents. The fact that exposure occurs almost always to mixtures rather than single substances complicates the risk assessment. Data available for less well-studied PFAA arrowheads and some PFAA precursors suggests that these PFAS have similar hazard properties to the well-studied substances (PFOA and PFOS) mentioned above (see Annex B.5). A striking feature of PFAS toxicity is the diversity of biological pathways that are affected, especially given that most of the toxic ological data c urrently available for PFAS are for a few individual PFAA (legac y PFAS, e.g. PFOS, PFOA, PFDA, PFNA). In almost all the biomonitoring studies ubiquitous presence of already restricted PFAS in the EU (legacy PFAS, e.g. PFOS, PFOA, PFDA, PFNA) were reported at detectable levels (see section B.9.23). In general, the detected PFAS are dominated by long-chain perfluoroalkyl sulfonates (PFSA with more than 6 fluorinated carbons) and out of the thousands of existing PFAS, only a very small fraction is addressed in targeted routine monitoring campaigns. Therefore, human exposure to PFAS may be underestimated. Studies of the European population demonstrate that a considerable fraction of the extractable organofluorine detected in human samples is not explained by the individual PFAS that are routinely analysed in target analysis (see section B.9.23.1). Available studies show that children are exposed to PFAS prenatally via placental transfer and postnatally via breast milk, as demonstrated by the presence of PFAS in umbilical cord blood, placenta, breast milk and in the blood of nursing children (see section B.9.21.). E.3.1.2. Health impact of the proposed restriction options The impact of continued use of, and increased human exposure to, PFAS on human health that can be prevented through the proposed restriction options cannot be quantified because of limited, or missing, data to assess (i) the hazard of many of the individual PFAS substances; (ii) the associated thresholds below which exposure is not expec ted to lead to adverse health effects, if such limits exist, (iii) the combined effects of co-occurring PFASs, and (iv) the prediction of future human exposure levels. However, for a large part of PFAAs sufficient 517 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) information is available to suggest that negative health impacts (see Table E.168) in the general population already occur in highly exposed communities or will occur at some point in the future due to increasing pollution stocks in the environment. Table E.168. Current health impacts in the general population due to exposure to the most analysed PFAS (see B.5.3.5.). Health impact category Immune outcomes Liver toxicity and metabolic disruption Reproduction and development C arcinogenicity Thyroid functioning Type of health effects Reduced vaccine responses in children Increased propensity of lower respiratory tract infections Reduced risk of atopic dermatitis Asthma- and allergy-related outcomes (hypersensitivity) Increased serum alanine transferase (ALT) whic h is a marker of liver toxicity and fatty liver diseases Increased total and LDL-cholesterol Increased risk of cardiovascular diseases Reduced birth weight Effects on male and female fertility Effects on sex hormones and related outcomes Preterm delivery Miscarriage and preeclampsia Increased risk of renal cell carcinoma and kidney cancer Thyroid disease or changes in thyroid hormones Table legend Evidence of an association between exposure and health effect, strengthened by new studies Limited evidence of an association between exposure and health effect, supported by new studies Suggestive evidence of an association between exposure and health effect, inconclusive new studies PFAS released during production or during the product life stage remain in the environment and will remain a source of exposure for generations to come. For some PFAS, specifically those already phased out or restricted under REACH in the EU, combined exposure already exceeds existing limit values for highly exposed communit ies in the population (section 1.1.4). Any additional exposure to other PFAS, that are to date less well investigated but for which comparable effects have already been demonstrated or can be expected because of structural similarities, will contribute to the magnitude of negative human health impacts in the future. Therefore, exposure to PFAS needs to be minimised. It is likely that under continued use, other (not well-studied) PFAS will be detected in human breast milk or umbilical cord blood. Continued use of PFAS might thus present a concern for (unborn) infants. The Nordic council of ministers published the report "The cost of inaction - a socioeconomic analysis of environmental and health impacts linked to exposure to PFAS" (Goldenman et al., 2019). The c onclusions are based on different scenarios but c onclude that the annual health c osts of exposure to PFAS in Europe c ould be between 52 and 84 billion. This exemplifies that the health costs could be significant in the baseline scenario and that there are substantial health benefits from the proposed restriction options. A recent analysis of the disease burden and associated costs of PFAS exposure in the United States shows health costs are in the same order of magnitude as estimated for Europe, when adjusted for population size and exc hange rates (Obsekov et al., 2022). 518 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Due to the persistence, PFAS will stay in the environment for a very long time once they are emitted. As emission prevention techniques are missing or too expensive, PFAS emissions from industrial and consumer uses to the environment cannot be avoided completely. Once in the environment it is very costly and impractical or even impossible to remove PFAS through remediation. The combination of these factors creates a risk of long-term, and potentially irreversible health damage at the global scale, which can to s ome extent be limited by the proposed restriction. In addition to the aforementioned physical health effects, the proximity to environmental contamination hotspots may affect residents' psychosocial health as affected communities may face a spectrum of negative mental and physical effects related to uncertainty around long-term health outcomes (Prior et al., 2019). In summary, the expected impact of the proposed restriction options are the avoided negative human health effects associated with the continued use of PFAS. The magnitude of the impact of continued use of PFAS on human health cannot be quantified but current combined exposure to some regulated PFAS already exceeds existing limit values. Therefore, due to structural similarities and a similar hazard profile, (co-)exposure to other, non-regulated PFAS should be minimized. This implies that the restriction option that reduces the inc rease of the environmental pollution burden of PFAS the most, compared to the baseline scenario, will result in the highest benefit to society in terms of avoided long-term human health impacts resulting from PFAS exposure. 519 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.4. Practicability and monitorability E.4.1. Practicability of restriction options E.4.1.1. Implementability Both RO1 (full ban with 18 months transition period) and RO2 (full ban with 18 months transition period and use-specific derogations) are concluded to be implementable. As described in Annex E for the specific use sectors, alternatives for PFASs are already being used by a number of stakeholders. For other uses, late stage product and process oriented research will make alternatives available on the short term. Stakeholders in several sectors are currently moving away from the use of PFASs in their processes and products for various reasons, e.g. c ustomer and investor requests, legislative and regulatory actions. Indic ations are that for a large number of applic ations alternatives for PFAS s are suffic iently available, and/or c ustomer demand for PFAS-containing products are decreasing. For specific uses for which the alternatives are not available or are not expected to become available in the short term, RO2 may be more readily implementable from an industry perspective. Usespec ific, time-limited derogations in this restric tion option give users and manufac turers the opportunity to develop functional alternatives for these specific uses or processes. The Dossier Submitters emphasize that only for uses for which stakeholders supplied sufficiently strong information demonstrating alternatives are not (readily) available, derogations are proposed. This approach was taken since derogations inevitably lead to a longer period that PFASs are being manufactured and brought to market, increasing the technical stock. Consequently, this leads to prolonged emissions of PFASs from the manufacture, use and waste phase to the environment, increasing the environmental stock which affects human health and the environment on an intergenerational level (due to the extreme persistence of the substances). Because of the concerns in this restriction, no derogations were proposed for uses and sec tors for whic h no, inc onclusive or weak evidence for the c urrent absence of alternatives was submitted. Implementability of the RO1 for these uses and sectors was considered to be sufficient. E.4.1.2. Enforceability Enforceability of both RO1 and RO2 is considered to be sufficient. Competent authorities of EU Member States responsible for REACH enforc ement activities have experience with REACH restric tions, inc luding restric tions dealing with spec ific (groups of) PFASs (see section 2.2.1. of the main report). Activities relating to RO1 and RO2 of this proposal can be integrated in current enforcement activities in the Member States. The enforceability is partly dependent on the availability of sufficiently efficient and effective analytical methods for monitoring, which are in rapid development. This is further described in the following paragraphs. The enforc eability c an also benefit from the reporting requirements for manufac turers, importers and formulators of PFAS containing products that are covered by a 13.5 year or nontimelimited derogation. Information on PFASs and type and amount of products containing PFASs can help in targeting uses and sectors for specific enforcement activities and actions, also based on these reporting requirements. These can for example be targeted on uses and/or sectors that are expected to make use of t hese derogations, but that do not follow-up on the reporting requirements. The broad chemical scope proposed in this dossier is beneficial to enforc ement, sinc e all PFASs are c overed by the sc ope of the restric tion, exc luding only a few substances which can fully degrade under normal environmental conditions. This is beneficial in avoiding discussions on applicability of the restriction and legal uncertainties when PFASs are being found during enforcement activities, also when it comes to import of PFAS containing products. 520 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.4.1.3. Manageability The restriction may be broad, the manageability however is sufficiently practical. As this restric tion targets manufacture and plac ing on the market besides use of PFASs, downstream users of PFASs that are less knowledgeable with regard to regulations and restrictions in partic ular, have knowledgeable partners (manufacturers). This is similar for import. When the restriction enters into force, manufacturers and importers can no longer provide the less knowledgeable downstream users with PFASs as such or with PFAS containing products, unless derogations apply. In this approach, their downstream users will be made aware of the restric tion c onditions by their suppliers. The reporting requirement is mainly applicable for larger, generally more knowledgeable stakeholders (manufacturers, importers and formulators) and require only annual reporting for 13.5 year time-limited derogations and for the non-timelimited derogations. Assigning this responsibility to a limited number of generally larger stakeholders helps in limiting the administrative burden for their downstream users. This also means that for authorities the number of received reports will be better manageable and processable than with a broad reporting requirement for all downstream users. E.4.1.4. Analytical methods The availability of analytical methods for PFAS was assessed and information collected and compiled in a Nordic Council report developed by Ramboll/VITO as a part of the work with this restriction proposal: "Analytical methods for PFAS in products and the environment" (NCM, 2022). A comprehensive review of analytical methods for PFAS is also found in the paper by Al Amin et al. (2020): "Recent advances in the analysis of per- and polyfluoroalkyl substances (PFAS)--A review", see also Appendix E.4. E.4.1.4.1. General introduction to analytical methods for PFAS A short introduction to the different types of analytical methods relevant for PFAS is found below. For additional details we refer to the Nordic Council report on PFAS analytical methods. In general, PFAS analytical methods may be distinguished in three types w ith respective sub types: 1. Targeted Substance Analysis, in which a certain subset of PFAS substances is analytic ally determined. The individual substances are quantified relative to analytical reference standards (today ca. 40 different substances available) in a gas/liquid chromatographic system coupled to an MS instrument . A key limitation of this method is the availability of referenc e standards. Several EU- wide and international standard methods are available that rely on targeted analysis. 2. Sum parameter: Total fluorine methods or oxidisable precursor measurements, that measure fluorine in all (organic) substances or PFASs after oxidative breakdown of precursors. So far, there is no standardised total fluorine analysis available. However, the US EPA is currently developing a standard for Total Oxidisable Precursors (TOP) assay and total organic fluorine (TOF) in environmental matrices that are planned to be published soon. Total fluorine may be measured directly on a sample or after some pre-treatment that is chosen in line with the purpose of the analysis and the matrix. Quantific ation of fluorine may be by a range of different methods whic h are described in the Nordic Council report, including the frequently used Combustion Ion Chromatography (CIC) and Particle-Induced Gamma-ray Emission spectroscopy (PIGE). Explanation of some relevant concepts for total fluorine measurements is found below: a. The Total Fluorine (TF) in a sample is equal to the sum of inorganic fluorine (IF, e.g. fluoride ions) and organic fluorine (OF, fluorine covalently bound to carbon), see Figure Y below. The organic fluorine may be extracted from a sample using a 521 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) solvent. However, there is a risk that a part of the OF is not extractable (e.g. polymeric PFAS). Methods relying on extractions are termed Extractable Organic Fluorine (EOF), while if an adsorption step is used to collect organic fluorine in a solution, the method is c alled Adsorbable Organic Fluorine (AOF). Alternatively, IF may be attempted removed from the sample, e.g. t hrough washing with water. The EOF part of a sample may be divided into quantifiable organic fluorine (for which analytical reference standards exist) and unquantifiable organic fluorine. Further, the unquantifiable organic fluorine may be divided into ide ntified and unidentified organic fluorine, depending on whether it is possible to find the struc tural identity of the substances through non-target or suspect sc reening. Figure Y. Mass balanc e analysis of fluorine. From Koc h et al. (2020). b. Total Organic Fluorine (TOF) gives a quantitative assessment of any organic fluorine substances in samples. TOF reports a c umulative single parameter, which is given as organic fluorine in mg F/L in liquid or as mg F/kg in solid samples, respectively. The fluorine cont ent of the sample can be determined by e.g. combustion ion chromatography (CIC), optionally after removal of inorganic fluorine. The organic fluorine as determined in the test may serve as a proxy for the overall concentration of PFASs (including end products as well as precursors). However, the method also includes potential organic fluorine substances that are not PFAS (e.g. hexafluorobenzene). c. Extrac table Organic Fluorine (EOF): There are several extraction methods available extracting organic fluorine from a sample to determine the levels of EOF. Conc eivably, different extraction procedures isolate different types and amounts of organic fluorine, and therefore solvent and method should be selected with care. Distinguishing between non-extractable fluorine (NEOF) and EOF may be needed. Fluorine content of the extracts can be determined by e.g. CIC. d. Adsorbable Organic Fluorine (AOF) allows for the determination of trace levels of organofluorine substances in water samples. The sample will need to pass through a mixed-mode anion exc hange solid phase extraction (SPE), whic h will a dsorb the PFAS compounds in the water. The PFAS are eluted from the solid phase with a solvent, and the overall content of fluorine can be determined by e.g. CIC. AOF is useful in the evaluation of PFASs but is more labour intensive and takes more time than EOF due to the extra steps. e. Total Oxidizable Precursor Assay (TOP assay or TOPA) converts PFAS precursor compounds under strong oxidative conditions into perfluoroalkyl carboxylic acids (PFCAs), which are subsequently quantified by standard targeted substance analysis. This method has generally a lower detection limit compared to the total fluorine methods. However, there is a risk that PFASs with degradation products that are not c overed by targeted analysis (due to lac k of reference standards) are overlooked, and there are also PFAS that may resist the oxidative treatment in 522 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) TOPA. Any analysis may report both pre-TOPA and post-TOPA data, i.e. concentrations of targeted PFAS before and after oxidation. It is important to note that the TOP assay does not identify and/or quantify the amount of PFAS precursors, just the PFCA oxidation products. 3. Non-target methods: Non-Target Screening (NTS) uses a high-resolution mass spectrometer, suc h as a Orbitrap or time-of-flight mass spectrometer for an accurate mass measurement of trace level compounds. From the accurate mass and fragmentation pattern in the MS instrument, information about the molecular structure may be deduced. More recently, hybrid instruments such as linear ion trap-orbitrap (LTQ-Orbitrap) and quadrupole-TOF (Q-TOF) have been used increasingly more, as they allow for ac curate-mass acquisition of both full-spectrum as well as produc t-ion spectrum data. Advantages of NTS are the broad screening of unknown samples and help detecting previously unknown compounds. Identified substances can be quantified using the same approaches as in targeted analysis (provided that the respective standards are commercially available) and similar detection limits can be reac hed. However, the methods are relatively labour intensive and require muc h time, and a high degree of analytical expertise is needed. In Suspect Screening Analysis (SSA) the accurate mass, isotope pattern and fragmentation pattern of molecular features obtained from high resolution MS are compared to databases with known PFASs (e.g. the USEPA CompTox Chemistry Dashboard and NORMAN Suspect List Exc hange). Total fluorine measurements are typically reported as mg F per kg or L sample material, while it is oftentimes desired to have the measured values in mg PFAS per kg or L sample. The c onversion from mg F to mg PFAS is dependent upon the specific PFAS substance(s) in the sample and the percentage of F atoms in their molecular structures. Some examples of substances and the perc entage of F atoms in their respec tive mo lec ular struc tures are given in Table E.169 below. Table E.169. Selected PFAS substances and the percentage fluorine content in their molecular structures. Substance TFA PFHxA PFOS Chemical formula C 2HF3O2 C 6HF11O2 C 8HF17O3S C 15H21F13N2O2S % Fluorine 50.0 66.5 64.6 45.7 Perfluorodekane C 10F22 77.7 Using the above perc entages of F in the molec ular struc tures for e.g. TFA and PFOS, we can calculate the concentration of TFA and PFOS in a sample that e.g. 50 mg F/ kg would c orrespond to (%F in PFAS substance x Mass PFAS in sample = measured F in sample): In the c ase of TFA: 50 mg F/kg -- >100 mg TFA/kg In the c ase of PFOS: 50 mg F/kg - - >77.4 mg PFOS/kg In general, the limit of detection (LOD) and quantification (LOQ) of the total fluorine methods is currently considerably higher as compared to the targeted PFAS analyses. In addition, LODs/LOQs at different levels have been reported for different products/matrices. For example, Schaider et al. (2017) operate with an LOD for PIGE in FCM paper of approximately 10 ppm. 523 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Bartlett and Davis (2018) looked at the risk of cross-contamination from PFASs that may occur during sampling as PFASs are commonly used in sampling materials and personal protective equipment. For reliable analytical results they recommended a conservative approach when developing and executing a PFAS sampling program including substituting known PFAS-containing products with PFAS-free alternatives, evaluating products and materials that are suspected of containing PFAS, and coordinating with the analytical laboratory to further reduce cross contamination and ensure data qualit y. Rodowa et al. (2020) investigated the potential for contamination of PFAS field samples by sampling materials and analyzed 66 relevant materials for PFASs as a possible source of contamination. However, they rec ommended that future efforts should foc us only on materials that c ome in direct contact with field samples and have a plausible pathway for impacting the concentrations of PFASs to levels of concern. The NORMAN Network PFAS Analytical Exchange (Environment Agenc y, 2022) also looked into what measures laboratories have implemented to minimize contamination during PFAS analysis. Hence, good routines and procedures (e.g. in line with Good Laboratory Practice, GLP) should be developed and used for work with PFAS analysis in laboratories, keeping in mind that PFAS-containing materials may be used in laboratory equipment. E.4.1.4.2. Analysis of polymeric PFAS In general, polymeric PFAS (defined in Figure 1, Section 1.1.1) cannot be quantified in the same way as low-molecular weight PFAS as reference standards are not available and the methods are unsuitable. However, the various total fluorine methods will include f luorine from polymeric PFASs (in addition to fluorine from non- polymeric PFASs). The side-chains of sidechain fluorinated polymers may be cleaved off from the polymeric backbone in TOP assay treatment and be included in the quantification of targeted PFAS when the identity of the side-chain c leavage products are c overed by the analytical reference standards. The Nordic Council report on PFAS analytical methods summarizes the methods available for the measurement of polymeric PFASs (NCM, 2022). Options exist for the determination of the type of polymer used, the molec ular weight and the layer thic kness of polymer. However, the methods are generally not suited for absolute quantification. E.4.1.4.3. Accredited, standard and validated methods Methods can be organised as accredited, standard, validated and research methods, where the former has the most stringent classification. It is advised to use an accredited method in an accredited laboratory when this is available. These methods have been (1) extensively developed and tested, (2) have an inherent quality c ontrol guarantee, (3) are c ross c hecked regularly between accredited laboratories and regulatory organs and (4) follow a fixed protocol that cannot be deviated from. This leads to results that can be compared between different laboratories, regions, time points, etc. When an accredited method is not available, it is advised to use a standard or at least a validated method. This validation should be extensive and cover accuracy, precision, linearity and application range, limit of detection (LOD), limit of quantification (LOQ), selectivity/specificity, recovery and robustness/ ruggedness. Extensive validation leads in most cases to results with a sufficient confidence to be used for reporting or as with accredited methods to compare between different laboratories, regions and time points. E.4.1.4.4. Cost considerations There is a large variety in analytical approaches to analyse PFASs in various matrices. Therefore, it is very difficult to set a specific price for a typical analysis. A number of different parameters with an analytical project will influence the price per sample, such as: number of samples, matrix, technique(s) used, number of PFASs to detect and report, targeted vs. untargeted methods, and post analysis work like modelling or data visualization. However, a rough cost estimate is 100 per sample for a standardized targeted LC-MS/MS analysis in a commercial lab. These prices increase with increasing level of complexity. For more complex 524 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) questions like non-target screening, commercial labs are most often not sufficiently equipped and universities, research institutes or high-end commercial labs need to be approached. In suc h c ases pric es c an inc rease signific antly. Total fluorine methods are signific antly c heaper and faster compared to substance-specific MS measurements. However, CIC instruments, which are most often used in these measurements, are not widely distributed. E.4.1.4.5. Analytical methods for PFASs in specific products and matrices The Nordic Council report "Analytical methods for PFAS in products and the environment" developed together with this restriction dossier, presents information on analytical methods for PFASs collected in a comprehensive literature search (NCM, 2022). The information is sorted into the following produc ts and matric es: Packaging material, FCM & food & feed processing equipment Fluorinated gases and refrigerants including blowing agents Ski wax Medical devices and pharmaceuticals Consumer products Flame retardants & resins Fire-fighting foams Cosmetics Textiles Waste treatment of PFAS articles & industrial waste Lubricants Oil, gas and mining Construction products Metal plating Production of PFAS, including polymers Transportation, automotive, airc raft, space and ships Electric and electronic equipment including semiconductors Human and environmental samples for monitoring For some PFAS applications and their respective matrices a standard analytical method for targeted PFAS is available. The standard CEN/TS 15968 has been adapted for use in food contact materials, ski wax, consumer articles and textiles, and may possibly be ada pted to fit other matric es as well. For other PFAS uses, no standard methods are c urrently available, but PFASs in these uses can be determined with variations of mass spectrometry as shown by many reports and sc ientific public ations, although some adaption might be nec essary. For a few of the PFAS application groups, neither standard methods nor relevant scientific publications been found, like for e.g. "transportation" or "oil, gas, and mining". However, this is primarily due to that these subgroups are defined at a sector level rather than at a product level. The analysis of PFAS in the matrices is not principally different from the measurements of other matrices. There is a large variety of analytical standards available for the monitoring of PFAS in environmental samples, e.g. water, sludge and soil: ISO 21675:2019, ISO 25101:2009, DIN 38407-42:2011-03, EPA METHOD 533 (12/2019), EPA Draft Method 1633, EPA METHOD 537.1 (12/2018), US EPA OTM45, EPA method 8327:2019, ASTM 7979-19:2019 (11/2019), ASTM D7968-17a, DIN 38414-14. It should however be highlighted that the substances addressed in the individual standards differ significantly. Harmonisation of the substances addressed would be beneficial for a harmonised approach to monitoring of PFAS. Reference is made to the Nordic Council report for specific details for the different matrices. The information on analytical methods is also compiled in a Documentation Sheet in excel which is included in Appendix E.4. The Documentation Sheet contains information on the relevant publications identified which is easily accessible by for example sorting via text search. Information on standard methods is included. Every matrix discussed in the report has a separate sub-sheet. Publications or standards which could be assigned to more than 525 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) one c ategory are available in eac h respective sub-sheet. The Documentation Sheet contains: Bibliographic information on the referenc e (author, title, journal, year, DOI) Substances addressed (if available with CAS) Sample amount used Pre-treatment of sample Extraction method Brief generic method classification Clean-up method Quantification method Working range of the method Possible matrices Reported levels - in the c ase indic ated Information on validation of the method Limitations (e.g. reported matrix effects) LOD and LOQ Further comments on the matrix A summary overview of the availability of analytical methods for the different matrices as assessed in the Nordic Council report may be found in Table E.170 and Table E.171. 526 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.170. Available analytical methods for PFAS in selected matrices as assessed in the Nordic Council report (part I) (NCM, 2022) Method FCM Ski Wax Consumer Cosmetics TULAC Metal plating Matrix products Main PFASs Side-chain fluorinated Perfluoroalkanes, Various PFC As, FTSs, Side-chain FTs, PASFs, used polymers, semifluorinated n- depending on PAPs, fluorinated PAC Fs, PFPEs or fluoropolymers, FT alkanes, article fluoropolymers polymers, other phosphate fluoropolymers, (e.g. PTFE) and fluoropolymers, fluoropolymers monoester, and others. PFC As, others PFC As, PFOAs, Perfluoropolyether- PFSAs and FTOHs various others based phosphates, may be present as PFC As (PFOA), PFSAs impurities PFOS, other perfluorinated Other bans/ surfactants PFASs prohibited in International Ski C alifornia128 US Senate: No Several eco labels None prohibitions (worldwide) DK as measured by TOF (20 ppm) 125 PFASs prohibited in C alifornia as Federation (FIS): ban on fluorine in ski wax will apply to all competition127 Product safety: juvenile products: chemicals: PFASs in cosmetics act130 ban use of PFAS (Blue Angel131, Oeko-Tex132) C alifornian measured by TOF (100 ppm)126 perfluoroalkyl and regulation of PFAS as a class in polyfluoroalkyl carpets and rugs substances under the Safer Blue Angel bans C onsumer Products 125 https://www.foedevarestyrelsen.dk/english/SiteC ollectionDocuments/Kemi%20og%20foedevarekvalitet/UK -Fact-sheet-fluorinated-substances.pdf, date of access: 2022-11-28. 126 https://leginfo.legislature.ca.gov/faces/billNavC lient.xhtml?bill_id=202120220AB1200, date of access; 2022-11-28. 127 https://www.fis-ski.com/en/ski-jumping/ski-jumping-news-multimedia/news/2020-21/ski-wax-only-without-fluorine, date of access: 2022-11-28. 128 https://leginfo.legislature.ca.gov/faces/billTextC lient.xhtml?bill_id=202120220AB652, date of access: 2022-11-28. 130 https://www.collins.senate.gov/imo/media/doc/No%20PFAS%20in%20C osmetics%20Act_0.pdf , date of access: 2022-11-28. 131 General ban on PFAS, no limit and analytical testing needs to be stated. https://produktinfo.blauer-engel.de/uploads/criteriafile/en/DE-UZ%20154201707-en-C riteria-V1.9.pdf, date of access: 2022-11-28. 132 Individual substances as stated in this document, no limits and analytical testings stated. https://www.oekotex.com/importedmedia/downloadfiles/STANDARD_100_by_OEKO -TEX_R___Limit_Values_and_Individual_Substances_According_to_Appendices_4___5_en.pdf , date of access: 2022-11-28. 527 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Method Matrix Available Standards FCM C EN/TS 15968 (adopted) DIN EN ISO 10304-1 & DIN 51723 Ski Wax C EN/TS (adopted) 15968 Consumer products use of certain PFASs in toys129 C EN/TS 15968 (adopted) Cosmetics None Targeted LC -MS/MS, LC -HRMS LC -HRMS, MS/MS LC - GC -MS, MS/MS, LC - GC -MS, LC - MS/MS, GC /EC NI/MS TULAC (SC P) framework133 C EN/TS 15968 (adopted) ISO standard 23702-1 DRAFT DIN standard 17681134 DIN standard 38407-42135 GC -MS, LC -MS/MS, GC /EC NI/MS Metal plating None LC -MS/MS- or GC -MS/MS Sum parameter (total fluorine) Non-targeted / Suspect screening TOF (PIGE; 2- 15 ppm), TF, EOF (C IC , PIGE, instrumental neutron activation analysis (INAA)), TOP Yes EOF TOF not possible NA EOF, TOF, TOP TOF, TF, EOF Yes NA TF, TOF, TOP, EOF NA NA NA 129 20 ppm for PFC A/Ss and 1000 ppm for FTOHs. Substances listed in Annex D . Measured with C EN/TS 15968. https://produktinfo.blauerengel.de/uploads/criteriafile/en/DE-UZ%20207-201701-en%20C riteria-V4.pdf, date of access: 2022-11-28. 133 https://dtsc.ca.gov/scp/carpets-and-rugs-with-perfluoroalkyl-and-polyfluoroalkyl-substances-pfass/, date of access: 2022-11-28. 134 Textiles and textile products. Organic fluorine Part 2. Determination of non- and volatile compounds by extraction method using gas chromatography https://www.beuth.de/en/draft-standard/din-en-17681-1/337939568, date of access: 2022-11-28. 135 https://www.beuth.de/en/standard/din-38407-42/137282966, date of access: 2022-11-28. 528 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Method Matrix Others (including non-standard methods) FCM X-ray photoelectron spectroscopy (XPS), C ontact angle measurement analysis to determine limits of performance (LOP) Ski Wax SkiFT (X-ray fluorescence = XRF) Consumer products X-ray photoelectron spectroscopy (XPS) Cosmetics NA TULAC Pyrolysis GC -MS Metal plating NA 529 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table E.171. Available analytical methods for PFAS in selected matrices as assessed in the Nordic Council report136 (part II). Method Matrix Fluorinate d gases Medical devices & Pharmace uticals Flame retardant s Used PF A S HFC s, PFC s, perfluoroke tones, HFEs, HFOs Fluorocarbo ns (only C & F), fluoropoly mer, 1bromoperfluorooctan e PFC As, PTFE Other bans/ prohibitio ns (worldwid e) F-Gas regulation137, Blue Angel138 bans use of halogenated substances in blowing None Blue Angel bans use of halogenate d flame retardants 139 Lubricants Mainly micropowder PTFE, PFPE, PFASbased additives and solvents None (PFAS/ fluor/ halogens not included in EU Ecolabel, Constructi on Fluoropoly mers. Ffluorinate d gases and others Blue Angel label prohibits use of halogenate d flame retardants and PFASProductio n Fluoropolymers, PFC As, PFEC A None Transport ation, Automotiv e, Aircraft, Space and Ships Fluoropoly mers, Fluoroorga nic additives (PTFE), Fluorinated gases None Oil, Gas, and mining Fluoropoly mers, Sidechain fluorinated polymers, Fluorinated gases None E&E PFEC A, Fluoropoly mers, 1Hpentafluoro ethane Blue Angel bans the use of halogenate d polymers and additives. Excluded 136 https://www.norden.org/en/publication/analytical-methods-pfas-products-and-environment, date of access: 2022-11-28. 137 https://ec.europa.eu/clima/eu-action/fluorinated-greenhouse-gases/eu-legislation-control-f-gases_en, date of access: 2022-11-28. 138 Indirectly as the Blue Angel-label requires that no halogenated blowing agent is used in insulating material above 1000 ppm https://produktinfo.blauerengel.de/uploads/criteriafile/en/DE-UZ%20132-201510-en%20C riteria-2020-01-07.pdf, date of access: 2022-11-28. 139 Indirectly as the Blue Angel-label requires that no halogenated flame retardant is used (above 1000 ppm) in many construction products, for example in insulating material. This method is applicable for solid, pasty and liq uid samples with more than 25 ppm. https://produktinfo.blauerengel.de/uploads/criteriafile/en/DE-UZ%20132-201510-en%20C riteria-2020-01-07.pdf, date of access: 2022-11-28. 530 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Method Matrix Fluorinate d gases Medical devices & Pharmace uticals Flame retardant s agents Available Standards Targeted DIN EN 14582141 GC -MS None NA DIN EN 14582141 NA Sum NA NA Total parameter fluorine as Lubricants Constructi on PFASProductio n Blue Angel, Nordic Swan) None blowing agents (see fluorinated gases and flame retardants) None None Time-ofFlight Secondary Ion Mass Spectromet ry (TOFSIMS), Laser Desorption Ionization Time of Flight NA multigas analyzer, LC -MS/MS, LC -HRMS NA LC -MSMS, LC -HRMS, LC conductivit y NA Transport ation, Automotiv e, Aircraft, Space and Ships Oil, Gas, and mining None None LC -MS/MS, GC -MS GC -EC D, GC -MS NA NA E&E are additives >0.5%w/w and fluoropolymers140 None GC -MS, LC MS/MS, NA 140 For example in printers and multifunction devices. No chemical testing is needed. https://produktinfo.blauer-engel.de/uploads/criteriafile/de/DE- UZ%20205-201701-de%20Kriterien-2020-07-17.pdf, date of access: 2022-11-28. 141 C haracterization of waste - Halogen and sulfur content - Oxygen combustion in closed systems and determination methods https://www.beuth.de/en/standard/din-en-14582/249016181, date of access: 2022-11-28. 531 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Method Matrix Fluorinate d gases Medical devices & Pharmace uticals Flame retardant s Lubricants Constructi on PFASProductio n (total fluorine) Nontargeted/ Suspect screening Other (including nonstandard methods) NA Perfluoroke tones using UV Absorption Spectrum, Infrared Absorption Spectra (IR) NA None described in DIN EN 1458215 NA NA LC -HRMS NA None 19F NMR, NA NA Gel permeation chromatogr aphy (GPC ) Transport ation, Automotiv e, Aircraft, Space and Ships Oil, Gas, and mining NA NA NA NA E&E NA NA 532 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.4.1.4.6. Other relevant work and ongoing activities In 2020 a workshop was organized by the European Commission on the monitoring of PFASs. A workshop report 142 from the event was c ompiled whic h c ontains a c ollection of analytical methods for PFAS used in monitoring, including analysis of PFASs in: abiotic environmental matrices air samples consumer products human matrices Details of the different analytical methods were compiled in a table format similar to the Documentation Sheet developed for this dossier. In the NORMAN Network143 different projects on PFAS monitoring and analysis have rec ently been c arried out or are in progress, inc luding: PFAS Analytical Exchange144 - A questionnaire was distributed to laboratories in 2021 to investigate topics such as which PFAS the laboratories are currently focusing on, current limits of detection for individual PFAS in different matrices, the analytical techniques currently being adopted, and the future direction which laboratories are planning. The questionnaire also included questions on measures implemented to minimize contamination during PFAS analysis. A report was published summarising the findings. Per- and polyfluoroalkyl substances (PFAS) TOP Assay Method Comparison - A survey with the purpose of establishing what methods are currently employed by different laboratories and gather information on their suitability, practicality and limitations, e.g. which media are being analysed, steps taken to improve recovery, accompanying analysis and instrument setup. The European research programme Partnership for the Assessment of Risks from Chemicals (PARC)145 may include work on the validation of methods for total fluorine analysis. Specific initiatives to develop analytical methods to support enforcement have already been initiated within the programme's task 4.2 Environmental Monitoring and 4.3 Innovative Tools and Methods, as well as activity 6.4.3 (under WP6: Innovation in regulatory risk assessment). During 2023, a project to evaluate and describe the regulatory needs for reliable enforc ement of restric ted PFASs in different matric es will be c arried out under the Nordic Council of Ministers subgroup NORAP (Nordic Risk Assessment Project). The project will include a description of what method development and/or standardization/validation of analyses of individual PFASs, precursor substances ("relat ed substances") and total organic fluorine/total fluorine (including screening methods) that is needed in order to enforce current and coming PFAS-restrictions. The project aims to inform decision makers, the scientific community, and relevant projects suc h as PARC on what concrete measures that are needed and to provide valuable input to ongoing PFAS restriction processes. The United States Environmental Protection Agency (US EPA) are developing validated analytical methods for PFAS in drinking water, groundwater, surface water, wastewater, and solids including soils, sediments, biota, and biosolids, which may eventually become 142 https://library.wur.nl/WebQuery/hydrotheek/2301946, date of access: 2022-11-28. 143 https://www.norman-network.net/, date of access: 2022-11-28. 144 https://www.norman-network.net/sites/default/files/files/QAQC %20Issues/2021%20NORMAN%20network%20PFAS%20Analytical%20Exchange%20Final%20 Report%2014022022.pdf, date of access: 2022-11-28. 145 https://www.anses.fr/en/content/european-partnership-assessment-risks-chemicals-parc, date of access: 2022-11-28. 533 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) standard methods or research methods. An overview of their current methods and ac tivities in this area may be found on their webpages, inc luding a list of finalized US EPA standard methods146. Standard methods for Total Organic Fluorine (TOF) and Total Oxidizable Precursor Assay (TOPA) are under development and will be published soon according to the webpage. ASTM International (Americ an Society for Testing and Materials) has published a Standard Guide for PFAS Analytical Methods Selection (ASTM E3302-21)147. The guide provides an overview of analytical methods, techniques, and procedures that may be used in determination of PFAS in environmental media. It may be used by various parties involved in response actions for PFAS-impacted environmental media, including regulatory agencies, project sponsors, environmental consultants and contractors, site remediation professionals, analytical testing laboratories, data reviewers, data users, academic institutions, research institutes, and other stakeholders. The organization is also in the process of developing a PFAS standard for consumer products. In the POPFREE148 project a suite of different analytical techniques are being tested on different consumer products (e.g. textiles, frying pans, cookware, skiwax, etc) and compared for performance (detection limits, specificity, robustness, etc). Of particular interest are rapid screening techniques such as HH-LIBS and ATR-FTIR, which would facilitate rapid, on-site screening of products for the presence of fluorine. They are also exploring methods that offer more structural information with minimal sample preparation, such as pyrolysis-GC. Finally, a survey of total fluorine on a wide range of products is being carried out using CIC. In the PERFORCE3149 project some of the more "emerging" analytical approaches (mostly CIC, TOP, HRMS) are applied to answer various questions related to occurrence, fate, and behaviour of PFAS. A tiered approach to gather information on the character of fluorine in samples is investigated. For example, TF measurements (if positive) may be followed by EOF analysis. A negative EOF measurement may then indicate the presence of polymeric PFAS. In another step, TOP assay may reveal if the polymer is degradable (likely sidechain fluorinated polymer) or non-degradable (likely fluoropolymer). The tiered approach may be used both for analysis of PFAS in products and to identify the identity of fluorine in environmental samples. Under the Drinking Water Directive, the Commission is obliged to establish technical guidelines by 12 January 2024 regarding methods of analysis for monitoring of PFASs under the parameters `PFAS Total' and `Sum of PFAS', including detection limits, parametric values and frequency of sampling. In the ZeroPM projec t, analytical proc edures are being developed to track the fate of TFA and other short chain PFAS during wastewater treatment (e.g. anaerobic digestion and hydrothermal carbonisation) and drinking water treatment. Methods are targeting wastewater effluents, sludge and emissions to the air to gauge the performance of advanc ed treatment proc edure to remove these substances from water and wastewater. Passive sampling methods and total fluorine analyses are being developed and applied to these matric es to provide time average c oncentrations and an idea of the total amount of organic fluorine in a specific sample or matrix. In addition, the substantially improved protocol for the TOP assay which allows for the inclusion of TFA and perfluoropropionic acid will be applied. The TOP assay will be optimized and evaluated for its suitability to be used as the parametric value 'PFAS Total' in the revised EU drinking water directive (DWD). 146 https://www.epa.gov/water-research/pfas-analytical-methods-development-and-samplingresearch, date of access: 2022-11-28. 147 www.astm.org/e3302-21.html date of access: 2022-11-27. 148 https://www.ri.se/en/popfree, date of access: 2022-11-28. 149 https://perforce3-itn.eu/, date of access: 2023-01-13. 534 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) E.5. Proportionality For details on the proportionality of the proposed restric tion, see section 2.4.4 of the main report. 535 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendices to Annex E Appendix E.2. 2023-03-14 E.2. Overview on alterna Appendix E.4. 2023-01-12 E.4. 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