Document vBREmNbnb018eGrY3bN5Kwz8Y

Ad Hoc BCR PFAS review of stakeholders input Please note that some of the information in this document is confidential and should not be distributed outside of the BCR Stakeholder name Green = presentation confirmed Essenscia Sector Federation: Representant of the chemical industry, life sciences and plastic convertors Confidential intervention/d ata Figures (for later meeting) Main points input (scope/def, impact, text/exemptions) FP = fluoropolymers CA = competent authorities Scope Derogation/exemption/timing Alternatives Redesign Socio-economic positive impact Socio-economic negative impact Environmental positive impact Environmental/hh negative impact Risk management Legal difficulty Scope/def: scope too broad, def does not meet backbone with only one fluorinated carbon atom. PFAS can't be considered as one unique group with same properties --> diversity not properly recognized. Impact: No exemption or derogation is currently planned for the use of FP. Defending the quality and safety of installation. Enumerating the use of FP and their utility for installations (protect for corrosion, leakfree join,...) If we can't replace the broken pieces containing FP (maintenance) during the lifespan of installations --> production of chemicals and pharma at risk Text: wants exclusion of FP of the scope or derogation for the use of it in installation. Wants a similar derogation as petro and mining ind (13,5y) at least bc lifespan of their installation > 13,5y (and a time-independent derog for installation with high safety requirement). Questions/ request Confidential slot requested once they have specific figures Other PC = public consult - Presentation before 12h30 - joined by a BASF material expert for the presentation - more detailed inputs during the PC - this position = first impression, info may be subject to change Agoria Federation No sector: manufacture, numeric, telecom Scope/def : scope too broad, some companies use PFAS as substance, others in articles Very low threshold is challenging. Finding alternatives is challenging bc of the broad range of sub covered by this restriction proposal Some substitution will be possible, but others will be very difficult/not feasible This too broad scope will be a challenge also for CA (bc including imported articles (identification, concentration) Impact : enumerating the impacted industry sector and substances/articles of Agoria group (very broad). Need a complete redesign of those products Alternatives to PFAS have less efficient (energy, safety and lifetime) ex: sealing property quality decreased --> lower lifetime, more maintenance, less safety Redesign of the products means redesign of the production facility Difficulty bc this restriction is added to others regulation framework: ecodesign, F-gases, safety reg (perfect sealing), certification aero and space industry. Text : very sceptical about managing all the specific exemptions as scope is really broad. Neglected in the proposal: needed exemptions, time frame or availability of alternatives Redesign of all products containing PFAS Open to interact directly with BECA Hope that dialogue can be put in place -Short presentation of 10min ( 5 slides) -First input and info are currently collected - will work on identifying the critical PFAS applications for which short term substitution is challenging Fedustria Represent No textile industry Viessmann, HVACR F-gases No Manufacturing of heating, industrial and refrigeration system Finding alternatives with same technical properties as PFAS Concerned by the rather limited timeframe of 6,5y Products must be redesigned completely before the PFAS can be substituted within the product. Exemptions needed for lifetime extension of products containing PFAS Scope/def : replacement of the current restriction (see request column) Impact : yes Not sure 13,5 will be sufficient Text : some uses have no derogation for the moment (police and army), protective clothing Scope/def : input focuses on hydronic space and water heating heat pumps (replacing gas and oil boiler) Other existent eu legislation on F-gases are not enough for EN concerns. Further clarification needed about the exclusion of some HFC, HFO substances (especially the exclusion of HFO-1132a should be reconsidered (bc risk of unintended transformation to substance with unforeseeable consequences) Impact : cover 5-10% of the hydronic heat pumps market in EEA Thinks transition to natural refrigerant legal framework is optimal (legal certainty for investments) Should precise that low GWP F-gases with PBT concerns are not a suitable alternatives. Investment towards alternatives to F-gazes bc safe, future-proof, energy efficient, suited for existing building --> benefits recognized In Germany, only natural refrigerant pumps will be financially eligible, additional bonus awarded to heat pumps with natural refrigerants. Fair competition in the sector hence supports EU jobs & growth in a key green technology. Restriction of F-gases --> EU would achieve its climate and environmental objectives faster by using sustainable and natural refrigerants with ultra-low GWP, such as R290 The price for propane is tenfold lower than for F-gases, independence of F-gas chemicals supply chains Text : The time-unlimited derogation for "refrigerants in HVACR-equipment (...)" not properly justified and goes against the objective of the restriction, and the CSS policy objectives. Unspecific and unjustified derogations due to "national safety standards and building codes" undermine legal certainty, create loopholes and unfair competition >< Justification for an EU-wide restriction measure --> avoids trade and competition distortions within the EU/EEA. National standards and building codes cannot be considered as an adequate risk management option Derogation for refrigerants in HVACR-equipment in buildings: no EU level legislation existing Incoherent approach regarding alternatives : in absence of strong data, no alternative becomes the key criteria for derogation (ex : for certain MD) DS grant time-unlimited derogation for refrigerants in HVACR-equipment in buildings --> incoherent with the approach taken for others sectors and conflicts with the CSS objectives to transition to non-toxic alternatives. Limit the derogation only to the applications for which there is strong evidence of lack of suitable alternatives. Timing : they would like a similar transition period as other scope as broad as this one ( ex: microplastics) ie. 6 y or 12y in specific cases where alternatives are missing. There is no technical barrier to replace currently used synthetic fluorinated gas refrigerants with natural working fluids. Will the new restriction replace the existing one? (eg PFHxA,...) Our ask is to revise this time-unlimited derogation and exclude hydronic heat pumps from its scope Chemours Chemical Industry - Manufacturing of Fluoropolymers and F-Gases Yes (keep the content of the document limited and not to share the document outside your organization) For heat pump applications (HVACR sub-segment), hydrocarbon-based alternatives are already on the market. Natural refrigerants have a low environmental impact and perform comparably better than synthetic alternatives, with acceptable and stable costs It is fundamental to distinguish between air-conditioning with heating function, and hydronic heat pumps. Viessmann believes that the 18 months of Transition Period after the Entering into Force (EiF) of the PFAS Restriction would be sufficient to avoid any major costs for the industry. Our ask is to revise this time-unlimited derogation and exclude hydronic heat pumps from its scope. Viessmann estimates that an immediate restriction on f-gases under REACH PFAS is actually set to have an overall positive impact and net economic benefits generated from upfront investments in the switch to natural refrigerants Scope/def : too broad. Do not support the grouping approach : persistance criteria alone can't be sufficient to justify restriction. Many PFAS have different properties and should be differentiated. Combining 10 000 substances altogether is scientifically incorrect the scope of the restriction Proposal is not defined in sufficient detail and is not in line with the requirements of Annex XV Difficulties for the Committees when analysing the stakeholder comments and preparing their opinions which may relate to specific PFAS substances rather than the whole group. Impact : industries faced with the challenge to continue to supply their products : specific F-gas uses would be subject to either a 18 months transition period, or 18 months + 5 years derogation or 18 months + 12 years derogation The removal of PFA from the semiconductor supply chain will directly cost the European economy over 66 billion. Over 21,000 individuals will lose their jobs throughout the supply chain under a non-use scenario In-situ spray foams are essential for the renovation of Europe's building stock : the ban will directly cost the European economy billions of Euros and thousands of individuals will lose their jobs Text : distinguish between "sufficiently strong evidence", "weak evidence" and "inconclusive evidence" for each of the proposed derogations. concept of "essential use" List of the comments on specific Dossier Submitter's : grouping, vpvb, safe use, f-gases, derogations, time framework Catastrophic disruptions throughout the different value chains ultimately impacting the European consumer the lack of alternatives in many applications and unrealistic timeline will cause significant effects on the market 12 years as the time necessary for new technology, developed to a commercial product, tested and implemented does not take into account the complexity of the F-gas sector and its value chain. FP are expensive then if viable alternatives exist the market would already transitioned. usage of non-fluorinated polymerization aids would lead to the formation of PFAS impurities and/or articles not meeting required standards. F-Gases : . Several alternatives were screened and most were rejected on the basis of either flammability such as propane), toxicity (ammonia) or relatively high GWP and potential to degrade to TFA spray foam applications : foams are essential for the renovation of Europe's building stock. Alternatives rejected bc : flammability and toxicity ratings (propane and methyl formate), thermal resistance, and structural integrity (water and cellulose). Rock wool and glass wool, which is not a blowing agent but an alternative insulation technology, less performant: This means that a larger quantity and thickness of keep the content of the document limited and not to share the document outside your organization Plastics Europe Director No Fluoropolymers Products Group Solvay Leader in the No manufacture of Materials, Chemicals and Solutions mineral wool needs to be used to achieve the same insulation value, which is not always feasible, particularly in renovations and requires an additional vapor barrier Scope/def : scope is too broad. PFAS are not all the same ( different properties abd hazard profiles) (ex of PFE with low hazard, non-toxic,...) Not agree with grouping , restriction will be a blunt regulatory instrument --> difficult to implement and will lead to unnecessary SE impacts. Subgroups are not scientiffically sounds. Impact : FPG members : big names. Restriction will affect manufacturers. Describing performance of FP resins, increase safety, resistance to heat (necessity for aerospace,...) resistance to fules, solvants, corrosivity --> undique properties. As FP resins are inert, don't fall under transport regulation and CLP reg. Text : direclty affected by a ban on use of FP, as no derogation on PFAS monomers --> manufacturer will need to cease within 18 months. Derogation of 6,5y for polymeric processing aids should extent to PTFE. This could lead to serious SE consequences (impacting quality and performance of MD and other critical equipment). Concerned that some important sectors arre not included in any time-limited derogations and are even targeted for an immediate ban (list of sectors). Derogations proposed are not substantiated by a strong evidence base, insufficient. Ask for realistic and well substantiated transition period. The dossier however provides little to no evidence about what these alternatives are, proposal should provide detailed information on alternatives. Ask for realistic and well substantiated transition period. Alternative assessment will be provided to the ECHA public consultation in the coming months. Scope/def : scope too broad, and not adopt scientific approach on risks to hh. Not agreed with the grouping of PFAS. FP produced whithout F-surfactant and PF-polyethers should be exempted from restriction bc no risk for HH and favorable (eco)toxic profile. Materials unique in terms of properties and durability (--> more sustainable society in different sector). This restriction opens the door for regrettable substitution The extrapolation of risk of PFAAs to other FP is not appropriate (technically and risk assessment). Impact : Solvay's products supply many value chains that would be severely impacted by a large ban on fluorinated materials. Text : not agreed with the grouping of all the PFAS, 9000 PFAs as one, not respecting the REACH art 68 Restriction will jeopardize sustainable society as batteries for EC, green hydrogen membranes, energy transition, ... Undermine EU competitiveness Time for transitionning is not enough as alternatives not existing for the moment, and if found one day, time to scale and industrialize. Wants derogation for key applications as batteries for EV Alternatives : same safety perfomance do not exist for FP or PFPE, need more time for technological development Solvay has x4 their investment in R&D since 2019 to find alternatives and manage already to phase out Fsurfactant by 2026. Ask to safeguard key sectors where no alternative is met Medtecheur MedDev No ope Jsrmicro Semiconductors No Vibrantz Pigments No Ineos Ineos No For certain market ( as semicon) currently no valuable alternative bc of the specific properties of F material --> loss of competitiveness of the European semicon industry Two scenario for alternative : - Scarifying some performances ( but lead to frequent maintenance, cost increase, impact on safety , hazard of alternatives substances) - No alternative suitable --> exposing European companies to reduced competitiveness. Request safeguard key sectors where no alternative is met Scope/def : No remarks yet Impact : A strict ban without derogations, will likely lead to the present medical technologies no longer being available Text : Welcome derogation on medical technologies Depend on suppliers: Some member companies have raised concerns about reasonable transition periods Scope/def : Remark: benefit/cost if C1 PFAS are excluded from the scope? Impact : Without PFAS there is currently no viable semiconductor manufacturing in the EU. Text : Concerned about Potential derogation for semiconductors (13.5 y) No reasonable timing Scope/def : Def does not differentiate between persistent and hazardous or takes REACH exempted substances into account. Propose: looking at hazardous properties, not chemical structure Impact : Specific pigments are targeted Text : Alternatives with the necessary properties to guarantee sustainability, dispersibility, safety, etc. will take time Substitution of one component (e.g. the pigment), the whole formulation and tinting systems need to be adapted of downstream users (ink & paint industry) In total, process will take min. 5 years (based on previous substitution projects): Development for suitable alternatives for targeted pigments R&D on the combination of each binder system with pigment Weather resistance testing Scope/def: Follow the position of FPP4EU: Def is an oversimplification, properties vary greatly among PFAS Inovyn: Use membrane and diaphragm technologies which are mostly made of fluoropolymers PFAS used for pipe, film and small and large blow moulding Timing is not reasonable, assessment concluded technically feasible alternatives are not available for performance same way current technologies used by INEOS Inovyn are Best Available Technologies No reasonable alternative can be found within the proposed 5 and 12 years derogation periods O&P: Request derogation: sufficient time to investigate and develop suitable alternatives Request: derogation for EUROCHLOR Working internally on an alternative assessment, will be published with public consultation Alternative assessment ongoing Europe Sealings No Sealing ECCA Coil coating No Fleishman Europe Public Health YES Security, Patient Safety and Occupational Health Only Piping and tubing for drinking water applications derogated Alternatives for polyolefin processing require food contact approval, minimum 3 years for pipes OXIDE: PFAS used for manufacture and transport of basic chemicals No exemptions means no spare parts available for production -> introduce disruptions Concerned by Teflon (PTFE) exemption for transport applications No alternatives available for seals: chemical resistant and should shut off mechanically Scope/def : Fluoropolymers should be excluded from the scope of the restriction Impact : Severely impacted, also downstream industry strongly reliant on FP to manufacture its products no viable alternative is currently available Text : Concerned about lack of derogation proposed Welcome Derogation for FP application in the Oil and Gas sector, with some concerns: Interconnectivity between market sectors, e.g. electronic components Supply of FP materials after the first 7 years, production in Europe would be halted Absence of the essential use concept in the restriction, especially for warranty & repair 18 months transition period is too short Even if alternatives become available, implementation min. 10 y Scope/def : Too broad, Fluoropolymers should be excluded from the scope of the restriction Impact : PVDF/FEVE-coated prepainted metal: Alternatives less durable, so impact on niche market PTFE waxes: substitutions means quality risk, a loss of functionality, a gigantic effort of requalification (min. 4 y) Text : Not a fan of restriction: no exemptions foreseen for foil coating Is not informed about Manufacturing processes (unlikely that PFAS are released to the environment), uses and end-of-life of our products Timing not manageable considering requalification Not certain that alternatives with sufficient supply capacity are available Scope/def : Too broad, covers consumer, professional and industrial uses PNEC or DNEL can be derived for individual substances, and thus these values should be taken into consideration Text : Concerned that exemptions are not inclusive enough 18 months transition period is too short assessment of alternatives, socio-economic assessment and risk assessment were conducted Confidential: PFAS are used as processing aids in manufacturing, no alternative available If processing aids are not derogated: unintended consequences Time and investment are required for alternatives: commercial scale and end use requalification takes min. 10 years Actively pursuing alternatives and needs more time through a targeted derogation Currently conducting alternative assessment New : EFPIA : see Pieter (instead of Janssens) Agfa Conclusions: Biopharmaceuti No? Scope/def : New definition of PFAS in this proposal does not match definition used outside of EU Request Exemption: cal (innovative) industry Impact : Active pharmaceutical substances are derogated in one scenario Any materials/chemicals required for manufacture are not Authorized products such as API or excipients, finished Restriction of primary packaging materials (under a valid market authorisations) pharmaceuticals Result: manufacture or sale of pharmaceutical products not possible Text : No alternatives available yet for: Starting Materials and Chemical Intermediates, Auxiliaries and Production Materials, Synthetic and Analytical Reagents, Primary Packaging Materials (derogation: 13.5y) including approved packaging and medical devices, raw materials, intermediates and auxiliaries Medical Devices (derogation: 13.5y) Replacement of a primary packaging material -> full requalification with the relevant Health Regulators, would take at least five years Digital imaging YES Scope/def : Too broad, Fluoropolymers should be excluded from the scope of the restriction Agfa already started proactively systems and IT solutions Impact : PFAS used in: Production installations Printing equipment with substitution in different applications (excluding equipment) Products placed on the market Difficult to substitute: Possible loss in revenue of 20 % Text : Would want exemptions for industrial use, like intermediates, use of PF in equipment, chemical installations 18 months transition period is too short Concerns about PFAS in FFF: deadline of total PFAS ban is earlier so possible early phase-out, with no alternatives available Scope is too broad, different substances with different properties AND no distinction of different uses Most of them do not agree with the grouping and extrapolation made Many stakeholders ask for FP to be excluded Some stakeholders want to introduce the concept of essential use 18 months, 5 or 12 years is considered too short a transition period for substitution and requalification. Need more time to find suitable and safe alternatives or to redesign products. All stakeholders emphasize impact on supply, manufacture and transport bc of complexity of the production process, even with derogations in place Concerns for products where no alternative is available, yet no derogation is included in the proposal Concern about regrettable substitution Concern about the competitiveness of EU market Two stakeholders underline positive SE impacts: Viessman and Solvay