Document 0JM5Z2axYeoVMYqJLVvnK01KM

Plasticsturope Fluoropolymers Product Group Position Paper for the Call of Evidence on a Broad Restriction for PFAS 2972509 Brussels July 2020 Key + Messages Fluoropolymers have a high societal value, since they are: o durable, stable and mechanically strong in harsh conditions in a variety of sectors including but not limited to aerospace, environmental controls, energy production and storage, and electronics, as well as in technical apparel; o stable in air, water, sunlight, chemicals and microbes; o chemically inert meeting the requirements for low levels of contaminants and particulates in manufacturing environments essential for the food and beverage, pharmaceutical, medical, and semiconductor industries; o biocompatible; o non-wetting, non-stick, and highly resistant to temperature, fire and weather. Fluoropolymers including `fluoroplastics' and `flucroelastomers' are high molecular weight polymers with unique physicochemical properties that are distinctly different among the PFAS. Fluoropolymers may be deemed to be PFASs based on the definition as described in the Call for Evidence. Nevertheless, fluoropolymers do not display the environmental and toxicological properties associated with certain fluorochemicals in the PFAS family. Fluoropolymers that meet the OECD polymer of low concern (PLC) criteria are non-toxic, biocompatible and non-soluble molecules and they are deemed as PLCs to have insignificant environmental and human health hazard. Persistence in a product means durability - a highly desirable trait in many safety critical products and applications. Fluoropolymers do not meet the REACH persistence criteria for restriction. * No existing treaty or regulatory framework seeks to restrict or classify a chemical on the basis of persistence alone, is such an inclusion grounded in sound science for fluoropolymers to be grouped with `PFASSs of concern' for regulatory purposes. e Persistence in in the environment does not equate to toxicity, bioaccumulation and mobility. Through rigorous application of existing environmental regulations, strict adherence to BAT (best available techniques), compliance with existing regulations and establishing strict limits for residual polymeric production aids (PPAs) in the final polymer, eventual concerns in relation to fluoropolymers can be controlled while retaining these products of high societal value. PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 Plasticsturope Fluoropolymers Product Group Introduction The Fluoropolymers Product Group is the voice of the fluoropolymer industry in Europe and members include 3M, AGC, ARKEMA, Chemours, DAIKIN, GORE and SOLVAY. We are a sector group of PlasticsEurope, which counts over 100 member companies, producing over 90% of all polymers across the EU27 plus the UK, Norway, Switzerland and Turkey. Together PlasticsEurope members directly employ 1.6 million workers in the EU27. The Fluoropolymers Product Group operates in accordance with PlasticsEurope's governance, including Competition Compliance Rules. What are PFASs? The Fluoropolymers Product Group would like to draw the attention of the REACH authorities to the definition presented by Buck et al (2011)" which proposed the following terminology for per and polyfluoroalkyl substances (PFAS): "A subset of fluorinated substances is the highly fluorinated aliphatic substances that contain 1 or more C atoms on which all the H substituents (present in the nonfluorinated analogues from which they are notionally derived) have been replaced by F atoms, in such a manner that they contain the perfluoroalkyl moiety CnF2n+1--. These compounds are hereafter referred to as "perfluoroalkyl and polyfluoroalkyl substances" and denoted by the acronym PFASs [...]". The Fluoropolymers Product Group recommends that this terminology be used in the context of any potential future regulatory initiatives, to avoid confusion. Consequently, CnF2n+1 covers CF3- rather than a CF2. It is important to note that the aliphatic CF2 or CF3 definition of PFAS would open the Call for Evidence up to the vast family of organic fluorinated compounds including many pharmaceuticals, veterinary drugs and agrochemicals already subject to existing EU regulations. These organic fluorine compounds often have very different properties and are typically subject to other EU regulations, for example the plant protection products regulation'. In Buck et al (2011) PFAS are initially divided into polymers and non-polymers with the polymeric PFAS classified as fluoropolymers, perfluorinated polyethers and side chain fluorinated polymers. The term `fluoropolymers' refers to materials, denoted by the acronyms PTFE, FEP, PFA, ETFE, ECTFE, PVDF, PVF, THV, Fluoroelastomers, etc., which are produced and/or used by various members of the PlasticsEurope Fluoropolymers Product Group. ! The European Medicines Agency handles both human pharmaceutical and veterinary drug regulation. For pharmaceutical regs in the EU see https://ec.europa.eu/health/documents/eudralex/vol-1_en For veterinary drug regulations see https://www.ema.europa.eu/en/veterinary-regulatory/overview/implementation-new-veterinarymedicines-regulation For agrochemical regulations see https://ec.europa.eu/food/plant/pesticides/approval active substances/eu rules en PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 Plasticsturope Fluoropolymers Product Group What are Fluoropolymers? Fluoropolymers are divided into two subsets: `fluoroplastics' and `fluoroelastomers', as detailed below. Fluoroplastics are made by homo- or copolymerization of monomers including, but not limited to: tetrafluoroethylene (TFE), hexafluoropropylene (HFP), vinylidene fluoride (VDF), chlorotrifluoroethylene (CTFE), vinyl fluoride (VF), trifluoroethylene (TrFE) and perfluoroalkyl vinyl ethers (PAVEs) which include trifluoromethyl trifluorovinyl ether (PMVE), pentafluoroethyl trifluorovinyl ether (PEVE) and heptafluoropropyl trifluorovinyl ether (PPVE). In the case of copolymers, monomers that do not contain fluorine attached to the olefinic carbons may be used. These include, but are not limited to, ethylene, propylene and perfluoroalkyl-substituted ethylenes. Fluoroplastics that are produced by homo- or copolymerization of the monomers listed above include, but are not limited to: polytetrafluoroethylene (PTFE), the TFE-HFP copolymer (FEP), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), polyvinyl fluoride (PVF), the ethylene-TFE copolymer (ETFE), the ethylene-CTFE copolymer (ECTFE), the VDF-HFP copolymer (VDF-co-HFP), terpolymers of TFE, HFP and VDF (THV), the VDF-TFE copolymer (VDF-co-TFE), terpolymer of TFE, perfluoroalkyl trifluorovinyl ether and chlorotrifluoroethylene (CPT), terpolymers of TFE, HFP and ethylene (EFEP), polytrifluoroethylene (PTrFE), and perfluorinated polymers with perfluoroalkoxy side-chains resulting from copolymerization of tetrafluoroethylene with either trifluoromethyl trifluorovinyl ether (MFA) or other perfluoroalkyl trifluorovinyl ethers (PFA). * Fluoroelastomers or `fluorocarbon elastomers' are rubbery materials based mainly on several of the same monomers as used for producing fluoroplastics, including but not limited to VDF, HFP, TFE, CTFE, PAVEs and propylene, as well as 1hydropentafluoropropene (HPFP) and 2,3,3,3-Tetrafluoropropene (HFO-1234yf). They are produced as highly viscous materials and then cross-linked (or `cured', or `vulcanized') to harden them and impart their elasticity. Cross-linking agents commonly used are multinucleophiles (diamines, bisphenols, diisocyanates (e.g. tryallyl isocyanurate), free-radical generators (peroxides), or radiation. Fluoroelastomers can be regarded as a distinct subset of fluoropolymers. While they are based on many of the same monomers as those used for synthesizing fluoroplastics, the main difference between the two families is that fluoroelastomers have unique elastomeric properties resulting from the crosslinking process, with low sub-ambient glass transition temperatures (Tg). Polymer Hazard Assessment and EU Regulation Although Fluoropolymers can be categorized as PFAS based on their structure, their environmental and toxicological profiles are distinctly different. The properties of fluoropolymers PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Flueropolymers Product Group are such that they do not display the environmental and toxicological profiles associated with PFASs that could be considered of concern. One international? and three EU level studies have affirmed that certain characteristics identify polymers with low health and environmental hazards; known as the polymer of low concern (PLC) criteria. The Wood/PFA report to the EC (2020)* stated that "Criteria to identify PLC are considered to be already well accepted (e.g., EC 2015% OECD 2009).". The report stated that the OECD 2009, EC 2012 and 2015 reports to the EC "provide a good foundation for the identification of PLC polymers and a mechanism for addressing PLC within EU policy". Therefore, polymers meeting the PLC are excluded from "polymers requiring REACH registration (PRR). The Fluoropolymers Product Group agrees with these international and European reports acknowledging that polymers meeting the PLC criteria represent low health and environmental hazard. We agree with the extensive review conducted by Henry et al." from 2018 which concludes that "fluoropolymers are distinctly different from other polymeric and nonpolymeric PFAS and should be separated from them for hazard assessment or regulatory purposes. Grouping fluoropolymers with all classes of PFAS for `read across' or structure--activity relationship assessment is not scientifically appropriate." Therefore, because a polymeric PFAS can satisfy the physical, chemical and biological criteria (to be considered a PLC) it would not meet the criteria to be considered toxic (T), bioaccumulative (B), or mobile (M) and it's stability (or persistence, P) would not result in health or environmental 2 Organisation for Economic Co-operation and Development. 2009. Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. OECD Task Force on New Chemicals Notification and Assessment, Expert Group Meeting on Polymers; 2007 Mar; Tokyo, Japan. Paris (FR). 3 European Commission. 2012. REVIEW OF REACH WITH REGARD TO THE REGISTRATION REQUIREMENTS ON POLYMERS 070307/2011/602175/SER/D3, Final Report Part A: Polymers, Prepared for European Commission DG Environment, December 2012, Risk & Policy Analysts Limited,; European Commission, 2015. Technical assistance related to the review of REACH with regard to the registration requirements of polymers, BIO by Deloitte; European Commission 2020. ENV.B.2 Sustainable Chemicals. Scientific and technical support for the development of criteria to identify and group polymers for Registration/Evaluation under REACH and their impact assessment. Final Report. Wood E&IS GmbH) 4 European Commission 2020. ENV.B.2 - Sustainable Chemicals. Scientific and technical support for the development of criteria to identify and group polymers for Registration/Evaluation under REACH and their impact assessment. Final Report. Wood E&IS GmbH 5 COM (2015). Technical assistance related to the review of REACH with regard to the registration requirements on polymer. Final Report. European Commission, 2015. Available at: https://ec.europa.eu/environment/chemicals/reach/pdf/FINAL%20REPORT%20POLYMER%102205S.1pd6f7. 8 OECD (2009). Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. Organisation for Economic Co-operation and Development, ENV/JM/MONO(2009)1, 27th January 2009. 7 Barbara J Henry, Joseph P Carlin,Jon A Hammerschmidt, Robert C Buck, L William Buxton, Heidelore Fiedler, Jennifer Seed, and Oscar Hernandez 2017. A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers Integrated Environmental Assessment and Management -- Volume 14, Number 3--pp. 316-334. https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4035 PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluoropolymers Product Group hazard (Henry et al., 20188; Supplement to Henry et al., 2018; USEPA 1999'%; UNEP 2001"; ECHA 2014'%;, EC 2008"; UBA 2017; Barlow 2005'4; Kalberlah et al. 2014'S). The only commonality with PFAS would be the common structural element of having at least one fully fluorinated carbon atom (by the CfE definition of PFAS). We believe the data demonstrates that PLC fluoropolymers do not cause a risk warranting restriction under REACH. Why do we believe fluoropolymers should not be included in a REACH restriction? Fluoropolymers should not be included in a REACH restriction. The terms `fluorinated substances', `organic fluorine compounds', `PFASs', `PFCs', `fluorinated polymers', `fluoropolymers', etc., are very broad terms that lack the differentiation needed for regulatory purposes. All these terms group together classes of substances with widely varying properties and hazard profiles. The definition of what constitutes a PFAS is based on its structure, rather than on its properties: PFASs are taken to be those organic fluorine compounds that contain at least one perfluoroalkyl (CnF2n+1--) group, with n 2 1, according to Buck et al (2011). OECD (20189) later broadened this definition to also include perfluoroalkylene groups (--Cn.F2--, n 2 3) and perfluoroalkylene ether groups (--C,F2nOCmF2m--, with both n and m = 1). This observation explains why the definition of PFAS is based on the mere presence of perfluoroalkyl groups in their structure: all PFASs thus defined are tacitly deemed to be hypothetically capable of transformation to PFAAs (Perfluoroalkyl Acids), whether or not there are experimental observations or a weight-of-evidence assessment with expert judgment to support this conclusion. However, it is known that certain PFAS do not degrade at all in the 8B. J. Henry, et al, `A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers'. Integr Environ Assess Manag, 14, 2018, p. 316-334 2 Supplemental data to A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers. 2018. Accessed at: ieam4035-sup-0001-SuppData-S1.docx 10 [USEPA] US Environmental Protection Agency. 1999. Category for persistent, bioaccumulative, and toxic new chemical substances. Fed Regis 4(213). 1999 Nov 4. [UNEP] United Nations Environment Programme. 2001. Conference of Plenipotentiaries on the Stockholm Convention. UNEP/POPS/CONF/2. [cited 2017 July 12]. http://www.wipo.int/edocs/tridocs/en/unep-pop/trt unep pop 2.pdf 12 [ECHA] European Chemicals Agency. 2014. Guidance on information requirements and chemical safety assessment. Chapter R.11: PBT/vPvB assessment version 2.0 November 2014. https://echa.europa.eu/documents/10162/13632/information_ requirements r11_en.pdf/aBcce23f-a65a-46d2-ac68-92fee1f9e54f 13 [EC] European Commission. 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance). htip://eurlex.europa.eu/legal-content/EN/TXT/?uri=celex:32008R1272 14 Barlow S. 2005. Threshold of toxicological concern (TTC): A tool for assessing substances of unknown toxicity present at low levels in the diet. Brussels (BE): ILSI Europe. ILSI Europe Concise Monograph Series 15 Kalberlah F, Oltmanns J, Schwartz MA, Baumeister J, and Stiffler A. 2014. Guidance for the precautionary protection of raw water destined for drinking water extraction from contaminants regulated under REACH. Dessau-Rollau (DE): Umweltbundesamt (UBA). Report FKZ 371265416. 6 OECD, 2018. Toward a new comprehensive global database of Per- and Polyfluoroalkyl Substances (PFASs): Summary report on updating the OECD 2007 list of per- and polyfluoroalkyl substances (PFASs). Series on Risk Management, No. 39, ENV/JM/MONOQ(2018)7 (http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV-JMMONO(2018)7&doclanguage=en) PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluoropolymers Product Group environment or in the presence of biota, so they cannot lead to `PFAAs of concern'. Examples include fluoropolymers, some of the structures of which correspond to the PFAS definition. Nevertheless, it is suggested that all the members of the structure-based family of PFAS should be regulated as a group, including fluoropolymers, under the implicit assumption that all of these have environmental and/or toxicological concerns equivalent to PFOS, PFOA and the other members of the family regulated so far." This intention demonstrates a shortcoming of the structure-based classification. Indeed, segmentation according to known properties is essential before assessing sub-groups of the PFAS family, some of which, especially fluoropolymers, are considered of low concern. Indiscriminate generalization to the whole family, with vastly diverse properties, would not be grounded in sound science. For these reasons, we strongly advocate for the segmentation of the PFAS family of substances before performing any grouping-based assessment. Environmentally stable compounds such as the fluoropolymers should be placed into a separate category. Persistence The criteria for PFAS as described in the Call for Evidence include many different substances with very different properties and environmental and safety profiles. While persistence in the environment may warrant further consideration, persistence alone does not imply that there is a present or future risk to human health or the environment. REACH has regulated Persistence so far in the context of PBTs and vPvBs where Persistence (P) must be associated with Bioaccumulation (B) and Toxicity (T) (or very Persistent (vP) properties must be associated with very Bioaccumulative (vB)) properties to justify qualification as a substance of very high concern (SVHC). In REACH, Persistence alone does not justify risk management measures. Considering the wide variety of persistent substances (including those that meet the definition of PFAS as described in the Call for Evidence), the level of priority in the assessment and management of persistent chemicals should vary not only on the basis of their respective level of persistence, but based on all other relevant factors. Fluoropolymers may meet the REACH definition to be considered persistent but are not mobile in the environment given their negligible solubility and have been demonstrated to have no systemic toxicity. The inertness and stability of fluoropolymers is precisely why they are 7 Both PFOS and PFOA, as well as their salts and `related compounds' (sometimes referred to loosely as `C8 chemistry'), are now regulated globally as `Persistent Organic Pollutants (POPs)' under the Stockholm Convention and they have been categorized as `Substances of Very High Concern' under REACH, as have certain homologues of PFOS and PFOA, also belonging to the family of PFAAs, which have so far been the main focus of regulatory attention. Undesirable properties assessed in this respect include persistence, bioaccumulation, hydrogeological mobility, long-range transport, toxicity, and combinations thereof. PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 Plasticsturope Fluoropolymers Product Group used in many diverse applications of high societal value necessary for modern life (e.g. medical devices, renewable energy, and automotive and semiconductor applications). There is no scientific agreement on `vP' substances being considered similar or equal to vPvB substances in terms of hazard and risk. Thus, persistence cannot be used in our view to justify a restriction under the current REACH framework. More work is necessary to clearly demonstrate the potential mechanism, which can be accepted by all stakeholders, and causal relationship between the `vP' properties and any potential adverse effects. Socio-Economic Impact Assessment Fluoropolymers provide vital performance characteristics to products or production processes. Collectively this creates socio-economic value far beyond the direct impact created by the fluoropolymers industry itself. Whilst not all of these benefits can be quantified, an independent Socio-economic Analysis of the European Fluoropolymer Industry carried out by amec foster wheeler on behalf of the Fluoropolymers Product Group and published in 2017 analysed eight strategically important sectors: + Transport: By providing durable and effective protection against heat, aggressive fluids and fuels, humidity, vibrations and compression. Fluoropolymers prolong the useful life of various components critical for performance, emission control and safety in both the automotive and aerospace industries, including lithium batteries. Looking specifically at cars, fluoropolymers contribute to safety, engine efficiency, weight reductions and emission control, thereby improving fuel efficiency and reducing leaks and fugitive emissions. Modern road transport emission standards could not have been achieved without these materials. Specifically, fluoropolymer use in fuel hoses alone enables fuel savings worth some 40m per year and lower emissions prevents health damage valued at a further 100m in Europe. Over the vehicle lifetime, this equates to fuel savings in Europe of some 200m. + Chemical and power: Fluoropolymers enable a high level of efficiency and environmental safety in the chemical and power sectors, helping them remain internationally competitive. Uses include piping, vessels, fluid-handling components, filters, vents and cable coatings. Fluoropolymer coatings, linings and components prevent corrosion in demanding environments. Each percent reduction in corrosion is estimated to deliver savings of some 150m per year across Europe. Amongst other benefits, they support savings in maintenance through increased component lifetime. Consultation suggested their use effectively doubled the lifetime of equipment, potentially yielding savings in the order of 100m annually. Furthermore, they provide important contributions to applications that prevent or remove pollution; in Combined Heat and Power (CHP)1 installations alone, PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 Plasticsturope Fluoropolymers Product Group fluoropolymer heat exchanger technology contributes to energy savings worth up to 8bn and CO2 emission reductions worth around 0.5-3bn, across Europe, per year. e Cookware: Fluoropolymer-coated cookware provides easy-clean, non-stick properties, saving time, water and energy. This facilitates cooking with less added fat contributing to a healthy diet. Electronics: Fluoropolymers are critical to the semiconductor manufacturing process. Here various fluoropolymer components can stand up to the aggressive etching chemicals and provide the necessary purity required in the production of microchips and other electronics, where even trace contaminants can severely affect production yield. Annual benefits of fluoropolymers in semiconductor manufacturing are substantial - estimated in a 2006 study at some 10bn, per year. Semiconductors, in turn, are found in millions of products which are becoming ever more powerful, but compact. More generally, fluoropolymers enable improved fire safety, reliability and performance of cables, notably data transmission cables enabling a wide range of ICT2, industrial, automotive, medical imaging and analysis and a huge range of other applications. A combination of high dielectric properties, high heat resistance and fire resistance is necessary to produce acceptable products. e Food and pharmaceuticals: Fluoropolymers enable durable processing equipment, ensuring high purity of food and pharmaceuticals as well as a high level of efficiency by preventing corrosion and facilitating cleaning. In the European biopharmaceutical manufacturing sector alone, 270m was saved in 2012 compared to 2008 from reductions in contamination and material failure. Such improvements can be attributed to a range of factors, but fluoropolymers play an important role in these efficiency gains. Textiles and architecture: In clothing and footwear fluoropolymers increase performance and comfort through combining waterproofing and breathability, in low weight but durable materials. They provide durable, fire-safe, easy-to-clean, building materials which can both reduce building cooling costs and energy use, whilst enabling novel "landmark" architectural designs not feasible with other materials. These include the O02 Dome (London), the Sony Centre (Berlin), Wimbledon Centre Court, the Allianz Arena (Munich), San Mams stadium (Bilbao) and the Eden Project in Cornwall, UK, all of which use fluoropolymers in the designs, for example woven PTFE fabric, fluoropolymer-coated glass fabric or extruded ETFE film. e Medical applications: Fluoropolymers enable excellent performance and long lifetimes in medical equipment such as surgically-implantable medical devices, catheters, guide wires, filters and pumps. This reduces the risks of failure, replacements, cross-infections and clogging of medical equipment, contributing to the reduction/avoidance of medical complications and the associated pain and public cost. PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Flueropolymers Product Group Renewable energy: Fluoropolymers exhibit a unique combination of properties within various components in renewable energy installations. We estimate that production efficiency increases of certain fluoropolymer-grade modules relative to glass provides a potential yearly saving -- depending on uptake -- in the order of 40m for European PV3 module manufacturers, or approximately 90m for PV module customers in the EU. Installed capacity of both PV and wind energy is increasing quickly; a pre-requisite is unit cost reductions driven by efficiency gains. They are also used in energy storage systems such as PEM fuel cells and lithium-ion batteries. PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org PlasticsEurope Fluoropolymers Product Group Socio-economic benefit of fluoropolymer applications Fluoropolymer sales to key sectors in the EU (2015) Transport 18,500 300 Tonnes m v Example application and benefit of fluoropolymers Fluor fueo l hp osesoenl ableyfum el se avir ngs and reduce damage from emissions, worth ~ 14 pe0 r yem ar in EU Chemicals & power 16,500 220 Tonnes m 3500 60 Cookware Tonnes <m Electronics 3500 50 Torres em Leii Corrosion prevse avin ng t huni dreo dsnof millions of each year in the EU # Easy clean non-stick propertialelsow,s cooking with less fat -- Led Critical in conductor actus enabling in IT that has trillions of globally in the last 20 years Fpohoadrm&a 3.000 40 &m r Sater and cheaper food and pharma by praventing contamination and material failure Enabling novel and unique landmark' wrchitectural designs Reduces the risks of failure, cross-infections and clogginogf medical equipment PV module production efficiency increases which save 40m -- 90m each year in the EU The fluoropolymer industry direct affects Produ Incthe e EdU Trade Tonnes of flucropolymerns (2015) noe 6,340M 380m pons 310m Imports So's i 111 el A A =FRY 43m=55%. - Note sil sas yanaes are roundiep qtr nearest 10 miko all tonnage Asta are roundehddMe 1 nearest S00 S00 torres PlasticsEurope AISBL Rue Belliard 40 * box 16 * 1040 Brussels * Belgium Phone +32 (0)2 792 3099 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 2972509 Plasticsturope Fluoropolymers Product Group The fluoropolymer industry -- direct effects The starting point of the value chain -- sales of fluoropolymers in their basic form -- is relatively small in comparison to the wider socio-economic benefits created by downstream fluoropolymer applications, described above. However, even the production and sale of fluoropolymers themselves creates significant direct socioeconomic effects in the EU. In 2015, around 52,000 tonnes of fluoropolymers worth around 780m were sold. By tonnage, the EU is a net importer of fluoropolymers, but the sales values of exports (380m) are around 18% higher than the sales value of imports (310m). EU fluoropolymer manufacturing is a highly innovative sector, with an estimated 43m invested in research and development (R&D) in 2015. This equates to 5.5% of turnover; around triple the EU average. The location of the fluoropolymer industry in Europe plays an important role in allowing EU-based customers to meet lead times for the various end user sectors. This is necessary in maintaining innovation and R&D, as companies are continually customising products for their local customers. Alternatives? A high-level analysis of alternatives has been carried out for all of the above sectors. Overall, whilst some alternatives might have a similar performance to fluoropolymers for a particular parameter or property, it is the combinations or ranges of properties required for the applications that sets fluoropolymers apart from the alternatives. In summary, whilst the implications of substituting fluoropolymers differ across specific applications, they include: Technical implications include lower performance, increased weight (with associated effects on fuel consumption and fuel efficiency), and reduced durability. This results in increased challenges (less compatibility and versatility) associated with component design/redesign and operating condition requirements. Economic implications include regression of advanced technologies and the reduced ability of Europe to compete and attract high and medium technology manufacturing investment (if it is not possible to prototype and produce competitive products), efficiency losses, higher initial (investment) costs and higher maintenance costs. The diversity of specific applications would pose major product qualification issues alongside design implications. + Environmental / health implications include the potential for higher risk of exposure of staff to hazardous substances, higher safety risks (vehicle or aircraft failure) and increases in emissions arising from technical regression (in transport, for example this includes inferior car emission sensors, inferior internal seals, increased fugitive emissions or weight increases). This could put at risk Europe's ability to meets its climate and energy goals. For more detailed information see the attached socio-economic report. PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 3099 - Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org PlasticsEurope Flueropolymers Product Group 2972509 Supporting sustainable product manufacturing & stewardship for fluoropolymers in Europe The Members of the PlasticsEurope Fluoropolymers Product Group strive for better chemicals manufacturing, which is essential in order to prevent unforeseen emissions to the environment. The Fluoropolymers Product Group is convinced that reducing emissions is of the utmost importance. Our manufacturing sites adhere to local and EU environmental regulation. Even so we are taking into account the continuous improvement via evaluation of additional measures that can further enhance responsible stewardship. Similarly, and submitted to this response to the call for evidence you will find a "Guide for the Safe Handling of Fluoropolymer Resins" which provides information for the supply chain on the safe handling of fluoropolymer substances. Annex | Fluoropolymers of low concern' include but are not limited to: Fluoropolymers PTFE ETFE FEP Cas Nr Structure 9002-840 -(CF2CF2)n- | 25038-71- | 250675, 68258- | 11-2 85-5 - (CH2-| -(CF- CH2)-- | CF2,) -- (CF2- (CF2-- CF2), CF 26655-00- | 24937- 5, 31784- (79-9 04-0 - (CF2- | (CF2|CF2,) -- | CH2). (CF2-CF 0) VDF-HEP Copolym er 9011-17-0 (CF2CH2),(C3F6)m- Carlin, 8 Information taken from: table 2 Barbara J Henry, Joseph P Jon A Hammerschmidt, Robert C Buck, L William Buxton, Heidelore Fiedler, Jennifer Seed, and Oscar Hernandez 2017. A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers Integrated Environmental Assessment and Management -- Volume 14, Number 3--pp. 316-- 334. https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/iienafmor.m4a0t3i5o;n on PVDF and Ethene, 1,1-difluoro-, 1,1,2,3,3,3- Hexafluoro-1-propene, copolymer (VDF-HEP Copolymer) provided by Arkema. PlasticsEurope AISBL Rue Belliard 40 + box 16 * 1040 Brussels * Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluerapolymers Product Group Fluoropolymers PTFE VDF-HEP Copolym er Polymer composition (must have C,H SiS, F, Cl | Yes Yes Br, orl covalently bound to C) Molecular weight | 389 000- | - 8 900 000 CF3)m R) Yes Yes Yes Yes - - - - (Mn > 1000 Da | 520 and oligomer 45 content < 1%) 000 Molecular weight distribution Mw number 000- | 530 000- | 241 | | 000 1200 000 wd 575 eq | | | | | -- | 000-- 000 200 000450 000 *=" 200000 600000 250000 --- 600000 average M, (My and heterogeneity of | 2.3" Mw 14-27% | 1.55- 2.099 1.71 2.7 2.7 distribution indicate if majority are >1000 or <1000 Da, which could penetrate the cell) Wt % oligomer (<5% for <100D0a | Negligibl oligomers, <2% |e for <Da | Negligible | Negligible | Negligible | Negligibl e | Negligible oligomers) Ionic character (cationic polymers associated aquatic with | Neutral Neutral Neutral Neutral PlasticsEurope AISBL Rue Belliard 40 + box 16 * 1040 Brussels * Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluerapolymers Product Group Fluoropolymers PTFE toxicity; polycationic with adverse human health effect) RFGsk (some highly reactive functional groups associated with adverse human health and ecotoxicology effects, e.g., acrylates, isocyanates, anhydrides, aziridines) FGEWk (typical value) (the lower the FGEW, the more reactive the polymer and the higher the potential for health and environmental impact) Low molecular weight leachables (MW < 1000 Da able to enter cell) <1 >105 107 <1 ppm Residual monomers (monomers have lower than MW <1 ppm ETFE <1 >10-108 No active leachable s by USP class VI ' (121) < 50 ppb <1 >10 No active leachable s by USP class VI (121) < 50 ppb <1 >10 No active leachables by USP class VI (121) < 50 ppb Not cationic polymer No concern No concern No active leachabl es by USP class VI' <1 ppm VDF-HEP Copolym er Not cationic polymer No concern No concern No active leachables by USP class VI' <1ppm PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluerapolymers Product Group Fluoropolymers PTFE ETFE FEP polymers; typically more hazardous than VDF-HEP Copolym (= g polymers) Ratio of residual monomers to molecular weight (typical value) (more low MW |~ 10" -| monomer content | 10 per mole increases ~ 10" 10 -|~10" (p18 ~ 1012 we 12 bioavailability and hazard potential) Structural similarities to RFG of concern None None None None None None (increases potential risk of adverse effects) Reference ASTM D| ASTM D| ASTM D|ASTM D standard see also | 4894 2116 ISO (ASTM (ASTM 1133 (ISO 2011), | 2015a),D | 2016a) ISO 12086 4895 3159 (ASTM 2015c) 3307 (ASTM 2016b) (ISO 2006) (ASTM 2015b) Water solubility (per USP 2011) (water solubility | Practicall | Practically | Practicall | Practically | Insoluble | Insoluble <10mg/L y insoluble |vy insoluble | at20C |at20C showed generally | insoluble | or insoluble | or low health or insoluble | or insoluble insoluble insoluble PlasticsEurope AISBL Rue Belliard 40 + box 16 * 1040 Brussels * Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluerapolymers Product Group Fluoropolymers PTFE concerns; 10mL/L to 10000mg/ L had potential health concern) Octanol-water partition coefficient, KOwW (higher KOW associated with lipophilicity and a high potential to bioaccumulate or bioconcentrate) Particle size (median mass aerodynamic diameter, MMAD, should be >5um) {1 x 10* mg/L) NA 100 - 500um (powders ) Hydrolysis (breaking M,< 1000 into Da increases hazard potential) Light (hv) (breaking into M, < 1000 Da increases hazard potential) Oxidation (breaking into Mn < Stable Stable Stable ETFE NA 50- 250um (powders) 2-4 mm (pellets) Stable Stable Stable FEP NA 50- 250pum (powders ) 2-4 mm (pellets) Stable Stable Stable NA 50-250pum (powders) 2-4 mm (pellets) Stable Stable Stable PVDF NA 5 = 300um (powders ) 2-4 mm (pellets) Stable Stable Stable VDF-HEP Copolym (= g NA 5 --300um (powders) 2-4 mm (pellets) Stable Stable Stable PlasticsEurope AISBL Rue Belliard 40 = box 16 = 1040 Brussels + Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org 2972509 PlasticsEurope Fluorapolymers Product Group [TooTg ) [Vo 7 1 1] =Td-S of If = =] 1000 Da increases hazard potential) Biodegradation (aerobic and anaerobic) (breaking into M, < 1000 Da Stable increases hazard potential) Thermal stability at normal foreseeable use maximum continuous temp | 260 (C) (breaking into M; < 1000 Da increases hazard potential) Meets PLC | Yes criteriaa (Y/N) Stable 150 Yes Stable Stable 200 260 Yes Yes ASTM =American Society for Testing and Materials CAS = Chemical Abstracts Service Da = Dalton ETFE = ethylene tetrafluoroethylene FEP = fluorinated ethylene propylene FGEW = functional group equivalent weight ISO = International Organization for Standardization MMAD = median mass aerodynamic diameter Mn = number average molecular weight MW = molecular weight MWD = molecular weight distribution OECD = Organisation for Economic Cooperation and PFA = perfluoroalkoxy polymer PFPE = perfluoropolyether PLC = polymer of low concern Development PlasticsEurope AISBL Rue Belliard 40 + box 16 * 1040 Brussels * Belgium Phone +32 (0)2 792 30 99 + Fax +32 (0)2 792 30 09 VAT BE 0416 155 338 www.plasticseurope.org Stable 150 Yes VDF-HEP Copolym (= g Stable 100 Yes 2972509 Plasticsturope Flueropolymers Product Group PTFE = polytetrafluoroethylene PVDF = polyvinylidene fluoride PVF = polyvinyl fluoride RFG = reactive functional groups USEPA = US Environmental Protection USP = US Pharmacopeia Agency 2 = see OECD 2009 and BIO by Deloitte 2015 for details on characteristics of a "polymer of low concern." b= molecular weight is number average molecular weight. = Berry and Peterson 1951; Doban et al. 1956. d= Suwa et al. 1973. = molecular weight is weight average molecular weight. f= Tuminello et al. 1993. 9= Tuminello 1989. h= Putnam 1986. '= Chu et al. 1989. I= Frick et al. 2012. k= For definition of reactive functional group; lists of low-, moderate-, and high-concern functional groups; and FGEW limits, see USEPA Polymer Exemption Guidance Manual (USEPA 1997b), BIO by Deloitte 2015 (p 191-192), and USEPA 2010. See Supplemental Data. '= In the USP testing for "class VI," 2 g of the plastic (e.g., FEP, ETFE, or PFA) were extracted at 121 C in: 1) 0.9% sodium chloride solution, 2) sesame oil, NF, 3) alcohol saline, and d) polyethylene glycol. The acute systemic toxicity and intracutaneous reactivity tests were conducted with those extracts. The intramuscular implantation was conducted with the plastic. Passing these 3 tests indicates that any leachables were not released in concentrations capable of causing these adverse effects,but does not result in a quantitative concentration of leachables. (See USP 2018.) 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