Document MDBVwaLK4a1kG6q07DkDOJKx

Comment on the Annex XV Restriction Report from 22 March 2023 concerning the substance group of PFAS Executive Summary Rubber articles, for example seals, hoses, moulded parts, or linings, contain fluoropolymers if they need to withstand harsh conditions and / or are critical for the safety of humans and the environment. Fluoropolymers do not share the hazard profile of low-molecular PFAS, they meet the OECD criteria for Polymers of Low Concern. Today, no alternatives with the same properties as the fluoropolymers used in rubber articles are known. Most of the applications of rubber articles which contain fluoropolymers are inside devices, under the hood of vehicles or in controlled industrial settings. Those rubber articles are not in direct contact with the natural environment. This risk of fluoropolymer emissions to the environment during the use phase of those articles is therefore minimal. A ban of fluoropolymers would have wide-ranged negative implications for the global competitiveness of the German rubber industry, its various downstream sectors, the safety of humans and the environment, and the implementation of the EU Green Deal. Due to the low hazard potential of fluoropolymers compared to the socioeconomic impacts of their restriction, we ask to exempt fluoropolymers from the restriction, without any time constraints. Wirtschaftsverband der deutschen Kautschukindustrie e. V. (German Rubber Manufacturers` Association) Zeppelinallee 69 D-60487 Frankfurt am Main 22 September 2023 wdk Comment on the PFAS Annex XV Restriction Report Table of Contents Introduction ........................................................................................................................... 4 Socioeconomic Aspects ........................................................................................................ 4 Risk management of hazards and emissions ........................................................................ 7 Applications of rubber articles that contain fluoroelastomers ................................................. 8 Fluoropolymers in the rubber manufacturing process ...........................................................14 Fluoroelastomer alternatives ................................................................................................14 Transition periods.................................................................................................................16 Request for exemption .........................................................................................................17 References ...........................................................................................................................17 Annex ...................................................................................................................................21 2 wdk Comment on the PFAS Annex XV Restriction Report Abbreviations ACM acrylate rubber AEM ethylene acrylate rubber BfR Bundesinstitut fr Risikobewertung (German Federal Institute for Risk Assessment) CR chloroprene rubber DIK Deutsches Institut fr Kautschuktechnologie (German Institute for Rubber Research) ECO epichlorhydrin rubber EFSA European Food Safety Authority EPM ethylene propylene rubber EPDM ethylene propylene diene rubber ERDF European Regional Development Fund EPA Environmental Protection Agency of the USA EEA European Economic Area FFKM perfluoro rubber FKM fluoro rubber (ASTM abbreviation) FPM fluoro rubber (DIN/ISO abbreviation) FVMQ fluoro silicone rubber GRG general rubber goods (all non-tyre rubber articles) GRW Joint Task for the Improvement of Regional Economic Structures (Gemeinschaftsaufgabe "Verbesserung der regionalen Wirtschaftsstruktur") HNBR hydrogenated nitril butadiene rubber HSE Health and Safety Executive of the UK IR isoprene rubber IIR isobutene isoprene rubber NACE Statistical classification of economic activities in the European Community (Nomenclature statistique des activits conomiques dans la Communaut europenne) NBR nitril butadiene rubber NR natural rubber PFAS per- and polyfluoroalkyl substances PTFE polytetrafluoroethylene SBR styrene butadiene rubber VMQ silicone rubber XIIR halogenated butyl rubber 3 wdk Comment on the PFAS Annex XV Restriction Report Introduction The universal ban of all PFAS as suggested in the restriction report would affect several substances, mixtures and articles that are used in or manufactured by the rubber industry. Rubber manufacturers use fluoropolymers as key materials to produce a plethora of rubber articles such as seals, gaskets, tubes, membranes, roll covers, cables and wires, and many more. Those fluoropolymers are mainly the fluoroelastomers FKM, FFKM, and FVMQ. Polytetrafluoroethylene (PTFE) is used as coating material for rubber articles. The plastics component of some rubber-plastics composite parts can also be made of PTFE or other fluoropolymers. In some rubber articles made from fluoroelastomers, Bisphenol AF (EC No. 216-036-7, CAS No. 1478-61-1) serves as a crosslinking agent. This substance is currently subject to another REACH restriction process1 and therefore not covered by this comment. The machinery and equipment used for the manufacturing, testing and development of tyres and general rubber goods has fluoropolymer-based parts or fluoropolymer coatings and is sometimes used in combination with fluoropolymer foils. Socioeconomic Aspects Directly affected companies in the rubber sector In total, 66.300 employees work in the German rubber industry, 19.000 of them for tyre manufacturers and 47.300 for manufacturers of general rubber goods (wdk, 2023, p. 36). General rubber goods include all rubber articles apart from tyres, e.g., seals and gaskets, diaphragms, hoses and tubes, anti-vibration components, cable and wire sheaths, and various rubber moulded parts for different applications. If general rubber goods need to meet high requirements regarding thermal stability, chemical resistance, weathering resistance, biocompatibility, longevity, and reliability, they are made of fluoroelastomers. We estimate that every second manufacturer of general rubber goods in Germany has at least one product in their portfolio that contains a fluoroelastomer. A substantial number of GRG companies are small or medium enterprises (SMEs), often managed by the owner family. These companies are dispersed across Germany, primarily in rural areas. Several of those regions are economically and socially challenged, rendering them eligible for ERDF (European Regional Development Fund) or GRW (Joint Task for the Improvement of Regional Economic Structures) funding. Manufacturing sites for general rubber goods are located in the following ERDF and GRW districts ("Landkreise"): Unna, Oberbergischer Kreism and Hochsauerlandkreis in Northrine-Westfalia; Osnabrck, Gttingen, Hxter in Lower Saxony; and Wittenberg in Saxony-Anhalt. Tyre manufacturers operate twelve production sites in Germany. Seven of them are located in the ERDF and GRW districts Bad Kreuznach, Bernkastel-Wittlich, Meien, Trier, Odenwaldkreis, Oder-Spree, and Waldeck-Frankenberg. Role of export for German GRG manufacturers German general rubber goods manufacturers are often so-called "hidden world champions". They provide highly engineered products for various applications. Foreign sales of German 1Restriction intention of bisphenols with endocrine disrupting properties for the environment and their salts in the ECHA registry of restriction intentions until outcome 4 wdk Comment on the PFAS Annex XV Restriction Report general rubber goods manufacturers amounted to 44% of total sales in 2022 (wdk, 2023, p. 7). The four largest export markets outside the European Economic Area (EEA) are the USA, the People's Republic of China, Switzerland, and the UK (wdk, 2023, p. 9). None of them has implemented a regulation of PFAS which is as strict as the two restriction options outlined in the restriction report. A PFAS ban on the proposed scale would necessitate the repositioning of corresponding production capacities to countries outside the EEA. Job losses in Germany would be the consequence. The subsequent paragraphs outline the PFAS regulation in the primary export markets of the German general rubber goods industry outside the EEA, supplementing the analysis presented in the restriction report (Restriction Report, p. 66). USA The US Environmental Protection Agency (EPA) is following a PFAS strategic roadmap "to protect public health and ecosystems by researching, restricting, and remediating PFAS contamination" (US Environmental Protection Agency, 2021). New regulation within this framework has already been adopted, e.g., regarding the limits of hazardous PFAS (PFOA and PFOS) in drinking water. Recently, the US EPA proposed a notification obligation for manufacturers of PFAS under the Toxic Substances control act (US Federal Register, 2023). Users of PFAS would not be subject to this regulation. People's Republic of China The Chinese "List of products with high pollution, high risk for environment" of the "Comprehensive Catalogue of Environmental Protection" records chemicals which are prioritized for regulation. It does not include any of the fluoroelastomers FKM, FFKM and FVMQ (Ministry of Ecology and Environment of the People's Republic of China, 2021). PFOAand PFOS-based fluoropolymers are listed, but only regarding their use as anti-stick coatings in cookware. Switzerland Annex 1.16 of the Swiss Chemical Risk Reduction Ordinance (Chemikalien-RisikoReduktions-Verordnung, ChemRRV)2 restricts the manufacturing, placing on the market and use of specific hazardous perfluorinated carboxylic acids and their precursors. Fluoropolymers are not subject to any restriction or on the regulatory agenda regarding PFAS (Bundesamt fr Umwelt der Schweizerischen Eidgenossenschaft , 2022). United Kingdom In their recent analysis of regulatory management options for PFAS, the UK Health and Safety Executive (HSE) and the UK Environment Agency concluded that there is no need to restrict fluoroplastics, fluoroelastomers, and monomers used for their manufacturing. This conclusion is based on to the low hazard level and low-risk applications of those substances (UK Health and Safety Executive, 2023). Processing aids for the manufacturing of fluoropolymers might be identified as Substance of Very High Concern (SVHC) in the short-term and subject to authorization in the medium-term. 2 Verordnung zur Reduktion von Risiken beim Umgang mit bestimmten besonders gefhrlichen Stoffen, Zubereitungen und Gegenstnden (Chemikalien-Risikoreduktions-Verordnung, ChemRRV) vom 18. Mai 2005 (Stand am 1. Juni 2023) 5 wdk Comment on the PFAS Annex XV Restriction Report Wide range of affected downstream sectors Fluoroelastomer articles are present in many industries as part of the machinery and equipment used for their operations, as components of the goods that they manufacture, or both. The restriction report covers a range of industries which use PFAS, but the use of fluoroelastomer articles in those sectors is not mentioned. Some other industries in which fluoroelastomer articles are used are not covered at all or not in detail. Table 1 provides an overview of the affected sectors, sorted by NACE codes. Table 1. Affected sectors by NACE code. NACE code A A01.41 B B6 C C10 C11 C17 C18 C19 C20 C21 C22 C26 C27 C28 C29 C30 C.32.3 C.32.5 C33 D D35 F F41 F42 F43.2 G G45.2 G45.3 G46.6 M M72.1 Sector Covered in restriction report Agriculture, forestry and fishing Raising of dairy cattle no Mining and quarrying Extraction of crude petroleum and natural gas in detail Manufacturing Manufacture of food products in detail Manufacture of beverages unclear Manufacture of paper and paper products no Printing and reproduction of recorded media no Manufacture of coke and refined petroleum products no Manufacture of chemicals and chemical products not in detail Manufacture of basic pharmaceutical products and pharmaceutical no preparations Manufacture of rubber and plastic products not in detail Manufacture of computer, electronic and optical products in detail Manufacture of electrical equipment no Manufacture of machinery and equipment n.e.c. no Manufacture of motor vehicles, trailers and semi-trailers in detail Manufacture of other transport equipment in detail Manufacture of sports goods no Manufacture of medical and dental instruments and supplies in detail Repair and installation of machinery and equipment no Electricity, gas, steam and air conditioning supply Electricity, gas, steam and air conditioning supply in detail Construction Construction of buildings in detail Civil engineering in detail Electrical, plumbing and other construction installation activities in detail Wholesale and retail trade; repair of motor vehicles and motorcycles Maintenance and repair of motor vehicles no Sale of motor vehicle parts and accessories no Wholesale of other machinery, equipment and supplies no Professional, scientific and technical activities Scientific research and development no 6 wdk Comment on the PFAS Annex XV Restriction Report Risk management of hazards and emissions Hazards related to fluoroelastomers A recent study shows that fluoropolymers meet the OECD criteria for "polymers of low concern" (Korzeniowski, 2023; OECD, 2021). Polymers which fulfil die OECD criteria for polymers of low concern also fulfil the polymers of low concern criteria proposed by CARACAL (CARACAL, 2021). Fluoropolymers are not classified as hazardous substances under the CLP regulation3. In the past, impurities of processing aids and unreacted monomers from the fluoropolymer production process caused concerns because those PFAS substances are hazardous . Today, more than 50% of the fluoropolymer production does not require the use of fluorinated polymerization aids. Experts state that with the technologies available today, even more than 80% of the global fluoropolymer production can be manufactured without the use of fluorinated polymerization aids (Amduri & Hori, 2023). Occupational health and safety measures As mentioned above, fluoropolymers are not classified as hazardous substances. However, the employees which are exposed to fluoropolymers at German rubber manufacturing sites receive regular trainings for the handling of hazardous substances according to the legal requirements (GefStoffV4, German directive on the protection against hazardous substances). Limiting emissions to the environment Figure 1 illustrates the fragment of the value chain in which rubber manufacturers can and do control the emissions of substances to the environment. They have implemented risk management measures for polymers, hazardous substances, and mixtures. Those measures are in compliance with the relevant environmental legislation, i.e., the Abwasserverordnung (Waste Water Ordinance, AbwV)5 and the IED6. Those regulations contain strict obligations and limits regarding the emission of hazardous substances to the environment. Production waste which contains fluoropolymers is either recycled by the rubber manufacturers themselves or disposed according to the existing waste laws. 3 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 4 Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStoffV) 5 Verordnung ber Anforderungen an das Einleiten von Abwasser in Gewsser (Abwasserverordnung - AbwV) 6 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (IED) 7 wdk Comment on the PFAS Annex XV Restriction Report Figure 1. The section of the value chain where PFAS emissions to the environment are controlled by the rubber manufacturers is marked with the blue background. Applications of rubber articles that contain fluoroelastomers Properties of fluoroelastomers Vulcanized elastomers have special mechanical properties which differentiate them from other materials. They are elastically deformable and can be stretched to multiple of their length without breaking. Typical applications of elastomers require those properties, e.g., seals (gaskets, O-rings, diaphragms, shaft seals, etc.), hoses and tubes, anti-vibration components, pipe connectors (e. g., gaiters), cable and wire sheaths, linings, protective gloves, valves, rollers for machinery, and other moulded parts. A wide range of elastomers exists. The fluoroelastomers FKM, FFKM and FVMQ are so-called specialty elastomers. They account for less than 0,1% of the total global production tonnage of all synthetic elastomers (Salinas & Petrovic, 2023). Compared with other synthetic elastomers, fluoropolymers combine a set of outstanding physical and chemical properties in one material, and they are significantly more expensive. Therefore, rubber manufacturers use fluoroelastomers only in products if the respective application requires their specific combination of properties. Fluoroelastomer rubber compounds contain between 15 and 80 wt% of fluoroelastomers. This equals a fluorine content of 10% to 54%7. Industrial machinery and equipment Industrial machinery and equipment are one of the main application fields of fluoroelastomer articles. The restriction report does not cover this PFAS use. Seals, gaskets, hoses, valves, diaphragms in pumps, tank linings, and rollers are just a few examples of elastomer articles that are made of fluoroelastomers if the respective application requires their properties. Many industries use machinery and equipment with fluoroelastomer articles, e. g., the chemical industry, the pharmaceutical industry, the electronics and semiconductor industries, the petroleum and gas industry, the paper industry, the printing industry, the packaging industry, the food and feed producing industry, the energy sector, and the metal-processing industry. 7 Fluorine content of fluoroelastomers according to Rthemeyer & Sommer, p. 192. 8 wdk Comment on the PFAS Annex XV Restriction Report Industrial machinery and equipment require the use of fluoroelastomer components to meet at least one, but usually several of the following technical demands: - They must withstand high temperatures and media like oil, aggressive chemicals, or strong solvents. - They must protect employees and the environment from emissions of hazardous substances. Therefore, they must be impermeable for the respective substances and reliable, i.e., the probability of material failure needs to be minimized as much as possible. - Their lifetime should match the use phase of the respective machinery or equipment to minimize maintenance and repair works and to use resources efficiently. For some applications in industrial machinery and equipment, it is sufficient to use nonfluorinated elastomers and finish the respective article with a fluoropolymer coating (PTFE). This approach can reduce the use of expensive fluoropolymers. However, it is suitable only for a few applications. Industrial machinery and equipment usually involve large investments by the owner companies and are in use for several decades. Many of the elastomer articles are designed to be replaced when they are worn out to extend the lifetime of the respective machinery or equipment. The replacement of machinery components with spare parts made of a different material is often not possible without compromising safety or performance. The demand for spare parts for industrial machinery and equipment will be much longer than the transition times suggested in the restriction report. The maintenance and disassembly of industrial machinery and equipment is performed by specialized, trained staff due to the complexity of the task. Those experts also make sure that end-of-life components are disposed of in accordance with the respective waste laws. Transport applications All means of transport such as automotive, air- and spacecraft, and railroad require elastomer articles like seals, hoses, profiles, membranes, and elastomer parts for the vehicle electronics. The elastomer articles in those applications are often exposed to extreme conditions, e. g., in the drive and cooling systems of vehicles. Those conditions are characterized by temperature differences ranging from cold outside temperatures to high operating temperatures well above 150C degrees. At the same time, elastomer articles in transport applications are in contact with various media such as oil, fuel, or exhaust gases. The reliability of elastomer articles in transport applications is indispensable. Passengers and the environment must be protected from the emissions of hazardous liquids or gases. In many transport applications, fluoroelastomers are the only known material that can reliably withstand the adverse environmental conditions outlined above over extended periods of time. Especially the combination of oil and high temperature resistance is not found for any other elastomer as Figure 2 illustrates. In addition, fluoroelastomers have a high compatibility with biofuels (Walker, 2010). 9 wdk Comment on the PFAS Annex XV Restriction Report Figure 2. Temperature and media resistance of various elastomers (Rthemeyer & Sommer, 2013, S. 1142). Axis labels translated from German by the comment submitter. Here, the ISO abbreviation for FKM, FPM, is used. Battery electric and hydrogen drives require fewer elastomer articles overall. Nevertheless, they still need fluoroelastomer articles that can withstand extreme conditions. Regardless of the mobility transformation, transport applications will require fluoroelastomer components. Fluoroelastomer articles in transport applications are usually installed under the hood, i.e., inside the vehicle, but outside of the passenger compartment. Therefore, passengers are not exposed to the fluoroelastomers and emissions to the environment are unlikely. Fluoroelastomer articles in vehicles reach the end of their use phase when they need to be replaced or when the use phase of the vehicle ends. The replacement of fluoroelastomer parts is usually performed by trained staff in professional facilities. This way, proper disposal of fluoroelastomer parts in accordance with the existing waste laws is ensured. In vehicle recycling, elastomer parts are assigned to the shredder light fraction. In Germany, ninety percent of this fraction are either recycled or recovered as energy in waste incineration plants or as substitute fuel (Umweltbundesamt, 2023). Fluoroelastomers do not decompose to other PFAS when they are incinerated in combustion plants, they mineralize to HF (Gehrmann, et al., 2023). Electronics and semiconductors The list of PFAS used in the electronics and semiconductor industry (table A.48 and table A.49 in Annex A of the restriction report) does not cover fluoroelastomers. Fluoroelastomer articles in electrical and electronical devices are, e.g., cable and sheaths, seals for cable connectors and rollers of printers. In the semiconductor industry, fluoroelastomer articles are also used. Depending on their respective field of application, components in electrical and electronic devices must meet demanding conditions. They must be resistant to various media and retain their elastic properties over a wide temperature range. For some applications, fluoroelastomers are the only elastomers which can meet those requirements. The fluoroelastomer components of electrical and electronic appliances are installed inside of the respective device and / or used in controlled industrial environments. Consumers are not exposed to the fluoroelastomer articles and emissions to the environment are unlikely. 10 wdk Comment on the PFAS Annex XV Restriction Report Upon reaching the end of their use phase, electrical and electronic devices undergo disposal procedures outlined by the WEEE Directive8. This legislative framework dictates that labels affixed to such devices serve as a reminder to both professional users and consumers, prompting them to adopt a specific disposal approach as illustrated in Figure 3. Specialists in dedicated facilities dismantle the waste electrical and electronic devices into their constituent parts for recycling. In Germany, elastomer parts are directed into the energy recovery system (Umweltbundesamt, 2022). Figure 3. Label according to the WEEE. Food contact materials In addition to the fluoropolymers listed in Annex A of the restriction report, fluoroelastomers serve as materials, e.g., for seals, within industrial machinery and equipment employed in food production (Restriction Report, 2023, Annex A, pp. 39-41). The resistance of fluoroelastomers against a wide range of chemically different media in combination with their thermal stability, facilitates the implementation of hygienic cleaning protocols between production cycles. This safeguard ensures the protection of consumers against potential contamination of food and beverages by microbes or other contaminants. In Germany, the use of fluoroelastomers as food contact materials is confined to scenarios where contact to food is either very short in time or limited to small surface areas. This delineation is in accordance with the recommendations on food contact materials established by the German Federal Institute for Risk Assessment (BfR) (German Federal Instutite for Risk Assessment, 2023, p. 3). The migration of substances into the food is not expected in those applications. Moreover, fluoroelastomers used as food contact materials adhere to the stipulations of Regulation (EC) No 1935/2004 on materials and articles intended for the contact with food9. According to this regulation, consumers must not be exposed to any hazardous substance above safe limits which are scientifically determined by experts from the European Food Safety Authority (EFSA). Energy sector In the restriction report, the use of fluoroelastomers in energy applications is only covered regarding hydrogen technology and fuel cells (Restriction Report, 2023, p. 118 f.). Fluoroelastomers are also present in other energy related fields, i.e., in photovoltaics (rollers for their production), in nuclear power plants (valves), and in the flue gas desulfurization unit of combustion power plants (anti-stick linings). 8 Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) 9 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC 11 wdk Comment on the PFAS Annex XV Restriction Report Fluoroelastomers are used in those applications because of the properties listed in table A.52 of the restriction report (p. 118). Many energy applications require fluoroelastomers components for their safe operation and the protection of the environment from emissions. Medical Devices In non-implantable medical devices, fluoroelastomer articles are used, e.g., in pumps (valves, seals) or in dental equipment (vibration damping). Fluoroelastomers are used in those applications because they meet the requirements regarding the design and manufacture of medical devices according to Regulation (EU) 2017/74510, Chapter II, paragraphs 10-22. The medical devices which contain fluoroelastomers components are usually electronical equipment, e. g., pumps. At their end of life, they are disposed either as medical or as electronical waste, depending on the respective application. Petroleum and mining The uses of fluoroelastomers in the petroleum and mining sector are fully covered in annex A of the restriction report on pp. 148. Construction products Annex A of the restriction report does not cover the use of fluoroelastomer articles in civil engineering applications or heating and plumbing applications. For example, district heating pipelines, building heating systems or fire sprinkler systems require fluoroelastomer articles such as seals. Heat resistance and longevity of the materials are crucial in those applications. Material failure could cause major damages of buildings or compromise the safety of infrastructure. TULAC The restriction report does not cover the use of fluoroelastomers in TULAC (Table A.75 in Annex A of the restriction report). However, they are used as glove materials for personal protection equipment due to their low permeability and high resistance against a wide range of chemicals. No other common glove material reaches a comparable performance level regarding permeation times according to the standard for protection gloves (Institut fr Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA), 2020; DIN EN ISO 3742:2020-04, 2020). Compared to gloves made from other materials, fluoroelastomer gloves are expensive. Therefore, they are only used in situations when other materials would not provide sufficient protection. Since fluoroelastomer gloves are used in industrial or professional environments and are often contaminated with chemicals after use, they are disposed of as chemical waste accordingly. Coverage of applications by the restriction report The restriction report does not cover all the applications described in the sections above. Table 2 gives an overview of the applications of rubber articles that contain fluoroelastomers that the comment submitter has identified. 10 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices 12 wdk Comment on the PFAS Annex XV Restriction Report Table 2. Non-exhaustive list of applications and subuses of rubber articles which contain fluoroelastomers. Applications and sub-uses that are not covered by the restriction report are highlighted in italics. Application Industrial machinery and equipment Chemical Industry Transport (automotive, aerospace, trains) Electronics and semiconductors Food Contact Materials Energy sector Medical devices (nonimplantable) Construction products Petroleum and mining Consumer products Sub-uses Production of metals Packaging industry Textile industry Food and feed production (food contact materials and articles without food contact) Pharmaceutical industry Paper industry Printing industry Chemical industry Listed under industrial machinery and equipment Battery systems Combustion engine systems incl. exhaust gas system Fuel cell systems Sealing applications Cooling system Vibration control Valves Equipment and machinery for chip and semiconductor production Electronic dental devices Medical pumps (nonimplantable) Semiconductor components Electrical household appliances and other electronic consumer products Listed under industrial machinery and equipment Nuclear powerplant Photovoltaic cells Hydrogen and fuel cell technologies Combustion power plants Listed under electrical and electronic devices Heating Plumbing Listed under electrical and electronic devices Fluoroelastomer articles seals, gaskets, valves, rollers, packaging, diaphragms, linings Seals, gaskets, moulded parts, hoses, media-carrying lines, profiles, membranes, cable jackets, connector seals, rupture discs Roller coverings, seals, valves, diaphragms, anti-vibration components Valves, manufacturing equipment, exhaust gas treatment systems Seals Seals, valves, diaphragms, linings, sensors, cables and wires 13 wdk Comment on the PFAS Annex XV Restriction Report Fluoropolymers in the rubber manufacturing process In the manufacturing of rubber articles such as tyres and general rubber goods, fluoropolymer (PTFE) coatings and foils are used to facilitate the release of the rubber components from moulds, without causing any damage to them. Currently, there is no known alternative material that possesses the combination of same anti-stick property, temperature resistance, and chemical resistance suitable for this application. The use of fluoropolymer coatings and foils plays a crucial role in minimizing scrap rates, which in turn reduces resource consumption and production waste. Fluoroelastomer alternatives Fluoroelastomers differ in their chemical and physical properties from other, fluorine-free elastomers: They are stable at within a wide temperature range, and especially at high temperatures (-35C to +230C). They are stable against a wide range of substances, solvents, and media. They are stable against weathering and ozone. They have flame-retardant and self-extinguishing properties. They are biocompatible. The mechanical properties of their vulcanizates 11 change only slightly even after prolonged exposure to high temperatures and/or media such as oil. Their vulcanizates have good permeation tightness to a wide range of different liquids and gases. No elastomers with the equivalent performance and combination of properties are known today. This is visualized in Table 3, Figure 4, Figure 5, Figure 6, and Figure 6. Table 3. Chemical resistance of non-fluorinated elastomers (EPDM, NBR, VMQ) versus fluoroelastomers (FVMQ, FKM, FFKM (Fernandez, 2008, p. 136). 11 In vulcanizates, the fluoroelastomers are chemically cross-linked to each other. 14 Service temperature wdk Comment on the PFAS Annex XV Restriction Report Figure 4. Compression set of FKM and other elastomers at elevated temperature over time (Fernandez, 2008, p. 136). Volume swelling (%) Figure 5. Service temperature over volume swelling in ASTM oil no. 3 (mixture of paraffines and aromatics (Kleemann, 1994, p. 36). Axis labels translated from German by the comment submitter. 15 wdk Comment on the PFAS Annex XV Restriction Report Figure 6. Retained sealing force of FKM and other elastomers at elevated temperature over time (Fernandez, 2008, p. 136). If it is possible to substitute fluoroelastomers with other, fluorine-free elastomers, depends on the respective application. In general, fluoroelastomers are used only if no other material meets the technical requirements of the application due to their comparatively high price. The restriction report lists some elastomers which could be used instead of fluoroelastomers if the conditions of the respective application allow (Annex E of the Restriction Report, pp. 349, pp. 414, pp. 499). DIK (Deutsches Institut fr Kautschuktechnologie, German Institute for Rubber Research) has prepared an overview of possible fluoroelastomer alternatives and their limitations in various application areas on behalf of the dossier submitter. The according table is in the annex of this comment (Table A.1 on p. 21). When evaluating possible alternatives, their availability on the market needs to be considered in addition to their physical and chemical properties. While some of them might be standard elastomers that are available in large quantities from various global suppliers, others such as ACM and AEM are specialty elastomers. Only very few global suppliers exist for those elastomers (Dick & Rader, 2013) and the demand for AEM is barely being met today. Regarding spare parts, the interdependence of geometry and material must be considered. A change of material usually requires the adaption of the geometry. Therefore, spare parts often cannot be made of alternative materials because the geometry is predefined by the application. Transition periods The substitution of fluoropolymers in elastomer articles requires actions at every single stage of the value chain from the polymer manufacturers to the companies which use elastomer articles that contain fluoropolymers. If viable alternatives would have been developed for specific applications, there are additional requirements that must be met before rubber manufacturers can supply the respective elastomer articles to downstream users: - The alternatives must comply with current regulations. This involves intensive testing by third parties which is mandatory for certain products, e. g., construction products, food contact materials, drinking water applications, and medical devices. - The alternatives must comply with European and national standards for the respective applications, e. g., the CEN and DIN standards for automotive, aerospace, chemical apparatus etc. 16 wdk Comment on the PFAS Annex XV Restriction Report - The alternatives must be approved by the downstream users. - Sufficient volumes of the fluoropolymer substitute must be available to meet the demand. Fluoroelastomers are specialty elastomers with limited production capacities. Assumably, this is also valid for possible alternatives. Considering all of these factors, the transition period towards adopting fluoropolymer-free rubber components is likely to extend beyond 15 years. Request for exemption Fluoropolymers, including fluoroelastomers, meet the OECD criteria and proposed EU definition of "polymers of low concern" (Korzeniowski, 2023; OECD, 2021; CARACAL, 2021). Fluoropolymers have a different chemical structure, higher molecular weight, and significantly lower hazard profile than other PFAS. Therefore, when evaluating regulatory measures related to PFAS, it is important to assess the hazards and risks linked to fluoropolymers separately from low-molecular PFAS. Applications involving fluoroelastomers are predominantly limited to controlled industrial settings or enclosed within devices. Consumers are usually not exposed to fluoroelastomers, or articles made thereof. There is no known link between the manufacturing of rubber goods from fluoroelastomers and PFAS emissions into the environment. Effective disposal methods are available for products containing fluoroelastomer articles, usually involving incineration, which leads to the complete transformation of fluoroelastomers into non-PFAS substances. Fluoropolymers are resource-efficient materials due to their extended lifespan and exceptional resistance to various substances, solvents and media, to high temperatures and to weathering. Viable alternatives to fluoropolymers would exhibit comparable properties regarding persistence. The implications of a restriction of fluoropolymers as proposed in the restriction report would encompass: Compromised safety for both individuals and the environment due to hazardous emissions. Reduced lifespans of products, machinery, and equipment. Limited selection of materials for the advancement of modern technologies essential for the Green Deal. Displacements of manufacturing sites and employment opportunities within the EU. The proposed restriction of fluoropolymers carries significant and extensive risks for both the European economy and society. Considering the low hazard potential of fluoropolymers, we ask for an exemption of fluoropolymers from the restriction, without any time constraints. In the interest of preserving resilient value chains, this should also include the manufacturing of fluoropolymers. References Amduri, B., & Hori, H. (2023). Recycling and the end of life assessment of. Chem Soc Rev, 52, 4208-4247. doi:10.1039/d2cs00763k BAuA Federal Institute for Occupational Safety and Health, Germany; BAuA Federal Institute for Occupational Safety and Health, The Netherlands; Swedish Chemicals Agency (KEMI); Norwegian Environment Agency; The Danish Environmental Protection 17 wdk Comment on the PFAS Annex XV Restriction Report Agency. (2022). Annex XV restriction report. Proposal for a restriction. Substance Name: Per- and polyfluoroalkyl substances (PFAS). Helsinki: European Chemicals Agency. Bundesamt fr Umwelt der Schweizerischen Eidgenossenschaft . (2022, October 24). Perund polyfluorierte Alkylverbindungen (PFAS). Retrieved July 13, 2023, from Bundesamt fr Umwelt BAFU. CARACAL. (2021). Proposal for an EU-definition of a polymer of low convern (PLC). Dick, J. S., & Rader, C. P. (2013). Raw Materials Supply Chain for Rubber Products. Mnchen, Germany: Carl Hanser Verlag. doi:10.3139/9781569905388 European Commission, Directorate-General for Environment, Bougas, K., Corden, C., Crookes, M. (2020). cientific and technical support for the development of criteria to identify and group polymers for registration/evaluation under REACH and their impact assessment : final report. Brussels. doi:10.2779/890644 Federal Institute for Occupational Safety and Health of Germany (BAuA); Bureau REACH, National Institute for Public Health and the Environment (RIVM); Swedish Chemicals Agency (KEMI); Norwegian Environment Agency; The Danish Environmental Protection Agen. (2023). Annex XV Resstriction Report. Proposal for a Restriction of Per- and Polyfluorinated Alkylic Substances (PFAS). Helsinki: European Chemicals Agency (ECHA). Fernandez, P. (2008). Fluoroelastomers, FKM, and FEPM. In R. C. Klingender (Ed.), Handbook of Specialty Elastomers (pp. 133-154). Boca Raton: CRC Press. Gehrmann, H.-J., Bologa, A., Aleksandrov, K., Bergdolt, P., Taylor, P., Schlipf, M., . . . Kapoor, D. (2023). Pilot-Scale Fluoropolymer Incineration Study: Thermal Treatment of a Mixture of Fluoropolymers under Representative European Municipal Waste Combustor Conditions. German Federal Environmental Agency. (2022). Bewertungsgrundlage. Anlagen der Bewertungsgrundlage fr Kunststoffe und andere organische Materialien im Kontakt mit Trinkwasser (KTW-BWGL). Polymerspezifischer Teil. Bad Elsterelastomere: Federal Envionrmental Agency. Retrieved from https://www.umweltbundesamt.de/sites/default/files/medien/5620/dokumente/ktw- bwgl_-_polymerspezifische_anlagen_-_3._aenderung_rev02_de.pdf German Federal Instutite for Risk Assessment. (2023, 02 01). Commodities based on natural and synthetic rubber in contact with food. Institut fr Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA). (2020, June). Welcher Handschuh ist der richtige? Retrieved August 05, 2023, from Institut fr Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung: https://www.dguv.de/ifa/praxishilfen/praxishilfen-persoenliche- schutzausruestungen/schutzhandschuhe-gegen-chemische-und-biologische- einwirkungen/auswahlhilfen-fuer-chemikalienschutzhandschuhe/index.jsp Kleemann, W. a. (1994). Formeln und Tabellen fr die Elastomerverarbeitung. Rathingen: Dr. Gupta Verlag. Korzeniowski, S. B. (2023). A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers. Integr Environ Assess Manag, 19(2), 326-354. doi:10.1002/ieam.4646 18 wdk Comment on the PFAS Annex XV Restriction Report Ministry of Ecology and Environment of the People's Republic of China. (2021). Comprehensive List of Environmental Protection (2021 Edition). People's Republic of China. Retrieved from https://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202111/W020211102723950004765. pdf OECD. (2021). Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance. Paris: OECD. Retrieved from https://one.oecd.org/document/ENV/CBC/MONO(2021)25/En/pdf Rthemeyer, F., & Sommer, F. (2013). Kautschuk Technologie. Werkstoffe - Verarbeitung Produkte. Mnchen: Carl Hanser Verlag. Salinas, J. R., & Petrovic, R. B. (2023). Worldwide Rubber Statistics 2023. Houston, Texas: International Institute of Synthetic Rubber Producers, Inc. Schutzhandschuhe gegen gefhrliche Chemikalien und Mikroorganismen - Teil 2: Bestimmung des Widerstandes gegen Penetration (ISO 374-2:2019); Deutsche Fassung EN ISO 374-2:2019. (2020). Berlin, Germany: Beuth Verlag. doi:10.31030/3083909 Schutzhandschuhe gegen gefhrliche Chemikalien und Mikroorganismen - Teil 2: Bestimmung des Widerstandes gegen Penetration (ISO 374-2:2019); Deutsche Fassung EN ISO 374-2:2019. (2020, April). Berlin, Germany: Beuth Verlag. UK Health and Safety Executive. (2023). Analysis of the most appropriate regulatory management options (RMOA). Poly- and perfluoroalkyl substances (PFAS). Retrieved from https://www.hse.gov.uk/REACH/rmoa.htm Umweltbundesamt. (2022). Produktverantwortung in der Abfallwirschaft - Elektroaltgerte. Retrieved May 16, 2023, from https://www.umweltbundesamt.de/themen/abfallressourcen/produktverantwortung-in-der-abfallwirtschaft/elektroaltgeraete Umweltbundesamt. (2023). Altfahrzeugverwertung und Fahrzeugverbleib. Retrieved May 16, 2023, from https://www.umweltbundesamt.de/daten/ressourcen-abfall/verwertungentsorgung-ausgewaehlter-abfallarten/altfahrzeugverwertungfahrzeugverbleib#altfahrzeuge-2020-niedrigste-anzahl-seit-beginn-deraufzeichnungen-in-2004 US Environmental Protection Agency. (2021). PFAS Strategic Roadmap: EPA's Commitment to Action. Retrieved from https://www.epa.gov/system/files/documents/2021-10/pfasroadmap_final-508.pdf US Federal Register. (2023, May 26). Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA). 88(102), 34100. Retrieved from https://www.govinfo.gov/content/pkg/FR-2023-05-26/pdf/2023-10735.pdf Walker, F. J. (2010). Einwirkung von Biokraftstoffen auf statische Elastomerdichtungen. Gummi Fasern Kunststoffe, 63(9), 560-563. wdk. (2020, April 28). Verteilung der Elastomer-Exporte aus Deutschland nach Abnehmerlndern im Jahr 2019. Retrieved August 03, 2023, from Statista: https://de.statista.com/statistik/daten/studie/1070059/umfrage/verteilung-derelastomer-exporte-aus-deutschland-nach-abnehmerlaendern/ 19 wdk Comment on the PFAS Annex XV Restriction Report wdk. (2023, May 05). Anzahl der Beschftigten in der deutschen Kautschukindustrie in den Jahren von 2005 bis 2022. Retrieved August 01, 2023, from Statista: https://de.statista.com/statistik/daten/studie/182303/umfrage/deutschekautschukindustrie-beschaeftigtenanzahl-seit-2005/ wdk. (2023). Die Kautschukindustrie 2022/2023. Frankfurt am Main. Retrieved from https://wdk.de/?jet_download=11562 wdk. (2023, May 05). Ein- und Ausfuhr der deutschen Kautschukindustrie bis 2022. Retrieved August 03, 2023, from Statista: https://de.statista.com/statistik/daten/studie/182299/umfrage/ein-und-ausfuhr-der- deutschen-kautschukindustrie-seit-2005/ 20 Annex Fluoroelastomer alternatives and their limitations in different applications Because of the overall highly sophisticated properties of fluoroelastomers, a substitution is only possible in special applications with specific restrictions and limitations. An overview is given in the following table which has been prepared on behalf of the dossier submitter by DIK (Deutsches Institut fr Kautschuktechnologie, German Institute for Rubber Research). Table A.1: Applications of FKM elastomers and selected special substitutes with exceptions and restrictions. Industrial machinery and equipment Chemical industry Electronics and semiconductors Fluoroelastomer use (examples) Seals, gaskets, hoses, valves, diaphragms in pumps, tank linings, rollers Protection layers in reactors and tanks for chemicals, seals, hoses, valves, membranes cable and wire and wire sheaths; seals for cable connectors; rollers of printers Alternatives None for the sum of general requirements Exception for special application: EPDM with limitations at hydrocarbon exposure and temperature range, (sulfur crosslinked max. appr. 140 C, peroxide crosslinked max. appr. 160 C) NBR, HNBR with limitations at exposure against polar chemicals (alcohols, acids, ketones, aldehydes and temperature range (NBR up to appr. 120 C HNBR, peroxide crosslinked, up to appr. 160 C) ECO with limitations at exposure against aromatics, chlorinated hydrocarbons, polar solvents like acetone, ethyl-acetate, glycols, oxidative acids hydraulic oils. ACM, AEM with limitations at the exposure against aromatic and chlorinated solvents, water, acids and alkali None for the sum of general requirements Exception for special application: EPDM with limitations at hydrocarbon exposure and temperature range, (sulfur crosslinked max. appr. 140 C, peroxide crosslinked max. appr. 160 C) NBR, HNBR with limitations at exposure against polar chemicals (alcohols, acids, ketones, aldehydes and temperature range (NBR up to appr. 120 C HNBR peroxide crosslinked, up to appr. 160 C ECO with limitations at exposure against aromatic, chlorinated hydrocarbons, polar solvents like acetone, ethyl-acetate, glycols, oxidative acids, hydraulic oils. ACM, AEM with limitations at the exposure against aromatics and chlorinated solvents, water, acids and alkali None for the sum of general requirements Exception for special applications: EPDM with limitations at hydrocarbon exposure and temperature range, (sulfur crosslinked max. appr. 140 C, peroxide crosslinked max. appr. 160 C) ECO in the case of hydrocarbon exposure Table continued on next page 21 wdk Comment on the PFAS Annex XV Restriction Report Table A.1 continued Fluoroelastomer use (examples) Food contact materials Seals, hoses, membranes, valves Alternatives None for the sum of general requirements Pharma-/Medical equipment Filtration elements (as PVDF), seals, hoses, membranes in pumps, valves, syringe plugs, vibration damping in dental equipment None for the sum of general requirements Energy sector Hydrogen-technology: Seals, protection layers for avoidance of steel corrosion in storage containers and lines. Fuel cell technology: PEM, seals, Photovoltaics (rollers for their production), nuclear power plants (valves), flue gas desulfurization unit of combustion power plants (anti-stick linings) None for the sum of general requirements Exception for special applications: NBR for contact with fat. EPDM or drinking water applications. Exception for special applications EPDM or IR of IIR with limitations at hydrocarbon exposure and temperature range, and oxidizing components EPDM, XIIR, IIR for seals and protection layers for hydrogen storage and transport, higher permeation rates Table A.1 continued Fluoroelastomer use (examples) Alternatives Continued on next page Electronics and semiconductors cable and wire and wire sheaths; seals for cable connectors; rollers of printers None for the sum of general requirements EPDM, if no hydrocarbon exposure, temperature resistance up to 160 C (peroxide crosslinked). Transport - Automotive, Combustion engine powered Seals, hoses, turbo charger hoses, radial shaft seals, profiles, membranes, parts for the vehicle electronics None for the sum of general requirements ACM, AEM, HNBR, NBR for radial shaft seals in contact with mineral oil-based lubricants ACM, AEM, Polyurethane, where only hydrocarbon media are in contact and low dynamic load ACM, AEM and CR for profiles Transport - Automotive, electric seals, profiles, parts for the vehicle electronics, battery seals and pads for stacks, seals, and PEM material for fuel cells None for the sum of general requirements Only for profiles and hoses, exception for application in exhaust system: HNBR, NBR, ACM, AEM, CR, EPDM for profiles 22 wdk Comment on the PFAS Annex XV Restriction Report Table A.1 continued Fluoroelastomer use (examples) Alternatives Transport - Aerospace seals, hoses, parts for turbines and motors, aircraft electronics, seals, hoses None for the sum of general requirements and from safety aspect Petroleum and Mining seals, hoses, protection layers in stators and stator motors, None for the sum of general requirements ECO, NBR, HNBR with for stators with restrictions Construction seals, e. g., in district heating pipelines, building heating systems or sprinkler systems require fluoro elastomer components such as seals None for the sum of general requirements EPDM, CR, silicone for applications without media exception air and water. outdoor contact, Table A.1 continued Fluoroelastomer use (examples) TULAC (Textile, upholstery, leather, apparel, clothing) glove material for personal protection equipment Alternatives bracelets with skin contact None for the sum of general requirements EPDM, IR, NR, SBR, if no hydrocarbon exposure 23