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D.1. Chemicals and Consumer Industries, REACH DG GROW Brussels 26 January 2021 Dear : European Tyre & Rubber Manufacturers Association (ETRMA) and Fluoropolymers Product Group at Plastic Europe (FPG) represent the value chain manufacturing raw materials and producing rubber goods containing fluoropolymers. General Rubber Goods are used in a large variety of sectors and applications. Rubber parts are essential pieces in automotive, aviation, offshore oil and gas industry and food contact materials. It is estimated that approximately 1450 kilotons of rubber goods require the use of fluoropolymers, accounting for 0,5 to 2% of the overall production of rubber goods in Europe. The use of fluoropolymers in rubber is essential to meet technical expectations on product performance. To date there are neither chemicals, nor technological alternatives, that could substitute the use of fluoropolymers in our industry. The restriction proposal of undecafluorohexanoic acid (PFHxA), its salts and related substances stipulates that it shall not be manufactured, used or placed on the market as substances on their own and shall not be used or placed on the market in another substance, as a constituent, a mixture, and an article in a concentration equal to or above 25 ppb for the sum of PFHxA and its salts or 1000 ppb for the sum of its related substances. PFHxA, its salts and related substances are not directly used by the producers of rubber goods. However, during the production of certain types of fluoropolymers, a subset of these substances may be needed or may be formed and traces of them may remain in the final product. FPG considers that those potential trace levels do not pose a risk for the environment under normal conditions of use. The dossier submitter recognizes the importance that fluoropolymers have for modern society. Paragraph 11 of Annex XV restriction proposal provides higher thresholds for fluoroelastomers and mixtures containing fluoroelastomers used in automotive and aerospace. We recognize the regulators wish to protect the use of fluoropolymers, covering both fluoroelastomers and fluoroplastics; unfortunately, it fails to address four essential points: The manufacture, import and use of PFHxA, its salts and PFHxArelated substances to be used for the production of not only fluoroelastomers but also fluoroplastics in the EU should be exempted without a time limit. The exemption for fluoropolymers should cover the production/use/import of PFHxA, its salts and related substances as process media as well as solvents intended for the production and use of fluoropolymers. If the import, manufacture or use of such process media and solvents were not exempted, one should question how the Exemption paragraph 11 can enable manufacturers in the EU to continue the production of certain highperformance fluoropolymers. It should also be questioned how the EU could secure the manufacturing of certain fluoropolymers in the EU. If fluoropolymers are not produced in the EU, the downstream sectors including ETRMA member companies would have to rely on the import of these materials to produce their own products. As mentioned above, certain fluoropolymers may contain PFHxA and/or PFHxArelated substances above the proposed thresholds. The industry is currently assessing its wide range of products to propose a feasible threshold that should be applied to all fluoropolymers. It only considers polymers and mixtures and explicitly excludes articles, while the final goods containing fluoropolymers used as automotive parts are rubber articles, and not mixtures. Only two sectors are considered strategic, automotive and aerospace, while rubber goods containing fluoropolymers are also used in many essential sectors such as offshore energy, food contact materials, electrics & electronics and machinery, to mention some. We would like to share with you some thoughts on a possible way forward and to receive your feedback to these. We kindly request a meeting with you via videoconference at your best convenience. In the meanwhile, we are ready to provide any further information you might require. Sincerely, ETRMA FPG