Document nkr8EaxOaeMb91rjEkLQz9MD1

Application for derogations from REACH PFAS restriction for fluoropolymer (PTFE) Topic: Application of Forever Derogation for Fluorine-containing Polymers (PTFE) Reasons: 1. The risk of polymers per se to environment and human is little; and 2. The processing aids used in the production of the polymers have been controlled or substituted by other laws or treaties; and 3. The raw material belt and reactor lining processed with polytetrafluoroethylene have sealing and high temperature resistance and corrosion resistance, and there is no substitute at present. Applicant: Shandong Dongyue Polymer Material CO., LTD., China Submitted on August,14 2023 From the fluoropolymers per se, such substances are a class of high molecular weight macromolecular polymers with a molecular weight well over 100000 Da, these fluoropolymers cannot cross the cell membrane, which to show that fluoropolymers satisfy widely accepted assessment criteria to be considered as "polymers of low concern" (PLC), and should be considered as distinctly different from other classes of PFAS (the grouping of all PFAS together is not supported by the scientific data). Data show that fluoropolymers have thermal, chemical, photochemical, hydrolytic, and biological stability, because of its strong chemical stability, it is difficult to pose a threat to the environment and human health. Fluoropolymers are not bioavailable or bioaccumulative, as evidenced by toxicology studies on polytetrafluoroethylene (PTFE): acute and subchronic systemic toxicity, irritation, sensitization, local toxicity on implantation, cytotoxicity, in vitro and in vivo genotoxicity, hemolysis, complement activation, and thrombogenicity. Clinical studies of patients receiving permanently implanted PTFE cardiovascular medical devices demonstrate no chronicl toxicity or carcinogenicity and no reproductive, developmental, or endocrine toxicity. These fluoropolymers cannot be substances of very high concern (SVHCs) under REACH, do not meet the PM (persistent mobile) and PMT (persistent mobile toxic) criteria proposed by UBA, and do not meet the criteria for listing as a POP under the Stockholm Convention. From the preparation process of fluoropolymers, the type and quantity of preparations used can be artificially controlled, and some countries have previously issued prohibition and replacement directives for preparations that may be PFAS in the production process, such as Canada's Prohibition of Certain Hazardous Substances Regulations (SOR/2012-285, and its amendments SOR/2016-252) in 2016. In 2019, the Ministry of Ecology and Environment of China issued the Announcement on the Prohibition of the Production, Circulation, Use, Import and Export of Persistent Organic Pollutants such as Lindane. And the 2019 EU POPs Regulation ((EU) 2019/1021) and its amendment Regulation (EU) 2020/784, etc. At present, there are no substances that may belong to PFAS in the preparation of fluoropolymers. From the application of polytetrafluoroethylene products, firstly, the raw material belt processed with polytetrafluoroethylene because of its strong corrosion resistance, long-term use temperature -100-200, insulation and other excellent properties, widely used as a variety of pipes, pipe fittings, valves, joints of anti-corrosion heat thread sealing belt, It can be used in the insulation covered pipeline of wire and cable, fuel cell diaphragm, heating and water supply and drainage. Secondly, the reactor lining processed with polytetrafluoroethylene has 1, excellent mechanical properties: with stainless steel performance advantages, can withstand higher working pressure; 2, good heat resistance: the working temperature range is very wide (- 80~200); 3, strong corrosion resistance: almost no reaction with any strong acid and base; 4, good heat transfer effect: compared with other reactors, heating and cooling faster; 5, good processing performance: according to the process requirements, made of a variety of different shapes and structures of the reactor. The wall of the kettle can be polished to make it free of hanging materials and easy to clean. The lining can be selected according to the working condition. Raw material strips and reactor linings processed with PTFE are widely used in different industries because of their particularly excellent properties, and there is no substitute at present. Based on the above three points, it can be seen that fluoropolymers from its production process and use and its downstream application, will not cause harm to the environment and human body, and there is no relevant substitute, should be exempted, allowing production and use Attachment: Barbara J Henry and etc. A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers, Integrated Environment Assessment and Management-Volume 14, Number 3-pp. 316-334