Document 6ReBrEo0qr8B2K660OLwnjjj3

Application for exemption from EU REACH PFAS control for fluoropolymers Topic: Application of Permanent Exemption for Fluorine-containing Polymers Reasons: 1. The polymer itself poses little threat to the environment and human body; 2. The processing aids used in the production of the polymers have been controlled or substituted by other laws or regulations; 3. Fluorine resin products (PTFE, PFA, FEP, PVDF) are widely used in important fields because of their excellent properties, which cannot be replaced by non-fluoropolymer materials. Applicant: Changzhou XCF Polymer Material Co., LTD. Changzhou Xingcheng Polymer Materials Co., LTD. Submitted Date: August 8, 2023 By physical characteristics, the fluoropolymer is a class of high molecular weight macromolecular substance with a molecular weight well over 100000 Da. These fluoropolymers cannot cross the cell membrane, are widely accepted as "polymers of low concern" (PLC), and should be considered as distinctly different from other classes of PFAS ( Actually 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 manufacturing process of fluoropolymers, the type and quantity of aids used can be manually controlled, and some countries have previously issued prohibition and replacement directives for processing aids 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, the 2019 EU POPs Regulation ((EU) 2019/1021) and its amendment Regulation (EU) 2020/784, etc. At present, there is no use of aids that may belong to PFAS in the preparation of fluoropolymers. From the fluorine resin products (PTFE, PFA, FEP, PVDF) application: 1. The fiber processed with fluorine resin (PTFE, PFA, FEP, PVDF) has excellent corrosion resistance, oxidation resistance, hydrolysis resistance, wide use temperature (-100-250). As a result, the fluorine fiber is widely used as liquid or gas solid filtration separation at thermal power plants, waste incineration plants, cement plants, non-ferrous metal metallurgy plants, etc., or be used for strong acid/alkali liquid and chemical solvent filtration in chemical industry, pharmaceutical industry, and semiconductor industry. At present, there is no other fiber material that can reach or exceed the fluorine resin fiber in the comprehensive performance, as illustrated in the table below: Fiber type PTFE Melting point () Corrosion resistance 327 Super strong oxygen index % 98 hydrolysis resistance Super strong Oxidation resistance Super strong operating temperature 260 PPS 285 Strong 34~35 Strong Average 175~185 P84 315 Strong 36~38 Weak Strong 240 NOMEX Average 29 Strong Strong 200 Glass 825 Strong Non- Strong Strong 260 fiber ignitable 2. The packing yarn processed with PTFE has strong corrosion resistance, long-term use temperature range of -100-200, insulation and other excellent performance features, so the packing yarn is widely used as the anti-corrosion and heat resistant thread sealing belt in a variety of pipes, pipe fittings, valves, joints, Used in electronic technology, aviation, machinery industry and other fieldsIts comprehensive properties cannot be replaced by other materials. 3. The self-lubricating bearing cloth processed with fluorine resin has low friction coefficient, high temperature resistance and a certain cushioning effect, so its application can make the joint bearing greatly extending the service life of the bearing without grease lubrication, truly achieving the goal of the maintenance-free joint bearing lifecycle, which feature cannot be replaced by other materials at present. 4.Medical implants, sutures and floss processed with fluorine resin are widely used for their soft and elastic features, high strength, low friction coefficient and good biocompatibility. Their comprehensive properties cannot be replaced by other materials. Based on the fluoropolymer itself, the processing AIDS used in the polymer and the application of fluoropolymer products, it can be seen that fluoropolymer from its production process and use and its downstream application will not cause harm to the environment and human body. There is no relevant substitute. Therefore, it should be exempted from EU REACH PFAS control, and should not be replaced by non-fluoropolymer materials. References: 1.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 2.FDA test report of the company's products: PTFE 1200D white sewing thread, PTFE white staple fiber, PTFE green sewing thread, PTFE 12000D yarn, PTFE white sewing thread, PTFE white staple fiber, PTFE fabric.