Document 5LQo9KybqJq1E0m6nDw3jZL8z

European Chemicals Agency P.O. Box 400, F-00121 Helsinki, Finland June 22, 2023 Sumitomo Electric Fine Polymer, Inc `Comments on Annex XV Restriction Report (PFAS Restriction Proposal) Sumitomo Electric Fine Polymer, Inc. is a wholly-owned subsidiary of Sumitomo Electric Indusiries, Ltd, specializing in electron beam imadiation technology and fluororesin processing technology. We supply unique products to a wide range of industries including automobiles, information and communications, home electronics and infrastructure. One of our novel products expected to be used in a wide variety of applications, especially for carbon neutral objectives, is FEXTM, which is based on a unique electron beam cross-linking technology for fluoropolymers. We welcome this public consultation opportunity, as we fully understand your tireless effort to protect EU citizens from harmful chemical substances. Whiwelaree in total agreement with the Dossier submitters conces per PFAS on human health and environment, we have diferent opinions on what and how PFAS should be regulated. We would ike to take this opportunity to provide our comments based on scientific grounds. Our views outined below are also being submitted by our parent company, Sumitomo Electric Industries, Ld., whose activities also cover basic research and development of FEXTM technology. During the public consuitation period, we plan to submit comments on several occasions to complete our views. This is our initial submission. 1) Request for exemption We strongly request that perfluoropolymers (e.g., PTFE, PFA, FEP) and those cross-linked by electron bea iadiation be exempt from the scope of PFAS in the proposal for the following reasons. Perfiuoropolymers and those cross-inked by electron beam irradiation are materials that are neither bioaccumulative nor biotoxic. Their unique and outstanding properties have made them indispensable to society, especially in solving environmental problems, as they provide solutions unmatched by other materials. Perfiuoropolymers have totally different properties and hazardous levels compared to ofher harmiul PFAS substances, such as PFOA or PFOS. If perfluoropolymers are collectively banned with those other PFAS simply because their chemical formulas are similar, without closely reviewing and classifying their properties, we may encounter serious consequences i terms of social economic impact. The reasons are detailed in sections 2) and 3) below: 1 2) Perfluoropolymers are neither bioaccumulative nor biotoxic Because perfluoropolymers are chemically and biologically persistent and inert, elution of these materials is known to be very limited (Olabisi et al, 2016). Complying with EU regulations on PFOA and PFOS, we have seen a drastic improvement in the production process of perfiuoropolymers. According to our analysis performed by a third party testing laboratory, PFOA was not detected from PTFE and PFA (see "PTFE_PFA_ analysis.pdf* as attached in Section IV). Therefore, no hazardous materials are expected to be leaching from perfluoropolymers, which indicates that animals or pants will not be absorbing PFOA nor perfluoropolymers themselves. If there is nothing being absorbed, then bioaccumulation and biotoxicity do not occur (Henry et al, 2009; OECD, 1993; Beyer EC.1993; KorzeniowskiS,. H, etal, 2023; FCJ, 2023, see "FCJ.pdf" as attached in Section IV). Since perfluoropolymers are chemically and biologically persistent and inert, they have been used as material for implantable artificial organs such as pericardial patches and artificial blood vessels (Henry et al. 2009; Olabisi, 2015; Gangal & Brothers, 2000). Itis also documented in the literature that perfluoropolymers are substances with distinctly different properties from potentially toxic low molecular weight compounds such as PFOA and PFOS, which were the starting point for this proposed restriction (Henry et al, 2009; OECD 1993; Olabisi, 2019; FCJ, 2023, see "FCJ pdf" as attached in Section IV). 3) Perfluoropolymers are irreplaceable materials that can contribute significantly to solving environmental concerns Perfluoropolymers have unique and excellent properties including persistency, inertness, non`adhesiveness, siding capability, heat resistance and a low dielectric constant. Such properties have made the substances essential to society. In addition, products that are coated with cross-linked perfluoropolymers have excellent sliding durabilty (several hundreds to thousands of times higher durabilty) while maintaining an unparalleled level of low friction coefficient (Ikeda, 2020, See "Ikeda pdf" as attached in Section IV). Moreover, the cross-linking occurs between the perfluoropolymer and the substrate material enhancing adhesive strength. This novel cross-linking technology has opened up new potential in areas where perfluoropolymers were once believed to be inapplicable due to the lack of durabilty. Its applications are expected to further expand and contribute to carbon neutrality in terms of `energy saving and promotion of adhesive-free/solvent.free processes. We would like to present some examples as follows, however please note that these are just a few of the many potential uses for these materials. Applications and sectors where perfluoropolymers contribute to solving environmental issues are not limited to those presented here. We are currently conducting R&D. on a wide variety of applications that can contribute highiy to carbon neutraity, including energy saving `and low environmental load with adhesive-free/solvent-free processes. Example 1: Reduce environmental load by solvent-free bonding with electron beam cross-linking By forming perfiuoropolymer coating on metal surface (.g., Al, Cu, and SUS) and cross-linking it with 2 electron beam iadiation, the perfluoropolymer is bonded to the surface of the substrate in a solvent-free condition where no adhesive or no solution with organic solvent is applied. We developed this coating technology and put it into practical use. Since a perfluoropolymer layer is formed by aqueous dispersion coating or extrusion method, this is a 100%-solvent-free process(lkeda, 2020, See "Ikeda pdf as attached in Section IV). This technology has made it possible for perfluoropolymers to not only adhere to metal in a solvent-free manner, butalsoto bring about benefits described in examples 2 10 6. Example 2: Reduce material waste and energy consumption by realizing higher durabilty with excellent sliding and non-adhesive capabilities on the coating Using the technology to coat devices such as extrusion dies for common polymer materials such as polyethylene, a substantial reduction in the material waste and product waste is realized. Therefore, crosslinked perfiuoropolymers contribute not only to reduction of environmental load but achieves this task with a solvent-free process. We will provide more details and reference(s) on this example in our subsequent public consultation submission Example 3: Improve energy conversion rate by enhancing the siding property Using the technology to coat sliding parts with perfluoropolymers, the energy conversion rate improves 50 that energy saving and reduction of environmental load are achieved. Wewil provide more details and reference(s) for this example in our subsequent public consultation submissions. Example 4: Improve the energy conversion rate of specific electric wires by achieving a low dielectric constant and adhesive-freelsolvent-free bonding Since this coating technology does not require primer or adhesive materials, specific-purpose electric wires with this coating can maintain almost the same low dielectric constant of 2.1 as that of a fluoropolymer-only coating. Therefore, it improves the energy conversion rate while reducing environmental load. We will provide more details and reference(s) for this example in our subsequent public consultation submissions. Example 5: Unique method for producing a specific medical product This coating technology s the only coating technology used for producing a specific medical product. We will provide more details and reference(s) for this in our subsequent public consultation submissions. Example 6: Reduction of load on production equipment and wear debris by applying FEXTM tape. FEXTTM tape allows users to easily utiize the high wear resistance of FEXTM just by attaching it to an abject. The use of FEXTM tape for equipment eliminates the need for frequent replacement of parts and tape due to wear and peeling, thus the product is expected to bring various advantages over conventional fluororesin tapes, such as extended service life and less frequent maintenance of equipment, improved workability, and the prevention of scratches on equipment. In addition, the product is environmentally 3 friendly because its excellent slipperiness and wear resistance contribute to the reduction of load on equipment and wear debris, respectively. We will provide further information in separate submission(s) to complete our comments on the restriction proposal. In the meantime, please feel free to contact us if any questions arise. Sincerely yours, ure 22,2023 Gist " SJ pet Yoshimasa Suzuki President `Sumitomo Electric Fine Polymer, Inc. 4 References 1. BeyerEC. Gapjunctions. International RevofiCyteolowgy. (1993). (Vol 137C) 1-37. PMID: 8367468, 2. Conference of Fluoro-Chemical Product Japan (FC), Comment on Proposed Restiiction of PFAS. (2023). PT (as attached at Section IV, public consultation #4195 submitted on May19, 2023) 3. Gangal, S. V., & Brothers, P. D. (2000). Perfluorinated Polymers. Kirk- Other Encyclopedia of Chemical Technology, 1-68. 4. Henry, B. J. Carlin, J. P, Hammerschmidt, J. A., Buck, R. C., Buxton, L. W,, Fiedler, H.,...& Hemandez, O. (2018). A critical review of the application of polymer of low concern and regulatory. criteria to fluoropolymers. Integrated Environmental Assessment and Management, 14(3), 316-334 5. Ikeda, K., Kubo, Y., & Okamoto, K. (2020). Elucidationof Molecular Structure and Adhesion State of Cross-Linked Fluororesin. SEI TECHNICAL REVIEW, (90), 47. 6. PFOAmeasurement analysis report provided by Sumika Chemical Analysis Service, Ltd in 2019 (as attached at Section IV) 7. Korzeniowski, S. H., Buck, R. C., Newkold, R. M., Kassmi, A. E.. Laganis, E., Matsuoka, Y.....& Musio, S. (2023). A critical review of the application of polymer of low concer regulatory criteria to fluoropolymers Ii: Fluoroplastics and fluoroelastomers. Integrated Environmental Assessment and Management, 19(2), 326-354 8. OlaO.b, &iAdsewaile,,K. (Eds). (2016). Handbookofthermoplastics (Vol. 41). CRC press. P402 L726 9. [OECD] Organisation for Economic Co-operation and Development. 1993. OECD Expert Group on Polymers. Third Meeting of the Experts on Polymers: Chairman's Report [ENVMCICHEMIRD(93)4]; 1993 Apr; Paris (FR). 5