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AR226-3063 DuPont HLR 903-96 HASKKLXi XABOXXTOX?

Regulation 61 sampling locations No specific location identified on AGCCE Permit, potential locations identified below.

Iidabashi Square Bldg.,8F Shimomiyabicho 3-2, Shinjuku-ku, Tokyo Tokyo 162-0822,Japan www.jfmda.gr.jp/ Comments on Annex XV Restriction Report on Per- and polyfluoroalkyl substances (PFAS) We JFMDA (The Japanese Federation of Medical Devices Association) was founded by medical device associations consisting of manufacturers and suppliers of medical and health-care devices, equipment, instruments and materials.

AR22G - 3272 454 ARage _ 3274 DuPont9478 --~ `TRADE SECRET Study Title (OY ric Tosicty '90-Day Oral Gavage Study in Rats Volume 1of3 - Laboratory Project ID: DuPont-9478 "Test GUIDELINES: U.S.

Mars. 3279 oi 7 5125025: Developmen Tosi Sty nats. ~ TRADE SECRET AR226_ 3279 Dwei13 Study Title H-25425: Developmental Toxicity Study in Rats Laboratory Project ID: DuPont-11347 TEST GUIDELINES: U.S.

AR A426 - 332] 503 AR226_ 332 Dupont13830 --~ TRADE SECRET Study Title H-25425:Repeated-DoseDermal Toxicity 28-Day Study in Male Rats TesT GUIDELINES: U.S.

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BVAA PFAS in industrial valves and actuators-a special use case 1.

Study Plan aerobicac soil/sedim fluorochert m --. -- StudyDesigns- 3M MicrobiaMletabolismProgram Goal:To optimizeconditiontshatpermitenrichmentofmicrobial populationcsapableofmetabolizinfgluorochemicals.

Fluororesin Products for Manufacturing Processes of paper Lining tank (PTFE), lining piping (PTFE, PFA), lining valve (PTFE, PFA), insertion tube (PTFE, PFA), gasket (PTFE), bellows (PTFE, PFA) Flexible hose (PTFE, PFA), pliable hose (PTFE, PFA) PFAS used in the products is PTFE and PFA, which are polymer materials, and there is no concern about exposure, leakage, or environmental release of eluates.

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Fluororesin Products for Manufacturing Processes of paper Lining tank (PTFE), lining piping (PTFE, PFA), lining valve (PTFE, PFA), insertion tube (PTFE, PFA), gasket (PTFE), bellows (PTFE, PFA) Flexible hose (PTFE, PFA), pliable hose (PTFE, PFA) PFAS used in the products is PTFE and PFA, which are polymer materials, and there is no concern about exposure, leakage, or environmental release of eluates.

EU PFAS restriction > 2020: NL, DE, DK, SE and NO announce preparation of restriction dossier > Group approach; OECD 2021 definition > Common concern persistency, additional concerns > All uses, except fire fighting foams > Restriction according to REACH article 69.5 EU PFAS restriction 15 June 2022 7 Image: EEA, Eionet Report - ETC/WMGE 2021/9, December 2021 Group approach EU PFAS restriction 9 15 June 2022 Uses Image source: https://defence.gov.au/environment/pfas/PFAS.asp EU PFAS restriction 15 June 2022 > EC/ECHA: fire fighting foams (not included) > Germany: consumer mixtures, metal plating, transport > Denmark: lubricants, construction products, electronics and energy > Sweden: textile, cosmetics > Norway: ski wax, petroleum and mining, Fgas uses > Netherlands: food contact materials, medical applications, production of fluoropolymers and waste and recycling > Additional uses will be added to the dossier 12 Consultation rounds Manufacure and import TULAC Food contact materials and packaging Metal plating and manufacturing of...