Introduction MedTech Europe, the European voice of the medical technology industry including diagnostics, medical devices and (PFAS), as published in January 2023 and subject to initial exchange at ECHA's scientific committees for Risk Asse MedTech Europe is committed to the ambition of the EU Chemicals Strategy for Sustainability to boost innovation fo to improve the performance of its products and processes, including through the phase out of uses of PFAS where t PFAS in the medical technology sector Where PFAS uses occur in the medical technology sector, this is due to their unique performance and combination either in a component or coating of the final medical device (MD) or in vitro diagnostic device (IVD), including inves or as a processing aid used during device or upstream manufacturing; or in the device part of an integral drug device combination, or as cell replacement therapies, or biomaterials, PFAS substances play a key role in achieving the required high performance and durability of the technologies whic (MDs) and Regulation (EU) 2017/746 on In-Vitro Diagnostics (IVDs).

Apr 25, 2023 Comment on Proposed Restriction of PFAS Conference of Fluoro-Chemical Product Japan (FCJ) On behalf of chemical manufacturers, we, Conference of Fluoro-Chemical Product Japan (FCJ), have been working tirelessly to comply with national chemical regulations.

Aug 1, 2023 Comment on Proposed Restriction of PFAS Japan Valve Manufacturers' Association (JVMA) Japan Valve Manufacturers' Association (JVMA) appreciates the opportunity to provide comments to the PFAS restriction proposal. 1.

PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS Statement#2: There are approximately 200+ marketed biologic drugs1 in prefilled syringes sold by 250+ different organizations** across Europe.

: PFAS Product name: Water electrolysis for hydrogen film requires all exemption from the PFAS ban : Submitted: Shandong Energy Co., Ltd Secketh Hydrogen :2023.08.23 Date: 2023.08.23 PEM product description: Water electrolysis hydrogen film is a kind of solid polymer electrolyte, is a kind of ion exchange function end base resin homogeneous membrane, has excellent thermal resistance, mechanical properties, electrochemical properties and chemical stability, can be used in strong acid, strong carbon, strong oxidant medium harsh conditions, widely used in PEM water electrolysis hydrogen production, etc.

Comment on Proposed Restriction of PFAS Aug 25, 2023 Japan Valve Manufactures' Association (JVMA) Japan Valve Manufacturers Association (JVMA) appreciates the opportunity to provide comments to the PFAS restriction proposal. 1.

SETTING THE STANDARD Two Park Avenue New York, NY 10016-5990 U.S.A.

CASE STUDY | JUNE 2023 Transene Company Eliminates its Use of PFAS and Saves Money SUMMARY Transene worked with the Toxics Use Reduction Institute (TURI), the Massachusetts Office of Technical Assistance (OTA), and the University of Massachusetts Lowell (UMass Lowell) to find safer alternatives to PFAS for etching in the semiconductor industry.

Apr 25, 2023 Comment on Proposed Restriction of PFAS Conference of Fluoro-Chemical Product Japan (FCJ) On behalf of chemical manufacturers, we, Conference of Fluoro-Chemical Product Japan (FCJ), have been working tirelessly to comply with national chemical regulations.

PFAS exemption application for HFO-1234yf 2,3,3,3-Tetrafluoropropene (HFO-1234yf), CAS No. 754-12-1, without ozone layer damage, with a GWP of 4, low toxicity, good flammability, stability, and compatibility, is an effective substitute for R134a.

1-141atC October 2022 REPORT OF THE HFC EMISSIONS ESTIMATING PROGRAM (HEEP) 2002 - 2020 DATA COLLECTION Introduction Hydrofluorocarbons (HFCs) have been commercialized as replacements for ozonedepleting substances such as chlorofluorocarbons (CFCs) and halons.

EUROM I Brussels, 31.

MEDICAL DEVICE MATERIAL PERFORMANCE STUDY PTFE Safety Profile Report Details Date of Submission March 31, 2021 Prepared For U.S.

gemm ed., EFCTC EFCTC submission to ECHA consultation on U-PFAS Annex 5 September 2023 Annex 5 - EFCTC technical paper on impurities and concentration limits for the U-PFAS restriction proposal Summary & Recommendations The PFAS impurity limits indicated within the restriction proposal do not consider the procedures and processes for the manufacturing, supply, recovery, recycling and reclamation of HFCs, HFOs and HCFOs (see substances listed in Annex I and Annex II Section 1 of the F-gas Regulation revision proposal).

Comment on Proposed Restriction of PFAS May 30, 2023 Japan Fluoropolymers Industry Association (JFIA) We, Japan Fluoropolymers Industry Association (JFIA), think that fluoropolymers should be distinguished from the proposed restriction of PFAS (Per- and polyfluoroalkyl substances), which collectively regulates more than 10,000 of organofluorine compounds (PFAS) on the grouping basis.