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.

Refrigerant is a necessity On 13 January 2023, the competent authorities of five EU/EEA countries (Dossier Submitters) submitted the PFAS REACH Annex XV Restriction Report (Proposal) to the European Chemical Agency (ECHA).

Apr 25, 2023 Comment on Proposed Restriction of PFAS Conference of Fluoro-Chemical Product Japan (FCJ) On behalf of chemical manufacturers, we, Conference of Fiuoro-Cherical Product Japan S(FuCpJp)o,rtheadveEUb'esenamwboirtkiionugs taitrteelemspstlsy ttoo croemdpulcye wriitshksnfatrioomnahlaczhaermdiocuasl regulations. substances We and have have sincerely responded to actual measutormeeest the requirements of EU chemical regulations such as REACH.

Caring for People's Health The widespread Use of PFAS in the Pharmaceutical Sector, focusing on Components used in Production Plants, Excipients and other Process Chemicals, Packaging Materials and Medical Devices, as well as on Goods sourced from Contract Manufacturers Provided as Comments to the Public Consultation on the REACH Restriction Proposal on Per- and Polyfluoroalkyl Substances (PFAS) Public Version Submitted by: Date: STADA Arzneimittel AG 21.09.2023 Property of STADA Arzneimittel AG 1 Caring for People's Health CONTENTS 1.

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.

Processed Product for Food Contact Materials and Packaging Materials Application Number: Food contact materials and packaging materials (Annex E.2.3) Materials used in this product is PTFE (CAS NO: 9002-84-0), PFA (CAS NO: 2665500-5), and PVDF (CAS NO:24937-79-9).

Submission in support of time-unlimited derogation request for refrigerant R-474A for electric vehicles (2nd submission) Daikin Chemical Europe GmbH, Dsseldorf, Germany 22 September 2023 Contents 1.

2023 PQRI Comments to ECHA REACH on Annex XV Restriction Report for Per- and polyfluoroalkyl substances (PFAS) About PQRI The Product Quality Research Institute (PQRI) (www.pqri.org) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality, manufacturing, and regulation. 0 PQRI Comments on Annex XV Restricon Report Contents Glossary............................................................................................................................................................................2 Introducon .....................................................................................................................................................................4 Background - Medicinal product lifecycle ....................................................................................................................4 Scope of Evaluaon ......................................................................................................................................................5 Summary of Core Findings............................................................................................................................................6 ECHA Specific Informaon Requests.................................................................................................................................7 Request #1 Sectors and Sub-uses .................................................................................................................................7 Request #1 Summary - Sectors and Sub-uses.............................................................................................................13 Risk to supply of medicines in EU ...........................................................................................................................13 Regulatory Challenges ............................................................................................................................................13 Pandemic and Catastrophic Event Preparedness ....................................................................................................14 Future populaon...................................................................................................................................................14 Aging populaon ....................................................................................................................................................14 Societal Impact and Unintended Consequences .....................................................................................................15 Request #2 Emissions in the end-of-life phase - manufacture, use, end-of-life..........................................................15 Request #2 Summary - Emissions in the end-of-life phase - manufacture, use, end-of-life........................................18 Request #3 Emissions in the end-of-life phase - incineraon effecveness................................................................18 Request #4 Impacts on the recycling industry ............................................................................................................18 Request #5 Proposed derogaons - Tonnage and emissions......................................................................................18 Request #6 Missing uses - Analysis of alternaves and socio-economic analysis.......................................................18 Defining PFAS: Grouping, Properes and Hazard Assessment ................................................................................18 PFAS in the Pharmaceucal Supply Chain...............................................................................................................20 Raonale for Pharmaceucal Sector PFAS Usage and Sub-uses..............................................................................23 PFAS Used to Produce and Deliver Medicinal Products Alternave Potenal.........................................................29 Request #6 Summary Missing Uses Alternaves and substuon consideraons......................................................34 Request #7 Potenal derogaons marked for reconsideraon-Analysis of alternaves and socio-economic analysis. ...................................................................................................................................................................................34 Request #7 Summary - Potenal derogaons marked for reconsideraon current derogaons not feasible. ...........36 Request #8 Other idenfied uses - Analysis of alternaves and socio-economic analysis..........................................37 Request #8 Summary - Other idenfied uses Societal Cost of Ban for Pharma ..........................................................43 Request #9 - Degradaon potenal of specific PFAS sub-groups................................................................................43 Request #10 - Analycal methods..............................................................................................................................43 Closing Remarks: Bringing back points to consider and paent impact..........................................................................43 References......................................................................................................................................................................46 1 PQRI Comments on Annex XV Restricon Report Glossary AD API CCS COPD CSS DDS EC ECHA ECTFE EEA EiF EMA EPPA SEA ETFE EU FEP FFKM FIH FKM FVQM GMP HVAC IMPD IND IPAC IPAC-RS MAA Mab Mfg OECD OELs PFAS PFOA PLC pMDI PMT POC PPE PQRI PTFE PVDF QC R&D Alzheimer's Disease Acve Pharmaceucal Ingredient Container closure system Chronic Obstrucve Pulmonary Disease European Commission Chemicals Strategy for Sustainability Drug delivery system European Community European chemicals agency Ethylenechlorotrifluoroethylene European Economic Area Entry into Force European Medicines Agency European Public Policy Advisors Socioeconomic Analysis Ethylene tetrafluoroethylene European Union Fluorinated ethylene propylene Perfluoroelastomers First In Human Fluoroelastomers Fluorosilicones Good Manufacturing Pracce Heang, Venlaon, Air Condioning, Refrigeraon Invesgaonal Medicinal Product Dossier Invesgaonal New Drug Internaonal Pharmaceucal Aerosol Consorum Internaonal Pharmaceucal Aerosol Consorum on Regulaon & Science Markeng Authorisaon Applicaon Monoclonal Anbodies Manufacturing Organisaon for Economic Co-operaon and Development Occupaonal Exposure Limits Per- and Polyfluoroalkyl substances Perfluorooctanoic Acid Polymers of Low Concern pressurized Metered Dose Inhaler Persistant, mobile, toxic Proof of Concept Personal Protecve Equipment Product Quality Research Instute Polytetrafluoroethylene Polyvinylidene fluoride Quality Control Research and Development 2 PQRI Comments on Annex XV Restricon Report REACH Registraon, Evaluaon, Authorizaon and Restricon of Chemicals RO1 Restricon opon 1 in Annex XV Restricon Report on PFAS RO2 Restricon opon 2 in Annex XV Restricon Report on PFAS SBT Science-Based Targets SBTi Science-Based Targets iniaves TULAC Texles, Upholstery, Leather, Apparel and Carpets UK United Kingdom 3 PQRI Comments on Annex XV Restricon Report Introducon The Competent Authories of Germany, The Netherlands, Sweden, Denmark, and Norway submited a joint REACH Annex XV restricon proposal for a broad group of PFAS.

1/4 2023-09-25 Case number HaV 03031-2023 European Chemicals Agency Telakkakatu 6 P.O.

EURATEX submission to ECHA consultation on the U-PFAS restriction Input on PPE Directive Category III (j) cuts by hand-held chainsaws September 2023 In the proposal sent to ECHA, Annex E (page 30) the following reasoning as to why PPE against chainsaws do not get a derogation, was provided: Firstly, to "bullet wounds and knife stabs", there must be a mistake at the report, as hand-held chainsaws are not clearly linked to bullet wounds and knife stabs.

Impacts of the PFAS Restriction on Trade Between the U.S. and the European Union Evaluation of PFAS applications across U.S. industries September 2023 Table of Contents Executive Summary ....................................................................................................................................... 2 Introduction and Context.............................................................................................................................. 5 Methodology and Approach ......................................................................................................................... 8 Main Findings .............................................................................................................................................. 17 Economic Impact Results in the United States ........................................................................................... 17 Environmental Impacts of the PFAS Restriction ......................................................................................... 23 Industry Case Studies .................................................................................................................................. 29 1 | THE ECONOMIC IMPACTS OF PFAS AND F-GAS REGULATIONS ON U.S.

Eidgenssisches Departement des Innern EDI Bundesamt fr Gesundheit BAG Direktionsbereich Verbraucherschutz Thema PFAS am BAG Austausch zu PFAS der Bundesmter vom 07.12.2020 Thema PFAS am BAG Chemikalien, Risikobeurteilung Christian Kropf 1 Eidgenssisches Departement des Innern EDI Bundesamt fr Gesundheit BAG Direktionsbereich Verbraucherschutz PFAS Aktivitten am BAG Faktenblatt Skiwachs Vorkampagne Skiwachs Gesundheitsstudie Thema PFAS am BAG Chemikalien, Risikobeurteilung Christian Kropf 2 Eidgenssisches Departement des Innern EDI Bundesamt fr Gesundheit BAG Direktionsbereich Verbraucherschutz Thema PFAS am BAG Startpunkt: Gesundheitliche Gefahren durch Skiwachs Factsheet Mr.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY New England Regional Laboratory Laboratory Services and Applied Sciences Division 11 Technology Drive North Chelmsford, MA 01863-2431 Drafted Date: 08/08/2023 Finalized Date: 09/05/2023 Subject: Sampling Inspection Report Clean Water Act - National Pollutant Discharge Elimination System Worcester, MA From: Shannon Shea, Inspector Laboratory Services and Applied Science Division (LSASD) Field Services Branch (FSB) Reviewed By: Jerome Keefe, Investigations Team Leader, LSASD-FSB To: Todd Borci, Manager, Enforcement and Compliance Assurance Division (ECAD) Water Compliance Section 1 CC: Douglas Koopman, Inspector, ECAD I.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Region 1 5 Post Office Square, Suite 100 Boston, MA 02109-3912 URGENT MATTER - EARLY WARNING NOTICE January 17, 2024 Dennis Reidy, Quality Coordinator C.I.L.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 10 1200 Sixth Avenue, Suite 155 Seattle, WA 98101 WATER DIVISION June 5, 2023 The Honorable RoseMary LaClair Chairwoman of the Nooksack Indian Tribe 5016 Deming Road Deming, WA 98244 RE: Maximum Contaminant Level (MCL) Violation: Exceedance of 10 mg/L Nitrate Nooksack Indian Tribe 5 Cedars Community Water System, PWS #105300028 Dear Chairwoman LaClair: The purpose of this letter is to inform you of a nitrate MCL exceedance at 5 Cedars community water system, which constitutes a violation of the National Primary Drinking Water Regulations, 40 CFR 141.62(b).