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.

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.

ONTWERPMETHODE MB 2023 Compendium voor monsterneming en analyse in uitvoering van het Materialendecreet en het Bodemdecreet Per- en polyfluoralkylverbindingen (PFAS) in bodem en sediment ONTWERPMETHODE MB 2023 Versie juli 2022 CMA/3/D ONTWERPMETHODE MB 2023 INHOUD Inhoud 1 Doel en toepassingsgebied_____________________________________________________ 3 2 Principe ____________________________________________________________________ 5 3 Apparatuur en materiaal ______________________________________________________ 5 4 Reagentia en standaarden _____________________________________________________ 5 5 Monsterbewaring en -voorbehandeling __________________________________________ 6 6 Analyseprocedure____________________________________________________________ 7 6.1 Extractie 7 6.2 Zuivering van het extract 7 6.3 LC-MS/MS analyse 7 6.3.1 LC-condities _________________________________________________________ 8 6.3.2 MS-condities ________________________________________________________ 9 6.3.3 Identificatie en integratie _____________________________________________ 12 6.3.4 Kalibratie __________________________________________________________ 12 7 Berekeningen ______________________________________________________________ 13 8 Kwaliteitscontrole___________________________________________________________ 13 8.1 Terugvinding van de isotoopgemerkte fluorverbindingen 13 9 Prestatiekenmerken _________________________________________________________ 14 10 Referenties ______________________________________________________________ 14 ONTWERPMETHODE MB 2023 ONTWERPMETHODE MB 2023 Organische analysemethoden PFAS in bodem en sediment 1 DOEL EN TOEPASSINGSGEBIED Deze procedure vervangt de procedure CMA/3/D van november 2021 en beschrijft de kwantitatieve bepaling van per- en polyfluoralkylverbindingen in bodem en sediment met behulp van vloeistofchromatografie.

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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.

General Comments for Annex XV restriction report on Per- and polyfluoroalkyl substances (PFAS) 22 May 2023 We welcome the opportunity to contribute to the public consultation initiated by the European Chemicals Agency regarding potential restriction of Per- and polyfluoroalkyl substances (PFAS) according to Regulation (EC) No. 1907/2006 ("REACH").

Bvided Bundesverband Medizintechnologie e.V.

European Semiconductor Industry Association Per- and polyfluoroalkyl substances (PFAS) ESIA comments on Annex XV restriction report Brussels, 2 June 2023 General Comments Introduction The semiconductor industry is very reliant upon many applications of materials (solids, liquid, and gases) falling under the definition of PFAS as set out in the EU REACH PFAS restriction proposal (any organic chemical with a perfluorinated methylene group (-CF2-) and/or perfluorinated methyl group (-CF3) moiety).

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.

Comment on Proposed Restriction of PFAS Jul 31, 2023 Japan Valve Manufacturers' Association (JVMA) Japan Valve Manufacturers Association (JVMA) appreciates the opportunity to provide comments to the PFAS restriction proposal. 1.