Assogomma comments on the Annex XV Dossier of the universal PFAS restriction proposal September, 6th 2023 1 1.

European rail sector's contribution to the public consultation on the PFAS restriction proposal - September 2023 Application for derogations from PFAS REACH restriction for specific uses in railways Contents 1) Introduction .................................................................................................................................... 4 The European rail sector ..................................................................................................................... 4 Preliminary statement and structure of the document ...................................................................... 7 List of abbreviations and chemicals .................................................................................................... 9 2) Where are PFAS used in railways and why?

STATEMENT PFAS restriction The per- and polyfluoroalkyl substances (PFAS) restriction proposal was pre-published on the ECHA (European Chemical Agency) portal on 7 February 2023. https://echa.europa.eu//echa-publishes-pfas-restriction-proposal This so-called Universal PFAS Restriction would prohibit the manufacture, use and placing on the market of around 10 000 PFAS, including fluoropolymers, F-gases and C6 fluorotelomers.

22 SEPTEMBER 2023 Euroalliages reply to the public consultation on a proposed restriction on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) I.

Vacuum Market Segmentation StlA I 15erMCCNIMICtfli loulgNol Inc Rough Vacuum Process Vacuum Industrial Vacuum Semiconductor Thin Film Deposition FPD Process Vacuum (non-Semiconductor) Solar inMsatrnuumfaecntutaretiorsn R&D Markets - Packaging (incept load) - Central Vacuum - Prnting and Paper Handling - Pick and Place Conveying - Moulding - Air sampling - Medical Markets -Chemical (Bulk.

Intertek Total Quality.

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.

BISPHENOL AF Consortium Initial input into public consultation on the restriction of BPA and Bisphenols of Similar Concern Brussels, 25 January,2023 The Bisphenol AF and related substances REACH registration Consortium groups the registrants of Bisphenol AF in Europe, both manufacturers and importers.

Draft agenda for PFAS-RESTRICTION WEBEX Meeting between DE, DK, NL, NO, SE CA and ECHA and COM 18 May, 9:00 - 13:00 (CET) Login details: See below Point 1 - Opening and adoption of the agenda (9:00-9:10 am) Point 2 - Minutes and action points (9:10 - 9:25 am) 2021-05-10_PFAS RESTR-16 Minutes and APs_Draft of FINAL.docx 2021-05-10_List of open APs.docx Point 3 - Status of COM/ECHA restriction on firefighting foams (9:25 - 9:40 am) - Update on collaboration with universal PFAS restriction (ECHA) Point 4 - Status update WP1 (09:40 - 09:50 am) - Comments received from COM and AT CA - Next steps Point 5 - Status update WP3 (09:50 - 10:10 am) - Feedback from discussion in PBT-EG (NO CA) - Hazard evaluation of alternatives (UBA) - Next steps for borderline documents (ENV and HH) Point 6 - Status update WP4 (10:10 - 10:40 pm) - Update from meeting on 12 May 2021 (Exposure and emission calculation) - 2nd round questionnaire (document to be circulated by ) Point 7 - Status update WP7 and Essential Use (10:40 - 10:45 am) Point 8 - Exchange of literature/references (10:45 - 11:00 pm) - Endnote library creation for dossier (see: PFAS Handling of literature.docx, circulated with this mail) Break 11:00 - 11:20 am Join by meeting number Meeting number (access code): Meeting password: 7nERmY2dyf3 (76376923 from phones and video systems) Tap to join from a mobile device (attendees only) ,1637174604#76376923# Germany Toll Some mobile devices may ask attendees to enter a numeric password.

RMOA CONCLUSION DOCUMENT _________________________________________________________________ Regulatory Management Option Analysis Conclusion Document Substance Name: EC Number: CAS Number: Per- and polyfluoroalkyl substances, PFAS - Authority: Date: Germany, the Netherlands, Sweden, Norway, Denmark June 2021 RMOA CONCLUSION DOCUMENT _________________________________________________________________ DISCLAIMER The author does not accept any liability with regard to the use that may be made of the information contained in this document.

Draft agenda for PFAS-RESTRICTION WEBEX Meeting between DE, DK, NL, NO, SE CA and ECHA and COM 18 May, 9:00 - 13:00 (CET) Login details: See below Point 1 - Opening and adoption of the agenda (9:00-9:10 am) Point 2 - Minutes and action points (9:10 - 9:25 am) 2021-05-10_PFAS RESTR-16 Minutes and APs_Draft of FINAL.docx 2021-05-10_List of open APs.docx Point 3 - Status of COM/ECHA restriction on firefighting foams (9:25 - 9:40 am) - Update on collaboration with universal PFAS restriction (ECHA) Point 4 - Status update WP1 (09:40 - 09:50 am) - Comments received from COM and AT CA - Next steps Point 5 - Status update WP3 (09:50 - 10:10 am) - Feedback from discussion in PBT-EG (NO CA) - Hazard evaluation of alternatives (UBA) - Next steps for borderline documents (ENV and HH) Point 6 - Status update WP4 (10:10 - 10:40 pm) - Update from meeting on 12 May 2021 (Exposure and emission calculation) - 2nd round questionnaire (document to be circulated by Point 7 - Status update WP7 and Essential Use (10:40 - 10:45 am) Point 8 - Exchange of literature/references (10:45 - 11:00 pm) - Endnote library creation for dossier (see: PFAS Handling of literature.docx, circulated with this mail) Break 11:00 - 11:20 am Join by meeting number Meeting number (access code): Meeting password: 7nERmY2dyf3 (76376923 from phones and video systems) Tap to join from a mobile device (attendees only) ,1637174604#76376923# Germany Toll Some mobile devices may ask attendees to enter a numeric password.

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Photochemical & Photobiological Sciences (2021) 20:1-67 https://doLorg/10.1007/s43630-020-00001-x PERSPECTIVES Environmental effects of stratospheric ozone depletion, UV radiation, and interactions with climate change: UNEP Environmental Effects Assessment Panel, Update 2020 R.

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.

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.