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.

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.

From: Sent: To: Subject: Ulla Bergman den 30 augusti 2023 16:02 @pentagroup.co' H23-07997-1- Bio-Rad question regarding PFAS dossier and life-sciences analytical equipment Dear Sir, We have received your request to access the document and will now start processing the case.

(SPF Sant Publique - FOD Volksgezondheid) From: Sent: To: Subject: Attachments: @envcoord.health.fgov.be on behalf of (SPF Sant Publique - FOD Volksgezondheid) < .

Van: Verzonden: Aan: Onderwerp: Bijlagen: Urgentie: ) (FOD Economie - SPF Economie) dinsdag, 23 januari 2024 14:18 Reach (SPF Sant Publique - FOD Volksgezondheid); (SPF Sant Publique - FOD Volksgezondheid) FW: Restrictievoorstel PFHxA (C6) 20240123_REACH restriction PFHxA_EURATEX Proposal.pdf; 20240123_REACH restriction PFHxA_EURATEX Proposal_Explanatory Note.pdf Hoog Pour info Groeten, Algemene Directie Economische Analyses en Internationale Economie Eenheid Duurzame Economie -- Cel Reach Attach A2 Vooruitgangstraat 50 - 1210 Brussel Ondernemingsnr.: 0314.595.348 Denk aan het milieu alvorens te printen!

Industry and Economy Division UN(0)4 environment programme Subject: Global Consultation on chemicals and waste Issues of Concern 11-12 July 2023, Geneva, Switzerland Date: 30 May 2023 Madam, Sir, We are honored to invite your country/institution to the UNEP face-to-face "Global Consultation on chemicals and waste Issues of Concern" on 11-12 July 2023 in Geneva, Switzerland at the Centre International de Conference de Geneve (CICG).

From: Sent: To: Cc: PF Sant Publique - FOD Volksgezondheid) SPF Sant Publique - FOD Volksgezondheid) vendredi, 19 janvier 2024 10:43 Subject: RE: (U)ICL Agenda IKW - 25/01/2024 [10u] - CIE(E) Ordre du jour IKW QQ points d'aenon : - La base lgale drogues est la bonne.

From: Sent: To: (SPF Sant Publique - FOD Volksgezondheid) vendredi, 6 janvier 2023 11:04 Subject: RE: Inventaris F-Gassen 2024 Inventaire gaz F Ok, bedankt Alain voor de verduidelijkingen.

La prsidente : Zakia KHATTABI Les autres membres : Frank VANDENBROUCKE Wouter BEKE Zuhal DEMIR Christie MORREALE Bndicte LINARD Cline TELLIER Antonios ANTONIADIS Alain MARON Elke VAN DEN BRANDT Barbara TRACHTE CIMES LARGIE 8 janvier 2024 Ministre fdrale du Climat, de l'Environnement, du Dveloppement durable et du Green Deal Vice-Premier ministre et ministre fdrale des Affaires sociales et de la Sant publique Ministre flamand du Bien-tre, de la Sant publique, de la Famille et de la Lutte contre la pauvret Ministre flamande de la Justice et du Maintien, de l'Environnement, de l'nergie et du Tourisme Vice-Prsidente et Ministre wallonne de l'Emploi, de la Formation, de la Sant, de l'Action sociale, de l'galit des chances et des Droits des femmes Ministre de l'Enfance, de la Sant, de la Culture, des Mdias et des Droits des Femmes de la Fdration Wallonie-Bruxelles Ministre wallonne de l'Environnement, de la Nature, de la Fort, de la Ruralit et du Bien-tre animal Vice-Prsident et Ministre de la Sant et des Affaires sociales, de l'Amnagement du Territoire et du Logement de la Communaut germanophone Ministre du Gouvernement de la Rgion de Bruxelles-Capitale, charg de la Transition climatique, de l'Environnement, de l'Energie et de la Dmocratie participative Prsidente du Collge de la Commission communautaire flamande (VGC) de Bruxelles, charge du Budget, du Bien-tre, de la Sant, de la Famille et de la Politique urbaine Ministre-Prsidente du Collge de la Commission communautaire franaise (COCOF) de Bruxelles, charge de la Promotion de la Sant, de la Famille, du Budget et de la Fonction publique Elke VAN DEN BRANDT Alain MARON Membres du Collge runi de la Commission communautaire commune (COCOM) de Bruxelles, chargs de la Sant et de l'Action sociale largi aux membres suivants : 1 / 4 David CLARINVAL Ministre fdrale des Classes moyennes, des Indpendants, des PME et de l'Agriculture, des Rformes institutionnelles et du Renouveau dmocratique Pierre-Yves DERMAGNE Vice-Premier ministre et Ministre fdrale de l'Economie et du Travail Ludivine DEDONDER Ministre de la Dfense DCISIONS DE LA CIMES ELARGIE POINTS CARACTRE POLITIQUE 1.

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