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.

CECHA EUROPEAN CHEMICALS AGENCY ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAMES: Undecafluorohexanoic acid (PFHxA), its salts and related substances CONTACT DETAILS OF THE DOSSIER SUBMITTER: BAuA Federal Institute for Occupational Safety and Health Division 5 - Federal Office for Chemicals Friedrich-Henkel-Weg 1-25 D-44149 Dortmund, Germany VERSION NUMBER: 1.0 DATE: 20.12.2019 Annankatu 18, P.O.

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.

Factsheet "PFAS in PAMCo" Process Automation - Monitoring - Control Fig. 1: True Air Radar Level measurement Fig. 2: Guided Wave Radar Level Measurement Fig. 3: Pressure sensors Electro and Digital Industry Association Fig. 4: Control valves and membrane valve for aseptic (pharma) and hygienic (food) applications Fig. 5: Flow Measurement device Fig. 6: Control valve Fig. 7: Common seal made of Fluoropolymers Fig. 8, Lined control valve Fig. 9, Self operated pressure regulator Fig. 10, Mixing /Flow dividing valve with Electric actuator or electric setpoint for District energy Fig. 11, Photo electric sensors 2 Fig. 12, Electric Accessories Positioner, solenoid, limit switch Fig. 13: Pneumatic accessories: Air volume booster, filter regulator, reversing amplifier Fig. 14: Dust measuring sensors Fig. 15: Diaphragm seal Fig. 16: Gas sample probe Fig. 17: Gas coolers / Peltier & compressor coolers Fig. 18: Filters / Heated & Unheated Fig. 19: Analyzer / Oxygen & multigas analyzers Fig. 20: Sample gas pump 3 Fig. 21: Mobile devices as workers equipments and batteries intended for use in environments as defined in 2014/34/EU (ATEX) Fig. 22: Human Machine Interface intended for use in environments as defined in 2014/34/EU (ATEX) Fig. 23: Field Junction Boxes and Control Cabinets (intended for use in environments as defined in 2014/34/EU (ATEX) Fig. 24.

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).

Fluororesin Products for Manufacturing Processes of Plastics lens monomers.

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.

OECD polymer of low concern (PLC) criteria and additional customeer related criteria OcoEnCsDide=rOflurgoaronpisoalytimonerfsoarsEbceoinngomofilcoCwo-operation and Development concern for environmental and human health.

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.

Annex I - List of acronyms and abbreviations Acronym AC B CAS CF2 CF3 CfE CF3C(O)F CFF CLP CO2 COC COP CSR CTFE DNEL EC ECHA EEA EEAP EFCTC EFSA EINECS ELV EMA EPA ETF EU EV EVOH F-Gas FCM FP GLP GWP HCFC HCFO-1233zd(E) HF HFC HFC-125 HFC-134a HFC-143a HFC-227ea HFC-236fa HFC-245fa HFC-32 Explanation Airconditioning Bioaccumulation Chemical Abstracts Service Methylene Fully fluorinated methyl Call for Evidence Trifluoroacetyl Fluoride Cold Form Foils Classification, Labelling and Packaging Carbon dioxide Cyclic olefin copolymer Cyclic olefin polymer Chemical Safety Report Chlorotrifluoroethylene Derived No-Effect Level European Commission European Chemicals Agency European Economic Area Environmental Effects Assessment Panel European Fluorocarbons Technical Committee European Food Safety Authority European Inventory of Existing Chemical Substances End of Life of Vehicles Directive European Medicines Agency Environmental Protection Agency Extrudable thermoplastics films European Union Electric Vehicle Ethylene vinyl alcohol Fluorinated Gas Food Contact Materials rules Fluorinated Products Good Laboratory Practice Global Warming Potential Hydrochlorofluorocarbon (1E)-1-chloro-3,3,3-trifluoroprop-1-ene Hydrogen Fluoride Hydrofluorocarbon Pentafluoroethane 1,1,1,2-tetrafluoroethane 1,1,1-trifluoroethane 1,1,1,2,3,3,3-heptafluoropropane 1,1,1,3,3,3-hexafluoropropane 1,1,1,3,3-pentafluoropropane Difluoromethane 1 HFC-365mfc HFO HFO-1233zd HCFO-1233zd(E) HFO-1234yf HFO-1234ze(E) HFO-1336mzz(E) HFO-1336mzz(Z) Honeywell HSE IUPAC IVD IVDR LRTP MAC MDI MDR Mln MoE NOAEL NOEC OECD OTC P PBT PCTFE PET PFAS PFC PFOA PFOS PLC PNDT PNEC PP PTFE Proposal PVC PVDC RAC RAAF R&D REACH RHVAC RMM RMOA RO RRM SAP SEAC 1,1,1,3,3-pentafluorobutane Hydrofluoroolefin (1E)-1-chloro-3,3,3-trifluoroprop-1-ene Trans 1-Chloro-3,3,3-trifluoroprop-1-ene 2,3,3,3- tetrafluoroprop-1-ene Trans-1,3,3,3-tetrafluoroprop-1-ene Trans-1,1,1,4,4,4-hexafluorobut-2-ene (2Z)-1,1,1,4,4,4-hexafluorobut-2-ene Honeywell International Inc.

8/25/23, 12:06 PM Maximum Continuous Service Temperature - Plastic Properties The material selection platform Plastics & Elastomers Max Continuous Service Temperature 1.

__ ABB ELSB contribution to the ECHA consultation on PFAS Who is ABB Electrification Smart Buildings (ELSB)?

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.