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Human Health Medicinal Products Sector Survey Impact of Proposed PFAS Restric=on on Pa=ent Access to Medicines & EU Strategic Autonomy Disclaimer: This document was prepared in good faith by represented associa6ons for the purposes of preparing the public consulta6on response to the PFAS Restric6on proposed under Title VIII of the REACH Regula6on.

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.

PFAS Restriction Testing of hydrocarbon membranes Evidence for ECHA PFAS RESTRICTION Hydrocarbon Membranes are NOT alternatives The H2 level in the O2 rapidly rose and resulted in cell failure around the 10hr mark.

Telakkakatu 6, P.O.

Senior adviser, Finnish Environment Institute / Contaminants mob.

Friedrich-Henkel-Weg 1 - 25 D - 44149 Dortmund, Germany phone: fax: e-mail: 2

Classification: General Business Use SHPP's Inputs to the Public Consultation Comments to Annex XV PFAS Restriction Proposal Question number 6.

Attachment-3List of properties 1.Plastics Plastic type Formability Physical properties Mechanical properties Thermal properties Electrical properties Other chemical property Formability Compression molding temperature Injection molding temperature Mold shrinkage rate Specific gravity Water absorption rate (24 -3 .18mm thickness ) Tensile strength MPa Elongation Tensile modulus of elasticity MPa Compressive strength MPa Flexural strength MPa Impact strength(Izod/notch)J/m Hardness (Rockwell) Coefficient of thermal expansion 105/ Continuous heat resistance temperature Melting point Deflection temperature under load (1 .81MPa) Volume resistance (50% , RH23) Dielectric breakdown strength Short-time Permittivity 103Hz(106Hz) Arc resistance sec Burning rate mm/min Effects of weak acids Effect of strong acid Effects of weak alkali Effect of strong alkali - D792 D570 D638/651 D638 D638 D638 D638 D638 D785 D696 D2117 D648 D257 D149 D150 D495 D635 D543 D543 D543 D543 Organic solvent resistance D543 Polytetrafluoroethylene PTFE 2 .13 - 2 .20 0 .01 20 - 35 200 - 400 10-15 150 - 160 R20 10 260 327 55 1018 19 2 .1 300 V-0 Fluorinated-ethylenepropylene FEP 319 - 399 329 - 404 3 .0 - 6 .0 2 .12 - 2 .17 0 .01 20 - 35 300 - 350 15 - 20 didn't break R50 12 260 310 47 1018 20 2 .1 300 V-0 Perfluoroalkoxy alkane PFA 329 - 371 371 - 427 2-3 2 .15 - 2 .17 0 .01 20 - 30 200 - 400 14 - 19 didn't break R50 9 200 260 50 1018 22 2 .1 300 V-0 Regulated materials Polychlorotrifluoroethylene PCTFE Ethylene tetrafluoroethylene ETFE 238 - 254 227 - 316 1 .0 - 1 .5 2 .10 - 2 .20 1 .73 - 1 .74 0 .01 0 .03 31 - 41 80 - 250 31 - 51 135 - 145 R80 38 - 42 300 - 400 40 - 50 didn't break R50 6 6 120 220 90 1018 22 2 .6 300 V-0 150 270 74 1017 16 2 .6 75 V-0 Ethylenechlorotrifluoroethylene ECTFE 1 .68 - 1 .69 0 .01 41 - 48 200 - 300 35 - 40 didn't break R50 8 150 245 77 1015 20 2 .6 18 V-0 Polyvinylidene fluoride PVDF 204 - 288 232 - 288 3 1 .75 - 1 .78 0 .03 30 - 70 200 - 370 32 - 74 160 - 375 R93 - 116 16 150 151 - 178 100 1015 11 8 .4 60 V-0 Plastic type Formability Formability Compression molding temperature Injection molding temperature Mold shrinkage rate Physical properties Specific gravity Water absorption rate (24 -3 .18mm ) Tensile strength /2 Elongation Mechanical properties Tensile modulus of elasticity 104kg/ Compressive strength /2 Flexural strength /2 Impact strength(Izod/notch)J/m Hardness (Rockwell) Thermal properties Electrical properties Coefficient of thermal expansion 105/ Continuous heat resistance temperature Heat deformation temperature (18 .5Kg/2) Volume resistance (50% , RH23) Dielectric breakdown strength Short-time Permittivity 103 Arc resistance sec Other Burning rate (flame resistance) Effects of weak acids Effect of strong acid chemical property Effects of weak alkali Effect of strong alkali Organic solvent resistance ECHA alternative candidate Polyvinyl chloride PVC Hard PVC Soft High density polyethylene HDPE - - - 141 - 204 141 - 177 149 - 232 D792 D570 149 - 204 0 .1 - 0 .5 1 .35 - 1 .45 0 .07 - 0 .40 160 - 195 1-5 1 .16 - 1 .35 0 .15 - 0 .75 149 - 316 2-5 0 .94 - 0 .97 0 .01 D 638/651 D 638 D 638 350 - 630 2 - 40 2 .5 - 4 .2 105 - 630 200 - 450 - 220 - 390 15 - 100 0 .42 - 1 .1 D 695 D 790 D 256 D 785 D 696 560 - 910 700 - 1130 2 .2 - 109 70 - 90 ( Shore D) 5 - 18 .5 63 - 120 - 50 - 100 ( Shore A ) 7-25 230 70 8 .2 - 10 .9 60 - 70 ( Shore D) 11-13 - 66 - 79 66 - 79 121 D 648 D 257 D 149 54 - 74 1016 16 .7 - 51 .1 1011 - 1015 11 .8 - 39 .3 43 - 54 1016 17 .7 - 19 .7 D 150 D 495 3 - 3 .3 60 - 80 4-8 2 .3 - 2 .35 - - D 635 Self-extinguishing Slow self-extinguishing Very slow D 543 D 543 D 543 D 543 D 543 - Swelling or soluble in ketones, esters, swelling in aromatics

PFAS additive consumption during battery life ref.