Response to the European Chemicals Agency (ECHA) restriction on the manufacture, placing on the market, and use of per- and polyfluoroalkyl substances (PFASs) Comments for Annex XV restriction report Report v2.0 CONFIDENTIAL PREPARED FOR: The European Chemicals Agency (ECHA) scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) DATE: 22nd September 2023 PREPARED BY: Name: Mtech Access on behalf of a group of industry stakeholders Alchimia S.r.L Bausch & Lomb BVI Carl Zeiss Meditec D.O.R.C.

Ruwe AEC-bodemas Omschrijving Algemene monstervoorbehandeling Samenstelling Laboratorium Samenstelling Perfluorobutanoate (PFBA) Perfluoropentanoate (PFPeA) Perfluorohexanoate (PFHxA) Perfluoroheptanoate (PFHpA) Perfluorononanoate (PFNA) Perfluorodecanoate (PFDA) Perfluoroundecanoate (PFUnDA) Perfluorododecanoate (PFDoDA) Perfluorotridecanoate (PFTrDA) Perfluorotetradecanoate (PFTeDA) Perfluorohexadecanoate (PFHxDA) Perfluorooctadecanoate (PFOcDA) Perfluorobutane sulfonate (PFBS) Perfluoropentane sulfonate (PFPeS) Perfluorohexane sulfonate (PFHxS) Perfluoroheptane sulfonate (PFHpS) Perfluorodecane sulfonate (PFDS) 4:2 Fluorotelomer alcohol (4:2 FTOH) (H4PFOS) 6:2 Fluorotelomer alcohol (6:2 FTOH) 8:2 Fluorotelomer alcohol (8:2 FTOH) 10:2 Fluorotelomer alcohol (10:2 FTOH) 2,3,4-tetrafluor-2-(heptafluorpropoxypropanoic acid (HPFO-DA) Perfluorooctanesulfonamide (PFOSA) 2-(N-methylperfluorooctanesulfonamido) (N-MeFOSA) 2-(N-methylperfluorooctanesulfonamido) acetic acid (N-MeFOSAA) N-ethylperfluorooctanesulfonamidoacetic acid (N-EtFOSAA) Sodium bis (1H, 1H, 2H, 2H-perfluorodecyl)phosphate (8;2 diPAP) PFOA (linear) Perfluorooctanoate(PFOA) (branched) PFOA (som) Perfluorooctane sulfonate (PFOS) (branched) Perfluorooctane sulfonate (PFOS) (linear) PFOS som Total Total Fluor Extractable Organic Fluor Anorganic Fluor PFBA PFPeA PFHxA PFHpA PFNA PFDA PFUnDA PFDoDA PFTrDA PFTeDA PFHxDA PFOcDA PFBS PFPeS PFHxS PFHpS PFDS 4:2 FTOH 6:2 FTOH 8:2 FTOH 10:2 FTOH HPFO-DA (GenX) PFOSA N-MeFOSA N-MeFOSAA N-EtFOSAA 8:2 diPAP PFOA(l) PFOA(b) PFOA(s) PFOS(b) PFOS(l) PFOS(s) g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds mg/kg ds mg/kg ds mg/kg ds Gemiddelde stdev Min Aantal metingen 120 Nu opgenomen grenzen (grond op landbodem, Aantal kleiner dan Max 95 Percentiel wonen of industrie) bepalingsgrens 0,47 0,14 0,23 0,11 0,11 0,11 0,11 0,08 0,10 0,11 0,11 0,31 1,87 0,11 0,13 0,11 0,10 0,09 2,90 0,26 0,12 0,71 0,11 0,11 0,11 0,12 0,10 0,29 0,10 0,37 0,30 0,27 0,54 9,81 230,00 0,14 10,10 0,69 0,14 0,30 0,09 0,12 0,10 0,09 0,05 0,09 0,09 0,09 0,47 4,28 0,10 0,13 0,10 0,08 0,07 7,62 0,52 0,14 2,76 0,11 0,11 0,16 0,11 0,09 0,43 0,10 0,47 0,42 0,53 0,77 14,10 90,00 0,00 6,90 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,07 0,14 0,07 0,07 0,14 0,00 140,00 0,14 3,20 4,00 1,20 1,60 0,35 1,00 0,40 0,40 0,35 0,35 0,35 0,35 1,40 25,00 0,44 0,79 0,40 0,35 0,35 54,00 3,20 0,86 20,00 0,88 0,74 1,50 0,50 0,35 3,75 0,80 4,32 2,79 3,90 4,14 79,33 320,00 0,14 17,00 1,60 0,35 0,90 0,35 0,35 0,35 0,35 0,07 0,35 0,35 0,35 1,40 10,02 0,35 0,35 0,35 0,35 0,35 13,00 0,90 0,35 2,84 0,35 0,35 0,35 0,35 0,35 0,84 0,35 0,91 1,18 0,75 1,99 33,14 311,00 0,14 16,31 3,00 51 3,00 97 3,00 80 3,00 107 3,00 114 3,00 111 3,00 117 3,00 107 3,00 117 3,00 118 3,00 117 3,00 117 3,00 35 3,00 114 3,00 103 3,00 112 3,00 113 3,00 109 3,00 40 3,00 82 3,00 99 3,00 99 3,00 113 3,00 116 3,00 116 3,00 100 3,00 114 64 99 7,00 10 63 76 3,00 3,00 0 3,00 0 3,00 2 3,00 0 31/10/22

9) OECD 408-OPPTS 870.3100, 90-day oral toxicity (rodent), 418026 SAN ITlZED Study Title OEC 0 9 2003 ORAL (GAVAGE) REPEATED DOSE 90-DAY TOXICITY STUDY OF POTASSIUM PERFLUOROBUTANE SULFONATE (PFBS) IN RATS SPONSOR'S STUDY NUMBER: T-7485.15 Data Requirement U S .

12) OECD 416-OPPTS 870.3800, Reproduction and fertility effects (Two generation reproduction toxicity), 4 18-021 part 2 of 2 ARGUS 4 18-021 RESEARCH PATHOLOGY SERVICES.

1 (7) Technology Industries of Finland - Comments on the proposal for a restriction of per- and polyfluoroalkyl substances (PFAS) Finland's Technology Industry's companies are committed to reducing the presence of harmful substances in their products to promote a more circular economy and enhance human health.

BVAA PFAS in industrial valves and actuators-a special use case 1.

ECHA EUROPEAN CHEMICALS AGENCY ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION (DRAFT) SUBSTANCE NAME(S): Polyfluoroalkyl and perfluoroalkyl substances (PFAS) in firefighting foams CONTACT DETAILS OF THE DOSSIER SUBMITTER: VERSION NUMBER: DATE: Telakkakatu 6, P.O.

EIF: ~July 2025 and 10y after EIF: ~January 2034 So, the proposal should normally not (too much) interfere with the POP regulation on PFOA which foresees a ban on use by 2023 or July 2025.

Public consultation for the preparation of a RMO analysis for restriction options for the PFAS group of substances (fluorinated substance(s) I.

Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 Claigan PFAS Submission #3 PFAS in Drinking Water Summary of News Articles and Related Science Papers Document is UNCONTROLLED if printed.

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Parmi les substances spcifiquement autorises par le gouvernement Belge, 5 font pourtant partie de la liste des produits candidats la substitution de l'UE.