Document wDkZXq49Q13bZBN6BOkrkg2RB

EU PFAS restrictions Process and relation between PFHxA, PFAS in firefighting foams, Universal PFAS and other restrictions Martijn Beekman European Commission, DG GROW Content 1. Stockholm Convention, POP regulation 2. REACH restriction 3. Common understanding paper 4. REACH SVHC 5. Need for grouping Disclaimer: several restriction dossiers are under development, the Commission cannot pre-empt on the outcome of on-going discussions Stockholm Convention - process 1. Proposal for listing a new chemical Any party of the Convention, proposal should contain Annex D information 2. Apply screening criteria Committee examines proposal, Secretariat invites Parties and observers to provide Annex E information 3. Develop a risk profile Committee develops a risk profile and evaluates, Secretariat invites Parties and observers to provide Annex F information 4. Develop a risk management evaluation Committee develops a risk management evaluation and recommends to COP if the chemicals should be listed 5. List the chemical in Annex A, B, and/or C COP decides on listing Stockholm Convention - Home page (pops.int) Stockholm Convention - PFAS Global ban on Persistent Organic Pollutants (POPs), in Europe implemented by the POP regulation Chemicals list in Annex A (elimination) PFOA PFHxS (EU implementation on-going) Chemicals list in Annex B (restriction) PFOS Chemicals proposed for listing Long chain PFCAs The New POPs REACH restriction - process Restriction process - ECHA (europa.eu) Registry of restriction intentions until outcome - ECHA (europa.eu) REACH restriction - PFAS Annex XVII of REACH C9-C14 PFCAs (entry 68) TDFAs1 (entry 73) PFHxS, RAC-SEAC opinion published 2020 POP regulation PFHxA, RAC-SEAC opinion published 2022 PFAS in firefighting foams, discussed by RAC-SEAC Universal PFAS, in preparation 1 Trideca-fluorooctyl silanetriol Common understanding paper (2014) REACH and the Stockholm Convention as well as the UNECE POP Protocol, a common understanding Relationship with other legislation (europa.eu) Most important: To avoid double regulation; no REACH restriction entry if the substance is regulated through the POP regulation, timing issues. REACH SVHC - process Authorisation process - ECHA (europa.eu) Registry of SVHC intentions until outcome - ECHA (europa.eu) REACH SVHC - PFAS PFASs identified as substances of very high concern (SVHC)(art. 59) Substance HFPO-DA (GenX) EC no - CAS no - Concern ELoC having probable serious effects to human health and environment (Article 57(f) - human health) PFBS (C4) PFHxS (C6) PFHpA (C7) PFOA (C8) PFNA (C9) PFDA (C10) PFUnDA (C11) PFDoDA (C12) PFTrDA (C13) PFTeDA (C14) - - 203-615-4 206-397-9 206-400-3 218-165-4 206-203-2 276-745-2 206-803-4 - - 335-67-1 335-76-2 2058-94-8 307-55-1 72629-94-8 376-06-7 ELoC having probable serious effects to human health and environment (Article 57(f) - human health) vPvB (Article 57e) Under discussion Toxic for reproduction (Article 57c) PBT (Article 57d) Toxic for reproduction (Article 57c) PBT (Article 57d) Toxic for reproduction (Article 57c) PBT (Article 57d) vPvB (Article 57e) vPvB (Article 57e) vPvB (Article 57e) vPvB (Article 57e) Need for grouping Regrettable substitution Linear chain: replaced by branched chains Functional ether group (-O-) added 8 C atoms, replaced by shorter or longer chains etc. C or S atom, replaced by P PFAS groups (OECD) perfluoroalkyl acids (PFASs; including perfluoroalkylether acids, PFEAAs) perfluoroalkyl carboxylic acids (PFCAs),C,,F,,,,,I-COOTI 4perfluoroalkane sulfonlc acids (PFSAs), ,.-4perfluoroalkyl phosphonlc adds (PFPAs), C, Fzn.fP03Hz perfluoroalkyl phosphinic adds (PFPIAs), perfluoroalkylether carboxylic acids (PFECA.$), e g_CylF50C2F40CFC0OH pertl ooroalky'ether sulfonic acids (PFE5As), e.g.C6E,30CF2CF,S03H pertluoroalkyl dicarboxylic acids (PFdiCAs), C perfluoroalkane perfluoroalkane disulfonic acids (PFdiSAs), H035-CnF,,-SO,FI sulflnic adds (PFSIAs), C,,F2,,,..,-SO2H polyfIuorcalkyl acids (PcIyFAAs; including polyfluoroalkylether adds, PolytEAP.sr polyflitoroaIkyl carboxylic acids (PFCAs or PolyFCAs),e.g. H-C,F n-COOH, rim polyfluoroaIkylether carboxylic acids (PFECAs), e.g. CF3OCF6OCHFCF2COOH polyfluoroaIkylether sulfonic acids (PFESAs), e.g.CIC6F,)17)CFCF2503H PFASs PFAn. precursors no fluorotelomer alcohols, CnF2n.v,CH.,OH" perfluoroalkanoyl fluorides (PACF5), CnF2,,,,COF perfluoroalkyl iodides (PFAls),CnF2,,,l - perfluoroalkane sulfonyl fluorides (PASFs), perfluoroalkylether non-polymers, e.g.C4VE 2F40C2F.,0CF,-CH,OH, CAS No.3)7817-24-6 perfluoroalkylether side-chain fluorinated polymers - perfluoroalkenes n>2) - semifluorinated alkanes (SFAs),Cr4F2,,,-CmH2 hydrofluorocarbons (If FCs, e.g. hydrofluoroethers (HFEs, e.g. CflF,,,,OC,.,,H2 ,), hydrofiuoroolefins (HF0s,e.g.CnFm..,-CH--CH) ) that have a perfl uoroalkyl chain perfluoroalkyl (e.g.C,,Fm+,C(O}C,nF2Tt1} and semi-fluorinated ketones (e.g. perfluoroalkyl alcohols (C,F., 1,01-1), e.g. (CF,),C-OH,CAS No.2378-02-1 other PFASs fluoropolymers (FPO} perfluoropolyethers (PFPEs), e.g. HOCH,0-(C.F2,,O)n-CH,0 side-chain fluorinated aromatics***,e.g.CnF2,aromatic rings perfluoroalkanes zn+z) perfluoroalkyl-tert-amines (COF,41,..)3N pernuoroalkylethers ie g others"" Nomenclature including acronyms well covered by Buck et al. (2011) Nomenclature including acronyms partially covered by Buck et al. (2011) Common nomenclature including acronyms exists Indicating that it is a synthesis pathway, instead of exa m pies fluorotelomer-ba sed substances, CnF,,,,CI-I,-1?"' PACF-based substances, C,,F,,,,CO2-I2 n2 fluorote lomer-based substances, C,Fm.,CH,CHR PASF-based substances, C,F,,,,S0,-R perfluoroaIkene derivatives, e.g. ICCF,}2CF],C=C(CF,J0C,H45.03Na), CAS No. 70829-87-7 side-chain fluorinated polymers e.g. {Meth)acrylate, urethane or aketane polymers, silicones non-polymers = NH, N.IHCFICHOH, etc polytetrafluoroethylene (PTFE) polyvinylidene fluoride (PVDF) fluorinated ethylene propylene (FEP) perfluoroa l koxyl polymer (PFA) Other FPs European Commission Universal PFAS Dossier will be submitted January 2023 by DE, DK, NL, NO, SE Broad chemical scope (OECD 2021), including F-gases and fluoropolymers Common concern: extreme persistence According to the current REACH legislation Provide your input in the consultation phase [restriction is under development] REACH revision - main elements Lack of information on certain hazards Increase information requirements (ED, low tonnage substances; use/exposure information, low tonnage CSR, DMEL) Polymers Safety data sheets "Cocktail effect" and mixture assessment factor Authorisation and restriction processes too complex Extend generic risk management approach Simplify authorisation and restriction processes Introduce essential use concept Insufficient enforcement Revoke registration numbers for constantly incompliant dossiers European Audit capacity Strenghten customs controls, combat fraud and tackle online sales Access to justice Next steps Finalisation of impact assessment on the basis of RSB comments Legal drafting has started Commission proposal foreseen in Commission work programme for Q4 2023 Thank you European Union 2020 Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are not owned by the EU, permission may need to be sought directly from the respective right holders. Slide xx: element concerned, source: e.g. Fotolia.com; Slide xx: element concerned, source: e.g. iStock.com