Document 3QEevypQX67KDaN6vzrO3be7O

EU PFAS restrictions Process and relation between PFHXA, PFAS in firefighting foams, Universal PFAS and other restrictions 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 F. F . Lbiynbearrancchahiend: crheapinlsa.ced ~~. . F /4 rd 8C atoms, replaced by 4 sho orlrongtercehairns .f -- . Functional ether group (-O-) added F. o +---- Corsatom, - replaced by P | oo | PFASgroups (OECD) -- 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 if nformati3 on on certain hazards N +[sInuscbrsietaasneeceisn;fusoelrexmpoasurteXiponosreiqnuifroermemnattsi(olEDno,w,lowtton:oagnenage g on -Safetydata sheets. + "Cocktail effect' and mixture assessment factor [AEutShoTriEsaNtoiIo(neIa0EnEdERY Q [eed . CInhsufaficeient N [- SEimEplSify authorisatio-- n and-- restri-- ction-- processes + Introduce essential use concept + + ERevuokerreAoguidsptirtaectiaopanacninutmybers for constantly incompliant dossiers + Stenghien customs controls, comoat fraud and ace online + Accesstojustice | oo 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 i. | oo