Document 71881L5XY4edRDKk3JqRyooYE

Link between the firefighting foam restriction and the wide PFAS restriction FPP4EU 15 June 2022 Peter SIMPSON Restriction Process Coordinator European Chemicals Agency Image: iStock.com Overview PFAS risk management in the EU Justification for grouping PFASs Links to wide restriction Hazard/risk paradigm Practicality Some frequently asked questions Next steps 2 Existing regulation of PFASs in EU Some PFAS already subject to [or pending] restrictions on manufacture/use under REACH or POPs regulation in EU (some also Stockholm Convention) Perfluoroalkyl sulfonic acids (PFOS; [PFHxS]) Perfluoroalkyl carboxylic acids (PFOA; C9-C14 PFCAs; [PFHxA]) Some identified as SVHCs E.g. HFOP-DA (GenX), PFBS, PFHxS Some undergoing REACH substance evaluation or have a harmonised classification under CLP regulation 3 Arrowhead approach Risk management has typically focused on `arrowheads' with confirmed hazard properties and their `precursors' Arrowheads - terminal degradation product typically PBT/vPvB properties e.g. PFOA, PFHxS, C9-C14 PFCAs `Precursors' or `related-substances' transform to arrowhead A single restriction can cover many different substances as long as they contain the arrowhead moiety Effective but slow and can result in a cascade of regrettable substitution PFOS PFOA PFHxA ???? 4 Mandate Request 20 July 2020 Assess PFASs as a group Build on previous studies on availability of alternatives Cooperate with authorities working on PFAS restriction Submission January 2022 5 PFASs in firefighting foams Around 18 000 tonnes of PFAS firefighting foams sold in the EU each year 500 tonnes of PFAS Oil/(petro-)chemical sector is the largest user Most sectors have examples of users that have substituted to fluorine-free foams (typically training) 6 PFASs as a group Boundaries by OECD definition (2021) Structural similarity Perfluorinated moieties Any substance that contains at least one fully fluorinated methyl (CF3) or methylene (CF2) carbon atom (without any H/Cl/Br/I attached to it) Single hazard/risk paradigm Developed by DE, NL, DK, SE, NO Ice-breaker in firefighting foams Includes fluoropolymers/F-gases Avoid regrettable substitution https://pubs.acs.org/doi/pdf/10.1021/acs.est.1c06896 7 Hazard/risk paradigm PFASs assessed as a group Persistence is the common property of the group Various supporting concerns 8 Properties Very high persistence Long-range transport potential Mobility Accumulation in plants Bioaccumulation potential Endocrine activity Ecotoxicity Effects to human health Hazard/risk paradigm PFASs are among the most stable organic compounds Resist (bio) degradation because of the stable C-F bond Many PFASs can be transported by air, water and matrices to which they are adsorbed or absorbed e.g., dust, sediments, migratory animals and polymer particles Many PFASs are ubiquitous in environmental compartments and biota (e.g. mammals, birds, fish) Plants accumulate many PFASs beyond expected levels Exposures may be higher than observed by monitoring For well studied PFASs effects on behaviour, growth, reproduction, metabolism, organs & immune system observed In silico, in vitro and in vivo data provide indications of interactions of various PFASs with the endocrine system Harmonised class. for PFOS, PFOA, PFNA, and PFDA (+ salts): carcinogenicity (Carc. 2), reproductive toxicity (Repr. 1B), effects on or via lactation (Lact.), specific target organ toxicity - repeated exposure (STOT RE 1). Hazard/risk paradigm Persistence combined with supporting concerns Quantitative risk assessment is not reliable or practicable Not possible to demonstrate safe use (no reliable DNEL/PNEC) Similar to PBT/vPvB Continued use would inevitably result in accumulation to levels causing adverse effects `Case-by-case' risk assessment according to Annex I (section 0.1) of REACH Risks of PFASs are considered as non-threshold and not adequately controlled Releases are a proxy for uncontrolled risk Risk management to minimise releases 10 Practicality Concentration limit of 1 ppm PFASs Expressed as `total organic fluorine' Presence and concentration of non-PFAS organofluorine substances shall be included on the product packaging Practical enforcement despite structural variability 11 Common questions Common questions (1) Scope (which substances are in/out?) Is analysis of degradation products (arrowheads) needed before a substance is within scope? No, the scope is set by the OECD definition Is substance-specific information on hazards or case-by case assessment of risks needed? No, the hazard / risk conclusion is applicable to the whole group, irrespective of substance-specific information (no threshold) Evidence to consider PFAS as non-persistent (OECD?) RAC/SEAC and DS will assess justifications case-by-case Will scope be based on PFASs used in firefighting foams? No, intention is to prevent regrettable substitution - whole lifecycle 13 Common questions (2) Existing OCs and RMMs Is existing legislation sufficient to address the identified risks (e.g. IED / OSH / F-gas) No, Annex XV report concludes existing measures are not sufficient to control the identified risk DS notes that regulatory baseline is dynamic Commission would need to reconcile any overlaps What measures could be put in place? Risk management objective is minimisation of risk Restriction can apply to a minimised risk - if proportionate; is restriction disproportionate? 14 Common questions (3) Exports Restriction applies use (e.g., formulation) Justified based on risks at this lifecycle stage (releases) Restriction prevents formulation for export Socio-economic analysis refers to impacts on exports DS will revise text after the consultation to prevent misinterpretation 15 Next steps https://www.echa.europa.eu/-/eu-restriction-of-per-andpolyfluoroalkyl-substances-pfas-in-firefighting-foams Next steps Proposal being evaluated by ECHA's committees for: Risk Assessment (RAC) Socio-Economic Analysis (SEAC) Six-month consultation of interested parties Stakeholder information session 5 April Q&A published on ECHA website 15 June Evaluation documented in `opinions' Commission and Member States decide on implementing the restriction in REACH Committee Scrutiny by Council and European Parliament 17 NECHA EUROPEAN CHEMICALS AGENCY Thank you! echa.europa.eu