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Risk management of PFASs at the European Chemicals Agency PFAS Global 2022 24 March 2022 Restriction Process Coordinator European Chemicals Agency Overview PFASs as a hot topic for EU risk management Risk management of PFASs based on `arrowheads' Proposed REACH restriction for all PFASs in firefighting foams 2 PFAS concern PFAS contain (numerous) carbon-fluorine bonds Very stable - resist (bio)degradation Some are highly soluble and mobile (i.e. surfactants) can be readily transport once in the environment frequently observed to contaminate groundwater, surface water and soil Some bioaccumulate notably `long chain' perfluoroalkyl substances Some met REACH criteria for persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) 3 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 4 Arrowheads and related substances Risk management has typically focused on specific `arrowheads' and their `precursors' Arrowheads are `terminal' degradation products with hazardous properties (typically PBT/vPvB) e.g. PFOA, PFHxS, C9-C14 PFCAs, PFHxA `Precursors' or `related-substances' transform to arrowhead A single restriction can cover many different substances as long as they can degrade/transform to the arrowhead Effective but have lead to regrettable substitution PFOS PFOA PFHxA ???? 5 F F F FF FF FF FF F F O S X O PFHxS sulfonic halides, X = F, Cl, Br F FF FF F FO S F FF FF F O O R PFHxS sulfonic ester, R = alkyl, olefin, aryl F F F FF FF FF FF F F O SR N O R' PFHxS sulfonamides, R, R' = H, alkyl, olefin, aryl hydrolysis or radical processes F F F FF FF FF FF F F S O O OH PFHxS + radical processes F FF F O F FF F F +F OH + ... F FF FF F OH F FF F O PFCAs 6 PFASs in firefighting foams Image: iStock.com 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) 8 https://pubs.acs.org/do i/pdf/10.1021/acs.est.1 c06896 9 Hazard assessment PFASs assessed as a group Persistence is the common property of the group Various supporting concerns 10 Hazard conclusions Persistence combined with supporting concerns Quantitative risk assessment is not reliable or practicable Not possible to demonstrate safe use Continued use would inevitably result in accumulation to levels causing adverse effects Restriction applied as a `safety net' `Case-by-case' risk assessment according to Annex I (section 0.1) of REACH Risks of PFASs are non-threshold Releases are a proxy for uncontrolled risk Risk management to minimise releases 11 Restriction option analysis 12 Evaluation and decision making Proposal being evaluated by ECHA's committees for: Risk Assessment (RAC) Socio-Economic Analysis (SEAC) Six-month consultation of interested parties Stakeholder information session 5th April Evaluation documented in `opinions' Commission and Member States decide on implementing the restriction in REACH Committee Scrutiny by Council of the EU and European Parliament 13 Thank you! @echa.europa.eu