Document DMq0RKKkjLEVRg21pKNbvkV6a

federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT Ad-Hoc BCR on the Universal PFAS restriction proposal federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT UPFAS restriction under REACH History of PFAS policy actions 2006: EU restriction of PFOS (under Dangerous Substance Directive) 2009: PFOS added to the Stockholm Convention on Persistent Organic Pollutants (POP regulation in EU) 2011: PFOA and APFO identified as SVHC + CLP classification 2012: ICCM3 identifies PFAS as emerging policy issue 2016: PFNA identified as Substance of Very High Concern (SVHC) + CLP 2017: PFOA added to the REACH restriction list (Annex XVII) 2017: PFDA identified SVHC + CLP 2019: HFPO-DA (Gen-X) identified SVHC 2020: PFOA added to Stockholm Convention Well know PFAS get regulated lesser known related PFAS replace them! = regrettable substitution 2020: PFBS identified as SVHC 2021: C9-C14 added to the REACH restriction list (enters into force in 2023) 2023: PFHxS and related substances will be added to the Stockholm Convention 3 Need for faster action using grouping approach: Universal PFAS Restriction preparation 5 MS (Germany, Netherlands, Norway, Denmark and Sweden) started working on proposal in 2020 Stakeholder consultations and workshops organized in 2020 and 2021 Originally planned to be submitted to ECHA in July 2022 Due to large amount of work it was delayed until 13th of January 2023 Dossier has been made available on ECHA site 07/02/2023 DE and NL held a press conference 07/02 to give first insights: https://echa.europa.eu/-/echa-publishes-pfas-restriction-proposal Public Consultation of the dossier started March 22nd REACH restriction process Limit or ban the manufacture, placing on the market (including imports) or use of a substance A restriction may apply to any substance on its own, in a mixture or in an article, including those that do not require registration Restriction dossier should include hazard, risk and socio-economic analysis (including alternative assessment) EU-wide unacceptable risk has to be proven See ECHA site: https://echa.europa.eu/restriction-process PFAS: Main concern identified "... the very high persistence, exceeding the criterion for very persistent (vP) according to Annex XIII of the REACH Regulation by far. "supporting concerns are their bioaccumulation, mobility, long range transport potential (LRTP), accumulation in plants, global warming potential and (eco)toxicological effects." "With the constantly increasing concentrations of PFASs in the environment due to their persistence and ongoing emissions, the exposure of humans and the environment to these substances will inevitably lead to negative effects" "exposure to PFASs has a high potential for intergenerational effects" Restriction Scope - PFAS Substances OECD definition roughly 10 000 substances With some specific exemptions According to DS not as persistent as "standard" PFASs See also Annex B section 4.1.4 for more detailed explanation Restriction Scope: all possible uses "manufacture, placing on the market, as well as the use of PFASs as such and as constituents in other substances, in mixtures and in articles above a certain concentration." "All uses of PFASs are covered by this restriction proposal, regardless of whether they have been specifically assessed by the Dossier Submitters and/or are mentioned in this report or not, unless a specific derogation has been formulated." "Grouping approach has been chosen to prevent regrettable substitution in the future" Meaning: every presence of PFAS (above certain threshold) planned to be banned in the EU Including import Including not yet developed PFAS or uses Proposed concentration thresholds After entry into force concentrations of PFAS in mixtures and articles will not exceed: 25 ppb for any PFAS measured with targeted PFAS analysis (excluding polymeric PFAS from quantification) 250 ppb for the sum of PFAS measured with targeted analysis (optional with prior degradation of precursors) (polymeric PFAS excluded from quantification) 50 ppm for PFAS (including polymeric PFAS) If total fluorine exceeds 50 mg/kg F proof on whether fluorine measured as content of either PFAS or non-PFAS Relationship between F and PFAS content depends on percentage of F in molecular structure Proposed (temporary) exemptions 30+ specific exemptions Including some exemptions that will only be retained if sufficient justification is provided Exemptions include: Personal protection equipment (PPE) textiles Certain fluorinated gasses used in heating and refrigerants Uses in automotive and electronics Medical uses Some exemptions are "unlimited" To avoid double regulation (Biocidal products, Plant Protection Products and Medical Devices) however reporting requirements are included National safety standards for buildings (not applicable for BE) Use in analytics (internal standards) Transition periods proposed under RO2 * ' " u z - -- z > ` w " Q z >z z < Reporting requirements and site management plans For most derogated uses manufacturers, importers and formulators have to report the following information: Specifying under which derogation they fall Identify and quantity of the substance placed on the market For derogated fluoropolymers and perfluoropolyethers site specific management plans, including: Information on the identity of the substances and the products they are used in A justification for the use Details on the conditions of use and safe disposal. Restriction Proposal Proposal as drafted by the DS Same proposal into overview table Further planning - Restriction process 22/03: Start Public Consultation In Parallel RAC and SEAC will start drafting Opinion 05/04: ECHA info webinar 22/09: End of Public Consultation RAC opinion will be finalized 2024: Draft SEAC Opinion consultation of 60 days 2024 - 2025: Final Opinions and Annex XV adopted 2025 - 2026: COM development of restriction proposal and REACH Cee (Member States) vote 2026-2027: Entry into force +/- 2030: first transition period ends +/- 2045: last transition period ends Input in the restriction process - Public Consultation Public Consultation is the best way to give input into the process Please provide data if: Specific uses need to be derogated Identified derogations are not justified Alternative assessment is incomplete for specific uses Any other comments are welcome important to substantiate them with data! Check Info note for more detailed requests for data: https://echa.europa.eu/documents/10162/cad38c27- ede8-2268-00c6-939ea066743c Any data submitted after the consultation period cannot be taken into account by the RAC! Second Public Consultation on SEAC draft opinion: possible to provide input on the SEA analysis, however very short timeline (60 days)! Will be planned for 2024/2025 UPFAS Public Consultation - Info needs? Information on PFAS tonnages and the fate of PFASs during the full lifecycle, especially the waste stage, is needed to allow for a better closed mass balance. Waste stage emissions for fluorinated gas are unknown and therefore not taken into account New data on monitoring and exposure Link between emission source and exposure Potential derogations justification Studies/reports that justify that these potential derogations are (not) needed Check whether the proposed derogations are justified and what their impacts can be Please make sure to inform your stakeholders of this restriction and the potential impact it may have on their sector! Documentation Documents can be found on the ECHA page: https://echa.europa.eu/registry-ofrestriction-intentions/-/dislist/details/0b0236e18663449b Annex XV report: this is the base dossier in which you can find a summary, the proposal and general info on the evaluation done by the dossier submitter Annex A: Manufacture and Use of PFAS Annex B: Information on Hazards and Risks of PFAS Annex C: Justification for action on Union-wide basis - this is an empty document referring to Section 1.2. of the base Annex XV report Annex D: Baseline - also an empty document referring to Section 1.3. of the Annex XV report Annex E: Impact Assessment Annex F: Assumptions, uncertainties and sensitivities Annex G: Stakeholder information Appendix G1: call for evidence on restriction options Appendix G2: second call for evidence on restriction options Appendix E4: available analytical methods Other interesting info Annex XV report Overall Summary and Conclusion Alternative assessment: Table 8 and 9 Enforceability: section 2.5. Available analytical methods: Appendix E.4 Uncertainty analysis: Annex F Table F.3 alternative assessment ECHA webinar: https://echa.europa.eu/-/restriction-of-per-andpolyfluoroalkyl-substances-pfass-under-reach