Document gbBavnjb2nZ4QzXNwYmmpB2KN

Universal PFAS restriction proposal FOD VVVL - DG EM - DPPC - MRBC 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 Background - PFAS Restriction dossier preparation 5 MS (Germany, Netherlands, Norway, Denmark and Sweden) started work few years ago DE and NL are the lead submitters of the dossier 2 stakeholder consultations have already been organized in 2020 and 2021 One workshop has been organized in 2020 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 DE and NL held a press conference 07/02 to give first insights: https://echa.europa.eu/-/echa-publishes-pfas-restriction-proposal 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 "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" 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 Risk Management Options Two Restriction Options (Ros) have been assessed: RO1: A full ban with no derogations and a transition period of 18 months RO2: full ban with use-specific time-limited derogations (18-month transition period plus either a 5 or 12-year derogation period). "As specific information on costs of a ban of PFASs for the different actors associated with the addressed uses was scarce and mainly qualitative, the derogations and their duration were mainly based on the availability and applicability of alternatives to PFASs" 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 F-gas uses in heating and refrigerants Uses in automotive and electronics Medical uses Subdivision between PFAS in general and fluoropolymers Some exemptions are "unlimited" To avoid double regulation (Boicidal products, Plant Protection Products and Medical Devices) However environmental concern might not be tackled! National safety standards for buildings Use in analytics (internal standards) Transition periods proposed under RO2 * ' " u z - -- z > ` w " Q z >z z < Reporting requirements and site management plans Most derogated uses are proposed to be subject to reporting: Specifying under which derogation they fall Identify and quantity of the substance placed on the market Manufacturers, importers and formulators have to report this information 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. Socio-economic analysis - Baseline "14 sectors and/or applications - subdivided in numerous sub-uses have been addressed" "Over a 30-year period the expected mean PFAS tonnage in the EEA is 49 million tonnes, leading to emissions of about 4.4 million tonnes during the manufacture and use phase when no action is taken" "emissions during the waste phase, which may be significant, are not accounted for in that estimate as they are highly uncertain. Hence, it can be assumed that emission estimates are severely underestimated." "The overall annual health costs following from exposure to PFAS in Europe has been estimated in a Nordic Council report from 2019 to be between 52 and 84 billion." PFAS applications assessed federal public HEALTH, FOO0 AND ENVIRON Table A.1. Overview of PFAS applications and the level at which they were researched. PFAS applications ['FAS rtanJfacture Consumer mixtures Textile, upholstery, leather, apparel and carpets (TULAC) Cosmetics Food contact materials and packaging Ski wax Medical devices Construction products Transport Lubricants Electronics and semiconductors Petroleum and mining Laboratory equipment Plant protection Chemical industry & filtration products and biocides Medicinal products Plastics (other than Pyrotechnics packaging) and rubberielastomer production (including flame retardants) Fracking (currently Immersion cooling Defence industry hardly applicable in (currently hardly EEA) applicable in EEA) Cement industry Professional cleaning Other niche and polishing applications Green uses are researched in detail Blue uses are researched in general Orange uses not researched in detail Purple use: Separate restriction proposal "IN Metal plating and manufacture of metal products Applications of fluorinated gases Energy sector Waste stage PFAS applications Firefighting foam Personal care products other than cosmetics __,14,46," Printing inks Uses (yet) unknown Socio-economic analysis - Impact Analysis Benefits "Environmental benefits are expressed as the expected total amount of emissions avoided" "Benefits to human health are evaluated qualitatively as data is limited, or missing, to assess: the hazard of many of the individual PFASs; the associated thresholds below which exposure is not expected to lead to adverse health effects, if such limits exist, and the prediction of future human exposure levels." Costs "costs to industry in the form of producer surplus losses" "consumer surplus losses as a result of changes to the product price, welfare losses and/or costs resulting from changes in the characteristics of goods, e.g." "welfare losses resulting from the absence of the product (where substitution is not feasible) as well as job losses." Example of emission reduction analysis Main function Impregnation (dirt/oil/water repellency) Tonnage(202 Circa 92 000 tonne per year Emissions (2020) Circa 23 000 tonne per year Estimated emissions(30 years 1 400 000 without restriction! Estimated missions(30 ye2irs) 66 000 full ban Emission reduction of 95%in case of full ban) ---- '-------- b u federal public service HEALTH,FOOD CHAIN SAFETY AND ENVIRONMENT 14:covec 4=1 L rreiIranirj y Proportionality "Dossier Submitters conclude that the extent of PFAS emissions warrants regulatory action" "additional emissions from use sectors and/or uses (as well as from the waste stage) have not been addressed (in detail) and thus only add to the concern and consequently to the call for regulatory risk management measures" "for a large number of uses, functional alternatives are already available" "Both RO1 and RO2 are deemed proportionate to the risk, as eventually the societal cost of inaction will always surpass the costs of a ban on the use of PFASs." "It has to be realized that once a restriction is in place, emissions will go on for many years to come due to the presence of PFASs in technical stock ((long-lived) products in use and on shelf) and waste" Proportionality "Although both restriction options (RO) are deemed proportionate to the risk, the Dossier Submitters propose RO2 as the most balanced option." "RO2 leaves room to mitigate unwanted effects to society due to the sudden unavailability of products for which alternatives are not yet in place and allows stakeholders and industry to prepare for a smooth transition to alternatives." "It should be noted, however, that a delay of banning PFASs as a result of the proposed derogations under RO2 will shift the cost burden arising from health and environmental impacts to future generations." Restriction Proposal Adobe Acrobat Document Microsoft Word-document federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT First thoughts on the proposal Positive points Very extensive and detailed analysis by the DS All PFAS in all uses are covered in the proposal Even uses not already existing are covered Only limited number of complete derogations proposed Good to see that they would need to be reported on Only very specific (temporary) derogations have been proposed Proposal seems to be following the "P sufficient" approach and the precautionary principle Points of concern Uncertainties on the waste phase and incineration of PFAS Uncertainties on derogated uses to be cleared out Only qualitative analysis of the benefits (based on avoided emissions only) Uncertainties on the reporting requirements and the "site management plans" Link between this restriction and other EU actions (IED, WFD, etc.) 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 BE input in the process - CCIEP PFAS Working Group Network of Authority experts working on PFAS (FPS Health Envi, FOD WASO, FOD economy, OVAM, Envi Brussels, SPW Wallonia, etc.) Main objectives Share data and information on ongoing activities regarding PFAS between different BE authorities Share PFAS information and data on EU and international level (REACH, POP, etc.) Act as expert advice body to other coordination structures on PFAS related topics Note: PFAS CCIM group does not have mandate to coordinate formal positions Only provide advice to groups that take the final decision (GDPC, BCR, etc.) For PFAS restrictions under REACH: CCIM PFAS group will provide data and input to BCR, who will decide on the final BE positions Example: BE comments to AFFF restriction proposal: drafted by CCIM PFAS group, approved and submitted via the BCR. 21 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 within your competence whether the proposed derogations are justified and what their impacts can be 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 03/05: ad-hoc BCR meeting on PFAS Questions? federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT