ECHA explains how to participate in the consultation for the Restriction of PFAS under REACH

Two Representatives of the Dossiers Submitters, Ms Wiebke Drost, UBA (DE) and Mr Thijs de Kort, RIVM (NL), respectively delivered a presentation on the rationale for submitting a restriction proposal and the specifics of the restriction proposal.

• Ms Wiebke Drost (UBA, DE) emphasized that the persistence of PFASs, in conjunction with the supporting concerns, signifies that a conventional quantitative risk assessment is not sufficiently reliable or practicable. Risk assessment is carried out in accordance with Annex I (section 0.1) of REACH. She also indicated that risks of PFASs are considered as non-threshold and releases are used as a proxy for risk.
  
  
• Mr Thijs de Kort (RIVM, NL). He stressed that it is the broadest restriction proposal under REACH so far with over 10,000 PFASs concerned. The Restriction Proposal laid down two options: Option 1 (RO1): a full ban, 18 months after entry into force; and Option 2 (RO2): a full ban, 18 months after entry into force, with time-limited, use-specific derogations. RO2 was eventually chosen as it was deemed to be proportional and most appropriate. It is based on the analysis of (availability of) alternatives in addition to socio-economic considerations. Mr de Kort also reasserted that work on alternatives by industry is necessary and that very specific uses have time-unlimited derogations. Proposed derogations will be warranted where they are supported by sufficiently strong evidence while potential derogations may be considered in the future in light of additional evidence. With regard to reporting requirements relating to the majority of derogations, manufacturers and importers of active substances are concerned. In terms of uses of fluorinated gases and uses with 12-year derogation period, manufacturers and importers will be required to report on substance and articles while formulators will have to report on mixtures. The mandatory reporting entails information on the use (which derogation) alongside identity and quantity of substance placed on market. Regarding management plans, the requirement for a site-specific management plan relating to fluoropolymers while making use of derogations concerns manufacturers, importers and downstream users. The management plan will encompass the identity of the substances and the products they are used in, the justification for the use, the conditions of use and the safe disposal.

During the second half, a live Q&A session unfolded with further panellists from the Dossiers Submitters: Frauke Averbeck (BAuA, DE), Thijs de Kort (RIVM, NL), Peter Juhl Nielsen (Danish EPA, DK), Audun Heggelund (NEA, NO), Jenny Ivarsson (Kemi, SE). During that Q&A session, further clarifications were provided. As regards the definition, all substances meeting the OECD definition of a PFAS are within the scope of the restriction proposal.

The key takeaways from ECHA’s comments on submission requirements:

• The consultation will close on 25 September 2023 at 23h59 (Helsinki time).
• Joint submissions are encouraged (e.g. per sector).
• The respondent can claim information confidential. However, it is the respondent’s responsibility to remove confidential information from the comments and attachments submitted with non-confidential status.
• This restriction proposal does not cover use in firefighting foams. It is addressed in another restriction proposal.
• In case the respondent provides information on the availability of alternatives, the respondent is required to provide information on how long it would take to transition to the alternatives, presenting clear steps and timelines.
• Stakeholders are invited to provide general comments which may tackle any aspect of the Annex XV restriction proposal, including issues related to socio-economic analysis. However, information on socio-economic impacts have to concentrate on the incremental costs and benefits, i.e. strictly those related to implementing the proposed restriction as compared with not implementing it. Also, the relevant contextual information (e.g. what sources the estimates are based on) are required as well as the calculations underpinning any estimates provided. Finally, specifications on whether the impacts are one-off (e.g. investment costs) or recurring (e.g. operating costs) are required.
• Stakeholders are also invited to provide comments on specific information requests:
• Sectors and (sub-)uses: all sectors and (sub)uses have to be specified (cf. Table 9 of the main report for list of sectors and (sub)uses identified in the restriction proposal).
• Emissions in the end-of-life phase: it entails Per (sub)use, information on share of emissions attributable to different product lifecycle phases (manufacture, use, end-of-life); Annual emission volumes in end-of-life phase at sector or sub-sector level; and Per (sub)use, information on share of waste treated through incineration, landfilling, recycling (including information on form of recycling).
• Emissions in the end-of-life phase: it entails information on effectiveness of incineration under normal operational conditions with respect to destruction of PFAS and prevention of PFAS emissions; for different waste types (e.g. hazardous, municipal).
• Impacts on the recycling industry: it entails impacts of proposed concentration limits (cf.paragraph 2 of proposed restriction) on technical and economic feasibility of recycling processes; waste streams to which the described impacts relate which have to be clearly indicated; measures that recyclers would need to take to achieve proposed concentration limits; costs associated with these measures.
• Proposed derogations – Tonnage and emissions: paragraphs 5 and 6 of the proposed restriction list several proposed derogations; for relevant uses, information is requested on: tonnage of PFAS used per year and resulting PFAS emissions to the environment.
• Missing uses – Analysis of alternatives and socio-economic analysis: Several PFAS uses not covered in detail (cf. Table A.1 in Annex A) and some relevant uses may not have been identified yet. For such uses, information on alternatives and socio-economic impacts is requested, including annual tonnage and emissions and type of PFAS; key functionalities provided by PFAS; number of companies affected; availability, technical and economic feasibility, hazards and risks of alternatives; alternatives are not yet available: information on status of R&D processes and time required for completing substitution; Substitution is technically and economically feasible but more time is required to substitute: type and magnitude of costs associated with substitution, time required for completing substitution, functionality differences and consequences for downstream users and consumers, benefits for alternative providers; substitution is not technically or economically feasible: information on socio-economic impacts for companies, consumers and other affected actors.
• Potential derogations marked for reconsideration – Analysis of alternatives and socio-economic analysis: Paragraphs 5 and 6 of proposed restriction list in [square brackets] several potential derogations for reconsideration after the consultation; for the uses in question, available evidence concerning substitution potential is considered insufficient to allow a firm conclusion; additional information requested on alternatives and socio-economic impacts covering points a) to g) described in question 6.
• Other identified uses – Analysis of alternatives and socio-economic analysis: Analysis of alternatives and socio-economic impacts in the restriction proposal generic and qualitative for many (sub)uses; evidence on alternatives was inconclusive for some applications within certain (sub)uses (cf. Table 8 in main report); more information are required on alternatives and socio-economic impacts covering points a) to g) described in question 6.
• Degradation potential of specific PFAS sub-groups: some specific PFAS sub-groups excluded from restriction proposal scope because they are expected to ultimately mineralise in the environment; RAC appreciates further information on potential degradation pathways, kinetics or produced metabolites in relevant environmental conditions and compartments for: Trifluoromethoxy; Trifluoromethylamino-derivatives; Difluoromethanedioxy-derivatives
• Analytical methods: Annex E contains an assessment ofavailability of analytical methods for PFAS; you may provide any new or additional information on new developments in analytical methods not yet considered.