Document 4v618LvNDk7x3ZR47kZNRk8Ep

Veo**g*l cefic FACTSHEET February 2023 The Universal PFAS restriction pre-publication Issued 7 February 2023 Following the large public pressure and attention for the topic, on 13 January 2023, the Competent Authorities of The Netherlands, Germany, Norway, Denmark, and Sweden ('Dossier Submitters') submitted a restriction dossier to the European Chemicals Agency (ECHA) on per- and polyfluoroalkyl substances (PFAS). ECHA issued a pre-publication of the proposal on 7 February, including the Annex XV Report, 7 Annexes and 3 Appendices ( 2000 pages in total). The final version of the restriction proposal is expected to be published on 22 March. The restriction in short Definition of PFAS and why they are grouped together in this restriction PFAS stands for per- and polyfluoroalkyl substances. The Dossier Submitters propose the following definition for PFAS: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/1attached to it). A substance that only contains the following structural elements is excluded from the scope of the restriction: CF3-X or X-CF2-X', where X = -OR or -NRR' X' = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(0)-), -OR", -SR" or --NR"R'" R/R7R"/R"' = hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(0)-). The proposal mentions that PFAS form a broad group of substances, including volatile as well as nonvolatile PFASs, anionic, cationic, zwitterionic and non-ionic substances, polymers of different kinds as well as non-polymers, amphoteric liquids (surfactants), etc., with various chain-lengths and degree of fluorination. The group of PFASs therefore cannot be characterised by (a) specific (range of) physicochemical properties. All PFAS have been grouped together, because they (and/or their degradation products) are considered to have the characteristic of 'very high persistence' in common. European Chemical Industry Council - Cefic aisbl Rue Belliard 40 b.15 B-1040 Brussels Belgium Tel. +32.2.436.93.00 Wcefic.be www.cefic.org EU Transparency Register n 64879142323-90 1 ca,,emins,,, Which PFAS and PFAS uses are proposed to be restricted by when The universal PFAS restriction imposes a manufacturing, sale, use and import ban on all PFAS, and PFAS containing products, materials and finished goods1. These bans are foreseen to apply 18 months from entry into force of the restriction. Three types of derogations to the aboveban are mentioned: An exclusion (timeunlimited derogation) for active substances in plant protection, biocidal, and human & veterinary medicinal products (with a reporting obligation). Timelimited derogations where there is sufficiently strong evidence that today there are no viable alternatives available. Depending on the current state of development of alternatives, uptake of alternatives etc., the derogation is granted for 6.5 or 13.5 years2 from the entry into force3. These derogations cover specific uses in food contact materials, medical devices, membranes in fuel cells, refrigerants, insulating materials, textiles, etc. Potential timelimited derogations where the current evidence on (non)availability of alternatives is inconclusive. These are mentioned between square brackets4 and cover inter alia certain uses of PFAS in textiles (incl. personal protective equipment (PPE)), very specific industrial uses, engineered fluids for medical devices, transport applications, etc. Stakeholders are expected to feed data into the upcoming public consultation to strengthen the evidencebased justification for a derogation. The restriction process The entire process, from introduction of the proposal to the final publication in Annex XVII of REACH, takes at least 18 months. Annex 1 depicts an indicative timeline, assuming all steps go through the streamlined process. A brief overview of the next steps: 1015 March 2023 22 March 2023: 5 Apr 2023: Mar 2023 Dec 2023: Mar 2023 Mar 2024: Conformity check assessment by the Risk Assessment Committee (RAC) and the Committee for SocioEconomic Analysis (SEAC) Expected publication of the final proposal; start of a 6month public consultation ECHA will hold an online information session to explain the restriction process and to help those interested in participating in the consultation. Risk Assessment Committee (RAC) opinion development: RAC will form an opinion on whether the proposed restriction is appropriate in reducing the risks to people's health and the environment. Committee for SocioEconomic Analysis (SEAC) opinion development: SEAC will look into the socioeconomic impacts, i.e. proportionality of the measure, benefits and costs to society; the ECHA's Enforcement Forum will also issue its advice. 1 Except for the import of PFAS containing product, materials and finished goods that only contains very low levels of PFAS: 25 ppb for one nonpolymer PFAS 250 ppb for the sum of nonpolymer PFAS 50 ppm for all polymeric PFAS 2 These 6.5 years and 13.5 years include the 18month (1.5year) transitional period. 3 Timelimited derogations are specified for 1) PFAS except for fluoropolymers and perfluoropolyethers and 2) fluoropolymers/ perfluoropolyethers 4 `Square brackets' are indicated in a way [hernia meshes until 13.5 years after EiF]' for instance, as on page 7 of the restriction dossier. 2 Dec 2023 Feb 2024: Mar 2024 Q1 2025: Q2 Q3 2025: Q4 2025 Q1 2026: 60day consultation on the draft opinion by Committee for SocioEconomic Analysis (SEAC) European Commission drafts the legal text of the restriction5; and REACH Committee (Member States) discusses and adopts the text. Scrutiny by EU Parliament and Council Publication in Official Journal The above dates are all indicative and the process is expected to be delayed, as for complex files, the ECHA and Commission assessment periods are usually extended. Important to note is that the durations of public consultations are fixed. Where you are needed Industry input needed/ highly recommended for already mentioned proposed derogations For the derogations indicated between square brackets, the dossier submitters invite stakeholders to provide data. If no supportive data are made available during the consultation period to minimise uncertainties, the derogation might not be supported by the ECHA committees and not included in the final restriction. Looking at the content summary tables for the regulatory options 1 and 2 (pages 80139 of the pre published restriction proposal), it becomes clear that the following data are highly relevant to feed into e ECHA's public consultation: Data on the (non)availability of alternatives Data on cost impact: producer surplus losses employment losses consumer surplus losses welfare losses Detailed data on emission/release control are very useful, as the base assumption is that emissions are unavoidable and high. 5 The Commission submits it to the World Trade Organisation (WTO) to ensure that it does not create technical barriers to international trade. 3 %cefic Industry input requested for lacking derogations If the use of a (group of) PFAS or PFAS-containing products is not included in any of the listed derogations in the proposal, it will be banned withinl8 months after entry into force of the restriction. PFAS containing products already in use can continue to be used until end-of life. Problems may thus arise with replacement of equipment and/ or its PFAS-containing spare parts. All stakeholders are therefore advised to: Carefully assess the list of derogations and identify those uses that are missing. Engage with other players in their value chains, in compliance with competition law6. Respond to the public consultation with data on the (non-)availability of potential alternatives for the missed uses and the cost impact of the proposed restriction (see Annex 2 for details on consultation page). Give an indication to the authorities of the time frames for developing viable alternatives in sufficient quantities (including re-design of end products). Final remark Special attention should be given to the use of PFAS in industrial settings (coated pipes, gaskets, valves, membranes, etc.), as these are not sufficiently covered. Also the use of PFAS as intermediates, precursors, etc. for the production of active substances for plant protection products, biocides and veterinary & human medicines is missing. The active substances may be mentioned with a time-unlimited derogation, but companies should also be able to produce them within the EU or import them into the EU, which means that intermediates, precursors, etc. would need also a derogation. Since the pre-published restriction proposal will further be modified by the time when the 6-month public consultation is launched, Cefic members are advised to assess and cite the conformity-checked dossier (to be published on 22 March) for response to the public consultation. Key contact Marleen Pauwels, Executive Director, Halogens Industry Sector (=ecefic.be). 6 Information sensitive under competition law should not be exchanged. This includes any information that could reveal the commercial policy on one company to its (potential) competitor(s). 4 ANNEX 1: The universal PFAS restriction's indicative timeline 5 ANNEX 2: Public Consultation Page Page set up for public consultations: https://echa.europa.eu/restrictions underconsideration//substance rev/72301/term It contains: The prepublication of the restriction proposal, its annexes and appendices All submitted comments Please note that Helsinki time applies to all deadlines. `Give comments' link to appear upon launch of public consultation 6