Document 5DJJwogd6YdN27yEOLbkYRQZ4

Proposal for a broad PFAS restriction Jenny Ivarsson Swedish Chemicals Agency Final meeting POPFREE Industry planning project 1 March 2023 The broadest restriction proposal in EU history Roughly 10 000 PFASs www.kemikalieinspektionen.se 75 000 tonnes of emissions in the EEA 3 000 tonnes in Sweden www.kemikalieinspektionen.se Tonnages and emissions Application Tonnage range Applications of fluorinated gases Textiles, upholstery, leather, apparel & carpets Medical devices Manufacture Food contact materials and packaging Transport Construction products Electronics and semiconductors Lubricants Petroleum and mining Energy sector Metal plating and manufacture of metal products Cosmetics Consumer mixtures Ski wax www.kemikalieinspektionen.se > 10 000 > 10 000 > 10 000 > 10 000 > 10 000 > 10 000 1 000 - 10 000 1 000 - 10 000 1 000 - 10 000 1 000 - 10 000 1 000 - 10 000 100 - 1 000 10 - 100 10 - 100 0 - 10 Emission range % emitted in manufacturing and use phase 5 - 25 5 - 25 5 - 25 0 - 5 0 - 5 0 - 5 25 - 75 5 - 25 5 - 25 0 - 5 0 - 5 0 - 5 > 95 75 - 95 25 - 75 Emission contribution Contribution to total emission [%] > 50 10 - 50 5 - 10 1 - 5 0 - 1 0 - 1 1 - 5 0 - 1 0 - 1 0 - 1 0 - 1 0 - 1 0 - 1 0 - 1 0 - 1 The proposal - chemical definition Column 1 Per- and polyfluoroalkyl substances (PFASs) defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached 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' and X' = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), OR'', -SR'' or -NR''R'''; and where R/R'/R''/R''' is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-). www.kemikalieinspektionen.se = OECD PFAS definition 2021 Over 10 000 substances covered! Some examples: The proposal - chemical definition Column 1 Per- and polyfluoroalkyl substances (PFASs) defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached 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' and X' = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), OR'', -SR'' or -NR''R'''; and where R/R'/R''/R''' is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-). A few specific types of PFAS can be completely degraded in the environment. These are therefore excluded from the scope: CF3-O- / CF3-N< -CF2-O- / -CF2-N< Examples: www.kemikalieinspektionen.se The restriction proposal Dossier: Risks, Impacts Two restriction options considered: o Full ban (Option 1) o Ban with use-specific derogations (Option 2) Proposed Restriction: option 2 o Based on analyses of alternatives, and o Socio-economic considerations www.kemikalieinspektionen.se Proposed restriction conditions Ban of manufacture, placing on the market and use PFASs as such, as constituent in other substances or in mixtures as well as in articles. Above a concentration limit of o 25 ppb for individual PFAS o 250 ppb for the sum of PFASs o 50 ppm for PFASs (based on total fluorine) Transition period: 18 months after entry into force Use-specific (time-limited) derogations General derogation for active substances in plant protection products, biocides and pharmaceuticals www.kemikalieinspektionen.se Proposed restriction conditions - derogations Two standard derogation timeframes chosen Examples: Food contact materials for industrial food and feed production Alternatives under development but not available at entry into force Implantable medical devices Identification, development and certification of alternatives needed 5 years 12 years www.kemikalieinspektionen.se www.kemikalieinspektionen.se Consequences for emissions 2025-2055 If no action is taken: Use of PFAS in the sectors investigated: 49 million tonnes Release of PFAS during manufacture and use: 4.4 million tonnes The difference is the PFAS that goes to the waste stream. These emissions are not quantified. Ban is decided in 2025 with an 18-month transition period (RO1): Emissions (production and use): 0.2 million tonnes (during the transition period) Reduction by 95% Ban with time-limited derogations (RO2): Emissions will be higher than in RO1 Calculations are in progress. Will be included in the version published for public consultation in March Next step, preliminary timeplan Consultation in scientific committees Including 6 months + 60 days stakeholder consultation 22 March 2023 Start of consultation 22 September 2023 End of 6 months consultation 5 April 2023 Online information session March 2024 Opinion of Committees 2025 COM decision Entry into Force 2026/2027 Restriction becomes effective Submitted restrictions under consideration - ECHA (europa.eu) www.kemikalieinspektionen.se www.kemikalieinspektionen.se