Document a4LvgY9B37Nnr6mQZ8BgkB4RY

Broad PFAS Restriction Proposal Jenny Ivarsson Swedish Chemicals Agency 13 September 2023 Preparation May - July 2020 Call for evidence July 2021 - Oct 2021 2nd stakeholder consultation Oct 2021 - Jan 2023 Drafting of proposal SSttaakkeehhoollddeerr iinntteerrvviieewwss,, lliitteerraattuurree sseeaarrcchh,, mmeeeettiinnggss Jan 2020 First meeting 13 January 2023 Submission of proposal 7 February 2023 Publication of proposal Hazard assessment PFAS Persistence Bioaccumulation Mobility Toxicity, Ecotoxicity, EA/ED, Accumulation in plants, LRTP 75 000 tonnes/year of emissions in the EEA Source: https://ec.europa.eu/environment/pdf/ chemicals/2020/10/SWD_PFAS.pdf Tonnages and emissions Application 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 Tonnage range > 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 Justification for EU wide measures Manufacture, import and uses in EU Global market with growing volumes Large variety of emission sources Ubiquitous presence and increasing levels in environmental media PFASs are mobile and cross borders EU internal market: level playing field EU-wide risk reduction measures: Implement control efficiently and uniformly 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)-). = 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 PFASs can be completely degraded in the environment. These are therefore excluded from the scope: CF3-O- / CF3-N< -CF2-O- / -CF2-N< Examples: Proposed restriction Ban on manufacture, use and placing on the market As substances on their own As a constituent in o another substance o a mixture o an article 25 ppb for any PFASs 250 ppb for sum of PFASs 50 ppm* for PFASs * If total fluorine exceeds 50 mg F/kg the manufacturer, importer or downstream user shall upon request provide to the enforcement authorities a proof for the fluorine measured as content of either PFASs or non-PFASs. Restriction Options assessed (RO) RO1 Full ban of all uses Transition period: 18 months Restriction Options assessed (RO) RO2 Ban with use-specific derogations Transition period: 18 months Duration of derogation: o 5-years o 12-years Time-unlimited derogations (specifically justified) o Active substances in biocidal products, plant protection products and pharmaceuticals o Refrigerants in HVACR-equipment in buildings where national safety standards and building codes prohibit the use of alternatives o Calibration of measurement instruments and as analytical reference materials Ban without a derogation Phase-out timelines 12 year derogation (33, of which 17 are marked for reconsideration) EIF 18 months 6.5 years 13.5 years 5 year derogation (11, of which 3 are marked for reconsideration) Time-unlimited derogations (5 derogations) Proposed restriction conditions - derogations Two standard derogation timeframes chosen Examples: Food contact materials for industrial food and feed production Implantable medical devices Alternatives under development but not available at entry into force Identification, development and certification of alternatives needed 5 years 12 years Proposed restriction: Reporting Mandatory reporting in relation to majority of derogations Who Active substances: Manufacturers, importers Uses of fluorinated gases & uses with 12 year derogation period: o Substance & articles: Manufacturers, importers o Mixtures: Formulators What Information on the use (which derogation) Identity and quantity of substance placed on market Proposed restriction: Management plan Requirement for a site-specific management plan in relation to fluoropolymers and perfluoropolyethers when making use of derogations Who What Manufacturers, importers and downstream users Identity of the substances and the products they are used in Justification for the use Conditions of use Safe disposal Consequences for emissions 2025-2055 If no action is taken: Use of PFASs in the sectors investigated: 49 million tonnes Release of PFASs during manufacture and use: 4.5 million tonnes The difference is the PFASs that go to the waste stream. These emissions are not quantified. Full ban of all uses with an 18-month transition period (RO1): Emissions (production and use): 0.2 million tonnes (during the transition period) Reduction by 96% Ban with time-limited derogations (RO2): Emission reduction estimates are per derogation Emissions will be higher than in RO1 Calculations are in progress Conclusions and next steps Need for EU wide restriction for PFASs based on identified risks RO2 effective measure to reduce environmental emissions o Ban with use-specific derogations in combination with reporting requirements/management plan o Emission reduction still to be determined (RO1: 96%) Proposed restriction is an appropriate measure to address these risks within a reasonable timeframe Next: Consultation is ongoing until 25 September Questions and outstanding issues