Document n9km46247Eoa3xOMLnMem2gjG

Proposal for a broad PFAS restriction Jenny Ivarsson Swedish Chemicals Agency Meeting of Polymeric Properties in Corrosive Environments Member Research Consortium, 11 May 2023 The broadest restriction proposal in EU history Roughly 10 000 PFASs www.kemikalieinspektionen.se Why do PFASs need to be restricted? High volumes in a variety of applications Emissions occur in all life cycle stages Extremely difficult to degrade ("Forever chemicals") Found everywhere in the environment and most people have PFAS in their bodies Difficult to remove once they are released into the environment - levels will increase over time Harmful effects on the environment and human health Uncontrolled risk from the use of PFAS in the EU Need for EU-wide regulatory measure(s) www.kemikalieinspektionen.se Hazard assessment PFAS Persistence Mobility Bioaccumulation 4 Toxicity, Ecotoxicity, EA/ED, Accumulation in plants, LRTP www.kemikalieinspektionen.se 75 000 tonnes/year of emissions in the EEA 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)-). = OECD PFAS definition 2021 Over 10 000 substances covered! Some examples: www.kemikalieinspektionen.se 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 Restriction Options assessed (RO) RO1 Full ban of all uses Transition period: 18 months www.kemikalieinspektionen.se Restriction Options assessed (RO) Ban with use-specific derogations RO2 Transition period: 18 months Duration of derogation: - 5-years - 12-years Time-unlimited derogations (specifically justified) - Active substances in biocidal products, plant protection products and pharmaceuticals - Refrigerants in HVACR-equipment in buildings where national safety standards and building codes prohibit the use of alternatives - Calibration of measurement instruments and as analytical reference materials 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 Proposed restriction Ban on manufacture, use and placing on the market As substances on their own As a constituent A mixture 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. www.kemikalieinspektionen.se www.kemikalieinspektionen.se 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: 4.4 million tonnes The difference is the PFASs that goes to the waste stream. These emissions are not quantified. www.kemikalieinspektionen.se Consequences for emissions 2025-2055 Ban is decided in 2025 with an 18month transition period (RO1): Emissions (production and use): 0.2 million tonnes (during the transition period) Reduction by 95% www.kemikalieinspektionen.se Consequences for emissions 2025-2055 Ban with time-limited derogations (RO2): Emissions will be higher than in RO1 Calculations are in progress Now you can contribute with information to the proposal for a broad PFAS ban in EU. Next steps Consultation is ongoing until 25 September The proposal is evaluated by the scientific committees (RAC and SEAC) of EU's chemicals agency ECHA 60-day consultation on draft opinion from SEAC The proposal and opinions are sent to the Commission The member states vote www.kemikalieinspektionen.se Submitted restrictions under consideration - ECHA (europa.eu)