Document Nek5w422b0q6odg5rX0dG408V

PFAS Restriction Proposal Presented by: Audun Heggelund, Norwegian Environment Agency 1 Restriction proposal - content REACH = Registration, Evaluation, Authorisation and restriction of CHemicals Restriction proposal: Chemical identity Hazards, risks, effects Applications Availability of alternatives Socio-economic analysis - impact assessment 2 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 3 Restriction process - next steps Public Consultation, 22 March - 25 September 2023 ECHA's scientific committees: Committee for Risk Assessment (RAC) Committee for Socio-Economic Analysis (SEAC) Decision by the Commission together with the member states, expected 2025/26 4 Next steps - key messages Dossier amendments are made on the basis of information submitted to the Public Consultation Well-substantiated scientific evidence is key: Alternatives, impacts (costs and benefits), missed uses, tonnages ECHA webinar and emissions, R&D efforts, etc. If available, quantitative information is p5refAerrepd ril Information on sector level preferred over individual submissions Position papers and unsubstantiated claims are not useful 5 PFAS - basis for restriction a u a : NationalInstitute forPublicHealth 6 KEMI N andtheEnvironment Ministry offlealth,WerfareandSport Sundesanstalt FAr Arbritsschiax and Arlieitsmedizin Swedish Chemicals Agency Norwegian Environment Agency Ministry of Environment of Denmark Environmental Protection Agency Global focus Exposure to PFAS in general has gained increasing attention EU chemicals strategy for sustainability PFAS linked to pollution of the environment, including drinking water Some PFASs already restricted in the EU (PFOS, PFOA, C9-C14 PFCAs) This proposal does not affect these existing restrictions Decision making for restrictions on PFHxS and PFHxA is ongoing PFAS in fire-fighting foam Several regulations in non-EU countries Certain US States (California, Washington, NY, etc.), Australia 7 Forever chemicals All PFASs in scope of this restriction proposal are either persistent themselves or degrade to other persistent PFASs Persistence due to strength of the carbon-fluorine bond PFASs remain in environment for decades to centuries 8 Hazard assessment PFAS Persistence Bioaccumulation Mobility Toxicity, Ecotoxicity, EA/ED, Accumulation in plants, LRTP 9 Human health effects Varies with PFAS chemical structure Most common effects: Reduced immune response - increased risk of infections Liver damage and disturbed metabolism Developmental effects - reduced growth of fetus and offspring Potentially carcinogenic 10 Properties Very high persistence Long-range transport potential Mobility Accumulation in plants Bioaccumulation potential (Eco)toxicity Endocrine activity Hazard assessment PFASs are among the most stable organic compounds Resist (bio) degradation because of the stable C-F bond PFASs can be transported by air, water and matrices to which they are adsorbed or absorbed e.g., dust, sediments, migratory animals and polymer particles PFASs are found in all environmental compartments as well as in biota (e.g. mammals, birds, fish, plants, ...) Plants accumulate many PFASs beyond expected levels Exposures may be higher than observed by monitoring For well studied PFASs effects on behaviour, growth, reproduction, metabolism, organs & immune system observed Harmonised class. for some PFASs: Carc. 2, Repr. 1B, lactation effects, STOT RE 1 In silico, in vitro and in vivo data provide indications of interactions of various PFASs with the endocrine system 11 Properties Very high persistence Long-range transport potential Mobility Accumulation in plants Bioaccumulation potential (Eco)toxicity Endocrine activity 12 Hazards concerns Concerns related to combinations of properties High potential for ubiquitous, increasing and irreversible exposures of the environment and humans; Difficulty to decontaminate raw water for drinking water, low effectiveness of end-of-pipe RMMs and difficulty to treat contaminated sites; High potential for human exposure via food and drinking water; Potential for intergenerational effects and delay of effects; Potential for causing serious effects although those would not be observed in standard tests; Estimation of future exposure levels and safe concentration limits is highly uncertain; Global warming potential. Monitoring data Illustration from Sunderland et al., 2019, J. Exposure Sci. Environ. Epidemiol., 29, 131-147. 13 PFAS - uses and emissions a u a : NationalInstitute forPublicHealth 14 KEMI N andtheEnvironment Ministry offlealth,WerfareandSport Sundesanstalt FAr Arbritsschiax and Arlieitsmedizin Swedish Chemicals Agency Norwegian Environment Agency Ministry of Environment of Denmark Environmental Protection Agency Function of PFASs Combination of useful properties from technical viewpoint Water, oil and dirt repellency Durability under extreme conditions: temperature, pressure, radiation, chemicals Electrical and thermal insulation Surfactants, refrigerants... Used in high tonnages in many different sectors 15 Sectors/uses of PFASs Industrial processes Firefighting foams TULAC Food contact materials (incl. packaging) Metal plating/metal products Consumer mixtures Ski wax Transport Applications of fluorinated gases Electronics and semiconductors Energy sector Construction products Lubricants Petroleum and mining Medical devices Cosmetics Other uses 16 Refrigeration Uses - subuses Many uses are further sub-divided Applications of fluorinated gases Air conditioning & heat pumps Foam blowing agents Solvents Propellants Magnesium casting Clean firesuppressing agents Preservation of cultural paper- based materials Insulating gas in electrical equipment 17 75 000 tonnes of emissions in 2020 4.5 million tonnes of emissions over 30 years including an estimated increase of PFAS use Emissions 18 Source: https://ec.europa.eu/environment/pdf/ chemicals/2020/10/SWD_PFAS.pdf Emissions estimations Focus on emissions to the environment (PBT/vPvB approach) One compartment model Emissions estimated for each use and life-cycle stage Input parameters based on literature, industry information and expert judgement 19 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 20 PFAS - risk-related considerations a u a : NationalInstitute forPublicHealth 21 KEMI N andtheEnvironment Ministry offlealth,WerfareandSport Sundesanstalt FAr Arbritsschiax and Arlieitsmedizin Swedish Chemicals Agency Norwegian Environment Agency Ministry of Environment of Denmark Environmental Protection Agency Substance scope A concern-based scope using the OECD (2021) PFAS definition as a starting point, but only including persistent substances Substances that contain at least one -CF2- or one -CF3 group, without any H/Cl/Br/I attached to it With some exceptions 22 Grouping approach Grouping based on two properties: chemical structure, i.e. in line with OECD 2021 PFAS definition persistence Acknowledged as a basis for risk reduction measures by several research groups: e.g. Cousins et al. (2020), Scheringer et al. (2022) Justified to avoid regrettable substitution Prevention of future exposures of PFAS which are not currently in use 23 Risk characterisation Risks are not adequately controlled, and emissions should be minimised... ... because of accumulation over time which leads to levels likely to cause effects for humans and environment Risks of PFASs are considered as non-threshold Emissions are used as a proxy for risk Effectiveness of the proposed restriction is based on the effectiveness of emission reduction 24 Analysis of alternatives Alternatives already adopted in many sectors/uses For some sectors alternatives already identified but time needed to implement or alternatives not available in sufficient quantities (e.g. industrial food and feed production) In other sectors research and development still needed (e.g. medical devices) 25 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 26 PFAS - some specifics of the restriction proposal a u a : NationalInstitute forPublicHealth 27 KEMI N andtheEnvironment Ministry offlealth,WerfareandSport Sundesanstalt FAr Arbritsschiax and Arlieitsmedizin Swedish Chemicals Agency Norwegian Environment Agency Ministry of Environment of Denmark Environmental Protection Agency Proposed restriction: Ban 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. 28 Restriction Options (RO`s) assessed RO1 Full ban of all uses Transition period: 18 months RO2 Ban with use-specific derogations Transition period: 18 months Duration of derogation: o 5 years (based on set criteria relating to alternatives) o 12 years (based on set criteria relating to alternatives) o Time-unlimited derogations (specifically justified) 29 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) 30 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 31 Proposed restriction: Management plan Requirement for a site-specific management plan in relation to fluoropolymers and perfluoropolyethers when making use of derogations Who Importers and downstream users What Identity of the substances and the products they are used in Justification for the use Conditions of use Safe disposal 32 PFAS - key take home messages a u a : NationalInstitute forPublicHealth 33 KEMI N andtheEnvironment Ministry offlealth,WerfareandSport Sundesanstalt FAr Arbritsschiax and Arlieitsmedizin Swedish Chemicals Agency Norwegian Environment Agency Ministry of Environment of Denmark Environmental Protection Agency Summary PFASs, both unrestricted and restricted, are widely present in humans and the environment Broad group restriction for PFAS - time-limited derogations (RO2) Based on very high persistence and supporting concerns Need for regulatory measures on an EU wide level 4.5 million tonnes of PFAS emissions over next 30 years without a restriction (96% reduction with RO1, somewhat less with RO2) 34 Next steps - key messages Public Consultation 22 March - 25 September 2023 Well-substantiated scientific evidence as input is key 35