Document Vj31rMarVy0nzK28g1Yd4xDDq

The FPP4EU proposed decision tree (food for thought) Marleen Pauwels Executive Director Halogens Industry Sector, European Chemical Industry Council (Cefic) FPP4EU covers a complex sector To group or not to group The decision tree Warm call for collaboration 2 FPP4EU covers a complex sector We are dealing with hundreds of substances with diverging properties, used in many applications across an extended value chain. 3 FPP4EU covers a complex sector Collaboration Platform 90 members Workshops with stakeholders OUR DOWNSTREAM USERS COVER THE MAJORITY OF INDUSTRIAL ECOSYSTEMS!! https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/european-industrial-strategy_en 4 FPP4EU covers a complex sector We are dealing with hundreds of substances with diverging properties, used in many applications across an extended value chain. We wish to be a valued partner in the wide PFAS REACH restriction From the manufacturers' side: Which (type of) data are lacking? Are there questions for us? From the users' side: How can we assist in completing the value chain mapping? We started our own reflection How could PFAS be grouped in the context of a REACH restriction? What elements could be useful in the process of granting derogations? 5 FPP4EU covers a complex sector To group or not to group The decision tree Warm call for collaboration 6 Can grouping work for the wide PFAS REACH restriction? Grouping Subteam Technical Working Group Management Committee (Eco)Toxicology Working Group Advocacy/Comms Working Group Collaboration Platform 7 Can grouping work for the wide PFAS REACH restriction? 8 Kwiatkowski et al, Environ. Sci. Technol. Lett. 2020, 7, 8, 532-543 Can grouping work for the wide PFAS REACH restriction? OECD, 2021 Series on Risk Management No. 61 https://www.oecd.org/chemicalsafety/portal- perfluorinated-chemicals/terminology-per-and- polyfluoroalkyl-substances.pdf 9 Can grouping work for the wide PFAS REACH restriction? Take a glance at this hypothetical situation Chemical class A Chemical class B Non-persistent, no specific hazards identified Acute Tox 4, Persistent, Aquatic Chronic 2 STOT RE 2, Mobile, Acute Tox 4 Acute Tox. 4, Skin Corr. 1A, Aquatic Chronic 3 There are combinations of properties (not just one property) to be considered Our conclusion : Grouping in chemical classes does not help 10 Can grouping work for the wide PFAS REACH restriction? Take a glance at this hypothetical situation Science-based class X Non-persistent, no specific hazards identified Acute Tox 4, Persistent, Aquatic Chronic 2 Science-based class Y Our conclusion : Science-based classes are too complex to be clearly defined FPP4EU covers a complex sector To group or not to group The decision tree Warm call for collaboration 12 FPP4EU supports the idea of a decision tree Does it meet EU NO PFAS definition? OUT OF SCOPE Assessment by authorities with IND/stakeholder input? Stopping points YES Subject to other EU YES Restriction prevails? NO (product) legislation? OUT OF SCOPE NO YES Industrial use only? YES Emissions controlled/ YES YES Workers' safety ensured? ALLOW DEROGATION controllable? NO NO NO YES Safety dossier complete? No unacceptable risk throughout life cycle? NO USE VITAL FOR SOCIETY? YES ALLOW WITH CONDITIONS (as appropriate) NO YES NO Generate data until dossier considered complete ALLOW DEROGATION RESTRICTION WITH DEADLINE 13 FPP4EU supports the idea of a decision tree Does it meet EU NO PFAS definition? OUT OF SCOPE YES Complex and diverse user community The tree follows the definition of PFAS used in the EU REACH restriction process. Breakdown products will also run through this process. Should certain categories of PFAS, either or not combined with specific uses, be covered by their own concept/ decision trees via other associations, we refer to those instead of our proposal. 14 FPP4EU supports the idea of a decision tree Subject to other EU YES Restriction prevails? NO (product) legislation? OUT OF SCOPE NO YES Here we refer to the decision taken by authorities on whether restriction prevails, within the spirit of Better Regulation and `One Substance One Assessment' principles. Green Deal objectives 15 FPP4EU supports the idea of a decision tree Industrial use only? YES Emissions controlled/ YES YES Workers' safety ensured? ALLOW DEROGATION controllable? NO NO NO Complex and diverse user community In the industrial setting, process-related controls exist: focus on industrial emissions (current and future IED-BREF), focus on workers' safety (current and future OSH/ REACH). Examples of industrial use (non-exhaustive list) may include: intermediates only, processing aids, PFAS used in eqGuripemenent (pipes/gaskets/membranes etc.), etc. Deal Such industrial useoPbFAjeScatirveensot intended to end up in consumers products/articles. 16 FPP4EU supports the idea of a decision tree YES Safety dossier complete? No unacceptable risk throughout life cycle? NO USE VITAL FOR SOCIETY? YES ALLOW WITH CONDITIONS (as appropriate) NO Generate data until dossier considered complete YES ALLOW DEROGATION NO Complex and diverRsEeSTDRuEICAsTDeIOLrINNEWITH community When is a safety dossier considered to be `complete'? Company/ consortium prepares the dossier according to EU REACH requirements (including data, data waivers, read-across proposals, testing proposals etc.). `Completeness' will to be confirmed/ rejected by authorities during compliance checks. 17 FPP4EU supports the idea of a decision tree YES Safety dossier complete? No unacceptable risk throughout life cycle? NO USE VITAL FOR SOCIETY? YES ALLOW WITH CONDITIONS (as appropriate) NO Generate data until dossier considered complete YES ALLOW DEROGATION NO Complex and diverRsEeSTDRuEICAsTDeIOLrINNEWITH community Risk assessment As per the EU REACH legal text, it must be assessed whether the substance poses any unacceptable risk to human health or the environment. Risk assessments are linked to function/ use/ exposure patterns and are based on important properties/ features: - Physico-chemical properties, incl. size/molecular weight, physical state, Kow, etc. - Presence in the environment (different media) - Official status of PBT, CMR , ED, ... - Human data, New Approach Methodologies (NAMs) for risk assessment and read-across proposals - Potential emissions throughout life cycle (involving DUs) - Circularity and end-of-life considerations; appropriate disposal 18 FPP4EU supports the idea of a decision tree YES Safety dossier complete? No unacceptable risk throughout life cycle? NO USE VITAL FOR SOCIETY? YES ALLOW WITH CONDITIONS (as appropriate) NO YES NO Generate data until dossier considered complete ALLOW DEROGATION RESTRICTION WITH DEADLINE Use `vital' for society Socio-economic value of the substance in its use and the costs of substitution, evaluated ECHA's Committee for Socio-Economic Assessment, well-informed by the downstream user community no assessment of `essentiality for society'. Over time, the word `vital' may need to be replaced by the word `essential' or `critical'. 19 FPP4EU supports the idea of a decision tree YES Safety dossier complete? No unacceptable risk throughout life cycle? NO USE VITAL FOR SOCIETY? YES ALLOW WITH CONDITIONS (as appropriate) NO YES NO Generate data until dossier considered complete ALLOW DEROGATION RESTRICTION WITH DEADLINE Conditions for derogations Companies/ downstream users can include assessments of (absence of) alternatives. Potential practical implementation timelines will also need to be considered. Societal debates will guide on how to deal, case by case, with (groups of) substances that may pose a health/ environmental risk but remain vital/ essential/ critical for society. 20 FPP4EU covers a complex sector To group or not to group The decision tree Warm call for collaboration 21 Collaboration is our route to piecing together the puzzle Broad range of chemical structures/ properties Complex and diverse user community Green Deal objectives Societal concerns 22 The FPP4EU proposed decision tree (Let's think together!) Marleen Pauwels Executive Director Halogens Industry Sector, European Chemical Industry Council (Cefic)