Document bByMpmGGpEQJO47dK5dk8BZ4Z

Views of FPP4EU on opportunities and challenges of PFAS regulatory measures for the chemical industry Executive Director Halogens Industry Sector, European Chemical Industry Council (Cefic) Covering a complex sector A solution-oriented organisation To group or not to group Call for collaboration 2 Introducing FluoroProducts and PFAS for Europe PFAS are defined as substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I atom attached to it).* * https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b 3 Introducing FluoroProducts and PFAS for Europe Vision - in a nutshell We seek to aid EU policymakers in achieving the ambitions set out in the EU Green Deal. We understand and support the need for balanced regulatory action on PFAS. Aim is to come jointly to a final regulatory measure which: is science-informed, implementable, and enforceable; enables the EU to meet its Green Deal, economic and other policy objectives. Our plans: obtain common understanding of what a PFAS restriction under REACH may look like, support further research and data generation to fill potential data gaps, collaborate and engage in constructive dialogues with all EU stakeholders. 4 The upcoming REACH PFAS restriction Very complex dossier on hundreds of substances with diverging properties, used in many applications across an extended value chain. Exact definition and scope? Will PFAS be grouped? What about `missed uses'? Which (type of) data waiving proposals will be accepted? Stakeholder meetings? 5 Covering a complex sector A solution-oriented organisation To group or not to group Call for collaboration 6 We focus on finding solutions... Management Committee 7 We focus on finding solutions... Grouping Subteam Management Committee 8 We focus on finding solutions... Grouping Subteam Management Committee (Eco)Toxicology Working Group 9 We focus on finding solutions... Grouping Subteam Technical Working Group Management Committee (Eco)Toxicology Working Group 10 We focus on finding solutions... Grouping Subteam Technical Working Group Management Committee (Eco)Toxicology Working Group Advocacy/Comms Working Group 11 We focus on finding solutions... Grouping Subteam Technical Working Group Management Committee (Eco)Toxicology Working Group Advocacy/Comms Working Group Collaboration Platform 12 ... in collaboration with others FPPk.,, EU FluoroProducts and PFAS for Europe Collaboration Platform AEROSPACE AND DEFENCE TOU7ISM . . . . . . . . . AGRI-FOOD s r A IS IS > 60 members Join us ! @cefic.be RETAIL TEXTILE PPOXIMITY, SOCIAL ECONriMY AND CIVIL SECUPITY MOBILITY TRANSPORT AUTOMOTIVE INDUSTRIAL ECOSYSTEMS CONSTRUCTION CU I-TU PAL AND CE4EATIVE INPiJSTKIES IGITAL HEALTH ELECTRONICS ......... ENERGY INTENSIVE INDUSTRIES ENERGYRENEWABLES 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 13 Covering a complex sector A solution-oriented organisation To group or not to group Call for collaboration 14 Upcoming restriction : can grouping work? 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 15 Upcoming restriction : can grouping work? 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 16 Upcoming restriction : can grouping work? 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 Upcoming restriction : can grouping work? 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 18 Upcoming restriction : can grouping work? FPP4EU supports the idea of a decision tree Assessment by authorities with IND/stakeholder input? Stopping points Does it meet EU NO PFAS definition? OUT OF SCOPE 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 19 Upcoming restriction : can grouping work? FPP4EU supports the idea of a decision tree Industrial uses versus PFAS ending up in consumer products/ articles 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 20 Upcoming restriction : can grouping work? FPP4EU supports the idea of a decision tree Risk assessment linked to function/ use/ exposure patterns and 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 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 21 Upcoming restriction : can grouping work? FPP4EU supports the idea of a decision tree Essential uses idea to be considered Companies/ downstream users to include assessments of (absence of) alternatives 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 22 Covering a complex sector A solution-oriented organisation To group or not to group Call for collaboration 23 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 24