Document k9284KGjR2wqdQDZ50Xp3nx2E

Ad-Hoc open BCR Meeting -- PFAS Restriction - 28/02/2023 in FPS premises 1. Please fill in this questionnaire if you want to present a topic during the Ad-Hoc PFAS meeting : The document should be send back before 13th March 2023 to: @health.fgov.be (health.fgov.be and Cc: It will help us to frame the agenda and organize the discussion on this large restriction. 2. Your presentation should be shared with the Authorities ( M@health.fgov.be and Cc: health.fgov.be ) no later than the 20th March 2023 . The presentation should be maximum 5 slides ( the time allowed to each stakeholders will be 10 min max ). 3. The final agenda will follow before the meeting including a Teams link to follow the discussion remotely. Registration is mandatory, not registered stakeholders will not be admitted in the room or online. Questionnaire to send back to the BCR secretariat before the 13 March 2023 Do you have remarks on the scope (definition of the PFAS ?) The scope is too broad. It should differentiate on the basis of the different properties and hazard profiles of PFAS. PFAS are not all the same: o The dossier does not reflect the differences between substances that can be considered PFAS. It is based on structural similarities and not the differences in their properties. o Due to their different properties PFAS do not exhibit the same environmental and toxicological profiles. For example, fluoropolymers like PTFE have properties that are predictive of low hazard: they are non-toxic, not bioavailable, non-water soluble and non-mobile molecules. o By grouping all PFAS with widely varying properties and hazard profiles the report has generalised the whole PFAS family, making the restriction a blunt regulatory instrument that will be difficult to implement and have unnecessary socio-economic impacts. o In addition, by not making a preliminary segmentation of PFAS into sub-groups, the result is a proposal which is not scientifically sound. o The proposal should regroup substances that present similar toxicological and ecotoxicological concerns. Please indicate your sector and describe briefly the Restriction impact/influence on your sector. The Fluoropolymers Product Group (FPG) , part of Plastics Europe represents Europe's leading fluoropolymer producers and experts and its members are 3M, AGC, Arkema, Chemours, Daikin Chemicals, DuPont, W. L. Gore & Associates, Gujarat, Honeywell, and Solvay. The PFAS REACH restriction directly affects fluoropolymer manufacturers. In all but a small number of applications, the dossier submitters propose that the use of fluoropolymers be banned in the coming years.  Fluoropolymer resins are produced and sold worldwide. They have found application in nearly every field of modern industrial, technological, and scientific endeavour. In applications ranging from power generation to emission controls on vehicles to semiconductor manufacture to aerospace, fluoropolymers provide superior performance in products that contribute to increased safety in offices, homes, industries and communities. Of the many properties that characterise fluoropolymer resins, one of the most important is the resistance to heat. While few plastic materials have continuous service temperatures much above the boiling point of water, fluoropolymer resins can withstand the temperatures in the engine compartments of jet aircraft. Heat resistance and a combination of resistance to a broad range of fuels, solvents and corrosive chemicals, and excellent dielectric stability means fluoropolymer resins yield an extremely versatile family of engineering materials. These unique properties may provide certain essential performance characteristics needed in the event of fire, in fluid containment or exclusion, electrical overload and similar emergencies. Due to the general inertness of the fluoropolymer resins, they fall outside all definitions of hazardous materials within European transport regulations and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. - Do you have specific remarks on the restriction text and its exemptions (derogations). Are you concerned by an exemption? We are manufacturers of fluoropolymers, so directly affected by a ban on their use in applications in the coming years (whether they have time-limited derogation or not). The PFAS proposal also does not provide for a derogation of key PFAS monomers used in fluoropolymer manufacture, meaning all fluoropolymer manufacture will cease within 18 months of the entry in to force of a restriction. Furthermore, based on the state of the art of fluoropolymer technology the derogation for polymeric processing aids should be extended to PTFE. As it stands, the proposal provides a derogation for the continued use of polymeric processing aids (6.5 years ) but it excludes PTFE, PVDF and FKM on the basis of very limited data about the viability of alternatives. The conclusion that fluoropolymers such as fine powder PTFE can be manufactured to the same standard without PFAS-based polymerization aids for all applications included in the proposal is false. This could have serious socio-economic consequences e.g. impacting the quality and performance of medical devices and other critical equipment. We are also concerned that important sectors where fluoropolymers are used today are not even included in the time-limited derogations and more are targeted for immediate ban (18 months after entry into force of the restriction). Examples of missing applications include, the chemical process industry including chloro-alkali processes, water and atmosphere purification, water electrolysis, energy/hydrogen storage, applications in pharmaceutical manufacturing equipment, electronics, aerospace, military & defense, transportation, semiconductor manufacturing and high-end niche applications. If yes, is the timing foreseen reasonable for your sector? We do not believe the proposed derogations, or lack of a derogation is reasonable. Regarding timing, we are concerned that the transition periods for the time limited derogations are not substantiated by a strong evidence base, appear to be arbitrarily chosen and in many cases are insufficient. The proposal should be revised to include realistic and well substantiated transition periods based on the realities of the industries in question and the technologies to be substituted. Have you conducted an alternative assessment that indicates that the proposed timing is reasonable or not? We are working with the value-chain to ensure this information is provided to the ECHA public consultation in the coming months. However, it is also important to note: The dossier submitters argue the availability of alternatives justifies their proposed phase-out of PFAS. The dossier however provides little to no evidence about what these alternatives are. As such ECHA and stakeholders are unable to assess the alternatives against the PFAS they are meant to replace. If a scientific and socio-ecomomic analysis is going to be conducted by ECHA the proposal should provide detailed information on alternatives. The ECHA guidance on socio-economic analysis for REACH restrictions clearly states information on alternatives should cover: "Availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned."