Document ZJLv0g4Ng8OeVqaJDbzozxwJp

Q: Do you have remarks on the scope (defini on of the PFAS?) The Dossier Submi ers decided to cover more than 10 000 PFAS substances by grouping PFAS substances on grounds of their structural similari es (primarily related to the alleged "very persistent" property of the substances)1. The used defini on is aligned with the OECD defini on, despite it "does not conclude that all PFASs have the same proper es, uses, exposure and risks" and "is not connected to decisions on how PFASs should be grouped in regulatory and voluntary ac ons"2. In this respect, we do not support this approach, since persistence alone should not be considered sufficient to jus fy a restric on in absence of addi onal classified hazards/proper es (e.g., bioaccumula on, toxicity) and if an unacceptable risk is not demonstrated. However, with this approach, the Dossier Submi ers indirectly assume that all PFAS share the same physchem proper es, hazards and risk profile. Many PFAS substances, however, have different proper es and should be differen ated one from another. Similar conclusions have been derived from a panel discussion on PFAS grouping summarized in a paper by Anderson et al3. which highlights the following: Most experts agreed that "all PFAS" should not be grouped together for risk assessment purposes. Most experts agreed that "persistence" is not sufficient for grouping PFAS for the purposes of assessing human health risk. Most panelists agreed that it is inappropriate to assume equal toxicity/potency for PFAS without confirmatory information. Therefore, it appears that combining 10 000 substances altogether is scien fically incorrect. As a result, the scope of the restric on Proposal is not defined in sufficient detail and is not in line with the requirements of Annex XV. Furthermore, this approach runs counter one of the guiding principles for the prepara on of Annex XV, i.e. enforceability4 . Given the broadness of the defini on, it would be difficult for relevant actors to comply with the restric on, 1 Annex XV PFAS REACH restric on Proposal, p. 21 2 OECD (2021), Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommenda ons and Prac cal Guidance, OECD Series on Risk Management, No. 61, OECD Publishing, Paris. 3 Anderson et al. Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts, 2022. h ps://doi.org/10.1016/j.yrtph.2022.105226 4 ECHA Guidance for the prepara on of an Annex XV dossier for restric ons (2007), p. 66 and consequently, for the enforcement authori es to supervise and enforce the proposed restric on. Addi onally, given the large grouping of substances, the scope of the Proposal is unclear, as defined in by the Restric on Task Force of ECHA . In this regard, it might lead to difficul es for the Commi ees when analysing the stakeholder comments and preparing their opinions which may relate to specific PFAS substances rather than the whole group. Q: Please indicate your sector and describe briefly the Restric on impact/influence on your sector. Sector: Chemical Industry - Manufacturing of Fluoropolymers and F-Gases Impact. All PFAS as per defini on, unless explicitly derogated, will be banned as from July 2027, if above a certain concentra on. Thus, most substances will be completely banned a er a transi on period (if at all). Fluorinated polymeriza on aids used in the manufacturing of PTFE, PVDF and FKM will be directly banned (despite the non-availability of alterna ves). Fluoropolymers are in scope of the restric on proposal. Only on-site isolated Intermediates (monomers) are exempted. According to the current proposal, specific F-gas uses would be subject to either a 18 months transi on period, or 18 months + 5 years deroga on or 18 months + 12 years deroga on, depending on the use considered, resul ng in en re industries faced with the challenge to con nue to supply their products to cri cal sectors such as food preserva on, building insula on, data centers, fire suppressants, medical applica ons or air condi oning in the automo ve sector (including electric vehicle heat pumps) without poten al available alterna ves. Expected impact downstream: For Fluoropolymers in semiconductors (case study automo ve), The European semiconductor manufacturing industry is severely impacted without access to PFA and other fluoropolymers. The removal of PFA from the semiconductor supply chain will directly cost the European economy over 66 billion. Over 21,000 individuals will lose their jobs throughout the supply chain under a non-use scenario Case study for PFA in automo ve (A complete ban of PFA in Europe) Economic contribu ons of 206 billion in profits 100% reliant on semiconductor chip imports Nega ve balance of payments Case study for PFA in automo ve (A complete ban of ALL fluoropolymers in Europe) Could result in cessa on of both industries Resul ng profit losses of 206 billion 1,890 enterprises would likely cease trading and close Total economic loss of more than 439 Bn Euro over the assessment period over the assessment period F-gases are used in a wide array of applica ons. Many of these sectors have long and complex value chain endorsement periods implemented to ensure the safety of operators and consumers alike and may have technical feasibility issues to implement alterna ves. Below are the impact of the ban of F-gases on two cri cal sectors for the European economy responsible not only for employment but also contribu ng to mee ng the European decarboniza on goals. For F-Gases, for example used in mobile air condi oning (MAC) in internal combus on engines (ICE) and heat pumps (HP) in ba ery electric vehicles (BEV): HFOs are used in ght systems as a refrigerant in mobile air condi oning and/or heat pumps in automo ve (in both light and heavy-duty vehicles). The European automo ve manufacturing industry is severely impacted without access to F-gases. The ban of F-gases used the automo ve industry will directly cost the European economy billions of Euros and hundreds of thousands of jobs throughout the supply chain under a non-use scenario. For F-Gases, for example used in in-situ spray foam applica ons (e.g. building insula on): HFOs are used as blowing agents in polyurethane in-situ spray foams used primarily for insula on applica ons. To achieve goals in the European Green Deal and Renova on Wave strategy, in-situ spray foams are essen al for the renova on of Europe's building stock thanks to their low thermal conduc vity meaning it can resist heat transfer resul ng in a lower u-value and a be er-insulated product. The ban of F-gases used in the in-situ spray foam industry will directly cost the European economy billions of Euros and thousands of individuals will lose their jobs throughout the supply chain under a non-use scenario. Q: Do you have specific remarks on the restric on text and its exemp ons. The Dossier Submi ers dis nguish between "sufficiently strong evidence", "weak evidence" and "inconclusive evidence" for each of the proposed deroga ons. The methodology followed is ques onable in as much as those levels of evidence are arbitrary and were not used equally to support the restric on, in certain cases relying on weak evidence to support a transi on without deroga on and in other cases not including informa on provided as part of the First and Second call for evidences. Moreover, the Dossier Submi ers failed to take into account the concept of "essen al use", as this was announced in the 2020 Chemical Strategy for Sustainability ("CSS"), and the PFAS restric on was envisaged there as a kind of case study for the concept. Similarly, the Dossier Submi ers have not proposed a deroga on for transported isolated intermediates. Although not explicitly provided in REACH, prac ce leans towards allowing for this deroga on. In fact, there are examples for which RAC proposed to exempt from a restric on transported isolated intermediates used under strictly controlled condi ons (e.g. PFOA and PFHxA). Addi onally, we would like to comment on specific Dossier Submi ers' claims, listed in the table below: Dossier Submi ers' claim Our view of the claim PFASs should be managed together as a group Very persistent chemicals should be regulated on the basis of their persistence alone It is not possible to demonstrate safe use of PFASs Emissions are a proxy for risk F-gases are in scope of the Dossier Submi ers proposal Deroga ons are based on the availability of alterna ves Physchem proper es, hazard classifica on and risk profile of individual PFASs are different, as well as exposure/emission pa erns. A grouping approach is therefore ques onable Persistence alone should not be considered sufficient to jus fy a restric on in absence of addi onal classified hazards/proper es (e.g., bioaccumula on, toxicity) and if an unacceptable risk is not demonstrated Safe concentra on levels have been derived for Chemours Substances requiring a risk assessment The F-gas regula on (EU 517-2014) foresees specific measures for emission control and reduc on, hence the risk is adequately controlled. F-gases risk to be double regulated in Europe (Fgas regula on) but also globally (Kigali amendment to the Montreal Protocol) Tradeoffs of alterna ves are not clearly discussed (flammability, toxicity, energy efficiency,..) 5-year and 12-year Restric on op ons are proposed Unclear whether destruc on and recovery of F-gases fully prevent emissions of fluorinated substances in these waste treatment processes Restric on op on meframes are defined without taking into considera on the specifici es of each applica on Recovery, recycling and Reuse (RRR) of F-gases are provisions already set in the F-gas regula on, guaranteeing the circularity of Fgases. Moreover, the restric on proposal does not assess the poten al impact of a restric on on the achievement of the EU Green Deal objec ves in the framework of the Socio economic and cost benefit analyses. F-gases are essen al to achieve key ini a ves under the European Green deal, such as: EU building decarboniza on, sustainable mobility, Fit for 55, REPower EU and farm to fork. Are you concerned by an exemp on? We are concerned by most of the fluoropolymer and F-gas restric on op ons. both enable a broad array of diverse applica ons and deroga ons will create catastrophic disrup ons throughout the different value chains ul mately impac ng the European consumer. This complexity implies that applica on needs to be reviewed on a case-by-case basis. As an example, for fluoropolymers, the Dossier Submi ers have proposed a deroga on for fluoropolymers used in the proton exchange membrane ("PEM") into fuel cells applica ons for 6.5 years a er the entry into force. However, they have not considered the deroga on for PEM in electrolyser for hydrogen produc on. Without the la er, the deroga on may be deprived of its effetu le, namely devoid of its prac cal applica on. As an example for F-Gases, in the automo ve industry, for already developed vehicles, a transi onal period of 15 years is needed un l the end of the produc on of these vehicles. A re-development of these vehicles is not possible from a technical and economic point of view. If alterna ves have been iden fied as poten ally suitable, for new vehicles whose development begins today would be on the market in 6 - 7 years (for trucks 10 -12 years) at the earliest. Under this condi on the suppliers would need to be prepared to produce poten ally unique components on an industrial scale, where the development meline is not included above. If yes, is the ming foreseen reasonable for your sector? Assuming entry into force of Annex XVII in January 2026 +/- , all PFAS as per defini on, unless explicitly derogated, will be banned as from July 2027, if above a certain concentra on. Most substances will be completely banned a er a transi on period (if at all). Given the short meframe, should the proposal materialize in its current form, the lack of alterna ves in many applica ons and unrealis c meline will cause significant effects on the market. (see AoA and other sec ons for more details) Defining 12 years as the me necessary for a new technology to be invented, developed to a commercial product, tested and implemented on a wide industrial scale does not take into account the complexity of the F-gas sector and its value chain. The deroga on period should be specific to allow the development of alterna ves for each applica on, taking into account the complex and lengthy approval processes needed to ensure safe use and avoid disrup on throughout the complex value chain. Have you conducted an alterna ve assessment that indicates that the proposed ming is reasonable or not? Fluoropolymers are specialized high end performance plas cs that bring unique combina on of proper es thanks to their C-F bond. They are expensive to manufacture and process them further. Should viable alterna ves exist the market would have transi oned due to economic incen ves already. This makes fluoropolymers substances of necessity rather than choice. For Fluorinated polymeriza on aids for the manufacturing of PTFE, PFA among others the development of alterna ve technologies, as effort to improve the overall processes is a con nuous effort. No alterna ves were iden fied so far as the usage of non-fluorinated polymeriza on aids would lead to the forma on of PFAS impuri es and/or ar cles not mee ng required standards. For PFA in semiconductors. No alterna ves meet the necessary technical feasibility and performance criteria. There are no alterna ves iden fied, and such alterna ves may never be iden fied. Poten ally R&D on alterna ves Subs tu on may require +10 years and 40 years for the process to the current level of manufacturing capacity. The required purity can only be met with TeflonTM PFA. The Purity requirements will con nue to decrease as die sizes decrease. Without TeflonTM PFA the ability to produce semiconductor components and infrastructure would not be possible. Significant effects throughout the supply chain and knock-on effects throughout other industries are expected. Hydrogen economy. Currently no viable alterna ves to fluoropolymer PEMs are available that can deliver performance requirements equivalent to NafionTM. F-Gases, used in mobile air condi oning (MAC) in internal combus on engines(ICE) and heat pumps (HP) in ba ery electric vehicles (BEV): To date, research has shown that HFO refrigerant technology, in par cular HFO1234yf, provides the safest, sustainable (from a global LCA perspec ve), and economical solu on for both tradi onal mobile air-condi oning as well as heat pumps, in the case of BEV. Several alterna ves were screened and most were rejected on the basis of either flammability such as propane), toxicity (ammonia) or rela vely high GWP and poten al to degrade to TFA. A poten al alterna ve might be CO2 (R-744), however, our assessment indicates that adop on of R-744 as a refrigerant in MAC in ICE vehicles and HP in BEV will result in decreased performance and efficiency at high ambient temperatures, making it technically or economically not feasible in hot climates. Par cularly in BEVs, the use of R744 could result in an increase of thermal runaway events, pu ng users at risks and reducing the longevity of ba eries. The European Green Deal, presented in 2019, has promised to reshape the European Union into a resource sustainable economy and be carbon neutral by 2050, while reducing greenhouse gas emissions by 55% in 2030. In the automo ve industry, the Fit for 55 ini a ve requires all cars or vans placed on the market from 2035 to be zero-emission vehicles. Similarly, the Sustainable and Smart Mobility Strategy aims to have at least 30 million zero-emission vehicles in opera on on European roads by 2030. Without the use of BEVs, it will not be possible to achieve these targets. In addi on, the RePowerEU plans to make Europe independent from Russian fossil fuels before 2030 following the Russian invasion of Ukraine. Without the use of HFOs to support the transi on to BEVs, and without a sufficiently long implementa on period that can support the supply chain to the move to an alterna ve refrigerant, it is difficult to envision how these goals will be achieved. F-Gases used in in-situ spray foam applica ons (e.g., building insula on) To achieve goals in the European Green Deal and Renova on Wave strategy, insitu spray foams are essen al for the renova on of Europe's building stock. A few alterna ve blowing agents and insula on technologies were explored, and their performance was compared against F-gas blowing agents and insula on products. A number of these alterna ves were rejected before a thorough assessment based on their flammability and toxicity ra ngs (propane and methyl formate), thermal resistance, and structural integrity (water and cellulose). The shortlisted alterna ve was rock wool and glass wool (mineral wool), which is not a blowing agent but an alterna ve insula on technology. The insula on performance of foams produced using HFOs is nearly double those of mineral wool, glass and rock wool. This means that a larger quan ty and thickness of mineral wool needs to be used to achieve the same insula on value, which is not always feasible, par cularly in renova ons. Also, the mineral wool technology requires an addi onal vapor barrier, which is not the case with in-situ spray foam.