Document LJpqJK6Re6kRk22MJOMn2zaZw

Apr 25, 2023 Comment on Proposed Restriction of PFAS Conference of Fluoro-Chemical Product Japan (FCJ) On behalf of chemical manufacturers, we, Conference of Fluoro-Chemical Product Japan (FCJ). have been working tirelessly to comply with national chemical regulations. We have supported EU's ambitious attempts to reduce fisks from hazardous substances and have sincerely responded to actual measures to meet the requirements of EU chemical regulations such as REACH. However, we believe that the proposed restriction of PFAS (Per- and Polyfiuoroalkyl substances) proposed by 5 European countries is an excessive measure because it restricts more than 10,000 of organofluorine compounds (PFAS) on the grouping basis that they are persistent as substancesof concern equivalent to the already regulated PFOS and PFOA. Therefore, we intend to present the following views at the public consultation of ECHA, to whichis one of the actions FCJ recommends. (1) Concerns about inconsistencies in the proposed restriction Article 68 (1) REACH refers to the scopeofthe restrictions, which regulates unacceptable risks to human health or the environment that need to be addressed by society as a whole. The proposed restriction lists persistent chemicals (which may remain in the environment longer than any other man-made chemical), bioconcentration, mobilty, the possibilty of long-distance transport, accumulation in plants, the possibilty of global warming, and toxicological effects as concerns and reasons for the restriction. Of these, persistent is `applicable to all targeted organofluorine compounds (PFAS), but other concerns are related to some compounds. Persistency common to all organofiuorine compounds (PFAS) can be rephrased as "high durabilty" by focusing on its advantages, however, we believe that itis not appropriate to regulate this property alone as an unacceptable iskto human health or the environment. In `addition, itis not appropriate to apply the concerns about some fluorinated compounds, such as bioconcentration potential and toxicological effects, by grouping all organofuorine: `compounds (PFAS) together, and ifthe need for new regulations is to be considered in the future, the risk of each substance should be quantitatively assessed and discussed. Hereafter, we respectfully submit our views on the proposed Restriction of PFAS and `express its concerns that restriction would contravene the applicable European and international rules and agreements for the following reasons: 1. The proposed Restriction would hinder the achievement of the European Green Deal PFASs have properties such as repelling water and ol, being resistant to heat, chemicals, `and not absorbing light, and have been widely used in water repellents, surface treatment agents, emulsifiers, fire extinguishers, coatings, etc., and in a wide range of industrial applications such as semiconductors, automobiles, and batteries. Manyofthese applications and uses are considered "essential uses". `The applications in which PFAS are used are also ical or the European Green Deal ~ that is comprehensive initiative that includes a range of policies in different areas aiming at make Europe climate-neutral by 2050. For example, the Horizon Europe program funds research `and innovation activities in transportation, including batteries, clean hydrogen, low-carbon steel manufacturing, the cyclical bio-based sector and the built environment. We therefore: believe that the proposed blanket Restriction of all PFAS for all uses, including uses that are criticatol the European Green Deal, would essentially hamper the achievement of European Green Deal objectives. 2 The proposed Restriction would significantly and disproportionately hamper intemational trade Ifthe proposed Restriction is implemented as currently announced, trade in essential goods in which PFAS are used would be considerably restricted and supply chains around theworld would be severely disrupted. In our view, evenif alternative substances are currently being developed, these would need to go though repeated demonstrations and evaluations and therefore they would take considerable time before they can be implemented. Moreover, for substances for which no alternatives have been identified yet, research and development will have to be promoted through tial and error in the future, and even a 12 year grace period may not be sufficient to confirm their availabilty. The serious and disproportionate negative effectsofthe proposed Restriction on ntemational rade could also constitute a violation of the proportionality principle as enshrined in Afticle 668(1) REACH. In particular `The proposed Restiction is disproportionate, contrary to Article 68 (1) REACH. Article 68(1) REACH requiresthatany restriction decision shal take into account "the socio`economic impact of the restriction, including the availabilty of alternatives". That socioeconomic impact may, among others, include, in accordance with Annex XY. i the impact of the restriction on the industry (e.g. manufacturers and importers) and on al other actors in the supply chain in terms of commercial consequences, including impact on investment, operating costs and innovation; i) the wider implications on trade, competion and economic development; i) alternative risk management measurements that could mest the aim of the proposed restriction and iv) the availabilty of stable and feasible alternatives. The proposed Restriction does not appropriately consider those elements of the socioeconomic impact and fails to balance the negative impact on interational trade and the Industry with the potential benefitsof the proposed measure. I rather proposes a blanket restictionofall PFAS substances for all uses (beyond some transitional periods for specific uses/applications) that goes well beyond what is necessary to achieve the legitimate objectives t pursues, and is not the least onerous measure tocontrol the potential risks posed by certain PFAS. In particular, the Proposed Restriction fails to conduct a substantial assessment of the "availability of altematives" including: i) where altematives have been identified, these must be compared as to their isks and benefis to the substances proposed to be restricted and ii where alternatives are not yet available, the risks of the continued use of the substances proposed to be restricted should be compared with the socio-economic consequences of them no longer being available and of the lack of available altematives. In light of the above, we request that the EU limits the scope of the restriction to the extent necessary to achieve the objectives that contribute to the social economyofthe EU. In that regard, we also request that if the restriction remains as itis, that the EU consideras review clause" that would enable the extension of the transitional periods in case suitable alternatives have not been developed by the given review date. 3. The proposed Restriction restricts al PFAS as a single group. In folowing this grouping approach, the proposed PFAS Restriction would restrict PFAS that have not been risk-assessed and for which an unacceptable risk has not been demonstrated, in breachofArticle 68(1) REACH. Article 68(1) REACH provides that substance(s) can be restricted only if they pose an unacceptable risk to human health or the environment. This unacceptable risk must be positively demonsbytcronaducttiengda risk assessment thatfollows the conditionsofAnnex XV to REACH (and by cross-reference of Annex | and Annex XI. Such risk assessment comprises hazard identification and characterisation, exposure assessment and. risk characterisation. By grouping all various PFAS substances together and restricting them as a single class, the proposed PFAS Restriction Proposal would restrict numerous PFAS substances that have not been risk-assessed and for which no unacceptable risk has been demonstrated, in breachof Article 68(1) REACH. More specifically, the scope of the proposed PFAS Restriction is based on the OECD definition of PFAS. That definition is only based on chemical structure and does not take into account hazardous properties or fisks of PFAS, as the proposed Restriction itself acknowledges (p. 19). As a result, it covers approximately 10,000 substances with very diverse physical, chemical and biological properties and behaviour. That broad definition does not take into account the specific, distinct properties of different individual PFAS or PFAS subgroups and is therefore not suitable for regulatory risk management purposes. `OECD itself acknowledges that this definition "does not conclude that all PFASS have the same properties uses, exposures and risks" and that it can only serve a starting and reference point as it `may be viewed as too broad" (OECD, 2021, Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance). In particular, the very broad scope of proposed Restriction --which is based on the OECD PFAS definition- does not enable a legally and scientifically sound risk assessment. By `grouping all PAS together in a single group for risk assessment, the proposed Restriction fails to identify and consider the specific, distinct properties of each individual PFAS of PFAS subgroup and, in tum, to assess and characterise the hazards and risks related to those properties in order to demonstrate that they pose an unacceptable risk to human health or the environment It rather restricts all PFAS substances on the assumption that they all share a very persistent property as their "key hazardous property" that triggers equivalent hazards and risks"(p.2122). However, (very) persistence is not per se a hazardous property nor does it indicate a risk on ts own. Persistence on its own is also not sufficient to consider PFAS as giving an "equivalent level of concern" to PBTS/VPVBS or to characterise an "unacceptable risk" within the meaning of Article 68(1) REACH and justify a restriction. It is for those reasons that persistence is only regulated in combination with other properties in the REACH and CLP Regulation (e.g. together with bioaccumulation, toxicity or -under the new hazard classes introduced to the CLP Regulation- moby), and not alone. Beyond PAS' purported very persistent property, the proposed Restriction does not identity any other hazardous properties that are common to all PFAS. It only refers to some additional properties that amplify the "overall concern" for some -not all- PFAS. Indeed, the Proposal contains evidence that concerns only certain sub-sets of PFAS (mostly some long-chain PFAS) and lacks data on ther PFAS substances/subgroups and an adequate justification as to why the conclusions for certain PFAS would be applicable to all PFAS covered by the proposed Restiiction (read-across). For example, the proposed Restriction acknowledges that "for the majority of PFAS no, or insufficient, data on bioaccumulation behaviour are available" and therefore that the "data on the bioaccumulation potential of PFAS [.] are not sufficient to substantiate bioaccumulation in the environment or all PEAS" (.28). With respect to ecotoxictty, it mentions that `the large: number of different substances with heterogenous properties [...] in the group of PFAS makes the assessment of their ecotoxicity very complex'(p.28). It then concludes that the bioaccumulation potential and (ecoloxicity is expected to vary among PFAS due to their "high diversity" and that "no overall conclusion on BVD and T criteria was derived for each PFAS substance! (sub-) group' (p. 47). In the absence of (sufficient) evidence, the proposed Restriction fails to conduct a risk assessment, comprising a hazard assessment and characterisation, exposure assessment and risk characterisation, to demonstrate an unacceptable risk posed by all PFAS substances proposed to be restricted. For example, in some applications, PFAS may be used in enclosed spaces, where exposure to the environment is extremely limited and the risk to human health and environmental conservation is even less. It is also possible that by not characterising the specific isk(s) each individual PFASIPFAS subgroup poses that the proposed Restriction would lead to the replacement of those PFAS with non-PFAS alternatives that could be potentially more harmful to human health and the environment (regrettable substitution). Evenif certain PFAS wouldbe demonstrated to pose an "unacceptable fisk to human health or the environment" within the meaning of Article 68(1) REACH, this cannot lead to the conclusion that all PFAS pose such an unacceptable isk, without considering their varying properties and behavior. 4. The proposed Restriction could not be lawfully based on the precautionary principle Article 68(1) REACH requires positive demonstration that there "is" an unacceptable risk. It is therefore not intended as a tool to address scientific uncertainties, as its the case with the precautionary principle. Therefore, the proposed Restriction thatis largely based on scientific uncertainties (e.g. `lack of toxicological data for the vast majority of [PFAS]'(p.32); * for most PFASs there are insufficient data to adequately assess their effects on human health and the environment" (p.13); "for the majority of PFASs no, or insufficient, data on bioaccumulation behaviour are available" (p. 28) would not meet the requirement of Article: 68(1) REACH to demonstrate an unacceptable risk. In the alternative, even if the proposed Restriction applies the precautionary principle (although it makes no mention of it,itmust had nevertheless met the conditionsof EU case law, as summarised in the Commission Communication on the precautionaryprinciple,which itfaled to do. In particular: According to settled EU case law (e.g. T-584/13), the precautionary principle is "a general principle of EU law requiring the authorities [..] to take appropriate measures to prevent `specific potential risks to public health, safety and the environment [..J". It should be used where "there is scientific uncertainty as to existence or extent of risks to human health or the environment...) While the risk assessment in the context of the precautionary principle is "not required to provide [...] conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to becomea reality", "a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified" (our emphasis). However, the proposed Restriction lacks evidence of effects, and especially, of effects that are adverse. Indeed, as the Proposal itself acknowledges "for most PFAS there are insufficient data to adequately assess their effects on human health and the environment' (p. 13) and that"i releases are not minimised, humans and other organisms wil be exposed to progressively increasing amounts of PFASS until such levels are reached where effects are: likely" (p. 50). In the same vein, the Proposal also mentions that `it is more likely that for the vast majority of these substances, no study data are available to serve asa basis for classification. In the absence of evidence to the contrary, it can therefore be assumed that `some of the less well-studied PFAAS and PFAA precursors also exhibit one or more of the properties of concern.'(p.30). Moreover, the persistence and accumulation of PFAS in the environment that the proposed Restriction mainly relies on, cannot be construed as adverse effects per se. The Proposal is therefore based merely on unsubstantiated assumptions. In addition, the proposed Restriction fails to meet the following conditions for the implementation of the precautionary principle set out in the Commission Communication on the Precautionary Principle (Communication from the Commission on the precautionary principle. Brussels, 22.2000 COM(2000) 1 fina) - Before the adoption ofa precautionary measure, there must be first a scientific risk `assessment, comprising four steps, namely hazard identification, hazard characterisation, appraisal of exposure and risk characterisation. In our opinion one could demonstrate that these four steps have not been followed in the PFAS Restriction Proposal. The alleged hazards of the PFAS have not been established and, likewise, thereis litle on the actual exposure to PFAS. These elements have rather been postulated on unsubstantiated `assumptions. In the absence of reliable information on hazard and exposure, there is no basis on which to characterise the risk, and therefore to conduct the required scientific risk `assessment forthe application of the precautionary principle. - The precautionary measure must be proportionate, non-discriminatory and consistent with similar measures, based on examinationof the potential benefits and costs. In our opinion, the proposed PFAS restriction could be demonstrated to be disproportionate and not the least restrictive measure that can be taken to address any PFAS-related concerns because i it restricts the entire class of PFAS for all applications on the basis of mainly a "persistency concern'; i) it does not sufficiently assess the risk and suitabilty of allegedly available alternatives, and ii) it does not (adequately) assess the socio-economic impact of such broad restriction against the alleged "significant benefits" ofthe restriction. - The Proposal must identify the measures that need to be taken in order to clarify the uncertainties that could justify precautionary measures. In particular, "measures based on the precautionary principle should be subject o [..] to review in the light of new scientific data." In that respect, the Proposal does not propose measures that could be taken to resolve the uncertainties it identifies -- it rather proposes a total, blanket ban of all PFAS for all `applications (beyond some transitional periods for some applications). 5. The proposed Restriction would restrict substances without isting them contrary to Article 68(1) REACH Article 68(1) provides that substances that pose an unacceptable risk to human health or the: environment could be the subject of a restriction. Article 68(1) restriction should therefore: identify the substances proposed to be restricted. Annex XV, Section 3 of REACH also specifies that the restriction "shall include the identity of the substance [..J'. Such identify should be chemical specific, including name, identification numbers, molecular and structural formulas, ete. Indeed, REACH defines a "substance" as "a chemical element and its compounds" (Article 3(1) REACH). Thisis also clearly reflected in the European Chemicals Agency (ECHA) Guidance fo the preparation of an Annex XV dossier (p. 108) that specifies that the restriction proposal must provide "details on the identity of the substance (name, CAS, EC number, registration number (if available), molecular formula, structural formula, purity and impurities)". In light of the above, the proposed Restriction fails to adequately identify and list the specific chemical substances proposed to be restricted. Instead, it prohibits the manufacturing, use or placing on the market of any substance "that contains at least one fully fluorinated methyl (GF3) or methylene (-CF2-) carbon atom, without any HICIIBrl attached to it" (p.4). Itdoes not provide the names or identification numbers of the specific substances that are covered by this broad definition, as required. (2) Exclusion by PFAS Sub-category(substance) As mentioned in (1), a classofcompounds (PFAS sub-category) having widely different properties, such as fluoropolymers and fluorinated gases, are all grouped as PFAS and subject o restrictions. On page 16 of the report, citing the OECD report, PFAS are subcategorised into 4 major categories and 30 middie categories. B.3 Classification and labeling and B.4 Environmental fate properties in the Annex B report and are evaluated based on these sub-categories, respectively, and we believe that isk can be more `appropriately assessed by sub-categorising rather than grouping as PFAS. For example, fluoropolymers are thermally, biologically, and chemically stable, barely soluble in water, immobile, insoluble (Water, Octanol, etc.), and too large to migrate to cell membranes, so they are not incorporated into the body and are considered low concern from a human and environmental health perspective'. The findings demonstrate that fluoropolymers are a distinct group from PFOA and PFOS and should not be combined with them for hazard assessment or regulatory purposes. Fluoropolymers are the only materials that simultaneously possess heat resistance, weather resistance, chemical resistance, water repellency, lubricity, and unique opticallelectical properties, and they have become indispensable materials in many fields, including the energy field (Fuel cells and lithium-ion batteries), semiconductor field (Clean members, etching gas), electrical and electronic: `communications field (Wire cladding and liquid crystal materials), transportation field (Cars, airplanes, railroads), and medica field (Catheters, protective clothing). Its necessary to carefully re-examine whether the uniform regulations for PFAS are appropriate in light of the chemical hazards and risks of the substances in question. In particular, fluoropolymers `should be excluded from the current regulations because they re highly stable materials `and have no concerns about bioconcentration or toxicological effects. Fluorinated gas is a highly safe compound in terms of toxicity and combustibity, and itis used in many applications in terms of eficiency and cost. In addition, fluorinated gas itself is not persistent in the persistent properties proposed in the PFAS restriction proposal. In `addition, trifluoroacetic acid, which is a degradable productoffluorinated gas itself and is a concer in the proposed restriction, has also been shown to pose a low risk oftoxicity to living organisms and human bodies in the reports of the Environment AgencyofGermany `and Norway, who actually submitted this restriction proposal. These results indicate that fluorinated gas should not be considered for regulation as a groupwith PFOA and PFOS. In addition, the reduction of fluorinated gas usage is being considered in the F-gas regulations, and from the standpoint of dual regulations, we do not believe that it should be considered in the PFAS regulations. Reference: 1: Barbara H et a. Integrated Environmental Assessment and Management, Vol14(3), p316-334. https: /isetac onliwilney.ecomildoifbfulri10.a100r2/ieyam. 4035 2: Stephen K et al, Integrated Environmental Assessment and Management, Vol19(2), p326-354 https:/isetac onlinelibrary wiey.comidoi10.1002fieam 4646 3: German Environment Agency, Reducing chemical input into water bodie--s triluoroacetate (TFA) as a persistent and mobile substance from many sources, 2021 4: Norwegian Environment Agency, Study on environmental and health effects of HFO refigerants, 2017