Document yr4x0yDyBXEerorYY8qyBy2D6

Comments on ECHA's proposed restriction for PFAS Director, Material Industries Division, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry of Japan is closely following ECHA's proposed resiriction for perfiuoroalkyl compounds and polyfiuoroalkyl substances (PFASS), published on March 22, 2023, and submits the following comments for consideration and appropriate action. Combining water and oil repellency, heat resistance, chemical resistance and non-light absorbing properties, PFASs are widely used as water repellents, surface treatment agents, emulsifiers, fire extinguishers, coating agents, high-performance resins, elastomers, refrigerants and electrical insulators. And as fluoropolymers, fluoroelastomers and fluorine gases, they are used in a wide range of industrial applications including semiconductors, automobiles, electrical and electronic equipment, batteries, refrigeration and air conditioning equipment, solar photovoltaic energy system, social infrastructure equipment (medical equipment, industrial monitoring, control, analysis, measurement equipment, etc.), and primary packaging containers for pharmaceuticals. In many cases, PFASs are used in fields that are important and essential for maintaining the functioning of society" Allowing the use of PFASS to an appropriate extent is also important for achieving the objectives of the European Green Deal, a comprehensive initiative involving a series of policies in various sectors aimed at making Europe climate neutral by 2050. In particular, the Horizon Europe program will promote research and innovation on transport, including batteries, clean hydrogen, low-carbon steel making, circular bio-based sectors and the built environmentZand PFASs are widely used as non-substitutable substances in these areas as well. Therefore, we consider it important to maintain the use of PFASs for critical applications in order to achieve the objectives of the European Green Deal. 1. Appropriate risk assessment (1) Paragraph 1 of Article 68 of the REACH states that the REACH shall introduce new restrictions or amend existing restrictions where there is an unacceptable risk to human health or the environment that needs to be addressed. The current proposalto restrict PFASs (the "Proposed Restriction") does not fulfil the requirements of Paragraph 1 of Article 68 of the REACH in that ituniformly covers all PFASs including PFASs which do not pose significant risk to human health or the environment, as explained in the following. (2) The Proposed Restriction considers all PAS as a single group. It justifies this grouping based on the structural similarity that all PFASS have very persistent property of the perfluorinated parts in their molecules. However, each individual PFAS or PFASs subgroups have different physical, chemical and biological properties, and have different usage, the hazards and risks are different for PFAS by PFAS. Moreover, the terminal degradation product of the environmental degradation of PFASs are not common for all PFASs. Therefore, it is not reasonable to consider PFASs as a single group for regulatory risk management purposes. E1 sEsuenrtoipaelaUnsCeoCmomnicsaspito,n,hiMpas:r/cohp.2e0u2r3o,paF.ienaulleRne/ppourbtl-iScuaptipoonr-tdientgatlhle-/Cpoumbmliicsasliioonn/i6n9Dd5eevae0ldo-pdi3n5g9-a1ned-a05c=0tEaua7r5oepde7atnatCaonmgumaidses-ieonn/,ioCromamlm-uPnOiFcsatoiuorncfero-m2t8h3e6c3om5m1i8ss9ion-The European Green Deal, hitps:eur: lex.europa,euflegal-conteni/ENTTXT/urizcelex%3A52019DCO640 1 (3) The definition of PFASS to be in the scope of the Proposed Restriction is consistent with the OECD definition of PFASs, which refers only to chemical structure. However, it should be noted that the OECD itself has stated that "[the general definition of PFAS] also does not conclude that all PFASS have the same properties, uses, exposure and risks. ** (4) The Proposed Restriction explains that the EU experience has shown that if PFASs are regulated individually or in specific groups, they can be expected to simply be replaced by slightly different but similarly risky PFASs that are not subject to restriction and therefore it is necessary to regulate "all PFASs with equivalent hazards and risks in a single restriction proposal, to avoid... replacement by other PFASS".* However, this explanation s erroneous in its assumption that all PFASs have equivalent hazards and risks. The hazards and risks of PFASs are diverse, and the risks of substitution can be avoided by regulating those PFASS that pose "unacceptable risks to human health or the environment". Therefore, the Proposed Restriction that covers all PFASs including PFASs with no significant risks in the scope of regulation is not justified. (5) Annex XV of the REACH states that "the risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex | and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report". However, as for the Proposed Resriction, such a process has not been followed for individual PFAS or PFASS subgroups involving the diverse physical, chemical and biological properties. The assessment of the hazard and risks required by related provisions of REACH is not adequately conducted. (6) Although the Proposed Restriction refers to the persistence of PFASs, it is not reasonable to conclude that a substance poses risks to human health or the environment only because it has the propertyofhigh persistence. The risksof a chemical substance should be assessed not only on the basis of the magnitude of its persistence, but also on the basis of its other hazards such `as human health effects or ecotoxicity. Even if a substance has the propertyofhigh persistence, when it has no other harmful effects, a conclusion of risk assessment will not be that there is an "unacceptable risk to human health or the environment. It is not reasonable to conclude all PFASs involve "unacceptable risk to human health or the environment" without assessment of the properties of individual PFAS other than persistence. The Proposed Restriction also acknowledges that "for most PFASs there are insufficient data to adequately assess their effects on human health and the environments (7) While the Proposed Restriction may take into account the precautionary principle, Paragraphs 2and 3 of Article 191 of the Treaty on the Functioning of the European Union (TFEU) obliges 3RoOcEoCmDm,en2d0a2t1i,oRnescoanncdilPirnagciTicealrGmuiidnaoncloefo,gthhyeiUpnivser.seooefcPd.oorr-lcahnedmiPcoallyslaleulryo/aplokrytlaSlu-bpsetrafnlcuoosr:inated: +cheEmGiHcAal,s/Ptreorpmoisnaollfoogry-apeRre-satnidc-ipoolnyVfelrusoiroonal2k,y-Ps2u1bs1t.a1.n2c.esJ.upstdiffication or grouping stating thal"hisobservation pprroopvoisdaels,tthoeamvaoiind rmeogtrievtattaibolnetsoubisniciltuudteioanlbl yPFoAtShSerhPaFvAiSnSg."eq.uivalent hazard and risk in a single restriction 5 ECHA, Proposalfor a Restriction Version 2, P13 1. Problem identification stating that "[alitiough for most iPncAreSasitnhgerreesaeraerncshueffifcoiretnstthdaatlpartoogardeesqsueadtebleyyoansdsePsFsOtSheiaenfdfPeFcOotAnsrehpuomrtaend hseiamliltahraanddvetrhseseenfvfiercotnsmfeonrto,ther PASS" 2 environmental policy by the European Union to take into account available scientific and technical data while adopting the precautionary principle. However, although there are the diverse physical, chemical and biological properties of different individual PFAS or PFASS subgroups, the Proposed Restriction does not clearly identify and characterize hazards for individual PFAS or PFASs subgroups, assess exposure, nor identify risks. Some PFASs are used only in enclosed spaces where exposure o the environment is restricted to very limited amounts, and the risks caused by such uses of PFASs to human health or environmental is even lower. The lack of risk identification may also lead to the possibilty of replacing PFASs vith non-PFAS alternatives that pose a higher risk of adverse effects on human health or the environment, and thus the Proposed Restriction may not contribute to achieving the objectives of the REACH. Again, it is not reasonable to consider PFASs as a single group for regulatory, risk management purposes. We request that these assessments will be conducted sufficiently for individual PFAS or PFASs subgroups by the Risk Assessment Committee and during the review of the report after the public consultations period. (8) It should be noted that the Stockholm Convention on Persistent Organic Pollutants (POPs Treaty) - a treaty that shares common objectives with the Proposed Restriction and to which 186 countries and regions are parties -- restricts the production and use of some PFASs such as perfluoro octancic acid (PFOA) and perfiuoro octane sulfonic acid (PFOS), but does not restrict the production and use of all PFASs. It is considered that there is currently no international consensus that all PFASs pose significant risks, and therefore, careful discussion is required in determining whether all PFASs are indeed posing significant risks. 2. Consideration of socio-economic impacts (1) Paragraph 1 of Article 68 of the REACH provides that when adopting a new restriction, "any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternative substances". The socio-economic impact includes, according to Annex XVI of the REACH, `the impact on industry (e.g., manufacturers and importers)', * the impact on all other actors in the supply chain, downstream users and associated businesses in terms of commercial consequences,... taking into account general trends in the market and technology", `and "wider implications on trade, competition and economic development (in particular for SMEs and in relation to third countries)". We understand that these points will be taken into account in the consideration by the Socio Economic Assessment Comittee. Since the socio-economic impactsof the PFAS restriction is extremely high, we request that the above process in particular be conducted carefully and be fully assessed and reflected in the final proposal. As tis expected that each industrial sector, industry association, and individual companies involved in PFASS will submit their opinions to the public consultations, we request that those opinions be contemplated and that the adverse socio-economic impact be minimized. As mentioned above, PFASs are used as "essential use" in a wide range of industries and no alternative substance has been identified for many PFASs at this point. Therefore, no quantitative socio-economic impact can be demonstrated for the restriction. Such impacts should also be fully considered. FuOnfcftiicioanliJngouomfatlheoEftuhreopEeuarnopUenainonUnPiarotn(TChr2e0e2/-4U32n)i,on6 PJoulliyci2e0s16A,ndCoInnsteorlniadlaAtcetdivoenrssiToinleoXfXth~eTErnovailryoonnmetnhte Article 191 (ex Article 174TEC)hitps:/leur-lex.europa.eulelil20t1r6e/artty1l9t1i/e0u} 3 (2) If the Proposed Restriction is implemented as currently announced, trade in essential goods in which PFASs are used will be severely restricted and supply chains around the world will be severely disrupted. It should be noted that even if alternative substances are currently being developed, it will take a considerable amount of time availabilly is assured, as subsequent demonstration and evaluation will need to be repeated in both of upstream and downstream industries. In addition, for substances for which alternative substances have not yet been identified, future research and development must be conducted involving trial and error, and even a 12-year derogation period may not be sufficient to ensure thelr feasibility and availabilty. In this regard, a "review clause" should be considered that would allow for an extension of the transition period in the event thaat suitable alternative substance cannot be practically available by the prescribed date. 3. Consistency with the WTO/TBT Agreement (1) Article 2.2 of the TBTAgreement stipulates that "technical regulations shal not be more trade- restrictive than necessary to fulf a legitimate objective, taking account of the risks non-fulfiment would create." (2) Although some PFASs are considered to have significant risks, there are considerable differences among PFASs in terms of hazards and risks. However, as indicated in Section 1 above, the Proposed Restriction uniformly covers all PFASs including PFASs which do not pose significant risks to human health or the environment, without sufficient scientific and rational basis. Furihermore, as indicated in Section 2 above, since many PFASs are used in a wide range of sectors and no alternative substance has been identified for many PFASs, a full ban on their use, trade, etc. across all PFASs would be extremely trade restrictive. Therefore, the Proposed Restriction which would introduce a uniform restriction on the manufacture, use or placing on the market of all PFASs, including PFASs that do not pose significant risk to human health or the environment would be inconsistent with Article 2.2 of the TBT Agreement as the Proposed Restriction is more trade-restrictive effect than necessary to fulfil the legitimate objectives. We believe that the EU will provide a reasonable interval in accordance with Article 2.12 of the TBT Agreement when introducing the Proposed Restriction. In ight of the above, we further request that the EU appropriatelyconsider and examine the comments already submitted or to be submitted by industries and other stakeholders and limit the scope of the restriction to an appropriate range for the regulatory objectives of protection of human health and the environment. 4 Apr 25, 2023 Comment on Proposed Restriction of PFAS Conferencs of Fluoro-Chemical Product Japan (FC) On bohal of chemical manufacturers, we, Conference of Fuoro-Chamical Product Japan (FG). have besn working trelssiy to comply with ational chemical roguations. We have. supported EU's ambilous attempts o reduce risks from hazardous substances and have sincerely respondodto actual measurestome the requiramens of EU chemical regulations such as REACH. However, wo believe thal the proposod restriction of PFAS (Per- and Polyoroalkyl substances) poposod by European countries Is an oxcessive measure because restricts more than 10,000 of organofuoine compounds (PFAS) on the grouping basis that they are persistent as substoafncocnceersn equivalent toth already regulated PFOS and PFOA, Therefore, we intend o prosent the following visws at the public consultationof ECHA, 0 whichis oneofthe actions FCJ recommends. (1) Concerns about inconsistencies in the proposed restriction Avice 68 (1) REACH refers to the scope of th resticons, which regulatos unacceplable risks o human heath or the environment that need to be addressed by Society sa whole. "Tho proposed restriction sts parsistnt chemicals (which may romain in the environment longor than any other man-made chamical, ioconcentration, malty, the possibilty of ongsistanco transport, accumulation in plants, the possibilty of global warming, and toxicological offocts as concerns and reasons for the esiricon. Of these, persistent is applicabl o ll targotod organafuorinecompounds (PFAS),but other concerns are related 10 some compounds. persistency common o all organofiorine compounds (PFAS) can ba rephrased as "igh urabity" by focusing on ts advantages, however, wo believe tha 5 not appropriate to rogulat tis property alone as an unacceptable risk to human health or the onvironmant. In aditon, ts not appropriats to apply the conoams about soma fluorinated compounds, such as bioconcentraton potential and toxicological effect, by grouping all orgarofiuorine `compounds (PFAS) together, and f the need for new regulations is to be considered in the future, the risk of each substance should be quantitatively assessed and discussed. Hereafter, wo rospectfully submit our views on the proposed Restriction of PFAS and `express fs concerns that restriction would contravene the applicable European and intornational 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 oil, being resistant to heat, chemicals, and not absorbing light, and have been widely used in water repellents, surface treatment agents, emulsifiers, fire extinguishers, coalings, etc. and in a wide range of industrial applications such as semiconductors, automobiles, and batteries. Many of these applications and uses are considered "essential uses". The applications in which PFAS are used are also crical for the European Green Deal ~ that is comprehensive intative that includes a rangeofpolicies in different areas aiming at make Europe climate-noutral 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 critical o the European Green Deal, would essentially hamper the achievement of European Green Deal objectives. 2 The proposed Restriction would significantly and disproportionately hamper Intemational rade Ifthe proposed Restriction is implemented as currently announced, trad in essential goods in which PFAS are used would be considerably restricted and supply chains around the world would be severely disrupted. In our view, even f alternative substances are currently being developed, these would need to go through repeated demonstrations and evaluations and therefore they would take considerable time bofore they can be implemented. Moreover, for substances for which no. alternatives have been identified yot, research and development will have to be promoted through rial and error in the fulure, and even a 12 year grace period may not be sufficient to confirm their availabilty. "The serious and disproportionate nogative effects of the proposed Restriction on international trade could also constitute a violation of the proportionality principle as enshrined in Article 68(1) REACH. In particular: "The proposed Restriction is disproportionate, contrary to Article 68 (1) REACH. Ariclo 68(1) REACH requires that any restriction decision shall take into account "the socio`economic. impact of the restriction, including the availabilty of altematives". That socio`economic impact may, among others, include, in accordance with Annex XV, 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 innovatioin); the wider implications on trade, competion and economic. dovelopment; il) alternative risk management measurements that could meet the aim of the. proposed restriction and iv) the availabilty of suitable and feasible altematives. The proposed Restriction does not appropriately consider those elements of the socio`economic impact and fails to balance the negative impact on intemational trade and the Industry with the potential benefits of the proposed measure. It rather proposes a blanket restrictionofall PFAS substances for al uses (beyond some transitional periods for specific usesfapplications) that goes well boyond what is necessary to achieve the legitimate objectives it pursues, and s not the least onerous measure to control the potential risks posed by certain PFAS. In particular, the Proposed Restriction fails to conduct a substantial assessment of the *avallabilityof atematives" including: ) where alternatives have been identified, these must be compared as to thei risks and benefits to the substances proposed to be restricted and ii) where alternatives are not yet available, the risksof the continued useofthe 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 allematives. In light of the above, we request that the EU limits the scopeofthe restriction to the extent necessary to achieve the objectives that contribute to the social economy of the EU. In that regard, we also request thal f the restriction remains as itis, that the EU considers a `review clause" that would enable the extension of the wansilional periods in case sultable alternatives have not been developed by the given review date. 3. The proposed Restriction restricts all PFAS as a single group In following ths grouping approach, the proposed PFAS Restriction would restrict PFAS that have not been risk-assessed and for which an unacceptable risk has not been demonsirated, in breach of Article 68(1) REACH. Adie 68(1) REACH provides that substanc(s) can be rosticted only if they pose an unacoaptable risk to human health or the environmont, This unacceptable risk must be posilivelydemonstratedbyconductaiinskg assessment tha follows the conditionsofAnnex XV to REACH (and by cross-reference of Annex | and Annex XI). Such fisk assessment comprises hazard identification and characterisation, oxposure assessment and risk characterisation. By grouping al various PFAS substances together and restricing tem as singl class, the proposed PFAS Restriction Proposal would restrict numerous PFAS substances that havo not beenriskassessed and for which no unacceptable risk has been demonstrated, in breach of Articlo 68(1) REACH. More specifically, the scope of tho proposed PFAS. Resticton is based on the OECD defiion of PEAS. Tha definition is only based on chemical sructure and dogs not take into account hazardous. properties or risks of PFAS, as the proposed Restiction itself acknowledges (p. 19). As a resull, 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, distinc properties of diferent individual PFAS or PFAS subgroups and Is therefore nat suitabl for regulatory isk management purposes. OECD itself acknowledges that this definon "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 viewad as too broad (ECD, 2021, Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practica Guidance). In particular, the very broad scope of proposed Restriction ~which is based on the OECD. PFAS definition does not enable a legally and scientiically sound risk assessment. By grouping all PFAS together in a single group or risk assossment, the proposed Restriction falls toidentify and considor the specif, distinct properties of each individual PFAS or PFAS subgroup and, in tum, to assess and characterise the hazards and risks related fo those. properties in order to demansirate that hey pose an unacceptable risk to human health or the environment. rather restits al PAS substances on the assumption tha they all shavrerey persistent property as thir "key hazardous property" that riggers equivalent hazards and risks"(p.2122), However, (very) persistence Is not per se a hazardous property nor does it indicate a tisk on its own. Persistenca on ts own is also not sufficient to consider PFAS as giving an "equivalent evel of concern" to PBTSIVPYBS o to characterise an "unacceptable risk" within the meaning of Arce 63(1) REACH and jusiy a restriction. I is for thoso 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 GLP Regulation- mobility), and not alone. Beyond PFAS' purported very persistent propery, the proposed Restriction does not identity anyother hazardous properties that are commontoall PFAS. It only refers to some additional propertios that amplify the "overall concer" for some -not all- PFAS. Indeed, the Proposal contains evidence that concems only certain sub-sets of PFAS (mostly some long-chain PFAS) and lacks data on other 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 Restriction (read-across). For example, the proposed Restriction acknowledges that "for the majority of PFAS no, or insufficient, data on bioaccumulation behaviourare available" and therefore that the "data on the bioaccumulation potential of PFAS [.] are not suficient to substantiate bioaccumulation in the environment for all PAS (9.28). With restopecoetoxcicitty, it mentions that "the large number of diferent substances with heterogenous properties [...] in the group of PFAS makes the assessment of their ecotoxiclty very complex'(p.28). It then concludes that the bioaccumulation potential and (ecojtoxicty is expected to vary among PFAS due to their "high diversity" and that "no overall conclusion on BAVb and T criteria was derived for each PFAS substance (sub) group' (p. 47). In the absence of (sufficient) evidence, the proposed Resiriction 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 tobo 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. I is also possible that by not characterising the specific risk(s) each individual PFASIPFAS subgroup poses that the proposed Restriction would lead to the roplacement of those PFAS wih non-PFAS altematives that could be potentially more hamnful to human health and the environment (regrettable substitution). Even if certain PFAS would be demonstrated to pose an "unacceptable risk to human health or the environment" within the meaning of Article 68(1) REACH, this cannot lead to the `conclusion that all PFAS pose stich an unacceptable risk, 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 demonsiration that thre "is" an unacceptable isk. It Is therefore not intended as a tool to address scientific uncerlainties, as itis the case with the precautionary principle. Therefore, the proposed Restiction thats largely based on scientific uncertainties (e.g. "lack of toxicological data for the vast majority of [PFASI'(p-32); * for most PFASs there are insufficient data to adequately assess their effects on human health and the environment" (p13); "for the majority of PFASs no, or insufficient, data on bioaccumulation behaviour are available" (p. 28) would not mee the requirement of Article 68(1) REACH to demonstrate an unacceptable risk. In the allemative, even if the proposed Restriction applies the precautionary principle (although it makes no mention of it, it must had nevertheless met the conditions of EU case law, as summarised in the Commission Communication on the precautionary principle, which itfailed 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 [...I. It should be used where "there is scientific uncertainty as to existence or extent of risks to human health or the environment ...1 While the risk assessment in the context of the precautionary principle is "not required to provide [..] conclusive scientific evidence of the reality of th isk and the seriousnessofthe potential adverse effects were that risk to become a reality', "a preventive `measure cannot properly be based on a purely hypothetical approach tothe 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" (. 13) and that "if 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 [tis more likely that for the vast majorly of these substances, no study data are available to serve as a 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. proportios of concer. (p.30). Moreover, the persistence and accumulation of PFAS in the environment that the proposed Restriction mainly relies on, cannot bo construed as adverse effects per se.The Proposal is therefore based merely on unsubstantiated assumptions. In addition, the proposed Restriction fais to meet the following conditions for tho implomentation of the precautionary principle sat out in the Commission Communication on the Precautionary Principle (Commurication from the Comission on the precautionary principle. Brussels, 2.2.2000 COM(2000) 1 final). ~ Boforo tho adoptionof a precautionary measure, there must be frst a sciontfc risk assossment, comprising four steps, namely hazard identification, hazard characterisation, `appraisal of exposure and risk characterisation. In our opinion ane could demonsiiate that these four steps have not been followed In the PFAS Restition Proposal. The alegod hazards of the PFAS have nt been established and, likewise, there is ltl on the actual exposura to PFAS. These elements have rather been postulated on unsubstantiated `assumptions. In the absence of ralable information on hazard and exposure, there is no basis on which to characterise the risk, and therefore o conduct the required scientific risk assessment or the application of the procautionary principle. ~The precauionary measure must be proportionate, nom-discriminatory and consistent with similar measures, based on examination of the potential benef and costs. In our opinion, the proposed PFAS resticion could be demonsirated fo be disproportional and nol the least restricivo measure that can be taken to address any PFAS-elalod concems bocausa i it restits the entire class of PFAS for al applications on the basis of mainly a `persistency concern' i) it does not sufiiently assess the risk and suiabiity of allegedly available alteratives, and i it doos not (adequately) assess the socio-aconomic impoafscucth broad restriction against the alleged `significant benefit"ofthe rostcton. ~The Proposal must identity the measures that need to be taken in order to clarify the unceraintes that couki jus precautionary measures. In particular, `measures based on the precautionary principle should be subject 10 [.. to review in the light of new scientific data. In that raspect, the Proposal doas nt propose measuresthatcould be takentoresolve the uncertainties t identifies -- i rather proposesa total, blarkot ban of all PFAS for all applications (beyond somo transitional periods for some applications). 5. The proposed Restiction would restrict substances withoul lsting them contrary to Article 68(1) REACH ticle 68(1) provides that substances that pose an unacceptable risk to human healthorthe environment could be the subject of a restriction. Avice 68(1) restriction should therefor identity the substances proposed 10 be restricted. Annox XV, Secon 3 of REACH also spacifies tha the restiction "shall include the donily of the substance [.." Such identity should be chemical specific, including name, identification numbers, molecular and structural formulas, etc. Indeed, REACH defines a "substance" as "a chemical clement and its compounds" (Article 3(1) REACH). This is alsa cloarly reflected In the European Chemicals. `Agency (ECHA) Guidance for the preparation of an AnXVndosesierx(p. 108) that specifies that the restriction proposal must provide "details on the dently of the substance (name, GAS, EC number, registration number (if available), molecular formula, structural formula, purity and impurities)". In light ofthe above, the proposed Restriction fails to adequately identify and fist the specific chemical substances proposed to be rested. Instead, it prohibits the manufacturing, use or placing on the market of any substance `that contains at least one fully fluorinated methyl (CF3) or methylene (-CF2-) carbon atom, without any HICUBr attached to i (p4). it does nol provide the names or identification numbersof the specific substances that are covered by this broad definition, as required. (2) Exclusion by PFAS Sub-category(substance) As mentioned in (1), a class of compounds (PFAS sub-category) having widely different properties, such as fluoropolymers and fluorinated gases, are al grouped as PFAS and Subject to restrictions. On page 16ofthe 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, respoctvely, and we believe tha isk can be more appropriately assessed by sub-catogorising rather than grouping as PFAS. For example, fluoropolymers are thermal, biologically, and chemically stable, barely Soluble in water, immobile, insoluble (Water, Octanal,etc.), and too large to migrate to cell membranes, so they are not incorporated into the body and are considered low concern froam human and environmental hoalth 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 repaliency, lubricity, and unique opticallsleciical properties, and they have become. indispensable materials in many fields, including the energy field (Fuol cels and lithium-ion bateries), semiconductor field (Clean members, etching gas), electrical and electronic: `communications fied (Wire cladding and liaid crystal material), transportation field (Cars, airplanes, railroads), and medical field (Catheters, protective clothing). It is necessary to carefully ro-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 are highly stable materials and have no concerns about bioconcentration or toxicological effects. Fluorinated gasIs a highly safe compound in terms of toxicity and combustibiity, and itis `used in many applications in terms of efficiency and cost. In aditon, fluorinated gas itself is not persistent in the persistent properties proposed in the PFAS restriction proposal. In addition, tifluoroacatic acid, which is a degradable product of fluorinated gas itself and is a concern in the proposed restriction, has also been shown to pose a low isk of toxicily to living organisms and human bodies in the reportsof the Environment Agency of Germany `and Norway, who actually submited this restriction proposal. These results indicate that fluorinated gas should not be considered for regulation as a group with 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 tal, Integrated Environmental Assessment and Management, Vol14(3), 316-334. hitps:isatac.onlinelibrary wiley.com/daif10.1002fi4e0a3m5 2: Stephen K et al, Integrated Environmental Assessment and Management, Vol19(2), pa26-354 hitps:/isetac.oninelibrary.wiey.com/doi/10.1002fieam 4646 3: German Environment Agency, Reducing chemical input nto water bodies -- tifluoroacetate (TFA) as a persistent and mobile substance from many sources, 2021 4 Norwegian Environment Agency, Study on environmental and health effects of HFO. refrigerants, 2017