Document rxE2DnZ94wOJxQZmGQJNjzzr

Apr 25, 2023 Comment on Proposed Restriction of PFAS Conference of Fluoro-Chemical Product Japan (FCJ) On behalf of chemical manufacturers, we, Conference of Fiuoro-Cherical Product Japan S(FuCpJp)o,rtheadveEUb'esenamwboirtkiionugs taitrteelemspstlsy ttoo croemdpulcye wriitshksnfatrioomnahlaczhaermdiocuasl regulations. substances We and have have sincerely responded to actual measutormeeest the requirements of EU chemical regulations such as REACH. However, we believe that the proposed restriction of PFAS (Per- and Polyfluoroalkyl substances) proposed by 5 European counties is an excessive measure because it restricts more than 10,000of rganofiuorine compounds (PFAS) on the grouping basis tha they are persistent as substances of concern equivalent to the already regulated PFOS and PFOA. Therefore, we intend to present the following views a the public consultation of ECHA, to whichis oneofthe actions FC.J recommends. (1) Concerns about inconsistencies in the proposed restriction Article 68 (1) REACH refers to the scope ofthe restrictions, which regulates unacceptable isks to human healthor the environment that need tobe addressed by `society as a whole. The proposed restriction lists persistent chemicals (which may remain in the environment fonger than any other man-made chemical, boconcentration, moby, the possibilty of long-distance transport, accumulation in plants, the possibiltyof global warming, and toricological efecs as concerns and reasonsfo the restction. Of hese, persistent is applicable to all targeted organofluorine compounds (PFAS), but other concerns are related to some compounds. persistency common to all organofiuoine compounds (PFAS) can be rephrased as "high durability" by focusing on its advantages, however, we believe that it is not appropriate to ardedgiutliaotne, tihtiiss pnrootpaeprptryoaplroinateeatso aanppulnyacthceepctoanbcleernrisskabtoouhtusmoamnehefallutorhoinrattehdeceonmvpioruonndmse,nt. In such as bioconcentraton potential and toxicological efects, by grouping al organofiuorine `compounds (PFAS) together, and if the needfo new regulations is tobeconsidered in the future, th risk of each substance should be quantitatively assessed and discussed, Hereafter, we respectfully submit our views on the proposed Restrictionof PFAS and. express its concerns that restriction would contravene the applicable European and international rues and agreements for the following reasons: 1. The proposed Restriction would hinder the achievement of the European Green Deal PFASs have properties such as repeling waler and oi, being resistant to heat, chemicals, and not absorbing light, and have been widely used in water repellents, surface treatment agents, emusifrs, fire extinguishers, coatings, elc., and in a wide range of industrial applications such as semiconductors, automobiles, and batteries. Many ofthese applications `and uses are considered "essential uses". "The applications in which PFAS are used are also critical or the European Green Deal = that is comprehensive initiative that includes a range of pliies in different areas aiming at make Europe clmate-neral by 2050. For example, the Horizon Europe program funds research and innovation actives 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 to the European Green Deal, would essentially hamper the achievement of European `Green Deal objectives. 2. The proposed Restiction would significantly and disproportionately hamper international 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 the world Would be severely disrupted. In our view, even if atemative substances are currently being developed, these vould need 10 go through 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 wil have to be promoted through trial and error in th future, and even a 12 year grace period may not be sufficient to confi thei availabilty. `The serious and disproportionate negative effectsofthe proposed Restriction on international trade could also constitute a violationof the proportionality principle as enshrined in Article 68(1) REACH. In particular: `The proposed Restriction is disproportionate, contrary to Article 68 (1) REACH. `Article 68(1) REACH requires that any restriction decision shall take into account the socio`economic impact of the restriction, including the availabilty of alternatives". 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 innovation; i the wider implications on trade, competition and economic development ii) alterative risk management measurements that could meet the aim of the proposed restriction and iv) the availability of suitable and feasible alternatives. `The proposed Restriction does not appropriately consider those elements of the socio`economic impact and fail to balance the negative impact on intemational trade and the Industry with the potential benefits of the proposed measure. It rather proposes a blanket restriction of all PFAS substances for all uses (beyond some transitional periods for specific usesiapplications) that goes well beyond what is necessary to achieve the legitimate objectives it pursues, and isnotthe least onerous measure to control the potential risks posed by certain PFAS. In particular, the Proposed Restriction fais to conduct a substantial assessment of the "availabilty of altematives" including: i) where alternatives have been identified, these must be compared as to their risks and benefits to the substances proposed to be restricted and ii) where altematives 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 andofthe lack of available alternatives. In light ofthe above, we request that the EU limits the scopeof the restriction to the extent necessary to achieve the objectives that contribute to the social economy of the EU. In that regard, we also request that i the restiction remains as itis, that the EU considers a 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 all PFAS as a single group In following this grouping approach, the proposed PFAS Restriction would restrict PFAS that have not been risk-assessed andforwhich an unacceptable risk has not been demonsirated, in breach of Article 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 posively demonsiratedbyconductinag isk assessment that falows the condiotfiAonnnesx 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 togetherand restricting themas asingle 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 breach of Atticle 68(1) REACH. More specifically, the scope of the proposed PFAS Restriction is based on the OECD definition of PFAS. That definition isonly 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 diferent 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 100 broad" (OECD, 2021, Reconciing 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 definiion- does not enable a legally and scientifically sound risk assessment. By `grouping all PFAS together in a single group for risk assessment, the proposed Restriction fails to identify and consider the specific, distinct properties of each individual PForAPFSAS 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. Itrather restricts all PFAS substances on the assumption that they al share a very persistent property as their "key hazardous property" that "riggers equivalent hazards andrisks"(p.2122). However, (very) persistence is not per se a hazardous property nor does it indicate a risk on its own. Persistence on is own is also not sufficient to consider PFAS as giving an "equivalent evel of concern" to PBTSVPVBS 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, toxicty or -under the new hazard classes introduced to the CLP Regulation- mobilty), and not alone. Beyond PFAS' purported very persistent property, the proposed Restriction does not identify any other hazardous properties that are common to al PFAS. It only reftoesromse additional properties that amplify the "overall concern" for some -not all- PEAS. Indeed, the Proposal contains evidence that concerns only certain sub-sets of PFAS (mostly some long-chain PFAS) and lacks data on other PFAS substances/subgroups and an adequate justification 50 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 behaviour are available" and therefore that the "Gata on the bioaccumulation potential of PFAS [] are not sufficient to substantiate bioaccumulation inthe environment for all PEAS" (5.28). With respect to ecotoxicty, t mentions that `the large number of diferent substances with heterogenous properties ... in the group of PFAS makes the assessment of their ecotoxiity 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 BIVb and T criteria was derived for each PFAS substance! (sub-) group" (p. 47). In the absence of (suffcien) evidence, the proposed Restriction fal 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 inited and the rsk to human health and environmental conservation is even less. tis also possible that by not characterising the specific isk(s) each individual PFASIPFAS subgroup poses that the proposed Restriction would lead 10 the replacement of those PFAS wih non-PFAS altematives that could be potentially more hammful to human health and the environment (regrettable substitution). Even ifcertain PFAS wouldbedemonstrated o pose an "unacceptable isk (0 human health or the environment: within the meaning of Atticle 68(1) REACH, this cannot lead to the conclusion that all PEAS pose such an unacceptable risk, without considering their varying properties and behavior. 4. The proposed Restriction could notbe lawl 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 itis the case with the precautionary principle. Therefore, the proposed Restriction that is largely based on scientific uncertainties (e.g. "lack of toxicological data for the vast majority of [PFASI'(p.32); * for most PASS 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 mest the requirement of Article 68(1) REACH to demonstrate an unacceptable risk. In the altemative, even if the proposed Restriction applies the precautionary principle (although it makes no mentoifoin) it must had nevertheless met the conditions of EU case law, as summarised in the Commission Communication on the precautionary principle, which it failed 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 scientiic uncertainty as to existence or extent of risks to human health or the: environment [.J" While the risk assessment in the context of the precautionary principle is "not required to provid|e...] conclusive scientific evidenceof the realityof the risk and the seriousnessof the potential adverse effects were that risk to become a reality, "a preventive measure cannot properly be based on a purely hypothetical approach to the isk, founded on mere conjecture which has not been scientifically verified" (our emphasis). However, the proposed Restriction lacks evidenceofeffects, and especially,ofeffects 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 "if releases are not minimised, humans and other organisms willbe 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 majority 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 of moreof 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 perse.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, 2.2.2000 COM(2000) 1 fina). - Before the adoption of a precautionary measure, there mustbe first a scientifc isk `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 PAS have not been established and, likewise, there is lite on the actual exposure to PFAS. These elements have rather been postulated on unsubstantiated assumptions. In the absence of refiable information on hazard and exposure, there is no basis on which to characterise the isk, and therefore to conduct the required scientific risk `assessment for the application of the precautionary principle. - The precautionary measure must be proportionate, non-discriminatory and consistent with similar measures, based on examination of the potential benefits and costs. 10 our opinion, the proposed PFAS restriction couldbe demonstrated to be disproportionate and not the least restrictive measure that can be taken to address any PFAS-related concems because i t restricts the entire class of PFAS for all applications on the basis of mainly a "persistency concen'; i) it does not sufficiently assess the risk and suiabily of allegedly available alternatives, and i) t does ot (adequately) assess the socio-economic impact of such broad restriction against the alleged "significant benefits" of the restriction. - The Proposal must identify the measures that need to be taken in order to clarity the uncertainties that could justify precautionary measures. In particular, `measures based on the precautionary principle should be subject 01... to review in the fight of new scientific data." In that respect, the Proposal does not propose measures that couldbetaken 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 listing 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 identity the substances proposed to be restricted. Annex XV, Section 3 of REACH also specifies that the restriction "shal include the identity of the substance [..'. Such identi shouldbe chemical specific including name, identification numbers,molecular and structural formulas, etc. Indeed, REACH defines a "substance" as "a chemical element and its compounds" (Article 3(1) REACH). This is also clearly reflected in the European Chemicals Agency (ECHA) Guidance for 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 (f available), molecular formula, structural formula, purity and impurities)". night of the above, the proposed Restriction fails to adequately identiy and ls the specific chemical substances proposed to be restricted. Instead, it prohibits the manufacturing, use or placing on the market of any substance "that contains atleast one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom, without any HICUBI attached to it (5.4). It does ot provide the names or dentfication 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 class of compounds (PFAS sub-category) having widely different properties, such as fluoropolymers and fluorinated gases, are all grouped as PFAS and subjectto restrictions. On page 16 of the report, citing the OECD report, PAS are subcategorised into 4 major categories and 30 middle 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 risk can be more `appropriately assessed by sub-categorising rather than grouping as PFAS, For example, luoropolymers are thermally, biologically. and chemically stable, barely Soluble in water, immobile, insoluble (Water, Octanal, etc), and too large to migrate to cel membranes, 50 they are not incorporated into the body and are considered low concern from a human and environmental health perspective'. The findings demonstrate that fluoropolymers areadistinct group from PFOA and PFOS and should nt 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 lthium-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 medical field (Catheters, protective clothing). It is necessary to carefully re-examine whether the uniform regulations for PFAS are appropriate in light of the chemical hazards and risksof 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 gas is a highly safe compound in terms of toxicity and combustibity, and itis used in many applications in terms of efficiency and cost. In adtion, fluorinated gas itself is not persistent in the persistent properties proposed in the PFAS restriction proposal. In `addition, trifluoroacetic acid, which is a degradable product of fluorinated gas itself and is a `concem in the proposed restriction, has also been shown to pose a low risk of toxicity to living organisms and human bodies in the reports of the Environment Agency of Germany `and Norway, who actually submitted 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 reductionof 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. hitps:setac.onlinelibrary.wiley.com/doifull10.1002/ieam.4035 2: Stephen K et a, Integrated Environmental Assessment and Management, Vol19(2), p326-354 hitps:/setac.onlinelibrary.wiley.com/doif10.1002/ieam. 4646 3 German Environment Agency, Reducing chemical input into water bodie--s riflsoroacetate (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 2 submission - Comment on Proposed Restriction of PFAS `ConoffeFluroreo-Cnhecmiceal Product Japan (FCJ) On behalf of chemical manufacturers, we, Conference of Fluoro-Cherical Product Japan (FC), have been working tirelessly to comply with national chemical regulations. We have supported EU's ambitious attempts to reduce risks from hazardous substances and have sincerely respondedtoactual measures to meet the requirements of EU chemical regulations such as REACH. However, we believe that the proposed restiction of PFAS (Per- and Polyfluoroalkyl substances) proposed by 5 European countries is an excessive measure because it restricts more than 10,000 of organofiuorine compounds (PFAS)on the grouping basis that they are persistent as substancesof concern equivalent to the already regulated PFOS and PFOA. In addition to our opinion submitted on 18 May, reference # 4149, we would like to submit our opinion on the following matters: [Positioning of intermediates] Intermediates (transported isolated intermediates) are used in strictly controlled conditions under the current REACH to convert to target compounds. As the above proposed restiction is unclear as to the positioning of intermediates, we hereby offer our opinions in this proposal 1. The importanceof intermediates Restriction does not apply for some uses under the proposed EU PFAS restriction, and 5. `and 12 year grace periods for the applicationof restriction are being proposed for uses that are both socio-economically important and difficult to substitute, That said, the proposed restriction does not address the handling of intermediates required to produce PFAS substances for these uses. In order to use PAS substances for exempted or deferred applications and apply them to their social functions, ti essential to use the intermediates in manufacturing, even if they. fall under PFAS by definition. In addition, maintaining the production of PFAS and the using of intermediates in Europe will not oly facilitate securing a stable supply of exempted or deferred substances in Europe, but also lead to the development of related industries and maintain employment. We would like to emphasize these points and argue for the proper positioning of intermediates in the proposed restriction. 2. Handlingofintermediates in REACH Under the REACH regulation, intermediates are defined as substances that are manufactured and used for chemical processing in order to be transformed into another Substance, and are classified as either non-isolated intermediates, on-site isolated intermediates, or transported isolated intermediates. Among these, non-solated intermediates are not applied to REACH (Atticle 2 of REACH). The registration requirements or on-site isolated intermediates and transported isolated intermediates are described in Articles 17 and 18 of REACH, respectively, and reduced registration is in `operation when they are used under strictly controlled conditions. As can be seen fiom the above regisiration measures, intermediates are expected to be handled by appropriately skied workers at controlled manufacturing sites and are substances for which environmental emissions and exposure risks can be controlled. With regard to PFAS restriction, Aticle 68of REACH states that on-site isolated intermediates are not subject o the adoptionofnew restrictions on manufacture, use, of placing on the market,o to the revision of existing restrictions in Annex XVII. On the other hand, transported isolated intermediates are not exempt from the adoption of new restiictions, and their positioning in the proposed restriction is unclear. Article 18(4) of REACH provides specific strict conditions for the use of transported isolated intermediates, and on that basis, the previous restriction proposals for PFOA" and PFHXA?were both `considered to exempt transported isolated intermediates from the restrictions. Asimilar approach should be considered with the proposed PFAS restriction. 3. Suggestions for countermeasures Based on the socio-economic importance of the intermediates as described above and the perspective of the isk of environmental impact, we propose the following regarding the positioning of transported isolated intermediates in the proposed EU PFAS restriction Transported isolated intermediates used in the manufacture of substances involved in `exempted or deferred applications under the proposed PFAS restriction should be subject tothe same restriction treatment (exemption or deferral of restriction) as the substances involved in exempted or deferred applications if subject to the controlofArticle 18(4) 4. Active substances in plant protection, biocidal products, and human and veterinary medicinal products From the Q&A responses? o the webinar held on April 5, 2023, we recognized the intention of the authorities in the five countries that the proposed derogation also cover al preceding steps that are necessary to produce the product" wih respect to these active substances. We recognize and endorse that this would exempt intermediates, as well as raw. materials, solvents, catalysts, etc. used in their production, with respect to the aforementioned active substances. [Concentration Limits under Paragraph (2)ofthe Proposed Restriction] In the proposed Restriction, 25 ppb for 1 PFAS, 250 ppb in total, and 50 ppm for polymeric PFAS are proposed as concentration limits for al PFAS except for polymeric PFAS. However, the underlying risk is not clearly stated for each limit proposed. In the proposed Restiction, the only common rationale for restriction of all PFASs is persistency. Therefore, we believe concentration limits commensurate with the risk should be established. As an example, PFOAis a compound regulated by EU-POPs due to bioaccumulation and toxicological effects in addition to persistence. While the concentration limit for PFOA and its salts is 25 ppb, the limit for PFOA-related substances, defined as those that can convert to PFOA, is 1,000 ppb. Furthermore, for SVHCS such as PBT and vPB that fall under the proviosfiArotinclse 57 REACH, the concentration limit as a criterion for providing data is set at 0.1%. For pharmaceutical products, the IMPURITIES IN NEW DRUG SUBSTANCES Q3A (R2) `which was established based on the agreement at the Intemational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in the US, EU, and Japan, set the reporting threshold for impurities at 0.05% (when the maximum dose is 2g/day or less) or 0.03% (when the maximum dose is over 2g/day). For highly toxic impurities, a lower concentration imit maybeset as appropriate. "Thus, other regulations appropriately set concentration limits according to isk level. `Therefore, in this proposed Restriction, PFASs with only persistence risk and PFASs with bioaccumulation and toxicological risks in addition to persistence risk should be considered `separately, and appropriate thresholds should be set according to the risk level, [Review of Period and Exemptions] `The proposed Restriction proposes grace periods of or 12 years besides the 18-month transition period. The rationale is limited to an assumed assessment of the availabilty of alternatives in the future EF (at the time of publication in the Offical Gazette) based on Some information provided in the CfE as of 2021, with no mention ofa review provision in case stich altematives prove to be impractical. In the consultations that began on March 22, ECHA requested that information on the Evidence base be provided. After careful investigation of these submitted opinions and information on the availabilty of altematives, an appropriate conversion time should be reestablished, taking into account the time required for demonstrations and evaluations. In addition, research and development will need to be conducted in the future for applications where no alternative has been identified. A framework should be considered to allow for a postponement of the transition period if several essential functionsiroles cannot be achieved within 12 years. We also believe a process should be established to consider new exemptions for technologies and applications that are currently unknown and for which PFAS is recognized as essential for social implementation. Without careful and periodic review provisions, trade restrictions and other restrictions on PFASs used in a wide varietyoffields and applications. will not only cause market disruption, but will also deny the use of technologies that will contribute to the attainment of a European Green Deal in the future. Reference: 1) Report on the request oreview a derogation request (entry 68ofAnnex XVItlo REACH) 42321560304e#htps lechaeuropa,euldocuments/10162/4d305dlc-1e-42b1-f1252705bbaBTd44 2) ANNEX XV RESTRICTIONREPORT hitpsecha,europa.eu/documents/10162/7268a452-3306-3686-7ide: 42321560304e#htos lechaeuropaeuldocuments/10162/4d305dic-fo1e-42b1-f1252705bbaBTd44 3) Restriction of per- and palyfluoroalkyl substances (PFAS) under REACH, Questions and answers teach S47E:text=Dounload%200%26A%20%28part%2011%20%2D%20conient%2001%20 the%20proposedt20restrictions20 4)ICH Q3A (R2) Impuriies in new drug substances heimtpas,euwrwopa,ewlen/ich-q3a-r2impuriies-new-rug-substances-scientiic: quideline 3rd submission - Comment on Proposed Restriction of PFAS. Conference of Fluoro-Cheical Product Japan (FCJ) (Regarding the requirementot provide information in paragraph 7) In paragraph 7 of the proposed restriction, the information requirement for derogated `applications in paragraph 5 and 6 states that article manufacturers and importers need to provide information related to the identification of substances placed on the market, To satisfy this requirement, the reporting entity needs to obtain relevant substances information from the upstream chemical substance manufacturers. To identify substances, itis anticipated that highly sensitive proprietary informaotnitohen type, function, and quantity of PFAS contained in the product may need to be disclosed by the chemical manufacturer through the supply chain. In such cases, the proposed restriction does not provide specific protection measures for such information, andwe have the following concerns. As stipulated in paragraph 5 and 6 of the proposed restriction, given that PFAS is essential for products in critical areas such as semiconductors, energy, miltary, medical, transportation, `and construction, national security and social infrastructure may be exposed to various risks if confidential information is not protected, and information related to specifications is shared through the supply chain. Without appropriate measures to protect the confidentiality of information, chemical manufacturers will be forced to disclose confidential information, putting them at a competitive disadvantage in the intemational marketplace. This could lead to chemical manufacturers choosing to avoid the European market, and as a resul, citizens in Europe could lose access to derogated applications that are considered essential in our society. (The above concerns regarding the protection of confidential information are also an issue in `complying with the requirements of paragraph 8.) To address such concerns, we request that the definition of information relevant to the identification of substances be clarified and that specific procedures for the protection of confidentiality be provided if such information is a trade secret. As a reference point, it is worth noting that in the United States, during the application process for the registration ofa chemical substance under the Toxic Substances ControlActPremanufacture Notice (TSCAPIN), chemical structures can be designated as confidential and reported to regulatory authorities using a designated code (referred to as an Accession Number) that represents the structure. This procedure effectively ensures the preservation of information confidentiality. In addition, we seek clarity regarding the legal framework and mechanisms that will be invoked to address unintentional information leaks to external parties once the requisite submissions have been made in accordance with the requirements.  Use application (CAS RN) Candidates for regulated substances(CAS RN) End-product name of application Product name of application () Application description Wiring for semiconductor manufacturing equipment Semiconductor cleanroom internal wiring FEP25067-11-2 PFA26656-00-5 ETFE68258-85-5 ULstyle133013331727 28-10 AWG Insulating material of the wire UL1330 14AWG UL1330 14AWG shows a wire photo as an example Wire Photo 1 UL1330 14AWG 2 An example of a semiconductor device which UL1330 14AWG is used is shown in Photo 2. Technical explanation of non-substitutability A semiconductor device Photo 2 1 150 The operating ambient temperature of the electric wire used in this apparatus is over 150. Thus, the following covering materials shown in the alternatives do not meet this requirement. EPDM 90 EPDM: Rated around 90 60105 Soft polyvinyl chloride: rated 60~105  80125 Polyethylene: Rated 80~125 2 180 Although silicone rubber is rated at 180, it cannot be replaced because it generates siloxanes that affect semiconductor equipment. We collectively refer to the gases containing large amounts of siloxanes as outgassing, here. UL1330 14AWG FEP) 1 Figure 1 shows amount of outgassing of fluoropolymer (FEP) applied to silicon rubber and UL1330xxAWG. 1 NASA TML The data in Figure 1 is outgassing data (TML) measured by NASA. FEP) 100 1 Amount of outgassing of fluoropolymer (FEP) material are less than 1/100th of silicone rubber. 1 Figure 1 Outgassing data Other issues that are difficult to substitute Mica and ceramic bases cannot be replaced because particles that affect the device are generated.  Information of usage Since fluoropolymer has high insulating ability, it can be thinwalled, so it can meet user requirements (thin electric wires).However, since other resins become thick, the outer diameter becomes thicker and is not suitable as a substitute. PFA 2.3-2.4 PFA 2.1PFA Specifically, the dielectric constant of fluoropolymer PFA and polyethylene is compared. Polyethylene is 2.3-2.4 compared to PFA 2.1. PFA is lower. This dielectric constant difference and dissipation factor difference affect whether or not the wire insulation thickness can be thin. PEEK PFA FEPETFE 1.7/PEEK 300kg/ PEEK cannot be substituted due to insufficient material supply capacity (PFA, FEP, ETFE is used at about 1.7 tons/month). PEEK material supply capacity is as low as up to 300 kg/month