Document jgjZgqRmBLqKY7DkeYeqjzdm9

Kuraray Europe GmbH, Philipp-Reis-Str. , Hattersheim, Germany Kuraray Europe GmbH position on REACH ANNEX XV report consultation of Per- and Polyfluoroalkyl substances (PFAS) Hattersheim in August Summary The European Chemical Agency (ECHA) plans to restrict or ban PFAS in the future. The abbreviation PFAS stands for "per- and polyfluorinated alkyl substances". This covers around , substance groups with more than , substances that are used in many industries and occur in countless products. The most prominent of these is polytetrafluoroethylene, better known as Teflon. PFASs are also used in water-repellent clothing, in fire-fighting foams, electronic equipment and in the automotive industry - and in the chemical industry as sealing materials and pipe in-liners. As Kuraray Europe GmbH, we support ECHA in its ambitious efforts to reduce the risks posed by hazardous substances to the environment and people. Article ( ) REACH refers to the scope of the restrictions, which regulates the following unacceptable risks to human health or the environment that must be addressed by society as a whole. In the proposed restriction, persistent chemicals (which can remain in the environment longer than any other man-made chemical), bioconcentration, mobility, the possibility of mobility, the possibility of long-distance transport, accumulation in plants, the possibility of global warming, and toxicological effects are concerns and reasons for restriction. Of these criteria, persistent is applicable to all targeted fluor organic compounds (PFAS), but other concerns relate to some compounds. Persistent, which applies to all organofluoride compounds (PFASs), can be rephrased as "high durability." longevity" by focusing on their benefits, but we believe it is not appropriate to regulate this property alone as an unacceptable risk to human health or the environment. In addition, it is not appropriate to apply concerns about some fluorinated compounds, such as bioconcentration potential and toxicological effects, by grouping all fluor organic compounds (PFAS) together. should quantitatively assess and discuss the risk of each substance. This position paper of Kuraray Europe GmbH addresses the importance of PFAS for the use as sealing materials in the chemical industry and shows the consequences that a blanket ban of the Kuraray Europe GmbH Philipp-Reis-Str. Hattersheim Germany P + F + www.kuraray.eu Registered office of the company - Hattersheim am Main Local court - Frankfurt am Main, HRB Supervisory Board - Werner Flach (Chairman) Managing Director - Dr. Matthias Gutweiler (Chairman), Jun Inoue, Keiji Taga VAT ID No. - EN Commerzbank AG - Frankfurt am Main - Sort Code SWIFT: DRESDEFF - IBAN: DE Commerzbank AG - Frankfurt am Main - Sort Code SWIFT: DRESDEFF - IBAN: DE Mizuho Corporate Bank Ltd. - Dsseldorf - Sort Code SWIFT: MHCBDEDD - IBAN: DE - Account No. - Account No. (USD) - Account No. (JPY) Page / substance groups would have for the compliance with legal requirements and plant safety. Kuraray Europe GmbH's requirements and solutions outline a pragmatic, risk-based approach to PFAS in order to take account of plant safety as well as environmental and health protection concerns. Key massage We understand that the proposed restriction proposal on PFAS is in line with the target of having "a zero-pollution ambition for a toxic-free environment" which was proposed in the "Chemicals Strategy for Sustainability -Towards a Toxic-Free Environment- (CSS)". Agreeing and supporting its concept and purpose to protect human health and the environment, we would like to point out that the currently proposed restriction raises various issues which need to be addressed in terms of scientific reasoning and socio-economic impact. Our main points of concern are listed below, and further explanation and evidence is provided later on. . Kuraray believes that chemical management should use a risk-based approach and, not solely hazard-based. In our view, any justification for a substance ban based on the precautionary principle - in this case persistence alone without any identified hazard - must stem from a thorough assessment of potential benefits and costs of such a ban, as well as the scientific evidence for the risk assessment. . Kuraray has grave concern with the idea of basing a potential REACH restriction only on the persistence. Actually, "persistent" by itself is not hazard. It should be recognized that the intrinsic property of persistence confers the desirable properties of high durability and unique functionality to products. . Kuraray believes that, if a restriction on the basis on persistence alone were to be established, this precedent would severely hamper and possibly prevent any future innovation in the chemical industry, in particular innovation aimed at durable materials. . Alternative for substance and/or substituent does not mean the direct alternative for products. Products which are used as alternative substances must meet the specifications of the original product. Furthermore, even if alternative substances other than PFAS are found, it is necessary to be mindful of the hazards and risks to human health and the environment. This could potentially lead to a different form of "regrettable substitution." . There are numerous examples of PFAS that can provide multiple necessary functionalities as a single substance. The availability of alternatives means to cover these functionalities is limited. It is crucial to ensure that necessary exemptions are not overlooked to avoid societal and supply chain disruptions. . Polymer PFAS should be reconsidered for further exemption as fluoropolymers have documented safety profiles; are thermally, biologically, and chemically stable, negligibly soluble in water, nonmobile, nonbioavailable, nonbioaccumulative, and nontoxic. Page / . Spare parts: the "repair as produced" principle should be introduced. Products need the same spare parts as those used in the first production of each product. A re-design of spare parts often also requires a re-design of the products, because otherwise the original performance (i.e. safety and durability) cannot be guaranteed. . We strongly request to establish the new system to be able to apply for further extension after the termination of the exemption period. We kindly ask to the authorities to take into consideration for the new submission system and process to enable to extend the transition period as for the RoHS exemptions. . Kuraray would also like to emphasize the importance of availability of analytical methods. Because of the difficulty in identifying which parts of complex articles to try to measure and the general lack of analysis methods applicable to the broad range of substances and matrices in which PFAS are used, enforcement of a broad PFAS restriction will not be feasible. . Kuraray would like to ask the European Chemicals Agency and the European Commission to take the above comments into consideration, and to have discussions with stakeholders and to make decisions in a clear and clear process. About Kuraray Europe GmbH Established in , Kuraray Europe GmbH is based in Hattersheim, near Frankfurt am Main, Germany. In the company generated annual sales of EUR . billion. It has more than employees in Germany at its sites in Hattersheim, Frankfurt and Troisdorf. Kuraray is a global speciality chemicals company and one of the largest suppliers of industrial polymers and synthetic microfibres for many sectors of industry. Examples are Kuraray PovalTM, Mowital, Trosifol and ClearfilTM. Kuraray Europe also has around employees at six other European sites. They are also working on the development and application of innovative high-performance materials for a wide range of sectors, including the automotive, paper, glass and packaging industries, as well as for architects and dentists. Kuraray Europe is a wholly owned subsidiary of the publicly listed Kuraray Group, which is based in Tokyo, Japan, and has more than , employees worldwide and sales of EUR . billion. Use of PFAS in Kuraray Europe GmbH Fluoropolymers and elastomers stand for safety, reliability, durability and good performance spectrum in many applications. They are non-toxic, inert, repellent, temperature resistant, chemically resistant, abrasion resistant, have low dielectric constant and are the suitable material for a wide range of industrial applications. Page / At Kuraray Europe GmbH, the following PFAS compounds are used as sealing materials in pipeline flanges, ball valves and valves, as well as in measuring equipment for monitoring chemical production plants: - PTFE (polytetraflourethylene), - PFA (polyfluoroalkoxy) - FFKM (Perflour rubber) as sealing materials In addition, PTFE is also used as an inliner in pipelines for corrosive media such as inorganic or organic acids. Requirements for sealing materials Our production facilities are subject to valid permits in accordance with the Federal Emission Control Act (BImSchG), which entails corresponding requirements regarding emissions. Furthermore, the production facilities are subject to the Major Accidents Ordinance (StV), which results in further requirements regarding plant safety. The sealing materials used in pipelines must meet these requirements. The sealing materials used must be able to cover wide temperature ranges from < C to > C. Sealing materials must also be able to withstand negative pressures of up to < bar and overpressures of up to bar, while being corrosion-resistant to inorganic and organic acids and alkalis and inert to organic solvents. Due to their broad temperature resistance, pressure resistance for various applications, corrosion resistance and resistance to organic media, PTFE, PFA and FFKM are suitable materials for ensuring plant safety in accordance with StV and for complying with legal requirements regarding emission avoidance in accordance with BImSchG and TA Luft. Polymer PFAS should be reconsidered for further exemption. A recent review states " unique families of commercially popular fluoropolymers meet the OECD Polymer of Low Concern criteria". Abstract says below: Fluoropolymers possess a unique combination of properties and unmatched functional performance critical to the products and manufacturing processes they enable and are irreplaceable in many uses. Fluoropolymers have documented safety profiles; are thermally, biologically, and chemically stable, negligibly soluble in water, nonmobile, nonbioavailable, nonbioaccumulative, and nontoxic. Although fluoropolymers fit the PFAS structural definition, they have very different physical, chemical, environmental, and toxicological properties when compared with other PFAS. Even if the polymer is persistent, large molecule such as polymer cannot permeate to cell membrane. Polymer PFAS should be reconsidered as further exemption. Page / Considering that fluoropolymers are not hazardous and as a consequence cannot be associated with any risks, we believe that they should be exempted from the restriction proposal. Furthermore, these products are required in many applications linked to several major EU projects (Green Deal, Decarbonization, Chips Act, etc...), and a complete ban of fluoropolymers would have a tremendous negative impact for EU's innovation projects and its overall economy. Alternatives to currently used fluoropolymers and fluor elastomers For the fluoropolymers and fluor elastomers currently in use, there are currently no unrestricted alternative materials. The extent to which this will change in the coming months, or or years, cannot be estimated. Since there are no similar universally applicable alternatives to date, the environmental impact due to alternative sealing materials would be many times higher. In addition, the cost-intensive tests currently underway with regard to the new TA Luft (issued by the German Federal Ministry for the Environment), based on ISO - (type testing of valves with regard to fugitive emissions) would become obsolete. New alternative sealing materials must also meet the requirements of ISO -. PFAS emission control measures The fluoropolymers and elastomers used are non-toxic, inert, repellent, temperature resistant, chemically resistant and abrasion resistant, and are used as sealing materials. Proper installation and use, as well as regular inspection of the condition, ensure that no unintentional release into the environment occurs. To date, no PFAS compounds have been detected in the company's wastewater either. Replaced gasket materials are disposed of properly via the waste incineration plant. The hydrofluoric acid (HF) produced in the incineration process is separated from the waste gas stream of the waste incineration plant via flue gas cleaning systems, so that there is no emission into the environment. Socio-economic effects of the restriction In addition to the consequences for plant safety and the impact on the environment mentioned in the previous paragraphs, there are further socio-economic implications. Assuming that suitable substitute materials to the currently used fluoropolymers and elastomers are developed and made available, the effort and cost of replacing the currently used materials will result. Based on the Page / number of seals used, material costs alone will amount to several million euros, plus additional costs for service providers and production losses due to production downtimes. Due to the energy and raw material costs in Europe, there is already a disadvantage for our sites in Germany. The additional costs and expenses incurred with the ban on PFAS compounds will further exacerbate this. This may lead to further reductions in production in Germany and, in the worst case, result in plant closures. For our customers, this means further disadvantages in the supply chain as a first step. Conclusions and proposed solutions Fluoropolymers can be classified as PFASs based on their molecular structure. However, their toxicological and ecotoxicological profile is essentially different from the majority of PFAS substances. Fluoropolymers that meet the OECD criteria of PLC (=polymer of low concern) are non-toxic, nonbioavailable, non-water soluble and non-mobile molecules and are judged to have no significant impact on the environment and humans Fluoropolymers and fluor elastomers make a significant contribution to plant safety and minimization of environmental impact in the chemical industry. As things stand today, a ban on these as a material in the chemical industry would lead to a deterioration compared with the current status quo. The stability of fluoropolymers can be directly translated into unique and durable performance properties in many applications. In addition to the large-scale application in the chemical industry as a sealing material, also for the new megatrends such as green hydrogen, G data transmission or e-mobility, fluoropolymers represent the suitable basis on which these innovations become possible in the first place. The PFAS-REACH restriction proposal provides for a far-reaching total ban on the production and use of a very large number (approx. , - , ) of substances. Within the scope of this group regulation, almost risk-free, merely persistent chemicals/materials are also covered and thereby put on an equal footing with substances of very high concern ("SVHC") and their properties requiring regulation. The substance grouping in the context of PFAS was established on the basis of chemical structural elements. Criteria for regulation, e.g. toxicity, behavior in the environment, accumulation, toxicity for animals and plants were not criteria. We therefore consider an approach on this grouping basis for regulatory purposes to be unsuitable or dubious. Page / We reject this undifferentiated approach of group regulation and urge the responsible government representatives in the Federal Republic of Germany and in the European Union to exempt the fluoropolymers recognized by the OECD*) as safe materials ("PLC" = Polymer of low concern) as well as the materials necessary for their production from PFAS regulation or application restrictions. With kind regards Kuraray Europe GmbH Dr. Jrg Schappel Director Safety, Health & Sustainability