Document rBRBbEvjOaOk8xdd6NgdXJboa

VDMA Welding and Pressure Gas Equipment Statement on the regulation of PFAS under the Reach Regulation Consultation process from 22.03. - 25.09.2023 The Mechanical Engineering Industry Association (VDMA) represents around 3,600 member companies in the medium-sized mechanical and plant engineering sector in Germany and Europe. Within this organization, the Welding and Pressure Gas Equipment Association forms the network of oxyfuel technology manufacturers who use non-electric welding processes with fuel gas (e.g. acetylene and oxygen). The corresponding products include gas cylinder valves as well as pressure reducers, hand cutting torches, brazing systems and safety devices such as flame or flashback arrestors. The companies we represent use per- and polyfluoroalkyl substances (PFAS) primarily as a material in seals, but also in membranes and hoses. To the background On March 22, 2023, the six-month public consultation period on the restriction project provided for in the REACH Regulation was launched. According to the systematics of Annex XVII of the REACH Regulation, the manufacture, placing on the market and use of PFAS would potentially be affected by a future restriction. The VDMA Welding and Pressure Gas Equipment Association stands for a sustainable world and basically supports the central idea of substituting materials and substances hazardous to health as well as the goal of no longer allowing PFAS classified as very hazardous (for example CMR, PBT, vPvB, PMT, vPvM or as ED) to enter the environment. In this respect, regulation of these PFAS classified as very hazardous is fundamentally correct. VDMA e.V. Lyoner Str. 18 60528 Frankfurt am Main, Germany Phone E-Mail M@vdma.org Internet https://vdma.org/sdg Reg. of Assn. Local Court Frankfurt/Main, No VR4278 Welding and Pressure Gas Equipment Association Chairman: Gerd Weissenfels Managing Director: Dr. Laura Dorfer Machinery and Equipment Manufacturers Association Fluoropolymers in the field of welding and pressure gas equipment The applications of plastic materials in the field of welding and pressure gas equipment primarily involve the use of fluoropolymers. These are high-performance plastics that are characterized by particularly high resistance. They have sealing and water-repellent properties, reduce friction and prevent the adhesion of substances. These include above all the widely used fluoroplastic PTFE (polytetrafluoroethylene, also known as "Teflon") or FKM ("fluororubber"). They are used in seals and diaphragms, among other things, and are also used in particular where extreme conditions prevail: High temperatures, heavy abrasion or aggressive, chemical conditions. There they also play a major role in preventing leaks (e.g. toxic intermediates in the chemical industry). However, some fluoropolymers have been scientifically evaluated as "polymers of low concern" (PTFE, ETFE, FEP, PFA, PVDF and VDF-co-HFP). They have been shown to be chemically stable, non-toxic, non-bioavailable, non-water soluble and non-mobile. For these reasons, the fluoropolymers are even approved as food contact or medical device materials. In addition, Henry et al. (2018) state that all fluoropolymers should be considered "polymers of low concern"1. These rather non-hazardous substances are safely contained in the valves and devices and remain there for many years without posing any risk to the environment. Even after the end of the product's life cycle, all components are recycled if possible, but in any case at least disposed of properly. Demand: Exempt fluoropolymers from restriction projects Against this background, the VDMA Welding and Pressure Gas Equipment Association calls for the general exemption of fluoropolymers, which (incidentally also according to the OECD definition) are generally considered "polymers of low concern", from the PFAS restriction project. In addition, substances such as monomers and processing aids that are required for fluoropolymer manufacture and production should be exempted from the ban, provided that safe use is ensured. This is also provided for in the study by the British Health and Safety Executive (HSE) 2. Therefore, in general, low-risk groups (e.g. fluoroelastomers, fluoropolymers assessed as "polymers of low concern") or uses without relevant risk (e.g. uses in closed systems), should be exempted. 1 Henry, B. J; Carlin, J. P; Hammerschmidt, J. A; Buck, R. C; Buxton, L W.; Fiedler, H.; Seed, J.; Hernandez, O. A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers. Integr. Environ. Assess. Manage. 2018, 14 (3), 316-334.) 2 https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf - 2 - Fluoropolymers indispensable In welding and pressure gas technology, fluoropolymers are a non-substitutable component of valves, devices and equipment, or of their components. This is especially true for seals: Without them, safe processes are not possible. Here, there are currently no alternatives to the use of materials classified as "polymers of low concern" that exhibit similar resistance over a comparable period of time. However, these are of the utmost importance, especially in welding and pressure gas technology, because here it is a question of protecting the equipment and the user, who, among other things, works in potentially explosive areas where a potentially explosive atmosphere can occur if, for example, a mixture of gases, vapors, mists or dusts (e.g. during welding work) combines in such a way that it can ignite. Permanently resistant seals in the products used and in the respective safety devices are indispensable for the protection of people and the environment there and in general when using oxyfuel technology. Incidentally, the manufacturers of products used accordingly already comply with the EU ATEX directives in the field of explosion protection, namely the ATEX Directive 2014/34/EU and the ATEX Operating Directive 1999/92/EC. In addition, the European Pressure Equipment Directive 2014/68 EU, which must also be complied with, contains requirements for materials regarding to their resistance and aging in Annex I, Paragraph 4.1 b and c. Alongside other measures, this has made a significant contribution to keeping accidents to a minimum. This success would be jeopardized if PFAS-containing seals used to date were to be replaced by inadequate alternatives. At this point, we would like to point out that possible alternative materials must first be developed and then tested. As part of a holistic approach, it must first be determined whether there are any equivalent substitution options at all that not only comply with technical regulations (national and international regulation as well as standardization), but also have the same level of technological maturity and fulfill the respective safety aspects. These processes not only cost a great deal of money, but also take years to complete, let alone because of the long-term testing required. In addition, there is a risk that the overall service life of products without the previously used fluoropolymers will be shortened, because alternative materials simply do not have comparable resistance. The consequence would be that valves, devices and equipment would have to be replaced more often and disposed of or recycled at great expense, which would be significantly less sustainable and thus also contradict the idea of the European Green Deal. - 3 - Consequences of a ban on fluoropolymers If the PFAS-containing materials such as PTFE, which were previously used primarily for seals, are banned, this will therefore pose a danger to users such as welders: If seals with lower resistances no longer fulfill their function, there is a risk of leaks and safety hazards that can have fatal consequences. However, the economic effects of a ban on fluoropolymers should not be ignored: Without PFAS-containing seals, diaphragms and hoses, equipment, valves and devices in the welding and pressure gas technology sector simply do not function, and a very central key industry would be threatened. The example of a medium-sized German manufacturer of safety valves, which are used in buildings as well as in industrial plants and in the supply of technical gases, shows how dramatic the consequences for individual companies can be. The company could not currently offer valves without PFAS-containing seals due to a lack of alternatives. This would affect 70 percent of all valves sold by the manufacturer, which account for 55 percent of total sales - an economic disaster that would acutely threaten not only jobs but also the future of the entire company. To avert such damage to our society and industry, fluoropolymers such as PTFE must therefore also be excluded from PFAS regulation in the context of welding and pressure gas equipment for the reasons stated above. Frankfurt, 08/25/23 Kind regards Dr. Laura Dorfer Stefan Oberdrfer - 4 -