Document qkMLZ8o8dgNKb0NR6ae4JL6pR

DRAFT MINUTES Meeting: Date & time: Place: Attendance Workplace FPP4EU Collaboration Platform 30 March 2023; 10:00-15:00 (CET) Thon Hotel EU, Brussels (Belgium), meeting room: Germany Virtual meeting via Microsoft Teams List of attendees on pages 7-11 Link to minutes and presentations are here 1. Welcome and Antitrust Guidelines welcomed the participants of the Collaboration Platform ("the Platform") and reminded them that the meeting should be conducted in respect of the Cefic antitrust guidelines. took the floor to give a welcome message. He underlined the importance of the wide EU PFAS restriction proposal for future regulations and called on downstream users to bring their data to the table. He also invited them to ask authorities for intelligence in order to help them fill data gaps where needed within the 6-month deadline. 2. Approval of proposed Agenda reviewed the key topics for discussion, as included in the agenda (meeting presentation attached in Annex 1). 3. The PFAS restriction proposal explained by the dossier submitters (Norwegian Environment Agency, Dr Audun Heggelund, Senior Adviser, Section for Chemicals) provided the participants with an overview of the REACH Regulation, the main aspects of a restriction proposal under this Regulation and also of the timeline regarding the work on the Universal PFAS (U-PFAS) restriction done thus far by the 5 Competent Authorities. ECHA's Public Consultation opened on 22 March and will run until 25 September 2023. Following the opinions from the Agency's scientific committees, RAC and SEAC, a decision by the Commission together with the member states is expected in 2025 or 2026. ECHA will also host a webinar on 5 April to answer to questions related to the U-PFAS restriction. He continued with the main reasons on why PFAS have gathered so much attention globally in recent years and the main concerns around them; persistence, mobility, bioaccumulation, ecotoxicity and accumulation in plants among others. The main human health effects associated with specific PFAS exposure include reduced immune response, liver damage, disturbed metabolism and developmental effects among others. also presented an overview of the hazard assessment for PFAS and the potential ways they end up in the environment or in contact with humans. 1 DRAFT MINUTES He described the main functions of PFAS, the sectors where they are mostly used and the emissions to the environment. Alternatives are already adopted in many sectors and uses. For some sectors alternatives are already identified but more time is needed to develop them and for other ones research and development is still needed. Finally, provided specific information on the U-PFAS restriction and opened the floor for questions from the audience. 4. Q&A session with the data submitters Q: The reporting obligation for downstream users refers to the uses in substances and mixtures and not articles. Is that correct? A: The producer of the article is responsible for the reporting. Q: How will the U-PFAS restriction work with other ongoing and finalised restrictions, as well as with the POPs Regulation? A: This restriction proposal does not overrule other PFAS regulations in the EU. All legislation currently in force, will continue to apply. Q: Have the dossier submitters taken into account the need for PFAS lubricants that help all machinery run properly, next to their use in important sectors? A: It is recognised that certain applications are very important for the society. The proposal is based on the information that has been assessed, which can be found in the dossier. In case there appear to be wrong statements or conclusions, all are invited to submit this information in the public consultation. The dossier submitters strongly welcome such submissions. Q: Sectors like the medical devices industry are very worried about the use of alternatives. Health issues may occur when alternatives are underperforming. This raises two questions: 1) Why have not all medical devices been exempted? 2) How can different sectors prove that they have sufficiently looked for alternatives? A: In relation to the second question, a justified explanation is needed. It can be explained technically, and the information does not need to be very long. A few pages explaining the problem and the research and development efforts done towards alternatives, may suffice. When assessing alternatives, information from other stakeholders within the same sector is very important. Coming to the first question: for medical devices, alternatives have been assessed. No general derogation was granted, but rather a large number of specific derogations. Q: What about PFAS used in industrial settings? A: It is very important that this information is submitted in the public consultation, so that it can be assessed properly. Q: How will this dossier be handled from a review process and how can it be ensured that all the different comments that will be provided will be assessed in the right way? A: The meetings will start in June. ECHA will provide guidance on how to proceed with the discussions. 2 DRAFT MINUTES Q: In some cases, PFAS alternatives such as asbestos, can also be dangerous. What about those cases? A: Industry is advised to provide detailed information into the public consultation, and it will be assessed. Q: How can we prove that lubricants for example are used under `harsh conditions'? A: There is an explanation of `harsh conditions' in the dossier. If, during a site visit, a company can show to the enforcement authorities how their production process works, they would be in a position to assess whether these conditions are fulfilled or not. Q: Is there a possibility for modifying the assessment process to allow more meetings and more consultations? By not taking sufficient time, there may be no fair assessment of alternatives, with regrettable non-PFAS substitutions as a consequence. A: The 5 Competent Authorities held Calls for Evidence and now ECHA will organise the public consultation and follow their process. They will provide guidance and there will be a public consultation on SEAC's opinion at a later stage. As the dossier submitters are not in the position to alter the upcoming process, ECHA would need to respond to this question. Q: There is a clear request for concise information to be provided in the public consultation, but at the same time the need for extensive data is expressed. How can companies deal with this issue? A: The dossier submitters encourage multiple companies to submit joint information. On the one hand, it makes clear what part of the sector is affected by the issue, and on the other hand, quantitative aggregated data allow to understand the impact on the entire sector. Q: For this public consultation there is no early deadline for comments. Is there a specific reason for his? A: The reason why there is no early deadline for submission to the public consultation is that many responses are expected and ECHA wants to streamline the work in the best possible way. It is also common that companies who submit data in the early deadline, submit again at a later stage. Q: Data on the development of alternatives will commonly be submitted under confidentiality. This cannot be done at sector level. Viewing that alternatives may be protected by intellectual property, participants ask how they should communicate them. A: It is possible to submit confidential information to the process, but all are encouraged to submit the information openly to the extent possible, as this is fairer to the process. The more everyone can see what the arguments are with regard to alternatives, the better. Q: How are alternatives assessed? A: Information from different stakeholders is combined and availability is considered. It is acknowledged that, in some cases, the conditions within the same use category can be different. In those cases, it is very important to submit detailed information on why the assessed alternative does not work for a very specific application. 3 DRAFT MINUTES Q: Why are fluoropolymers in scope of the PFAS restriction? A: When assessing fluoropolymers, the dossier submitters looked into the whole life cycle and concluded that fluoropolymers were of concern. There can be emissions during their manufacturing, use and waste stage as well. Q: In the proposal there are derogations for specific applications, but the intermediates to produce these products are not derogated. How can Europe remain resilient and maintain its strategic autonomy if that is the case? A: This is a misunderstanding. If a use or an application receives a derogation, then this derogation applies to the whole supply chain. If an application for a membrane is derogated, it should be possible to manufacture it. An explanation regarding this issue will be added. Q: Would a derogation for fluoropolymers be possible if industry can prove that all concerns of the whole life cycle are addressed in the right way? A: The authorities will take the provided detailed argumentation into consideration and evaluate it. Q: What does the transportation derogation exactly include? A: This derogation refers to any vehicle used for transportation of goods or people. It thus includes cars, buses, trains, airplanes, ... Q: Have submissions been sent that took the entire value chain into consideration? A: Improving the information flow and communication throughout the entire value chain is key. Importers and producers are expected to know the chemical content of their products and the required information should be flowing through the supply chain. Data submitters received iinformation from different parts of the supply chain and put it together to obtain a better view. Q: Food contact materials are derogated, but food manufacturers also need water purification systems. Does this derogation also relate to water and wastewater systems? A: This requires an additional check. Water might be covered but wastewater is not. If companies provide sufficient and convincing data in the public consultation, a specific derogation for this application may be added. 5. PFAS downstream users' views on the restriction proposal 5.1 "A DIGITAL View on the PFAS restriction" - Kim Jansen, DIGITALEUROPE described the impact that the U-PFAS restriction could have on the EU's digital sector. There are many uses of PFAS in this sector, which is also characterised by the complexity of its supply chain. Even a simple circuit board contains dozens of different components. There are no drop-in alternatives for most applications and in many cases, there is no alternative for PFAS yet (e.g., Li ion batteries). Once an alternative is available, the product redesign normally takes a minimum of 24 months. Apart from the proposed 12-year derogation for the semiconductor manufacturing process, no derogations for the 4 DRAFT MINUTES electronics sector were included in the proposal. Use and emissions from electronics are less than 1% of the total PFAS use and emission. 5.2 "Safety vs Regulation?" - Triin Kaup, EURATEX provided an overview of the U-PFAS restriction's repercussions for the textiles industry. The European textile and apparel industry covers a diverse manufacturing scope, including clothing, home textiles, technical textiles, medical textiles, PPE, etc. The sector mostly uses PFHxA (C6 chemistry), the only technically feasible and available alternative to the already restricted C8 that can deliver the needed safety and performance standards. described the current derogations in the proposal, relevant to the textiles industry and highlighted some that they believe are missing, as well as a EURATEX proposal to address those issues. 5.3 "PFAS in the medical technologies sector - MedTech Europe's preliminary views on the Restriction pre-publication" - Roumiana Santos, MedTech Europe presented MedTech Europe's preliminary views on the pre-publication of the PFAS Restriction. Medical technologies are invasive and/or come into contact with the human body. Therefore, they are strictly regulated for their safety, design, performance, quality and risk management. Individual devices differ greatly in complexity; it is not uncommon for routinely used devices to have hundreds and thousands of components and parts. PFAS substances are often key to achieving the required high performance and durability of the products in the various use areas. Sometimes, the alternative is also another type of PFAS. highlighted some issues regarding the absence of derogations for the sector in the proposal and showcased future actions foreseen by the medical technology sector to help the authorities gather more information. 5.4 `'The Unique Role of Fluoropolymers in Sealing Devices'' - Mark Neal, European Sealing Association gave a presentation on the role of fluoropolymers as a representative of the sealing industry. He highlighted that all of 50 members of the European Sealing Association have a technical department and/or research functions engaged in assessing the suitability of sealing materials to meet the conditions and approval requirements. The sealing materials chosen are very application specific, heavily researched and understood. He stressed that fluoropolymers are used when there are no alternatives available, since they provide chemical resistance, thermal capability (high/low), mechanical integrity and low coefficient of friction among others. also stated that the current restriction proposal has no recognition of the crucial role of fluoropolymers, no reference to sealing devices and no reference to maintenance and repair requirements. 6. PFAS producers'/large users' views on the restriction proposal 6.1 `'Fluoropolymers comments on the PFAS REACH restriction'' - Nicolas Robin, Plastics Europe Fluoropolymer Product Group (FPG) shared the view of Plastics Europe's Fluoropolymers Product Group (FPG) with regard to the PFAS restriction. He noted that the proposal makes limited reference to the fact that fluoropolymers have very different hazard profiles to other PFAS substances. FPG member companies continue 5 DRAFT MINUTES investigating and developing R&D programs for the advancement of fluoropolymer production technologies, allowing for a transition away from using PFAS based polymerisation aids. Many critical applications where fluoropolymers are used are not proposed for derogation and will be banned 18 months after entry in to force. FPG understands the regulatory concern related to emissions during manufacturing and at end of life. 6.2 `'Universal PFAS restriction and possible impact on F-gases'' - Elisa Consoli, European FluoroCarbons Technical Committee (EFCTC) discussed the PFAS restriction proposal from the point of view of the F-gases producers and large users. Although F-gas emissions may have an impact on climate change due to their global warming potential (GWP), equipment containing F-gases is considered safe and energy efficient. They will play a key role in decarbonising critical European industries relying on heating and cooling technology. continued with an overview of the proposed derogations for F-gases included in the restriction proposal. She also provided the audience with some information on the revision of the F- gas Regulation, scheduled for vote in the European Parliament's Plenary Session. The group is currently liaising with downstream users and associations to provide support in understanding the possible restriction and has also funded an independent socio-economic assessment and a Regulatory Management Option Analysis of F-gases for input into the ECHA process. 6.3 ''Universal PFAS restriction and FPP4EU views'' - Patricia Muoz, FluoroProducts and PFAS for Europe (FPP4EU) restriction: outlined the key requests mentioned in FPP4EU's position paper on the U-PFAS Avoid missing PFAS uses: all PFAS uses need to be assessed to avoid supply chain disruptions and to ensure that key applications are not unintentionally eliminated. Add a time unlimited derogation on PFAS used in industrial settings to avoid banning the use of critical PFAS-containing pieces of equipment in industrial plants. Further reflect on the key fact that not all PFAS are the same. Address primary and secondary financial impacts of the proposal along the entire value chain. Consider the drive for a competitive, resilient and sustainable Europe. Robustly review the enforceability of the proposal considering the sheer number of end products and substances that will have to be checked at EU borders. 7. Closure reminded that workshops such as this one, bringing all stakeholders and authorities together to exchange opinions, were the reason that the Collaboration Platform was created. He thanked all presenters and participants and closed the meeting at 15:05 CET. 6 DRAFT MINUTES LIST OF PARTICIPANTS Meeting: FPP4EU Collaboration Platform Date: Place: 30 March 2023; 10:00-15:00 CET Thon Hotel EU, Brussels (Belgium), meeting room: Germany Virtual meeting via Microsoft Teams Watson-Marlow The Boeing Company Axplora Dynamit Nobel - EFCG Adisseo Bundesanstalt fr Arbeitsschutz und Arbeitsmedizin Baua Cefic Eastman Chemicals Preservation Technologies LLC Norwegian Environment Agency German Lubricant Manufacturers Association VSI-Schmierstoffe Arkema France DG GROW FEIQUE Merck KGaA Lanxess - Eurofluor DG Environment Cefic Watson-Marlow Fluid Technology Solutions Tesla AGC Hydrogen Europe KEMI Lanxess - Eurofluor Kingspan Derivados del Fluor - Euroflour Arkema France Cefic KEMI Austrian Federal Economic Chamber ExxonMobil BP Cefic Euromcontact BASF Evolis 7 DRAFT MINUTES NuclearEurope EPEE European Heating Industry TotalEnergies Solvay RIVM EHPA Cefic Inventec Dehon Akzo Nobel FR Ministry for ecological transition PU Europe Contamac Textil Mode FCIO Fachverband der Chemischen Industrie sterreichs IOGP Europump European Association of Pump Manufacturers Federazione Gomma Plastica - ETRMA Viatris Cefic Orgalim APQuimica EUPC DuPont ACEA Gujarat Flurochemicals Leoni Kabel Zeiss JCI Johnson Controls Department of Enterprise, Trade and Employment, Ireland Norwegian Environment Agency Bayer BMW Group Parker Hannifin Manufacturing Germany KEMI Arkema IPC International Cefic Digitaleurope-Canon KEMI Nuclear Europe Eastman Solvay TotalEnergies Lubrifiants 8 DRAFT MINUTES The Danish Environmental Protection Agency VCI Gujarat Flurochemicals Aspen Oss - EFCG Euratex Solvay VDMA Europump European Association of Pump Manufacturers Flemish Department for the Environment ACEA KEMI Smiths Eurofeu SICOS Cefic IOGP ETRMA EFPIA Trioworld Emulseo Solvay APPLIA Solvay Cefic P&G EFPIA - Lilly Cefic BDI ZVEI - Zentralverband Elektrotechnik- und Elektronikindustrie e.V. Cefic Japan Business Council in Europe (JBCE) Intel Ireland Daikin Cefic ESIA Aflex Hose Cefic SPECTARIS Daikin European Sealing Association Elanova - ETRMA ExxonMobil Petroleum & Chemical BV Cefic Cefic 9 DRAFT MINUTES Chemours Medicines for Europe Emulseo P&G W.L. Gore & Associates GmbH W.L. Gore & Associates GmbH IOGP Veolia France Chimie PlasticsEurope FoodDrinkEurope Olon S.p.A. Smiths Group Daikin CEPE MedTech Europe Cefic 3M IPC ABB pro-K Industrieverband Halbzeuge und Konsumprodukte aus Kunststoff e.V. Merck KGaA Olonspa ExxonMobil 3M DIGITALEUROPE FEC Federation of European manufacturers of Cookware and cutlery P&G IPC International ZCHFP SR - Association of Chemical & Pharmaceutical Industry of the Slovakia Solvay MAVESZ Apple ACEA French Federation of Mechanical Engineering Industries (FIM) EIGA (European Industrial Gases Association) Zoetis RIVM European Safety Federation DuPont Medicines for Europe DuPont Deutschland Holding GmbH & Co KG Estonian Chemical Industry Association BP 10 DRAFT MINUTES Parker Hannifin Manufacturing Germany American Chemistry Council Confederation of Danish Industry (DI) 11