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PUBLIC VERSION Chapter 1: General comments on the restriction option analysis and scope of the restriction proposal Chapter 2: Hazard Assessment Chapter 3: Environmental emissions Chapter 4: Analysis of alternatives and socio-economic analysis Chapter 1: General comments on the restriction option analysis and scope of the restriction proposal Solvay Specialty Polymers PUBLIC VERSION The aim of this first submission is to provide Solvay Specialty Polymers' high-level view on the PFAS restriction proposal recently published under the framework of Regulation (EC) 1907/2006 (`REACH'). Solvay Specialty Polymers (from here on simply referred as Solvay) understands the public concern around PFAS and has been taking actions to address those concerns. Most importantly, we have been innovating to find alternatives for those PFAS that may trigger concerns, which is why our focus has been on phasing out the use of fluorosurfactants. Over the last years Solvay has been very proactive in developing new polymerization processes (Non-Fluorosurfactant technologies, NFS) that no longer require the use of fluorosurfactants in the manufacture of some very specialized FPs. Since 2019 we have heavily invested in the development of NFS products and we are fully committed to the transition of more than 99% of our FPs portfolio to NFS technologies by 2026. For the remaining 1% of our portfolio, our Research and Innovation (R&I) teams is investing consistent resources to find a viable alternative. We also want to show that FPs and PFPEs manufacturing plants have made tremendous progress in terms of emissions, notably in the last years, and today these are state of the art plants with emissions levels reduced to the maximum extent possible and very strict regulatory monitoring. Finally, with the increasing transition from linear to a circular economy, we are pleased to share multiple projects that Solvay is developing with downstream users on new recycling technologies which will bring future solutions to the End of Life (EoL) of FPs and PFPEs. We believe that a PFAS restriction should outline a clear segmentation between the different PFAS families and that risk mitigation strategies should be directly proportionate to the (eco)tox profile of the families to be regulated. Proposing a "one-size fits all approach" for all PFAS is not scientifically or legally supported, and risks having a tremendous negative impact on the competitiveness and existence of the industry (in the EU and beyond) as well as on the implementation of the European energy transition ambition. Additionally, using solely the persistence property ("p-factor") as criteria to justify an EU ban does not find validation in EU law, where persistency per se is not defined as a hazard. Lastly, we must consider that persistency does not necessarily correlate with a negative connotation, as persistent products are more durable, hence reducing the frequency of replacing with new articles and also allowing recycling. We, Solvay, are committed to provide during the public consultations information with regards to the hazard profile of our products, the emission of our plants, the progress we make on our product's End of Life (EoL) and the socioeconomic impact of such broad restrictions on our business. We believe that fluoropolymers (FPs) and perfluoropolyethers (PFPEs) manufactured without fluorosurfactants present low hazard to human health and the environment. With the present submission we intend to promote a sciencebased discussion about the universal PFAS ban among stakeholders, and provide scientific and solid evidence to facilitate the development of rational and scientifically grounded opinion. Fluoropolymers (FPs, incl. fluoroelastomers) and Perfluoropolyethers (PFPEs) play a critical role in society and for a more sustainable future - including the transition to a low-carbon Europe. Solvay's products mainly serve industrial applications that contribute to a more sustainable future for our economy and the society at large, including electric vehicle batteries, hybrid vehicle engines, green hydrogen applications, renewable energy installations, semiconductor manufacturing, medical devices, and more. We believe that FPs (incl. fluoroelastomers) and PFPEs manufactured without fluorosurfactants and that fulfil the criteria of Polymer of Low Concern (PLC) should be excluded from the scope of the proposal, or should be exempted by way of a time-unlimited derogation for all uses, as they do not present an unacceptable risk that needs to be addressed at the EU level by means of a REACH restriction, due to their recognised low hazard to human health and the environment. Additionally, PFPEs not meeting all PLC criteria should be derogated according to DUs requests, where they are solely applied in industrial uses, present low (eco)tox risk according to their conditions of use and have no technically (in terms of performance) and economically feasible alternatives. The derogation should be extended to all PFAS-based raw materials (i.e. monomers, intermediates and processing aids) that are needed for the industrial synthesis of the products mentioned above, according to the outlined principles. These materials are assessed based on current requirements of REACH. Based on the same rationale, manufacture and place on the market of future products (i.e. R&I products) which are manufactured without fluorosurfactants and that either fulfil the PLC criteria or are not known to pose risks based on their (eco)-toxicological profile and conditions of use, should be considered for the same derogations as exposed above (incl. potential PFAS precursors). We, Solvay, are committed in characterizing the human health and environmental hazard properties of our R&I products according to the type of molecule during the performance of the R&I activities and prior to their release on the market. The statement and data provided in the present dossier will be further substantiated with a second submission which will take place in late August/beginning of September, where additional granularity about our products and business will be made available to the ECHA committees referenced under Articles 70 and 71 REACH and to the general public. In the second submission, further details about emissions, hazard, alternatives and socioeconomic aspects will be provided. Chapter 2: Hazard Assessment Solvay Specialty Polymers PUBLIC VERSION The restriction proposal identifies persistence as the primary hazardous concern for all PFAS covered. Since considerations about persistence are not seen under EU-Legislation as a hazard, it is questionable whether persistence alone is sufficient to demonstrate a concern. Persistence on its own is not sufficient to consider PFAS, especially fluoropolymers (FPs) and perfluoropolyethers (PFPEs), as providing an equivalent level of concern (ELoC) compared to other PBTs / vPvB substances, or to constitute an unacceptable risk which is required to justify a REACH restriction. Solvay understands the public concern around PFAS and has been taking actions to address those concerns. Most importantly, we have been innovating to find alternatives for those PFAS that may trigger concerns, which is why our focus has been on phasing out the use of fluorosurfactants. Over the last years, Solvay has been very proactive in developing new polymerization processes (NonFluorosurfactant technologies, NFS) that no longer require the use of fluorosurfactants in the manufacture of some very specialized FPs. Since 2019, we have heavily invested in the development of NFS products and we are fully committed to the transition of more than 99% of our FPs portfolio to NFS technologies by 2026. For the remaining 1% of our portfolio, our Research and Innovation (R&I) teams are investing consistent resources to find a viable alternative. Persistence is stemming from properties such as high chemical or thermal resistance. Those properties are key in numerous applications (leading to e.g. more durable articles, hence reducing the frequency of replacements and also allowing recycling). Any substitutes to FPs and PFPEs should also demonstrate a high chemical or thermal resistance, hence is likely to have similar persistence. This could lead to regrettable substitutions, should persistence be the reason for the substitution. Persistence alone does not constitute a hazard to the environment. Persistence on its own does not lead to any hazard category or classification class under the CLP Regulation. Scientific information is available concerning Solvay products falling within the scope of the PFAS restriction proposal, which are compiled here and demonstrate that there are no risks or, where there are potential risks associated to the PFAS referenced in this Chapter, they can be adequately addressed by means other than the blanket ban proposed by the submitters of the current REACH restriction proposal (see section 2.2). FPs and PFPEs have an extremely high thermal, oxidative and chemical stability, and are shown to have environmentally stable characteristics when considering either biotic or abiotic degradation pathways. FPs only exist as water-insoluble and inert solids and so are not likely to be transported in either the air or water compartment. Concerns with regards to the mobility of the majority of PFPEs can also be considered limited due to their insolubility and low volatility. In summary, FPs and PFPEs do not readily degrade and are not mobile in the environment. Due to their molecular weight, all of the FPs and many of the PFPEs are not considered bioavailable and are therefore not expected to bioaccumulate within organisms. Whilst some PFPEs do have potentially bioavailable oligomers, the occurrence of these substances is very low, and there is currently no indication that these oligomers bioaccumulate. FPs are insoluble (e.g., water, octanol) with solids too large to migrate into the cell membrane making them non-bioavailable, and therefore, of low concern from a human and environmental health standpoint despite being environmentally persistent. Published results of toxicological studies 1 do not lead to classification for repeated dose toxicity and reproduction/development toxicity. 1,2 Solvay proprietary data on the branched and linear PFPEs covering a range of average molecular weights indicate they have a low acute and sub-acute toxicity in mammalian toxicity studies following dermal or oral exposure. All the test results indicate PFPEs polymers show no relevant toxicological concern and as a result, they are not classified as hazardous under the CLP regulation (see Table 3, Table 4, Table 5 and Table 6 in chapter 2). Most of these substances (about 96%3 of PFAS manufactured by Solvay Specialty Polymers in terms of volume)) meet the criteria for polymer of low concern (PLC), and even for those not fully meeting the PLC criteria, existing evidence shows indication of non significant risk, which is adequately controlled. The PFAS included in the restriction proposal should be grouped according to hazards and the risk presented (if any). We request that Non-fluorosurfactant Fluoropolymers (FPs, incl. fluoroelastomers) and Perfluoropolyethers (PFPEs) that fulfil the criteria of Polymer of Low Concern (PLC) should be excluded from the scope of the proposal, or should be exempted by way of a timeunlimited derogation for all uses, as they do not present an unacceptable risk that needs to be addressed at the EU level by means of a REACH restriction, due to their recognised low or no hazard to human health and the environment. For those compounds that do not fully meet the PLC criteria, rather than assuming the same hazards are presented for all, a case-by-case risk assessment approach should be followed, in line with established case law of the CJEU, and risk management measures developed for the relevant applications. It is important that building blocks necessary for the production of the concerned substances (e.g. monomers already registered under REACH) also receive the same derogation/exemption for all uses. Additionally remaining risk can be adequately controlled through existing or incoming regulations (e.g., PRR regulation will cover mapping of existing polymers). 1 Henry B., Carlin J., Hammerschmidt J., Buck R. C., Buxton L., Fiedler H., Seed J., Hernandez O., 2018. A critical review of the application of polymers of low concern and regulatory criteria to fluoropolymers. Integrated Environmental Assessment and Management, 14, 316-334. https://doi.org/10.1002/ieam.4035 2 Korzeniowski S.H., Buck R.C., Newkold R.M., El kassmi A., Laganis E., Matsuoka Y., Dinelli B., Beauchet S., Adamsky F., Weilandt K., Kumar Soni V., Kapoor D., Gunasekar P., Malvasi M., Brinati G., Musio S., 2022. A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers. Integrated Environmental Assessment and Management 0, 1-30. https://doi.org/10.1002/ieam.4646 3 Reference: 2022 fiscal year 2 Chapter 3: Environmental emissions Solvay Specialty Polymers PUBLIC VERSION Within the EEA, we manufacture the FPs and PFPEs described in this dossier in two industrial plants, i.e.: Spinetta Marengo (Italy) -> a wide range of FPs and PFPEs and F-monomers Tavaux (France) ->only PVDF suspension (monoproduct) without FS Additionally, we run an R&D Centre in Bollate (Italy), focused on the development of new FPs and PFPEs and the relative manufacturing processes. One of the main advances developed in our R&D Centre are Non-Fluorosurfactants (NFS) technologies, which are substantially contributing to the abatement of fluorosurfactant emissions. The no need of use of fluorsurfactants is the first strategy to reduce emissions. Our two industrial sites covered in the present chapter (i.e. Spinetta Marengo and Tavaux) have currently implemented all recommended Best Available Techniques (BATs) to minimize and successfully mitigate F-gases, fluorosurfacts used as polymersation aid and other perfluorocarboxilic acids emissions (the 2 latter relevant only for Spinetta Marengo) during FPs and PFPEs manufacturing process. As remarked in Chapter 1, Tavaux site does not use fluorosurfactants during the manufacturing process of PVDF (suspension process). At Spinetta Marengo we use fluorosurfactants as processing aids during the production of certain FPs. As mentioned, Solvay has started an ambitious transition to Non Fluorsurfactant (NFS) Technologies which will drive to almost completely phase-out fluorosurfactants from our production process by 2026, leaving its use only in one low-volume manufacturing line where R&I is ongoing to identify a suitable NFS technology. Additionally, Solvay has invested 60 million EUR to put in place state of the art reverse osmosis and active carbon abatement technologies in Spinetta Marengo to significantly reduce fluorosurfacts used as polymersation aid and other perfluorocarboxilic acids water emissions resulting in a decline of these emissions by 50% every single year since 2018. We have also started the second step of a new abatement technology for CF4 (air emissions, CASPI1 project) which together with step 1 should result (according to CF4 emissions projected for 2023) in a reduction of about 85%, in comparison to the CF4 emissions recorded in 2018. We continue working on the roadmap to implement new treatments and abatement technologies in order to further reduce water and air emissions as far as technically possible (close to technical zero). This chapter will present data on total production volumes, the environmental emissions, treatments and abatement technologies implemented and the new BAT roadmap for Spinetta Marengo and Tavaux plants, to show the progress that have been done in reducing emissions in the last years and the efforts planned for the near future all integrated in our responsible manufacturing commitment. Moreover this chapter will present data on emissions in relation to FPs and PFPEs life cycle with a focus on recycling and disposal at the end of life. In particular we present the power of Solvay's innovation deployed to address the End of life of FPs and PFPEs, describing several Solvay's projects related to the End of Life (EoL) of FPs and PFPEs. Results clearly demonstrate how durability and 1 CF4 Abatement SPInetta 1 resistance of FPs and PFPEs allow a reuse (recycle) of these materials without release of potential short chain degradation products. Additionally, in order to investigate the inertness of our FPs and PFPEs, a series of leaching and weathering studies on our FPs and PFPEs were conducted in our laboratories. The studies performed confirmed the stability of different FPs and PFPEs under the applied leaching and weathering conditions to mime landfill disposal conditions. In conclusion, our intention is to transparently provide all figures available in our hands about PFAS to show how we have been able to significantly reduce emissions to the environment during the last years and the roadmap we have put in place to further reduce emission from our plants notably through the transition to NFS technologies and implementation of new BATs to reduce emissions as far as technically possible. 2 Chapter 4: Analysis of alternatives and socio-economic analysis Solvay Specialty Polymers PUBLIC VERSION Executive Summary Fluoropolymers exhibit a combination of properties that make them the most suitable material for a broad range of applications, where durability to extreme temperatures, aggressive chemical agents and mechanical stress are essential, together with oil- and water-resistance or low coefficient of friction. As a result, they are often the only type of materials suitable for use in applications where such harsh, extreme conditions are expected to be present. Many comments by downstream users to the restriction proposal have shown and demonstrated how, for the vast majority of uses and applications, little or no alternatives that can meet the unique properties of FPs and PFPEs are available on the market. The restriction as proposed today would have a direct impact on Solvay's production lines of FP's and PFPE's and on its related research activities in Europe. Potential impacts in terms of annual sales, cumulative capital investment and direct job losses are detailed in this chapter. Industries reliant on Solvay, such as automotive, Li-ion batteries, semi-conductor, green hydrogen, sealings and lubricants, would face significant disruptions in the EEA. These disruptions are anticipated to cause production halts, business closures and eventually an important negative impact on Europe's market position in these sectors. As a result, Europe's dependency on other countries for critical resources would drastically increase. In addition to the economic consequences, Europe's sustainability goals in areas like electrification, circular economy, and hydrogen strategy would be jeopardised due to the challenges faced by these industries. The lack of technical innovation in the semiconductor sector would also be expected to impede progress in digital transformation efforts. The critical role of FPs and PFPEs in durable sealings, along with the absence of viable alternatives in chemical plants, automotive safety, and healthcare applications, would pose risks to workers, the public, and the environment. These risks are likely to have negative spillover effects throughout the EEA. 1