Document 4J2YkadGkoxyqR0BxRZx1RdDN

REACH restriction PFAS Ensure continuity and safety of chemical, pharmaceutical, bioscience production processes BCR 28/03/2023 Director product policy Director Industrial & Medical Gases @essenscia.be BASF Antwerpen NV Material expert 1 Federatie van de Belgische chemische industrie, life sciences en kunststoffen 60% are SMEs 2 Current PFAS restriction proposal concerns Restriction = "PFAS shall not be manufactured, used (?) or placed on the market" Derogations: use-specific and time-limited (18 months transition + possible 5 or 12 yr derogation) PFAS definition: description of the group of substances too broad The use/placing on the market of fluoropolymers in the chemical, pharmaceutical, life sciences sector in process installations and equipement is not listed nor evaluated in the Echa-report. so far no derogations foreseen for this use or placing on the market need derogation/exemption to continue production processes & installations Process installations and equipment Lab equipment Spare parts ... 3 PFAS = wide diversity of substances with different properties Per- and Polyfluoroalkyl Substances - Stable bonds - Not the same hazards a wide diversity of molecules with different properties EU Commission Chemicals Strategy for Sustainability Staff working document PFAS (Oct 2020) OECD PFAS terminology guide: not all PFAS the same "It should be noted that this general PFAS definition is based only on chemical structure, and the decision to broaden this definition compared to Buck et al. (2011) is not connected to decisions on how PFASs should be grouped and managed in regulatory and voluntary actions." (p8) "As PFASs are a chemical class with diverse molecular structures and physical, chemical and biological properties, it is highly recommended that such diversity be properly recognized and communicated in a clear, specific and descriptive manner. The term "PFASs" is a broad, general, non-specific term, which does not inform Reconciling Terminology of the Universe of Perand Polyfluoroalkyl Substances: whether a compound is harmful or not, but only communicates that the compounds under this term share the same trait for having a fully fluorinated methyl or Recommendations and Practical Guidance (oecd.org) methylene carbon moiety." 6 OECD PFAS terminology guide: not all PFAS the same Chapter 3: "As shown above, PFASs are a chemical class with diverse molecular structures (e.g. neutral, anionic, cationic or zwitterionic; with or without aromatic rings; non-polymers or polymers; low molecular weight or high molecular weight) and thus diverse physical, chemical and biological properties (e.g. involatile or volatile; water soluble or water insoluble; reactive vs. inert; bioaccumulative or non-bioaccumulative). Therefore, it is highly recommended that such diversity be properly recognized and communicated in a clear, specific and descriptive manner. The following sections aim to provide practical guidance to governments and other stakeholders on how to use the PFAS terminology, starting from the distinction between the general definition described here and user-specific working scopes of PFASs." Reconciling Terminology of the Universe of Perand Polyfluoroalkyl Substances: Recommendations and Practical Guidance (oecd.org) 7 C-F stable bond The C-F chemical bond is one of the most stable bonds in organic chemistry leading to superior chemical resistance against acids, caustics, solvents, oxidizing materials etc. By definition any possible future alternative with the comparable chemical stability will carry the risk of very high persistence. Current draft annex XV report: No difference is made in approach between structural long-lifetime materials (for example gaskets, mm-thick liners) and liquids/gases (foaming agents, lubricants, anti-stick sprays,...). 8 Process equipment and installations Process continuity and safety to be guaranteed Fluoropolymer materials need to be exempted/derogated Current use of Fluoropolymers in the chemical industry From very small and widely used... Gaskets, joints, sealants, seal rings,... for example in valves 44% of all valve types (>2000 valve types) are impacted Detailed analysis on 2 recent world-scale plants Number of valve types installed Total Number of valves installed % of Total number of installed valves Impacted by Restriction 261 52.000 135 93.000 70% 83% Small components & small volumes/tonnes, but large numbers and huge impact on industry 10 Current use of Fluoropolymers in the chemical industry From very small and widely used... Gaskets, joints, sealants, seal rings,... for example in valves 44% of all valve types (>2000 valve types) are impacted Detailed analysis on 2 recent world-scale plants Number of valve types installed Total Number of valves installed % of Total number of installed valves Impacted by Restriction Valve types 261 52.000 70% 135 93.000 83% Small components & small volumes/tonnes, but large numbers and huge impact on industry Not Technically Tight Technically Tight The restriction has a more than proportional impact on the Technically Tight Valves (Technically Tight = TA-Luft-qualified = low fugitive emissions) Approx. half of the (>2000) valve types is qualified as Technically Tight and these are specifically used on critical products Possible risk/impact of implementation on fugitive emissions is currently unclear 11 Current use of Fluoropolymers in the chemical industry ...to very large & specific applications Linings (mm-thickness) in pipes, valves, pumps, measurement devices,... up to vessels, columns and complete plant sections to protect from corrosion (eg HCl, H2SO4, HNO3, caustic service,...). Widely used in analytical equipment as gasket or tubing. Under these severe corrosive conditions currently no alternatives are available. 0,8 m 26m 12 Alternatives possible? For some applications in theory alternatives are possible, however feasibility of implementation needs further investigation. For other applications alternative materials are not resistant at all or have only limited lifetime, resulting in increased safety and reliability risks. For some applications, glass lined piping and equipment could be an alternative, however glass lined material has to be flanged and is much more brittle, requiring Soft gaskets (only fluoropolymers possible) Flexible expansion bellows on the main connections (only fluoropolymers possible) Currently no superior materials are available (compared to fluoropolymers) fulfilling the necessary functionalities. By definition any possible future alternative with comparable chemical stability will carry the risk of very high persistence. 13 conclusion Responsible Care conclusion Restriction should be risk based and enforceable Understandable scope Analytical methods Avoid double regulations (F-gases, medical products, PPPR, BPR, ...) Secure industrial uses of fluoropolymers in the chemical, pharmaceutical, life sciences sector in process installations and equipement via a derogation/ exemption. 15 1. essenscia Belgian Federation for Chemistry and Life Sciences Industries Bluepoint Boulevard Auguste Reyerslaan 83 B-1030 Brussels Tel + 32 2 238 97 11 FOLLOW US ON www.facebook.com/essenscia D @essenscia_NL / @essenscia FR ED linkedin.com/cornaany/essenscia/ Discover ourwebsite on www.essenscia.be Subscribe to receive your essenscia weekly newsletter and our press releases. Responsible Care' Internal