Document KG2d7NJ4vrr5BgRyKLpDMz51X

CHEMICAL SAFETY REPORT PROVIDED AS COMMENTS TO THE PUBLIC CONSULTATION ON THE REACH RESTRICTION PROPOSAL ON PER- AND POLYFLUOROALKYL SUBSTANCES (PFAS) Submitted by figawa e.V. Date 22.09.2023 CHEMICAL SAFETY REPORT Table of Contents Table of Tables .................................................................................................... ii Table of Figures .................................................................................................. iii Abbreviations ......................................................................................................1 Chemical Safety Report.........................................................................................2 1. Introduction .............................................................................................2 2. DATA COLLECTION AND ANALYSIS ..............................................................5 3. COMPANIES, PRODUCTS AND COMPONENTS.................................................7 3.1. Companies & Products..........................................................................7 3.2. Components ..................................................................................... 10 4. LIFE CYCLE STAGES AND CONSIDERATIONS ON EMISSIONS ........................ 15 4.1. Manufacturing ................................................................................... 15 4.2. Use phase ........................................................................................ 18 4.3. End-of-life stage................................................................................ 21 5. SUMMARY & CONCLUSIONS ..................................................................... 25 References........................................................................................................ 27 Annex .............................................................................................................. 29 I. Process description - Selection options in questionnaire ............................... 29 II. Additional tasks reported ......................................................................... 30 i CHEMICAL SAFETY REPORT Table of Tables Table 1: Polymeric PFAS used by figawa members ....................................................4 Table 2: End-product groups and included product types ...........................................5 Table 3: Component groups and included component types .......................................6 Table 4: Estimated proportion of FPs in end-product groups in % w/w .........................8 Table 5: FP-containing components and use in end-product groups ........................... 10 Table 6: Average, estimated total FP concentrations (%) in components .................... 13 Table 7: FPs reported in components .................................................................... 14 Table 8: Process description - Assembly ............................................................... 15 Table 9: Process description - Extrusion/injection molding/casting ............................ 16 Table 10: pH ranges to which components are exposed during use ........................... 18 Table 11: Process description - Delivery and storage .............................................. 30 Table 12: Process description - Post-treatment/Quality control................................. 30 ii CHEMICAL SAFETY REPORT Table of Figures Figure 1: End-product groups manufactured within cluster.........................................7 Figure 2: Components' origin in relation to the components sub-group ...................... 12 Figure 3: Overview on contact media of components during use ............................... 19 Figure 4: Average service-life duration of end-product groups .................................. 21 Figure 5: Assumed disposal routes of end-products................................................. 22 iii CHEMICAL SAFETY REPORT Abbreviations AoA CSR ECTFE ETFE FEP FKM/FFKM FPs FVMQ HVAC LEV PFA PFAS PFPEs PLC PPE PTFE PVDF PVDF-HFP SCFPs SEA WWTP Analysis of Alternatives Chemical Safety Report Ethylene, chlorotrifluoroethylene copolymer Polyethylene-cotetrafluoroethylene Perfluorinated ethylene propylene; Ethylene, Chlorotrifluorethylene, hexafluoroisobutylene terpolymer; Polytetrafluoroethylene-cohexafluoropropylene Fluorkautschuk / Fluorine rubber / Fluorocarbon-based fluoroelastomer Fluorpolymers Fluorosilicone Heating, ventilation, air conditioning Local Exhaust Ventilation Perfluoroalkoxy polymer Per- and polyfluoroalkyl substances Perfluorpolyethers Poylmers of low concern Personal Protective Equipment Polytetrafluoroethylene Polyvinylidene fluoride Vinylidene fluoride, hexafluoropropene copolymer Side-chain fluorinated poylmers Socio-economic Analysis Wastewater treatment plant 1 CHEMICAL SAFETY REPORT Chemical Safety Report 1. INTRODUCTION This comment is submitted in the name of figawa e.V.1, the German association of companies for gas and water technologies supported by DGMT e.V.2 (German Society for Membrane Technology) and Aqua Europa AISBL3. Our members provide products and services for the utilisation and distribution of gas and liquid fuels as well as the distribution and the treatment of drinking water and water for industrial and municipal purposes including wastewater and pool water treatment. figawa has more than 275 member companies, which generate around EUR 34 billion of revenues annually. As an industry association, we bring together interests and advocate for standardized regulations and legislative processes to ensure long-term legal and planning certainty for all market participants. With our expertise, technology, and open dialogue, we aim to drive progress and innovation in our industries. Cross-cutting issues, as well as needs and requirements of our members are addressed in our industry aligned sector coordination groups. The figawa members have aligned into three clusters based on the presence of PFAS in their product portfolio and applications to provide comments for the PFAS restriction proposal. These clusters are: Water treatment (drinking water, wastewater, industrial water, water reuse, and pool water) Water supply (public infrastructure, water distribution in buildings and water measurement, distribution of thermal energy) and Gas & liquid fuels (application and distribution) To fulfil their responsibility of providing millions of private households, municipalities and industry with resources such as gas, oil, and water, our members depend on a variety of fluoropolymer-based technical components, all of which with high requirements towards their mechanical and chemical properties. This does not only guarantee a functioning infrastructure with an enormous economic impact on the European society but also the very safety of the European population. It is important to note that figawa members and the contributing DGMT members are not manufacturers of per- and polyfluoroalkyl substances (PFAS) or polymer PFAS raw material4. They mainly assemble end-products from components and are only a part of the supply-chain. They are thus not directly involved in the development process of PFASfree alternatives, which exhibit the complex set of physicochemical properties required for their products. It is additionally worth noting that due to the members' position in the supply chain, the exact composition of components in relation to PFAS is often unknown to them. Under this premise, the members identified that polymeric PFAS are of extraordinary importance for the safe and durable operation of their products, and to fulfill the high 1 https://figawa.org/ 2 https://www.dgmt.org/the-dgmt.html 3 https://aqua-europa.eu/ 4 In general, the DGMT does contain members that are manufacturers of (polymeric) PFAS 2 CHEMICAL SAFETY REPORT requirements set out in various standards (cf. AoA/SEA report submitted along with this CSR, section 1.2). Polymeric PFAS may be categorized into three groups: Fluoropolymers (FPs), Perfluoropolyethers (PFPEs), and Side-Chain Fluorinated Polymers (SCFPs) (ECHA et al., 2023a; Korzeniowski et al., 2023). Of these three classes, FPs including fluoroplastics (e.g., polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF)) and fluoroelastomers (e.g., fluorine rubber (FKM)) are the most important for the figawa members (Table 1). This is also reflected by the first comment submitted by figawa, in which a time-unlimited derogation for FPs was proposed5. The importance of FPs for the members' products becomes apparent when analyzing the components used for the manufacture of their end-products (see section 3.2). According to a report by Wood (2022), the total market volume of FPs sold in the EEA in 2020 was 40,000 tons, and PTFE makes up more than 50 % of the market (European Environment Information and Observation Network (EIONET) et al., 2021). As summarized by Henry et al. (2018), PTFE combined with fluorinated ethylene propylene (FEP), polyethylene-cotetrafluoroethylene (ETFE) and other TFE-copolymers (e.g., perfluoroalkoxy polymer (PFA)) correspond to 70 to 75 % of FPs consumed worldwide. FPs are famed for their physico-chemical properties: They have a high chemical and thermal stability; their photochemical, oxidative, hydrolytic and biological stability is also high, which contributes to making them durable and resistant to weather (Henry et al., 2018; Korzeniowski et al., 2023). Furthermore, FPs have been considered to be polymers of low concern (PLC) according to criteria that were discussed by the OECD (2009). Henry et al. (2018) applied the PLC criteria to four FPs - including PTFE, ETFE and FEP - and found the polymers in accordance with the concept. Similarly, Korzeniowski et al. (2023) extended the analysis to further FPs and included not only fluoroplastics but also fluoroelastomers. PFPEs contain similar properties as FPs as they are exemplarily described by manufacturers as thermally and chemically stable with good dielectric properties, depending on the product6. However, PFPEs have not been covered in the PLC analysis cited above. figawa members are not in all cases aware of the composition of components which are purchased on the open market. A reason for this may be that manufacturers do not disclose the formula of their products as they are recognized as confidential business information. As such, the content or type of PFAS has often been reported to be unknown in a questionnaire issued for this report. Disregarding potential unknown PFAS in components, specific nominations of PFPEs and SCFPs were only made in individual cases. Due to these reasons, the groups PFPEs and SCFPs were not excluded. However, it is highlighted that FPs are considered the most important polymeric PFAS for figawa members. In accordance with the first submission made by figawa, the main focus is therefore put on FPs when analyzing potential emission sources during manufacture, use and end-of-life phase of products. 5 Comment 4433 from 2023-06-02 accessible via https://echa.europa.eu/documents/10162/8d917581-7faf4e1a-26d4-073d52b3406e (last accessed 2023-09-15) 6 See e.g., https://www.solvay.com/en/brands/fomblin-pfpe-lubricants/properties (last accessed 2023-09-13) or https://www.solvay.com/en/brands/galden-pfpe/properties (last accessed 2023-08-29) 3 CHEMICAL SAFETY REPORT Table 1: Polymeric PFAS used by figawa members Short name Name CAS Group Class PLC PTFE Polytetrafluoroethylene 9002-84-0 Fluoropolymers Fluoroplastics Yes PVDF Polyvinylidene fluoride 24937-79-9 Fluoropolymers Fluoroplastics Yes PVDF-HFP Vinylidene fluoride, hexafluoropropene copolymer 9011-17-0 Fluoropolymers Fluoroplastics Yes ETFE Polyethylene-cotetrafluoroethylene 25038-71-5; 68258-85-5 Fluoropolymers Fluoroplastics Yes ECTFE Ethylene, chlorotrifluoroethylene copolymer Ethylene, chlorotrifluorethylene, hexafluoroisobutylene terpolymer 25101-45-5 54302-04-04 Fluoropolymers Fluoroplastics Yes Fluoropolymers Fluoroplastics Yes FEP Polytetrafluoroethylene-cohexafluoropropylene 25067-11-2 Fluoropolymers Fluoroplastics Yes FKM 1-Propene,1,1,2,3,3,3-hexafluoro-polymer with 1,1- difluoroethylene copolymer and terpolymers 9011-17-0; 26425-79-6; 25190-89-0 Fluoropolymers Fluoroelastomers Yes (Flurocarbon) FFKM Tetrafluoroethylenetrifluoromethyltrifluorovinylether copolymer 26425-79-6 Fluoropolymers Fluoroelastomers Yes (Fluorocarbon) FVMQ Fluorosilicone Fluoropolymers F(Fluluoororoeslailsictoonmee)r1s) n/a PFPE Per- and polyfluoropolyethers Per- and n/a polyfluoropolyethers Fluorinated acrylate polymer Side-chain n/a fluorinated polymers Note: Information summarized from Henry et al. (2018), Letcher et al. (2020), Eionet (2021), ECHA (2023a), Korzeniowski et al. (2023) 1) FVMQ may also be counted towards SCFPs; however, it is often compared or listed with FKM/FFKM and was thus included in the class of fluoroelastomers in this report 4 CHEMICAL SAFETY REPORT 2. DATA COLLECTION AND ANALYSIS Data were collected using questionnaires. The data were collected to provide an aggregated overview about the end-products groups manufactured by participating companies of three clusters - water supply, water treatment, gas and liquid fuel components -, typical conditions of application, as well as the components used for manufacturing of end-product groups. With help of these information, a qualitative assessment of potential emission sources during manufacturing, use and end-of-life phase was conducted. First, information on end-products groups were collected. Data included, e.g., the estimated annual growth, the total estimated concentration of PFAS/FPs, and the typical waste disposal route. For data analysis, end-product groups reported to be manufactured by the participating companies were split into subgroups. Please note that the list of end-products is non-exhaustive and described subgroups may contain additional similar end-products; however, due to the wide variety of end-products not all can be listed. Moreover, the list contains all defined end-product groups 1-8, irrespective of the cluster but are included here for consistency with the other cluster reports. Specific information on data gathered are presented in section 3.1. Table 2: End-product groups and included product types End-product group Type of product included (non-exhaustive list) 1 Faucets, showers 2 Seals, (O-)rings, membranes, sleeves 3 Bedaullcvtiaolnveosf, gvaaslveess/l,iqbuuitdtserfly valves, flow/pressure regulators and monitors, injectors for 4 Pipes, piping systems (for showers, sinks, drinking water, drainage) 5 Odorization systems, peripheral systems, blowers, fans Water treatment including water softening systems (membranes clearly specified for use in 6 water treatment systems, ion exchanger, ozone, active bromine, electro-chlorination, chlorine dioxide, chlorine, chemical dosing, UV) 7 Meters, sensors, analysis tools and controls 8 Accessories 1) 1) Tools were reported by participants, too, but were not included in the assessment. Second, information on components, of which end-product groups are made of, were gathered. Information queried covered the origin of the component - whether it was purchased as a ready-to-use article or is manufactured by the participating company -, FPs used and the estimated concentration in the component, as well as information on the conditions during use. Similarly to the end-product groups, components which are used for the production of the above-mentioned end-product groups, have been split into subgroups. Please note that the list of components is non-exhaustive and described subgroups may contain additional similar components. In addition, the list contains all defined component groups 1-8, irrespective of the cluster. 5 CHEMICAL SAFETY REPORT Table 3: Component groups and included component types Component group Type of component included (non-exhaustive list) 1 Scopnanceecrsti,oannsc/hhoosrse,s,cavpaslv,enso/zvzallevse, sfietatitnsgs, ball valves, pump heads, hose 2 Use as processing aid, contact passivation, etc. 3 Ebaletctetrroiensic components (circuit boards, displays, injection units, flow meters, etc.), cables, 4 Housings, containers, reactors, flame retardant plastic components 5 Paints, adhesives, potting compounds, binders, multi-component compounds, coatings 1) 6 Membranes 7 O-rings, retaining rings, shaft seals, molded seals (gaskets)/(flat) sealings 8 Lubricants (greases, oils), lubricant coatings, bearings/slide bearings 1) Coating of tools were not included in the assessment as they were considered out of scope Please note that depending on the position in the supply chain and the product portfolio certain products may be counted towards both end-products and components. This includes e.g. membranes or valves. In addition, the participants were requested to delineate the standard production process per end-product group. Participants could add any number of steps to outline a process flow for the production. Contextual information was collected per process step; amongst other, information on process type (automatic, manual), place of execution (internal, external), Personal Protective Equipment (PPE) worn by employees, and process temperature were covered. Questions in the questionnaire did not differentiate between unspecified PFAS as well as FPs. As the main focus of this report are FPs, all data submitted were considered to be provided for FPs. As mentioned in section 1, data were included in the assessment if the PFAS compounds was reported to be unknown. In few cases specific information on nonpolymeric PFAS or non-PFAS compounds were provided; where identifiable and no relevance to polymeric PFAS was found, these were not included in the assessment. Also, PFAS-containing substances that were indicated as processing aids during galvanic surface treatment were not considered within scope of this report and were excluded from the analysis. Furthermore, the use of PFAS as a coating for tools which are used in the manufacture of products were considered outside of scope of this report. For a qualitative description of potential FP emissions associated to production, information on the presence of local exhaust ventilation and air cleaning systems, the presence of more general ventilation systems, the generation and amount of wastewater, as well as waste tonnage, estimated FP-concentrations in waste, as well as typical disposal pathways were requested. Specific information on data analyses is reported as required in the respective place within the document. 6 CHEMICAL SAFETY REPORT 3. COMPANIES, PRODUCTS AND COMPONENTS 3.1. Companies & Products Irrespective of the cluster considered, companies manufacture a wide range of endproduct groups, which consist of several individual components. The participants of this cluster reported to mainly produce pipes/piping systems (end-product group 4) and faucets/showers (end-product group 1). An illustrative distribution of end-product groups is depicted in Figure 1. Water distribution 0% 20% 40% 60% 80% 100% END-PRODUCT GROUPS MANUFACTURED PROPORTIONAL DISTRIBUTION BASED ON TOTAL COUNT OF NOMINATIONS (%) End-product group 1 End-product group 4 End-product group 2 End-product group 7 End-product group 3 Figure 1: End-product groups manufactured within cluster Total count of nominations is the number of times an end-product was entered. Each reported entry was allocated to an end-product group. Accordingly, the proportional distribution is based on the total count of entries reported for this cluster; the number of responses were not weighted to account for differing numbers of entries per company. For example, if a company individually reported "faucets" and "showers", n = 2 entries were allocated to end-product group 1. If another company individually reported "faucets for bathrooms", "faucets for kitchens" and "showers" n = 3 entries were allocated to end-product group 1. The total count of nominations for this endproduct group is therefore 5 in this hypothetical example. The proportion puts this number into relation to all entries (products) after allocation to their end-product groups. Groups are defined as End-product group 1: Faucets, showers; End-product group 2: Seals, (O-)rings, membranes, sleeves; End-product group 3: Ball valves, valves, butterfly valves, flow/pressure regulators and monitors, injectors for eduction of gases/liquids; End-product group 4: Pipes, piping systems (for showers, sinks, drinking water, drainage); End-product group 7: Meters, sensors, analysis tools and controls 7 CHEMICAL SAFETY REPORT The proportion (% w/w) of polymeric PFAS (in the following referred to as FP, as this is considered the main scope of this dossier) in end-products groups is summarized in Table 47. End-product groups may comprise of a range of individual products of differing composition. Furthermore, the concentration of FPs in components used for the manufacture of end-products is not in all cases known. The presented values should therefore be considered as indicative. Table 4: Estimated proportion of FPs in end-product groups in % w/w End-product group Average Median Minimum Maximum End-product group 1 0.3 0.01 0.01 1.0 End-product group 2 100.0 100.0 100.0 End-product group 3 0.3 0.2 0.2 0.5 End-product group 4 30.8 0.5 0.0 95.0 End-product group 7 0.5 0.5 0.5 Acronyms: End-product group 1: Faucets, showers; End-product group 2: Seals, (O-)rings, membranes, sleeves; End-product group 3: Ball valves, valves, butterfly valves, flow/pressure regulators and monitors, injectors for eduction of gases/liquids; End-product group 4: Pipes, piping systems (for showers, sinks, drinking water, drainage); End-product group 7: Meters, sensors, analysis tools and controls As expected, end-product group 2 - including e.g., sleeves and membranes - completely consist of FPs. These products are considered end-products for the products' manufacturer but can be used by other manufacturers for the finalization of further end-products. The FPs material used provides the characteristics required for the product's area of application (e.g., in case of membranes). Likewise, a maximum FP concentration of 95.0 % was observed for end-product group 4 (pipes/piping systems). However, the data suggest that this end-product group is either made completely from FP materials or contains no / small residues only (0.0 % to 95.0%). Moreover, when comparing the average concentration (30.8 %) and the median value (0.5 %), it is indicated that the distribution is skewed to lower concentrations. Raw data reported can be distributed into two groups: One group ranging from 0.0 to 1.0 % and one ranging from 90.0 to 95.0 %. No concentrations between > 1.0 and < 90.0 % have been reported. A larger difference between mean and median values is also observed for end-product group 1 (faucets/showers). Comparison of the mean value (0.3 %) and the median value (0.01 %) suggest that the maximum reported concentration may be an overestimate of actual FP concentration. It is additionally highlighted that the total concentration is in any case still low, with a reported maximum concentration of 1.0 %. Overall, the FP concentrations are homogeneous, not only within but also between endproduct groups. The average concentration is 0.5 % for three of the five end-product groups, demonstrating that the use of FPs is already limited but required for very specific tasks within the end-products. For end-product group 2, FPs were listed as the main constituent; this group includes membranes, sealings/rings, and shafts though. These are considered to be either processed further or used directly, for example as membranes. 7 In the questionnaire, the estimated PFAS concentration in end-products was requested; however, as the scope of this report regards FPs, the wording was adopted in the report. 8 CHEMICAL SAFETY REPORT Pipes and piping systems (end-product group 4), may be counted to both high and low concentration groups which is sensible considering their intended use. A more detailed overview on components and the related FP material used for the manufacture of products is discussed in section 3.2. 9 CHEMICAL SAFETY REPORT 3.2. Components Companies covered in this report mainly manufacture end-products via assembly (see section 4.1); components with and without FPs are used to build the end-products described above (section 3.1). In this section, components containing FPs are described and their composition, FP concentrations and origin are assessed. To facilitate a comprehensive analysis, components reported were grouped. The grouping is based on assumed functionality of the components (e.g., electronic component, sealing function, or lubricant function).8 Table 5 provides an overview on the component groups and the related end-product groups for which they are used. In consistency to the structure of the market - endproducts are mostly assembled from various components - several FP-containing components are used per end-product group. Also, the same component group may be used in different end-product groups. For example, (O-)rings and other sealings as well as lubricants are used in most end-product groups. Table 5: FP-containing components and use in end-product groups Componen t group Component details End-product group 1 2 3 4 7 Spacers, anchors, caps, nozzles, fittings, ball valves, 1 pump heads, hose connections/hoses, valves/valve + - - + + seats 2 Use as processing aid, contact passivation, etc. - - - + - 3 Electronic components (circuit boards, displays, - - - + + injection units, flow meters, etc.), cables, batteries 4 Housings, containers, reactors, flame retardant - - - - + plastic components 6 Membranes - + - - + 7 O-rings, retaining rings, shaft seals, molded seals + + + + + (gaskets)/(flat) sealings 8 Lubricants (greases, oils), lubricant coatings, + - + + + bearings/slide bearings Acronyms: +: Components used for the manufacture of this end-product group; -: Components not used for the manufacture of this end-product group; End-product group 1: Faucets, showers; End-product group 2: Seals, (O-)rings, membranes, sleeves; Endproduct group 3: Ball valves, valves, butterfly valves, flow/pressure regulators and monitors, injectors for eduction of gases/liquids; End-product group 4: Pipes, piping systems (for showers, sinks, drinking water, drainage); End-product group 7: Meters, sensors, analysis tools and controls 8 Please note that FP-containing substances that were indicated as processing aids during galvanic surface treatment were not considered within scope of this report and were excluded from the analysis. Furthermore, the use of FP as a coating for tools which are used in the manufacture of products were considered outside of scope of this report. 10 CHEMICAL SAFETY REPORT With regard to the origin of the components, three categories were defined: Category 1 - Obtained as PFAS raw material (substance), e.g., VDF for polymerization of PVDF; PFAS for dissolution in solvents) [not relevant for this cluster - water distribution] Category 2 - Obtained as FP raw material (mixture/intermediate), e.g., PVDF for own manufacturing of membranes; different kinds of oils/solutions for own mixing processes Category 3 -Obtained as ready-to-use article, e.g., industrially-manufactured Oring; purchased, unchanged solution/oil Underlining the importance that the figawa members are mainly assembling their endproducts, the largest proportion of the components are obtained from third-party suppliers. These components are used directly without further processing. 73 % of all reported components used in this cluster fall into category 3. The remaining 27 % are manufactured from FP raw material (e.g., membranes made from PVDF/use of oils or solutions for own mixing processes), falling under category 2. No non-FP PFAS raw materials were reportedly used, e.g., for the own polymerization of FP, or for the dissolution in solvents (category 1). Please note that it cannot be derived from the data, however, to which proportion the individual component groups contribute to the final endproducts or to the companies' sales. For an in-depth analysis of sales and revenue dependency of FP-related products, please refer to the SEA document submitted along this CSR. Category 2 is dominated by component group 1 (spacers, anchors, caps, nozzles, fittings, ball valves, pump heads, hose connections/hoses, valves/valve seats). Companies mentioned e.g., pipes, fittings for which FP raw material was used. Examples from further component groups include sleeves or the use as a lubricant. The larger category 3 is dominated by component groups 7 (45 %) and 8 (24 %). In agreement with previous market description, industrially bought sealings including O-rings (component group 7) are mentioned most often. Please note again that this proportion does not allow inferences to volumes of the component used. It indicates nonetheless the dependency of companies on very basic working components which they may not produce themselves and on the substitution of which they have very limited influence. Due to the importance of this category, only the distribution of component groups in category 3 is visualized in Figure 2. 11 CHEMICAL SAFETY REPORT CATEGORY 3 - COMPONENT OBTAINED READY-TO-USE 7% 24% 14% Component group 1 3% Component group 3 Component group 4 7% Component group 6 Component group 7 Component group 8 45% Figure 2: Components' origin in relation to the components sub-group Acronyms: Groups are defined as Component group 1: Spacers, anchors, caps, nozzles, fittings, ball valves, pump heads, hose connections/hoses, valves/valve seats; Component group 2: Use as processing aid, contact passivation, etc.; Component group 3: Electronic components (circuit boards, displays, injection units, flow meters, etc.), cables, batteries, Component group 4: Housings, containers, reactors, flame retardant plastic components; Component group 6: Membranes; Component group 7: O-rings, retaining rings, shaft seals, molded seals (gaskets)/(flat) sealings; Component group 8: Lubricants (greases, oils), lubricant coatings, bearings/slide bearings The composition of the components used is oftentimes not exactly known to the purchasers and might be subject to confidential business information. The estimated concentration of FP in components is presented in Table 69. It is acknowledged that that the FP concentration differs distinctly from the total concentration estimated for the end-products (cf. Table 4). The end-products may consist though of non-FP and FP-containing materials. For specific end-products, e.g. pipes/piping systems, the FP concentrations may be higher as they consist of individual or few components only. This is also reflected by the high average concentration of 65.6 % for component group 1, which includes pipes and fittings. As discussed in section 3.1, the total concentration of FPs in most endproducts groups is however low, and three of five end-product groups showed concentrations below 0.5 %. The data indicate therefore that even at high concentrations of FP in most component groups, the impact on the final concentration in end-products is limited. 9 In the questionnaire, the estimated PFAS concentration in components was requested; however, based on the first submission of figawa (please see comment 4433 from 2023-06-02 accessible via https://echa.europa.eu/documents/10162/8d917581-7faf-4e1a-26d4-073d52b3406e (last accessed 2023-0915)), the scope of the requested derogation and the exceptional importance of FPs for figawa members, the wording was adopted in the report and focused on FP. 12 CHEMICAL SAFETY REPORT Table 6: Average, estimated total FP concentrations (%) in components Component group Components Average concentration of FP (%) 1 Spupmacperhse,aadnsc,hhoorss,eccaopnsn,encotizoznless/h, ofistteisn,gvsa, lbvaelsl/vvaallvvees,seats 65.6 2 Use as processing aid, contact passivation, etc. 0.5 3 Eulneictstr,ofnloicwcmometpeorsn,enettcs.)(,cicracubiltesb,obaardttse,rdieissplays, injection 5.5 4 Hcoomuspionngesn, tcsontainers, reactors, flame retardant plastic 100.0 6 Membranes 75.0 7 O-rings, retaining rings, (flat) sealings 85.4 8 Lbuebarriincagnst/ssl(idgerebaesaersi,ngosils), lubricant coatings, 1) Please note that not all components were necessarily reported in this cluster. 50.0 It is important to note that estimated FP-concentrations in components are based on the expert knowledge of participating companies but not necessarily on information from the suppliers of the component. This is similarly true regarding the individual FPs used in the components. Individual FPs identified in components are listed in Table 7 below. 13 CHEMICAL SAFETY REPORT Table 7: FPs reported in components Component group PTFE ETFE ECTFE PVDF PVDFHFP FKM FFKM PFPE Fluor acry- lat polymer FEP 1 + - + + + + - - - - 2 - - - - - - - - - - 3 + + - + - + - - + + 4 - - - - - + - - - - 6 + - - - - + + - - - 7 + - - + - + + - - - 8 + - - - - - - + - - Groups are defined as Component group 1: Spacers, anchors, caps, nozzles, fittings, ball valves, pump heads, hose connections/hoses, valves/valve seats; Component group 2: Use as processing aid, contact passivation, etc.; Component group 3: Electronic components (circuit boards, displays, injection units, flow meters, etc.), cables, batteries, Component group 4: Housings, containers, reactors, flame retardant plastic components; Component group 6: Membranes; Component group 7: O-rings, retaining rings, shaft seals, molded seals (gaskets)/(flat) sealings; Component group 8: Lubricants (greases, oils), lubricant coatings, bearings/slide bearings The exact composition of the components used is in many cases unknown, since this information is confidential business information by many suppliers or manufacturers. As such, the information prepared by the figawa members may be incomplete, and for certain components no information could be provided. Once again, this illustrates the difficult situation which companies of this marketface. As the companies of this dossier are a small part within the supply chain of FP-containing materials, it is not only inherently difficult to collect such information, but also even more challenging to provide adequate alternatives to ensure the quality, longevity and safety of their products. 14 CHEMICAL SAFETY REPORT 4. LIFE CYCLE STAGES AND CONSIDERATIONS ON EMISSIONS 4.1. Manufacturing Based on the data gathered for the manufacturing, the assembly was identified as the main task. It is primarily conducted manually, internally and at room temperature. No specific PPE is required for employees. Due to the low potential for generation of fumes or dusts, no Local Exhaust Ventilation (LEV) system is installed at assembly workstations. However, general hall/room ventilation systems are in place for air renewal/conditioning. The generation of wastewater during this process step was reported occasionally (38 %). No estimation could be made on the related annual wastewater volume. Regarding emissions, it is assumed that water consumed during assembly tasks is in most cases not directly related to and/or in contact with FP components or end-products. If water comes in contact with components or end-products, the potential migration of FPs into the wastewater is considered very low based on the physico-chemical properties, such as the practical insolubility of FPs in water (Korzeniowski et al., 2023). Moreover, companies stated that wastewater is treated in company-operated or municipal wastewater treatment plants (WWTP). Importantly, a proportion of companies also reported that wastewater is treated differently, or collected and disposed by a contractor. Waste is disposed with other process waste, which is then considered to disposed of as residual waste under standard conditions; the major proportion of such waste is assumed to be incinerated (including waste-to-energy recovery), while smaller proportions may end up in landfills. The concentration of FPs in waste is estimated to be 0.09 %. For further information on waste-treatment options please refer to section 4.3. A summary of the data for the assembly step is provided in Table 8. Table 8: Process description - Assembly Process parameters Selection 1) Process type Manually, automatically, or Both manual and automatic steps Task is performed Internally or externally PPE Standard work clothes, overall/coat or Other Process temperature 15 - 25 C (room temperature) LEV No Filter systems after LEV No filter system after extraction or Other Hall ventilation (e.g., HVAC) Yes Generation of wastewater Partially possible Wastewater volume [m] n/a Waste tonnage [tons] n/a Proportion of FP in waste [%] 0.09 Waste disposal route Collected and disposed with other process waste 1) See Annex I for a list of selection options In addition to the assembly, the tasks of extrusion/injection molding/casting are highlighted (Table 9). Such tasks may for example be used for the manufacturing of membranes or pipes, and may use FP raw materials. 15 CHEMICAL SAFETY REPORT Table 9: Process description - Extrusion/injection molding/casting Process parameters Selection 1) Process type Manually or Both manual and automatic steps Task is performed Internally PPE Standard work clothes (shirt/long-sleeve, long trousers, safety shoes/boots) or Standard work clothes, overall/coat or Other Process temperature > 150 C LEV Yes Filter systems after LEV No filter system after extraction or Other Hall ventilation (e.g., HVAC) Yes Generation of wastewater No Wastewater volume [m] n/a Waste tonnage [tons] 0.2 Proportion of FP in waste [%] 0.05 Waste disposal route Collected and disposed with other process waste or Collected and disposed separately 1) See Annex I for a list of selection options For the task of extrusion/injection molding/casting10 the process temperature was reported as > 150 C. As these processes involve heating, the potential for exposure is increased compared to other tasks, such as assembly. It is outlined in a processing guide by PlasticsEurope (2021) that typical processing temperatures, e.g., of PTFE or PVDF, are 380 C and 230C, respectively. Especially from anoccupational safety perspective, it is noted in the document that the generation of fumes from FP decomposition may occur even at processing temperatures. Importantly, it is additionally stated that "significant decomposition occurs only above the recommended continuous service temperature for the polymer in question" (PlasticsEurope, 2021). Workplace exposure and emissions can be controlled by LEV. Accordingly, the availability of LEV was consistently reported for these process steps. Furthermore, to control emissions, additional filter systems associated to the LEV were reported in 66 % of the related responses. General hall ventilation systems or heating, ventilation, air conditioning (HVAC) systems were also reported for extrusion/injection molding/casting processes. Dissolving or casting steps on the other hand pose a very limited potential for emissions as no volatilization and/or decomposition of FPs is expected. Wastewater was not reported to generated. The waste tonnage and FP concentration therein were estimated to be 0.2 tons and 0.05 %, respectively. Similar as described above, waste is disposed with other process waste but might also be collected and disposed separately. During manufacture, emissions may potentially occur via exhaust air, especially during heating steps and such steps with LEV systems for exposure control, and via wastewater. No measurements are available to estimate potential emissions - especially to air - from these steps. It is highlighted though that the primary way of operating is the assembly of 10 The coating of tools was described but considered outside of scope of this report and not included in the analysis. 16 CHEMICAL SAFETY REPORT components to end-products, from which no emissions are expected. The own preparation of parts from raw material components is limited; it was also reported that LEV systems are in place. Moreover, a significant degradation of FP material takes only place above recommended process temperatures (PlasticsEurope, 2021). Other tasks, such as delivery and storage or post-treatment and quality control are considered to have a comparably low potential for emissions. Process descriptions of these tasks are outlined in Annex I. Despite the very low potential for emissions during manufacturrng processes of endproduct groups, figawa members are open towards the implementation of regular monitoring programs - provided that guidance on the target substance analysis exists, or sensitive and appropriate untargeted (e.g., Total Organic Fluorine) measurement methods become widely available. figawa members are also supportive of repetitive evaluation programs and the potential improvement of implemented risk management measures. 17 CHEMICAL SAFETY REPORT 4.2. Use phase Components may be exposed individually to different conditions during their intended use. For example, membranes build into an end-product would most likely not be exposed to the same conditions as electronic compartments. FPs have remarkable properties and are chemically stable (Korzeniowski et al., 2023). As an example, little effect on PVDF is expected by acid exposure, because PVDF is considered to be stable in acidic environments (Marshall et al., 2021). The authors further elaborate that in strong alkaline conditions (pH 11), PVDF may undergo de-hydrofluorination. However, based on market experience and longevity of products, degradation due to chemical exposure of PVDF has not been recognized as an issue of concern as uses at pH 11 are rare. In addition, it has to be attributed to the companies that expert knowledge on the applicability of their products - not only containing PVDF - but also other FP-based components - is extensive. Based on the market experience and customer satisfaction no significant degradation has been described under standard operation conditions. The pH range to which components are exposed during their use are outlined in Table 10. Most components are in contact with media having a neutral pH. No applications are expected exclusively in the acidic range. However, it was also reported that the pH of contact media may range from acidic to alkaline conditions. Table 10: pH ranges to which components are exposed during use Component group Components pH conditions under which parts are operated Acidic Neutral Alkaline Whole pH scale Spacers, anchors, caps, nozzles, 1 fittings, ball valves, pump heads, hose - + - + connections/hoses, valves/valve seats 2 Upassesaivsaptiroonc,eestscing aid, contact - - - + Electronic components (circuit boards, 3 displays, injection units, flow meters, - + + + etc.), cables, batteries 4 Hreotuasrdinagnst, pcloansttaicinceorms,proenaecntotsrs, flame - + - - 6 Membranes - + - + 7 mO-orlidnegds,sreeatlasi,n(inflgatr)insgesa,linshgasft seals, - + + + 8 Lcouabtriincgans,tsbe(garreinagsse/ss,liodiels)b,elaurbinrigcsant - + + + It cannot be excluded that wear- and tear-effects may contribute to emissions of FPs. For example, O-rings or sealings may be exposed to friction or pressure during use. While no quantitative data is available, it is important to note that the service-life of products is long and a high durability is required for correct and safe functionality. The extent of wearand tear-effects is thus considered limited. Furthermore, not all components come into contact with water, which is used as drinking water or emitted to wastewater and has a higher potential for release into the environment. In this regard, it is expected that wearand tear-effects will to a lesser or no proportion contribute to environmental emissions if industrial solutions or air/gases are processed by end-products. An overview on typical 18 CHEMICAL SAFETY REPORT contact media of components is provided in Figure 3. It is highlighted that the largest proportion of components may be expected to come into contact with drinking water (81 %), for which high standards and requirements exist. Please see also section 1.2 of the related AoA/SEA report. 39% 2% 15% Drinking water Air/Gases 17% (Waste-)Water & Drinking water All mentioned Different combination 27% Figure 3: Overview on contact media of components during use Participants were able to choose from different options and combinations of options: Option1: (Waste-)Water; Option 2: Drinking water; Option 3: Liquid fuels (e.g. oil/heating oil/HVO); Option 4: Other solutions (incl acids and bases)/solvents; Option 5: Air/Gases; Option 6: (Waste-)Water & Drinking water; Option 7: Liquid fuels (e.g. oil/heating oil/HVO) & other solutions (incl acids and bases)/solvents; Option 8: All mentioned; Option 9: Different combination (this option is not only considered to include a different combination of mentioned options but also those not named, such as e.g., swimming pool water, industrial water of different constitution, etc.) Emissions during the use phase may also be of special importance for component groups 1, 2 and 811. Especially for the case of lubricants, FP-containing components may under certain circumstances be rinsed out during intended use. It needs to be specified however, that this is only relevant for components in direct contact with water or other liquids. No potential for wash-off is considered for contact media such as gas or air. For this cluster, this relates to end-products such as faucets, showers, or other water supplying stations. Lubricants may also be used in components like valves or already applied as coatings to sealings, which are oftentimes bought as components from thirdparty suppliers. An assessment of the exact composition and amount of lubricants used is - as mentioned previously - not possible, and components such as valves or pre-coated parts have consequently not been considered here. 11 Component group 1: Spacers, anchors, caps, nozzles, fittings, ball valves, pump heads, hose connections/hoses, valves/valve seats Component group 2: Use as processing aid, contact passivation, etc.; Component group 8: Lubricants (greases, oils), lubricant coatings, bearings/slide bearings 19 CHEMICAL SAFETY REPORT From data collected from figawa members, an average annual lubricant tonnage of 8.9 tons (0.2 to 20 tons) was identified, which is directly used in end-products mentioned above. FPs concentrations in lubricants reportedly range from 30 to 90 %, resulting in annual tonnages of 0.13 to 10 tons/a used. ECHA reported an emission range of 5 to 25 % for lubricants during the manufacture and use phase (ECHA et al., 2023b). As this covers the whole sector of suppliers as well as consumers the emission range is considered highly conservative. Specifically for this cluster, it has to be considered that not the total amount of PFAS used is in direct contact with the transported medium. Moreover, the main contact medium is drinking water, and FPs are practically insoluble in water (Korzeniowski et al., 2023). For the calculation of emissions, the lower end (5 %) of the emission range reported by ECHA was used. Emissions of companies range from of 0.007 to 0.5 tons. On average, 0.2 tons may be emitted annually. Including a reported service-life of at least 25 years (faucets, showers), roughly estimated annual emissions from use of end-products of an average company may amount to 0.008 tons/a, or 8.1 kg/a. It is imperative to note that only a small proportion of companies reported the use of lubricants in their applications, and in contact to drinking water/wastewater or other relevant liquids. This estimate is therefore not applicable for the whole cluster and cannot be used for the assessment of total emissions. It is in this regard also noteworthy that for drinking water, compliance with separate German regulatory limit values (PFAS-2012) is required and ensured13. It was also reported by at least one company that additional studies are performed to assess potential emissions from the use of their products. In summary, the emission potential of FPs from most of the components described is considered very low. This is mainly based on the fact that FPs are thermally and chemically inert. Moreover, only a limited number of components is in direct contact to media - such as water or wastewater - which provide an entry route of FPs into the environment. Wearand tear may lead to emissions of FPs but given the long service-life and required durability of products, the potential for emissions is limited. For a small group of end-products, which use lubricants directly and are in contact to (waste-)water or other solutions, the potential for rinse off exists. The derived emission values are most likely an overestimate considering that the release range reported by ECHA covers the whole sector of lubricants, including manufacture. In any case, in relation to the total emissions of 123 to 225 tons/a (2020) estimated for the application of lubricants in the restriction proposal (ECHA et al., 2023b), the emissions from the described end-products are small. In relation to the total emissions reported by ECHA, average annual emissions (0.2 tons/a) correspond to 0.09 to 0.2 % of total emissions. If related to the service life duration (0.008 tons/a), a contribution of 0.004 to 0.007 % may be calculated. This has also to be put into relation that lubricants as such only make up a fraction of total PFAS and FP emissions (ECHA et al., 2023b). 12 PFAS-20 refers to non-FP PFAS which must not exceed a summed limit of 0.00010 mg/L from 12.01.2026. 13 Zweite Verordnung zur Novellierung der Trinkwasserverordnung BGBl. 2023 I Nr. 159 vom 23.06.2023 (https://www.recht.bund.de/bgbl/1/2023/159/VO.html) 20 CHEMICAL SAFETY REPORT 4.3. End-of-life stage The area of application for products manufactured by figawa members is of high public interest. They help to ensure the safe supply of (drinking) water not only for industrial applications but also for private households. As such a high quality and durability is required, which is also achieved by the use FP-containing materials due to their distinct physicochemical properties and low hazard profile. The resulting service life of endproducts is long, reducing expensive replacement of products and therefore also reducing the amount of waste generated (see Figure 4). Please also note that for certain endproducts an even longer service life duration may be assumed standard. For example, for pipes a life-time of 50 years or longer is not untypical. End-product group 7 End-product group 4 End-product group 3 End-product group 2 End-product group 1 0 10 20 30 40 50 YEARS Figure 4: Average service-life duration of end-product groups Groups are defined as End-product group 1: Faucets, showers; End-product group 2: Seals, (O-)rings, membranes, sleeves; End-product group 3: Ball valves, valves, butterfly valves, flow/pressure regulators and monitors, injectors for eduction of gases/liquids; End-product group 4: Pipes, piping systems (for showers, sinks, drinking water, drainage); End-product group; End-product group 7: Meters, sensors, analysis tools and controls It was also queried which proportions of waste - according to the participants market knowledge - are incinerated (including waste-to-energy), landfilled or recycled.14 The assumed disposal route dependent strongly on the end-product group or its built-in components. For example, it was estimated that the largest proportion of seals and Orings was incinerated, while metal-based components are rather subject to recycling (see Figure 5). Similarly, electronic components are to a large fraction disposed according to electronic-waste regulations. The data are subject to uncertainty, however, as the disposal of end-products is in most cases of out scope of the manufacturers. It is noted that due to the partly small sample size collected for the individual end-product groups, the distribution may deviate from actual waste disposal procedures. This is striking in case of end-product group 7, which is considered to mainly fall under the WEEE 14 For the analysis of the responses the average was calculated for each section and sub-group of end-product separately. However, as not in all cases the sum of all three disposal routes equaled 100 % (e.g., 10 % incineration, 10 % landfill, 55 % recycling), the calculated averages were subsequently normalized to 100 % (i.e. 13.3 % incineration, 13.3 % landfilling, 73.3% recycling). 21 CHEMICAL SAFETY REPORT directive. It must be assumed that these are not disposed via landfilling - as indicated - but are rather recycled or incinerated; this is based on the high brass content, as well as a thermal treatment (and waste-to-energy recovery) of plastic compartments. Electronical components are also not assumed to be disposed via landfills as the main route of disposal. End-product group 7 End-product group 4 End-product group 3 End-product group 2 End-product group 1 0% 20% 40% 60% 80% 100% DISTRIBUTION OF WASTE DISPOSAL ROUTES Incineration incl. waste-to-energy (%) Landfilled (%) Recycled (%) Figure 5: Assumed disposal routes of end-products Groups are defined as End-product group 1: Faucets, showers; End-product group 2: Seals, (O-)rings, membranes, sleeves; End-product group 3: Ball valves, valves, butterfly valves, flow/pressure regulators and monitors, injectors for eduction of gases/liquids; End-product group 4: Pipes, piping systems (for showers, sinks, drinking water, drainage); End-product group; End-product group 7: Meters, sensors, analysis tools and controls Potential emissions from waste disposal are difficult to standardize as they depend not only on the proportion of PFAS in the component but also on the specific PFAS within the product, the associated formation of by-products e.g., from incineration, or whether an end-product is dismantled before final disposal. As presented in Table 4, the overall concentration of FPs is low in most end-products ( 0.50 %). Fewer end-product groups - such as membranes - may have FP concentrations of up to 100 %. Regarding landfilling, Lohmann et al. (2020) report that FP "landfilling [...] leads to contamination of leachates with PFAS", mainly due to weathering and physical stress. On the other hand, it has been summarized by Korzeniowski et al. (2023) that FPs "[...] such as PTFE do not degrade in the environment or release substances of toxicological or environmental concern" due to the stability of FPs. With regard to landfilling, the authors further conclude that - because of the chemical, thermal and biological properties - FPs "[...] therefore are not expected to transform to dispersive nonpolymeric PFAS when 22 CHEMICAL SAFETY REPORT disposed of in a landfill". No information has been provided specifically for FPs in Annex B to the ECHA restriction proposal (2023a). It is therefore not clear whether landfilled FPs cause emissions to the environment via landfill leachates. While not specifically related to landfill conditions, a summary of a set of studies on leaching and (bio)degradation of PTFE published by Gore (2022) supports the stability of PTFE, stating - amongst others - that PTFE "was insoluble in water", and "was determined not to be biodegradable"; it is summarized that PTFE does "not partition to air, water, or soil" and that there is a "lack of transformation to other PFAS, such as perfluoroalkyl acids". Recycling is most likely related to metals or other valuable raw materials used in endproducts, for which relevant recycling approaches exist. FP recycling from post-consumer waste is however difficult; as outlined in a report by Conversio (2022) this is because for FPs the overall share "[...] is too low to establish any sorting and recycling approach" in mixed waste streams. Despite the current difficulties regarding recycling, figawa members would like to highlight that FPs are important and valuable materials. Recycling is also an effective measure to reduce the amount of waste entering other waste-streams. The development of a regulatory framework for the recycling of FP materials should thus be emphasized. figawa members are in support of the development of legal requirements leading to the implementation of a recycling system for FPs. Even though partly high landfilling and recycling rates were reported for specific endproduct groups, the main route of waste disposal in Europe is considered incineration. Incineration may either take place in municipal incinerators with or without waste-toenergy recovery or in hazardous waste incinerators. Latter one's are usually operating at higher furnace temperatures. Complete, uncatalyzed, destruction of PFAS is expected at temperatures > 1,400 C (ECHA et al., 2023a), which is not typically achieved by municipal incinerators. Korzeniowski et al. (2023) point out in a review that FPs are mineralized during commercial waste-to-energy incineration. For example, Aleksandrov et al. (2019), which are also cited by Korzeniowski et al. (2023), report for the incineration of PTFE that hydrofluoric acid (HF) is the main decomposition product. In a report by RIVM from Bakker et al. ((2021)), which is cited by Korzeniowski et al. (2023), it is summarized that FPs including PTFE are "one of the most thermally stable plastics" but for PTFE "complete thermal decomposition is achieved at a temperature of about 800 C". However, the formation of by-products is described possible during incineration (Bakker, Bokkers and Broekman, 2021). The authors conclude though that "based on a literature review, RIVM expects that most of the PFASs will largely degrade during the incineration process and then be removed when the flue gases are cleaned". Silva et al. (2020) similarly report the formation of HF for thermal degradation of PVDF, but also of other by-products. Annex B to the ECHA restriction proposal (2023a) summarizes literature sources and concludes that thermal degradation products from FP degradation may not only contain CO2 or HF, but also trifluoroacetic acid and other perfluorinated gases, and further substances. It is therefore acknowledged that incineration of FP-containing end-product groups may lead to the formation of fluorinated by-products via thermal degradation. The ratio of main- (HF) to by-product formation is however unclear. Regarding SCFPs, it is acknowledged that they were counted towards PFAA precursors for the impact assessment presented in the restriction proposal (ECHA et al., 2023b, 2023a). 23 CHEMICAL SAFETY REPORT A higher reactivity is expected and degradation into other PFAS is expected (ECHA et al., 2023a). However, it should be stressed that SCFPs in form of fluorinated acrylate polymers were only mentioned individually for electronic compartments with air/gases as the respective contact media. Electronic compartments are already subject to separate waste regulations, and it can be assumed that both the use and end-of-life phase are strictly controlled. From market knowledge and previous comments submitted to ECHA with regard to the restriction proposal15 (state: 25th of August, 2023) it is understood that more detailed information on incineration of PFAS has been provided, and studies on incineration are being conducted. It is also expected that - induced by the ECHA restriction proposal (2023b) - necessary research on waste treatment options is enabled even further. It is therefore assumed that knowledge on by-product formation as well as progress on (new) abatement technologies will be made available in quick succession, not only for solid wastes but also for wastewater (Verma et al., 2023). On this basis, regulatory threshold values, e.g., on exhaust air emission from waste incinerators or from wastewater treatment plants could be implemented. As the necessity and potential to examine and subsequently minimize emissions from waste treatment of FPs is seen, this approach is supported by figawa members. 15 https://echa.europa.eu/de/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b 24 CHEMICAL SAFETY REPORT 5. SUMMARY & CONCLUSIONS figawa members require FPs for the safe and durable operation of their products. It has been shown that members purchase most components on the open market. In addition, figawa members are only involved to a limited extent in the design of the components used as the main task conducted at their sites is the assembly of end-products. As such, emissions from the manufacturing phase of products are considered to be controlled and negligible. During the intended use of end-products, emissions are likewise considered to be controlled, as FPs are chemically and thermally stable as well as durable. Emissions may arise from wear- and tear of specific components, which are exposed to extensive mechanical pressure (e.g., sealings or membranes). As products are very durable, and market knowledge and customer feedback did not lead to an increased concern of endproduct wear- and tear, no quantification is possible. Potential emissions from wear- and tear may thus be subject to further research, and figawa members are supportive of such regulatory measures if proposed by authorities. Emissions may be caused by the use of lubricants if in contact with wastewater or drinking water. Overall, potential emissions are estimated to be small in comparison to emissions of other sectors and uses. It is important to note that drinking water itself is strictly regulated, to ensure high quality standards. For the end-of-life phase, data regarding emissions from waste treatment are scarce. It is acknowledged that during incineration the generation of by-products may occur. Incineration is nonetheless considered a valid treatment option as complete degradation of FPs is possible. It is assumed that new information regarding waste treatment will be published in near future, driven by the restriction proposal by ECHA. A solidified understanding of the emission potential may correlate in an improvement of abatement technologies, if required. While regulation of emissions is endorsed by figawa and their members, it is emphasized that more data are required for an appropriate regulatory approach. It is in this respect noted that manufacturers of FPs are already reacting to reduce emissions. In relation to emissions counted towards the life-cycle of FPs, Lohmann et al. (2020) identified the use of polymerization aids as a large concern. However, Solvay - a large producer of FPs and PFPEs - recently announced the goal to phase out the use of fluorosurfactants for the production of FPs (Solvay, 2023). Similarly, Gujarat Fluorochemicals (GFL) announced the development of a non-fluorinated polymerization aid for the manufacturing of PTFE via emulsion polymerization (Gujarat Fluorochemicals, 2022). In summary, figawa members produce key products for the safe supply and treatment of water as well as for heating and cooling systems. The overall concentration of FPs in such products is low. The figawa members mainly rely on continued supply of products within the supply chain. The exposure potential during their own manufacturing processes as well as the use-phase and disposal of their products is low. Limited emissions may not be excluded due to wear- and tear, the use of lubricants when in contact with water or other liquid media, as well as from waste treatment such as incineration. It is however emphasized that the largest proportion of processes, components and end-products are not prone to emissions. Instead, research is required for a better understanding of the 25 CHEMICAL SAFETY REPORT extent of these potential emissions. On that basis, regulation may be applied more targeted, including limit values for irreplaceable uses. 26 CHEMICAL SAFETY REPORT References Aleksandrov, K. et al. (2019) `Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential formation of per- and Poly-Fluorinated Alkyl Substances (PFAS) in flue gas', Chemosphere, 226, pp. 898-906. Available at: https://doi.org/10.1016/j.chemosphere.2019.03.191. Bakker, J., Bokkers, B. and Broekman, M. (2021) Per- and polyfluorinated substances in waste incinerator flue gases - RIVM report 2021-0143. Available at: https://www.rivm.nl/bibliotheek/rapporten/2021-0143.pdf (Accessed: 15 September 2023). Conversio (2022) Fluoropolymer waste in Europe 2020. Available at: https://www.ft.dk/samling/20222/almdel/euu/spm/49/svar/1951975/2698345.pdf (Accessed: 25 August 2023). ECHA et al. (2023a) Annex B to the Annex XV restriction report - Proposal for a restriction: Per- and polyfluoroalkyl substances (PFASs) - Version number 2, pp. 1-714. ECHA et al. (2023b) Annex XV restriction report - Proposal for a restriction: Per- and polyfluoroalkyl substances (PFASs) - Version number 2, pp. 1-224. European Environment Information and Observation Network (EIONET) et al. (2021) Fluorinated polymers in a low carbon, circular and toxic-free economy - Technical report (ETC/WMGE 2021/9). Available at: https://www.eionet.europa.eu/etcs/etccm/products/etc-cme-and-etc-wmge-report-9-2021-fluorinated-polymers-in-a-lowcarbon-circular-and-toxic-freeeconomy/@@download/file/EEA%20task%20on%20fluoropolymers_Full%20report_Dece mber%2014%202021%20(1).pdf (Accessed: 28 August 2023). Gore (2022) Summary of the PTFE studies performed with independent laboratories to investigate persistence, degradation, transformation to or release of substances of concern. Available at: https://www.gore.com/system/files/2023-03/Summary-of-CRLand-ALS-Studies-on-PTFE.pdf (Accessed: 25 August 2023). Gujarat Fluorochemicals (2022) Company announcement (09.03.2022). Available at: https://www.gfl.co.in/upload/pages/ebce5fed9030753d0ee651bf1f48d0a0.pdf (Accessed: 29 August 2023). Henry, B.J. et al. (2018) `A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers', Integrated Environmental Assessment and Management, 14(3), pp. 316-334. Available at: https://doi.org/10.1002/ieam.4035. Korzeniowski, S.H. et al. (2023) `A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers', Integrated Environmental Assessment and Management, 19(2), pp. 326-354. Available at: https://doi.org/10.1002/ieam.4646. Letcher, R.J., Chu, S. and Smyth, S.-A. (2020) `Side-chain fluorinated polymer surfactants in biosolids from wastewater treatment plants', Journal of Hazardous Materials, 388, p. 122044. Available at: https://doi.org/10.1016/j.jhazmat.2020.122044. Lohmann, R. et al. (2020) `Are Fluoropolymers Really of Low Concern for Human and Environmental Health and Separate from Other PFAS?', Environmental Science & Technology, 54(20), pp. 12820-12828. Available at: https://doi.org/10.1021/acs.est.0c03244. 27 CHEMICAL SAFETY REPORT Marshall, J.E. et al. (2021) `On the Solubility and Stability of Polyvinylidene Fluoride.', Polymers, 13(9). Available at: https://doi.org/10.3390/polym13091354. OECD (2009) Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. Available at: https://www.oecd.org/env/ehs/risk-assessment/42081261.pdf (Accessed: 28 August 2023). PlasticsEurope (2021) Guide for the safe handling of fluoropolymer resins, pp. 1-29. Available at: https://fluoropolymers.plasticseurope.org/application/files/6216/3178/0517/Fluoropolym ers_Safe_Hand_EN__June_2021.pdf (Accessed: 23 August 2023). Silva, A.J. de J. et al. (2020) `Kinetics of thermal degradation and lifetime study of poly(vinylidene fluoride) (PVDF) subjected to bioethanol fuel accelerated aging', Heliyon, 6(7), p. e04573. Available at: https://doi.org/10.1016/j.heliyon.2020.e04573. Solvay (2023) Phasing out fluorosurfactants at Solvay. Available at: https://www.solvay.com/sites/g/files/srpend221/files/202303/Phasing%20out%20Fluorosurfactants%20V2.pdf (Accessed: 28 August 2023). Verma, S. et al. (2023) `Recent advances on PFAS degradation via thermal and nonthermal methods', Chemical Engineering Journal Advances, 13, p. 100421. Available at: https://doi.org/10.1016/j.ceja.2022.100421. Wood Group UK Limited (2022) Fluoropolymer product group of PlasticsEurope: Update of market data for the socioeconomic analysis (SEA) of the European fluoropolymer industry - Final report. Available at: https://fluoropolymers.plasticseurope.org/application/files/1216/5485/3500/Fluoropolym ers_Market_Data_Update_-_Final_report_-_May_2022.pdf. 28 CHEMICAL SAFETY REPORT Annex I. PROCESS DESCRIPTION - SELECTION OPTIONS IN QUESTIONNAIRE Process type Manually Automatically Both manual and automatic steps Task is performed Internally Externally PPE 1) Standard work clothes (shirt/long-sleeve, long trousers, safety shoes/boots) Standard work clothes, gloves (chemicals) Standard work clothes, gloves (chemicals) + RPE 1) Standard work clothes, overall/coat Standard work clothes, overall/coat, gloves (chemicals) Standard work clothes, overall/coat, gloves (chemicals), RPE 1) Other Process temperature < 15 C 15 - 25 C (room temperature) 25 - 50 C 50 - 150 C > 150 C LEV Yes No Filter systems after LEV No filter system after extraction One-step membrane filter to reduce particles Multi-step membrane filter to reduce particles Multi-step membrane filter to reduce particles + additional filter steps Wet scrubber Wet scrubber + additional filter steps Other Hall ventilation (e.g., HVAC) Yes No Generation of wastewater Yes No Wastewater volume [m] #### Waste tonnage [tons] #### Proportion of FP in waste #### [%] Waste disposal route Collected and disposed with other process waste Separate collection and disposal 1) Please note that safety goggles were not specifically part of the selection options but are considered to be included in the set of standard work clothes. 29 CHEMICAL SAFETY REPORT II. ADDITIONAL TASKS REPORTED Table 11: Process description - Delivery and storage Conditions of useConditions of use Selection 1) Process type Automatically or Both manual and automatic steps Task is performed Internally PPE Standard work clothes (shirt/long-sleeve, long trousers, safety shoes/boots) or Standard work clothes, overall/coat Process temperature 15 - 25 C (room temperature) or > 150 C LEV Partially available Filter systems after LEV No filter system after extraction Hall ventilation (e.g., HVAC) Yes Generation of wastewater Partially possible Wastewater volume [m] 0.01 Waste tonnage [tons] n/a Proportion of FP in waste [%] n/a Waste disposal route n/a 1) See Annex I for a list of selection options Table 12: Process description - Post-treatment/Quality control Conditions of use Selection 1) Process type Both manual and automatic steps Task is performed Internally PPE Standard work clothes, gloves (chemicals) Process temperature 15 - 25 C (room temperature) LEV No Filter systems after LEV Other Hall ventilation (e.g., HVAC) Yes Generation of wastewater Yes Wastewater volume [m] n/a Waste tonnage [tons] n/a Proportion of FP in waste [%] n/a Waste disposal route n/a 1) See Annex I for a list of selection options 30