Document ppZGkNn1VKzvyoGXRywoQ4daE

CECHA EUROPEAN CHEMICALS AGENCY Annex to the ANNEX XV RESTRICTION REPORT PROPOSAL4 FOR A RESTRICTION SUBSTANCE NAME(S): Per- and polyfluoroalkyl substances (PFASs) IUPAC NAME(S): n.a. EC NUMBER(S): n.a. CAS NUMBER(S): n.a. CONTACT DETAILS OF THE DOSSIER SUBMITTERS: BAuA Federal Institute for Occupational Safety and Health Division 5 - Federal Office for Chemicals Friedrich-Henkel-Weg 1-25 D-44149 Dortmund, Germany Bureau REACH, National Institute for Public Health and the Environment (RIVM) Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven, The Netherlands Swedish Chemicals Agency (KEMI) PO Box 2, SE-172 13 Sundbyberg, Sweden Norwegian Environment Agency P.O. Box 5672 Torgarden N-7485 Trondheim, Norway The Danish Environmental Protection Agency Tolderlundsvej 5 5000 Odense C, Denmark VERSION NUMBER: 1 DATE: 07.02.2023 P.O. Box 400, FI-00121 Helsinki, Finland I Tel. I Fax +358 9 68618210 I echa.europa.eu ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) TABLE OF CONTENTS Annex A Manufacture and uses ............................................................................ 1 A.1. Introduction ................................................................................................................. 1 A.2. Manufacture, import and export ...................................................................................... 5 A.2.1. PFASs manufacture ................................................................................................ 5 A.2.2. Import ................................................................................................................ 17 A.2.3. Export ................................................................................................................ 17 ite A.3. Uses .......................................................................................................................... 18 c A.3.1. Summary ............................................................................................................ 18 t A.3.2. Introduction ........................................................................................................ 20 o A.3.3. Textiles, upholstery, leather, apparel and carpets..................................................... 24 n A.3.4. Food contact materials and packaging .................................................................... 35 o A.3.5. Metal plating and manufacture of metal products ..................................................... 46 d A.3.6. Consumer mixtures .............................................................................................. 50 - A.3.7. Cosmetics ........................................................................................................... 52 n A.3.8. Ski wax............................................................................................................... 55 io A.3.9. Applications of fluorinated gases ............................................................................ 60 t A.3.10. Medical devices .................................................................................................. 77 lica A.3.11. Transport .......................................................................................................... 90 A.3.12. Electronics and semiconductors .......................................................................... 102 b A.3.13. Energy sector .................................................................................................. 116 pu A.3.14. Construction products ....................................................................................... 123 - A.3.15. Lubricants ....................................................................................................... 129 re A.3.16. Petroleum and mining ....................................................................................... 145 pA.3.17. Active substances in Plant Protection Products (PPP), Biocidal Products (BP) and Medicinal Products (MP) ............................................................................................................. 150 A.3.18. Waste ............................................................................................................. 152 A.4. Uses advised against by the registrants ....................................................................... 163 Appendices to Annex A ....................................................................................... 164 Appendix A.2. Manufacture, import and uses ....................................................................... 164 Appendix A.3.2. Fluoropolymer applications, including fluoroelastomers.................................. 176 i ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.3. Textiles, upholstery, leather, apparel and carpets ......................................... 187 Appendix A.3.4. Food contact materials and packaging ......................................................... 203 Appendix A.3.5. Metal plating and manufacture of metal products.......................................... 234 Appendix A.3.6. Consumer mixtures................................................................................... 236 Appendix A.3.7. Cosmetics ................................................................................................ 240 Appendix A.3.8. Ski wax ................................................................................................... 243 Appendix A.3.9. Applications of fluorinated gases................................................................. 246 Appendix A.3.10. Medical devices ...................................................................................... 263 ite Appendix A.3.15. Lubricants .............................................................................................. 269 c Appendix A.3.17. Active substances in Plant Production Products (PPP), Biocidal Products (BP) and Medicinal Products (MP) .................................................................................................... 270 ot References ......................................................................................................... 283 o n TABLES d Table Table - Table Table n Table io Table Table t Table a Table Table lic Table Table b Table Table u Table p Table Table - Table e Table r Table p Table A.1. Overview of PFAS applications and the level at which they were researched. ..... 5 A.2. Fluorinated gas production in Europe ............................................................ 8 A.3. Main global manufacturers of PFASs according to stakeholder information. ...... 11 A.4. Non-exhaustive overview of European (including UK) PFASs manufacturers ..... 12 A.5. Annual volumes of fluorinated gases in PFAS scope manufactured in the EEA... 15 A.6. Global and EEA fluoropolymer production volume, including PTFE and PVDF. ... 16 A.7. PFASs manufacturing volumes in EEA ......................................................... 16 A.8. PFASs imported into the EEA from third countries (t/y) based on consultations. 17 A.9. PFASs exported from the EEA (in t/y) ......................................................... 18 A.10. Estimated tonnages for PFAS manufacture and major PFAS use sectors......... 19 A.11. Uses sorted on volume range. .................................................................. 20 A.12. Examples of sectors, properties, and applications of fluoropolymers. ............. 21 A.13. Fluoroelastomers - non-exhaustive overview.............................................. 22 A.14. Volumes of fluorinated gas used in the EU in 2018 (rounded numbers). ........ 23 A.15. Overview of different TULAC categories. .................................................... 24 A.16. Applied concentrations of PFASs in a range of textile products...................... 27 A.17. Side-chain fluorinated polymers used for TULAC applications. ...................... 29 A.18. Tonnages of PFAS used in TULAC industry in EEA (2020). ............................ 32 A.19. Tonnages of PFASs used in the TULAC industry in EEA in year 2020 ............. 33 A.20: Total tonnages of subgroups of PFAS used per year for TULAC ..................... 34 A.21. Paper and board packaging consumption ................................................... 39 Table A.22. Estimates of intentionally added PFASs ..................................................... 39 Table A.23. Estimates of PFAS in carton board and paper wrapping packaging ................ 40 Table A.24. Volume data (2015) used for the emission estimates from fluoropolymers ..... 43 Table A.25. PFAS EEA volume per year per sub-use. .................................................... 44 Table A.26. Volumes of PFAS estimated to be used in food, feed and packaging industry .. 45 Table A.27. Uses of PFASs in metal plating processes and manufacture of metal products. 47 Table A.28. PFAS volumes in metal plating processes and manufacture of metal products 48 Table A.29. Main PFAS and identified properties in cosmetics. ....................................... 52 Table A.30. Share of cosmetic products and product versions containing PFAS*. ............. 53 Table A.31. Calculated total amount of cosmetic products sold per year in the EEA .......... 54 Table A.32. Total annual PFAS volume per main cosmetics category in EEA. ................... 54 Table A.33. Overview of different ski wax types (both grip and glide wax). ..................... 55 ii ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.34. Overview of different ski wax composition. ................................................ 57 Table A.35. Assumed production rates ....................................................................... 59 Table A.36. Yearly total volume of HFCs and PFCs in EEA per main use category. ............ 68 Table A.37. Fluoropolymers used in medical devices. ................................................... 82 Table A.38. Yearly total volume of side-chain fluorinated PFASs .................................... 86 Table A.39. Overview of usage and/or production volumes of polymeric PFASs................ 87 Table A.40. Yearly total PFAS volume in EEA per main medical use category. .................. 88 Table A.41. Overview of uses of PFASs in the transportation sector................................ 90 Table A.42. PFASs used in the transportation sector..................................................... 98 Table A.43. Stakeholder information on the volumes of polymeric PFASs .......................100 Table A.44. Polymeric PFASs volumes used in coatings and finishes ..............................101 Table Table Table e Table it Table Table c Table t Table Table o Table n Table Table Table o Table d Table Table - Table Table Table n Table io Table Table t Table a Table Table lic Table Table b Table Table u Table p Table - Table Table e Table r Table p Table A.45. A.46. A.47. A.48. A.49. A.50. A.51. A.52. A.53. A.54. A.55. A.56. A.57. A.58. A.59. A.60. A.61. A.62. A.63. A.64. A.65. A.66. A.67. A.68. A.69. A.70. A.71. A.72. A.73. A.74. A.75. A.76. A.77. A.78. A.79. A.80. PFAS properties relevant to the electronics and semiconductor industry .......102 Uses in electronic products and components (including semiconductors).......102 Uses of PFASs in the production process ...................................................103 Uses and properties of PFASs in the electronics industry .............................104 Uses and properties of PFASs in the semiconductor industry .......................109 Estimated yearly PFASs use in the electronics and semiconductor industry ...114 Estimated yearly PFASs use in the electronics and semiconductor industry ...114 PFAS properties relevant to the energy industry ........................................116 PFASs uses in the energy industry ...........................................................116 Identified uses and application of PFASs in the energy industry ...................117 Estimated yearly PFASs use in the energy sector in the EEA........................121 Estimated yearly PFASs use in the energy sector in the EEA........................121 Identified PFAS uses, technical function and examples of PFAS....................123 Estimated PFASs volumes in building materials/construction products ..........128 Non-exhaustive list of PFASs uses in lubricants .........................................133 Estimated PFASs volumes in lubricants used in the EEA in 2020. .................143 Main PFASs uses in petroleum industry.....................................................146 Summary of polymeric PFASs used in the petroleum and mining industries...147 Baseline projections (including UK) for volumes of PFASs and fluoropolymers148 Active substances in PPP, BP and MP and their respective regulations. .........150 PFAS numbers, used as active substances in PPP, BP, and MP. ....................151 PFAS entering the solid waste stage.........................................................153 PFAS tonnages entering the solid waste stage (t/y in EEA)..........................153 Collected fluoropolymer waste in Europe in 2020 per industry segment. .......155 Summary of numbers and capacity of European waste incinerators..............160 PFAS from the OECD and REACH registry database combined. ....................164 Volume bands of PFASs non-polymers with unsaturated bonds....................173 Volume bands of perfluoroethers non-polymers with saturated bonds. .........174 A summary of annual imports of PFAS chemicals from third countries ..........174 A summary of annual exports of PFAS chemicals .......................................175 Non-exhaustive overview of common commercial FPs and their applications .176 Non exhaustive overview of common commercial FPs and their applications .180 Uses and applications for unspecified fluoropolymers .................................186 Requirements/Standards relating to PPE (specific technical standards) .........187 Summary of data used for estimating PFAS (surfactants) volume ................203 Substances (indicative list with some examples) used in FCM and packaging.204 Table A.81. PFAS that have been identified for all food contact and packaging use..........205 Table A.82. PFAS Positively Identified as Used/Were Used in Consumer Cookware. .........230 Table A.83. PFAS used (or patented).........................................................................234 Table A.84. Examples for specific PFAs used for certain applications .............................236 Table A.85. Sum of PFAS and TOF content for several consumer mixtures .....................237 Table A.86. Measured PFAS content for several consumer mixtures ..............................237 Table A.87. Quantified PFAs content for a group of polishes and cleaners ......................238 Table A.88. Determined Fluorotelomers for cleaning products, waxes and sealants. ........238 Table A.89. Quantified PFAS in cleaners ....................................................................238 Table A.90. Sum of 45 analysed PFAS and extractable organic fluorine (EOF).................239 Table A.91. Sum of 16 analysed PFAS and TOF for four different anti-fog sprays ............239 Table A.92. PFAS INCI names found in cosmetic products in the different databases. ......241 iii ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.93. Examples of PFAS-based ski waxes, applications and normalised prices........243 Table A.94. Examples of fluorine-free waxes, applications and normalized prices ............243 Table A.95. Fluorinated gases currently in commercial use ..........................................246 Table A.96. List of specific fluorinated gas substances .................................................259 Table A.97. Intended applications of EU-28 total supply of fluorinated gases..................261 Table A.98. Estimation of quantities of Hydrofluoroolefins Used ....................................262 Table A.99. Medical implants and materials................................................................263 Table A.100. Main coatings reported .........................................................................264 Table A.101. Main applications of PFAS in technology..................................................264 Table A.102. Polymers and elastomers used in medical devices ....................................265 Table A.103. List of additional uses of PFASs in medical devices ...................................265 Table A.104. Estimated fluorinated gas greenhouse warming potential (GWP) ................267 Table A.105. Other polymeric PFASs (non-PTFE).........................................................268 Table A.106. Other uses of PFAS. .............................................................................268 e Table A.107. Examples of PFASs used in lubricant applications. ....................................269 it Table A.108. Non-exhaustive list of EU approved active substances for PPPs ..................270 Table A.109. Non- exhaustive list of EU approved biocidal active substances..................280 c Table A.110. Non- exhaustive list of active pharmaceutical ingredients (APIs) ................280 ot FIGURES n Figure Figure o Figure Figure d Figure Figure - Figure Figure n Figure Figure io Figure Figure t Figure a Figure lic Figure Figure Figure b Figure Figure u Figure p Figure - Figure pre Figure A.1. The lifecycle of PFASs (EC, 2020). ............................................................... 1 A.2. Overview of PFASs groups used for impact assessment (Annex E). .................. 3 A.3. Schematic simplified presentation of PFASs supply chain, including main uses. . 4 A.4. Hydrofluoric acid (HF) use (Evich et al., 2022). ............................................. 6 A.5. Distinction between F-gases (blue) and fluorinated gases in scope (orange). .... 7 A.6. Schematic presentation of timeline synthetic refrigerants. .............................. 8 A.7. Supply of HFC and HFO in EU ..................................................................... 9 A.8. Landscape of main fluoropolymers taken from Zeus (2019). ......................... 10 A.9. Annual import, export, production, and consumption flows of textile products. 30 A.10. Automatic Chappati making (left) and hydraulic seal kit (right). .................. 38 A.11. Overview of metal plating types. ............................................................. 46 A.12. High level market overview of ski waxes in the EEA ................................... 58 A.13. Prefabricated XPS foundation insulation.................................................... 65 A.14. Material Flow diagram ............................................................................ 71 A.15. Fluorinated gases filled into new manufactured products ............................ 72 A.16. Intended applications of EU total supply of fluorinated gases ...................... 73 A.17. EU imports of fluorinated gases ............................................................... 74 A.18. 2019 total supply by types and groups of fluorinated gases ........................ 75 A.19. Supply of gases outside the scope of the PFAS restriction proposal .............. 76 A.20. Proportion of PFASs (types) applied in the medical device industry .............. 85 A.21. Fluoropolymer waste collection in Europe (2020) and main sectors .............155 A.22. A car's last journey. ..............................................................................159 A.23. Functions of INCI names in cosmetics. ....................................................240 iv ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Annex A Manufacture and uses Annex A contains an introduction to this Annex (A.1), information on PFAS manufacture, import and export (A.2), and information on main uses/use sectors (A.3). For 15 sectors, data on uses, volumes, and main PFASs applied is summarized in sections A.3.3 to A.3.17. Finally, the waste stage of the PFAS life cycle is described in section A.3.18. In the Appendix to Annex A, background information to uses, volumes and PFASs applied, is included. A.1. Introduction Many different PFASs are used in a wide range of applications. As actions taken so far have not sufficiently addressed the concerns related to the use of PFASs, the goal is to minimise environmental and human exposure to PFASs, at all stages of their life cycle. An illustrative e picture of the life cycle of PFASs, including manufacturing and use as well as waste it management, is depicted in Figure A.1. publication - do not c Figure A.1. The lifecycle of PFASs (EC, 2020). re- PFASs have typical properties like chemical inertness, radiation resistance, temperature resistance, weathering resistance, oil-, water- and stain repellence, electrical inertness, p corrosion protection, low coefficient of friction and non-flammability. These (combined) properties, partly the result from the very strong carbon-fluorine bond (C-F), make PFASs useful in a very broad range of processes and products (Glge et al., 2020; ITRC, 2022). In particular fluoropolymers and side-chain fluorinated polymers are used in a broad range of applications. In their key paper on PFAS applications, Glge et al. (2020) provide a more detailed overview of many use categories where PFASs have been employed and for which function. The article also specifies which PFASs have been used and discusses the magnitude of the uses. Despite being non-exhaustive, the study clearly demonstrates that PFASs are used in almost all industry branches and many consumer products. In total, more than 200 use categories and 1 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) subcategories are identified for more than 1400 individual PFASs. In addition to well-known categories such as textile impregnation, fire-fighting foams, and electroplating, the identified use categories also include many categories not described in the scientific literature, including PFASs in ammunition, climbing ropes, guitar strings, artificial turf, and soil remediation. For this dossier, the major uses of PFASs have been identified from literature and stakeholder consultations. Data on uses, volumes and PFASs applied was collected by approaching stakeholders through a call for evidence (CfE) from May to July 2020. Data for different sectors was compiled and verified by consultants and was complimented with data from public sources. Subsequently, data was again verified by a second stakeholder consultation round from July to October 2021. For each sector a separate report was drafted. Summarised details on manufacture and uses, including volumes, are included in Annex A. PFAS volumes/ tonnages could, in most cases, not be disaggregated to tonnages at substance level, although many PFAS are mentioned in the Appendix of this Annex. A more detailed description of the e data collection process is provided in Annex G. it No information is available on the participation rate of stakeholders. It is likely that not all c stakeholders provided information and that therefore the volumes presented in Annex A are t an underestimation of the actual volumes used in the sectors. Stakeholders provided in general more data on polymeric PFASs and fluorinated gases than on non-polymeric PFASs. o Where possible data from literature was added. Sometimes assumptions regarding volumes n had to be made (see the sections on uses). A more detailed description of assumptions, uncertainties and sensitivities is provided in Annex F. o For most sectors, a summary table is provided in which the volumes of PFASs used are d presented. The summary tables include data collected from stakeholders and from public sources unless otherwise indicated, at the highest level of detail possible. - As described in detail in the main report and in Annex B.1, PFAS grouping in the restriction proposal is based on the OECD 2021 PFAS report (OECD, 2021). It should however be noted n that in Annex A PFAS grouping is slightly different, the difference concerning the side-chain io fluorinated polymers (SCFPs). SCFPs are chemically speaking polymers and in that sense belong to the polymeric PFAS group (as done by OECD), but for impact assessment purposes t they are grouped under PFAA precursors. Hence, the following three main PFAS groups were a chosen for the impact assessments, see also Figure A.2: lic 1. PFAAs and PFAA precursors (including side-chain fluorinated polymers) 2. Fluorinated gases b 3. Polymeric PFASs u Per use sector, the impact assessment is performed for total PFAS and additionally for the p three main groups mentioned above. Of note, total PFAS does not only include PFASs in the three main groups, but also PFASs that cannot priori be allocated to the main groups. These pre- non-allocated PFASs are included in the `Other PFASs' group in Figure A.2. 2 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) 1. 2. 3. PFAAs and PFAA precursors F-gases Polymeric PFASs Perfluoroalkyl acids (PFAAs) Fluoropolymers PFAA precursors (inc. side-chain fluorinated polymers) PFAAs and PFAA precursors Perfluoro not cite polyethers Contains the perfluoroalkyl acids (PFAAs), and precursors of PFAAs, including side-chain fluorinated polymers (and perfluoroalkyl ether side-chain fluorinated polymers); excludes F-gases. o F-gases Contains the gases that fulfil the PFAS definition. Not restricted to d the substances mentioned by the F-gas regulation. Polymeric PFASs Contains fluoropolymers as PTFE, PVDF and perfluoropolyethers; - excludes side chain fluorinated polymers. Other PFASs Contains all PFAS substances which are not covered by the three ion main categories. Other PFASs CF3 on active substances Side-chain fluorinated aromatics Perfluoroalkanes (non- gaseous) Perfluoroalkyl-tert- amines Perfluoroalkylethers Others at Figure A.2. Overview of PFASs groups used for impact assessment (Annex E). lic Figure A.3 presents the structure of the PFASs supply chain. The top tier consists of the b suppliers of raw materials like fluorite (also called fluorspar, calcium fluoride, CaF2). Raw u materials are used by manufacturers of PFASs as well as manufacturers of PFAS containing materials (e.g., PFAAs (including PFAA precursors), side-chain fluorinated polymers and p fluorinated gases). Raw materials and production aids can either be manufactured in the EEA - or imported from third countries, either directly from manufacturers based outside the EEA e or through EEA based distributors or importers. PFASs can either be used to formulate other r PFAS containing products or be directly used by downstream users. PFASs can be placed on p the EEA market either directly by EEA based manufacturers/processors or via imports from third countries. 3 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) lication - do not cite Figure A.3. Schematic simplified presentation of PFASs supply chain, including main uses. ub With the 15 major use sectors, the Dossier Submitters believe to have covered rather exhaustively the PFAS uses. It is recognized though that it is impossible to be complete, given p the large number of PFASs and the broad range of processes and products they are useful - for. From literature and stakeholder consultations indeed some additional uses/applications e were identified. For these however no detailed assessment was performed, e.g. because they r concerned niche applications or because the applications are currently of little relevance in p the EU. Important to note is that although not every single application has been assessed in detail, all applications are covered by the restriction proposal as the PFASs used eventually end up in the environment due to releases during manufacture, use or in the waste stage. Table A.1 presents an overview of all the more and less researched PFAS applications (including PFAS manufacturing and waste stage). 4 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.1. Overview of PFAS applications and the level at which they were researched. PFAS applications PFAS manufacture Textile, upholstery, Food contact materials Metal plating and leather, apparel and and packaging manufacture of metal carpets (TULAC) products Consumer mixtures Cosmetics Ski wax Applications of fluorinated gases Medical devices Transport Electronics and Energy sector semiconductors Construction products Lubricants Petroleum and mining Waste stage PFAS Laboratory equipment & filtration Medicinal products Fracking (currently hardly applicable in Plant protection products and biocides Plastics (other than packaging) and rubber/elastomer production (including flame retardants) Immersion cooling (currently hardly Chemical industry Pyrotechnics Defence industry applications Firefighting foam e Personal care it products other than c cosmetics notPrinting inks EEA) applicable in EEA) Cement industry Professional cleaning o and polishing Green uses are researched in detail d Blue uses are researched in general Orange uses not researched in detail - Purple use: Separate restriction proposal Other niche applications Uses (yet) unknown ion A.2. Manufacture, import and export t A.2.1. PFASs manufacture lica A.2.1.1. Introduction In this section, PFASs manufacturing and related processes are discussed, from the mining of b raw materials to the synthesis of specific PFASs. u All organic fluorine compounds in the supply chain are synthetically manufactured. All fluorine p used in the manufacturing of these organic fluorine compounds are made from mined fluorite - (CaF2), also called fluorspar (Harsanyi and Sandford, 2015). About 11% of fluorite consumed in Europe is used to produce fluoropolymers (Wahlstrm et al., 2021). re About half of all fluorite produced is used in iron and steel production, while the second half p is used for production of anhydrous hydrogen fluoride (HF). Almost 70% of the HF is used for fluorinated organic substances. The link between HF and PFASs is presented in Figure A.4. With current global reserves of 500 million tonnes fluorite, there is less than 100 years left at the current mining level (Harsanyi and Sandford, 2015). 5 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Figure A.4. Hydrofluoric acid (HF) use (Evich et al., 2022). ite A.2.1.2. PFAA and PFAA precursors c Perfluoroalkyl acids (PFAAs) are fully fluorinated alkyl acids. Substances which can react to t form PFAA are called PFAA precursors, and include for example perfluoroalkyl iodides, o perfluoroalkane sulfonyl fluorides and perfluoroalkenes. n There are two main manufacturing methods to produce compounds containing perfluoroalkyl chains, described in detail in Buck et al. (2011). Below are short summaries of the two o methods: d Electrochemical fluorination (ECF) - In the ECF method, an organic raw material (e.g., octane sulfonyl fluoride, C8H17SO2F) undergoes electrolysis in anhydrous HF, leading to the replacement of all the H atoms by F n atoms. In this process, carbon-chain rearrangement and breakage may occur, resulting in a mixture of linear and branched perfluoroalkyl isomers and homologues of the raw material. io When octane sulfonyl fluoride is used as a substrate in the ECF process, t perfluorooctanesulfonyl fluoride is formed. This is the major raw material used to manufacture PFOS and its salts. lica Telomerisation In this process, a perfluoroalkyl iodide, most commonly perfluoroethyl iodide (C2F5I), is b reacted with tetrafluoroethylene (CF2=CF2) to yield perfluoroalkyl iodides with extended u perfluoroalkyl chains. The perfluoroalkyl iodide mixture is often further reacted with ethylene to introduce a non-fluorinated tail to the molecule. The iodide may be substituted with for p example an alcohol group for the formation of fluorotelomer alcohols (FTOH). Telomerisation - is applied at least at one site in Europe in Gendorf. Here, C6 fluorotelomers are being e produced. prSide-chain fluorinated polymers Side-chain fluorinated polymers are polymeric PFASs consisting of variable compositions of non-fluorinated carbon backbones with per- or polyfluoroalkyl side-chains, as well as sidechains that partly have no fluorinated carbons. Some examples of side-chain fluorinated polymers are fluorinated acrylate, urethane and oxetane polymers. During the lifetime, the side-chains can be released mostly as telomeric PFASs, (e.g., fluorotelomer alcohols) that can degrade further into perfluoroalkylcarboxylic acids (PFCA) which is why side-chain fluorinated polymers are considered to be PFAA precursors. 6 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Side-chain fluorinated polymers are made by polymerisation e.g., a fluorinated acrylate or methacrylate monomer. These fluorinated acrylate monomers are copolymerized with one or more non-fluorinated acrylate monomers, and possibly other monomers, to give the final side-chain fluorinated acrylate polymers. These polymers are made using fluorotelomers and perfluoroalkane sulfonamido (meth)acrylates, but also include side-chain fluorinated siloxane derivatives. Fluorinated urethane polymers may also be based on urethane polymers formed by reacting fluorotelomer alcohols, or perfluoroalkane sulfonamidoethanols, with polyisocyanate homopolymers, followed by a cross-linking step. To provide a rough estimate of the volume range of PFAA and PFAA precursors currently produced in the EEA, REACH registered substance datasheets were reviewed for all relevant PFASs. These are summarised in the appendix Table A.71 and Table A.72. Estimation of the total volume might not be accurate, due to the lack of information submitted by manufacturers and producers of PFASs. Volumes are low (400 - 4 500, rounded) compared e to fluorinated gases and polymeric PFASs. it A.2.1.3. Fluorinated gases t c Not all F-gases included in the F-gas regulation, are PFASs according to the definition used for the restriction proposal (see section 1.1.1 of main document, e.g. HFC-22 and SF6). On o the other hand, there are PFASs which are volatile and reside in the gaseous state which are n not in the F-gas regulation but are within the definition used for the restriction proposal. These include for example fluorotelomer alcohols or perfluorinated trialkylamines (which are gases in the atmosphere but liquids under normal conditions). In Annex A, unless specifically o explained, fluorinated gases are those gases that are within the definition used for the d restriction proposal (see Figure A.5). Fluorinated gases are mainly used as starting materials in the production of fluoropolymers and as heat transfer agent in refrigeration and air - conditioning. -publication Figure A.5. Distinction between F-gases (blue) and fluorinated gases in scope (orange). preFluorinated gases as starting materials in the production of polymeric PFASs According to stakeholders, about 45% of fluorinated gases are used as monomers in the production of polymeric PFASs. This means that these gases are starting materials for fluoropolymer production and are consumed in the process. There are about 20 manufacturers of PFASs (Table A.4). Like mentioned before, some of the fluorinated gases contain fluorine but are not PFASs. Examples are HCFC-22, used for PTFE manufacturing, and HCFC-142b, used for PVDF manufacturing. Fluorinated gases used as refrigerants 7 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The change in fluorinated gases use in refrigerants over time, from Chlorofluorocarbon (CFC) through Hydrofluorocarbon (HCFC) and Hydrofluorocarbon (HFC) to Hydrofluoroolefins (HFO) is explained in Figure A.6. There is a current transition to using HFO, due to lower global warming and ozone depletion potential. However, many HFO can degrade to PFASs such as TFA. t cite Figure A.6. Schematic presentation of timeline synthetic refrigerants. no Industry introduced CFCs as synthetic refrigerants for use in these applications in the 1930s, leading to widespread use by the 1950s of freons, such as CFC-11, CFC-12 and CFC-13. o However, CFCs were identified as the causal agent in damage to the stratospheric ozone layer that protects the earth from the harmful effects of ultraviolet radiation from the sun during d the 1970s, which led to their being banned under the 1987 Montreal Protocol. Subsequent amendments increased the scope of the protocol, for example leading to the banning of HCFCs - that replaced CFCs because of lower (but not negligible) ozone depletion potential. These measures have contributed to the phase-out of CFC use around the world, as well as the n phase-out of HCFC use to be achieved by 2030. In Europe HCFCs have been phased out already, in accordance with the EU regulation on ozone depleting substances. io Industry developed hydrofluorocarbons (HFCs) as in-kind replacements for CFCs and HCFCs. t HFCs did not damage the ozone layer. Refrigerant examples include HFC-134a and blends of a HFCs such as R-407C. However, many HFCs have a high global warming potential (GWP) lic contributing to the greenhouse effect. HFC use was addressed by the 1997 Kyoto Protocol, an international treaty that extended the 1992 United Nations Framework Convention on Climate Change (UNFCCC) to reduce greenhouse gas emissions. However, some HFCs are still b in use today in Europe, for certain applications and where the GWP is below a specified level as defined in the EU F-gas regulation. This regulation has contributed considerably to the u reduction in impact of HFCs on the climate. -p Hydrofluoroolefins (HFOs) are the latest generation of drop-in fluorinated refrigerants. HFOs do not impact the ozone layer and have low GWP. However, these substances degrade in e various quantities in the environment to persistent substances such as trifluoroacetic acid r (TFA). p The production of HFC requires many starting materials. By-products are formed as well. See table Table A.2 for illustration. Table A.2. Fluorinated gas production in Europe (UBA, 2021). Gas produced Production in t/y and EU Starting materials, intermediates, by- productions sites (2018) products and potential minor components PFC-218 10 to < 100 tonnes, Italy (1 plant) HFC-227ea >1 000, Germany (1 plant) HCC-20 (trichloromethane, chloroform) 8 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Gas produced Production in t/y and EU Starting materials, intermediates, by- productions sites (2018) products and potential minor components Hexafluoropropene (HFO-1216) Tetrafluoroethene (HFO-1114) HCFC-124 HCFC-22 HFC-23 HFC-134a <10 000, Germany (1 plant), HCC-1120 (trichloroethene) France (1 plant) HCFC-131a HCFC-132b e HFC-143a it HFC-365mfc c HFO-1234yf <1 000, France (1 plant) <10 0000, France (1 plant) 10 000 - 100 000, France (1 plant) + import HCFC-133a u-HCFO-1122 Unknown Pentachlorobutane 2-chloropropene Unknown if this plant produces HFO-1234yf due to legal disputes (ARKEMA, 2020) not Production of fluorinated gases is dominated by HFC, which accounts for more than 90 % of the total, with HFC-134a and HFC-365mfc accounting for the largest parts. HFC-134a (in scope) is by far the most relevant regarding EEA production volume. It is REACH registered o in the tonnage band 10 000 - 100 000 tonnes/y. HFC-365mfc (in scope) is registered as d confidential, so no tonnage band is available. HFC-365mfc is being produced in one plant in Europe. HFC-134a is currently being replaced with HFO-1234yf (in scope) especially in mobile air conditioning (for passenger cars). On a global scale Europe is not a large producer of HFC - and HCFC (Booten et al., 2020). n The trend to use the "low global warming potential" refrigerant in cooling systems is io stimulated by the F-gas regulation. HFO are key in this transition as they have low global warming potential due to short atmospheric lifetimes. See also Figure A.7 below, which is pre-publicat based on data from Table A.97 in the appendix. Figure A.7. Supply of HFC and HFO in EU (tonnes; see Table A.97), taken from EEA (2021). One key HFO substance is HFO-1234yf. It is REACH registered in the tonnage band 10 000 - 100 000 tonnes/y. Another key HFO substance is HFO-1234ze(E), which has been mainly used as a foam blowing agent in polyurethane foam and as refrigerant. It is registered in the tonnage band 1 000 - 10 000 tonnes/y. Other important HFOs now are HFO-1336mzz(Z) 9 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) (100 - 1 000 tonnes/y) HFO-1336mzz(E) (10 - 100 tonnes). A.2.1.4. Polymeric PFASs Polymeric PFASs is a main group of PFASs, according to Figure A.2. It includes fluoropolymers, perfluoropolyethers and side-chain fluorinated polymers. The latter group left out for impact assessment purposes. Fluoropolymers have various material properties (mechanical strength, inert, thermal stability, resistance to degradation, etc) and are used in very diverse applications. Fluoropolymers are made by (co)polymerisation of monomers, at least one of which contains fluorine bound to one or both of the olefinic carbon atoms, to form a carbon-only polymer e backbone with fluorine atoms directly attached to it. Typical monomers used include it tetrafluoroethylene (TFE), hexafluoropropylene (HFP), vinylidene fluoride (VDF), chlorotrifluoroethylene (CTFE), vinyl fluoride (VF), trifluoroethylene (TrFE) and perfluoroalkyl c vinyl ethers (PAVE). Figure A.8 presents an overview of widely used homo- and cot fluoropolymers. publication - do no Figure A.8. Landscape of main fluoropolymers taken from Zeus (2019). re- Fluoropolymer production often requires not only fluorine containing monomers but also p fluorinated production aids. Production of fluoropolymers is performed at different levels: The polymerisation: Molecules that start the reaction (initiators) and catalysts may be required, depending on the type of polymerisation. The medium: polymerisation is carried out in a dispersion (suspension or emulsion), this creates a microbubble (solid or liquid) in which the polymers are formed. Surfactants or emulsifiers are called polymerisation aids. Polymer processing: after the reaction is finished, the polymers are shaped into their desired form, for example by extrusion, for which polymer processing aids are used. Fluoropolymers are generally produced by one of two processes: emulsion polymerisation or suspension polymerization (Lohmann et al., 2020). 10 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Polymerisation aid Polymerisation aid is the term used to describe a surfactant or emulsifier, fluorinated or nonfluorinated. According to a stakeholder, about 50-60% of fluoropolymers are manufactured without fluorinated polymerization aids. Examples of PFAS polymerisation aids are: PFOA, PFNA, PFHxA, 6:2 FTSA, the ammonium salt of hexafluoropropylene oxide dimer acid (HFPODA) and dodecafluoro-3H-4,8-dioxanonanoate. Currently, industry seems to be in transition to use polymerisation aids without PFASs. Some manufacturers, e.g., Gujarat, recently announced they can produce fluoropolymers PTFE and PVDF without polymerisation aids containing PFASs (Chemical Watch, 2022). Four companies have recently reported replacement of fluorinated polymerisation aids with nonfluorinated polymerisation aids1. e Polymer processing aid it Polymer processing aids are used in the extrusion of various thermoplastic polymers. Polymer c processing aids behave as lubricants and improve the extrusion quality, homogenisation of t pigments and fillers and output of thermoplastic polymers. Polymer processing aids are fluoropolymer-based additives which perform at low concentrations as extrusion aids. They o are for instance used in blown film extrusion of linear low-density polyethylene (LLDPE). Other n applications include pipe extrusion of high-density polyethylene (HDPE). Typical processes include blown and cast film, pipe, sheet, cable, extrusion blow moulding, monofilament, tapes and fibres. Substances used as polymer processing aids are e.g., low molecular weight PTFE, o FEP, perfluoroalkoxy alkanes (PFA), etc. (Lohmann et al., 2020). d Perfluoropolyethers (PFPE) - PFPE are polymers from perfluorether monomers. One structural trait is that they have moieties of -CnF2n-O-CmF2m- in the polymer backbone. For an overview, see the Nordic n Working Paper (Wang et al., 2020), chapter 4. io PFPEs are used as lubricants in specific industrial sectors, as well as certain consumer t applications related to surface protection. a A.2.1.5. Manufacturing sites lic Globally, there are eight manufacturers, making up 60% of the worldwide PFASs market. b (Table A.3). According to a stakeholder, China's market share is larger than indicated in Table A.3, the stakeholder estimates a market share for all Chinese producers of >65%. S&P u Global's (2022) mentions a Chinese market share of about 40%. Chinese manufacturers p include Fuxin Ltd., Dongyue Group, Juhua Group Corp., Changshu 3F Zhonghau and Zhejiang - Yonghe Refrigerant Co., Ltd. In Table A.3, the main manufacturers of fluorinated gases are included. re Table A.3. Main global manufacturers of PFASs according to stakeholder information. p Manufacturers of PFASs Location Approximate Global Market share (%) AGC Inc. Japan / USA 4 Arkema France / China / USA 7 Chemours USA / Netherlands / China 12 1 https://chemicalwatch.com/439992/indian-company-plans-to-substitute-pfass-in-ptfe-productionvia-emulsion, https://www.chemours.com/en/news-media-center/all-news/pressreleases/2022/chemours-announces-process-innovation-with-new-viton-fluoroelastomers-advancedpolymer-architecture, https://kynar500.arkema.com/en/product-information/fluorosurfactant-free/, https://www.solvay.com/en/article/eliminating-pfas, date of access for all: 2022-12-16. 11 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Manufacturers of PFASs Daikin 3M / Dyneon Solvay Shandong Donyue Group Archroma Others Location Japan / USA / China US / Japan Belgium / China / USA China Germany Global Approximate Global Market share (%) 11 5 8 13 unknown 40 The main global manufacturers of fluorinated gases are situated in China (9 sites), Japan (4 sites), India (1 site), USA (1 site) (Seidel and Andersen, 2015). e An overview of the most important European manufacturers / producers of PFASs is presented it in Table A.4. c Table A.4. Non-exhaustive (stakeholder information). t Location no Italy overview of Company European (including UK) PFASs manufacturers Manufactured (Currently and or in past) Porto Marghera Fluorsid S.p.A. Collebeato BS Daikin (Heroflon S.p.A.) Spinetta-Marengo - France Pierre-Bnite Cedex n Salindres licatio Pierre-Benite Cedex b Tavaux u Villers St. Paul p Germany - Gendorf pre Industriepark Solvay Solexis SPA Arkema Solvay Daikin Chemical France S.A.S Solvay Solexis Chemours Archroma CF Carbons GmbH dohydrofluoric acid and derivatives + polymers 2021 PTFE compounds and micropowders FKM, HCFC-22, HFC-218 and PTFE HFC-134a, PVDF Trifluoromethanesulfonic acid (TA), Trifluoromethanesulfonic anhydride (TAA), Trifluoroacetic acid (TFA), Potassium trifluoromethanesulphinate (TFSK) high-performance fluoroelastomers (source: Daikin 2020 Public comment PFHxA #3066.pdf) HFC-365mfc, PVDF, PTFE, PFBa, HFA, vinylidene fluoride No data C6 fluorotelomers, Textile Chemicals, Paper Specialties and Emulsions on basis of C6 fluorotelomers HCFC-22 (out of scope), HF Hchst,Frankfurt am Main Bas Wimpfen Solvay HFC-365mfc, Solkane; 4-Ethoxy- 1,1,1-trifluoro-3-buten-2-one (ETFBO), Trifluoroacetyl chloride (TFAC), Trifluoroacetic acid (TFA), Trifluoroacetic acid anhydride (TFAH), Trifluoroacetic acid ethyl ester (TFAEt), Trifluoroacetic acid methyl ester (TFAMe), Trifluoroacetic acid isopropyl ester (TFAiP), 1,1,1- 12 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Location Company Manufactured (Currently and or in past) Trifluoroacetone (TFK) Industriepark Hchst,Frankfurt am Main Germany = Burgkirchen Ludwigshaven Seelze, Hannover Belgium Zwijndrecht Daikin Refrigerants Frankfurt GmbH Dyneon BASF Honeywell Specialty Chemicals Dyneon LLC (Division of 3M) Mechelen The Netherlands - Dordrecht Chemours DuPont Performance Elastomers LLC n Oss tio Poland Daikin Chemical Netherlands B.V. Tarnow Zaklady Azotowe, aPoland lic United Kingdom (not EEA anymore) Preston F2 Chemicals Ltd b Runcorn, Cheshire Mexichem/Koura u Thornton-Cleveley, p Lancashire AGC re- A.2.1.6. Volumes p PFAAs and PFAA precursors refrigerant gas and pharma propellants: HFC-227 pharma and e HFC-134a pharma it fluoropolymers, PTFE, PFA, FEP, ETFE No data c Fluoroaromates not compounding of fluoro-elastomers, dovinylidenefluoride, HFP, HF, 1,1,1,2,2,4,5,5,5-Nonafluoro-4(trifluormethyl)-3-pentanone Teflon coatings PTFE, FEP, Chlorotrifluoroethylenevinylidene fluoride (FPM/FKM) VitonTM Pre compounded base-polymers PTFE (Tarflen) perfluorinated fluids CFCS, HCFC, HFC; Hydrofluorocarbon (HFC) refrigerants HFC-125 PTFE, ETFE, PFA Based on responses from stakeholders, the volume of PFAA and PFAA precursors manufactured, is between 10 000 and >100 000 tonnes. A stakeholder estimated the volumes of side-chain fluorinated polymers manufactured and imported in the EEA between 10 000 and 100 000 tonnes. Fluorinated gases Fluorinated gases are manufactured in the EU/EEA at 92 000 tonnes (midpoint) annually: see 13 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.5. Fluorinated gases for the European market are mainly manufactured outside of the EU/EEA and imported, see text below Table A.3 and Table A.8. Fluorinated gases are mainly produced for use in HVACR applications. Annual fluorinated gas manufacturing volumes were derived from EEA reports, REACH registrations and stakeholder information. As mentioned before, HFC and HCFC production in Europe is low compared to China and USA: See HFO production in Europe appears to be hardly existing. Fluorinated gases for the European market are mainly manufactured outside of the EU/EEA and imported, see Table A.8. The volume of HFC-134a supplied to the EEA market is around 26 000 t/y (EEA, 2020). In the ECHA registration database, volumes of between 10 000 and 100 000 tonnes are included. A stakeholder confirmed this volume range. e HFC-125 and HFC-134a are used as component in refrigerant blends. In the ECHA registration it database, volumes of between 10 000 and 100 000 tonnes of fluorinated gases that are used as components in refrigerant blends are included. This number also includes gases that are c not PFASs. The EEA is the only region that produces HFC-365mfc, with 15 000 tonnes t produced per year (Stemmler et al., 2007). o According to stakeholders, there is no known production of HFC-152a in EEA and according n to the European Environmental Agency, the total supply to the EEA was 3 100 tonnes in 2019 (EEA, 2020). o In Table A.5, EEA production volumes of fluorinated gases are included. As a starting point, d the volumes of F-gases on the 2018 OECD list, that are registered under REACH in the EU, were calculated and fluorinated gases in scope were marked. Addition of the midpoint volumes led to a total of a production + import tonnage of fluorinated gases of 131 530 t/y. - Several fluorinated gases that are registered, to a total of 127 000 tonnes, are not included n in the OECD list and midpoint volumes were added to the total volume. A volume of 1 285 io t/y of additional fluorinated gases, mentioned by a stakeholder, was added to the total volume as well. at It should be noted that ECHA registrations also include imported volumes that cannot be disaggregated from manufactured volumes. Based on EEA (2021) data this amounts to 83 lic 267 t/y for 2019. This volume is subtracted from the total fluorinated gases manufactured and imported in Table A.5. Very likely, the volume of 83 267 t/y is an under estimation. This b can be illustrated by an example: octafluorocyclobutane, is registered in the tonnage band 10 000 to < 100 000 tonnes and none of the registrants seem to be producers, so likely it is u imported to EEA. The tonnage band for octafluorocyclobutane (likely used a.o. as refrigerant) p therefore alone already covers the total reported import tonnage by EEA of 83 267 t/y. - Additional information is provided in Table A.70 in the Appendix. re The total amount of fluorinated gases manufactured, based on midpoint registrations of p volumes, is estimated to be 175 000 t/y (rounded). The EEA F-gas reporting (2021) indicates a lower number of 15 000 t/y for 2019. The number of EEA is likely an underestimation as it is based on (mandatory) reporting, but not all companies report. This is i.e., reflected in the highly variable numbers of reporting companies. In the EEA these numbers are not considered as this is not required in the F-gas reporting framework. The tonnages the Dossier Submitters are looking for therefore could be higher. Also REACH registrations suggest far higher tonnages. A broad manufacturing tonnage range, between 15 000 and 176 000 t/y year, the latter based on REACH midpoint registration, is most likely. Stakeholder information on manufactured PFAS tonnage in EEA suggested a range between 14 000 and 53 000 t/y. 14 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.5. Annual volumes of fluorinated gases in PFAS scope manufactured in the EEA. PFAS group Volume (t/y)a Subtotal fluorinated gases REACH registered substances (midpoint) from OECD database: Manufacturing and import 131 530 Subtotal fluorinated gases REACH registered substances (midpoint) nonOECD: Manufacturing and import 127 000 Subtotal fluorinated gases mentioned by a stakeholder: Manufacturing and import > 1 285 TOTAL fluorinated gases manufactured and imported Import EEA (2021) reporting 2020 259 815 83 267b Total fluorinated gases manufactured based on REACH registrations 176 548 (corrected with EEA import figure) Total fluorinated gases manufactured based on EEA (2021) reporting e 2019 it a REACH midpoint registration numbers were used. b From (EEA, 2021). 15 000 t c Polymeric PFASs o EEA fluoropolymers volumes n Wood (2022) estimated that in 2020, around 49 000 tonnes of fluoropolymers per year were produced in the EEA, where processing aids were not included. For processing aids production o volumes are unaccounted for (Glge et al., 2020). Stakeholders indicated volumes between d 49 458 and 101 763 tonnes. - ACG Chemicals estimated the EEA volumes of PTFE at 34 000 tonnes, whereas one stakeholder mentioned a volume of 3 500 tonnes for PTFE as a micro-powder (AGC Chemicals Europe, 2020). In a study in 2019, production volumes of 15 000 - 20 000 tonnes of PVDF n were estimated. During the stakeholder consultation it was indicated that 8 300 tonnes io fluoroelastomers were manufactured in 2018. t Worldwide fluoropolymer volumes a According to AGC Chemicals Europe, in 2018, the global fluoropolymer production capacity of lic the six largest producers was 468 000 tonnes (AGC Chemicals Europe, 2020). b The main polymers produced are PTFE and PVDF. According to industry PTFE, PVDF, and FEP, represent approximately 80 % of the total global fluoropolymer production. pu K-profi, Sympatex, and AGC Chemicals estimated worldwide volumes of PTFE to be between 150 000 and 170 000 tonnes for different years (2016, 2017, 2018) (AGC Chemicals Europe, - 2020; K-Profi, 2016; Sympatex Technologies GmbH, 2021) (Table A.6). re Estimates indicate that current PVDF production capacity in Europe is mainly available at p Solvay and Arkema. Current global PVDF production capacity is estimated to be around 80 000 tonnes2 but increasing mainly due to electric vehicles3. Global and EEA production volumes for fluoropolymers with separate information for PTFE and PVDF are provided in Table A.6. 2 https://www.plasteurope.com/news/SOLVAY_t249594/, date of access: 2022-12-02. 3 https://www.icis.com/explore/resources/news/2022/06/13/10774387/belgium-s-solvay-more-thandoubles-china-pvdf-capacity/, date of access: 2022-12-02. 15 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.6. Global and EEA fluoropolymer production volume, including PTFE and PVDF. Fluoropolymer EEA volumes Source Global volumes Source (t/y) (Publication year in (t/y) (Publication brackets) year in brackets) Total 49 000 (2020) Plastics Europe (2021) 405 000 (2020) https://www.glob albiotechinsights. com/articles/223 23/2020- fluoropolymer- technology- e PTFE it Micropowder ot c PVDF 34 000 3 500 AGC Chemicals Europe (2020) Stakeholder consultation 150 000 - 170 000 (2016, 2017, 2018) 15 000 - 20 000 (2019) Plastics Europe (2021) 80 000 estimation (2022) highlights-byidtechex K-Profi (2016), Sympatex Technologies GmbH (2021), AGC Chemicals Europe (2020) Plastics Europe (2021) o n Worldwide perfluoropolyether volumes d Eight of the polymeric substances that are currently in the market are PFPEs (Buck et al., 2021). - EEA PFASs manufacturing volumes ion Table A.7 includes a summary of PFASs manufacturing volumes. t Table A.7. PFASs manufacturing volumes in EEA (in tonnes per year in 2020)a. a PFAS group Low volume (t/y) Midpoint (t/y) High volume (t/y) lic PFAA and PFAA precursors Fluorinated gases 53 902 15 000 85 977 95 774 118 051 176 548 pub Polymeric PFASs 49 000 75 381 101 763 - Light blue cells denote PFAS-volumes that have been used for impact assessment. re a The lower and upper estimates reflect the responses to the survey, or other industry data. Some p companies reported exact figures, while others reported ranges. In some cases, companies reported volume data as "greater than x", with no upper bound included (e.g., "> 1 000 tonnes"). Therefore, the "upper estimate" is not a true maximum value. 16 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.2.2. Import Stakeholders provided information on volumes of PFASs imported into the EEA (excluding PFASs in articles). Data on imports of specific PFASs into the EU were also retrieved from the Eurostat International Trade in Goods database4 and from literature. An overview is provided in Table A.8. More details are provided in Table A.73 in the appendix. The annual import volume of fluorinated gases was estimated to be 84 250 tonnes (EEA, 2020). The European Fluorocarbons Technical Committee (EFCTC), a sector group of Cefic) estimated that illegal import could be as high as 33% of the legal EU HFC market5. EFCTC, highlights those Chinese exports to the EU could be 27% larger than what the EU reports as imports from China (EFCTC, 2020). Table A.8. PFASs imported into the EEA from third countries (t/y) based on consultations. In e brackets the reference year. Eurostat data and literature review. it PFAS group Minimum Maximum volume Eurostat (t/y) Literature (t/y) c volume (t/y) (t/y) (2019)a (stakeholders) (stakeholders) t PFAAs and PFAA precursors 4 053 6 120 103 586 no data no Fluorinated gases 11 500 51 800 19 198 84 284b (2019) (EEA, 2020) o 21 500 (2015) (Wood, 2022) ion - d Polymeric PFASs 10 419 37 900 (2018) Stakeholder Fluoroelastomer: 6 400 (2018) Stakeholder, 36 148 15 000 (2020) (Wood, 2022) t15 000 (2020) a(Wood, 2022) lic TOTAL 25 972 95 820 158 932 99 284 a Eurostat data might underestimate volumes because GN/HS codes are selective. On the other hand, b presented volumes might include formulated products where PFASs are a percentage of the formulation. b Includes bulk fluorinated gases import (73 478 tonnes) as well as import of fluorinated gases within u products and equipment (10 806 tonnes) based on EEA (2020). -p It should be noted that these numbers do not include all PFASs and should be interpreted with caution. EU is a net importer of fluoropolymers, with an import volume of 15 000 tonnes e in 2020 according to Plastics Europe (Wood, 2022). pr A.2.3. Export The annual export volume of fluorinated gases was estimated to be 24 033 tonnes, excluding SF6 as it is not a PFAS (EEA, 2020). Plastics Europe (2021) estimates export volumes for fluoropolymers at 24 000 tonnes (2020) and stakeholders estimate the volumes at 40 500 tonnes (2018). Stakeholders also mention 6 900 tonnes (2018) for fluoroelastomer 4 https://ec.europa.eu/eurostat/databrowser/view/DS-045409/legacyMultiFreq/table?lang=en, date of access: 2022-12-15. 5 https://www.fluorocarbons.org/news/illegal-trade-round-up-february-2021/, date of access: 2022-12-15. 17 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) export. A summary of the volumes of PFASs exports, retrieved from Eurostat is presented in Table A.9. A detailed overview is presented in Table A.74 of the appendix. Table A.9. PFASs exported from the EEA (in t/y) based on consultations, Eurostat data and literature review. PFAS group Minimum Maximum Eurostat (t/y) Estimates from volume (t/y) volume (t/y) (2019) literature (t/y) (consultation) (consultation) PFAAs and PFAA precursors No data No data 131 866 No data 24 033 Fluorinated gases No data ite Polymeric PFASs 24 000 (2020) c TOTAL No data 40 500 (2018) 6 900 (2018) fluoroelastomer 10 371 28 718 170 955 (2019) based on EEA (2020) No data not A.3. Uses o A.3.1. Summary d PFASs are used in numerous applications. All these applications sooner or later reach an end- of-life stage: The waste stage. Because of high waste tonnages and main PFAS application in - articles, the waste treatment is of higher relevance for some PFAS applications: TULAC, food contact material & packaging, electronics and end-of-life-vehicles (ELV) are examples of such n applications. io In waste treatment landfilling and incineration are the most important final waste treatment methods. Recycling can extend the lifetime but eventually for almost all substances, mixtures t or articles only landfilling and incineration apply. In recycling, PFASs currently cannot be a removed. It therefore can be present in recycled articles like paper or plastics. lic There is no direct link between PFAS tonnage put on the market in a certain year and the PFAS waste tonnage for that application. Applications with longer lifetimes i.e., passenger b cars or construction material, might have highly deviating waste quantities compared to production volumes in the same year (because of lower sales volume in the past and/or lower u PFAS content in the past). As PFAS use has increased over the last decades the waste stage p will remain an important source of PFAS emissions for many years to come, even in case of - a full PFAS ban. e The PFAS tonnages of all checked uses are summarised in Table A.10 below, based on the pr grouping used for impact assessment and presented in Figure A.2. 18 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.10. Estimated tonnages for PFAS manufacture and major PFAS use sectors for 2020. Tonnages are for new products on the market, unless stated otherwise. PFAAs and PFAA e precursors it Application (tonnes/year) Fluorinated gases (tonnes/year) Polymeric PFASs (tonnes/year) Total PFASs (tonnes/year) c low mid high low mid high low mid high low mid high Manufacture t TULACb o Food contact n materials and packaging Metal plating and o manufacture of metal d products Consumer mixtures 53 902 8 092 3 267 2 85 977 20 620 6 305 30 118 051 33 148 15 000 9 342 57 95 774 176 548 49 000 33 091 15 330 960 75 381 71 318 17 880 960 101 763 109 544 20 430 117 902 41 183 257 132 91 938 396 362 142 692 18 597 24 185 29 772 960 962 990 1 017 21 26 30 - Cosmetics 0.028 32.1 64.2 Ski wax n Applications of fluorinated gasesc,d io Medical devices t Transportc a Electronics and lic semiconductors Energy sector 1 279 841 293 2 387 1 195 294 3 495 1 549 294 493 173 30 671 20 160 140 493 173 30 671 33 080 140 493 173 30 671 46 000 140 3 233 97 216 6 410 1 560 2 592 7 633 159 712 10 532 3 088 2 756 12 032 222 208 14 653 4 615 2 920 1.6 493 173 30 671 24 672 97 216 6 410 2 541 2 885 1.6 493 173 30 671 43 100 159 712 10 532 4 423 3 050 1.6 493 173 30 671 61 527 222 208 14 653 6 304 3 214 Construction products 987 1 696 2 405 4 254 7 287 10 320 5 241 8 983 12 725 b Lubricants 1 6 10 70 110 150 1 100 1 550 2 000 1 171 1 666 2 160 u Petroleum and mining 4.4 7 9.5 3 500 5 500 7 500 3 504 5 507 7 510 p TOTAL (excl. - manufacture)e 14 766 32 540 50 310 513 543 526 503 539 463 162 836 277 684 392 529 691 168 836 787 982 398 Totalf 14 766 32 540 50 310 51 041 64 001 76 961 72 030 128 504 184 974 137 860 225 105 312 341 e a: In some cases a basis for providing a range is lacking. There the available estimate is applied throughout; b: TULAC = Textile, upholstery, leather, apparel and carpets; c: For r these sectors the tonnages relate to "technical stock volume" (presented in italics), representing an estimated 2020 PFAS volume in use in the sector as a whole. For reference p only, the tonnages brought new to market in 2020 are also given; d: Includes tonnages for fluorinated gases in transport sector; e: Total based on best available data (stock if available, new to market if stock is not available); f: For reference only, also the total new manufactured tonnage put on market in 2020 is presented. 19 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A summary of PFAS volumes per use category distinguished is given in the main dossier. In Table A.11 the PFAS volume are sorted based on volume ranges. Table A.11. Uses sorted on volume range. Application Tonnage range Applications of fluorinated 5 gases TULAC 5 Medical devices 5 Manufacture 5 Food contact materials and 5 packaging Transport 5 Construction products 4 Electronics and 4 semiconductors Lubricants 4 Petroleum and mining 4 Energy sector 4 cite not Metal plating and manufacture of metal 3 o products d Cosmetics 2 Consumer mixtures 2 Ski wax 1 - Table legend Tonnage range (tonnes/year) n 1 0 - 10 2 10 - 100 io 3 100 - 1 000 t 4 1 000 - 10 000 5 > 10 000 lica A.3.2. Introduction b Many different PFASs are used in a wide range of applications, and there is no comprehensive source of information on the many individual substances and their functions in different u applications. PFAS are used in almost all industry branches and many consumer products. p Glge et al. (2020) presented a comprehensive overview of the applications of PFASs, and - they identified more than 200 use categories and subcategories for more than 4700 different PFASs. re In A.3 the use of PFASs in 15 sectors is discussed. In this section (A.3.2), a brief overview of p European use of PFASs is provided. In sections A.3.3 to A.3.17 detailed data on uses and volumes in various sectors is presented. In A.3.18, the waste stage is discussed. Use of PFASs For polymeric PFASs (of which fluoropolymers and perfluoropolyethers are main subgroups for impact assessment purposes), substantial information is available. Fluoropolymers According to Glge et al. (2020), fluoropolymers are mostly used in the production of plastic 20 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and rubber, coatings, paints, lubricants, greases, and in the chemical industry. Many fluoropolymers are used in articles that are (partly) imported. This applies to textiles, electronics, cars, etc. The group of fluoropolymers is dominated by PTFE, combined with fluorinated ethylene propylene (FEP), perfluoroalkoxy alkanes (PFA), ethylene tetrafluoroethylene (ETFE), and other tetrafluoroethylene-copolymers; they account for around 75% of the fluoropolymer market. Other important fluoropolymers include polyvinylidene fluoride (PVDF) and fluoroelastomers. Fluoropolymers are used in a variety of sectors requiring properties such as: chemical resistance and inertness thermal stability e cryogenic properties it low coefficient of friction c low surface energy low dielectric constant t Resistant to UV degradation o Resistant to degradation by hydrolysis n High levels of bio-resistance (resistant to biological contaminants) o For an extensive overview on fluoropolymers, see Table A.75 and Table A.76. d Table A.12 below illustrates a selection of sectors where fluoropolymers are used and for which applications certain fluoropolymers have proven suitable due to their specific - properties. n Table A.12. Examples of sectors, properties, and applications of fluoropolymers6. io Sectors Properties Applications t O-rings, gaskets, valve stem Mechanical property, thermal seals, shaft seals, linings for a Automotive property, chemical property, fuel hoses, power steering, licand friction property transmission, lubricants, and coatings Coatings for heat exchangers, pub Chemical industry Chemical resistance, mechanical property, thermal property, and weather stability pumps, diaphragms, impellers, tanks, reaction vessels, autoclaves, containers, flue duct expansion joints, heavy- - wall solid pipe and fittings pre Electrical/electronic Dielectric constant, flame resistance, and thermal stability Electrical insulation, flexible printed circuits, ultrapure components for semiconductor manufacture Water-repellent fabric, Weatherability, flame architectural fabric, non-stick Architectural and domestic retardancy, friction property, coatings for cookware, and thermal stability fiberglass composite for constructions Mechanical property, thermal Seats and plugs, bearings, non- Engineering stability, chemical stability, stick surfaces, coatings for weatherability, and surface pipes, fittings, valve and pump 6 https://www.sciencedirect.com/topics/materials-science/fluoropolymer, date of access: 2022-12-15. 21 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Sectors Medical Properties energy Surface energy, biological stability, mechanical property, chemical resistance Applications parts, and gears Cardiovascular grafts, ligament replacement, and heart patches Fluoroelastomers Fluoroelastomers have high heat and flame resistance, and good resistance to ageing, ozone, oxidizers, oils and many chemicals. They also have low gas permeability and low compression set. However, they usually have only limited low temperature capabilities, although some special lower temperature grades are available. They have limited resistance to steam, hot water, and polar fluids such as strong organic acids (e.g., formic acid), methanol, ammonia e and some amines and are swollen by ketones and ethers, whereas new peroxide cured grades it have somewhat improved chemical resistance. They can also become glassy at temperatures c not far below room temperature. Principal applications are as temperature-resistant O-rings, seals and gaskets as illustrated in table Table A.13 of non-exhausted specific uses and t applications overview in various industrial sectors. no Table A.13. Fluoroelastomers - non-exhaustive overview over specific uses and applications in various industrial sectors7. o Automotive Aerospace Industrial d Shaft seals O-ring seals in fuel, Hydraulic O-ring seals lubrication, and hydraulic - systems Valve stem and valve seals Manifold gaskets Check valve balls n Fuel injector O-rings Fuel tank bladders Military flare binders Fuel hoses and fuel hose liner Firewall seals Diaphragms io In-tank and quick connect fuel t system seals a Gaskets (valve and manifold) Engine lube siphon hose Clips for jet engines Electrical connectors Flue duct expansion joints lic Balls for check valves Electrical connectors Valve liners Heat-sealable tubing for wire insulation b Bellows for turbocharger u lubricating systems p Lathe cut gaskets Shaft seals Traps for hot engine lubricants Tire valve stem seals US FDA approved seals in food handling processes Industrial roll covers (100% FKM or laminates with other elastomers) Safety clothing and gloves e- Engine head gaskets Heat-sealable tubing for wire and cable insulation V-ring packers pr USA based Interstate Technology and Regulation Council (IPRCO) provided an overview of PFAS uses with a specific section for fluoropolymers (ITRC, 2022). According to AGC chemicals, a total of 50 900 tonnes of fluoropolymers were used in 2018 in western Europe8. AGC Chemicals estimated the European consumption of PTFE to be 34 000 tonnes. 7 https://www.sciencedirect.com/topics/engineering/fluoroelastomers, date of access: 2022-12-15. 8 https://www.agcce.com/fluoroplastics/, date of access: 2022-12-15. 22 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) According to PlasticsEurope (Wood, 2022), 40 000 ton of fluoropolymers is used in 2020 in the EEA. With yearly 49 000 ton production and 15 000 ton import and 24 000 ton export. The automotive industry is the main user of FKM, a fluoroelastomer (64%), followed by chemicals/plastics (11%), aerospace (9%)and other (16%). Worldwide fluoroelastomer consumption was estimated to be 13 800 tonnes in 2019 (Ebnesajjad, 2021). For fluorinated gases, a volume of 69 000 t/y (2018) was found, see Table A.14 (rounded numbers)(UBA, 2021). This number excludes HFO use in Europe (which is on the rise) (Nystedt, 2022). Table A.14. Volumes of fluorinated gas used in the EU in 2018 (rounded numbers). e Substance name EU 2018 fluorinated gas use (t/y) it HFC-125 13 000 HFC-134a 33 000 c HFC-143a confidential t HFC-227ea 1 400 Other HFC 4 100 no HFO-1234yf 11 000 Other HFO and HCFO TOTAL 6 300 68 800 pre-publication - do For the use of PFAA and PFAA precursors in the EEA, no information was available. 23 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.3. Textiles, upholstery, leather, apparel and carpets A.3.3.1. Uses PFASs have commonly been used across multiple Textiles, Upholstery, Leather, Apparel and Carpets (TULAC) products, as well as in mixtures for re-impregnation of different TULAC products. The key function that PFASs provide in these applications are water and oil repellence. Based on a review of a paper by Glge et al. (2020), as well as further literature and industry input (through the CfE and second stakeholder consultation round), a number of specific application categories within the TULAC sectors have been identified. Table A.15 demonstrates the major use categories that are within the scope of this Annex XV dossier along with key sub uses and the functionality that PFAS provides for these products. Note that medical devices can also include textiles in some cases. Medical devices are covered e by a separate part of the Annex XV dossier (see paragraph A.3.10). To maintain clarity, it medical textiles used in this section refers to any use of textiles in a medical setting, excluding c use within or on the patient (e.g., implantable textiles like gauzes or exterior bandages). This definition includes articles such as mattress protectors upon hospital beds, curtains and t drapes around the bed, and gowns and personal protective equipment (PPE) used by medical professionals. no In addition, textiles for use in the transport sector (such as automotive and aerospace industry) are described in section A.3.11 and thus not included in this section. o The major use categories can be distinguished as shown below in Table A.15. d Table A.15. Overview of different TULAC categories. - Major use category Subcategory-uses with examples included Technical function of PFASs claimed by stakeholders ation Home textiles public Consumer apparel and pre- accessories Carpets and rugs Curtains and blinds Textile based coverings (e.g., fabrics for soft-furnishings, tablecloths, bedding) Indoor and outdoor wear Sportswear Footwear Accessories (e.g., umbrellas, bags, wallets) Professional sportswear and footwear Water repellence, oil repellence Water repellence, oil repellence Water repellence, oil repellence Water repellence Water repellence, oil repellence Water repellence, oil repellence Water repellence Water repellence, oil repellence Professional apparel PPE for industrial and Water repellence, oil professional use (other than repellence, stain-resistance, sportswear) soil protection Outdoor technical textiles Water repellence, oil (e.g., canvas, awnings, tarps, repellence, stain-resistance, tents, sails, rope) soil protection Technical textilesa Medical applications Water repellence, oil (e.g., surgical drapes, gowns, repellence, stain-resistance curtains) High performance membranes Water repellence, oil 24 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Major use category Subcategory-uses with examples included Technical function of PFASs claimed by stakeholders (e.g., automotive and medical) repellence, stain-resistance, thermal stability Leather based goods (e.g., Water repellence, oil repellence leather bags, wallets, belts) Leather applications Indoor and outdoor wear Footwear Water repellence, oil repellence Water repellence, oil repellence Professional sportswear and Water repellence, oil repellence footwear E.g., home fabric treatments Water repellence, oil e Other (sprays) for leather/textiles repellence, stain-resistance, it soil protection a Textile product manufactured for non-aesthetic purposes, where function is the primary criterion. c The analysis presented in this report will be limited to the applications listed above. In addition t to the function listed above, PTFE is used across multiple TULAC sectors and is reported to o have specific functions in TULAC with regard to chemical inertness (protective clothing), n hydrophobicity9 (protective and outdoor clothing) and water vapour permeability. The function and purpose of using PFASs in TULAC was elaborated further by respondents o from the CfE, stating that TULAC materials made with these substances exhibit the following benefits and properties: d Waterproof properties (lower water permeability and wettability). - Chemical resistance and inertness. Protection against exposure to liquid such as blood and other body fluids, but also n chemicals and electrical discharge. Extremely robust mechanical properties (e.g., resistance to abrasion) and provides io low friction. t Weatherability including UV protection and resistance to corrosion from salt water: Resistant to high temperatures (thermally stable), but at the same time flexible. lica Fluorochemicals are not necessarily specified within TULAC product standards within the EEA but the function of PFASs is important to the fulfilment of some technical standards10. b Use of PFASs in filtration and separation media u Filtration and separation media11 covers various professional uses. One example is nonwoven p filters coated with side-chain fluorinated polymers for oil and water separation in e.g., gas - turbines, hydraulic applications, nuclear industry, respiratory applications and air pollution e control and dust collection. r Filtration and separation media also include high performance membranes as a subgroup with p special properties, such as ePTFE membranes and filters. An ePTFE membrane is created when PTFE, a linear polymer consisting of fluorine and carbon molecules, is expanded, creating a microporous structure with highly desirable characteristics, including a high strength-to-weight ratio, biocompatibility, high thermal resistance and many others. The filters function by physically trapping and removing unwanted molecules and particles, either by adsorption or chemical reactions, while the membranes use a thin, permeable layer or sheet of material, e.g., expanded porous layers such as ePTFE, where the medium passes 9 A hydrophobic surface is a water repelling, low surface energy surface that resists wetting of water. 10 Table A.78 contains a list of standards that apply to TULAC products. 11 A subset of technical textiles is shown in Table A.16. 25 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) through to remove unwanted molecules and particles. Membranes of ePTFE are used in various high-tech applications such as medical devices implanted in the human body and electronic cables transmitting signals from outer space. Use of C6 side-chain fluorinated polymers in filtration and separation media Filtration and separation media treated with C6 side-chain fluorinated polymers consist primarily of non-woven material or paper composed of manmade fibres, natural fibres (or a combination of both), with resins that contribute to the structural or physical properties of the media. Filtration and separation media manufactured with C6 side-chain fluorinated polymers play a critical role in the following applications, among others: medical devices, PPE, HVACR (including EPA/HEPA/ULPA), Air Pollution Controls (APC), dust collectors, hydraulic systems, coalescers, gas turbines, and fuel systems. There are alternatives to C6 available for these applications since only water-repellence is needed. ite The restriction proposal for PFHxA includes a derogation for filtration and separation media used in high performance air and liquid applications that require a combination of water- and c oil-repellence. SEAC concluded in its opinion that: t During the consultation on the Annex XV report, several stakeholders requested a o complete derogation for the use of PFHxA in filters and membranes. The Dossier n Submitter proposes a derogation for filtration and separation media used in high performance air and liquid applications that require a combination of water- and oil repellence properties, even though it is well-noted in the Background Document and o by SEAC that such a broad derogation leads to a certain degree of uncertainty as it d might be possible that alternatives are already available or will become so in near future for some applications. Cost estimates for the uses affected are scarce, only some information was provided by stakeholders during the consultations. This - information mainly indicates that specifically costs related to substitution, e.g. loss of effectiveness of products due to no alternatives being available currently, could be n potentially very high. Stakeholders reported that appropriate filtration reduces io maintenance needs, extends service life and prevents failures of equipment; they also expect energy consumption and related greenhouse gas emissions to increase in the t absence of C6-treated filtration media. During the consultations on the Annex XV a report and the SEAC draft opinion, it was stated that the absence of a derogation will put manufacturing facilities located in the EU at risk and result in a supply interruption lic of filtration and separation media for several purposes until adequate alternative candidates are identified and requalified. SEAC agrees to the Dossier Submitter's b conclusion that more information on the different applications and specifically a more detailed discussion on substitution possibilities as well as on any potential related costs u would be needed in order to draw a robust conclusion on the socio-economic impacts. p The Dossier Submitter has not received any information that affects this conclusion. e- Use of ePTFE-based filter applications pr Over the decades, PTFE as a woven fabric and as a needlefelt material has been used in various filtration applications, particularly those involving aggressive chemical environments. The PTFE filters can be used in liquid applications as well as dry dust applications12. Expanded PTFE is used as a film or membrane on a growing number of filters across every industry including food and packaging, pharmaceutical, minerals, power generation, metals, chemicals, engineering, automotive, and aerospace. The membrane is laminated to a wide variety of substrates such as polyester needle felts and woven glass fibre to be made into 12 https://www.sciencedirect.com/topics/engineering/expanded-polytetrafluoroethylene, date of access: 2022-12-15. 26 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) filter bags, and pleatable materials such as polyester and cellulose for filter cartridges and elements. The substrate acts as a stable supporting base for the membrane. The type of substrate is determined based on the specific application requirements to which the filters will be subjected13. One of the key advantages of ePTFE membrane filters is the filtration efficacy of sub-micron sized particles, assisting in meeting the terms with the increasingly rigorous norms and regulations pertaining to health and the atmosphere in working areas. The shape of the dust, rather than its size, is an important factor when considering the abrasive potential of the dust. Angular particles like those present in cement have a far more abrasive potential despite them being very small in size. The velocity of airflow carrying the dust, the filter unit and ductwork design are other important aspects that demand attention to make sure that the service durability of the filters is not significantly reduced due to degradation (Reports And Data, 2020). ite Use of PFAS in Personal Protective Equipment (PPE) c Personal Protective Equipment (PPE) can include items such as safety helmets, gloves, eye t protection, hazmat suits, high-visibility clothing, safety footwear, safety harnesses, ear plugs, ear defenders and respiratory protective equipment. This section focuses on protective o clothing used for professional and industrial uses, however, not for medical applications14. n PPE requires CE marking, by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in EU legislation. This means that a set of European (EN) o standards must be met for PPE placed on the EEA market. Table E.13. in Annex E.2.2.2.1. d contains a summary of performance and test standards for types of PPE where PFAS is commonly used. - Annex I of the PPE regulation (EU 2016/425) defines three risk categories; where Category I includes a list of minimal risks, Category III covers a list of risks that may cause very serious n consequences such as death or irreversible damage to health, and Category II includes risks io other than those listed in I and III. t Requirements, including specific technical standards, for PPE are mentioned in Table A.78. a Reported concentrations of PFASs in TULAC lic Limited information is available on the concentrations of PFASs in a range of textile products. b With respect to the concentration of PFASs that are present in the finished TULAC products, there are varying concentrations reported. One stakeholder suggested that overall, the PFASs u concentration across TULAC products can be summarised as in the range of <0.1 - 7%15. p Further detailed information was received during the CfE for specific TULAC products. Working concentrations of PFASs in a range of textile products noted by respondents are listed in Table - A.16 below. re Table A.16. Applied concentrations of PFASs in a range of textile products. p Textile product % in the final textile product High performance upholstery <0.1% C6 SCFP in final textile product Outdoor textiles 2% of FEP/PFAA in final product 13 https://www.filtsep.com/content/features/membranes-expanded-ptfe-finds-new-markets, date of access: 2022-12-15. 14 Regulation (EU) 2016/425 (PPE) does not apply to PPE: (a) specifically designed for use by the armed forces or in the maintenance of law and order; (b) designed to be used for self-defence, except for PPE intended for sporting activities; (c) designed for private use to protect against: (i) atmospheric conditions that are not of an extreme nature, (ii) damp and water during dishwashing. 15 Euratex Submission to stakeholder consultation. 27 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Textile product % in the final textile product Chemical protective suits PTFE (max 1%), THV (max 1%) or FKM or Fluorosilicone (50-90%) Protective and technical textiles where PTFE is 100% of membrane is PTFE used as a membrane material PPE - (non-medical) 1.5 - 3% Medical gowns, drapes and PPE C6 concentration average for all products <0.5% Within some face masks 1.9% of ePTFE in final products (by weight). Leather straps 200 micrograms/m2 Architectural polyester / PVC fabrics as <1% as a protection of polyester PVC fabrics. fluoropolymers Non-Launderable Textiles e Membrane 0.1% total fluorine on weight of fabric C6 PFAS represent approximately less than 1% of total weight of the membrane cit As a comparison, the reported concentration ranges for PFOS presented in UNEP (2018b) for t the TULAC categories were textiles and upholstery: 2 - 3%; synthetic carpets: 0.03%; and leather: 0.025 - 0.05%. These concentrations are broadly in line with those reported during o the CfE, except for PTFE where concentrations vary widely. However, very little information n was provided for the home textiles sector. A variety of PFASs are in use for TULAC applications. The identified substances have been o disaggregated into PFAAs and PFAA precursors (including side-chain fluorinated polymers) d and polymeric PFASs before developing the following groupings: - PFAA and PFAA precursors All C2-C3 PFAS substances All C4 PFAS substances n All C5 PFAS substances io All C6 PFAS substances All C9 - C14 PFAS substances t Other non-polymer PFAS substances a All side-chain fluorinated polymer groupings lic Non-polymeric PFASs are used in the production of side-chain fluorinated polymers and are not in themselves present in the TULAC final product (other than as impurities). b For the "other" non-polymer PFAS, this broadly covers longer chain PFASs (C15), and a u range of aromatic substances. Note that a wide range of substances are described as `reaction p products', some of which are oligomeric / polymeric, and some of these are non-polymers. - PFAAs PFAA precursors re The side-chain fluorinated polymer group was a smaller sub-set overall (in terms of tonnage, p see Table A.20) and in many cases the respondents from CfE simply replied with terms like `perfluorinated C4 and C6 side-chain polymer', rather than naming specific substances. However, based on the concerns raised in the academic literature this group was identified a potentially important, so has been separated from the fluoropolymers group. Side-chain fluorinated polymers with various perfluorinated chain lengths from C2 to C14, that occur in TULAC applications either intentionally or as contaminants, are described in Table A.17 (Knepper and Lange, 2012). 28 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.17. Side-chain fluorinated polymers used for TULAC applications. Category Subcategory Applications Hydrophilic group Alcohols, silanes, alkoxylates, fatty acid esters, adipates, urethanes, polyesters, acrylates Soil/water repellence for carpet, fabric/upholstery, apparel, leather, metal/glass Side-chain Phosphate esters fluorinated polymers Soil/water repellence for carpet, fabric/upholstery, apparel, leather, metal/glass. Oil/water repellence for plates, food containers, bags, wraps, folding cartons, containers, carbonless e forms, masking papers cit Whether side-chain fluorinated polymers bestow water- or oil-repellent functions to TULAC is t determined by the chemical linkages within the polymer backbone and the fluorinated side- chain. These can be esters (using acrylate or methacrylate monomers) urethane, or ethers o (using oxetane monomers). n Fluorinated gases o Stakeholders mention fluorinated gases to be used in significant quantities for manufacturing d of polyurethane foam in the seating of furniture. However, the gases mentioned are not PFASs. It cannot be excluded that fluorinated gases that are PFASs are used as well. - Polymeric PFASs n PTFE io PVDF FEP t PFPEs (as a family) a PFA (as a family) Other fluoropolymers blic The approach taken for polymers was to create separate entries for the substances with the highest tonnages of use. The "other" category in this case covers two general groups, u remaining unique polymer substances (e.g., THV, FKM, FFKM) which are used in much lower p quantities, and a range of reaction products, which are either oligomeric or polymeric. Note that in many cases this includes aromatic structures. e- Based on the data gathered from the CfE, stakeholder engagement, and market research, r around 120 unique PFAS (82 of which had CAS numbers, the rest contained many polymers p without a CAS number) are identified in the TULAC sector which are used intentionally or are the product of degradation or an impurity. The majority of substances reportedly used in TULAC sector in the EEA are fluoropolymers (particularly PTFE) and to some extent side-chain fluorinated polymers. Notably, all the substances reported to be used in professional textiles were PTFE or fluoropolymers of >20 carbon chain length, whereas in all the other use categories a broader array of chain length PFASs are currently reported to be used. The list of PFASs used in this sector is not provided here due to Confidential Business Information. A.3.3.2. Volumes In 2017, the EU-28 produced 7.4 kg of textile products per person while consuming nearly 26 29 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) kg (Table A.10) (EEA, 2019). This indicates that around 12 million tonnes of textile products were consumed in the EEA based on the current population. A large proportion of textiles within the EEA are imported (mainly finished products from Asia). Exports mainly comprise intermediate textile products, such as technical fibres and high-quality fabrics in which the European industry specialises. Indicative estimates of quantities sold, as well as import and export data, per sub-category of TULAC are presented in Tables 25 and 26 in Annex E.2.2.4.2. o not cite Figure A.9. Annual import, export, production, and consumption flows of textile products in d the EEA-28, 2017. Source: EEA (2019). - In the EU-27 in 2021, there were around 143 000 companies operating in the textile and clothing industry (EURATEX, 2022). The number of companies dealing with articles containing n PFAS has not been identified. io The textile industry is quoted to be one of the most extensive users of PFAS. For example, t the Annex XV Restriction Dossier for PFHxA (ECHA, 2019) estimates that ~78% of the PFHxA used in the EEA is for clothing, while ~4% is used in firefighting foams, and ~3% for other a uses (e.g., chrome plating, paper, inks, paints etc). Overall, textile applications account for lic an estimated 35% of the demand for fluorotelomers globally (Goldenman et al., 2019). Tonnage estimates below are based on the information gathered in the CfE. It is estimated b that between 41 000 (low estimate) and 143 000 tonnes (high estimate) of PFAS are used u within TULAC products in the EEA annually. These estimates might include some degree of double counting of "functional PFAS", precursors and intermediates. The reason for this is p that, based on the information from the CfE, it has been difficult to distinguish between these - groups and there is therefore a risk that precursors have been calculated separately and e added with the "functional PFASs" formed by these precursors, resulting in a doubled or higher r quantity estimate (see Appendix VI for a more detailed description). p The report by Wood (2020) concludes that TULAC is approximately 45 000 - 80 000 t/y. Based on this, the "low estimate" (41 000 tonnes) appears more credible than the "high estimate". There is however some uncertainty regarding how well quantities of PFAS in imported TULAC articles are covered by these estimates. No data has been provided or found on the proportion of imported textiles that contain PFAS. One question in the consultation was if the calculations (based on data from the CfE) also covered imported TULAC sufficiently. Approximately 30% replied "yes", 20% answered "no", and the remaining 50% did not have an opinion or information. The estimated tonnages of PFAS in different applications are reported in Table A.18. According 30 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) to the information received in the CfE, around 80% of the estimated total tonnage is fluoropolymers. The CfE also indicates that the key dominant TULAC sectors using PFAS are consumer apparel, followed by home textiles and technical textiles. This information on the use of PFAS per subcategory of TULAC is uncertain since tonnages reported for several subcategories in the CfE have been split equally across the subcategories when there is no other information. The report by Wood (2020) estimates that PFAS use is substantially larger in the subcategories home textiles and consumer apparel than in professional apparel and technical textiles. No responses on PFAS in leather applications were received during the CfE. According to CfE input from the Filtration and Separation Coalition, the volume of C6 PFAS used for the filtration and separation media placed on the EU market is approximately 67 t/y. This volume covers professional and industrial uses. C6-treated filters for consumer use (e.g., vacuum cleaners, air purifiers) constitute a marginal fraction. e As indicated in Table A.18, the estimated tonnage of PFAS used in `Professional apparel' is it 5 220 - 20 044 tonnes total PFAS and 101 - 1 100 tonnes total non-polymeric PFAS. Some part of this is used in PPEs, but a more exact quantification has not been possible to derive. t c During stakeholder consultations following the second stakeholder consultation (see Annex G) three companies16 in the PPE sector indicated that around 20 percent of the PFAS used in o the PPEs they put on the EEA market were used in PPEs protecting against Category III risks. n The remaining 80 percent were used in PPEs protecting against Category I or II risks. Several stakeholders indicate that there may be a risk of overuse of PFAS, with a higher level o of protection than necessary, as the customer's way of using PPE is not always clear. This d could, for example, be because PPE customer's want their entire work force at a facility to have uniform clothing and, consequently, that the tasks that require the highest level of protection sets the standard for the PPE used by all workers. - There is no publicly available quantity data of PFAS for maintenance and reimpregnation of n PPE in the EEA. An approximative calculation provided by the European Textile Services io Association (ETSA) indicates that around 20 tonnes of pure PFAS are used in the European market to reimpregnate PPE17. at The reported concentration ranges for PFAS for the TULAC categories are listed in Appendix . However, limited information is available on the concentrations of PFAS in a range of textile pre-public products. 16 These companies make up a limited share of the market. Their total annual quantity of PFAS use in PPE articles for the EEA market is approximately 3 tonnes. Therefore, it is unclear if these estimates can be extrapolated to the entire EEA PPE market. 17 Written communication with Home European Textile Services Association (ETSA) November 2021. 31 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.18. Tonnages of PFAS used in TULAC industry in EEA (2020). Sub use C2- C3 PFAS PFAA C4 Side-chain Total PFAAs substances (t/y) fluorinated and PFAA (t/y) polymers precursors (t/y) (t/y) low high low high low high low high Home textiles 717 3 433 363 770 230 559 1 310 4 761 Consumer 717 3 433 363 770 1 019 10 034 2 099 14 237 apparel Professional 0 0 apparel 1 101 100 1 000 101 1 101 Technical 717 3 433 364 869 14 22 textiles 1 095 4 324 Medical textiles Leather textiles Other Total (TULAC) 0 0 0 0 0 0 0 0 pre-publication - - - - - 0 0 2 422 6 103 1 067 2 621 3 489 2 150 10 300 3 512 8 612 2 430 14 236 8 092 8 724 33 148 Fluoro (t/y) low 4 658 5 801 polymers PFPE ite (t/y) Total polymeric PFASs (t/y) c high low high t 22 049 262 558 low 4 920 high 22 607 no 32 353 261 557 6 062 32 910 5 119 18 943 0 0 o 4 845 21 659 262 558 - d 331 1 096 0 0 5 119 5 107 331 18 943 22 217 1 096 - - - - 11 551 11 762 1 10 11 552 11 772 32 305 107 861 786 1 683 33 091 109 544 Total PFAS (t/y) low 6 230 high 27 368 8 161 47 148 5 220 20 044 6 201 26 541 331 1 095 - - 15 041 20 496 41 183 142 692 32 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.19. Tonnages of PFASs used in the TULAC industry in EEA in year 2020, as taken for impact assessment (mid points from low and high estimates as presented in table above). Sub use C2- C3 PFAS PFAA C4 Side-chain Total PFAAs substances (t/y) fluorinated and PFAA (t/y) polymers precursors (t/y) (t/y) Home 2 075 566 395 textiles 3 036 Consumer 2 075 566 5 527 8 168 apparel Professiona 0 l apparel 51 550 601 Technical 2 075 617 18 textiles 2 710 Medical 0 0 0 0 textiles Leather textiles Other Total (TULAC) 0 6 225 pre-publication - 4 278 6 062 1 844 8 333 6 107 20 620 Fluoro polymers (t/y) 13 354 19 077 12 031 o 13 252 d 714 - - 11 657 70 083 PFPE (t/y) not410 409 0 410 0 6 1 235 citeTotal polymeric PFASs (t/y) 13 764 19 486 12 031 13 662 714 11 662 71 318 Total PFAS (t/y) 16 799 27 655 12 632 16 371 714 17 769 91 938 33 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Total estimated PFAS use per substance type over all TULAC uses is presented in Table A.20. Table A.20: Total tonnages of subgroups of PFAS used per year for TULAC in the EEA in 2020 (low and high estimate). PFAS substance Low High estimate estimate (t/y) (t/y) PFAAs and PFAA precursors All C2- C3 PFAS substances 2 150 10 300 All C4 PFAS substances All C5 PFAS substances All C6 PFAS substances All C9-C14 PFAS substances Other non-polymeric PFAS Side-chain fluorinated polymers Polymeric PFASs PTFE PVDF PFPE 17 1 3 399 2 93 2 430 15 202 1 058 786 46 1 8 435 2 129 14 236 68 465 5 082 1 683 cite not FEP PFA o Other and unspecified fluoropolymers d PFAAs and PFAA precursors TOTAL Polymeric PFASs TOTAL Total tonnage used per year (all - PFAS) 55 7 15 984 8 092 33 091 41 183 189 21 34 104 33 148 109 544 142 692 ion A.3.3.3. Summary t Because of the vast range of properties, PFASs are widely used in the textiles, upholstery, a leather, apparel and carpets (TULAC) industry. The main properties PFASs provide in this lic industry are, water repellence, oil repellence, protection against stain-resistance and thermal stability. Stakeholders report an estimated annual use of between 41 000 and 143 000 tonnes (rounded numbers). Over 75% of the PFASs used are fluoropolymers, almost b half of which is PTFE. Other fluoropolymers used include PVDF, PFPE, FEP, PFA, and others. C2-C3 and C6 PFAS, as well as side-chain fluorinated polymers, are the most abundant u PFAAs and PFAA precursor that are being applied in the TULAC sector. TULAC thereby is a p large PFAS use sector. A large proportion of textiles within the EEA are imported (mainly pre- finished products from Asia). 34 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.4. Food contact materials and packaging A.3.4.1. Uses PFASs in food contact material (FCM) and packaging are largely used to confer oil and grease resistance in the following main applications: - Packaging (including non-FCM packaging); - Consumer cookware; - Industrial food and feed production equipment. Fluoropolymers are mainly used for non-stick properties of material coatings for consumer cookware and industrial applications. ite Oil and grease resistant food contact paper packaging products are often based on the surface application of side-chain fluorinated polymers (SCFP). For production of thin film c (PP and PE) plastic packaging, PFASs are mainly used as polymer processing aids. Often fluoroelastomers are used as polymer processing aids in the extrusion of PP, PE and t polyolefin films. no Numerous PFAS are used in food contact materials and packaging, see Table A.80, Table A.81 and Table A.82. o Packaging d Packaging is a very broad sub-use. PFASs are used where oil and grease resistance are important. In food and feed packaging PFASs are intentionally applied to paper and board - packaging to confer primarily fat, but also repel stain and water (included water vapour). This repellence function is especially important in the food packaging sector in which oils, n greases and water may migrate from food during baking, transport and storage, or for use with fast food that is intended to be portable. As such, the packaging is intended to be, or io can reasonably expected to be, in contact with the food product. Some pet food and feed t packaging applications require particularly high-performance grease/water resistant for example to maintain quality of dried food (OECD, 2020). lica A major use for PFASs is application to paper and board substrate for fast food wrapping. Not only is food packaging of relevance, but also feed packaging and generic packaging. The following sub-uses were seen in packaging: ub Food packaging p Greaseproof paper; - Baking paper; e Heat resistant packaging; r Other food packaging (e.g. milk containers, stretch and shrink films, pouches, frozen food packaging); p Coating of (food and beverage) cans (Often PTFE wax and micropowder PTFE are used). PFAS coatings may also be applied to disposable packaging items used for food consumption such as paper plates, bowls and ice cream tubs. Feed packaging Pet food; Agricultural feed. 35 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Generic packaging Paper and board for non-food/feed applications; Folding packaging cartons, carbonless forms / pressure sensitive paper, masking papers, tablecloths, and wall papers; Coated drums: fluorination of plastic (food or non-food) containers; Coated chemical containment bottles used for non-food packaging; Other packaging (coated plastic, glass, metal) for non-food/feed applications; Plastic films for health and hygiene; Processing and polymerisation aids application in especially PP and PE thin film production PFASs are also used as processing aids in the manufacture of plastic materials including e thermoplastic packaging, to improve the flow properties of the plastic for example in the it production of plastic sheets. The use of the processing aid may enhance the throughput of material and permits production of thinner films18. c Currently there are three main types of PFASs used in packaging: ot a) Short chain fluorotelomer side-chain (C6) polymeric PFASs, with high molecular weight acrylic polymers that contain fluorotelomer functionality to provide repellent performance. n b) Perfluoropolyether (PFPE) based oil and grease repellent products. o c) Fluoroplastics: FEP, PFA (perfluoroalkoxy ethanes), and FKM (fluorocarbon-based d fluoroelastomer materials); Largely unknown PFASs (by-product of fluorine gas treatment of plastic containers - such as HDPE containers); Fluorinated HDPE containers used for substances in various applications. ion Consumer cookware t Fluoropolymers such as PTFE are used as non-stick coatings in consumer cookware. Nona stick properties prevent food from sticking, facilitate cleaning, provide durability, prevent corrosion and reduce the need for oil in cooking. Fluoropolymer coatings also tend to lic withstand high temperatures, such that they can be used in cooking. They are also insulators and do not conduct electricity19. b These coatings may be found in pans, in baking tins and on the surface of electrical cooking u appliances such as toastie makers and grills. They may also be used in dishwashers p (Plastics Europe, 2017). - Temperature resistant coatings are dispersions or solutions of artificial organic resins in e water or organic solvents for producing non-stick coating for utensils and other food r contact articles. Usually, the coatings consist of combinations of fine-grain homo- or p copolymers of tetrafluoroethylene with solutions or dispersions of film-forming artificial organic resins20. PTFE non-stick coatings normally consist of up to three coats and have an operating temperature of up to 260C21. They are selected due to low friction properties, good 18 http://www.plastemart.com/plastic-technical-articles/polymeric-processing-aid-performs-betterthan-conventional-waxes/1592#, date of access: 2022-12-16. 19 https://coatingsystems.com/fep-coating-beneficial-kitchen/, date of access: 2022-12-16. 20 https://www.bfr.bund.de/de/bfr_empfehlungen_zu_materialien_fuer_den_lebensmittelkontakt447.html, date of access: 2022-12-16. 21 http://www.ptfecoatings.com/ptfe-coatings/non-stick.php, date of access: 2022-12-16. 36 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) abrasion resistance and good chemical resistance, which make them easier to clean without damage. Fluorinated ethylene propylene (FEP) non-stick coatings melt and flow during baking to provide non-porous films, they have good chemical resistance and are low friction. The maximum recommended use temperature for FEP coatings is 200C. Perfluoroalkoxy (PFA) coatings also melt and flow during baking to create non-porous films but have a higher continuous use temperature of 260C. PFA coatings are harder than those of PTFE or FEP. Ethylene tetrafluoroethylene (ETFE) coatings have good chemical resistance but a lower continuous operating temperature of 150C; conversely, they are very durable. Consumer cookware can be divided in the following sub-uses. Non-stick coatings for: Frying pans; Baking trays and bake pans; e Sauce pans; it Cooking plates in electric appliances such as sandwich toasters, waffle irons; Consumer bakeware including cake tins, bread-loaf tins, etc.; c Seals, O-rings, gaskets, tubing and pipes in consumer electrical equipment such as t coffee machines (mentioned and described under industrial applications); o Filters to capture contaminants from for example steam filtration in food n processing. Key PFASs found to be used in consumer cookware are: do Fluoropolymers: o PTFE - o ETFE o ECTFE n o FEP o hexafluoropropylene; io PFA (perfluoroalkoxy ethanes) t Perfluoroelastomers and FKMs (PTFE) coated elastomers lica Industrial applications b Industrial applications cover the equipment to produce food and feed, as well as their u packaging materials at an industrial scale. See for instance a website for PFTE coatings22. p PFAS are used in food processing equipment primarily for their non-stick properties - combined with non-reactivity with chemicals, thermal resilience during cooking and wear e resistance providing durability. The majority of PFASs used in this market segment are r fluoropolymers. One of the main uses for PFASs in industrial applications is in food and p feed processing lines where PFAS (polymers) provides a non-stick coating to conveyor belts, using PTFE or PVDF. Fluoropolymer dispersions are, for example, formulated into coatings for conveyor belts for commercial food and feed products. PVDF is used in fabrication of industrial cookware equipment mainly for its mechanical properties and chemical resistance. Fluoropolymers are widely used in industrial bakeware moulds and trays because they provide long-lasting oil and fat-free mould release. Fluorothermoplastics and PTFE are also processed into valves and fittings for commercial food and feed products. PTFE impregnated glass cloth is commonly used in food contact applications as a release agent. 22 http://www.ptfecoatings.com/industries/packaging.php, date of access: 2022-12-15. 37 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Other applications: Piping and tubing for drinking water applications; Filters to capture contaminants from, for example, steam filtration in food processing; Seals, O-rings, gaskets, tubing and pipes, expansion joints; Valves and fitments, conveyor belting, chutes, guiding rails, rollers, funnels and sliding plates, tanks, funnels, rollers, linings, blades of knives and scissors, springs, filter membranes and sensor covers, lubricants; Re-coating of industrial bakeware. In industrial applications, PFASs are often used to enhance productivity, to prevent clotting, to enable hygienic conditions etc. PFASs most often used in industrial processing e are PTFE, FEP, PFA and ETFE. it Key PFASs used: c Fluoropolymers: t o PTFE o o ETFE n o ECTFE o FEP o o Hexafluoropropylene variations d o PVDF-based PFA (perfluoroalkoxy ethanes); - Perfluoroelastomers (liquid processing systems) PTFE coated elastomers are often used as seasling in pressure bearing equipment Others n o PFMVE pre-publicatio o PTFE copolymers Figure A.10. Automatic Chappati making (left) and hydraulic seal kit (right). Source: Creative Commons BY-SA 2.0. According to a stakeholder, transport rollers, baking trays, extruders and tanks often have a thickness of 20 - 100 m, consisting of about 50% by weight of the fluoropolymers PTFE, 38 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) FEP and PFA. Dry lube coatings for guide rails, O-rings (Figure A.10), bearings, and valve seats often have a thickness of 5 - 20 m, consisting of about 50% by weight of PTFE. Anti-corrosion coatings for tanks and pipelines often have a thickness of 500 - 1 500 m, consisting of about 95% by weight of the fluoropolymers PFA, FEP, ETFE, and ECTFE. In the appendix, Table A.80, the main substances used in FCM and packaging are mentioned. A.3.4.2. Volumes Packaging Paper and board packaging Paper and board packaging volumes were based on information from CEPI, the European e association representing the paper industry (Table A.21). it Table A.21. Paper and board packaging consumption for food and feed and c packaging in Europe in 2019and beverage can EEA production (Cepi, 2020). Quantity (million t/y) t Case materials 28.4 o Carton board 6.2 Wrappings 2.6 n Other paper and board for packaging 4.2 Total 41.4 generic do EEA-wide volume figures of PFASs used in paper and board food packaging have not been - identified in literature or from stakeholders. Instead, the PFAS volumes utilised as a basis for deriving emission estimates have been calculated from available data with a few assumptions applied. Data sources are shown in the Appendix in Table A.79. ion In Table A.22, based on paper and board packaging volumes and average intentionally added PFAS content (values from German and Dutch regulation) from Table A.79 (see t Appendix) PFAS quantity is calculated. a Table A.22. Estimates of intentionally added PFASs in total paper and board food lic packaging for different assumptions according to in EU-27, UK and NO 2019. Proportion of total Quantity of paper Permitted Level Quantity of PFAS b paper and board with and boarda (t) PFAS (%) (t) PFAS (%) u 0.5 206 755b 0.4 827 p 206 755 1.2 2 481 - 1.0 413 510b 0.4 1 654 e 413 510 1.2 4 962 r a Based on total paper and board Packaging consumption = 41 351 000 t. See table Table A.21. p b Based on the calculation in the text below. Range of paper and board packaging containing PFAS: If 0.5% of the total paper and board packaging consumed contains PFAS = 0.5/100 x 41 351 000 = 206 755 t of paper and board packaging If 1.0% of the total paper and board packaging consumed contains PFAS = 1.0/100 x 41 351 000 = 413 510 t of paper and board packaging i.e., the quantity of paper and board packaging containing PFAS in 2019 was 206 755 - 413 510 t. 39 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) For comparison purposes, the quantities of PFASs in paper and board food packaging were estimated in addition using a different starting assumption i.e., the fluorine content of the paper and board packaging. From Dinsmore (2020), the quantity of fluorine that is present in paper and board packaging is a maximum of 1 200 mg/kg (equivalent to g/t) or an average of 537 g/t. These two figures, shown in Table A.22 and Table A.23, have been used to derive a range of the total quantity of PFASs in paper wrapping and carton board packaging. To estimate the PFAS content of paper wrapping and carton board packaging an approximation of the PFAS content has been derived assuming an estimated average fluoride content of the total molecular weight. This is assuming that the PFASs present can be like perfluorohexanoic acid (PFHxA) (fluorine content 66%), or side-chain fluorinated polyacrylates e.g. polymethacrylates (fluorine content is 12.8% Yao et al. (2014)) that e was also utilised in the proposed restriction for PFHxA (ECHA, 2019). See Table A.23 for it the results. c Table A.23. Estimates of PFAS in carton board and paper wrapping packaging for different assumptions based on detected fluorine levels in EU-27, UK and NO (2019). t Proportion Quantity of Quantity Detected Quantity Quantity of o of Wrapping carton and with PFASs fluorine fluorine in PFASsc n and Carton wrappinga (t/y) concentrationb paper or (t/y) board with (t) (g/t) board PFASs (%) (t) o 46 (paper) 2 647 000 1 217 620 537 654 1 308 d 2 647 000 1 217 620 1 200 1 461 2 922 95 (paper) 2 647 000 2 514 650 537 1 350 2 700 2 647 000 2 514 650 1 200 3 018 6 036 - 20 (board) 6 169 000 1 233 800 537 663 1 326 6 169 000 1 233 800 1 200 1 481 2 962 n Notes: io a From Table A.79 in the appendix. b Maximum and average concentration of fluorine detected in supermarket and fast-food restaurant t paper and board packaging (Dinsmore, 2020). These numbers are in line with the ChemTrust total a organic fluorine content of throwaway packaging lic c Quantity of PFAS is calculated from the fluorine content assuming fluorine comprises 50% of the molecular weight ub The PFAS loads in Table A.22 and Table A.23 are in the same range. However, Table A.23 focused on all PFASs (intentionally added and unintentionally present) and Table A.22 p solely focuses on intentionally added PFASs. Without further information to enable a more - accurate analysis, the upper and lower bounds of each volume range, from Table A.22 and e Table A.23, have been utilised to estimate emissions during the service-life of paper and r board packaging. p PFAS in lacquers and ink (for paper-based and aluminium-based packaging) About 70% of the PFAS residues in paper and aluminium based packaging products are present in lacquers and inks according to a stakeholder. Mainly PTFE wax/micro powder PTFE is used in printing ink. According to stakeholders about 500 t/y of PFASs in the EEA are used in lacquers and inks. As lacquers and ink are also used for non-packaging the total PFAS use could be far higher. Generic plastic (food) packaging PFAS polymer processing aid use Generic (plastic) packaging tonnages can be better derived via waste statistics than via 40 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) production statistics as waste databases are more centralised and accessible. In the year 2019 packaging waste generated was 177 kg per inhabitant in the EU. Paper and cardboard (41%), plastic (19%), glass (19%), wood (16%) and metal (5%) are the most common packaging types. PFAS polymer processing aids are used in the manufacturing of generic plastic packaging and plastic food packaging. It is likely also used in the production of rubber and non-plastic packaging uses especially in cases where thermoplastics are used (Glge et al., 2020). Polymer processing aids enable polymers such as PP, PE, and polyolefins to be processed (e.g., extruded) at higher rates and can also reduce energy consumption. Polymer processing aids are based on fluoropolymers (fluoroelastomers or fluorothermoplastics) and not on low molecular weight PFASs or side-chain fluorinated polymers according to a stakeholder. Elastomer-based polymer processing aids are manufactured without the use e of a fluorinated emulsifier. Polymer processing aids are frequently formulated with it inorganics and non-fluorinated aliphatic polyethers or polyesters as synergists. Some polymer processing aids require fluorinated emulsifiers in their manufacturing process. c According to information from an industry association PFAS processing aids are only t needed for thin film production. Other stakeholders mention that for all plastic extrusion, o PFAS processing aids are needed. n According to stakeholders PFAS polymer processing aid concentrations normally range between 500 - 1 000 ppm. This quantity is carried over from production and has no o function in the finished plastic. No information was available on the fate of the PFASs that is not carried over to the product in the packaging production facility. For new production d batches and according to stakeholders, new PFASs are added on a regular basis but details on volumes and emissions are lacking. - Combining volume data: 20.000.000 ton plastic packaging demand in EEA market/y. 16 n % of plastic (packaging) material are being produced in EEA, so not imported = 32.000.000 ton plastic packaging material produced in EEA (Plastics Europe, 2020). io PFAS polymer processing aid concentrations of 500 - 1 000 ppm result in a yearly t estimated 1 640 - 3 280 tonnes of PFAS processing aids being used for plastic packaging a production in EEA. lic The presence of PFASs in common non-food plastics packaging (and possibly even all plastics) also raises questions about recyclability claims as these types of plastic packaging b are commonly recycled. u Plastic food packaging PFAS residues -p As PFASs are used as processing aids for PE and PP flexible packaging production, PFAS residues might be present in the final article. According to a stakeholder the yearly EEA e market for flexible food packaging is around 300 000 t and the concentration of PFASs in r the finished packaging articles is around 0.1% (stakeholder information) representing a p carry-over of material from production. This leads to a volume of 0.1 * 300 000 = 300 tonnes PFASs residues in EEA per year in food packaging only. This is excluding other flexible, non-food, packaging. Assuming that the total packaging volume could be twice as high as the food packaging volume, providing the following range for PFAS in flexible food packaging production: 300- 600 t PFASs residues in flexible food packaging production in EEA/y. Fluorine surface treatment of plastic containers Fluorine gas treatment of plastic containers is used to introduce desired surface properties 41 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) for storage of certain products such as (bulk) chemicals but also food. A barrier on the plastic surface is created by leading fluorine over polymer containers like HDPE type containers. This treatment of the HDPE like containers degrades to PFCAs which is found in the content in the container (by leaching from surface of the container to the content), according to a study conducted in the USA by Environmental Defense Fund (EDF). The USA EPA has a webpage regarding this topic23. PFAS leaching from HDPE containers increases with time24. It is estimated that hundreds of millions of polyethylene and polypropylene containers are treated this way each year. EPA indicated that this might be a very significant use (see also Rand and Mabury (2011)). Details on volumes are not yet available in USA or in EEA since this use was recently identified in USA. e Wrapping of cars it Different materials are used (PE, PVC, polyester, PET, polyurethane, and Teflon polymers). c When 1 kg wrapping is used per car and if every brand and model use wrapping, assuming 25% market share of Teflon polymers (see PR Newswire (2018)) the calculation below t could be a indication of tonnage: o "In 2019 15 769 041 passenger vehicles were manufactured in the EU (ACEA, 2020). For n trucks and busses the number of newly registered vehicles had to be used as proxy for newly manufactured vehicles. Comparing the numbers for newly manufactured and newly o registered passenger cars (15 769 041 to 15 340 188 (ACEA, 2020)) the assumption can be made that these numbers, order of magnitude, correspond. In 2019 2 503 992 new d trucks (sum of light and heavy commercial vehicles) and 42 838 new buses were registered in the EU (ACEA, 2020)." - 750 000*1 kg = 10 000 t wrapping sheet*25% fluoropolymer (PTFE) = 3 950 t/y. The n fluoropolymer wrap share and market volumes for wrapping cars already on the market are unclear. io Coating of cans at Cans and especially beverage cans are often coated with PTFE wax or micropowder PTFE lic to reduce friction and facilitate easy sliding of cans on production lines. It can be used to protect cans from rusting and to protect the can liner from acid in the food or drink inside the can. b PTFE coated beverage cans are not considered FCM when the outside of the can is coated u and food is not in direct contact with the coating (note: sometimes the inside of the can is p coated as well). - The production volume of aluminium cans (2019) in Europe for food and beverage is e around 488 kt (Wielenga, 2021). There is no data on the import of food and beverage r cans. 488 kt is therefore an underestimation of food and beverage can use in the EEA; p 0.1% PTFE wax * 488 000 t = 4 880 t PTFE use in EEA/y. This is a minimum tonnage since import of food and beverage cans is not considered and coating of other cans other than food and beverage is not considered in this calculation. According to Food Packaging Forum approximately one third of can coatings were used in non-food packaging (Geueke, 2016). 23 https://www.epa.gov/pesticides/pfas-packaging, date of access: 2022-12-15. 24 https://www.epa.gov/pesticides/epa-releases-data-leaching-pfas-fluorinated-packaging, date of access: 2022-12-15. 42 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) No detailed information on market prices of PFASs used in packaging production has been identified. There is information on price-differences to alternatives (see the Alternatives chapter). The autonomous market development is also presented in the tables in the Annex. Consumer cookware There are 195 million households in the EU according to FEC (Federation of European manufactures of cookware and cutlery). FEC assumes that there are at least 3 pieces of coated cookware in each household resulting in 600 million pieces of coated cookware in EU households. Assuming a replacement of every 4 years this results in 150 million pieces of coated cookware being sold in Europe per year. e For consumer cook and bakeware, data from Plastics Europe 2017 was used and is it reported as 3 500 tonnes per year as presented in Table A.24. It should be noted that stakeholders in the second consultation in summer 2021 mentioned 5 600 tonnes of c fluoropolymer use for consumer cookware (GlobalInfoResearch, 2022). t From the description in Plastics Europe (2017) this data does not include any polymer o PPAs that have been used in the production of fluoropolymers, except it can be assumed that any PPA still present is an impurity in the final fluoropolymer. n No detailed information on market prices of PFASs applied in consumer cookware has been o identified. There is information on price-differences to alternatives (see Annex E.2.3.). For autonomous market development see also Annex E. d Industrial applications - These data cover EU-28 (including the UK) and include imported fluoropolymers as well n as those manufactured in the EEA. io Stakeholders indicated that drinking water and beverage production uses approx. 3 000 t/y of fluoropolymers as gasketing and membrane materials (e.g. water purification and t processing). Stakeholders in 2021 consultation mentioned 1 800 t/y in EEA of PTFE being a used for the maintenance of free bearings and sliding elements using PTFE compounds. lic For a small niche application 61 t was mentioned. German stakeholders mentioned that in 2020 at least 140 t was applied in Germany for bakeware coating and this use continues to increase. Therefore, in 2015 3 000 t for industrial applications seems a reasonable b estimate, noting that a further 3 000 t/y for drinking water and beverage production might have to be added. pu In Table A.24 the fluoropolymer volume data for cookware and industrial applications is - summarized. e Table A.24. Volume data (2015) used for the emission estimates from fluoropolymers r taken from Plastics Europe (2017). pMarket segment Quantity of Fluoropolymers sold (t/y) Consumer Cook and Bakeware Industrial Food Production and Pharmaceuticals Drinking water and beverage production 3 500 Stakeholder feedback second consultation 2021 mentioned 5 600 ton for cookware and food processing (GlobalInfoResearch, 2022) >3 000 (1 800 t/y already for maintenance) - 6 000 43 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Given the uncertainties, the volume and emission estimates described here should be regarded as indicative only. According to a stakeholder, it was estimated (in the summer 2021 second stakeholder consultation) that 2.8 million tonnes of rubber goods were produced in Europe annually. A figure that has been stable over the last years (part of this volume includes rubber uses for which PFAS is applied, often as processing aid like in thermoplastics production). It is estimated that the use of fluoropolymers in the rubber sector is in the range of 4 500 - 18 000 t/y. Approximately 4-5% are products for the food contact and drinking water sector. That leads to 180 - 900 t fluoropolymer coated rubber for the sector. Because it is not clear if this tonnage is included in other numbers presented below, it was not used for tonnage calculations. e The yearly EEA PFAS volumes used are summarised for the three main applications in it Table A.25 and in the generic table format distinguishing between the three main PFAS groups in Table A.26. c Table A.25. PFAS EEA volume per year per sub-use. t Sub-use* Specific use PFAS (t/y) o Paper and board n packaging PPAs used in o (thermoplastic) d packaging production and rubber production 827 - 4 962 1 640 - 3 280 - Packaging Flexible (thermoplastic) n packaging PPAs residues io Lacquers and ink residue 300 - 600 >> 500 licat Consumer cookware Car wrapping Consumer cookware coating 3 950 3 500 - 5 600 Main PFAS type Polymeric PFAS Non-polymeric PFASs Non-polymeric PFASs Polymeric PFASs, mainly PTFE wax Polymeric PFAS Polymeric PFAS Source Estimate, in EU-27 & UK & NO (2019) Estimate based on CEPI and literature data and stakeholder data on rubber manufacturing Estimate, based on stakeholder data Estimate, based on stakeholder data Estimate Plastics Europe data (2015) ub Industrial p application Beverage can coating pre-Industrial applications 4 880 (minimum as import of food and beverage cans is not considered nor coating of nonbeverage cans). Polymeric PFAS (e.g., PTFE wax) Polymeric PFAS Estimate, based on stakeholder input and market volume Plastics Europe coating 3 000 - 6 000 (2015) and stakeholder input Drinking and beverage >3 000 Polymeric PFAS Stakeholder input production Of which 180 - 900 coated rubber * PFAS from gas treatment of fluorinated HDPE containers not clear and not mentioned in table. 44 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.26. Volumes of PFAS estimated to be used in food, feed and packaging industry in the EEA per year. Total PFAAs and PFAA Total polymeric PFASs Total PFAS precursors (t/y) (t/y) (t/y) low midpoint high low midpoint high low midpoint high (Surfactants) in Paper and Board Food Packaging Generic Plastic packaging & rubber (processing aids) Consumer Cook and Bakeware Industrial Food Production and 827 1 640 2 895 2 460 4 962 3 280 3 500 3 000 4 550 4 500 827 1 640 not 5 600 3 500 6 000 3 000 4 962 cite 2 460 3 280 4 550 5 600 4 500 6 000 Pharmaceuticals PFAS residues in o packaging d Lacquers and ink Car wrapping - Beverage can coating n Total 300 >> 500 3 267 450 >> 500 6 305 600 >> 500 9 342 3 950 4 880 15 330 3 950 4 880 17 880 3 950 4 880 20 430 300 450 600 500 3 950 500 3 950 500 3 950 4 880 4 880 4 880 18 597 24 185 29 772 tio A.3.4.3. Summary a PFASs in food contact material (FCM) and packaging are primarily used for their grease lic repellent properties and can be found in the following main applications: packaging, consumer cookware, and industrial food and feed production equipment. Plastic packaging b is excluded here. u Packaging covers a broad spectrum of uses including food, feed, generic packaging in p paper and processing aids to produce thin films plastics. The three main types of PFAS used in packaging cover PFPEs, side-chain (C6) fluorinated polymers and fluoropolymers. - In the extrusion of thermoplastic packaging or the polymerization, fluoropolymers are e often used as processing aids. pr For consumer cookware (polymer) PFASs (i.e TFE, PTF, PFA, PTFE, FKMs are mainly used to achieve non-stick coatings for goods such as frying pans, plates, baking wear, and electrical equipment. Finally, PFAS polymers including PTFE, FEP, PFA and ETFE are commonly found in the equipment of food and feed at an industrial scale and are used for instance in non-stick coatings for conveyer belt, the fabrication of cookware, and in valves and fitting for commercial food and feed products. PFASs used in industrial application are often used to enhance productivity, such as by preventing clotting or enabling hygienic conditions. Total volume of PFASs in FCM and packaging are estimated to be 18 600 - 30 000 tonnes per year in the EEA, with fluoropolymers as major contribution to the volume. 45 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.5. Metal plating and manufacture of metal products A.3.5.1. Uses PFASs are used in metal plating processes and in the manufacture of metal products. In metal plating, PFASs are used to lower the surface tension of the plating solution and to decrease aerosol emissions (wetting agent, mist suppressing agent) (Blepp M. et al., 2017; UNEP, 2018a; Willand W., 2022). In the manufacture of metal products PFASs are used to e.g., lower the surface tension, to promote the flow of metal coatings or to inhibit the formation of acid mist, to inhibit corrosion on steel and to improve the life of baths. The uses and applications of PFASs are described in Figure A.11 and Table A.27. Metal plating Chrome plating functional chrome plating decorative chrome plating cite not plastic etching do Nickel plating n - Copper plating atio Tin plating blic Alkaline zinc plating and u zinc alloy plating -p Deposition of fluoropolymer e particles onto steel pr Figure A.11. Overview of metal plating types. 46 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.27. Uses of PFASs in metal plating processes and manufacture of metal products. Process Examples Mist suppressant Lowering surface tension of plating solution (Glge et al., 2020; Willand W., 2022) Pretreatment (etching) of plastic followed by electroplating (e.g., chrome coating) (Glge et al., 2021) Nickel-plating: non-foaming surfactant - increasing the strength of the nickel Metal plating electroplate by eliminating pinholes, cracks, and peeling (EC, 2006; Kissa, 2001); sliding characteristics to prevent seizure of parts Copper plating: preventing haze by regulating foam and improving stability while improving brightness and adhesion (EC, 2006; Poulsen et al., 2005) ite Tin plating: produce a plate of uniform thickness (EC, 2006; Kissa, 2001) Supporting the deposition of fluoropolymers onto steels for surface protection c (EC, 2006). t Inhibit the formation of acid mist or spray over metal electrowinning tanks (Glge et al., 2020) no Treatment of coatings of metal surfaces (Glge et al., 2020), lowering the tion - do Manufacture of metal pre-publica products surface tension and thus promoting the flow of metal coatings and the prevention of cracks in the coating during drying. Use as corrosion inhibitor on steel (Kissa, 2001). For this purpose, cationic and amphoteric fluorinated surfactants are used to impart a positive charge to fluoropolymer particles which facilitates the electroplating of the fluoropolymer (Kissa, 2001). Coatings on metal (Glge et al., 2020) Used for processing of aluminum e.g., during etching of aluminum to improve the efficient life of alkali baths or in the phosphating process of aluminum to dissolve the oxide layer of the aluminum (Glge et al., 2020; Kissa, 2001). Cleaning of metal surfaces (Glge et al., 2020; Kissa, 2001). The fluorinated surfactants disperse scum in molten-salt baths, speed runoffs of acid when metal is removed from the bath and increase the bath life. Solvent displacement drying (e.g., for water removal prior to plating, coating, and other surface treatments) (Glge et al., 2020) Electrical insulation of bearing houses Seals, valves, bearing coating, hose products, tank liners, gaskets and packing in food processing, medical and pharmaceutical industries, chemical and oil industries, aerospace and automotive industries, industrial equipment for sensor technology; Fluoropolymers are used due to high chemical and temperature resistance, high durability (reduction of friction and wear), good sliding properties, pressure resistance Anti-stick coating and anti-stick parts in silicone moulding processes (e.g., automobile industry); coating of processing tools or moulds (function as mould release aid) Information on the use of fluorinated substances in tin, copper and nickel-plating processes is limited. Some information on chrome plating is available indicating that mainly C6 fluorinated substances are used. With the identification of PFOS as a persistent organic pollutant (POP) and inclusion in Annex B of the POP regulation (EU 2019/1021) 47 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) only the use of PFOS as a mist suppressant for non-decorative hard chromium (VI) plating in closed loop systems is allowed. The ban of PFOS led to the substitution with 6:2 fluorotelomer sulfonate (6:2 FTS also known as H4-PFOS) in chrome plating processes (UNEP, 2018a). A survey conducted by the German Environment Agency (Willand W., 2022) showed that in functional25 chrome plating and plastic electroplating only 6:2 FTScontaining wetting agents were used (30 facilities participated in the survey). In decorative26 chrome plating 6:2 FTS-containing (60%) as well as fluorine-free (40%) wetting agents were used. The use of fluorinated substances other than 6:2 FTS was not noted. PFAS used in metal plating processes and in the manufacture of metal products are described in the Appendix, Table A.83. A.3.5.2. Volumes e Information on the concentration of PFASs, the annual production volume or annual import it and export volumes of these PFASs relating to the specific use in chrome/metal plating processes and processes for manufacture of metal products, is only scarcely available. c Information on the concentration of PFASs per use, annual production volumes volumes/ import volumes of all used PFASs for metal plating/ manufacture of metal products, t information on annual emissions/release and future emissions and information on costs is o not available. n Metal plating o Based on the PFHxA restriction dossier an annual use volume of 30 t/y (central estimate, range 2-57 t/y) for 6:2 FTS in the EU (incl. UK) was estimated. d Manufacture of metal products - During manufacture of metal products mainly fluoropolymers and C6 fluorinated n substances are used (see Appendix Table A.83). Glge et al. (2020) estimated that around 900 t PFASs (fluoropolymers) were used in the manufacture of metal products in Sweden, io Finland, Norway and Denmark between 2000 and 2017. With the assumption that the four t countries account for about 5.2% of the EEA population the Dossier Submitters estimated that on average around 960 tonnes of PFASs are used in the manufacture of metal products a in the EEA per year. lic In Table A.28, an overview of volumes is presented for both metal plating and manufacture of metal products. b Table A.28. PFAS volumes in metal plating processes and manufacture of metal products u estimated for EEA (t/y). pTotal PFAAs and PFAA -precursors (t/y) Total polymeric PFASs (t/y) Total PFAS (t/y) elow midpoint high low midpoint high low midpoint high r Metal plating 2 30 57 2 30 57 p Manufacture of metal 960 960 960 960 960 960 products Total 2 30 57 960 960 960 962 990 1 017 25 Functional chrome plating (also known as hard chrome plating): aim of functional chrome plating (layer thickness mostly 10 - 100 m) is to provide e.g. hardness, corrosion and wear resistance, lubricity and high resistance against chemicals. 26 Decorative chrome plating: used for decorative surface finish. The thin layer of metal (layer thickness 0.05 - 0.5 m) provides properties like aesthetically pleasing appearance or nontarnishing. 48 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.5.3. Summary Because of the vast range of properties PFASs are widely used in metal plating processes and in the manufacture of metal products. In metal plating processes PFASs are used to lower the surface tension of the plating solution and to decrease aerosol emissions. In the manufacture of metal products PFASs are used e.g., to lower the surface tension, as corrosion inhibitor on steel and to improve the life of baths. Stakeholders report an estimate annual use of 1017 tonnes (rounded numbers). Approximately 960 tonnes of PFASs are used in the manufacture of metal products in the EEA per year and approximately 57 tonnes of PFASs are used in metal plating in the EEA per year. cite not do n - licatio -pub pre 49 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.6. Consumer mixtures A.3.6.1. Uses PFASs are found in a high number of diverse applications that are used by consumers, including textiles, cosmetics and food contact materials, which are described in other parts of this dossier. This chapter focuses on PFAS used in mixtures intended for consumer use and analyses PFAS use in the following applications: PFASs are utilised in: Cleaners for glass, metal, ceramic, carpet and upholstery Waxes and polishes for e.g., furniture, floors and cars e Floor polish removers it Drycleaning products c Dishwashing products as rinse aid Windscreen treatments for automobiles and windscreen wiper fluids t Car care products o Rain-repellent fluids in the aviation industry Anti-fog agents n PTFE spray for lubrication of doors, locks, bike chains, motorcycles etc. Musical instruments: o o Lubricants for music instruments d o Guitar strings o In piano keys n - More details on PFASs used and CAS numbers are mentioned in the Appendix, Table A.84 to Table A.90. A variety of PFAS including fluorotelomer alcohols and ethoxylates, io perfluoroalkylcarboxylic acids, perfluoroalkylethers, perfluoroalkanesulfonamide acetates t and polymers such as PTFE are used in consumer mixtures for various technical functions such as for achieving water and stain repellence and as wetting agents. More detail on a specific PFASs used in the different applications is given in the Appendix based on Glge lic et al. (2020). Information on concentrations of PFAS in cleaning compositions, polishes, and waxes is b sparse and comes with a wide range of uncertainty. Three different sources of information u were used for the purpose of this dossier: p 1. Information given by industry on websites and in brochures - 2. Information found in safety data sheets or submitted by companies during the CfE eand consultation r3. Information from literature (mainly measurements) p Information on specific PFAS concentrations is rather sparse; however, end-use concentrations of PFAS in cleaning compositions, polishes and waxes generally are reported to be in the range of 10 - 1 000 ppm, concentrations of 200 ppm or less are typical (Chemours, 2017; ICT). Regarding specific PFAS concentrations in musical instruments, no information was found. Available data on concentrations of PFAS in consumer mixtures (polishes, waxes, cleaning agents and anti-fog agents) can be found in Table A.85 until Table A.91 in the appendix to this section. 50 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) For concentrations significantly below 10 ppm, an intended functional role seems doubtful. More information was obtained via an explorative research of product labels and information gained from the CfE. Rather large concentrations were found in one car polish product (12 % PTFE (waxyclean, 2020)) and a rain-repellent fluid used in the aviation industry. Due to the limited number of products for which information is available, it is unclear whether these concentrations are typical for such products. A.3.6.2. Volumes There is limited information available to the Dossier Submitters regarding the volume of PFAS manufactured for cleaning agents, polishes, and waxes. In detail, for the Scandinavian countries Norway, Denmark, Sweden, Finland it was estimated (using the SPIN database) that in a period of 17 years (2000 - 2017), 21 tonnes PFAS was used in e cleaning agents (Glge et al., 2021). Extrapolation from this figure to an annual tonnage it for the entire population of the European Economic Area (EEA) results in an estimation of 20 t/a (assuming a population of 27 million of the a forementioned Scandinavian countries c and 453 million for the EEA). This estimate is uncertain, given that consumer behaviour and prevalence of PFAS in cleaning products within the EEA varies. Moreover, the estimate t for the Scandinavian countries comes with uncertainties. For example, PFAS o concentrations of only a small number of substances are known, which may not constitute n all the PFAS present in cleaning products. Therefore, there is the possibility that for cleaning agents, the total volume is substantially higher than the estimate given above. On the other hand, this volume also includes industrial cleaning, thus possibly o overestimating the volume for non-industrial cleaning agents. d Only incomplete information is available to the Dossier Submitters regarding the market for PFAS in musical instruments. Based on stakeholder information it is assumed that 1 - - 10 t/a of PFAS are used for musical instruments. There is, however, a relatively large uncertainty with respect to the total volume used in the EU because no information on n products by other companies was available to the respondent. io There is (incomplete) information on the PFAS total tonnage in the consumer mixtures t sector. The Dossier Submitters, however, cannot disaggregate PFAS volumes in more detail than presented here, despite knowing (main) PFAS used in consumer mixtures. See a Table A.84 in the Appendix. lic A.3.6.3. Summary b Because of the vast range of properties, PFASs are used in the consumer mixtures u industry. PFASs are used in cleaning products, products that bestow water repellent properties, and musical instruments. Stakeholders report a large uncertainty regarding pre-p the use volumes, the best estimate is an annual use of 21 - 30 tonnes. 51 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.7. Cosmetics A.3.7.1. Uses PFASs are used intentionally in various categories of cosmetics as, for instance, emulsifiers, antistatics, stabilizers, surfactants, film formers, viscosity regulators and solvents (Ptz et al., 2022). Out of these, the most frequently occurring properties for these PFASs are the functions skin conditioning, film forming, solvent and surfactant. Table A.29 and Figure A.23 (Appendix) illustrates the identified properties of the most frequently used PFASs in cosmetics. Table A.29. Main PFAS and identified properties in cosmetics. PFAS PFAS category PTFE C9-15 fluoroalcohol phosphatea Perfluorodecalin Polymeric PFASs PFAA and PFAA precursors PFAA and PFAA precursors Identified properties e according to CosIng it Bulking c Skin conditioning ot Detangling nSkin conditioning Perfluorooctyl triethoxysilaneb do Perfluorononyl dimethiconea Polyperfluoromethylisopropyl ether PFAA and PFAA precursors PFAA and PFAA precursors Polymeric PFASs Solvent Binding Skin conditioning Skin conditioning - Octafluoropentyl methacrylate PFAA and PFAA Binding precursors n Acetyl trifluoromethylphenyl valylglycine PFAA and PFAA Skin conditioning ioprecursors Methyl perfluorobutyl ether PFAA and PFAA Solvent t precursors Viscosity controlling a a Covered by the PFOA restriction in POPs and the C9-C14 PFCAs restriction in REACH. lic b Covered by the (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and TDFAs restriction in REACH. b The estimates of use are split according to the following product groups listed below and u are based on databases (CosmEthics, Kemiluppen, ToxFox) of cosmetic products identifying which PFASs are used, their functions and how commonly found they are in p different product groups: e- Skin care r Toiletries p Hair care Perfumes and fragrances Decorative cosmetics A.3.7.2. Volumes Based on the most reliable cosmetic databases, Kemiluppen and CosmEthics, the total number of cosmetic products and market share of PFAS-containing products were estimated. The market share of PFAS-containing cosmetic products (based on units sold) ranged from 1.1 to 1.4%. An even more similar range was obtained after removing discontinued products listed in the Kemiluppen database (1.3 compared to 1.4%). 52 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) An analysis of the market share of PFAS-containing products revealed that most occurred in the product category decorative cosmetics (3.7 %), followed by skin care, hair care and toiletries (0.78, 0.65 and 0.27 % respectively). The occurrence of PFASs in perfumes and fragrances was negligible with 0.03 % (Based on cosmEthics). Table A.30 illustrates the share of cosmetic products and product versions that contain PFASs (%) sorted according to the Cosmetics Europe categories for the emission calculations. Data is based on the total number of products and product versions containing and not containing PFAS according to the CosmEthics database (entire database information included, i.e., product and product versions, EU/EEA and non-EU/EEA). Note that the CosmEthics product sub-categories were rearranged into Cosmetics Europe product categories and ambiguous product sub-categories such as "other" were removed. e Table A.30. Share of cosmetic products and product versions containing PFAS*. it Product category Total number of Total number of Share of cosmetic (Cosmetics Europe) products and cosmetic products products and c product and product product versions versions versions containing containing PFAS (%) t PFAS o Decorative cosmetics 29 118 1 068 3.67 n Hair care 21 938 142 0.65 Perfumes and fragrances 3 637 1 0.03 o Skin care 40 103 314 0.78 d Toiletries 17 844 49 0.27 Total 112 639 1 574 1.40 - * The numbers are slightly overestimated as they also include Hydrofluorocarbon 152a which is not a PFAS. ion The different databases were consulted to get an overview of the identity and frequency of occurrence of PFAS (i.e., compounds with at least one -CF2) in cosmetic products. t Around 170 unique PFAS ingredients potentially in cosmetic products were identified within the cosmetic ingredient database (CosIng). Forty-two of these were present in products a within three European cosmetic databases, among which polytetrafluoroethylene (PTFE; a lic PFAS polymer) and C9-15 fluoroalcohol phosphate were most frequent. Analysis of the data shows that three out of the top ten listed PFAS among all considered cosmetic databases are under current or pending restriction. In total about 1/5 to 1/3 (KEMI, 2021) b of the cosmetic products listed in the cosmetic product databases consulted contain PFASs u that are or are about to be restricted. Table A.92 in the Appendix shows more details on PFAS INCI names found in cosmetic products in the different databases. -p Due to limited information, the yearly tonnage of cosmetic products per category was e indirectly derived from data on market value per product category and assumptions on r price per kg of product (see KEMI (2021) for more details). p Based on data on market value per product category and assumptions on price per kg of product (see KEMI (2021) for more details) the annual volume per cosmetic product category was estimated (Table A.31). These estimates were used together with data on share of products per category that contain PFAS and PFAS concentrations based on analytical data to estimate annual PFAS volumes (Table A.32). Although there is information on the PFAS total tonnage is cosmetics and PFAS in cosmetics, the Dossier Submitters cannot disaggregate tonnages despite knowing (most) PFAS used. Table A.92 in the Appendix demonstrates identified PFAS used. The concentration of PFASs in the products was derived by measuring total fluorine (TF), the extractable organic fluorine (EOF) and individual PFASs (targeted analysis) in 53 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) purchased cosmetic products with at least one PFAS on the ingredient list (see KEMI (2021) for more details). Please note that total PFAS volume for Perfumes and Fragrances are not provided in Table A.32 as only one out of 3 637 products (CosmEthics database) within Perfumes and Fragrances listed a PFAS as an intended ingredient. As a result, this category's product concentration was assumed to be equal to zero. Table A.31. Calculated total amount of cosmetic products sold per year in the EEA in 2019; data based on assumptions and Retail Sales Price, as well as market share from Cosmetics Europe as well as assumptions and data from the CosmEthics database (metric tonnes). Product category Total amount of products (t/y in 2019) Skin Care 273 000 Toiletries 1 110 000 ite Hair Care 838 000 Perfumes and Fragrances 77 600 c Decorative Cosmetics 18 800 t Total EEA marketa 2 320 000 a EU-27 and Norway (i.e., EEA without Lichtenstein and Iceland) no Table A.32. Total annual PFAS volume per main cosmetics category in EEA. Total PFASs o (t/y) low midpoint high d Skin care 0.014 25 49.9 Toiletries 0.002 1.25 2.5 - Hair care 0.003 2.30 4.6 n Decorative cosmetics 0.010 3.55 7.1 io Total 0.028 32.11 64.2 at A.3.7.3. Summary lic PFASs have a myriad of uses in various cosmetic products, for instance as emulsifiers, b antistatic properties, stabilizers, skin conditioning, binding, and viscosity regulators. The most frequently identified properties of PFASs in cosmetics included conditioning, film u forming, solvents and surfactants. Based on the analysis of three European databases p (CosIng, Kemiluppen, and CosmEthics) C9-15 fluoroalcohol phosphate and PTFE were reported most often found in cosmetic products. A large share of cosmetic products (in - total about 1/5 up to 1/3) listed in the cosmetic product databases consulted for this study e contained PFASs that are or are about to be restricted. According to this report, the total r PFAS volumes are estimated to be between 0.028 to 64.2 t/y. Based on market share, 1.1 p to 1.4% of products contain PFASs. Within that they are found most in decorative cosmetics (3.7%), followed by skin care, hair care and toiletries (0.78, 0.65, and 0.27%, respectively). 54 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.8. Ski wax A.3.8.1. Uses PFASs have commonly been used in the production of gliders and other ski wax products used for preparation of skis (including both cross country and downhill / alpine skis, freestyle skis), snowboards, as well as in mixtures for cleaning and impregnation. The key property that PFASs provide in this application is a high-water repellence (hydrophobicity) thus allowing a suitably low surface tension for the skis on snow. Waxes are an important means of lubrication in skiing, to reduce friction between the base of the skis and snow, allowing the skis to glide more freely. It has been shown that the use of high fluorinated waxes can result, on average, in a 4% increase in performance of the skis (Breitschadel et al., 2014). There are three main types of friction that require specific lubrication in e skiing: it Dry friction - when dry snow granules come in contact with the ski base. c Wet friction - when a high moisture content snow creates suction between the ski base and snow. t Electrostatic friction - when a ski base runs on snow creating an electrostatic o attraction between the ski and snow. n PFASs, including fluoropolymers (e.g., PTFE), are also sometimes used in in the sole of skis as well as in shoes and different equipment for skiing. However, the present o assessment covers the treatment of skis with PFAS-containing mixtures. d Fluorinated waxes tend to be used primarily during competitions. However, professionals are known to use fluorine-free waxes during training. Similarly, amateur skiers mostly use - fluorine-free alternatives. However, in some countries it is still common to use fluorinated waxes, also among amateur skiers. Ski wax can come in a variety of different types, each n designed for specific conditions, compositions, or a certain performance level. The most common forms of wax are listed in Table A.33. tio Table A.33. Overview of different ski wax types (both grip and glide wax)27. Type Market insights Method of application Use a Block wax Most common wax Block wax needs to be melted on Waxes in block form lic form the ski base once it is heated up last the longest on with an iron, then ironed into the skis. pores of the bases evenly to b allow faster gliding. u Liquid wax Found at high and low Supposed to be applied onto a Short-term solution end of the cost cloth or it comes with an to allow for faster pspectrum applicator then rubbed on the gliding properties for - bases of the skis. up to 24hrs. e Often used in conjunction with r other forms of wax including p fluorocarbon waxes. Paste wax Very economical and Small fabric applicator to apply Typically available in easy to apply and buff in. The longer you buff it a universal into the base the longer it lasts temperature range. on your skis. Can be used as an overlay. Powder Typically have high Designed to be used after a few Often used sparingly wax costs due to the high layers of block wax are applied. for important races 27 https://www.skis.com/Buying-Guide-for-Ski-Wax/buying-guide-5-3-2013,default,pg.html, date of access: 2022-12-15. 55 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Type Spray wax Market insights number of fluorocarbons they contain Typically used on top of several layers of highend block wax to offer the best gliding properties Method of application Used to increase gliding properties. Once it is sprayed on, allow it to absorb and dry for 5 minutes, then use a cork to further buff it in. Use only. Most found in highend finishing racing wax as an overlay. Lists of examples of PFAS-based and fluorine free ski waxes is provided in Table A.93 and Table A.94 in Appendix A.3.8. ite Skin skis c Skin skis differ from traditional skis in that they are designed to allow skis to slide forward t but not backward. Initially, animal fur or mohair, a natural material from the hair of goats, was used for skin skis. It was then substituted by nylon skin material treated with Teflon o or by a mix of the two. n Real mohair treated with Teflon is used on high-performance models28. Nowadays, mainly synthetic skins are used for both cross country and alpine skiing when going uphill. The o skins grip the snow, thus providing a forward kick. The skins are then easily removed for d skiing downhill3, while they may be permanently attached under the ski on cross country skis. Given that the skin mimics the functions provided by the grip wax, it is not necessary to use grip wax on the skis. However, it can be necessary to apply anti-icing products to - the skins to eliminate icing, as it is done for grip wax-treated skis. In addition, the skin should be cleaned periodically28. The glide zone of the skis (i.e., in front of and behind the n kick) needs to be re-waxed every 100km travelled, similar to classic skis29 and in most io cases, it is possible to use the same wax for both skin and traditional skis. t Main PFAS a The main PFAS used in ski waxes are perfluoroalkanes and semi-fluorinated alkanes. The lic semi-fluorinated alkanes used are di-block and tri-block semi-fluorinated n-alkanes (SFAs) and are typically mixed with normal paraffins in the formulations of ski waxes. Perfluoroalkyl carboxylic acids (PFCAs) of varying carbon chain lengths (6-22 carbons) are b often found as residual impurities from the manufacture in commercially available u fluorinated ski waxes, see the studies by Nilsson et al. (2010) and Fang et al. (2020). PFCAs are not thought to have a technical function in the ski waxes given their relative p low levels compared to the perfluoroalkanes and SFAs. Perfluoroalkane sulfonic acids - (PFSAs) have also been measured in ski wax, but often at even lower levels than the e PFCAs. pr Fluoropolymers are also used in some waxes. Based on the complex interplay of PFAS, regarding some PFASs being a precursor and/or impurity to each other, it is in some cases difficult to state if individual substances are used intentionally or are the product of degradation or an impurity. In each case, the specific composition of the wax varies depending on the different snow conditions, humidity levels and weather conditions for which they are designed. Commonly the 28 https://www.webcyclery.com/about/skin-skis-101-pg259.htm, date of access: 2022-12-15. 29 https://www.crosscountrysports.com/care-for-your-skin-skis/, date of access: 2022-12-15. 56 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) composition of waxes is divided into the following categories (Table A.34). Table A.34. Overview of different ski wax composition. Wax composition Price Properties Labelling Pure Fluorocarbon Expensive products Comes in liquid, powder or Typically have FC as they have a high block form. Liquid form is or Cera in the title fluorocarbon content. the most popular. High of the wax. resistance to dirt and oils to provide a long lasting, fast gliding ski. High Fluorocarbon Typically, more Provide the highest number Typically has HF in t cite Low Fluorocarbon o no Hydrocarbon ion - d Eco-friendly/plantat based wax expensive ski waxes. The higher the fluorocarbon content the more expensive. Best value wax when you compare price and performance. of gliding properties in areas with high humidity, man-made snow, dirty snow or places with very cold temperatures. Made for every temperature range. Available in every temperature range. Can be used by themselves or to prepare the base. the title of the wax. Typically has LF in the title of the wax. Contain no fluorocarbons and are very economical. More expensive than typical hydrocarbon wax. Very durable and repel dirty snow conditions very well. Can be used by themselves (best in colder conditions), or they can be used to help prepare bases for use with higher-end waxes. Often made from a mix of naturally occurring waxes. Tend to be biodegradable. Typically has CH in the title of the wax. Often labelled `eco'. lic A.3.8.2. Volumes ub Information obtained from stakeholders suggests that the total ski wax market is split approximately 50/50 between consumer and professional sales, and the racing market p accounts for ~10% of the market sales. (EEA as well as world market) is split - approximately 50/50 between consumer and professional sales, and the racing market e accounts for ~10% of the market sales (ECHA, 2016). No information was available on r the sales of specific alternative products, nor the volumes associated with the various wax p types (block, liquid, powder etc). PFASs in ski wax seems to have been introduced in the late 1980s (Masia, 2010). Historical trends in use of ski wax indicate that: The highest use year for non-PFAS based ski wax globally was 1978, where 300 tonnes of glide waxes were used. Some companies no longer manufacture ski waxes containing PFASs and are currently selling off their remaining stock. Companies have been working on the development of non-fluorinated alternatives since 2013. Since 2017 the PFAS-based ski wax market has shrunk for various reasons, because of the higher prices of some PFAS-based waxes, due to global policy developments related to the use of PFOS and PFOA, and also due to decreasing number of professional athletes. 57 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Production of PFASs based waxes is expected to decrease in the following years. Due to increasing concern and publicity regarding the potential human health and environmental effects caused by the use of PFASs in ski wax treatments, there is a concerted move within this sector towards phasing out the use of PFASs and moving towards safer alternatives. In particular, in 2019 the International Ski Federation (FIS) set to introduce a full ban on all PFASs in waxes in all competitive ski disciplines from their 2020-2021 season, a move that follows national-level bans imposed, for example by the Norwegian Ski Association in 2017. However, enforcement of the FIS ban has been postponed until after the season 2021-22 (FIS, 2021). This delay was because they are still developing a Fluorine Tracker, an instrument that would instantly detect the presence of PFASs on the ski, thus making the competitions fair. At the same time FIS has prohibited any products containing C8 fluorocarbons/PFOA at all FIS events from season 2021 and 2022 onwards to mirror the PFOA regulations in the chemical legislation. ite Based on stakeholder information it is estimated that the total global production of ski wax is 120 tonnes (in 2020). Of these, the EU produces 60%, which equals 72 tonnes. Ca. c 30% of the 72 tonnes of ski wax produced in the EU annually is PFAS-based, i.e., 21 tonnes. An average PFAS concentration of 7.6% w/w. is assumed in fluorine-based wax t (which includes both fluoropolymers and non-polymeric PFAS), which amounts to 1.6 o tonnes (or 1 640 kg) of PFASs used annually in the EEA for ski-wax formulations. The n Dossier Submitters, however, cannot disaggregate PFAS volumes in more detail, despite knowing the (main) PFASs used. o Since the EU is a major manufacturer of ski-waxes according to stakeholders, 60% of global production, it is assumed that no imported ski-wax will be needed and that all ski- d wax manufactured will service the EU's needs, hence that net export/import is zero. It is possible that the EU is a net-exporter of ski-wax but data on exports was not identified. - Regarding manufacturing in the text above already information has been given. In Figure n A.12 a high-level market overview in EEA is given. pre-publicatio Figure A.12. High level market overview of ski waxes in the EEA (information obtained from stakeholder consultation). In Table A.35, an historic overview of production volumes is listed. Information from stakeholders indicate that the peak year for production and consumption of ski-wax globally (all formulations, including both PFAS and fluorine free) was 1978, where 300 tonnes of wax was used. However, it is important to note that the use of PFAS based substances only came into circulation later, with the first patents lodged in 1990. Based on feedback from EU's largest manufacturer, market data for the latest year suggests total global production for ski-wax in 2020 (again, all formulations) was 120 tonnes. This 58 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) suggests that overall global consumption of ski-wax has declined since the peak years of the late 1970s. Further information about assumptions behind the volumes in Table 29 can be found in the report by the Norwegian Environment Agency (Nicol et al., 2021). Table A.35. Assumed production rates, based on stakeholder information and consultant assessment, for PFAS-based wax used to calculate the backward-looking time-series. Year Global EEA fraction Total EEA ski- Proportion of PFAS-based production of production wax EEA production ski-waxes (t/y) (percentage) production (all covering produced in formulation) fluorinated the EEA (t/y) waxes (%) (t/y) 1978 300 60% 180 1990 250 60% 150 e 1995 225 60% 135 it 2000 200 60% 120 2005 175 60% 105 c 2010 150 60% 90 t 2015 135 60% 81 2020 120 60% 72 0% 10% 30% 50% 50% 50% 40% 30% 0 15 40.5 60 52.5 45 32.4 21 no Mobile air conditioning is an application where HFOs have replaced HFCs to a considerable o extent, and use volumes are underestimated if only volumes of HFCs and PFCs, as reported in the GHG Inventory Data, are taken into account, which is the case in Table A.35. In d section A.3.11 on PFAS applications within transportation, the overall volumes of fluorinated gases used in mobile airconditioning was estimated at 12 222 t/y with basis in - the number of new vehicles manufactured and registered in the EU and typical refrigerant loading in each type of vehicle. n A.3.8.3. Summary tio PFASs used in ski wax allow for easy gliding and skiing due to their specific properties of high-water repellence and low surface tension. The most used PFASs in fluorinated waxes a are perfluoroalkanes and semi-fluorinated alkanes. Other PFASs include PFSAs, PFCAs of lic varying carbon chain lengths (6-22 carbons) which are often found as residual impurities, and fluoropolymers. The EU is currently a major manufacturer of ski wax, producing 60% of global production, which equals to 72 tonnes according to stakeholder data from 2020. b Assuming an average PFAS concentration of 7.6% w/w, it is estimated that 1.6 tonnes of u PFASs are used annually in the EEA for ski-wax formulations. There is a concerted move within this sector towards phasing out the use of PFASs and moving towards safer pre-p alternatives. 59 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.9. Applications of fluorinated gases A.3.9.1. Uses A short summary of the applications of fluorinated gases for various uses in the EU/EEA was prepared by Exponent and published by the Norwegian Environment Agency (Exponent International Ltd., 2021). As the definition of PFAS, used by the Dossier Submiter (as well as OECD) include substances with only one fully fluorinated carbon atom, several small fluorinated molecules that are often gases are covered. Some of these substances, in this dossier called fluorinated gases, are well-known heat transfer agents familiar from freezers, heat pumps, air-conditioning and other applications. Some of the fluorinated gases are common with e the set of gases addressed in the F-gas regulation, but there are also differences in the it scope of the F-gas regulation and the PFAS restriction proposal. c This definition covers most F-gases as defined by the European F-gas regulation and the Montreal Protocol. Fluorinated gases are a family of man-made gases used in a range of t industrial and consumer applications. There are however, fluorinated gases which are o grouped as F-gas according to the European F-gas regulation and the Montreal Protocol n but are not a PFASs. This is for instance the case for SF6, HFC-23 and HFC-152a. On the other hand, there are volatile PFASs which partition considerably to air while they are not among the F-gases in the F-gas regulation. For example, fluorotelomer alcohols or o perfluorinated trialkylamines (gases in the atmosphere but liquids under normal conditions). The current assessment covers substances that are both F-gases and fall d within the PFAS-definition. See also Figure A.5. These substances are used primarily in the applications which are covered by the F-gas regulation and the Montreal Protocol, including - heating, ventilation, air-conditioning and refrigeration (HVACR), and as foam blowing agents, propellants, solvents, cover gases in magnesium industry and as clean fire n suppressing agents. io These uses are presented in Figure A.15. In this figure, it can be seen that the main uses t are air conditioning (41%) and refrigeration (34%). Fluorinated gases may be used either alone or in blends. They are sometimes used in combination with gases outside of the a scope of Annex A or with non-fluorinated gases. lic Not assessed in this section: b A considerable fraction of fluorinated gases produced is used as starting materials u or monomers in the manufacture of other fluorochemicals and polymers. In principle, these gases are consumed in such manufacturing processes, and p therefore they are not considered in this section which covers end uses of - fluorinated gases. Chemical manufacture with fluorinated gases as building blocks eis often claimed to be handled in closed systems with incineration of off-gas. rHowever, emissions may occur from the manufacturing plants. In the case of fluoropolymer manufacture, releases of fluorinated gases are sometimes punderestimated. One example is the release of perfluorocyclobutane (PFC-318) in the manufacture of PTFE from HCFC-22 (CHClF2) as reported by (Muhle et al., 2022). According to atmospheric measurements, PFC-318 has increased sharply since the early 2000s. Fluorinated gases used in medical applications, mainly metered dose inhalers (MDI), are mentioned in section A.3.10 (Medical devices). Some of the fluorinated gas substances in the proposed restriction scope can sometimes also be used as a fluid. There is not a clear border between gas and liquid for these (and many other) compounds. Sometimes they are used as a refrigerant gas, but in other cases the same substance can be used as a solvent for cleaning in its liquid form - although it may evaporate fast after use. Some of the 60 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) applications of fluorinated solvents are in closed systems or in applications in which users can manage and minimize emissions. In many applications, the fluids are filtered in situ and can be recycled and reused. This liquid application of fluorinated gases/liquids in PFAS scope is not described in detail here (nor in another section of the dossier). Fluorinated gases used for the different applications are mentioned in this section. Chapter 1 includes hydrofluorocarbons (HFC), perfluorocarbons (PFC), hydrochlorofluorocarbons (HCFC), unsaturated hydro(chloro)fluorocarbons (HFO and HCFO), hydrofluoroethers (HFE), fluoroketones (FK) and other fluorinated compounds. Fluorinated gases may be used either alone or in blends. It is common to use specific codes for the different fluorinated gases in the sector. For e example, HFC-134a represents a specific hydrofluorocarbon, while HFO-1234yf refers to a it certain hydrofluoroolefin compound. Sometimes the "HFO"/"HFC" is replaced by a common "R" which means the same, but without specifying the subclass, e.g. R-134a and R-1234yf. c The identity of all fluorinated gases mentioned in this report can be found in Table A.96. t Use of fluorinated gases for the manufacture of PFAS is covered in more detail in Section o A.2.1. Key related regulations are the F-gas regulation and the Mobile Air-conditioning n (MAC) directive (Directive 2006/40/EC). The current F-gas Regulation (Regulation (EU) No 517/2014), which applies since 1 January 2015, replaces the original F-gas Regulation adopted in 2006. The F-gas regulation has the following ambitions: Limiting the use of o some important F-gases that can be produced and imported into the EU; Banning the use of F-gases in many new types of equipment where less harmful alternatives are widely d available; Preventing emissions of F-gases from existing equipment. However, the basis for the F-gas regulation is the GWP of the substances in scope and their contribution to - global warming (and not their volumes per se), while other concerns are not taken into account, e.g., atmospheric degradation to TFA which precipitates and causes exposure to n the humans and the environment. The Mobile Air-Conditioning (MAC Directive prohibits the use of F-gases with a GWP of more than 150 in new types of cars and vans introduced io from 2011, and in all new cars and vans produced from 2017. One consequence of the t MAC directive is the transition to low-GWP HFO in large volumes which are a considerable source of TFA in the environment. As the current dossier focuses on different a environmental concerns as the F-gas regulation and MAC directive, an evaluation of lic substances and applications independent from these regulations is performed. A list of the specific fluorinated gas substances identified in different uses and sub-uses b on the market is found in Table A.95, and a condensed list of the fluorinated gases together with their chemical identity is found in Table A.96. Data on trend in the supply in EU-28 of u fluorinated gases 2007 - 2019 is found in Table A.96. -p An overview of the annual volumes for the different applications follows after their introduction, in Table A.36. In total 43 different substances have been identified as e relevant in this assessment. Five of them are not within scope of this restriction proposal r as they do not carry a fully fluorinated C-atom. However, they are of interest for the p understanding of the relevant applications as they are used in blends together with other fluorinated gases that are within the scope. Altogether 14 HFCs/HCFCs have been identified as being in use, as well as 12 HFOs/HCFOs, several of which are isomers. Two fluoroketones, six hydrofluoroethers (HFE), 16 HFC and HFC/non-PFAS blends and 20 HFC/HFO blends have been found to be relevant. In addition, nine substances grouped as 'others' are in use, including perfluoroalkyl amines and a nitrile. The substances HFC-23 (CHF3), HFC-32 (CH2F2), HFC-152a (CHF2-CH3), HCFC-141b (CCl2F-CH3) and HFO-1132a (CH2=CF2) are not covered by the scope definition of the 61 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) present restriction proposal due to their chemical structures. However, they are used in blends with other fluorinated gases that are within scope. Besides, the full overall volume of the different applications (including both PFAS and non-PFAS gases) is of relevance as a shift to a different specific gas could affect the whole application volume. Fluorinated gases are a group of industrial chemicals used as heat-transfer medium in heating, ventilation, air conditioning and refrigeration (HVACR), and as foam blowing agents, propellants, solvents, cover gases in magnesium industry and as fire suppressants. These major sectors may be further divided into sub-applications. There are also several niche applications (e.g., for gas leak detection) that are not specifically addressed in the current assessment. In the present assessment primarily applications with use volumes and emissions reported to the UN Framework Convention on Climate Change (UNFCCC) are covered as the methodology to collect relevant data would be the same for these e applications and based on reporting under the convention. It should also be recognized it that there is a gradual transition from the traditional applications of fluorinated gases to the uses of fluorinated liquids that may be of the same or similar chemical structures to c the gases, often called functional or engineered fluids. Information has been included in this section when this has been submitted by stakeholders as comments to this sector, t see `Minor uses' at the end of this section. no Reclaim and recycling or destruction of fluorinated gases plays an increasing role in the sector and promotes a circular economy and further reduces emissions. Several companies offer collection and regeneration service for used refrigerants. However, emissions are still o large from the sector. d Below the main uses of fluorinated gases are introduced. A list of all specific substances identified together with their respective uses and sub-uses is found in Table A.95. - Refrigeration, air conditioning and heat pumps n Main sub-use categories assessed: io Domestic refrigeration t Commercial refrigeration a Industrial refrigeration lic Transport refrigeration Mobile air conditioning (MAC) Stationary air conditioning and heat pumps b Domestic air conditioning and domestic heat pumps for space heating u Commercial air conditioning and heat pumps p Domestic heat pumps (clothes dryers) - Refrigerants are commonly used in refrigerators, freezers, chillers and air conditioning e units at home, in stores and in cars. An emerging market concerns the use of heat pumps r for space and water heating, and domestic hot water production, as well as in some p consumer products such as `tumble dryers' for clothes. Refrigeration and heat pumps are also widely used commercially and in industry, for example, supermarket refrigerators and freezers, drinks chillers in bars and restaurants, manufacturing and transporting chilled and frozen goods, and in specialised applications such as for cooling large data centres, for servers, electronics and for industrial processes. There are also refrigeration systems found in commercial aircrafts. In many cases the refrigerant, or heat transfer liquid, is a fluorinated gas. There are a range of different gases available for such purposes, with different properties that are suitable for different specific applications. However, often fluorine-free alternatives are available, like the natural refrigerants carbon dioxide (CO2), hydrocarbons and ammonia. Isobutane (R-600a) is the major refrigerant used in domestic refrigeration in Europe and around 50% of light commercial systems are using propane (R-290) and its use is growing. In larger commercial systems CO2 is technically feasible 62 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and a frequently used option. The technical function of refrigerators or heat pumps relies on a refrigerant substance or mixture that acts as working fluids to maintain low temperatures in an enclosed environment. The most common refrigeration and air conditioning cycle used in these settings is the vapour-compression cycle, in which the circulating refrigerant absorbs and removes heat from the space to be cooled and expels the heat elsewhere. Heat pumps work on the same principle, but in reverse. Reversible air-to-air heat pumps are increasingly used not only to cool, but also to provide heating to buildings in an energy efficient manner. Large scale industrial heat pumps for district heating (more than 3 MW, use of turbo compressors) often rely on fluorinated gases as working fluid. Fluorinated gases are also sometimes used in refrigeration air dryers, although this is a e minor application. it Mobile air conditioning is used to cool the interiors of cars, trucks, buses, trains, ships and c construction machinery etc. Previously, HFC-134a was extensively used for this purpose, while HFO-1234yf now replaces the former in new vehicles in order to reduce the climate t impact. The refrigerant circuits for electric vehicles are more complex and larger, as the o battery must also be cooled. Therefore, more refrigerant must be used per vehicle with n increasing electrification of the vehicle fleet. One stakeholder has pointed out that future cars and vehicles will be electrically driven and that combined air-conditioning and heat pump systems will be the standard solution due to energy efficiency constraints. o Secondary loop MACs (SL-MAC), also called indirect systems, are vapor compression d refrigerant systems where the evaporator is replaced with a chiller with a coolant flow loop to provide cooling for passenger comfort, window defogging, and thermal control of - batteries and other components (Chen et al., 2020). Such systems are designed so that only a secondary fluid (antifreeze coolant, water/glycol, etc.), not the refrigerant, enters n the passenger cabin, while the refrigerant sub-system stays in the engine compartment. This increases refrigerant choice, since refrigerants that may be flammable but have more io desirable thermo-physical characteristics can be used more safely. SL-MAC systems have also proven to have higher energy efficiencies compared to direct expansion systems. HFC- t 152a (not a PFAS) has been shown to be an affordable and efficient refrigerant in SL-MAC. lica Refrigeration is used widely in chemical, pharmaceutical and food processing industry, throughout the supply chain, including manufacturing, storage and transportation. Fluorinated gases are often used in refrigeration equipment where extreme controlled b temperatures are required (below -40 C), more specifically in vaccines and biopharmaceuticals manufacturing. Blood banks, medical examination and tissue and cell u diagnostics may also rely on the use of fluorinated gas refrigerants. Fluorinated gases are p frequently used in ultra-low temperature freezers or cryogenic storage. Furthermore, such - gases are used in refrigerated laboratory equipment that require precise temperature control over a large temperature range, e.g., test and measurement equipment and e refrigerated centrifuges. However, this equipment is usually designed with hermetically r sealed systems to avoid leakage, and at end of life, the fluorinated gas is normally collected p under controlled circumstances to avoid releases. Low temperature refrigeration also has applications within commercial refrigeration. HFOs may be used in organic rankine cycle (ORC) technology to generate electricity by recovering waste heat from industrial processes such as glass/ceramics factory and using geothermal energy and biomass. The same technology is also used for cooling purposes in data centres to minimize energy consumption by half compared to the current system and thus enhance energy efficiency. Variable refrigerant flow (VRF) and direct expansion appliances show enhanced energy efficiency compared to hydronic heating system. For those appliances, fluorinated gases 63 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) will stay relevant in the future according to stakeholder input. Nuclear energy plants also use fluorinated gas refrigerants for certain purposes. Fluorinated gases are often used as refrigerants in military aircrafts, naval ships and submarines, and land vehicles for the common refrigerant applications, as well as for cooling of weapon systems and storage of sensitive material like ammunition, pharmaceuticals and fuels. Fluorinated gases used as Foam-Blowing Agents Main sub-use categories assessed: e Foam-blowing agent (closed cell) it Foam-blowing agent (open cell) c Foams are widely used in household, commercial and industrial settings often to provide thermal insulation, for example to retain heat within a building or boiler, to keep heat out t of refrigerated areas, or to prevent pipes from freezing and cracking in cold weather conditions. Foam is also used to fill gaps in buildings to prevent excessive air movement o and can be used as a protective and cushioning cover, such as for seat covers or vehicle n steering wheels. Key factors in selection of foam blowing agents relate to the cost of substances, flammability and efficiency of insulation. Additional factors apply in some o applications for specific foams, for example relating to compression and flexural strength and resistance to water. See Figure A.13 for an example of insulation foam application. d Foam-blowing agents are present in the mixtures created for foam production, ensuring - that foam expands after release and prior to solidifying. Foams may be open-cell or closed- cell depending on application. For open-cell foams, emissions of blowing agents occur during manufacture and use or shortly after. Most emissions from closed-cell foams occur n during the service-life of the foams or at disposal of the product into which the foam has io been added. From a business perspective, the use of fluorinated gases in open cell foam is not wise since the (expensive) blowing agent gets out of the product. at Polyurethane (PU) foams used in refrigeration are closed-cell foams, and applications lic include domestic refrigerators and freezers, commercial refrigerators, freezers, cold rooms and vending equipment and also refrigerated trucks and reefers, as well as domestic hot water tanks. PU boardstock is a closed-cell foam which may be flexible or rigid and includes b polyisocyanurate boardstock (PIR board) and continuous boardstock with a flexible facer. It is used in residential and commercial construction for applications such as easy to install u insulation boards for loft conversions or for pitched roofs in between rafters. PU Spray p foam may be open-celled or closed-celled. Closed-cell spray foam retains the blowing - agent in the foam cells and has better insulating properties than open-cell foams. It is used for insulating structures that would be hard to get to, such as around windows and e doors, gaps around pipes, as a filler insulate with solid preformed foams, an example being pr an insulated road tanker. 64 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) e Figure A.13. Prefabricated XPS foundation insulation being installed at a building site it (left) and direct application of insulating foams (right). Both images used royalty-free from CC BY 2.0, photographers akhouseproject and dunktanktechnician. t c In building materials, the olefinic fluorinated gas FA-188 is used as a foam insulation o additive due to its effectiveness in reducing the foam cell size and thus the thermal n conductivity of polyurethane and other rigid foam formulations. Rigid Polyurethane pipe-in-pipe and block foam is closed-cell and may be used as pipe o insulation particularly for larger scale applications such as district water pipes, to prevent d pipes from freezing and cracking. This type of insulation foam may also be used in central heating, manufacturing and in the mining industry. - Polyurethane integral skin foams are open-cell foam used in cushions, mattresses, furniture, toys and sporting equipment. Extruded polystyrene foam (XPS) boards are used n for building insulation, including under floor insulation and often competes with PU board stock. This type of foam has also been used for its high strength insulating properties in io the construction of roads, railway tracks and airport runways. XPS board foam may also t be used for marine and leisure buoyancy products such as surf and body boards. Phenolic foams are closed cell foams and include phenolic board stock and block foams which are a used primarily for industrial heating and ventilation applications for the insulation of pipe lic work, for insulation in roofing, cavity walls and flooring. In the home appliance sector, foam insulation is sometimes used in constrained spaces in b white goods, and in order to reach a sufficient level of insulation, fluorinated gases are u used as blowing agents. p New techniques and innovative pathways are developed for the recycling PU/PIR products - and collection of blowing agent. However, some of the infrastructure applications using e foam blown with fluorinated gases have a long lifetime, up to 40 years. prSolvents According to stakeholder input the main applications of fluorinated gases used as solvents (sometimes referred to as functional fluids or fluorinated liquids) are industrial metal cleaning to remove oil and grease, electronics cleaning for the removal of flux, and precision cleaning to remove particulates or dust, and cleaning in relation to various lubrication processes. Such techniques may be in use for example during the manufacture and maintenance of electronics, fibre optics and equipment for aerospace, medical devices and defence. In some applications components must be absolutely reliable throughout their designed lifetime and must meet the strictest cleaning and safety standards. Particularly relevant are fluorinated solvents used for cleaning of parts and component in oxygen-enriched environments. 65 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) An industrial use of fluorinated solvents is the use as carrier fluids to deposit lubricants, silicones, coatings, adhesives and other materials in smooth coatings, as well as for the formulation of dissolved polymeric PFAS oils and greases. Furthermore, fluorinated gases/solvents may be used as heat transfer media, thermal testing fluids and in electrical/electronics testing. Fluorinated solvents (e.g., hexafluoroisopropanol, HFIP) are used in additive (3D) printing as a debinding agent prior to sintering for 3D printing of metals. They are also used as a smoothing agent for some polymer 3D printing applications, including for respiratory medical articles, Covid-19 diagnostic items, automotive and aerospace components, electronics and consumer items. Key factors in selection of solvents relate to the cost of substances, non-flammability, e thermal and chemical stability, dielectric properties (poor electrical conductance meaning it that they can be used safely in contact with electronics), compatibility with dissolved materials, low surface tension and viscosity, high liquid density, and low toxicity. Although c there are many alternatives for this use, PFAS-substances, such as HFCs, HFEs and HFOs, are still claimed to be required for some applications, especially precision cleaning. ot Propellants n Propellants are used to expel the contents of an aerosol from a canister through a nozzle, in products such as deodorants and hair sprays. Technical propellants are used for o industrial uses for items such as lubricant sprays, dusters, cleaners, safety horns, degreasers, cold sprays, and paints. Propellants used in medical applications like MDI d (Metered Dose Inhalers) are covered in section A.3.10. - Liquified compressed gases are widely used as propellants, as they maintain a relatively constant pressure as the contents are dispensed, maintaining consistent droplet size and n spray rate which may be required for technical aerosols. In contrast, compressed gases, such as carbon dioxide, cannot produce a consistent particle size and spray rate, thereby io limiting their applicability, with performance falling as the contents of a can are used up and pressure within the can falls. Where a non-flammable propellant is required, HFOs are t often used, alone or in a propellant blend. lica Cover gases Main sub-use categories assessed: b Die casting u Sand casting -p A cover gas (or shielding gas) is used to prevent rapid oxidation of a molten metal surface for example in magnesium casting and recycling industries. The function of the cover gas e is to provide a protective film above the molten metal, preventing oxidation. Fluorinated r gases have suitable properties for this application. p Fire suppressants Main sub-use categories assessed: Total flooding systems Local streaming agents Fire-fighting foams are not part of this assessment. They are covered in a separate restriction proposal. In the present assessment only clean fire suppressing agents, which are not foams, are included. 66 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluorinated gases (e.g., HFC-125 and HFC-227ea) are used for fire protection purposes where their main advantage is that they are `clean', non-conductive to electricity (i.e., have good dielectric properties) and are considered safe for humans to breathe at the concentrations used. In this context, `clean' refers to the ability of the fire suppressant to not leave non-volatile residues after discharge, i.e., avoid the potential damage caused by conventional extinguishing agents. This means that fluorinated gas fire suppressants occupy a niche market, when there is a need to protect items that otherwise would be damaged by a fire extinguishing agent, and in enclosed spaces where some other fire suppressants would pose a risk to human health. Fire suppressants may be divided into total flooding agents and local streaming agents. Areas of use include portable and fixed aircraft fire protection systems (e.g., engine, auxiliary power units and cargo cite compartments), as well as specific risk situations (e.g., clean-room protection, electronic- , IT- and control room installations mainly at critical infrastructures) including the defence sector. 2-BTP (CH2=CBrCF3) is a frequently applied substance for fire suppression. The substance not is a halogenated clean agent (HCA) used as halon replacement agent in handheld extinguishers onboard aircraft. Some fluoroketones, (e.g., FK-5-1-12 (CF3CF(CF3)C(=O)CF2CF3), are also introduced as a third-generation fire suppressant. Clean fluorinated gas fire suppressants may also be used in archives and museums with paper archives, historical documents, priceless works of art and antiquities where other fire protection fluids cannot be used. o Fluorinated gas fire suppressants are specifically used for several military applications, e.g., in engine- and crew compartment systems on army ground vehicles (e.g., HFC- d 236fa) and in fixed systems protecting flight simulators and command centres. In combat the soldiers have very limited possibilities to leave the vehicle and are therefore exposed - to the extinguishing media. n Minor uses io Insulation gas in electrical equipment t Historically, SF6 has been used as an insulation gas in high-voltage power generation and a distribution equipment, including gas insulated switchgear and gas insulated lines. lic Recently, research and development has led to the replacement of SF6 (very high GWP) with low-GWP fluorinated gas alternatives that would reduce the contribution to climate effects considerably. Specifically, the nitrile C4-FN and the ketone C5-FK are used for this b purpose, including in medium- and high-voltage gas insulated power generation and distribution equipment such as switchgear and lines. This application is considered in detail u in section A.3.12 on electric/electronic equipment. -p Electronics and semiconductors manufacture e In the electronics and semiconductor industry fluorinated gases are used in etching and r chamber cleaning processes to form nano-level fine semiconductor integrated circuits etc. p CHF3, CF4, perfluoroethane, perfluorinated alkanes and cycloalkanes are examples of fluorinated gases used for these purposes. In most cases the substances are used as a solvent. Although the amount used is small, today's electronics products require extremely complicated and delicate processing to realize various functions such as high performance, multi-function, and low power consumption. To achieve this, various gases/liquids are combined to perform processing with advanced and delicate control. Fluorinated gases are also used in Carnot cooling cycles in electronics and switchgear, as well as in industrial process refrigeration in the manufacturing plant, while hydrofluoroethers and perfluoropolyethers are used within as high-performance heat transfer fluids. Further details may be found in section A.3.12 on electronics and semiconductors electric/electronic equipment. 67 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) IT hardware immersion cooling Immersion cooling is a method for cooling data centre IT hardware, including 5G network components, by directly immersing the hardware in a non-conductive fluorochemical liquid. The heat generated by the electronic components is directly and efficiently transferred to the fluid. This reduces the need for interface materials, heat sinks, fans, shrouds, sheet metal and other components that are common in traditional cooling methods. This application is considered in detail in section A.3.12 on electric/electronic equipment. Preservation of cultural paper-based materials Fluorinated -gases/liquids are used in a procedure for preservation of paper-based cultural e heritage materials. The procedure includes suspending MgO in a fluorinated solvent for it treatment of paper materials to stop acid corrosion and preserve the objects. Fluorinated solvents can deliver the alkaline buffer without degrading ink, binding materials, glue or c discolour the paper. t Plasma coating o Some fluorinated gases are used in plasma coating of recycled HDPE plastic containers to n limit the migration from recycled plastic to filling goods. The gases react with the plastic under the conditions with formation of a fluorinated protective layer. o Calibration and reference materials d Fluorinated gases and liquids are used as analytical reference materials and for the - calibration of measurement instruments. n A.3.9.2. Volumes io In Table A.36 an overview of PFAS volumes is presented. The main use groups are t distinguished. A description of the methodology used in the estimation of volumes for the different applications is found below the table. lica Table A.36. Yearly total volume of HFCs and PFCs in EEA per main use category. Total fluorinated gases (t/y) ub Commercial refrigeration Manufactured products Stocks 7 915 90 992 -pDecommissioning 5 717 re Domestic refrigeration Manufactured products Stocks 122 4 496 p Decommissioning 671 Industrial refrigeration Manufactured products Stocks 2 360 34 358 Decommissioning 1 219 Transport refrigeration Manufactured products Stocks 1 010 9 915 Decommissioning 226 68 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Total fluorinated gases (t/y) Mobile air conditioning Manufactured products Stocks 5 221 115 763 Decommissioning 4 647 Stationary air conditioning Manufactured products Stocks 7 465 148 791 Decommissioning 6 865 Foam blowing Manufactured products 4 940 agent (closed cell) Stocks Decommissioning 57 635 170 Foam blowing t agent (open cell) no Fire protection - do Aerosols (non- MDI) ion Solvents licat Other -pub Total HVACR Manufactured products Stocks Decommissioning Manufactured products Stocks Decommissioning Manufactured products Stocks Decommissioning Manufactured products Stocks Decommissioning Manufactured products Stocks Decommissioning Manufactured products Stocks Decommissioning 271 9 848 No data 863 20 201 208 504 907 No data No data 0 no data No data 267 No data 30 671 493 173 19 724 pre There are two main data sources that have been used extensively for cite market data (volumes) on fluorinated gases and their different applications, each with different strengths and limitations: Greenhouse Gas Inventory: EU/EEA Governments annually report to the United Nations Framework Convention on Climate Change, UNFCCC (EEA, 2022) - the socalled Greenhouse Gas (GHG) Inventory data. This is compiled according to the standard methodology and guidance set out by the Intergovernmental Panel on Climate Change (IPCC). Data from the GHG Inventory for 2018 (published in 2020) have been used in this assessment. The data used were mainly the data for fluorinated gases that are included in the GHG Inventory which is titled the `Sectoral 69 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) background data for industrial processes and product use'. These data are included in Table 2(II). B-H of the inventory and have been used. The reporting includes emission data in addition to market volumes. The GHG Inventory includes fluorinated gases of the type HFCs and PFCs, which are the most important subclasses, but it does not include for example the HFOs which are growing in use. The geographical scope of the GHG Inventory data for 2018 is EU28 plus Iceland (IS). Norway (NO) reports separately to the UNFCCC process, so for the purposes of this project the Norwegian data has been added to the EU GHG Inventory data to provide a geographical coverage of EU-28 & IS & NO. No data were available for Liechtenstein. F-gas report: The European Environment Agency annually collects and publishes F- e gas data reported by industry according to the obligations under Regulation (EC) it No 517/2014 (the `F-Gas Regulation'). The report used in this project was published in 2020 as the `F-Gas Report' (EEA, 2020) and provides EU data up to and including c 2019 and covers F-gas activity (production, reclamation, imports, exports, destruction and feedstock use), supply of F-gases (trends in supply) and progress t of phasing down the use of hydrofluorocarbons (HFCs). The F-gas report does not o include data for Iceland and Norway. The reporting threshold is 1 metric tonne, or n 100 tonnes CO2 equivalents of F-gas produced or imported/exported in bulk, and 500 tonnes CO2-equivalents for F-gases in products30. The F-gas report is limited to volumes of F-gases placed on the market and does not cover emissions. o However, it includes market volumes for the emerging HFOs (in principle also HFEs, but data are generally confidential for these). d Market data on fluorinated gases filled into new products and in stocks each year have - primarily been derived from data collated by the EU/EEA for the GHG Inventory and summarized for EU-27 & IS & NO & UK. Data for HFOs, which are not reported in the GHG n Inventory, have been extracted from the F-gas report. io Volumes of fluorinated gases from manufacturing to decommissioning is available at the t sub-application level and is indicated in the material flow diagram in Figure A.14. The data are disaggregated as follows: 1) Filled into new manufactured products; 2) In operating a systems (annual stocks); 3) Remaining in products at decommissioning, while data are lic not disaggregated at the substance-in-each-sub-application level. In 2018 in total, 30 671 t/y fluorinated gases were filled into new products for the first b time during their manufacturing process, while 493 173 t/y were found in operating u systems (Annual stocks in operating systems refers to products that already contain fluorinated gases and are in operation) used in EU-27 & the United Kingdom (UK) & Iceland p (IS) & Norway (NO) (EEA, 2022). Remaining in products at decommissioning is 19 724 t/y - gases. From the GHG Inventory data for 2018, refrigeration and air conditioning account e for 78% (24 093 t/y) of the total amount of these fluorinated gases filled into new manufactured products and 82% (404 315 t/y) of the gases in operating systems pr (technical stocks). 30 An implication of the high reporting threshold for products (in CO2e) is that HFOs often are underreported due to their low GWP. For example, HFO-1234yf with a GWP of 4 is replacing HFC134a with GWP 1430 for use in AC in passenger cars. With a specific charge of approximately 0.5 kg per passenger car, the 500 t CO2 e reporting threshold corresponds to 250 000 passenger cars with HFO-1234yf refrigerant. 70 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) pre-publication - do not cite Figure A.14. Material Flow diagram - fluorinated gases from product manufacturing until decommissioning, 2018. 71 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Looking at the fluorinated gases filled into new manufacturing products in Figure A.14 and comparing the volumes of the different applications, the distribution shown in Figure A.15 below can be obtained. The total amount of fluorinated gases filled into new products equals 30 671 t/y. ot cite Figure A.15. Fluorinated gases filled into new manufactured products in 2018 (EU-27 & IS & n NO & UK). Figure adapted from GHG Inventory (EEA, 2020). o According to stakeholder input, the market volumes of closed cell insulation foams can be split between polyurethane spray foams, extruded polystyrene and phenolic foams, with d phenolic foams potentially accounting for around 50%. - In the GHG Inventory the reporting on applications of solvents is very limited. This may be due to the volume threshold for reporting to the GHG Inventory is high and not suitable for these applications. However, it is evident that the volumes of fluorinated solvents used are n low compared to other applications. According to stakeholder information, an amount of 140 io tonnes of fluorinated solvents is used annually within electronics and semiconductors, mostly for cleaning, see section A.3.12. Furthermore, an estimated 35 - 75 t/y of fluorinated solvents t is used for cleaning in relation to lubrication processes, see section A.3.15. lica In addition to the above-mentioned fluorinated gas market data from the GHG Inventory, HFOs are being increasingly used. These are not reported in the GHG Inventory, but data may be found in the F-gas report. The F-gas report investigates trends in the supply of fluorinated b gases in the EU, and Figure A.16 below, copied from the report (EEA, 2020), shows the pre-pu estimated trends in different intended applications since 2007. 72 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) do not cite Figure A.16. Intended applications of EU total supply of fluorinated gases in tonnes and in tonnes CO2 equivalents, 2007-2019. Reproduced from F-gas Report, Figure 4.7 and 4.8 (EEA, - 2020). n Data collected from the F-gas report on the use volumes of HFOs and HCFOs and compared io with other fluorinated gases can be found in Table A.97 in the Appendix. The majority of HFOs currently being used commercially as a single substance (rather than a blend) are in mobile t air conditioning (MAC) systems for passenger cars and in light goods vehicles, commercial air a conditioning, heat pumps and process cooling. In commercial and transport refrigeration HFOs lic are mainly used in HFC/HFO blends such as R-448A, R-449A, R-450A, R-452A and R-513A. The overall volumes of HFOs/HCFOs for all applications increased from 6 305 tonnes in 2016 to 18 350 tonnes in 2019, while the relative proportion of HFOs/HCFOs compared to other b fluorinated gases in the same period increased from 6 to 24% (Table A.97). u According to the GHG Inventory data 5 221 t/y of HFCs were supplied to the EU market in p 2018 for mobile air conditioning, Figure A.14. The F-gas report lists 1 206 t/y imported - fluorinated for MAC in 2018, while EU total imports of HFOs/HCFOs in 2018 was 19 235 t/y. With basis in the number of newly produced/registered road vehicles and the volumes of e gases used in different types of vehicles, it was estimated that 12 222 tonnes of fluorinated r gases were used in HVACR-systems for passenger comfort in new vehicles in the EU in 2019, p see section A.3.11. Figure A.17 shows the imports of fluorinated gases into the EU-28, including both bulk imports and imports contained in products and equipment (EEA, 2020). The overall import volume of fluorinated gases decreased by 14% from 2018 to 2019 (EEA, 2020). Imports of HFCs fell by 19%, while imports of HFOs/HCFOs increased by 6%. The share of HFCs in total imports was 79% in 2018 and 74% in 2019. 73 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) do not cite Figure A.17. EU imports of fluorinated gases, both bulk imports and imports contained in - products. Copied from the F-gas Report, Figure 3.3 in EEA (2020). ion Figure A.18 provides an overview of the supply of fluorinated gases in 2019 in more detail: the largest proportion is HFCs delivered in bulk (61% of total EU supply), while about 13% is t HFCs delivered in products and equipment. Unsaturated HFCs (= HFOs) have risen to a share a of 23%. PFCs, SF6 and other gases are supplied almost exclusively in bulk. The picture looks pre-public quite different when looking at the total supply measured in CO2-equivalents. 74 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) o not cite Figure A.18. 2019 total supply by types and groups of fluorinated gases in both percentage of tonnes and percentage of CO2 equivalents. Reproduced from F-gas Report, Figure 4.3 and d 4.4 in EEA (2020). - To get an impression of the relative importance of the different fluorinated gases that are not within the chemical scope of the present restriction proposal, one can look at the total supply n of fluorinated gases (in tonnes) reported at the substance level in the F-gas Report (EEA, io 2020), Table A5.17. An extract for the substances HFC-23 (CHF3), HFC-32 (CH2F2) and HFC- 152a (CHF2-CH3) is presented in Figure A.19 below. Data were not available for HCFC-141b t and HFO-1132a, but their uses are expected to be limited. The use of HFC-32 is evidently a increasing, and in 2019 constituted 18.5% of total supply of the fluorinated gases on volume lic basis. The total EU supply of HFC-32 in 2019 was 14 483 tonnes. HFC-152a is fairly stable pre-pub around 4%, while HFC-23 is negligible in comparison to the overall supply. 75 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Volume of selected F-gases as % of total supply of F-gases 100 90 80 70 60 50 40 30 20 10 e 0 cit HFC-23 HFC-32 HFC-152a not Figure A.19. Supply of gases outside the scope of the PFAS restriction proposal in the EU as percentage of total supply of fluorinated gases based on tonnes supplied. o Although some fluorinated gases used in various applications and in considerable overall d volumes are outside of the chemical scope of the PFAS restriction proposal (e.g., HFC-32), the overall volumes of gases (both PFASs and non-PFASs) for the different applications is of - interest as trends and shifts may affect the whole sector use volume as a response to technical or regulatory development. Furthermore, the gases outside of the chemical scope are often n used in blends with fluorinated gases within scope. io Illegal use and trade of HFCs is a considerable problem in the EU/EEA. The illegal trade t undermines regulations, results in more HFC emissions that fuel global warming and significantly reduces government income and the profits of legitimate businesses. It is very a difficult to provide an accurate estimate of the extent of these illegal activities. However, one lic estimate was provided by the Environmental Investigation Agency which estimated that 16.3 million tonnes CO2 equivalents of bulk HFCs were illegally placed on the EU market in 2018 (EIA, 2019). This represents more than 16% of the 2018 quota. The number represents the b amount of HFCs imported through normal customs channels outside of the quota system, and u traditional smuggling comes in addition to this and is much more difficult to quantify. There is a large variation in the fraction that the illegal import of HFCs constitutes between the p European countries. e- A.3.9.3. Summary pr Fluorinated gases are widely used in certain specific areas, e.g., refrigeration, foam blowing agents and as clean fire suppressing agents. The main uses of such gases are in airconditioning (stationary and mobile) (41%) and refrigeration (commercial, industrial and transport) (34%). The total annual use volume of fluorinated gases for HVACR for manufactured products is 30 671 tonnes, for stocks 493 173 tonnes, and for decommissioning 19 724 tonnes. 76 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.10. Medical devices A.3.10.1. Uses Medical devices are regulated under EU Regulation 2017/745. Various items can be considered medical devices, see text below as defined in the currently abovementioned regulation (EC, 2017a). `medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: --diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, ite --diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, c --investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, t --providing information by means of in vitro examination of specimens derived from the no human body, including organ, blood and tissue donations o In vitro diagnostic medical devices, on which the restriction proposal is also applicable, are regulated under EU Regulation 2017/746. Various items can be considered in vitro diagnostic d medical devices, see text below as defined in the currently abovementioned regulation (EC, 2017b). - `in vitro diagnostic medical device' means any medical device which is a reagent, reagent n product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in io vitro for the examination of specimens, including blood and tissue donations, derived from t the human body, solely or principally for the purpose of providing information on one or more of the following: lica (a) concerning a physiological or pathological process or state; b (b) concerning congenital physical or mental impairments; u (c) concerning the predisposition to a medical condition or a disease; p (d) to determine the safety and compatibility with potential recipients; - (e) to predict treatment response or reactions; re (f) to define or monitoring therapeutic measures. p Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; Medicinal products (including active pharmaceutical ingredients), anaesthetics and contrast media are considered not in scope of medical devices. Furthermore, personal protective equipment (clothing, drapes), medical electronics and constructive applications in hospitals are also not included, since these are part of TULAC (A.3.3), electronics (A.3.12) and construction (A.3.14), respectively. The EU Medical Device Regulation has classified medical devices into three classes with increasing risk: Class I, II and III. Each device class requires a different level of regulation 77 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and compliance. Class I are devices like tongue depressors, bandages, gloves, bedpans, and simple surgical devices Class II devices include wheelchairs, X-ray machines, MRI machines, surgical needles, catheter and diagnostic equipment Class III devices are used inside the body, for example heart valves, stents, implanted pacemakers, silicone implants and hip and bone transplants In future these devices will be registered in the European database on medical devices (EUDAMED)31 with a harmonised nomenclature through the European Medical Device Nomenclature (EMDN)32. Production of medical devices requires a high degree of cleanliness, purity, chemical stability e and thermal resistance. In the final products (substance, mixtures and articles), PFAS it properties like temperature resistance, dielectric strength as well as very high autoclavability, c chemical resistance, oil repellence, water repellence, sliding properties and good biocompatibility are important. t The majority of medical devices are introduced to the EEA market via imported articles o containing PFAS. n Main medical devices containing PFAS are listed below. Each mentioned sub-use will be discussed in more detail in the section below. do Fluorinated meshes and wound treatment; Medical textiles; - Medical implants; Tubes and catheters; Coatings; n Cleaning and heat transfer: engineered fluids; io Sterilization gases; t Packaging; Electronic equipment; a Diagnostic laboratory testing; lic Metered Dose Inhalers (MDI); pre-pub Others. 31 https://ec.europa.eu/tools/eudamed/#/screen/home, date of access: 2022-12-15. 32 https://webgate.ec.europa.eu/dyna2/emdn/, date of access: 2022-12-15. 78 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Implantable medical devices Meshes, wound treatment products (bandages, surgical tapes, surgical staples), tubes and catheters are covered in separate sections. Polymers in medical implants are listed in Table A.99 in the appendix (McKeen, 2014). Polymers are used for medical implants, with PTFE being the most abundant fluoropolymer. Fluoropolymers such as PVDF and FEP are also used as biocompatible materials. Fluorinated meshes and wound treatment The most frequently used textile implants worldwide are hernia meshes. The closure of the defect is important and is one of the most common surgical procedures. More than 1 million operations are implanted every year in Europe. Porous membranes containing ePTFE e (expanded PTFE) or PVDF are used as mesh material or patches, because they reduce it adhesion, one of the possible complications in hernia reinforcement. c Also, part of medical and silicone tapes and wound dressings rely on PFPE-enabled release t liners for their function. Surgical staples leverage a PBSF surfactant as a coating to approximate skin for surgical or acute wounds. no Tubes and catheters Tubes play a role in many medical operations, such as cardiovascular, neurovascular and o peripheral blood vessel treatment, atrial fibrillation, endoscopy (pulmonary endoscopy, d colonoscopy), endometrial ablation (against abnormal menstrual bleeding) and vitreoretinal surgery. There is a growing demand for minimally invasive procedures. Especially high lubricity (smoothness) of the catheters is a desired quality in medical applications (Bates and - Campbell, 2015). Additionally, the use of catheters is a cost-effective technique compared to more invasive procedures. ion Catheter tubes are usually made of ePTFE because this provides a very smooth surface and minimizes the need to use force. There are limitations of PTFE that include low tensile t strength, wear resistance, creep resistance and radiation resistance. Therefore, FEP is a sometimes used since FEP has better impact strength and wear resistance, yet slightly higher frictional properties and lower resistance to thermal stress cracking than PTFE (Teng, 2012). lic Finally, ePTFE is sterilizable without loss of these properties. PVDF is applied in connection devices for catheters, for instance with peritoneal catheters. b Coatings u Coatings are applied in catheters, metal stents, catheter balloons, plunger stoppers, needle p shields, and membranes. Fluoropolymers are often used as coating because of their - advantageous properties. For example, PTFE limits the ability of bacteria and other infectious e agents to adhere to catheters which reduces infections. For the same reason PTFE is used as r coating on protective clothing and other textiles in the hospital environment. In some cases, p e.g. for plunger stoppers, the fluoropolymer coating prevents compounds from leaching into the drug product. Fluoroplastics (mainly elastomers) allow for protein-resistant and sterile filters, tubings, Orings, seals and gaskets for kidney dialysis machines, and immuno-diagnostic instruments. PFAS coatings, mainy polymeric PFAS, can be successfully deposited on many different types of surfaces, including metals, plastics and elastomers. Specific deposition applications include hypodermic needles, surgical and cutting blades, blood bags, filters and PVC tubing. Metered dose inhalers are made of an aluminium casing with a fluorinated coating, to prevent interaction of the medical ingredient with the casing. A way of coating of aluminium metered 79 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) dose inhalers is done with a polymer layer of PFA or FEP. The main coatings mentioned during the CfE are listed in Table A.100. Cleaning and heat transfer: engineered fluids For cleaning and heat transfer, so-called engineered fluids are often used. Engineered fluids is a term used for fluorinated fluids. These fluids are used in applications such as electronics, cooling, heating, testing, as well as chip technology. Engineered fluids are also used in medical devices. Perfluorinated engineered fluids can be used to deposit a wide variety of coatings, including silicone, PTFE and heparin. These coatings can be deposited on many different types of surfaces, including metals, plastics and elastomers. Specific deposition applications include hypodermic needles, surgical and cutting blades, blood bags, filters and PVC tubing. e Engineered fluids are also applied as solvents during chemical reactions, as inert media, and it in microfluidic applications. c Sterilization gases t Ethylene oxide can be used as a sterilant either alone or diluted with other gases to make o non-flammable mixtures. A mixture of 12 per cent by weight ethylene oxide and 88 per cent n chlorofluorocarbon-12 (CFC-12) (12/88) had previously been widely used for this purpose. Hydrochlorofluorocarbons (HCFCs) were introduced as drop-in replacement for ethylene o oxide/CFC-12 mixtures but have been phased out in Europe, because of the Montreal Protocol d legislation. Packaging - PFAS, especially fluoropolymers, are widely used in medical packaging applications. Packaging n components like ampoules, single and multi-dose containers, bottles (also in caps and io actuators), cartridges; pressurized containers, syringes and vials are known to (partly) contain PFAS, especially fluoropolymers. at Liquid drug products for injection (e.g., vials, prefilled syringes) are packed in closed container systems. These types of packaging are mostly a combination of glass (vial, barrel) and lic elastomers (stoppers, plungers, seals). Because of the extended period of contact between the drug product and packaging, elastomer extractables could leach into the drug product, potentially affecting the product safety. ETFE or PTFE coated elastomeric components are b often used to minimize interaction between the drug and the packaging. As this kind of u packaging is in direct contact with the drug product, they are part of the drug product registration. -p PTFE is also used in ophthalmic solutions packaging. It acts as hydrophobic membrane in e certain ophthalmic solutions' packaging, allowing the venting of air, while retaining fluid within r the container, preventing leakage. In blister packaging also fluoropolymers are applied33. And p packaging of operating tools can contain fluoropolymers as well. Over-the-counter pharmaceuticals and animal health packaging often contains PCTFE. PCTFE has high moisture barrier when compared to other extrudable thermoplastic films, which makes PTFE coatings popular in packaging materials. For many medical devices specific packaging materials are used which are permeable for ethylene oxide. Ethylene oxide is only permitted for sterilization of medical devices. Shelf-life studies (and possible sterilisation process) need to be performed before an authorization is 33 For instance https://www.nichrome.com/blog/importance-of-blister-packaging-in-the-pharmaindustry/ or https://www.pharmaceutical-technology.com/contractors/packaging/tekni/, date of access for both: 2022-12-15. 80 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) granted. Electronic equipment Although electronics is a separate use section, it should be noted that numerous electric medical devices such as scanners, screens etc. qualify as electronic devices. In electronics, PFAS is mainly applied in cables and wires, printed circuit boards and in (LCD) screens. See for more details the Electronics and Energy section A.3.12. Diagnostic laboratory testing Examples where PFASs are used in laboratory equipment include precision refrigeration (blood bank refrigerator, vaccine storage), ultra-low temperature freezers or cryogenic storage, refrigerated centrifuges for sample separation, process chillers for precise temperature control e and freeze-drying equipment. PFASs are also used in in vitro diagnostic devices. See Table it A.101 in the appendix for additional information on main applications in this area. c Vision applications - contact lenses and ophthalmic lenses t For ophthalmic lenses, PFAS-based coatings are applied to lenses which make them easy to o clean, hydrophobic, oleophobic and scratch resistant. These coatings are industry standard, n and customers expect this performance from their spectacles. Rigid gas permeable contact lenses rely on PFAS currently and typically use o fluoromethylacrylates. Major suppliers of the blanks for rigid gas permeable contact lenses d are based outside the EU and supply the blanks (referred to as buttons within this industry) into the EU where they are then formed into contact lenses for specific customers by EU companies. The buttons are then converted into contact lenses for two main uses: fitting sets - and prescription lenses. Prescription lenses typically may need replacement every 12 months. n Propellants in Metered Dose Inhalers (MDI) io Fluorinated gases are also applied in metered dose inhalers (MDI) where they act as a t propellant for the active pharmaceutical ingredient (API). In 1987, the Montreal Protocol was a signed and called for the elimination of CFC propellants. lic Metered-Dose Inhalers (MDIs) are typically used for the treatment of asthma and other respiratory conditions. These devices are regulated under the Aerosol Dispenser Directive. MDI, nasal sprays and nebulizers are used to administer pharmaceuticals directly into the b lungs. This enables the achievement of high active pharmaceutical ingredient concentrations, u while minimizing systemic exposure. The best-known application of MDI is the treatment of patients with COPD or asthma. Additionally, treatment of cystic fibrosis, chronic lung p infections, influenza, osteoporosis, pulmonary hypertension has been reported (Stein & Thiel, - 2017). The number of pMDI (pressured MDI) is 20 million per year (CI, Presspart). reMembranes used for venting of medical devices p Hydrophobic / oleophobic membranes based on PTFE and PET with fluorinated C6 based side chain coatings are used for (sterile) venting of several medical devices, for example cell culture devices, analytical devices, blood tube systems for dialyzer systems, tube systems for eye surgery. Others Fluoropolymers, especially PTFE, are applied in e.g., sealant (tape or monofilament/cord) and in devices such as breathing air devices, medical ventilators and oxygen supply systems. Furthermore, surgical trays, surgical tools, filters, dilator, pharmaceutical stoppers contain PFASs. PFAS are also used in contact lenses. An additional list of (minor) uses is listed in 81 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Annex B based on stakeholder feedback from the second consultation in summer 2021. In Table A.37, an overview of fluoropolymers in medical devices is given. In Table A.99 (Appendix), the PFAS polymers used in medical implants, a subcategory of medical devices, are listed in detail. Stakeholders provided several additional uses for PFASs in medical devices, these are listed in Table A.103 in the Appendix. Table A.37. Fluoropolymers used in medical devices. (Key) fluoropolymers Uses (examples) PVDF Coating: (Kynar, Solef); Packaging polyvinylidene fluoride PTFE/PFA (Teflon) Polytetrafluoroethylene/ Perfluoroalkoxy Hoses and seals As useful material: Membranes in cochlear implants Catheters Coating: Guide wires Catheters Stone catchers Polypectomy snares Anti-adhesive coating cite not ion - do ECTFE t (HALAR); a Ethylene- lic chlorotrifluoroethylene Handles Speculars Obturator bars As useful material: Multi-lumen catheter High-purity transfer line Working channels in flexible endoscopes Seals Heat shrink tubing Insulation of wires, cables and complex electronic components Coating: Electrosurgery/ monopolar and bipolar high-frequency surgery Biopsy forceps with high-frequency connection Coagulation probes Papillotomes for use in high-frequency surgery b Below, the main PFAS substance groups that are applied in medical devices are described in u more detail. p PFAAs and PFAA precursors e- Trifluoroacetic acid (TFA) is used in analytical and production processes. It is an additive to r the mobile phase in high-performance liquid chromatography applications. There are also p many ingredients that are used as TFA salt. Fluorotelomers Fluorotelomers are being used for their contamination-resistant properties in medical textiles to protect doctors, nurses and researchers against contact with microbiological contaminants, such as viruses or bacteria, for example in surgical gowns and drapes. The COVID-19 crisis has highlighted the importance of such traditional fluorotelomer applications, such as medical barrier fabrics for (COVID-19) masks, surgical gowns and drapes. Fluorotelomers are used in woven and non-woven fabrics, textiles for the treatment of patients (such as bandages, absorption mats, hernia mats) and textiles in medical applications 82 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and medical laboratories (such as filter membranes). Fluorinated gases Fluorinated gases are used in contrast agents for different imaging techniques and as propellants in metered dose inhalers (MDI). Orally inhaled CFC propellants for metered dose inhalers are exempted from the elimination of CFC propellant (Montreal Protocol ban) until medically acceptable alternatives are available. This has led to the development of HFA-propellants which are more environmentally friendly than the CFC-propellants. Currently no ozone-depleting MDI-propellants are on the market, although they still fall in the list of greenhouse gasses. There are two main propellants used in MDI: HFC-134a (in scope), and to a smaller extent e HFC-227ea (in scope). These fluorinated gases are used as propellants because they have it properties that cannot be easily found in other chemical structures. A propellant must have the right density, viscosity, temperature operating range and must be inert, in order to be c able to deliver the intended amount of active pharmaceutical ingredient to the patient. The t propellant must be non-toxic as well. HFC-134a, HFC-227ea fulfil these criteria. A less fluorinated HFC is currently under development as a propellant: HFC-152a (outside scope). no Polymeric PFASs Polymeric PFASs, like PTFE and PVDF, are used in several components of medical devices. o The applications include components, such as valves and connectors, where the specific d mechanical, chemical or biocompatibility properties of these materials are required. Most of in-body implantable tubes (e.g., probes, stents) consist of or are coated with fluoropolymers due to their bio-inertness. Fluoropolymers are the most widely applied PFAS type within - medical devices. n Fluoropolymer tubes are used in various medical operations. The tubes are mostly made of io fully consolidated, sintered PTFE tubes. PTFE (tradename Teflon) is used for instance as coating on vascular guidewires to ensure its smooth progress in the vascular system and t prevent vascular trauma and the risk of blood clots. PTFE tubings are used in instruments a dispensing easily contaminated or chemically active material. Washable parts in instruments are also often coated with PTFE to reduce the risk of cross contamination. Additionally, PTFE lic can provide anti-finger printing and anti-fouling properties. b PTFE tubes are used in working channels for endoscopes, in inner tubes for catheters and as indwelling needle tubes. Keyhole surgery, heat shrink sleeving, delivery tubes, coating of u temperature sensors, lab equipment and auto-sampling devices are further PTFE applications. p PFTE is widely applied as coating on catheters, metal stents, catheter balloons, and membranes, but also on protective clothing and other textiles in the hospital environment. e- A more permeable form of PTFE is ePTFE, which contains micropores that make it permeable r to air. Expanded PTFE is often used in the form of cord, sealing tape or tubing. ePTFE is also p used to produce a mesh-like structure for implants, which whilst being soft, strong and flexible, is also very porous. When implanted, this allows body-tissue to grow seamlessly into it, making it an excellent material for use in vascular grafts, hernia repair and other reconstructive surgery. Other fluoropolymers, such as FEP and PFA, are applied in the medical field as well. PVDF, for example, is used in filter devices. PVDF as pure material is widely used as sutures, surgical meshes in wound healing. Fluoropolymers are also used to provide stain (lipid, protein) resistance and oxygen permeability on copolymers for Rigid Gas Permeable contact lenses. Fluoroplastics are applied when high dielectric insulation is critical to the proper function of electronics that rely on high frequency signals such as defibrillators, pacemakers and CRT, 83 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PET and MRI imaging devices. PTFE, PVDF, etc. are also often used in electronic medical devices (see also section A.3.12). PFOA is used as well in electronic medical devices. In the PFOA restriction, some exemptions for medical devices (and medical textiles) are mentioned (ECHA, 2020). PTFE and PVDF are used as well in several components for analytical instruments. The applications include components, e.g., valves, tubing and connectors, where the specific mechanical, chemical, and/or biocompatibility properties of these materials are required. PTFE is also used in ophthalmic solutions. Fluoropolymers are also used as coating on the inside of pressurised metered dose inhalers (pMDI). The polymer-concentration on the pMDI is 0.05 - 0.1% w/w. Finally, fluoropolymers are also used for packaging of medical and operating tools as well as e packaging of medical drugs. For example, PTFE is used in ophthalmic solution packaging. it Good moisture barrier, bio-chemical inertness, chemical resistance, high crystal clarity (if required) and nonflammability are characteristics for the selection of these materials. c Fluoropolymers have good machineability and can be used without retrofitting packaging t machinery. Fluoropolymers used in the pharmaceutical packaging sector are subject to requirements of the EU legislation on regulation of medicinal products for human or veterinary o use (i.e., Regulation (EC) 726/2004 (EC, 2004), Directive 2001/83/EC (EC, 2001b), Directive n 2001/82/EC) (EC, 2001a). Fluoroelastomers do Fluoroelastomers form flexible polymeric materials that are particularly suitable as seals, stoppers, films, tubes, o-rings etc. - The resistance of fluoroelastomers to irradiation is an important quality in medical applications. Exposure to radiation can cause unwanted molecular cross-linking in the polymer n which affects both performance and function. io Fluoroelastomers are used in all kinds of sealing applications, particularly when high levels t of chemical resistance and durability are essential. Fluoroelastomers are used in seals and a bearings for machines and equipment for the health and medical segment as well as parts for manufacturing of medical devices. Fluoroelastomers are also used in cables and wires of lic medical equipment. b There are two very different sets of elastomer usage in medical devices, each with different technical and legal requirements. pu Elastomer usage in non-invasive medical devices and equipment Elastomers used in invasive medical procedures and implantable devices re- Perfluoropolyethers p PFPE (perfluoropolyethers) are not intended for incorporation in medical and pharmaceutical products and applications in which the product will be temporarily or permanently implanted. When the product is used for applications where the finished device is implanted into the body, no residual solvent may remain on the parts. PFPE is used as coating for ophthalmic lenses. It is also being applied in medical equipment such as phthalmoscopy. PFPE is also used in cardiovascular implants. Segregated hydrofluoroethers (HFEs) can also be used as reaction media or inert media and in microfluidics applications for medical testing applications. Segregated hydrofluoroethers (HFEs) can also be used as reaction media or inert media and in microfluidics applications for medical testing applications. Fluids are used as heat transfer agents in medical equipment and laboratory diagnostic devices, in freeze drying applications 84 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) in the manufacture of pharmaceuticals. They are used for industrial use only and are not intended for use in a medical device or drug. An overview of polymeric PFAS is given in Table A.102 as well as in Table A.105. PFAS liquids for cleaning and heat transfer fluids: engineered fluids Cleaning applications include the cleaning of metal and plastic parts, such as orthopaedic, dental and spinal implants, artificial hearts, heart valves, catheters, needles and stents. Often engineered (fluorinated) fluids are used for cleaning and rinsing. The mentioned solvents are intended for industrial use only and are not intended for use as a medical device or drug. Perfluorinated engineered fluids are replacements for n-propyl bromide, trichloroethylene (TCE), ozone-depleting solvents such as HCFC-225 and HCFC-141b, and HFCs with high global warming potential. ite For heat transfer in medical equipment (e.g., surgical lasers) and laboratory diagnostic devices other PFAS fluids like 1-methoxyheptafluoropropane and 3-ethoxyperfluoro(2- c methylhexane) are used. t An overview of to what extent specific PFASs (types) are used throughout the medical devices o industry is presented in Figure A.20. This information was provided by the members of n Spectaris (a German industry association for the high-tech business sector). An overview of other uses is mentioned in Table A.106. do 9 22 - 7 tion 16 blica 27 PTFE F-gases 37 PFAS type unkown Fluoroelastomers ECTFE PVDF Others (each <1%) u Figure A.20. Proportion of PFASs (types) applied in the medical device industry , according p to members of Spectaris (an industry association). re- A.3.10.2. Volumes p Most medical devices are authorized for EEA via imported articles containing PFAS. PFAAs and PFAA precursors Side-chain fluorinated PFAS are used as surfactants and coatings, also in medical devices. Based on stakeholder information the yearly use in EEA is > 800 tonnes (Table A.38). 85 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.38. Yearly total volume of side-chain fluorinated PFASs as surfactants and coatings in EEA. Polymer name Usage (t/y) in EEA C6-side-chain >800 fluorinated PFAS surfactants and coatings Total >800 Fluorinated gases A total approximately 33 000 tonnes (midpoint) fluorinated gases are used in industrial e processes related to medical devices like MDI's, medical lasers according to the ECHA it database. Disaggregation of the tonnage to medical devices in scope is not always possible, however. c On top of the mentioned tonnage, fluorinated gases are used in exempted uses such as t anaesthetics, contrast media and pharmaceutical use which is exempted as well (HCWH, o 2019). n Three gases are responsible for 99.9% of the medical fluorinated gases reported (based on data from ECHA search and response to the CfE). In table Table A.104 in the appendix the o greenhouse warming potential of these gases is listed as well as the importance of HFC-134a. HFC-134a is the most used gas, followed by HFC-227ea and HFE-152a (HFE-152a is outside d scope). Generic worldwide use of these three main medical gases is mentioned in (Booten et al., 2020). - The volume of fluorinated gases for metered dose inhalers (MDI's) has been estimated in n three different ways: production based on stakeholder information, ECHA database information, and MDI sales data / a report of Health Care Without Harm (HCWH, 2019). io Volumes ranged between: t 6 000 t/y (stakeholders); lica 400 t/y (HCWH and MDI sales data); 15 000 - > 30 000 t/y (ECHA volumes, including volumes for export: amongst others b HFC-134a: 12 000-20 000 t/y, HFC-227ea >3 000 t/y and HFC-152a 650- 6 500 t/y. All numbers including production for export). u Stakeholder information (6 000 t/y) was used for impact assessment. -p Polymeric PFASs re Based on the response of the sector to the CfE, a volume between 3 200 - 12 000 t/y (midpoint p 8 500 t/y) was calculated. Table A.39 lists the volume of individual polymeric PFASs. In some case the volumes are not reported or reported as sum of a variety of polymers. 86 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.39. Overview of usage and/or production volumes of polymeric PFASs. Also mentioned in Table A.40. Polymer name Usage (t/y) in EEA PTFEa 1 300-10 000 FEP >200 PVDF 10-100 PFA 23-32 others incl. lumped 1 700 Total 3 233 - 12 032 a For medical masks, one producer mentioned 13 t/y for the EEA market. See also the research by EPA- DK (2021). For surface protection of rubber stoppers for pharmaceutical syringes and vials, one producer mentioned 60 t/y for the EEA market. Contact lenses: 5 t/y. ite PCTFE fluoropolymers used in human and veterinary medicinal products packaging in the EU in 2015 - 2020 were considered by stakeholders in average to be around 1 000 t/y. pre-publication - do not c In Table A.40, an overview of all PFAS volumes in medical devices is presented. 87 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.40. Yearly total PFAS volume in EEA per main medical use category. PFAAs and PFAA Fluorinated gases precursors (t/y) (t/y) Low Midpoint High Low Midpoint High Propellants in MDI 160 3 080 6 000* Fluorinated gases used in industrial processes related 2 2 2 20 000 30 000 40 000 to medical application (For instance medical lasers) Other applications e.g. heat 477 1 585 2 692 Coatings and surfactants in 800 800 800 medical devices Total for all medical device uses categories 1 279 2 387 pre-publication - *: Estimate confirmed by stakeholder. 3 495 20 160 33 080 46 000 Polymeric PFAS (t/y) ite Low Midpoint High not c 3 233 do3 233 7 633 12 032 12 032 Total PFASs (t/y) Low Midpoint 160 3 080 20 002 30 001 477 4 033 1 585 8 433 24 672 43 100 High 6 000 40 002 2 693 12 832 61 527 88 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.10.3. Summary Because of PFAS properties (bio-inertness, flexibility, resistance to various solvents, ability to withstand aggressive sterilization procedures, chemical and temperature resistance, etc.), PFAS is broadly applied in medical devices. PFASs found in medical devices are fluorinated gases and fluoropolymers. Fluoropolymers can be found in the following applications, ranging from invasive products like implants, tubes and valves to non-invasive products like medical textiles, meshes and surfactants. Fluorinated gases can be found in the following applications, from MDI propellant use to use in medical lasers and heat transfer agents. The medical technology sector is a highly complex sector, with multi-tiered global supply chains that may comprise six or more layers of suppliers. This leads to a large degree of e uncertainty when reporting PFAS use volumes, and likely to an underestimation of the total it tonnage. Especially for PFASs used in the production of medical devices, in engineered fluids, in vitro diagnostic products, and analytical equipment, volume data is lacking. PFAS volumes c are significant, especially for polymers and fluorinated gases. With the current available pre-publication - do not information, annual use is estimated at 25 000 - 62 000 tonnes. 89 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.11. Transport A.3.11.1. Uses Products and articles used in the transportation sector containing PFAS are very diverse. The transportation sector encompasses the sub-sectors automotive, maritime, aviation, and railway. The PFAS containing products and articles in the transportation sector are divided into subgroups according to their application and are presented in Table A.41. Table A.41. Overview Transportation subgroup Body-, hull-, and fuselage construction of uses of PFASs in the transportation sector. Examples ite PFASs and especially polymeric PFASs are important for body-, hull-, and fuselage construction e.g., as industrial feedstock or as functional c chemicals. Examples are: Release film for mould components for the manufacture of plastic t parts (e.g., PTFE, ETFE). o Surface tension modifiers in plating processes during the body-, n hull-, or fuselage construction (minimizing the generation of Sealing applicationsa lication - do Combustion engine b system pre-pu Lubricantsa chromium mists). Polymeric PFASs (e.g.,fluoroelastomers such as FKM or fluoropolymers such as PTFE) are used to produce seals for various parts of transportation vehicles. Most of these parts belong to the propulsion system. Sealing applications with polymeric PFASs (e.g., PTFE) is likely the largest subgroup of PFASs applications in transportation: 60% or more of the fluoroelastomers produced are used in sealing applications in the transportation sector (information received by stakeholder). Examples are: O-rings. Seals in valves and gaskets. Shaft or piston seals. Seals for electronic devices such as NOX- and oxygen sensors in the exhaust monitoring. Seals for battery electrodes in Li-Ion or dry cell batteries. Most of the PFAS applications in combustion engine systems fall into the subgroup of sealing and coating applications. However, there are some special applications that are not covered under these subgroups e.g., non-woven textiles covering the engine bay area as acoustic insulation inside the vehicle engine compartment (treated with low molecular PFASs as well as with polymeric PFASs to achieve oil repellence and high temperature resistance and make them nonflammable). Lubricants based on polymeric PFASs (e.g., PTFE, PFPE) are used in transportation vehicles, mainly to reduce friction in a wide range of applications and over a wide range of temperatures. Examples are: Bearings. Chain guide in automotive engines. Bushings (e.g., engine mount bush, stabilizer bush). Fill-for-life lubricant in small gearboxes, actuators, or hydraulic cylinders (e.g., clutch systems). Electric and thermal protection of connectors in electronic systems. Weather strips. 90 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Transportation - Examples subgroup Sunroof guiderail. Hydraulic fluids PFASs are used in hydraulic fluids e.g., as corrosion inhibitors. Examples are: Steering systems. Brake systems. Systems for lifting and lowering of vehicle parts or cargo. Electrical engineering PFASs play an important role in all electrical engineering and and information information technology in the transportation sector as they are an technologyb integral part of the manufacturing processes for semiconductors and pre-publication - do not cite Coating and finishes in some cases also of the semiconductor itself. Examples are: Computer-based systems e.g., control systems, telecommunication, safety systems. Data transmission: Optical fibres made of fluoropolymers are used for data transmission where electromagnetic interference is a concern. The fluoropolymer serves as a low refractive index layer. Batteries: Fluorinated polymer seals are used (see sealing applications). Often PVDF is used for such purposes. Fluorinated gases are used in HVACR-systems to cool down/heat traction batteries of electric vehicles. Polymeric PFASs are used as coating for the separator film in Li-Ion batteries. Fuel cells: Perfluoropolymeric Sulfonyl Fluoride Ionomers act as a binder and proton conductor in the catalyst layers in fuel cells. PTFE is part of the gas diffusion layer and controls the hydrophobicity of the components, which in turn regulates the water management of a fuel cell. Other electricity-based processes specific to the transportation sector (e.g. disinfection of ballast water using UV-radiation). Polymeric PFASs are used in the transportation sector for coating applications e.g., PTFE, ETFE, PFA, or FEVE. Examples are: Coating of cables in the selective catalytic reduction system for diesel engines (ad blue). Coating of diesel and gasoline particle filter hoses. Turbo charger hoses and coolant lines, engine coolant lines and oil cooler lines. UV-stable coatings (e.g., paint protection for transportation vehicles for cosmetic and protective reasons e.g., FEVE is used as coating for car wrappings). Coating of insulation materials to lower their thermal conductivity resulting in better insulating properties. Glass surface treatment with fluoroalkylsilanes for non-stick properties to achieve permanent water and stain repellence and thus improve the visibility for the vehicle operator in bad weather conditions; small use but expected to increase; no alternatives available. High abrasion resistance in windshield wipers or brake pads. Use of polymeric PFASs for the coating of trim materials of transportation vehicles to achieve stain protection and give surfaces a valuable feel and look. Use in the treatment of textiles e.g. for seats, carpets, roof linings, to give the textiles water and dirt repellent properties (for the treatment of textiles usually side-chain fluorinated polymers are applied)c. Anti-fouling coatings on ship hull can contain PFASs to increase their stability as well as hydrophobic properties. HVACR-systems in PFASs are used in the functional fluids of heating, ventilation, air 91 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Transportation - Examples subgroup transportation conditioning and refrigeration (HVACR)-systems. Examples for the vehiclesd different applications for such functional fluids are: Use of fluorinated gases in the various HVACR-systems in transport vehicles for passenger cabin air conditioning or transport refrigeration. Special heat transfer fluids (e.g. Methoxyheptafluoropropanes) for the immersion-cooling/heating of electronic equipment. Use as cleaning fluids. Use as blowing-agents. Lifesaving and fire Airbags. protection Seatbelts (retractor mechanism only). Life jackets. e Life raft. it Other uses related to There are a few transportation-related applications of PFASs which do transportation not fall into one of the previous subgroups, or for which information c on the application is not sufficient to allocate them to one of the subgroups. Examples are: t Reflective and protective coatings for traffic signs / roads o o Surface-treated pavement marking tapes and beaded retroreflective sheeting (used for driver and pedestrian n safety). o ETFE film is used as an anti-graffiti overlay for traffic o signage. d Adhesive tape as paint replacements (e.g. for marking of aircrafts). The product provides a chemical resistant surface for the aircraft, as well as reducing the aircraft's surface energy. - Flotation fluids in gyroscopes (mainly used in aircrafts ("artificial horizon") but also in trains (inclination sensors), and road vehicles n (navigation system and control systems). io Wheel weights: Acrylic foam tape; PFASs are used as stabilising agent in production of tape layer, which is used to affix the weight t to the wheel surface. A fluoropolymer incorporated in the weight a provides weatherability and reduces the potential of the weight to liccorrode. Cover sheets for new vehicles a Also covered in section A.3.15 on lubricants b b Also covered in section A.3.12 on electronics u c Also covered in section A.3.3 on textiles d Also covered in section A.3.9 on HVACR -p Body-, hull-, and fuselage construction e PFAS containing products, especially polymeric PFASs are known on the one hand for their r long-life and durability and, on the other hand for their flexibility and stability at low weight. p Polymeric PFASs show high performance over a wide range of harsh operating conditions like heat, cold, chemicals or radiation. Many fluoropolymers prevent the propagation of flames or the generation of smoke. Above that, several of these polymers are non-flammable. Additionally, PFASs can alter the properties of surfaces due to their amphiphilic nature. They can, e.g. act as surfactants. In plating processes PFASs are therefore used to minimize the generation of chromium mists (see also A.3.5 Metal plating). Due to the properties describe above, fluoropolymers are important industrial consumables for body, hull-, and fuselage construction. PFAS based surface tension modifiers are used in plating processes during the body-, hull-, 92 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) or fuselage construction. Furthermore, polymeric PFASs (e.g., PTFE, ETFE) are used as release film for mould components from the manufacture of plastic parts. Membrane textiles are used in mould-injection processes of carbon fibre composite parts due to their good release properties. Polymeric PFASs are also used as sound absorbers in a craft body. In aerospace, strips of PTFE are used to improve the wear resistance of moving parts as well as miscellaneous fixation of parts for internal or external hull. In automotive vehicles some exterior parts are fixed with tape that contains 0.1-1% PFASs to gain heat, weather and general wear resistance as well as increased flexibility (stakeholder information). In planes, the sidewalls often contain PFASs (because of hygienic reasons). The same applies for the overhead bins. Sealing applications e 60% or more of the fluorelastomers (e.g., FKM) produced are used in sealing applications in it the transportation sector (stakeholder information). Polymeric PFASs are used in sealing applications because of the following properties: t c Durability against aggressive chemicals e.g., lubricants, fuels, electrolytes, cooling agents and other fluids. o Good sealing properties (avoidance of permeation, impermeability to gases) over a n wide range of temperatures and under influence of aggressive chemicals. Good compression stress resistance over a wide range of temperatures and under influence of aggressive chemicals. do The main function of seals in transportation crafts is to protect parts from dust and aggressive chemicals (e.g., lubricants, fuels, electrolytes) thus ensuring functionality and reducing service intervals. Another function of seals is to prevent leakage (e.g., in fuel injectors) which - results also in an emission reduction. n O-rings made from polymeric PFASs are the most common product used for sealing. io Depending on the application, specially formed polymeric PFASs are used. Polymeric PFASs are used as seals in valves and gaskets, as shaft or piston seals, as seals for electronic devices t such as NOX- and oxygen sensors in the exhaust monitoring, or as seals for battery electrodes a in Li-Ion or dry cell batteries. lic The PFAS content which is necessary to fulfil the desired function depends on the material which is used and the application. In the consultation, stakeholders provided numbers ranging b from 60% (in case of FKM use) to up to 70 - 100% (in case of PTFE use). u Combustion engine system -p Currently, combustion engines in all transportation sectors are based on combustion of either fuel, diesel or natural gas. In the future, more systems using alternative fuels like hydrogen e or electric propulsion systems can be expected. pr In the core engine, as well as in the exhaust system, heat and pressure conditions are extreme. In addition, petrol-based fuels and partially also exhaust gases are aggressive and corrosive chemicals. So, the fuel system with storage tanks and fuel hoses, or turbo charger hoses, as well as seals and valves have to be protected from destruction by fuels. PFAS containing materials are robust materials which are resistant against heat, pressure and corrosive chemicals and also have a low friction coefficient. Further, these materials are much lighter than e.g., metal-based materials. Therefore, PFASs are used in large quantities in combustion engine systems. The main use of PFAS containing materials in combustion engines are in sealing and coating applications. Non-woven textiles are applied as cover in the engine bay area of many vehicles as acoustic insulation inside the vehicle engine compartment. They are treated with PFASs for oil repellence and high temperature resistance 93 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) and make them non-flammable. PTFE is used to produce mono-wall tubes and hoses (not coatings) for applications like turbo chargers, exhaust gas recirculation, diesel particulate filters, or the engine brake. Guides for pistons and piston rods are also made of PTFE. FFKM are used in numerous gas turbine engines for aircrafts to achieve higher engine efficiency as it allows the use of high thermal stability oils which in turn allow for higher engine temperatures lowering fuel emissions (Thomas, 2003). Lubricants The use of PFASs in lubricants is described in the section below. e Hydraulic fluids it There is not much information available on PFASs in hydraulic fluids. One stakeholder c mentioned that PFASs are used as anti-erosion agent which is added to the hydraulic fluid. t The anti-erosion agent contains several fluorinated cyclohexanes and trace amounts of unidentified residual fluorochemicals (most likely a by-product of the manufacturing process). o The anti-erosion agent is added to address in-services issues. This information specifically n focused on hydraulic fluids in aerospace, but this might also be valid for other sectors of transportation. o Hydraulic fluids are used in the transportation sector in steering systems, brake systems or d other special applications such as systems for lifting and lowering of vehicle parts or cargo. Applications in the aerospace sector include: - Aircraft flight control systems, actuators for flying surfaces. Aircraft landing gear. n Actuators in defence systems. These include, but are not limited to steering io mechanisms, munitions loading systems, turrets. t It is unclear if all hydraulic fluids in the transportation sector are fluorinated or only those for a specific applications. lic Electrical engineering and information technology b PFASs play an important role in all electrical engineering and information technology in the transportation sector as they are an integral part of the manufacturing processes for u semiconductors and in some cases also of the semiconductor itself. PFASs also play an p important role in batteries and fuel cells. A.3.12 The use of PFASs in electronics and semiconductors is described in section A.3.12. The use of PFASs in batteries and fuel cells is - described in section A.3.13. Only the information that is not already provided in section A.3.12 e or in section A.3.13 is included in this chapter. pr PTFE based printed circuit boards are used in the automotive sector to create patch antennas for 77 GhZ automotive radar sensors which are used for different safety applications such as distance sensors or blind spot detection. This application is potentially relevant also for other transportation sectors. A fluorinated functional fluid is used as dielectric fluid in traction enclosures for the rolling stock of trams to cool high voltage electronic components e.g., traction insulated gate bipolar transistors. Currently, HFC are used for this application, but it is expected that there will be a switch to HFO or Hydrofluoroethers (HFE) like Opteon or other PFAS fluids. To disinfect ballast water, ships are equipped with a ballast water treatment reactor that is usually installed in the engine room. The ballast water treatment reactor uses UV-radiation. 94 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) In the process of generating UV-radiation, electrostatic charge of parts of the reactor may occur which may cause fires. In addition, UV radiation leads to an enforced erosion especially of polymers. From the sea water entering the UV reactor, most water sediments have to be removed. Therefore, an upstream A filter cascade is an essential part of a ballast water treatment system to prevent corrosion of components. To prevent fires and erosion, polymeric PFASs that are heat resistant, prevent electrostatic charges and are inert against erosion by UV radiation and, when in contact with water, resistant against saltwater are used. Therefore, polymeric PFASs are required for a save and reliable operation of many devices installed on board a ship, like ballast water treatment systems. Coating and finishes Polymeric PFASs are used in coating applications in the transportation sector because of their good performance over a wide range of temperatures (anti crack resistance and low e volumetric expansion), abrasion resistance, fire resistance and resistance to aggressive it chemicals as well as their hydrophobic and anti-fouling properties. In some special coating applications, polymeric PFASs are used because of their dielectric properties, low thermal c conductivity, non-stick properties and UV-stability. Use of polymeric PFASs as coating of t cables in the selective catalytic reduction system for diesel engines (ad blue, a fuel additive) or coating of diesel and gasoline particle filter hoses helps diesel exhaust emission reduction. o In aerospace turbine engines, PTFE fibres in fan blade wear strips enhance low friction n performance, thus increasing engine efficiency, with consequential reductions in fuel consumption and emissions. Insulation materials are coated with polymeric PFASs to lower their thermal conductivity resulting in better insulating properties do Different polymeric PFASs are used in the transportation sector for coating applications including PTFE, ETFE, PFA, or FEVE. - Fluorinated polymer coatings are used to achieve heat resistance, and resistance to aggressive chemicals in all kinds of engine hoses, like turbo charger hoses and coolant lines, n engine coolant lines, brake hoses, or oil cooler lines. io UV-stable coatings are used to protect paint of transportation vehicles. An example includes t the use of FEVE as coating for car wrappings. Fluorinated polymer coatings are also used as a automobile brightness enhancement film or matte films to achieve good coating quality and to enhance appearance. Other trim materials in transportation vehicles are coated with lic polymeric PFASs to enhance appearance. In convertibles, a coating, containing PFASs, on the convertible top, provides repellence against dry soil and against the impact of cleaning agents b like white spirit, as well as a dynamic rain repellence. u PTFE, ETFE or PFA are used for lubrication free bearings to achieve a low friction in p combination with low stiffness and high temperature resistance. Such bearings are used in various places in transportation vehicles e.g., in ball joints, belt tensioners, decoupled pulleys, - dual mass flywheels, solenoid valves, clutch release, steering torque sensors, seat height e adjustment, pedal work, seat folding mechanism, headrest height adjustment and centre r console lid. p Insulation materials are coated with polymeric PFASs to lower their thermal conductivity resulting in better insulating properties. Glass surfaces are treated with fluoroalkylsilanes or PFPE (functionalized PFPE e.g. silanes or acrylates) to achieve permanent water and stain repellence and thus improve visibility. The fluoroalkylsilanes polymerizes to siloxanes with polyfluoroalkyl side e-chains. The siloxane backbone will form covalent bond with glass (ECHA, 2017). The surface of exterior sensors or cameras can be coated with PFPE to achieve durable antifouling of the surface. In some cases, PFPE is also used because of its low refractive index. 95 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) In windshield wipers coatings are used to achieve high abrasion resistance. Polymeric PFASs used as coating on brake pads provide better brake efficiency and help absorb pressure, compared to non-fluorinated brake pad coatings. In high voltage insulators, which are in direct contact with the carbon strip of the pantographs (the power pickups for overhead lines on locomotives) coatings are also used. The pantographs are exposed to high electric fields, rain, contaminants, electric arcs and mechanical constraints, temperature changes and sun radiation. They must be self-cleaning to avoid getting electrically conductive. For heavy machinery, PTFE wax is used to coat parts which need a high abrasion resistance (e.g., containers, excavators). In the interior of transportation vehicles, polymeric PFASs are used for the coating of trim materials to achieve stain protection and give surfaces an expensive feel and look. PFASs are used to provide water and dirt repellence to textiles used in the interiors of transportation vehicles e.g., seats, carpets and roof linings. Generally, side-chain fluorinated polymers are e applied. Apart from water and dirt repellence, PFASs also improve safety because of their fireit protective properties of fluoropolymers. c Anti-fouling coatings on ship hull can contain PFASs to increase their stability and to give t them more hydrophobic properties (Glge et al., 2020). o PFASs are used in reflective and protective coatings for traffic signs and roads. Examples n include surface-treated pavement marking tapes and beaded retroreflective sheets which are applied for driver and pedestrian safety. ETFE films are used as an anti-graffiti overlay for traffic signage. Machinery, that is used in the production of tyres, is partly coated with o polymeric PFASs (e.g., the curing mould) because of non-stick properties. d The PFAS content which is needed to achieve the desired function depends on the material to which the coating is applied. Stakeholders estimate a range from 1% (PTFE waxes), < 5% - (windshield coatings to achieve water repellence) - 100%. n HVACR-systems in transportation vehicles io HVACR-systems are used to control the ambient conditions of various compartments of t transport vehicles. Examples are the air-conditioning (AC) system to cool/heat the passenger a cabin of a car for personal comfort and to minimise accidents due to heat-fatigue. Furthermore, filters of the AC-system ensure that the air which arrives in the passenger cabin lic is free from particulate matter. Larger refrigeration systems are necessary to transport cooled and frozen produce. Furthermore, fluorinated gases are used as heat-exchange media in b systems to cool down or heat batteries in electric vehicles because of their dielectric properties. This may also be applicable to electric vehicle charging stations and charging u cables. p The use of PFASs in HVACR is included in section A.3.9. e- High Efficiency Particulate Air (HEPA) filters for AC-systems are produced using PTFE. r According to stakeholder information, PTFE is needed to manufacture filters with p microstructures which are necessary for the filter to meet the set requirements. HEPA filters are commonly used for aeroplane AC-systems but are also increasingly used in road transport vehicles. Lifesaving and fire protection PFASs provide important functions to lifesaving and fire protection systems in all kinds of transportation vehicles due to their specific properties which are outlined in the chapters above. Most of the applications of PFASs in lifesaving and fire protection systems are covered under the respective chapters for coatings and finishes and sealing applications. PFASs are used in: 96 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Life jackets. Life rafts. Airbag systems (likely the housing, airbag material). Seatbelts (retractor mechanism only). Fluoropolymer insulation on the cables of brake wear sensors, in collision prevention or adaptive cruise control systems. Fluoropolymer tubing in ABS. Emergency ventilation blowers in tunnels. The products mentioned are often made of durable age-resistant polyamid fabrics34. By incorporation of trifluoromethyl groups into the backbone or as side-chain of polyamides, an increased thermal and mechanical stability as well as a low friction coefficient of the polymers e are achieved (Zhou et al., 2019). The low friction coefficient and the age-resistance are it required for save operations in case of accidents. Additionally, a high temperature resistance is needed in some cases as the systems are required to work reliably also in case of fires. t c PFASs are used as flame retardants and anti-dripping additives in polymers e.g., in interiors of transportation vehicles. no 2-Bromo-3,3,3-trifluoro-1-propene (2-BTP) is used in hand-held fire extinguishers in aircrafts or in fire extinguishers for protection of critical infrastructure such as national defence systems or power grid and power generation (see also A.3.9). The fire primarily is extinguished by o increasing the heat capacity of the atmosphere, extracting heat from the flame, thus lowering d the flame temperature to the point of extinction. The fluorinated gas is non-conductive and chemically inert and thus suitable to extinguish fires of electronic components. - Other uses related to transportation n Adhesive PTFE based tape serves as a substitute for paints e.g., for marking of aircrafts. The io products provide a chemically resistant surface for the aircraft and reduce the aircraft's surface energy. at PFASs are also used in flotation fluids in gyroscopes. These are mainly used in aircrafts to provide a "artificial horizon" but also in trains (inclination sensors), and road vehicles lic (navigation system and control systems). The function of PFASs in these flotation fluids is unclear. b In wheel weights, which are used to balance wheels of transportation vehicles, a (acrylic foam u tape layer is used to affix the weight to the wheel surface. Furthermore, a fluoropolymer p incorporated into in the weight provides weatherability and reduces the potential of the weight to corrode. e- Sealing and lubrication applications play an important role in the transportation of fuel rods r for nuclear power plants, according to stakeholder information. But no specific information p was provided. PFASs are also used in cover sheets for new vehicles. No stakeholder information for this specific use was provided but considering the large numbers (> 15 000 000) of yearly manufactured road vehicles (ACEA, 2020). 34 https://www.hella.com/techworld/de/Technik/Elektrik-Elektronik/Airbag-System-3083/, date of access: 2021-11-24. 97 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.11.2. Volumes Table A.42 provides an overview of the different PFASs used in the transportation sector, their applications and (where available) the volumes used. All numbers presented refer to the EEA, unless stated otherwise. A detailed explanation of the origin of the volumes presented is provided after Table A.42. Table A.42. PFASs used in the transportation sector. All numbers presented refer to the EEA, unless stated otherwise. PFASs Volumes used in transportation Source sector (t/y)a Polymeric PFASs e.g., PTFE, ETFE, PFPE, PFA, e FEVE, FKM cit Side-chain fluorinated t polymers o e.g., C6-SCFP o n Ionomers e.g., perfluoropolymeric sulfonyl d fluoride Fluoroalkylsilanes - PFASs in HVACR applicationsb n e.g., R1234yf io (tetrafluoropropene), R134a (1,1,1,2-tetrafluoroethane), R- t 407C [blend of R-32 a (difluoromethane), R-125 (pentafluoroethane), and R134a lic (1,1,1,2-tetrafluoroethane)], 1- methoxyheptafluoropropane b 2-BTP -pu Low molecular C6 telomer pre substances Stock volume: in EEA registered road vehicles: 97 216 and 222 208a t Yearly volume: used in newly manufactured road vehicles: 6 410 - 14 653 t Volume unknown. Used for impregnating textiles and to equip non-woven textiles for different applications like wheel arch liners and sound and dash insulators to reduce noise, vibration and harshness. Volume unknown. Used in electronics (e.g., LED or in fuel cells) Stakeholder information + calculation by the Dossier Submitters Stakeholder information Stakeholder information Yearly volume: < 1 Yearly volume: ca. 12 222 in EEA in newly manufactured road vehicles for passenger comfort Yearly volume: ca. 1 010 filled into newly manufactured products for transport refrigeration Stakeholder information Stakeholder information, publicly available information and calculations by the Dossier Submitters based on this information Yearly volume: 10 - 100 in handheld fire extinguishers in aircrafts Yearly volume: 100 - 1 000 t/y for initial technical textile finishing (unclear if this figure only relates to textiles used in transportation Stakeholder information Stakeholder information applications) a Note that PlasticsEurope mentions 15 500 - 18 500 tonnes for the transport sector (not only cars; 2020 and 2015 figures resp.). Fluoropolymer Market update (Wood, 2022). b Volumes in the transport sector are not used for environmental or socio-economic impact assessment. A general impact assessment for all PFAS in HVACR applications in all sectors has been made. Low molecular C6 telomer substances Low molecular C6 telomer substances are used for a for initial technical textile finishing in an amount of 100 - 1 000 t/y. It remains unclear if this figure only relates to textiles used in transportation applications or if it is a general figure for the treatment of textiles. 98 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Side-chain fluorinated polymers According to stakeholder information side-chain fluorinated polymers are used for impregnating textiles and to equip non-woven textiles for different applications like in wheel arch linters and sound and dash insulators to reduce noise, vibration and harshness. A different stakeholder provided input that 10 - 100 t/y of C6-SCFP are used for this application in the EEA. PFAS in HVACR systems HVACR-systems According to stakeholder information the following amounts of PFAS containing heat exchange media are used in the HVACR-systems of road vehicles to cool/heat the passenger cabins: ite Ca. 0.6 kg / personal vehicle; Ca 1 kg / unit per truck; c Ca 6 kg / unit per bus. t In 2019, 15 769 041 passenger vehicles were manufactured and registered in the EU (ACEA, o 2020). For trucks and busses, the number of newly registered vehicles was used as proxy for n newly manufactured vehicles. In 2019, 2 503 992 new trucks (sum of light and heavy commercial vehicles) and 42 838 new busses were registered in the EU (ACEA, 2020). This amounts to a total number of newly registered vehicles of 18 315 844. Using the information o on the amount of PFASs per vehicle, the total annual volume of PFASs in HVACR-systems of d road vehicles amount to 12 222 tonnes. Approximately 1 010 t/y is filled into newly manufactured HVACR-systems for transport - refrigeration (stakeholder information), see also A.3.9.2. n PFASs in life saving and fire protection systems io One stakeholder provided information on the use of 2-BTP in hand-held fire-extinguishers in t aircrafts. According to this information 10 - 100 t/y are sold for this application in the EEA. a Polymeric PFASs lic According to stakeholders, in 2018, 65 000 tonnes of polymeric PFASs were sold worldwide in the automotive sector. Using the number of vehicles produced worldwide in 2019 (79 095 b 10435), this results in approximately 800 g of polymeric PFASs per vehicle. This number is in u line with "350 g of fluoropolymer per car" as was estimated by Amduri (2020). With a total amount of 277 759 682 registered vehicles in the EEA, this amounts to a stock of polymeric p PFASs of between 97216 and 222 208 tonnes in all road vehicles (cars, vans, trucks, busses) - registered in 2020 (ACEA, 2020). re Using the number of newly registered vehicles in 2019 that was used to calculate the p fluorinated gases use, a total volume of polymeric PFASs of between 6 410 and 14 653 tonnes is estimated (0). Regarding other sectors of transportation (aerospace, marine, railway) only limited information was provided. One stakeholder provided input from market research reports. One of these reports estimated that market size for fluoropolymers (without PVDF) was 12 800 tonnes for 2020 for the EMEA (Europe, Middle East and Africa) region. However, it is unclear if this figure relates to the transportation sector. Another report estimated the market 35 https://www.vda.de/de/aktuelles/zahlen-und-daten/jahreszahlen/automobilproduktion, date of access: 22.11.2021. 99 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) size of fluoroelastomers in the automotive and aerospace sector to be 5 355 t for 2020. Body-, hull-, and fuselage construction For fuselage construction in the aerospace sector information was provided that 100 - 1000 t/y are used by one stakeholder in the form of PTFE strips or miscellaneous fixation parts for internal hull. Sealing applications Stakeholders provided different estimations on the used volume in sealing applications. The total European demand for fluoroelastomers for sealing applications is in the range of 1000 - 10 000 t/y, and for PTFE it is in the range of 100 - 1 000 t/y. Another stakeholder uses 100 - 1 000 tonnes PTFE per year for sealing applications in cars. A different stakeholder uses of e 10 - 100 t/y of polymeric PFASs to produce seals for marine vessels. it Lubricants t c One stakeholder mentioned an annual use of PTFE of 1 000 - 10 000 tonnes to produce lubricants for maintenance free bearings and sliding elements. Another stakeholder used 0.1 o - 0.2 g of fluorinated lubricants "per component" in automotive applications. However, no n details were provided on the number of parts of automotive vehicles that need lubrication. Another stakeholder mentioned a European demand of 100 - 1 000 t/y of fluoropolymers for lubrication. do Electrical engineering and information technology Various stakeholders provided input on the volumes of polymeric PFASs used in electric - engineering and information technology in the transport sector. The information is summarised in Table A.43. n Table A.43. Stakeholder information on the volumes of polymeric PFASs used in electric io engineering and information technology applications. t Polymeric PFASs Range Specific application a (if specified) (t/y) (if provided) PTFE 100 - 1 000 lic FEP 100 - 1 000 PVDF 1 000 - 10 000 Energy storage in electric cars: used as binder and for the b ion-permeable separator in batteries and membranes Porous PTFE 100 - 1 000 For the ventilation of electronic components in road u vehicles (e.g., housings of electronic equipment such as p lamps) - PTFE 100 - 1 000 PTFE tape for cable electrical insulation in aircrafts e PTFE 10 - 100 Cable conduit in aircrafts r 100 - 1 000 For the ventilation of electronic components in road p vehicles (e.g., housings of electronic equipment such as lamps, control units) and for tank ventilation (e.g., fuel and urea tanks) in road vehicles Ionomers e.g., Used in ion exchange membranes (IEMs) that provide perfluoropolymeric mechanical and chemical stability while delivering high sulfonyl fluoride proton conductivity. It separates anode and cathode, but facilitates the transport of hydrogen-ions from the anode to the cathode side 100 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Coatings and finishes Various stakeholders provided input on the volumes of polymeric PFASs used for coatings and finishes. The information is summarised in Table A.44. Table A.44. Polymeric PFASs volumes used in coatings and finishes according to stakeholder information. Polymeric Range Specific application PFASs (t/y) (if provided) (if specified) PTFE 100 - 1 000 Interior coating systems for public transportation vehicles PTFE PTFE e PTFE 100 - 1 000 100 - 1 000 10 - 100 production of PTFE lined hoses Production of braking hoses Production of hoses for hydraulic fluids and fuel for aircrafts cit A.3.11.3. Summary t Because of the vast range of properties, PFASs are widely used in the transport sector. PFASs o are used in body-, hull and fuselage construction; sealing applications and lubricants; fuel engine systems; hydraulic fluids; electrical engineering and information technology; coatings n and finishes; HVACR-systems and lifesaving and fire protection. Stakeholders estimate a stock of polymeric PFASs in the automotive subsector of 100 000 tonnes (rounded number) and an o annual volume of between 6 000 and 14 500 tonnes (rounded numbers). The main d fluoropolymers used are PTFE, PVDF, FEP and fluoroelastomers. For the other subsectors (besides automotive), nor for PFAA, PFAA precursors and side-chain polymers estimates could be made. Volumes of PFASs in HVACR systems amount to 12 000t/y (rounded number) in - newly manufactured vehicles and 1000 t/y (rounded number) filled into newly manufactured pre-publication products for transport refrigeration. 101 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.12. Electronics and semiconductors A.3.12.1. Uses Glge et al. (2020) identified uses of PFASs in the electronics industry and listed the main properties of PFAS. Uses and properties were confirmed by a stakeholder and additions were made by this stakeholder. Also, literature and publicly available sources were consulted. roperties of PFASs relevant to the electronics industry and those that are relevant specifically to the semiconductor industry are included in Table A.45, whereas an overview of uses in products and components, is provided in Table A.46. Table A.45. PFAS properties relevant to the electronics and semiconductor industry - Literature and publicly available sources, complemented by a stakeholder. e Industry Identified properties it Non-reactive, stable, low surface tension, non-sticking, high purity, low dielectric constant, low off-gassing, ensuring vacuum environment, low c dissipation factor, ultra- thin, resistant to oil, resistant to water, resistant to t Electronics sulphur, high volume/surface resistivity, high dielectric breakdown strength, piezoelectric and pyroelectric properties, dipoles, hydrophobic, good solubility o in polymers, optically clear, low loss insulation, flame resistance, thermal n stability, low refractive indices, good heat conductivity, good evaporative cooling, acidic, insulation. Heat resistance, low dielectric constant, clearness, plasma resistance, high o photosensitivity, ability to generate acids, low surface tension, Marangoni d Semiconductor effect, low refractive index, acidic, non-reactive, stable, non-corrosive, temperature uniformity, generation for reactive oxygen/fluoride species, - chemical resistance, high purity, anti-adhesion, insulation, barrier properties, thermal stability. ion Table A.46. Uses in electronic products and components (including semiconductors) - Literature and publicly available sources, complemented by a stakeholder. t Product / component Used as/for a Wires and cables Insulator lic Printed Circuit Boards Fibre reinforced layer, coating Flat panel displays Reduce static electricity build-up, reduce dust attraction b Multilayer circuit board Bonding ply composition u Capacitators Separation of high voltage components Polymer optical fibres Transparency, flexibility, low refractive index p LCD Provide liquid crystal with dipole moment, moisture - sensitive coating e Tactile sensor r Gauge wire p Audio transducers Piezoelectric panels Electroluminescent lamps Coating Razors Friction reduction Acoustical equipment Provide electrical signal 5 G communication equipment Semiconductor, photoresist matrix Change solubility when exposed to light Semiconductor, wafers Wafer thinning, non-stick coating on carrier wafer Semiconductor Antireflective coating 102 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PFASs are not only used in electronic products and components to enhance their functionality, but also in the production process of those products or components. Here, the latter is divided into two use categories: process chemicals (e.g., solvent, grease, deposition fluid) and production tools/equipment that are used in the process (e.g., valves, containers, tubes). Table A.47 provides an overview of the uses in the production process that were identified by Glge et al. (2020). The information was checked and complemented by a stakeholder. Table A.47. Uses of PFASs in the production process of electronics and semiconductor products and components. Complemented by a stakeholder. Used as / for Specification Industry Electronics Semiconductor Testing fluid Heat transfer fluid Solvent Additive Cleaning Sealing Wafer testing, electronics testing Submersion cooling, chemical vapour deposition Cleaning, deposition of lubricants, ultra clean seals and damping material Additive to lubricants Drying, etch cleaning, remove cured epoxy resins, remove dielectric film build up Technical equipment in contact with X X X X ite X X c X X X not X chemicals or reactive plasma Carrier fluid Dissolve lubricants. See also A.3.15 X o Fluid for lubricant See also A.3.15 X d deposition Etching Etching of piezoelectric ceramic filters, X - wetting agent, reduce reflection of etching solution, dry etching Quenching Controlling diffusion of acid X n Rinsing Removing developer X io Developing Control of development process X Working fluid X t Photosensitizer Increase Photosensitivity X a Photo acid generator Generate strong acids X lic Ultra-pure chemical Ultra-pure environment, submersion in X process chemicals b Technical equipment Ultra-pure environment X for handling, storage u and transport -p In Table A.48, an overview of the identified uses and properties of PFASs in the electronics e industry (excluding semiconductors) is provided based on input from stakeholders. In general, r the information received varied in level of detail pertaining to substance, sub-uses, p application(s) and sectors. For instance, not all substances were associated with a use or function, stakeholders sometimes listed properties of each PFAS without specifying details in application etc. Due to limited information, use categories are roughly split between electronic products and components and uses in the production process of those products or components. 103 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.48. Uses and properties of PFASs in the electronics industry identified by stakeholders. Use category Wires and cables Coating of electronic components Sub-use Heating cables, coaxial cable Membranes Properties Precise and constant transmission e Stable insulation under high it temperature conditions c Moldability Low particulation t UV-resistance Chemical / radiative resistance at o elevated temperatures n Dielectric and thermal properties Resistance to corrosion o Water and oil resistant Stress crack resistance d longevity/durability Flex life - Light weight Low density n Fire retardancy Low mechanical friction io Hydrophobic/oleophobic coating, can t also act as gas barrier so some electronic components can be in a proximity to corrosive gases, lic Adhesion to copper Anti-adhesive b Excellent dielectric performance for low signal loss u High water- and oil- repellence to p provide protective coating - Antireflective pre Low surface tension Area of use/application(s) Insulated wires and cables in electrical, energy and semiconductor applications (this includes data cable/5G, LAN cables, automotive parts, medical, sub-sea, aerospace, clean room production etc). Examples of PFASs PTFE, PFA, ETFE, FEP, FEPM, PFPE Printed circuit boards, switches, connectors, relays, resistors, capacitors, transformers, inductors, integrated circuits, display device, small motors and bearings present in electronic devices like PCs, automobile, game machine, various home applications, mechanical equipment. Touch screen coating and various electronics also in smart phones. Feedstock for plasma polymerization coatings of electronic components and devices to provide a protective nanolayer. Micro Electro-Mechanical Systems, Conformal and anti-solder coating, copper clad laminates, hard disk. PTFE, FEP and PFA, 2(perfluorohexyl)ethyl acrylate, 2-(Difluoromethoxymethyl)1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,2,2,3,3,4,4Nonafluoro-4-methoxy-butane, PFHxA 104 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Electronic components Vent filters Soundpermeable membrane Air filter Tactile switch components Printed circuit boards Properties Air permeability Water pressure resistance Liquid repellent Heat-resistant Durability Chemical resistance Weatherability Dustproof characteristic Air permeability Area of use/application(s) Examples of PFASs Vent filter for automobile electrical components such as Electronic Control e Unit, battery box, motor control substrate it case, lamps and power windows modules c etc. Vent filters for home appliances such as electric toothbrushes and washable t shavers PTFE, no Sound-permeable membrane for mobile PTFE Fluoropolymers Water pressure resistance Liquid repellent o Acoustic characteristics Particle collection efficiency d Pressure loss Durability - Repeated dust release characteristics Filtration n Chemical resistance Water resistant io Dustproof t Tensile strength a Heat-resistant Tensile strength lic Durability b Dielectric performance, Low signal loss, u Adhesion to copper and laminate p Thermal resistance - Heat conductivity Electrical insulation e Oil/water repellent r Low refractive index p Chemical resistance phones and digital cameras Air filter for vacuum cleaner / air purifier Blended into the matrix to reduce signal losses in new 5G and higher speeds, PTFE PTFE PFA Mold release 105 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Unspecified Sub-use Antennas and membranes Liquid crystal displays (LCD) Organic lightemitting diode (OLED) Optical fibres (Polymer optical fibre) Rod lenses Others Properties Reduction of dielectric loses Prevention of signal losses Water repellent Surface tension Contact angle Strong dipole No surface activity Antistatic Conductivity Area of use/application(s) Examples of PFASs Mobile phones PTFE, PFA cite Displays for computer monitors, TV's, t control units (medical device, cars), laptops, smart phones and tablets. no Surface protection. Non polymeric PFHxA. PFASs, - Displays and lights for consumers (smart phones, tablet, TV, monitor) do Low signal loss, Core and cladding. Transmission media in- - Integration friendly vehicle data communication systems, to Transmittance/low signal loss property achieve safe driving or auto-pilot system n(Advanced Driver Assistance Systems, ADAS, and self-driving cars) io - Small portable scanning printing t equipment, including barcode readers a Flame retardant Displays, touch screen, sensors, foldable Anti-fouling smartphone, scintillator panels, high lic Smoothness temperature film capacitors, Hydrophobic/oleophobic potentiometers, copy machine, cable and b fault locator. Heat-resistant Unspecified u Realisability p Dimensional stability - Tensile strength Control and Influence of e Tribological properties r Flame retardancy p Wear protection Non-polymeric PFASs , PFHxA. F-PMMA F-PMMA PTFE PFHxA, Fluoropolymers Melt behaviour 106 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Anti-drip agent Fire protection fluid Heat transfer fluids Properties Area of use/application(s) Examples of PFASs Antistatic/Antidust agent Visual effect e Low Surface tension cit pre-publication - do not - In electrical enclosures, connectors, appliances, consumer electronics (mobiles, TV, laptops, computer hardware, building and construction parts/articles, automotive batteries, equipment housing, lighting etc. In electrical substation or electrical control rooms, data centres, telecommunications switch rooms, computer control rooms, airport control towers, clean rooms, and computer-controlled manufacturing operations. Heat transfer fluids for liquid immersion cooling PTFE, 1-Propene, 1,1,2,3,3,3hexafluoro-, polymer with 1,1difluoroethene and tetrafluoroethene 1,1,1,2,2,4,5,5,5-nonafluoro4-(trifluoromethyl)-3pentanonea (Z)-1,1,1,4,4,4-Hexafluoro-2butena, Butane, 1-ethoxy1,1,2,2,3,3,4,4,4-nonafluoro-, 2,3,3,4,4-pentafluoro-5methoxy-2,5-bis[1,2,2,2tetrafluoro-1(trifluoromethyl)ethyl]tetrahyd rofuran, Perfluamine, 1,1,1,2,2,4,5,5,5-nonafluoro4-(trifluoromethyl)-3pentanone, 2-(Trifluoromethyl)-3ethoxydodecafluorohexane, Reaction mass of 1,1,2,2,3,3,4,4,4-nonafluoroN,N-bis(nonafluorobutyl)butan1-amine and 1,1,2,2,3,3,4,4,4nonafluoro-N-[1,1,2,3,3- hexafluoro-2- 107 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Sealing for electronic components Properties Temperature and chemical resistance Abrasion resistance Oil resistance - Area of use/application(s) Examples of PFASs cite Sealing for LCD, home appliance production equipment. Sealing for reducer t of industrial robot for automation. Sealing for hard disk of servers no For a variety of materials, including (trifluoromethyl)propyl]-N(1,1,2,2,3,3,4,4,4nonafluorobutyl)butan-1amine. Fluorinated gases Solvent do Aerosol/ Solvent - cleaning of electronics n components tio Lubricant lica Lubricating oilb Drying / rinsing agent Optics cleaning Particulate / ionic removal Precision cleaning Chemical resistance Heat resistance Cleanliness ub Lubricant p depositionb re- a Covered in section A.3.9 on fluorinated gases p b Covered in section A.3.15 on lubricants lubricants, coatings, silicones, and in industrial cleaning formulations. Solvent to post process 3D printed articles Hard disk drives Various electronic applications Fluorinated gasesa 2-(Difluoromethoxymethyl)1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,2,2,3,4,5,5,5-decafluoro3-methoxy-4(trifluoromethyl)pentane PTFE, PFA, ETFE, PFPE, Tetrabutylphosphonium Perfluorobutylsulfonate PFPEs and PCTFE base oils (Z)-1,1,1,4,4,4-Hexafluoro-2buten, Butane, 1,1,1,2,2,3,3,4,4-nonafluoro4-methoxy-, Butane, 1-ethoxy1,1,2,2,3,3,4,4,4-nonafluoro- 108 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) In Table A.49, an overview of the identified uses of PFASs in the semiconductor industry is provided based on input from stakeholders. Uses identified in the semiconductor industry were primarily focused on semiconductor manufacturing and related equipment that is used to produce semiconductors. PFAS offer several essential functionalities including coating ability for making uniform and thin films on wafers, photo-imaging e ability for printing electronic circuits, and durability to etchant for making electronic circuits. it Table A.49. Uses and properties of PFASs in the semiconductor industry identified by stakeholders. c Use category Sub-use Properties Examples of PFAS t Semiconductor manufacturing o no Photolithography Photoacid generators Strong electronegativity of F atom Fluorinated salts in the complex resist/chemical matrix allows for controlled generation of strong acid upon exposure to UV light n - d Photolithography Antireflection coatings Low dielectric constant Low refractive index Good thermal stability Good barrier properties Acrylate and methacrylate-based copolymers io Photolithography blicat Photolithography Topcoats and Embedded Hydrophobicity Fluoropolymers Barrier Layers Surfactants Uniformity in coating with minimal Non-polymeric PFASs (non-ionic) effect on properties provided by other critical resist/chemical ingredients (i.e., without impact to refractive indexes) u Photolithography p Nanoimprint Lithography - Plasma Etch and Wafer e Cleaning pr Wafer Filters Wet etch Chemical resistance Low surface adherence Anisotropic etching capabilities Wetting agents Selective metal oxide removal Fluoropolymers Fluoropolymers PFC, HFC and HFO gases Fluorinated organic acids 109 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Vapour deposition chamber Heat Transfer Fluids Vacuum pump Thermal Testing of Semiconductor Devices (in-line and end of line) Advanced Semiconductor Packaging Advanced Semiconductor Packaging Advanced Semiconductor Packaging Sub-use Cleaning Properties Provision of reactive fluoride to enable cleaning of surfaces High precision temperature control imparted by thermal stability Viscosity vs temperature characteristics Specific heat o Vacuum fluid lication - d Encapsulants and b Thermal Interface u Materials -p Flux pre Temporary Adhesives Electrical conductivity characteristics Thermally stable Non-flammable and insoluble in water, acids, bases and most organic solvents High precision temperature control imparted by thermal stability Viscosity vs temperature characteristics, Specific heat and electrical conductivity characteristics Temperature resistance Beneficial material flow Wetting, degassing and composite homogeneity High-temperature thermal stability (>160C) Solubility in organic solvents, low dielectric constants, and high Examples of PFAS PFC, HFC and HFO gases ite Hydrofluoroethers, perfluoropolyethers (including PFPMIE), and other fully fluorinated liquids c (perfluorinated amines and perfluoroalkylmorpholines, t PFPE, Butane, 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluoro-, 2,3,3,4,4-pentafluoro-5-methoxy-2,5-bis[1,2,2,2- o tetrafluoro-1-(trifluoromethyl)ethyl]tetrahydrofuran, nPerfluamine, 1,1,1,2,2,4,5,5,5-nonafluoro-4- (trifluoromethyl )-3-pentanone Fluorocarbon ether polymers of polyhexafluoropropylene oxide, Hydrofluoroethers, perfluoropolyethers (including PFPMIE), and other fully fluorinated liquids (perfluorinated amines and perfluoroalkylmorpholines, Reaction mass of 1,1,2,2,3,3,4,4,4-nonafluoro-N,Nbis(nonafluorobutyl)butan-1-amine and 1,1,2,2,3,3,4,4,4-nonafluoro-N-[1,1,2,3,3-hexafluoro-2(trifluoromethyl)propyl]-N-(1,1,2,2,3,3,4,4,4nonafluorobutyl)butan-1-amine Fluoropolymers Surfactants Fluorinated Tetracarboxylic acid anhydride derivatives, aromatic diamines, acrylate and methacrylate-based copolymers 110 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Advanced Semiconductor Packaging: Semiconductor Manufacturing Equipment & Infrastructure - Enabling Uses of Fluoropolymer Articles (polymer parts embedded within manufacturing equipment, spare parts and infrastructure, piping, tubing, gaskets, etc.) Release sheet for thermocompression bonding process of semiconductor chips Data Centres - Immersion Cooling of Semiconductor Devices/Servers Sub-use Properties thermal and thermo-oxidative stability Hydrophobic Unique hydrophobicity coating/hermetic seal packages Chemical resistance Low volatility/high stability Thermal resistance Cleanliness UV resistance o Flame resistance - d Heat-resistant n Releasability Flexibility io Tensile strength t High precision temperature control imparted by thermal astability lic Viscosity vs temperature characteristics Specific heat and electrical b conductivity characteristics u Non flammable Material compatibility pre-p Ease of IT hardware maintenance Examples of PFAS ite Fluoropolymers t c Fluoropolymers (i.e., teflon, viton, PTFE, PFA, FEP, no ETFE, PVDF, FFKM, etc) PTFE Perfluoroalkanes, Hydrofluoroethers, perfluoropolyethers (including PFPMIE), fluoroketones and other fully fluorinated liquids (perfluorinated amines and perfluoroalkylmorpholines, 2,2,3,3,5,5,6,6octafluoro-4-(trifluoromethyl)morpholine, Perfluamine, Reaction mass of 1,1,2,2,3,3,4,4,4-nonafluoro-N,Nbis(nonafluorobutyl)butan-1-amine and 1,1,2,2,3,3,4,4,4-nonafluoro-N-[1,1,2,3,3-hexafluoro-2(trifluoromethyl)propyl]-N-(1,1,2,2,3,3,4,4,4nonafluorobutyl)butan-1-amine, 2,2,3,3,5,5,6,6-octafluoro-4(trifluoromethyl)morpholine, Methyl Perfluoropropyl Ether, 2-(Difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoropropane, 111 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Properties Production, storage, usage of high-purity chemicals Chemical transportation Semiconductor Products and components Photoresist Epoxy, case masking Resistance to fire, grease, stain, etc. Plastics such as PC/ABS do Fluoroelastomers, polymers including polyimides, polyamides, - polyesters, polycarbonate Adhesive, coating, n lubricanta pre-publicatio a Covered in section A.3.15 on lubricants. Flame retardancy Cross linking agent for fluoroelastomers, monomer, high temperature composites and electronic materials Solvability Examples of PFAS 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl)-3pentanone. e PVDF t cit Fluorotelomer-related compounds no Perfluoroalkane sulfonic acids (PFSA), their salts and esters Bisphenol AF and its salts Perfluoroalkylethers 112 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Based on input from stakeholders and information from literature (Glge et al., 2020), 163 PFASs were identified at being in use or used at some point in the electronics and semiconductor industry combined. Glge et al., 2020 further identified 93 PFASs as being patented for use in the electronics and semiconductor industry and two PFASs as analytically detected. Of the 163 PFASs identified at being in use or used at some point in the electronics and semiconductor industry, 48 are polymeric PFASs (18 fluoropolymers, 11 side-chain fluorinated polymers, 16 PFPE and three unknown), 114 are non-polymeric PFASs (42 ionic and 72 nonionic of which 17 are fluorinated gases) and one is unknown. A.3.12.2. Volumes In Table A.50 and Table A.51, a summary is provided of the yearly use volumes in the e electronics and semiconductor industries in the EEA in 2020, as provided by stakeholders. it The estimates are based on responses of 27 out of the 30 companies' active in the pre-publication - do not c electronics/semiconductor industry; three companies did not provided quantities. 113 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.50. Estimated yearly PFASs use in the electronics and semiconductor industry in the EEA. C2- C3 (non-ionic) PFAS substances (t/y) low high Total electronics and 159 221 semiconductors Table A.51. Estimated yearly C2- C3 (non-ionic) PFAS substances (t/y) midpoint Total electronics 190 and semiconductors PFAAs C4 ite (t/y) Side-chain fluorinated polymers (t/y) Total PFAAs and PFAA precursors (t/y) Total fluorinated gases (t/y) Fluoro polymers (t/y) PFPE (t/y) Total polymeric PFASs (t/y) Total PFASs (t/y) c low high low high low high low high low high low high low high low high ot 671 1 315 11 13 841 1 549 140 140 1 551 4 063 9 552 1 560 4 615 2 541 6 304 o n PFASs use in the electronics and semiconductor industry in the EEA. (Midpoint used in impact assessment) d PFAAs C4 Side-chain Total Total Fluoro PFPE Total Total PFASs (t/y) fluorinated PFAAs and fluorinated polymers (t/y) polymeric (t/y) polymers PFAA gases (t/y) PFASs - (t/y) precursors (t/y) (t/y) (t/y) n midpoint midpoint midpoint midpoint midpoint midpoint midpoint midpoint pre-publicatio 993 12 1 195 140 2 807 281 3 088 4 423 114 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) According to stakeholders, approximately 65% of the PFASs used are polymeric PFASs. The semiconductors industry accounts for approximately 45 % of the polymeric PFASs use and approximately 7% of the non-polymeric PFAS use. Stakeholders indicate the use of an amount of 140 tonnes of 12 different fluorinated gases. The Fluorinated gases are mostly used as a solvent cleaner. Between 400 and 840 tonnes per year were reported to be used as intermediate. The main polymeric PFASs used in the electronics and semiconductor industry are PTFE, PFA, PVDF, ETFE and FEP. FEP is highly used for Local Area network (LAN) cabling (fire resistance). The main non-polymer ionic PFAS used in the electronics and semiconductor industry is perfluorobutanesulfonate (PFBS), a surfactant. The non-polymer non-ionic PFASs are mainly solvent cleaners and heat transfer fluids. ite A.3.12.3. Summary c Because of the vast range of properties, PFASs are widely used in the electronics and t semiconductors industry. PFASs are used in products and components to enhance their functionality and in the process to make those products and components. Stakeholders report o an estimated annual use of between 2 500 and 6 300 tonnes (rounded numbers). n Approximately 65% of the PFASs used are fluoropolymers. The main fluoropolymers used are PTFE, PFA, PVDF, ETFE and FEP. The main non-polymeric ionic PFAS is perfluorobutanesulfonate (PFBS), a surfactant. Non-polymeric non-ionic PFASs are mainly o used as solvent cleaners and heat transfer fluids. The semiconductor industry accounts for d approximately 45 % of the polymeric PFASs and approximately 7% of the non-polymeric pre-publication - PFASs. 115 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.13. Energy sector A.3.13.1. Uses Glge et al. (2020) identified uses of PFAS in the energy industry and listed the main properties of PFASs. For this study, both the uses and properties were confirmed by a stakeholder and additional uses and properties were added. Also, literature and publicly available sources were consulted (JRC, 2018)36. PFASs properties are included in Table A.52. Table A.52. PFAS properties relevant to the energy industry - literature and publicly available sources, complemented by a stakeholder. Industry ot cite Energy Identified properties Chemical/thermal resistance, ion transportation, high weatherability, high transparency, corrosion resistance, oleophobic, hydrophobic, low surface tension, stable, non-reactive, acid gas scrubber, heat absorption, conductivity, capacity to dissolve gases, bipolar, resistance to acids, and highly oxidizing species, wettability, heat conductivity, high dielectric strength, low global warming potential, forms no residue, dirt repellence, high vapour barrier, high transparency, particular and chemical filtration. o n An overview of PFAS uses in the energy industry is provided in Table A.53. d Table A.53. PFASs uses in the energy industry - literature and publicly available sources, complemented by a stakeholder. - Energy facility/unit Use as/for Solar collector Front and back sheet, adhesive n Photovoltaic cells Adhesive to hold mesh cathode in place io Heat exchanger Coating Coal based power plant Acid gas scrubber, separation of gases, filter t Nuclear power plant Sealing for aggressive chemicals a Lithium batteries Binder for electrodes, prevent thermal runaway reaction, oxygen lictransport, electrolyte, sealing Vanadium redox batteries Ion exchange membrane Zinc batteries Prevent formation of dendrites, hydrogen evolution and electrode b corrosion due to adsorption to electrode u Alkaline batteries Surfactant Flow batteries Membranes p Battery systems Cooling - Fuel cells Membranes, sealing, binding e Power transformers Cooling liquid r Gas insulated equipment Insulation p Electrical components Testing Fluid Electrical substations Fire protection fluid Unknown Heat transfer fluid In Table A.54, an overview of the identified uses and properties of PFASs in the energy industry is provided, based on input from stakeholders. In general, the information received varied in the level of detail pertaining to substance, sub-uses application(s) and sectors. For instance, not all substances were associated with a use or function, stakeholders sometimes 36 https://www.engineeredfluids.com/post/are-pfas-the-next-pcbs, date of access: 2022-12-16. 116 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) listed properties of each PFAS without specifying details in application etc. Table A.54. Identified uses and application of PFASs in the energy industry identified by stakeholders. Use category Sub-use Properties Area of use/application(s) Examples of PFAS Solar Solar array bearings PTFE collector (for tracking systems) Photovoltaic Film/coating Water repellency Front and back PVDF, ETFE, cells Tape Soil sheets of PV modules FEVE, PFPE repellency Thermal stability Electric stability Weather resistance (UV, humidity, temperatures ) Sand abrasion Antifouling Barrier properties pre-publication Wind energy Film/coating and cables as well Light weight Low flammability Extreme durability Durability Weatherability Lubricant Coal based Heat exchanger High (The PV back sheet is designed to protect the inner components of the module, not specifically the photovoltaic cells and electrical components from external stresses as well as act as an electric - do insulator) cite Wind Blade Protection Coating (prevent moisture in the air from affecting curing process), Windmill towersa,b. Release film for wind turbines. FEVE, ETFE, Perfluorobutane sulphonamide Used as lubricants/oils/grease s for wind turbinesa,b PTFE Power plants PTFE, power plant tubing temperature Fluoropolymers Filters resistance Steam resistant UV and chemical inert Durability 117 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Properties Area of use/application(s) Examples of PFAS High flexibility Particulate filtration Nuclear Infrastructure: Containing Closed vessels PTFE power plant Gasket material aggressive acid and alkaline media PEM fuel Membrane Hydrophobic Transportation PTFE cells electrode agent (avoid assemblies flooding of (MEA); Gas the cell) Diffusion Layer Binder (GDL)/Microporou Electrical s layer, Gaskets, insulator sealant. Conductor Chemical resistant Thermal resistant Mechanical resistant Durability pre-publication Membrane electrode assemblies (MEA); membrane Best association of conductivity, chemical stability and mechanical strength Hydrophobic (PTFE backbone) Membrane electrode assemblies (MEA); Microporous layers (MPL) Hydrophobic (automotive, aviation etc.), zero-emission powertrains for cars and busesc, backup power for critical systems and remote locations, portable t generators and o compact charging devices, Combined n heat and power systems for homes o and commercial dbuildings, mobile power systems for material handling -equipment such as cite forklifts Separates protones Perfluoroalkane and electrons and sulfonic acids provides the proton (PFSA) or conductivity (thereby perfluoroalkylethe producing electric r sulfonic acids current) while (PFAE) ionomers, separating the PTFE reactants: hydrogen and air (oxygen), in the case of a fuel cell MPL are placed inside PTFE an MEA to prevent water leakage, ensure insulation, and improve contact between GDL and the electrode Sealant Seal on MEAb Fluoropolymers, fluoroelastomers PEM Sealing materials; Inert b Fluoropolymers, electrolyser gaskets Chemical fluoroelastomers / PEM fuel resistant cells PEM PFSA ionomer, electrolyser PTFE Lithium-ion Seals, Cooling Use to contain Fluoroelastomer, 118 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Properties batteries electrode binders, Electric stability separator films/coatings, electrolyte additives, thermal management pack/module Batteries Battery fluid, Compounds for separator films, Binder Flow Ionomer Ionic batteries membranes resistance Ion exchange Mechanical membrane properties Durability Chemical stability Corrosion resistance Thermal resistance Electro-lysis Equipment: Stability technologies gaskets, tubes, Durability pre-publication (not PEM) inline of pipes/tanks Oil and gas appli-cation Equipment: gaskets, tubes, inline of pipes/tanks. Wires and capacitors. Mechanical compression Creep characteristics and chemical resistance Inert, Hydrophobic Chemical and temperature resistant Corrosion protection barrier High mechanical strength and resistance Air permeability Flexibility/ductilit y Others Switchgears Chemical and High Voltage DC temperature Converter Valves resistant Dielectric properties Flame retardancy Area of use/application(s) aggressive electrolytes Examples of PFAS PVDF Rechargeable batteries e Rechargeable it batteries Sealing for c aggressive chemicalsb Fluoropolymers do not Alkaline water electrolysis -(technology for large scale hydrogen Polymeric PFASs: PTFE, FKM, PVDF, TFM (chemically modified PTFE), production) FEP, ECTFE, PFA, PFPE d Used as insulation gas in Medium & High Voltage Switchgear Power Transmission Technologies Used in conversion of electric power (AC to Fluoropolymers; PTFE, PVDF. Non-polymeric PFASs; PFBS, C4FN and C5-FK 119 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use Properties a Covered in section A.3.14 on construction products b Covered in section A.3.15 on lubricants c Covered in section A.3.11 on transport d Covered in section A.3.16 on petroleum and mining Area of use/application(s) DC) due to their chemical and thermal properties. Used in polycarbonates. Examples of PFAS Based on input from stakeholders and information from literature (Glge et al., 2020), 40 PFASs were identified at being in use or used at some point in the energy industry. Glge et e al. (2020), further identified 13 PFASs as being patented for use in the energy industry and it four PFASs as analytically detected. c Of the 40 PFASs identified as being in use or used at some point in the energy industry, 23 are polymeric PFASs (15 fluoropolymers, two side-chain polymers, five PFPE and one t unknown) and 17 are non-polymeric PFASs (six ionic and 11 non-ionic of which one is a o fluorinated gas). n A.3.13.2. Volumes o A summary of the use volumes in the energy industry in the EEA is presented in Table A.55 and Table A.56. The estimates are based on responses of 30 companies active in the energy d industry. Based on data from the Urban mine platform on the volume of lithium-ion batteries (157 000 t/y) and estimations from stakeholders that the PFASs content (PTFE and PVDF) in - batteries is around 1%, the volume of polymeric PFASs in batteries was estimated at 1 600 t/y. It should be noted that the lithium-ion battery data from the Urban Mine platform also n contains data on batteries used in electric vehicles. No PFAS volume data is available for other pre-publicatio types of batteries (e.g., flow batteries)37. 37 http://www.urbanmineplatform.eu/homepage, date of access: 2022-12-16. 120 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table Total Table Total A.55. A.56. Estimated yearly PFASs use in the energy sector in the EEA. e C2- C3 PFAAs C4 Side-chain Total PFAAs it (non-ionic) (t/y) fluorinated and PFAA PFAS polymers precursors c substances (t/y) (t/y) (t/y) t low high low high low high low high no 233 233 20 20 40 41 293 294 Fluoropolyme rs (t/y) PFPE (t/y) low high low 2 590 2 917 2 high 3 Total polymeric PFASs (t/y) low high 2 592 2920 o Estimated yearly PFASs use in the energy sector in the EEA. (Midpoint used in impact assessment) d C2- C3 PFAAs C4 Side-chain Total PFAAs Fluoropoly PFPE (non-ionic) (t/y) fluorinated and PFAA mers (t/y) - PFAS polymers precursors (t/y) substances (t/y) (t/y) n (t/y) io Midpoint Midpoint Midpoint Midpoint Midpoint Midpoint pre-publicat 233 20 41 294 2 754 3 Total polymeric PFASs (t/y) Midpoint 2 756 Total PFASs (t/y) low high 2 884 3 214 Total PFASs (t/y) Midpoint 3 049 121 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) According to stakeholders, the main polymeric PFASs used in the energy industry are PTFE, PFA and a PFSA-ionomer, which account for 65%, 14% and 5% of the total fluorinated polymer use, respectively. A.3.13.3. Summary Because of the vast range of properties, PFASs are widely used in the energy industry. Stakeholders report an estimated annual use of between 2 900 and 3 200 tonnes (rounded numbers). Approximately 84% of the PFASs used are polymeric PFASs. The main fluoropolymers used are PTFE, PFA and a PFSA-ionomer, which account for 65% 14% and 5% of the total fluoropolymer use respectively. Literature sources indicate an annual volume of PFASs (mainly PVDF and PTFE) in batteries of 1600 tonnes. do n - licatio -pub pre not cite 122 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.14. Construction products A.3.14.1. Uses PFASs have many uses in construction products and the building industry, including in architectural membranes and other roofing materials, wires and cables, paints and coatings/impregnations, sealants, adhesives, and more. They are applied because they have desirable technical functions such as wetting, weatherproofing, UV resistance, corrosion prevention, chemical and thermal resistance, friction reduction, durable, soil and water resistance. Table A.57 provides identified use categories, sub-uses, technical function and examples of PFASs in building materials/construction products based on Glge et al. (2020), Green Science Policy Institute (2021), OECD (2022) and stakeholder input. ite It should be noted that there are some overlaps between the use categories in Table A.57 - c e.g., between the broad category coatings and paints and some more sector specific uses like the metal sector. It should also be noted that there are some overlaps between some use t categories in the table and uses described in other sections of Annex A. The use category wires and cables are included in the table for the sake of completeness, as this category is in o general handled in section A.3.12 (Electronics and semiconductors). The same goes for the n foam blowing agents that is included in section A.3.9 (Applications of fluorinated gases). Table A.57. Identified PFAS uses, technical function and examples of PFAS in building o material /construction products based on literature and stakeholder input. d Use category Sub-use(s) Technical functions Examples of PFASs Architectural Durability, chemical and Fluorinated polymers - membranes including UV resistance, light e.g., PTFE, ETFE, FEP, fluoropolymer films weight, low maintenance, PVDF n (ETFE) and fabrics or wetting during Non-polymeric PFASs fiber glass io coated/laminated with application of film e.g., PBSF, HCFO1233zd1 t fluoropolymers in e.g., stadium roofs, a greenhouses, flexible lic solar panels Roofing Weatherproofing Membranes made of Durability and stain resistance, moisture Fluoropolymers b materials such as control and solar usynthetic rubber, reflectivity polyvinyl chloride (PVC), ppolyolefin, or other - heavy-duty e thermoplastics, and r coated with a p fluoropolymer layer. Used for e.g., flat-type roofs Electrical cable and wire Flexible, durable, PTFE, PCTFE, ETFE, FEP, insulation (in e.g., air temperature resistance PVDF conditioner units, Wires and computers, light fixtures cables and heated flooring), PTFE-impregnated plastic or a fiberglass- based tapes for electrical 123 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use(s) applications (e.g., to wrap bundles of wires), gasket hoses Technical functions Examples of PFASs Skidways for Low moisture absorption, PTFE constructions strong weather Skidways resistance, chemical inertness, electrical and thermal insulation Construction bearings - do not cite Sealings and pre-publication adhesives Bridge bearings Sealing of porous materials such as stone, grout, unglazed tile, and concrete in e.g., kitchen and bathroom tilework, and stone, tile or concrete flooring. Also used in exterior applications such as patios, staircases, foundations, and parking garages. PTFE tape (and liquid/paste pipe thread sealant) is also a type of sealing used to seal e.g., pipe connections Adhesives for e.g., tiles, flooring, drywall, ceiling, wood-related materials and molded structures. Tapes for structural glazing are also included as well as caulks to fill gaps and crevices, creating a water-proof seal in building facings, elevators and furniture PTFE tape (also PTFE tape for professional applications like for Water repellence and low friction Create a smooth, waterresistant protective barrier that increases resistance to oil, water, stains, snow, ice, and graffiti Increase the strength of the bond adhering materials together by increasing wettability and/or enhance the penetration into substrates Polymeric PFASs e.g., PTFE, PCTFE, ETFE, PVDF, FKM Polymeric PFASs e.g., PTFE and acrylate- and urethane -based sidechain fluorinated polymers Non-polymeric PFASs: e.g., fluorosurfactant Polymeric PFASs e.g., fluoroelastomers Non-polymeric PFASs: fluorosurfactants PTFE drinking water, compressed air systems Household application and installation of windows and doors) DIY sealant and For DIY sealant and Polymeric PFASs e.g., adhesive products as adhesive, see sealants PTFE and acrylate-, e.g., foam mounting and adhesives above urethane- and siloxane- tapes and squares, and based side-chain damage-free hanging fluorinated polymers solutions for e.g., Non-polymeric PFASs: 124 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use(s) pictures Technical functions Examples of PFASs e.g., fluorosurfactant For production of certain Specific uses confidential Non-polymeric PFASs Processing aids (PA) types of construction products (articles) The PAs is not part of the (surfactant or solvent) final product. Used as internal Eliminate of melt fracture Micro-powder PTFE, high- t cite Polymer o processing n additives (PPA) lication - do Other polymer additives pub Foam blowing - agents/additiv pre es lubricant / additive / polymeric processing aid in thermoplastics (e.g., PE and PP) thermo setting plastics and elastomers Flame retardants (e.g., PFBS as additive to polycarbonate resins). High-MW PTFE additive as drip suppression of burning plastics. PFHxSLi+ as antistatic. Coating of plastics with fluoropolymers. Pigments Foam insulation for e.g., polyurethane and other foam formulations Wetting agent and sealers in (shark-skin effect), improve wear and abrasion resistance, reduce coefficients of friction (COF), make surfaces easier to clean, increase melt tension and strength, and improve processability and mould release, reduce of die build-up, improve of the surface finish with high gloss levels, increase production start-up, reduce pressure, increase output at constant die pressure and temperature, lower energy consumption Flame retardant. Antidrip additive. Antistatic agent to prevent the buildup of static electricity and dissipate the electric charge formed on the substrate MW PTFE, PVDF, PFPE Polymeric PFASs e.g., PTFE, High-MW PTFE, PVDF Non-polymeric PFASs: PFBS, PFHxS-Li+, pigments Reduce thermal conductivity Improve levelling and spreading and increase Fluorinated gases1 Polymeric PFASs e.g., acrylate-, urethane- and coatings/paints/varnishe resistance to oil, water siloxane-based side- s/lacquers for wood and stains chain fluorinated substrate polymers Wood sector Non-polymeric PFAS: e.g., fluorosurfactants Resin/adhesive for Urea-formaldehyde Non-polymeric PFASs: particleboard/chipboard/ adhesive resins: fluorosurfactants low-density fiberboard Improved cold-water swelling and internal bond strength 125 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use(s) Technical functions Examples of PFASs Surface Increase the durability of Polymeric PFASs e.g., treatment/coating of glass and limit the PTFE, PCTFE glass buildup of dust and Non-polymeric PFASs Glass sector building/construction debris on glass surfaces. e.g., PBSF materials such as Wetting agent during windows, doors, and coating step mirrors Coating/painting of Protects metal building Polymeric PFASs e.g., metal (including coil products against PTFE, FEP, PVDF, FEVE coating). Exterior weathering and staining and silane/siloxane- ite Metal industry c / sector n - do not Outdoor io electrical energy t components re-publica Surface p protection finishes for large buildings, bridges, and industrial structures, in addition to high touch metal surfaces such as elevators and sanitary fixtures. Metal entrances, doors, and door components (hinges, frames, latches, handles, locks, etc) may be coated with PFAS Surface-protective films/coatings for wind turbine blades Surface coatings for solar panels of glass or ETFE Surface treatments of both absorbing and nonabsorbing surfaces (e.g., glass, enamel, ceramics, metal, stone, concrete and linoleum, laminated plastic floor). Often sol- and increases corrosion resistance. Coatings also used to increase the energy efficiency of metal roofs and exterior walls (by increasing reflectivity), to keep snow and ice from sticking to roofs and gutters and to aid in the penetration of coated roofing nails Resistance to rain erosion of the blades. Weathering (UV and oxidation attacking resin in composite), abrasion and light impacts. Prevention of moisture in the air from affecting curing process. Resistance to weathering and rain, and also maintain a clean surface and reduce dirt build-up, which can block light and reduce conversion efficiency Make surfaces durable, soil and water resistant based side-chain fluorinated polymers Polymeric PFAS: FEVE, ETFE Non-polymeric PFASs: Perfluorobutane sulphonamides Polymeric PFASs e.g., FEP fluoropolymer and silane/siloxane-based side-chain fluorinated polymers Polymeric PFASs e.g., acrylate-, urethane- and silane/siloxane-based side-chain fluorinated polymers gel method is used for creating (polymerisation of) a nanometer thin film on the surface. Coating of surfaces of Corrosion resistance, Polymeric PFAS: PTFE, Architectural bridges and buildings, thermal stability, flame PVDF, ECTFE, FEVE, FEP, coatings and including anti-graffiti resistance, weather PFPE & acrylate- and paints coating resistance, UV durability silane/siloxane-based side-chain fluorinated 126 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use category Sub-use(s) Technical functions Examples of PFASs polymers Fluorinated additives in Wetting and levelling Polymeric PFASs e.g., paints to achieve specific agents that lower surface PVDF, FEVE, ECTFE, finishes and durability tension for even flow and PTFE, FEP, PFPEs requirements on spread. Provide non- Non-polymeric PFASs: buildings and stick, dirt and stain surfactants, pigments constructions resistant, oil- and water- repellent, and anti- corrosive properties. Binders that join e ingredients together it and/or help impregnate the substrate to decrease c bubbling and peeling. t De-aerator to decrease bubbling. o 1 HCFO-1233zd(E) is used as foam blowing agent in e.g., roofing. Fluorinated gases/foam blowing agents n are covered in section A.3.9. o In Glge et al. (2020), the following industries and use categories are considered to be relevant for the use of construction products within the building industry: building and d construction, coatings, paints, and varnishes, production of plastic and rubber, plastic, rubber and resins, wood processing, treatment and coating of metals, pipes, pumps, fittings and - liners, sealants and adhesives, stone, concrete and tile (treatment), wire and cable insulation, gaskets and hoses. Based on this, 76 PFASs were identified as (potentially) being in use or used at some point in construction products. Glge et al. (2020) further identified 67 PFASs n as being patented for use in construction products. Sub-uses that were clearly out of scope io of being considered construction products (e.g., mold release agents in production of plastic and rubber that is covered in section A.3.15) was removed from the count. at Of the 76 PFASs identified at being in use or used at some point in construction products, 28 lic are polymeric PFASs (15 fluoropolymers, nine side-chain fluorinated polymers, three PFPEs, and one `unknown'). 47 are non-polymeric (30 ionic and 15 non-ionic) and one substance is considered as `unknown', as no information was available on its chemical identity. b Several substances are used across different use categories of building materials/construction u products. This is also reflected in Table A.57, where e.g., PTFE is mentioned in almost all use p categories. - A.3.14.2. Volumes re In Table A.58 the estimated annual volumes of PFASs in building materials/construction p products uses in the EEA are given. The estimate for polymeric PFASs is based on input from stakeholders whereas the estimate for non-polymeric PFASs is based on the split between polymeric PFASs and non-polymeric PFASs in the categories `building and construction' and coatings and paints' in Glge et al. (2020). The reason for using this approach is that the input from stakeholders on the annual volume of non-polymeric PFASs is considered to be too low. 127 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) The total annual volumes of PFASs for the construction sector in table Table A.58 has the following caveats: i) The data on polymeric PFASs provided by stakeholders likely does not cover all relevant users. ii) The data provided on polymeric PFASs was, in some cases, not clearly split by uses, and it can't be excluded that it may include some double counting (when different supply chain stages report volumes for the same products). iii) Where data has been provided as ranges, the upper bounds have been used to quantify a `worst-case' scenario. iv) Estimations of annual volumes of non-polymeric PFASs is partly based on Glge et al. (2020)Glge et al., 2020. This approach has uncertainties but is used in lieu of better data. The volumes can't be split by uses. ite Table A.58. Estimated PFASs volumes in building materials/construction products used in the EEA. c Volume (t/y) t Range Midpoint o PFAAs and PFAA Side-chain fluorinated 13 n precursors polymers 40 27 Non-polymeric PFASs 974 2 365 1 670 o Polymeric PFASs* 4 254 10 320 7 287 d Total PFASs 5 241 12 725 8 983 *Polymeric PFASs here only refers to fluoropolymers as no information on PFPEs was received - PTFE, ETFE and PVDF make-up 97% of the reported total usage of fluoropolymers in building n materials/construction products. The remaining 3% covers a range of fluoropolymers io including fluoroelastomers such as FKM, FFKM and THV. t Wood (2022) estimated the total quantity of fluoropolymers sold in the construction sector in the EEA in 2020 to be 4 500 tonnes, which is similar to the lower end for fluoropolymers in a Table A.58. It is, however, not clear if Wood (2022) included the same uses as is included lic Table A.57. Stakeholders only provided input on acrylate-based side-chain fluorinated polymers which is b different to Glge et al. (2020), who also identified the use of urethane- and silane/siloxaneu based side-chain fluorinated polymers. The volumes in Table A.58 for side-chain fluorinated polymers might therefore be an underestimation. -p A.3.14.3. Summary re Because of the wide range of properties, PFASs are widely used in construction products. An p annual PFASs use of between 5 000 and 13 000 tonnes (rounded numbers) is estimated based on literature and numbers reported by stakeholders. Approximately 81% of the PFASs used are polymeric PFASs. The main fluoropolymers used are PTFE, ETFE and PVDF which account for 97% of the total fluoropolymer use. 128 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.15. Lubricants A.3.15.1. Uses Uses and properties of PFAS-based and PFAS containing lubricants were identified by stakeholders and in literature (Ebnesajjad S. & Morgan R (Eds.), 2019; Glge et al., 2020; Rudnick, 2020). Ebnesajjad & Morgan (2019) separates lubricants into five categories, low viscosity lubricants, engine oils, greases, solid/dry-films, and release-agents. It should, however, be noted that the same commercial products are sometimes used as low viscosity, dry film, or releaseagent lubricants. An overview of PFAS seen in lubricants is given in Table A.103. ite Low viscosity lubricants c According to Ebnesajjad & Morgan (2019) the fluid phase for low viscosity lubricants is t typically either mineral oil or synthetic oil. Low viscosity lubricants can be 100% base oil, but they often contain solid additives, such as e.g., micro-powder PTFE, graphite, molybdenum o disulphide (MoS2), tungsten disulphide (WS2) or boron nitride (BN). Dispersants or wetting n agents can be used to assure particle suspension. Besides this, other additives like rust inhibitors can be added. Fluorosilicone oils can also be used as base oils (Ebnesajjad S. & Morgan R (Eds.), 2019). do Engine oil - Engine oil is a low viscosity lubricant. The most common base oil in engine oil is mineral oil. However, synthetic base oil is occasionally also used (Somayaji, 2008). Micro-powder PTFE can/may be added as an anti-wear additive. However, the use of PTFE in engine oils is rather n limited due to its inherent instability in oil, the risk of oil filter clogging, as well as difficulties io with recycling (JRC, 2016). Engine oil is only mentioned here for the sake of completeness and will not be discussed further in this section on lubricants. at Grease lic Grease is basically a base oil that contains a thickening agent to increase its viscosity. Greases are typically produced using mineral, synthetic or plant-derived oils. Thickening agents may b be soaps or it can be a solid with a high surface area. According to Ebnesajjad S. & Morgan R (Eds.) (2019) micro-powder PTFE can be used as thickener/ solid additive/ fortifier alone or u in combination with other thickeners, however, most greases based on mineral oils do not p use fluoropolymers as thickeners. The use of PFASs as thickeners is more common for some - synthetic oils (PFPEs, oligomer PCTFE, polyalphaolefin oils, fluorosililicone oils). When used alone, the PTFE level ranges from 20-40% and when used together with other thickeners the e range is from 3-40% (Ebnesajjad S. & Morgan R (Eds.), 2019). Micro-powder PTFE is often r used as thickener in PFPE-based greases. Silica, micro-powder PTFE and/or high-MW PCTFE p is commonly used as thickener in PCTFE-based greases (base oil of oligomer/low-MW PCTFE) (Rudnick, 2020). Solid/Dry films Easy volatilisation of the liquid is usually important for these applications, therefore, the fluid phase for dry films can be oil but is more likely to be water, a very low-MW hydrocarbon, or a polar organic compound such as isopropanol or acetone, as these will evaporate before end use. After evaporation of the solvent, the solid additive (e.g., graphite or micro-powder PTFE) will be left as a dry film. Dry film lubricants may be applied multiple times (Ebnesajjad S. & Morgan R (Eds.), 2019). 129 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Release-agents Release-agents can be considered as a special case of dry film use. Release-agents are also known as anti-blocking agents, surface lubricants, parting agents, or slip-aids. They are used particularly in the manufacture or modification of (thermo)plastic and elastomer shapes, preventing sticking and build-up of resin on process equipment. External lubricants are typically coated from liquid suspension or solution on a mould or contact surface by (aerosol)spraying or brushing. Most external release-agents must be applied multiple times as resin is processed. Internal lubricants/release-agents are incorporated into the resin before the forming or processing of the plastic or elastomeric part. Internal lubricants (releaseagents/slip-agents) is therefore a type of processing aid (PA) (Ebnesajjad S. & Morgan R (Eds.), 2019). Internal lubricants are not considered a lubricant as such and is mentioned here for the sake of completeness. e As described above the most common PFASs in lubricants are polymeric PFASs like microit powder PTFE (solid additive), PFPE (base oil) and PCTFE (base oil). According to Ebnesajjad S. & Morgan R (Eds.) (2019) other polymeric PFASs such as polyfluorosiloxane/fluorosilicone c oils (base oils or additives), FEP and PAVE (additive) are occasionally also present in t lubricants. o Non-polymeric PFASs such as dispersants/wetting agents in lubricants and solvents in n lubricants and lubricant applications (e.g., cleaning before adding a lubricant) are sometimes also used. o PFPE, PCTFE and fluorosilicone base oils d PFPE, PCTFE and fluorosilicone oils can be used directly as lubricants, or they can be used as base oil for greases (Rudnick, 2020). PFPE are fluids known to be chemically inert, have low - outgassing, are thermally stabile (service temperature range from approx. -80 C to approx. 350 C (depending on the type of PFPE)), are non-flammable and radiation resistant. The n vapour pressure and volatility of the PFPE oils vary with average MW so that higher-viscosity io (higher MW) oils generally have lower volatility losses (Rudnick, 2020). Commonly used thickening agents for PFPE-greases are finely divided silica, `attapulgus clay', montmorillonite, t ammeline, boron nitride, talc, calcium carbonate, zinc oxides, micro-powder PTFE and FEP a (Rudnick, 2020). PFPE greases are especially used for applications that require performance over a significant temperature range and wherein oxygen-resistance is needed. For PFPE lic greases thickened with micro-powder PTFE, DuPont (Chemours) and Solvay make a point of saying that special grades of PTFE are used for the thickening (Ebnesajjad S. & Morgan R b (Eds.), 2019). u PCTFE lubricants are known to have good lubricity, to be chemically inert to a high number of p aggressive chemicals, be non-flammable, have low outgassing, be thermally stabile, radiation resistant, have high dielectric strength, high density and low compressibility (Rudnick, 2020). - PCTFE-based greases (base oil of oligomer/low-MW PCTFE) thickened with silica, microe powder PTFE and/or high-MW PCTFE is commercially available (Rudnick, 2020). pr Fluorosilicone oils (polyfluorosiloxane oils) can resists oxidation, harsh chemicals, fuels, has a low evaporation and a wide service temperature range (-40 to 204C). Greases based on fluorosilicone oils can be thickened with amorphous fumed silica, PTFE and organics (Dow Corning, 2005). Micro-powder PTFE as additive in lubricants The extremely low coefficient of friction of (micro-powder) PTFE in combination with its good thermal stability makes it attractive as a solid lubricant additive. Micro-powder PTFE is compatible with PFPE and PCTFE. It is therefore used as additive in low viscosity lubricants based on PFPE and PCTFE and is also used as thickener and additive in PFPE, PCTFE and fluorosilicone greases. Micro-powder PTFE is also used as a solid additive in non-PFAS based 130 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) low viscosity lubricants and greases as well in dry-film lubrication/external release-agents where the solvent can be PFASs or a non-PFASs. Examples of uses of dry-film lubrication ((Ebnesajjad S. & Morgan R (Eds.), 2019) and input from stakeholders) include glass cloth for automotive (bushings for car door hinges, trunk lids, seats and wipers), electronics (bushings for office machines), hydraulics (cylindrical bushings for hydraulic machinery), industrial machinery (thrust washers for conveyor belts), food processing (industrial, retail or Quick Service Restaurants) and consumer use (bike chains and waterproof zippers). Lubricant additives other than micro-powder PTFE According to Ebnesajjad S. & Morgan R (Eds.) (2019) there are many types of low-MW PFASs (besides micro-powder PTFE) that may be used as additives for lubricants including e fluorosurfactants and fluorinated or partially fluorinated alkanes, ethers, amines, esters, and it metal salts of alkyl phosphates. The low-MW PFASs are typically used in specialised applications such as for recording media, hydraulic fluids, firearms, and conveyor chains but c recent patents have also described their use in internal combustion engines. t Perfluoropolyether and perfluoroalkyl phosphates, phosphonates, and salts thereof have been disclosed as lubricants for magnetic media lubrication. They were applied from solution in a o hydrofluoroether solvent. Essentially the same compounds have been disclosed as corrosion n inhibitors for perfluoropolyethers oils and grease (Rudnick, 2020). PFAS-based solvents used in lubricants and lubricant applications do Various PFAS-based solvents (functional fluids) are applied in relation to lubrication. Based on input from stakeholders generally, these uses can be divided in: - PFAS-based carrier and deposition solvent as part of a lubricant dispersion. According to industry, these processes take place in closed system where the evaporated solvent n is captured, and VOC regulations complied with. io Cleaning agents: o This can be for cleaning parts/articles to be lubricated (to avoid contamination t of the lubricant), or a It can be for maintenance. Specific examples have been provided by an industry stakeholder lic referring to PFAS-based solvents: "PFAS are essential for cleaners, which are used to clean switch cabinets or fuse boxes as well as transformers in power plants and wind power under voltage / high voltage. For equipment that cannot be shut down, there is no alternative. For b large production facilities (e.g., automotive plants), cleaning can be performed with these u products in full operation. The alternative is usually to stop the entire production line to perform the cleaning. The financial cost is very high." -p Please note that these solvents used for cleaning are NOT part of the lubricants. re Properties of PFAS-based lubricants and specific properties p According to industry stakeholders, PFAS-based lubricants are used in situations where they are superior in terms of technical performance compared to other lubricants and/or where other types of lubricants would not be technically feasible. Temperature resilience, chemical inertness and a very low friction coefficient are often referred to as key aspects, but also other properties are illuded to. Below, the main properties referred to - alone or in combination are listed: Temperature resilience. Use in outdoor environments (incl. aerospace, airplanes, offshore) and/or in equipment which can become very hot (e.g., ovens, heaters, corrugated paper machinery, steel mills and printers). The temperature resilience of fluorinated lubricants is a 131 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) key property. E.g., lubricated bearings can be used in almost any application subject to high and/or low temperatures. Use when chemical inertness is crucial, including production of oxidising/reactive chemicals (including acids and alkalis, aggressive gases such as ammonia or chlorine) and to prevent reaction with oxygen in other applications (preventing fire, self-ignition, and explosion). The latter includes e.g., breathing equipment in hospitals (e.g., moving parts in respirators, lubrication of cannulas, lubrication of artificial joints) and diving equipment. This property combined with pressure shock resistance is also important for some applications. Quote from an industry stakeholder: "Only PFPE can achieve oxygen pressure shock resistance for greases/pastes beyond 30 bar. This is essential for valve manufacturers and oxygen processing industries, such as the steel industry or the medical sector." The 'slide-ability' is associated with the fact that PFPE lubricants have the highest film thickness of all base oils. e Related to the above, these lubricants are also resistant to radiation which is important in it aerospace and nuclear power plant applications, and resistant to electric current, which is important in many electrical applications. t c Further related to the above, the non-solubility in water is also of importance for avoiding the lubricant in interacting and possibly degrading following contact with water and moist. no Low vapour pressure preventing outgassing (e.g., one benefit is lifetime lubrication of some parts, rather than frequent re-lubrication of e.g., bearings or in fine instruments where maintenance is difficult). Low outgassing is also important for many vacuum pumps and o combined with the inertness preventing degradation products, this is also key in clean-room d production such as for wafers, semiconductors, and other high-tech equipment and for some aerospace applications. This is also considered vital for electrical contacts in many applications, optical instruments (e.g., cameras) and light housings where lubricant - condensate needs to be minimized. n A very low friction coefficient which is in particular important in applications were rotating or io sliding movements need lubrication. For micro-powder PTFE a stakeholder states: "They also possess very low coefficients of friction, typically 0.01 for PTFE lubricant powders, allowing t for excellent non-stick properties..." NB! It shall be noted that PFASs are not applicable for a 'high load'. Quote from an industry stakeholder: "PTFE doesn't carry load very well (here molybdenum disulphide is the best - PTFE films rupture at 5 000 psi, whereas molybdenum lic disulphide films rupture at 500 000 psi), but PTFE is beneficial as a friction modifier in finished grease formulations." The very low friction coefficient combined with inertness and low b outgassing is also crucial for many applications within electronics. u Noise and vibration reduction. The low friction coefficient will in turn reduce noise and p vibrations and is e.g., in relation to the automotive industry pointed at as an additional benefit from the use of fluorinated lubricants. e- Good chemical compatibility with metals, elastomers, and plastics/polymers of PFPEs. r Combined with some of the above properties, PFAS-based lubricants are often applied to p reduce friction between plastic parts e.g., in electronics, electromechanical applications, and in plastic gears. "Less need for lubrication". In combination, the above properties are often referred to by industry when arguing that the need for maintenance and re-lubrication is low or not needed. This ageing stability in turn might lead to less environmental impact in terms of lower amount / less resources needed and longer lifetime of equipment. This in turn also reduces the lifetime costs for maintenance. This aspect is also elaborated by Grechin et al. (2018), who furthermore elaborated how PFAS-based lubricants, even though more expensive than PFASsfree lubricants can lead to a lower total cost of ownership due to decreased operating/maintenance costs. 132 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Olfactorily hardly noticeable. Combined with low vapour pressure/low outgassing this prevents odour in e.g., car applications where smell is no longer allowed. Alternatives to PFAS-based lubricants might result in emission of VOC, which is no longer allowed within the car industry. In combination with the above properties many industrial stakeholders refer to the low toxicity of PTFE and PFPEs as key issue in relation their approval for use in medical technology, food processing and drinking water applications. Many stakeholders highlight that in many applications it is the combination of specific tribological properties that make PFASsbased lubricants the preferred choice in high-performance applications. Many stakeholders highlight that in many applications it is the combination of specific tribological properties that make PFASs-based lubricants the preferred choice in high- performance applications. Table A.59 below gives a non-exhaustive list of PFAS uses in lubricants, based on literature and information from stakeholders. The properties that are listed, are identified as most important by the stakeholders or presented in literature e (Ebnesajjad S. & Morgan R (Eds.), 2019; Glge et al., 2020; Rudnick, 2020). it Table A.59. Non-exhaustive list of PFASs uses in lubricants based on literature and c information from stakeholders. t Branch / sector Application lication - do no Food sector Chains and bearings (e.g., in ovens) Lifetime lubrication in microamounts in closed parts. Moving mechanical parts, semi-closed. Lubricants and lubricant sprays for incidental food contact (NSF-H1[1]a). As a lubrication additive on the inside coating of metal food and beverages containers - it enables filling without damaging the coating. Combustion engines Properties High temperature applications (e.g., ovens) "Unique tribological function", chemical stability, temperature resilience PFASs (and concentration examples provided by stakeholders) PFTE (90-99%; 30-70%) PFPE (60-75%; 30-70%) PTFE (1-10%) PFPE (80-90%) 'Slide-ability' PTFE (2.5 - 100%) High temperature PTFE (5-50%) b Hydraulic systems incl. control valves. re-pu Civil/milita p ry aircrafts Anti-erosion, temperature resilience, chemical stability Potassium decafluoro(pentafluoroet hyl)cyclohexanesulphona te ('low concentration' in ppm range) 'PFAS' (another stakeholder refers to 'a PFAS' without further specification (50 ppm) and Bearings Thermo-oxidative PTFE (30-70%) aerospace stability, low vapour PFPE (30-70%) pressure, low flammability, chemically inert Actuators of jet engines, and Temperature, wear PTFE (10-30%) landing gears resistance, chemically inert, high-pressure stability, minimal oil bleed 133 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / sector Application Properties PFASs (and concentration examples provided by stakeholders) Engine starter spline shafts, hydraulic pumps splines and fuel pump splines in aircraft engines. High/low temperature, low volatility PFPE (grease) Brake and hydraulic fluids High temperature PFPE Bearings, gears and ball High/low temperature PFPE (grease) screws in electro-mechanical actuator. PFPE greases used due to wide operating window e (-70 to 180), low starting it torque and anti-fretting properties. c Couplings, valves, regulators and seals (PFPE greases) in t oxygen systems in space and o aviation applications. n Moving parts of astronauts' pressure suits. o Bearings of antenna arrays on d spacecraft's - Bearings that permit extension of the paddle arms n supporting solar cells on spacecraft's io Slide wire of potentiometers t in spacecraft's a O-ring lubrication in lic spacecraft's ub Flotation fluids in gyroscopes in aircrafts and missiles pHydraulic oil and heat transfer -fluids for aircrafts eOxygen delivery system to pr spacecraft oxidizer tanks Contact with reactive, corrosive or explosive liquids and gases (oxygen compatibility and long-time stability) Non-flammability Minimise wear and does not migrate to other parts of the system. Minimise ware and does not migrate to other parts of the system. Minimise wear and does not migrate to other parts of the system. Contact with reactive, corrosive or explosive liquids and gases (inertness to fuels and oxidants) Damping/reducing frictional loss Non-flammable, high temperature Contact with reactive, corrosive or explosive liquids and gases PFPE PFPE (oil) PFPE (oil) PFPE (oil) PFPE (oil) PFPE (oil & grease) PCTFE (oil) PCTFE (oil) PCTFE (oil) Breathing systems in airplanes and submarines Low outgassing, Chemical inertness in contact with reactive, corrosive or explosive liquids and gases PCTFE Military - defence application s Various military lubrication functions (e.g., aircraft and electronics) Not specified PTFE Automotive Combustion engines High temperature PTFE (5-50%) 134 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / Application Properties PFASs (and sector concentration examples provided by stakeholders) Friction reduction in various Low friction, chemical PFPE (base oils) mechanical devices including stability, compatibility PFTE (lubricating aid and automotive brake system with seals, noise thickener) components. reduction Bearings and throttle sensors Temperature resistance, PTFE non-stick properties, PFPE good slide-ability ESP systems in cars to measure turning speed of the e wheels and many other it applications. Automotive Electrical c Components and Auxiliary Components ot Mechanisms of the sliding of n doors and windows Mould release agents, assembly aids, grease for o e.g., throttle sensors, d bearings, moveable parts, seat rail, door hinge, switch - actuation. NB! Unclear whether 'mould release' shall be seen a 'lubricant use'. n Automotive interior. PFPE io lubricants used to reduce noises, itch or judder where t different materials come into a contact. Lifetime lubrication. lic Window wiper motors, electronic waste gate actuators, O-rings in fuel b connectors (combustion u engines), intake manifolds shaft and seals, Exhaust gas precirculation (EGR) valves, -overrun clutches, alternator ebearings and water pumps. r PFPE lubricants used for these p applications due to high- Viscosity regulation, temperature resilience, water repellence, chemically resistant Temperature resilience, chemical stability, arcresistant, low vapour pressure/little outgassing Temperature resilience Non-stick, chemical stability, slide-ability, temperature, water repellence Various High temperature PTFE PTFE PFPE PTFE (10-30%) PTFE (1-100%) PFPE PFPE temperature stability, chemical resistance and material compatibility. Several stakeholders refer to "Lifetime lubrication" of 'various car parts', which would otherwise need to be re- lubricated every year if more mainstream 135 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / sector Application Properties lubricants were used PFASs (and concentration examples provided by stakeholders) Valves in powertrains High temperature PTFE Trains do not cite Nuclear ublication - Watchp making re- Hearing loss p application s Train door lubrication Bearings in pumps Laboratory glassware to prevent locking Bearings and other moving parts Critical bearings, manipulator greases for nuclear waste handling, fuel manufacturer equipment lubrication, compaction equipment lubrication for example. Anti-galling thread lubricant for stainless steel assemblies Lubricant for processing uranium hexafluoride Oil for use in nuclear service Lubrication of controls for nuclear applications Lubricants and greases Vacuum pumps and bearings during production. Note that it is not clear whether the PFASs as lubricant also plays a role in the final products. resilience; chemical resistance Temperature resilience Resistance to degradation caused by radiation, no-sludge and gum formation Temperature reliance and chemical inertness Low friction PFPE PTFE (10-30%) PFPE PTFE PTFE Chemically inert, temperature resilience, low friction Fluoropolymer (not further specified) Contact with reactive, corrosive or explosive liquids and gases Resistance to degradation caused by radiation Hydrogen-free oil PCTFE PCTFE PCTFE (oil) PCTFE (grease) Very high stability, extremely low pour point, anti-wear additives, excellent water demixion, extremely low surface tension, etc. Temperature resilience and low degradation/chemical stability, UV-resistance Polymeric PFASs + From C3 to C6 fluorinated chains (not further specified) PFPE PTFE Electric circuit breakers Temperature resilience, PTFE Electronics (including semiconductor; see A.3.12) Semi-conductors manufacturing: Multiple uses, such as wafer handling chemical stability, arcresistant, low vapour pressure/little outgassing Low friction PFPE PTFE mechanisms, vacuum grease, 136 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / Application Properties PFASs (and sector concentration examples provided by stakeholders) linear guides of multibeam inspection stage, source mirror actuators, and several other bearing applications. Working fluid and seals in Contact with reactive, PFPE (oil) vacuum pumps exposed to corrosive or explosive aggressive environment liquids and gases Emergency smoke ventilation fans in e.g., tunnels. ite Grease for sliding contacts in electric switch and for c pushbuttons Rack and pinion disk drive t lubricant o Spindle and actuator bearings n in disk drives Top coating lubricant on computer disc drives o Vacuum pump oil for semid conductor manufacturing equipment - Vacuum pump oil for equipment used to plasma- n desmear multilayer printed circuit boards io Inert grease for semit conductor processing equipment a Vacuum pump oil for lic equipment used to plasma clean electronics and medical devices b Instrument fill fluids where u strong oxidizing agents prelude the use of glycerine por silicon oil fill fluids e.g., -Diaphragm seals, pressure egauges, manometers, dead r weigh testers and sensors. p Diagnostically and optical Temperature resilience (the fans need to function at 400C for 2h) Non-oxidizable, nonflammable, lifetime lubrication Temperature resilience Temperature resilience Low outgassing Temperature resilience, low outgassing Temperature resilience, low outgassing Chemically inert Temperature resilience, low outgassing Chemical stability in contact with reactive, corrosive or explosive liquids and gases Low outgassing PFPE (grease) PFPE PFPE PFPE PFPE PCTFE (oil) PCTFE (oil) PCTFE (grease) PCTFE (oil) PCTFE (oil) PTFE equipment: Lubrication of PFPE Laboratory supplies, equipment, and instrument ation moveable parts, for instance ball-bearings in various applications where parts need to be moved without friction Bearings, jewels, and pivots in many kinds of instruments Optical instruments and light Not specified Low outgassing PFPE PFPE housings where lubricant condensate needs to be 137 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / sector Application minimised. Properties PFASs (and concentration examples provided by stakeholders) Wax coating to protect glass Chemical stability in PCTFE (grease/wax) from attack by aggressive contact with reactive, compounds corrosive or explosive liquids and gases Hospital equipment (see A.3.10) Vacuum pump oil for mass spectrometers Valves, fittings, O-rings, pressure gauges in oxygen enriched environments (ventilators) Medical injection device (Syringe, pumps, pens) Hospital (and home oxygen systems/units). Hyperbaric Very low vapour e pressure. Long-term it stability and functionality. c Low friction t Life-supporting systems no where an oxygen- PCTFE (oil) PFPE/PFTE Fluorocarbon gel (not further specified) PCTFE (oils and greases) n - do Renewable io energy t (see pre-publica A.3.13) oxygen chambers. Anaesthesia machines. Nitrous oxide systems. Wind power - lubrication of screws, nuts, magnetic anchors, bolts etc. Wind power (bearings) Fuel cell technology - assembly aid e.g., grease for O-rings Energy storage and energy conversion via hydrogen such as PEM - bearings and as lubricant additive in plastics Lubrications of screws, nuts, magnetic anchors, bolts etc. Casing/tubing sealants for high-definition threads in high enriched atmosphere (>23% O2) or highpressure air is required Low friction; very good wear-resistant and tribologically irreplaceable properties High temperature resilience; chemical resistance Excellent tribological properties, very good friction properties, eliminate noise, easy assembly Temperature, low outgassing (vacuum, applications) Low friction; very good wear-resistant and tribological properties Not specified PTFE (0.25 - 25%) PTFE PFPE PTFE PFPE Fluoropolymer (not further specified) PTFE (0.25 - 25%) PTFE Off-shore / Oil & gas (see A.3.16) chrome steel Bearings Thermo-oxidative stability, low vapour pressure, low flammability, chemically PTFE (30-70%) PFPE (30-70%) inert Sealing systems for Chemically stable in PCTFE (oils) centrifugal and rotary pumps contact with reactive, corrosive or explosive liquids and gases 138 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / Application Properties PFASs (and sector concentration examples provided by stakeholders) Anti-seize lubricant for drilling PCTFE tools in hydrogen sulphide environments Alkylation lubricant PCTFE (compatible with HF and sulphuric acids) Instrument fill fluid for oil PCTFE exploration equipment Machinery for production of PFASs-based lubricants PTFE oxidising chemicals do not react with oxygen and thereby ion - do not Chemical pre-publicat industry Bursting discs and gaskets for heat exchangers, synthesis units and reactors Valves, fittings, couplings, Orings and seals exposed to reactive and corrosive chemicals. Chlorine (and bromine) industry: Vacuum pump oils, compressor oil, valve and plug cock grease, lubrication for chlorine vaporiser, valve stem lubricant, assembly and repair of chlorine cylinder valves, tank car maintenance (valves), thread lubricant Sealing systems for centrifugal and rotary pumps. Sealing systems for rotary agitators and mixers in reactive chemical processes. Sealants for flange faces. Lubricants for equipment used in the fluorination process for blow-moulding polyethylene bottles and lower/prevent the risk of fire, auto ignition and explosion compared to other types of lubricants Chemical inertness Chemical inertness in contact with reactive, corrosive or explosive liquids and gases Chemical resistance in aggressive environment Chemical inertness in contact with reactive, corrosive or explosive liquids and gases Chemical inertness in contact with reactive, corrosive or explosive liquids and gases PTFE PFPE PCTFE PCTFE PCTFE cite (oils and greases) (oils) gasoline tanks Sulphur trioxide spill control Chemical inertness in PCTFE (oil slurried with mixture contact with reactive, hollow glass beads) corrosive or explosive liquids and gases 139 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / Application Properties PFASs (and sector concentration examples provided by stakeholders) Oxygen service - lubricants Chemical inertness in PCTFE (oils and greases) for remote control solenoid contact with reactive, valves, thread lubricant, corrosive or explosive instrument fill fluid, rotary liquids and gases meter lubricant, diaphragm compressor oil, vacuum pump oils for evacuating oxygen cylinders and bulk (cryogenic) storage tanks, vacuum pump oils for oxygen plasma cleaning, bearing grease for Bulk gas industry liquid oxygen (LOX) pumps and lubricant for compressors in portable oxygen plants Welding gases - lubricants for Low outgassing, bearings in LOX pumps and Chemical inertness in ation - do Metallic working industry (see A.3.5) re-pub Steel industry p (see A.3.5) vacuum pump oils for evacuating oxygen cylinders Helium service - oil for helium compressors and lubricants for helium regulators Carbon dioxide pump oil Cutting/drawing/forming oil for processing refractory metals such as tantalum, molybdenum, tungsten, rhenium, titanium and niobium Manufacture of woven wire and cable for safe use in aggressive applications Additive to other cutting oils for enhanced tool life Machining of high nickel alloys Grease for swivel joints in oxygen delivery systems and oxygen heating systems contact with reactive, corrosive or explosive liquids and gases Low outgassing, Chemical inertness in contact with reactive, corrosive or explosive liquids and gases Low outgassing Chemical inertness in contact with reactive, corrosive or explosive liquids and gases Chemical inertness in contact with reactive, corrosive or explosive liquids and gases not cite PCTFE (oils) PCTFE (Oils) PCTFE (Oils) PCTFE PCTFE PCTFE PCTFE PCTFE (grease) Wastewater chemicals - PCTFE lubricants are PCTFE lubricants that are compatible compatible with e.g.: Water and with water treatment oxygen, ozone, hydrogen wastewater chemicals that are used in peroxide, chlorine, treatment chlorinators, pumps valves calcium hypochlorite, etc. sodium hypochlorite and chlorinated cyanurates 140 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / Application Properties PFASs (and sector concentration examples provided by stakeholders) Swimming pool chemicals - PCTFE lubricants are PCTFE lubricants compatible with compatible with e.g.: compacting equipment for calcium hypochlorite and tableting swimming pool chlorinated cyanurates chemicals Lubricant encased within Chemical inertness Not specified peristaltic pumps which are not cite Diving equipment n - do Handicap io assistant equipment t (medical a devices, lic see A.3.10) used in applications of the potable water industry for chemical dosing Diving Equipment with O2 contact Valves, fittings, O-rings, pressure gauges in oxygen enriched environments Diving gear Prosthesis, orthosis, wheelchair, exoskeleton etc.; piston and gear wheel applications; Lubricant additive in plastic components Roller bearings of corrugated paper machinery PFAS-based lubricants do not react with oxygen and thereby lower/prevent the risk of fire, autoignition and explosion compared to other types of lubricants Long-term stability and functionality are crucial PTFE PFPE Life-supporting systems where an oxygenenriched atmosphere (>23% O2) or highpressure air is required Temperature resilience, chemically resistant, non-stick, not flammable, noise reduction PCTFE (oil and grease) PTFE High temperature resilience PTFE (3-100%) PFPE (3-100%) pre-pub Paper Lubrication processes in relation to pulp-bleaching chlorine, sodium chlorate, chlorine dioxide, oxygen and hydrogen peroxide. Polymer processing industry (injection mould lubrication). Chemical compatible with chlorine, sodium chlorate, chlorine dioxide, oxygen and hydrogen peroxide Temperature resilience, low friction PCTFE PTFE (5-30%) PFPE (5-30%) Often micro-powder PTFE is added as lubrication/polymer processing additive to the Plastics polymer before processing (internal lubrication). Lubrication of ejector pins, sliders, folding units and sliding surfaces in plastic injection moulding tools (external lubrication). 141 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / Application Properties PFASs (and sector concentration examples provided by stakeholders) Lubrication on silicone cable PFPE is compatible with PFPE accessories silicone Bearings that support chains High temperature PFPE that runs through an oven. resilience Plastic films are generally heat-treated in continuous ovens at high temperatures (> 200C) Rubber/tir e industry Lubrication of tire moulds to reduce galling, roughing or warping at movable joints. High temperature resilience Bearings that support chains High temperature that runs through an oven. resilience Textile (see Textiles are generally heat- A.3.3) treated in continuous ovens at high temperatures (> Pharmaceu tical o industry d Consumer - (see A.3.6) blication Other u sectors and p industrial - application e s not r specifically mentioned p aboveb 200C). Clean room applications (including robots in clean room) Dry-film lubrication of bike chains Dry-film lubrication of Waterproof zippers Chains, bearings/ballbearings/sliding bearings, pivots, valves, and selfoperated regulators Plain bearings for e.g., hinges, seat recliners, vibration dampers, chain tensioners, shock absorbers, pumps, ropeway suspensions, etc. All kinds of industrial machines with moving parts Valves Dry lubrication for assembly of bolts, screws nuts and joints in general Various 'oxygen service' applications, i.e., lubrication Low outgassing Various PFPE (grease) ite PFPE not c PFPE PTFE PTFE PFTE PFPE Various PTFE and PFPE combinations in systems with a high risk of contact with high oxygen concentration (e.g., when applying some types of pumps). Mechanisms and devices under high vacuum Offices machines, including heaters and printers 142 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Branch / sector Application Properties PFASs (and concentration examples provided by stakeholders) Power tools Lifts and escalators a"NSF-H1" is an approval system for food-grade lubricants. b Agriculture, construction, fluid power, process industries, robots and robotics, 3-D printing at industrial scale, power and energy distribution, district energy and building automation, metallurgy and mining, marine equipment, pulp and paper, machinery sector (e.g., snow blowers, lawn movers, gears and belts of conveyers) Name and other identifiers of PFASs used in lubricants ite Based on input from stakeholders and information from literature (Glge et al., 2020) 38 PFASs was identified at being in use or used at some point in lubricant applications. Glge et c al. (2020) further identified three PFASs as being patented for use in lubricant applications. t Of the 38 PFASs identified at being in use or used at some point in lubricant applications 19 o are polymeric PFASs (15 PFPEs, four fluoropolymers and one other), 18 are non-polymeric n PFASs (15 non-ionic and three ionic) and one substance is considered as unknown, as no information was available on its chemical identity. o Six of the 15 identified PFPE are used as base oils in lubricants and two are used as additives. d For the last seven identified PFPE, the properties in lubricants is not available. Most of non-polymeric PFAS-based solvents identified are fluorinated liquids often called - functional or engineered fluids. These substances are also mentioned in section A.3.9 and A.3.10. ion In Table A.107 of the appendix examples of PFASs used in lubricant applications are provided. t A.3.15.2. Volumes a In Table A.60 the estimated annual volumes of PFASs in lubricant uses in the EEA is given. lic The estimates are primarily based on input from stakeholders. Table A.60. Estimated PFASs volumes in lubricants used in the EEA in 2020. b PFAS use Volume (t/y) Comments uRange Midpoint re-p Base oil 300 - 800 550 This covers only PFPE base oils as no information on the volume of other PFASs-based base oils like PCTFE and fluorosilicon oils was received. p Micro-powder PTFE additive 800 - 1 200 1 000 Other additives than 1 - 10 6 PTFE PFAS-based carrier and deposition 35 - 75 55 solvents PFAS-based cleaning 35 - 75 55 solvents Total PFASs 1 171 - 2 160 1 666 143 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Wood (2022) estimated the total quantity sold in the EEA of fluoropolymers used in lubricants to be 1 500 tonnes in 2020 which is higher than for fluoropolymers (PTFE) in Table A.60. According to information received from an industry stakeholder, between 1 000 and 5 000 tonnes fluorinated lubricants are produces in the EU per year. Note that this volume includes other components than PFASs. No data has been identified to quantify in any detail the share between formulation, import and export of lubricants containing PFASs, although one estimate is that about 90% of lubricants used in the EU are manufactured in the EU. This estimate has been challenged by stakeholders in the second stakeholder consultation based on the high PFPE manufacturing capacity in EU (Solvay Solexis (Italy)). A stakeholder also states that: "In recent years, there has also been an uptick in the EU importation of PFPE base oils from emerging Chinese producers". ite Further it shall be noted that there is international trade in articles containing PFASs-based lubricants (in cars, pumps, bearings, etc.). No quantitative data on these trade aspects have c identified or received. t A.3.15.3. Summary no Because of the wide range of properties, PFASs are widely used in lubricants, either as (part of) base oils (PFPEs and PCTFE), as micro-powder additive (PTFE), or in very low volumes as other additive (wide range of PFASs) or as a solvent. Stakeholders report an estimated annual o PFASs use of between 1 200 and 2 200 tonnes (rounded numbers). Approximately one third pre-publication - d of the PFASs used are (part of) base oils and two thirds are micro-powder additives. 144 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.16. Petroleum and mining A.3.16.1. Uses Because of the vast range of properties PFASs are also used in the petroleum and mining industries. A summary for the general public was made available (NEA, 2021). First the uses of non-polymeric PFASs are described for both the petroleum and mining industry followed by the uses of polymeric PFASs. Use of non-polymeric PFASs in petroleum industry The uses of PFASs in the oil and gas industry, as discussed by Glge et al. (2020), and defined according to the OSPAR0F38 categorisation of chemicals used in the oil and gas sector, are e the following: cit Drilling fluids: Fluorinated surfactants act as a foaming agent that initiates and extends the fractures in the formation. Stimulation chemicals: fluorinated surfactants have t become more commonly used in enhanced oil and gas recovery (EOR) to support the displacement of the oil/gas from the underground sand and rock formations. o Production chemicals: PFAS-based products are commonly used as anti-foaming n agents. Water and gas tracers: PFAS-based tracers are used as water and gas tracers to map oil and gas reservoirs. They are considered low risk and can be detected at extremely o low concentrations. d Other uses: Evaporation of liquid fuels (e.g. gasoline) can be prevented by an aqueous surface film containing anionic surfactants, including PFAS-based chemicals (Glge et - al., 2020). The same properties may be exploited in the containment of gas and oil within transport of petroleum products. However, this has so far not been confirmed in active use in Europe. Oil spills on water can be contained and prevented from n spreading by a chemical barrier consisting of a fluorinated surfactant (Glge et al., io 2020). Further minor use of PFAS as extraction solvents in analytical equipment for oil content analysis has been identified. t EOR may be performed after production in a well has already been conducted for a a while in order to support the displacement of the oil or making it easier to flow by lic altering its properties and thereby increase the production. Data collected during the consultation indicated minimal use of PFASs for enhanced oil/gas recovery stimulation products in Europe. There are no identified products currently on the market for this b application. u Use of non-polymeric PFASs in mining industry p In the mining sector, PFASs (including both PFCA salts and PASF compounds) are reported to - have been used, for example to increase the extraction efficiency in copper and gold mining. e Based on the Glge et al. (2020) review, the specific functions provided by PFAS in the mining r sector include the following: p Use as an acid mist suppressing agent in mineral recovery. Agents to increase wetting of the sulfuric acid or cyanide used to leach ore, enhancing the amount of metal recovery. Use as hydrocarbon foaming agent. Fluorinated surfactants used in ore floating to create stable aqueous foams to separate the metal salts from soil. Use in the recovery of metal salts from aqueous solutions. 38 The Oslo and Paris convention for the Protection of the Marine Environment of the North-East Atlantic. 145 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) It is unclear to what extent these practices are currently required/utilised in Europe and hence if/which PFAS compounds are currently being used for these applications. It has been indicated, based on input by industry, that non-polymeric PFASs are not being used widely in the mining sector in Europe. However, no further input has been received to definitively confirm the level of ongoing use, and the specific application of PFASs in this sector. Uses of fluoropolymers in the petroleum industry A wide range of fluoropolymers such as fluoroplastics and fluoroelastomers are identified as being used in the oil and gas industry. The most common use for these materials in this sector is in the components of the equipment and piping used in extraction, transport and storage of petroleum resources. Oil and gas transport and storage equipment ite Pipes and tubes used in the production and transportation of oil are generally large and for economic reasons are typically manufactured from carbon steel rather than more expensive c corrosion resistant alloy (Glge et al., 2020). Lining the interior surface of oil well pipes with t fluorocarbons, such as PTFE, can help to prevent or reduce oil-induced corrosion, caused by its acidic nature. Lining the exterior of offshore pipes also protects them from corrosion o through sea water. Furthermore, fluoropolymers are used in leak proofness layers for flexible n pipes conveying oil or gas and for elastic tubes for submersible pumps. Fluoropolymers are widely used in the equipment and piping used in extraction machinery or o infrastructure. Based on the input from industry (manufacturers, suppliers, and downstream d users, through CfE responses and further consultation), the main uses for fluoropolymers include the production of the following components used in oil and gas extraction equipment. In Table A.61 a summary of uses in the petroleum industry is given. - Table A.61. Main PFASs uses in petroleum industry. n Examples of sub-uses of fluoropolymers in the petroleum industry io Lining of piping, flowmeters and fittings, Filtration equipment (e.g., HEPA filters - a t compensator joints, fluid-handling synthetic composite with `expanded' PTFE a components, process vessels, tanks, storage membrane) lic and transport containers Flexible risers and flowlines Vibration dampers Liners in the high-pressure lines used in Packer elements b offshore choke and kill systems Seals used in downhole drilling operations Pneumatic actuators, pneumatic regulating u (e.g., flange sealing applications, wellhead devices p and Christmas tree equipment) - Valve bodies Blow-out preventors e Valve packing Stators and "mud motors" r Valve seals, elastic tubes Submersible pumps p O-rings Pump liners Pipe gaskets Packaging vents - leaking and rupturing Capacitive sensors and their connecting Dispensers, nozzles, compressors cables Ball valves, Subsea hydraulic couplers Fluid transfer equipment Heat exchangers Flexible pipes The key functional property that makes fluoropolymers important in this sector is the extreme durability and capability of maintaining their form and mechanical strength and corrosion 146 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) resistance under the extreme environments found in down hole drilling (e.g., high temperature, high pressure, presence of steam and harsh chemicals). Fluoroelastomers have elastomeric properties resulting from crosslinking at molecular level. Fluoroelastomers are widely used to produce components (e.g., seals, liners, valves, O-rings, gaskets and packer elements). Other properties include e.g., rapid gas decompression resistance, extrusion resistance and resistance to compression fluids. Cables Polymeric PFASs are used in the cable insulation for communication cables in oil and gas drilling. For example, the resistance of several fluoropolymers to harsh chemicals and heat have allowed them to be used and marketed in numerous wire and cable applications in the onshore and offshore oil and gas sector, including electrical downhole cables, fibre optic e downhole cables and hybrid electric/fibre cables. Cable insulation made from PFA, PVDF, FEP it or ETFE can withstand extremely high temperatures near the bottom of the well. c Use of fluoropolymers in mining t There are indications of fluoropolymer use (fluoroplastics and fluoroelastomers) in the mining o sector in Europe. However, very limited input from the mining industry was provided. n The key applications for which PFAS-based chemicals are used in the petroleum and mining industries are summarised in Table A.62. While it is expected that PFASs will be used in o refineries of petroleum products, no data was available on current products, or their volumes d of use in Europe in the CfE. It is not clear if refineries are covered by the use category of chemical processing where the use of PTFE gaskets for petroleum refineries (e.g., Philips alkylation process) has been noted. - Table A.62. Summary of polymeric PFASs used in the petroleum and mining industries. n Use Sub-usea Property licatio Petroleum exploration pre-pub and production Drilling fluid/production chemicalsb Stimulation chemicals Water and gas tracers Other Extraction of ores and minerals Fluorosurfactants and anti-foaming agents Enhanced oil/gas recovery stimulation products Tracers used to map oilfields Chemicals used in the storage or containment of oil and gas Fluoropolymer used in pipeline, valves, gaskets, O-rings, seals, cable and wiring insulation, flexible pipes Acid mist suppressing agent Wetting agents Mining applicationsc Hydrocarbon foaming agent (Flotation) Fluorinated surfactants used in ore floating (Flotation) Equipment Fluoropolymer used in pipes, cables, hoses, conveyor belts, gaskets, bearings, membranes a For petroleum extraction, as defined under the Harmonised Mandatory Control System under OSPAR Decision 2000/2. This does not apply to mining. b Referred to as `Chemicals used in the actual production and processing of hydrocarbons' under OSPAR c Uses not covered under OSPAR Decision 2000/2. 147 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A variety of PFASs (non-polymer PFASs, fluoropolymers) are used in petroleum and mining. Around 100 substances (with and without CAS numbers) are identified in this sector. The list of PFASs used in this sector is not provided here as it is partly reported in the Glge et al. (2020) recent publication and partly due to Confidential Business Information. A.3.16.2. Volumes For the forward-looking trends (2020-2050), it is noted that petroleum production is expected to decline significantly in Europe over this period (Table A.63). It is, however, noted that the demand for PFAS-based tracer and anti-foaming agents and fluoropolymers is expected to increase in future years due to harsher conditions for future oil and gas exploration and production applications. Table A.63. Baseline projections (including UK) for volumes of PFASs and fluoropolymers e used (t/y) in the petroleum and mining sector. it Compound Estimated volume of PFASs (t/y) c 1990 2000 2010 2020 2020 range midpoint t Water and PFAS-based 0.0 0.3 0.6 1.0 1.0 gas tracers no tracers Production chemicals do Fluoro- polymers - (all) Fluorosiloxanebased antifoaming agents - 0.0 2 000 4 300 1.1 - 2.8 2.3 - 5.6 3.4 - 8.5 6 2 500 5 400 3 000 6 400 3 500 - 7 500 5 500 ion Water and gas tracers t According to stakeholder information fluorinated alkanes are used as tracers in certain cases, a depending on reservoir characteristics and the range of other tracers used. Industry input notes that such tracers are used sporadically in small (10-15 kg) quantities39. Additional data, lic provided by national authorities on the basis that the chemical identity of the tracers is confidential, demonstrates that other PFAS-based compounds are also used as tracers in the b oil and gas sector in quantities at about 1.0 t/y. Hence, the volumes of PFAS-based tracers of confidential identity represent the main bulk (ca. 99%) of PFAS used for this application, u and a total volume of use is estimated at 1.0 t / y. p Production chemicals e- Information on the volumes of production and sales of fluorinated polysiloxane-based antir foaming agent products in Europe has been provided by a small number of suppliers (two) as p part of the CfE. In the absence of information of the current market share of hese suppliers, it has not been possible to produce an estimate for total levels of production and sales of these products on the European market. However, data has been provided from national authorities to allow an estimate of current total volumes of use in Europe is ~170 tonnes per year. 39 https://www.bp.com/en/global/corporate/energy-economics/statistical-review-of-worldenergy.html, date of access: 2022-12-16. 148 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Stimulation chemicals Very little information on specific oil/gas well stimulation products currently being marketed and sold in the EU has been obtained. Information on current production or use of these products in Europe was not divulged in any responses to the CfE. When manufacturers or suppliers were contacted in direct consultation they did not know if these products were currently being marketed or used. Therefore, to the best of knowledge of the Dossier Submitters the use of PFAS-based products for well stimulation is likely to be minimal in Europe. Fluoropolymer applications Based on stakeholder input from one supplier a very approximate estimate has been derived for the use of fluoropolymers in the sector at 3 500 to 7 500 tonnes per year in 2020. e Estimates for historic use volumes of fluoropolymers were developed with basis in the it assumption that fluoropolymer use in 1950 was 0 and that the trend in levels of sale have grown with linear progression from 0 kg in 1950 up to present volumes in the 2020 baseline. c Very little information on volumes of fluoropolymer products specific for petroleum and mining t are available. However, in the consultation one stakeholder commented that the estimated volumes might be underestimated. no A.3.16.3. Summary Because of the vast range of properties PFASs are widely used in the petroleum and mining o industries. In petroleum exploration and production PFASs are used as e.g., drilling/fluid d production chemicals, stimulation chemicals and water and gas tracers. A wide range of fluoropolymers are identified as being used in the oil and gas industry. The most common use - is in the components of the equipment and piping used in extraction, transport and storage of petroleum resources. In mining, PFASs are applied for e.g., extraction of ores and minerals and in several equipment (e.g., in pipes, cables, hoses and membranes). A very approximate n estimate has been derived from this assessment, suggesting the estimated total sales of io fluoropolymers in Europe in 2020 for use in the petroleum and mining sector is 3 500 to 7 pre-publicat 500 tonnes per year. 149 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.17. Active substances in Plant Protection Products (PPP), Biocidal Products (BP) and Medicinal Products (MP) A.3.17.1. Uses Active substances in Plant Protection Products (PPP), Biocidal Products (BP), and Medicinal Products (MP) are considered being somewhat different chemically from other PFAS subgroups. Generally, these active substances are substances that are characterized by the presence of one or more CF3-group(s) in their molecular structure40, mostly aromatics. Introducing this group in the molecular structure of biologically active substances could alter specific properties, such as stability and lipophilicity. A side effect of the introduction of the CF3-groups in the molecular structure, is that e metabolites and/or degradation products can be formed that are extremely stable and it potentially hazardous. Trifluoroacetic acid (TFA) is one of the possible major metabolites/degradation products for these types of substances. TFA is extremely persistent c in the environment. t In this chapter an overview is given of active substances in PPP, BP and active pharmaceutical ingredients (API) in MP, regulated in the EU by their respective regulations (Table A.64). no Table A.64. Active substances in PPP, BP and MP and their respective regulations. Uses Legislation o Active substances in plant protection products Regulation (EC) No 1107/2009 (PPPR) d Active substances in biocidal products - Active pharmaceutical ingredients (API) in human and veterinary medicinal products Regulation (EU) No 528/2012 (BPR) Directive 2001/83/EC (human); Regulation (EC) 726/2004 (human and veterinary) tion To provide an impression of the amount of PFAS used as active substances in MP, PPP or BP, a non-exhaustive overview of these substances is given in Table A.108 to Table A.110 in the a Appendix: lic A search for PFAS within the scope of the current chemical definition yielded 48 hits for active substances in PPP (see Table A.108). Some of them are listed being active b substances in PPP as well as in BP. u A search on ECHA's webpage for EU biocidal active substances containing fluorine yielded nine biocidal active substances that fulfil the current PFAS definition. These p substances are currently approved as biocidal active substances and include the - product types PT18 (insecticides), PT08 (wood preservatives), PT14 (rodenticides), e PT07 (film preservatives), PT09 (fibre, leather, rubber, polymer preservatives), PT10 r(building material preservatives), and/or PT 21 (antifouling agents) (see Table A.109). p A search for substances following current PFAS definition, yielded 65 medicinal products authorised in the EU. It is also indicated whether the medicinal product appears on the WHO essential medicines list. The anatomical/therapeutical group (assigned by WHO) and CAS no are added. The ATC is a drug classification system that classifies the active substances of medicinal products according to the organ or system on which they act and their therapeutic, pharmacological, and chemical properties (see Table A.110). 40 Co-formulants present in PPP, BP, and MP may also be defined as PFAS. These substances are not covered here. 150 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.17.2. Volumes These substances will be shortly mentioned, but no detailed information on volumes, emissions and alternatives will be collected and assessed since in Annex E the proposal is outlined to exempt these regulated substances from the restriction. As indicated in Table A.65, a rough estimation of less than 5% of total PFASs is the already regulated PPP, BP and MP: 0.2% for active pharmaceutical ingredients in medicinal products and 2% for the active substances in plant protection products. No data was available on active substances in biocidal products. Table A.65. PFAS numbers, used as active substances in PPP, BP, and MP. Use Amount EU Details and assumptions e Human use numbers, prescribed medicines, numbers are it extrapolated to EU based on number of inhabitants. PFAS Active c Pharmaceutical t Ingredients (API) in o human n medicines > 500 t/y > 0.2% compared to total PFAS do PFAS Active Pharmaceutical Ingredients - (API) in veterinary n medicines tio PFAS active substances in a Plant lic Protection Products 5 479 t/y 2% compared to total PFAS b PFAS active u substances in p Biocidal - Products At human use, the non-prescribed medicines (also known as over the counter (OTC) sold medicines) are not considered. This estimation is on human use only. Per- and polyfluorinated gases used in propellants are not included. When a substance is used as propellant it is not considered an API. Whereas when the same substance is used as an anaesthetic, it is considered an API. No information on volumes is available. Rough estimation based on ratio of PFAS PPP/total PPP in NL times total PPP in EU. o Total PPP in NL (2019) is 9 294 t/y (according to The Netherlands Food and Consumer Product Safety Authority (NVWA)) o PFAS PPP in NL (2019) is 152 t/y (1.6% of total PPP in NL) (NVWA) o Total PPP in EU is 335 000 t/y (Eurostat) No information on volumes is available. pre A.3.17.3. Summary PFASs used as active substances in PPP, BP and MP are generally characterized by the presence of one or more CF3-group(s) that have been introduced in their molecular structure to alter properties such as stability and lipophilicity. At least 48 active substances in PPP were identified as PFASs, 9 active substances in biocidal products in various PT groups and 65 active substances in medicinal products. However, these active substances were exempted from this assessment. Based on extrapolated data from the NL on use and prescribed medicines, volumes are estimated to be > 500 t/y for API in human medicines and for active substances in PPP the volume was estimated to be 5 479 t/y. No data was available for BP and veterinary medicines. 151 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.3.18. Waste A.3.18.1. Introduction REACH does not cover substances, mixtures and articles when they enter the end-of-life stage and become waste. However, the methodology for the REACH identification of risks of a substance for the environment and human health should take the waste stage into consideration (ECHA, 2010). Waste stage is the end-of-life stage. There will be delay between production and waste stage: Products put on the market will, depending on the substance / mixture / article lifetime, enter the waste stage (far) later. Applications with longer lifetimes i.e., passenger cars or construction material might have highly deviating waste quantities compared to production volumes in the same year. Also, EEA import/export disbalances might lead to deviating waste e tonnages compared to production tonnages. cit For destruction or recovery of fluorinated gases (partly) specific regulations exists and it must be reported to EU as part of the F-gas regulation (UBA, 2021). When prices rise, recovery t and reclamation become more important. Generally, waste streams for small residential appliances such as small air conditioning units, differs from the end-of life treatment for large o commercial and industrial systems: For the smaller appliances collection, storage and n treatment is organized under WEEE regulation. For the larger systems certified technical personnel is needed for the mandatory recovery of the Fluorinated gases according to the F- o gas Regulation. d Specific regulation does not exist for PFASs other than F-gases / fluorinated gases. - In this section an overview of waste collection and waste treatment is provided. Objects or substances that have become waste are not within the scope of REACH. However, PFASs in waste are important for the identification of risks of a substance for human health and the n environment. The information in this section is based on information from the individual io studies (volumes) in A.3.3 to A.3.17. t To identify waste streams that contribute most to human and environmental exposure the a following factors are of relevance: lic Waste streams with high volumes in the EU/EEA Waste streams with high average PFAS concentration or freight. b Waste streams with high recycling rates. Waste streams with high releases into the environment (landfilling, land application, u recycling). -p A.3.18.2. Fate of waste from use sectors e The following four use sectors of PFASs were therefore studied in more detail: pr 1. TULAC (textiles solely) 2. Food contact material and packaging (paper & board solely) 3. Electrical and electronic equipment (WEEE) 4. Transport: End-of-life-vehicles (ELV) Other uses also reach the end-of-life stage. For some uses the solid waste stage is less relevant i.e. because of most emissions are expected during use. See Table A.66 and Table A.67 below. This applies for ski wax, consumer mixture, metal plating and cosmetics for instance. The latter two will have emissions but mostly directly via water to WWTP. Uses, other than the 4 mentioned above, are not elaborated on in detail, but waste stage emissions in Annex B.9. will calculated using ERCs. 152 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.66. PFAS entering the solid waste stage. In light green the uses for which the waste stage is described in more detail because it is considered of higher relevance. PFAS use Polymeri Fluorinat PFAAs Open Articles c PFASs ed gases application (high relevance for (low PFAS load waste stage & entering waste recycling if ticked) stage) Lubricants x x x TULAC x x x Food contact x x x materials and packaging Consumer mixtures Construction x products Cosmetics Metal plating x Ski wax Transportation x x x x x x x x cite not x Petroleum & Mining o Medical x d applications HVACR Electronics, x - semiconductor Energy x x x x x x x x x x ion Table A.67. PFAS tonnages entering the solid waste stage (t/y in t Use Tonnages enter solid awaste stage (t/y) lic TULAC 50 853 FCM & packaging 24.565 b Manufacturing of metal 984 u products and metal plating -p Consumer mixtures ** re Cosmetics ** p Ski wax 1 x x x x EEA). HVACR decommissioning 19 724 Medical devices 8 500 Transport 6 410 Electronics and semiconductors 3 752 Energy* 2 995 Construction products 6 495 153 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Use Tonnages enter solid waste stage (t/y) Lubricants 1 447 Petroleum and mining 1 PPP, BP and MP ** *: Waste from the energy sector is expected to sharply increase as many of the first windmills from 2025 years ago are currently replaced. Amount of accruing blade material from stripping down wind turbines in Germany alone: 20 000 t/y. (Windmill blades are often coated with fluoropolymers). For solar panels the same is applicable: Sharply increasing waste volumes. (And solar panels front- and back sheet are often coated with fluoropolymers). **: Waste stage emissions of lesser importance (use phase emissions of most importance). ite Additionally, PFASs in sewage sludge were investigated as this is a potentially important indirect source for PFAS emission in the waste stage. c Finally common waste treatment methods, which are applicable for almost all PFAS uses, t haven been studied: landfilling and incineration. Next to that also land application/composting and recycling have been studied. Emissions from waste treatment (waste collection emissions o exempted because of lacking data) are mentioned in Annex B.9. n Waste collection o Waste is collected by private or municipal waste collection services. Via bins and containers d waste is loaded on/into trucks and lorries and transported to pre-sorting / waste transfer stations or directly to final treatment such as landfilling or waste incinerators. - For PFAAs the production waste of PFAS manufacturers is of importance as was seen in the Netherlands where PFAA / PFASs polymerization aids were spread broadly via waste collection n companies. For fluorinated gas appliances collection specific regulations exist as mentioned io above. t For end-of-life fluoropolymer applications, commercial and industrial waste streams are the a most relevant. A smaller proportion of fluoropolymers ends up in municipal waste. In Figure lic A.21 an overview of fluoropolymer waste is plotted based on data of PlasticsEurope (Conversio, 2022). The chemical industry, automotive, electronics & semiconductor and Medical & Pharma are the largest contributors to fluoropolymer waste in Europe (Table A.68). pre-pub Statistical gaps exist between officially collected waste and waste generated. 154 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) ot cite Figure A.21. Fluoropolymer waste collection in Europe (2020) and main sectors based on stakeholder information. o n Table A.68. Collected fluoropolymer waste in Europe in 2020 per industry segment. d Industry segment Collected fluoropolymer waste in 2020 (in kt) - Transport (automotive only) 3.5 Aerospace 0.3 ion Electronics & semiconductor 2.7 t Medical & Parma 2.3 lica Chemical industry 9.4 Other 5.3 ub TOTAL 23.5 -p Textile waste re Watson et al. (2018) estimated that an average of 36% of textile is collected separately, in p seven EU countries (DE, DK, FR, IT, NL, SE and UK, years assessed 2010-2016). The overall amount of textile entering a specific waste treatment option cannot be determined precisely e.g., because of a lack of data on the share of textile waste in "Health care and biological wastes". A high share of textiles enters "Household and similar waste" (64% are not collected separately). Most of this waste category is incinerated (with or without energy recovery) or is disposed of in landfills. It is therefore assumed that the largest proportion of textile waste is treated accordingly. In line with this, it was stated by Boiten (2021) that 87% of the total fibre input in Europe is ultimately destined for landfill or incineration, with significant leakages into natural environments. 155 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Generally, it must be noted, that apparel and other textiles which are reused can contribute to the global distribution of PFASs. Considering the average lifetime of textiles and apparel, it can be estimated that if a full ban of PFASs was to take place in 2025, PFAS concentration will still be present in waste streams until 2037 and beyond, dependent on the increase of recycling. Export of second-hand textile outside EEA is likely also of relevance. Waste from FCM - paper and board packaging The yearly EEA quantity of PFAS used in paper and board packaging was estimated between 827 and 4 962 tonnes, based on intentionally added PFASs (Hollins, N/A). According to a stakeholder "PTFE coated/ printed materials need to be correctly collected, e sorted and recycled. In recycling processes PTFE waxes should be removed before releasing it washing water into the environment ". As PTFE is persistent, it likely stays either in the recycled paper or aluminium and/ or is released to water. Non polymeric PFASs are also likely c to be present in lacquers and ink applied to (food contact) paper. t The average lifetime of food packaging can be assumed to be around one year based on o information on plastic packaging (Conversio, 2018), but could be higher for other applications n such as cupcake forms. Depending on the food collection system in place within the country and sometimes the o municipality, the collection of these items can differ. Food-contact articles and thermal paper, d wet-proof and/or greaseproof impregnated and/or glued paper and cardboard41 shall be disposed of in the residual waste in Germany (UBA, 2020). Similar approaches are assumed for other European countries as paper for recycling must be kept separate from other waste - as contaminated papers are not acceptable for recycling (EPRC, 2021). n The reality, however, can differ, and items can be and are partly disposed of via the separately io collected paper waste. t Within Eurostat "Paper and cardboard waste" encompasses waste from paper and cardboard a packaging (15 01 01) as well as paper and cardboard waste from mechanical treatment (19 12 01) and separately collected fractions (20 01 01) (EC, 2010). Considering the findings on lic the littering of plastic waste from Jepsen et al. (2020) it is not unlikely, that part of PFAS- containing paper and cardboard waste fractions are not accounted for in Eurostat waste data b as they enter into the environment directly via littering. u Within Eurostat, the waste fraction "Household and similar waste" contains bulky waste (20 03 07) as well as street-cleaning residues (street-cleaning residues). Based on Eurostat data p from 1990-2001 bulky waste presents a share of on average 8% of household and similar - waste. This is based on data reported for 2000 and 2001 for several European countries e (European Communities, 2003). pr In the "Paper and Cardboard" waste stream all of the waste amount in EEA is treated by recovery through recycling (see Appendix), except a minor amount in Western Europe that is recorded under energy recovery (R1). Considering that FCM packaging end up in the paper and cardboard waste stream to a limited extent, it is likely, that a large share of FCM is either landfilled, incinerated or composted if it is disposed of as residual waste. With regards to the fraction of paper in household waste (see Appendix), the Netherlands 41 such as posters, coffee-to-go cups, fast food wrappers, baking paper, muffin forms as well as solid, empty paper packaging such as pizza cardboard packaging, varnished, glazed or chromo papers, and boards produce with plastic varnishes or films as well as papers with adhesives applications which cannot be easily separated such as sticky notes, self-adhesive seals for envelopes. 156 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) report around 20% of the paper in the household residual waste based on samples taken (Rijkswaterstaat, 2017). Germany states that around 5.2% of the residual household waste corresponds to waste paper, other European countries indicated shares of around 21 to 30% of the paper in residual waste (BMUV, 2020; Zero Waste Europe, 2020). Based on the calculated average, as no information on all EEA countries is available, an average share of paper and cardboard in the household/residual waste of 19% can be assumed. Considering the average lifetime of FCM and especially paper and board packaging, it can be estimated that if a full ban of PFASs was to take place in 2025, PFAS concentrations will likely decrease within a few years depending however on paper recycling. WEEE The quantity of PFAS used in WEEE including the semiconductor and the energy industry is e estimated with a midpoint of around 5 800 tonnes per year. Substances regulated under the it F-gas Regulation were not considered within this estimation. c With regards to exports, a study conducted by the Basel Coordination Centre for Africa (BCCC) t and the United Nations University (UNU) found many incorrectly or completely undeclared WEEE exported to Nigeria during the research period (2015 to 2016). Appropriate disposal or o recycling leading to the destruction of the PFAS content is not necessarily ensured in the n importing countries. Thus, the disposal of WEEE in recipient countries may contribute to the global distribution of PFASs and thus to possible risks to human health and the environment. o The WEEE Directive currently does not contain any explicit provisions or requirements d concerning PFASs. Furthermore, despite the applicable regulatory framework of the WEEE Directive, illegal or unsound treatment may take place, creating a risk of emissions of PFAS contained in WEEE into the environment. - Finally, while Regulation (EC) No 1013/2006 on shipments of waste prohibits the export of n WEEE to non-OECD countries for recovery, recycling and disposal, illegal export can occur io (Odeyingbo et al., 2018). WEEE which is illegally transported to non-OECD countries could in turn undergo unsound treatment methods leading to emissions of PFASs and risks to the t environment in these countries. a In some cases, batteries will be treated together with the WEEE categories as batteries and lic accumulators are installed permanently. However, batteries must be removed under Article 12 (3) of the Batteries Directive (Directive 2006/66/EC)42 which in practice applies to some b applications (batteries in TV remotes). Data on the battery waste stream (alkaline, lead, Ni- Cd and other batteries) has been considered. No assumptions were made on the possible u quantities of batteries within WEEE as information is lacking and batteries should be removed p prior to treatment. - Especially lithium-ion batteries are used heavily and the growth due to electrification of e transport is extreme. These batteries contain PVDF (a binder) in about 1-1.4%. In the endr of-life stage risks related to toxicity and toxic emissions of lithium-ion batteries become p apparent and amplified. These emissions, including PFAS emissions, are of high risks since chemical transformation processes are not well understood. Incomplete combustion (temperatures< 850C) of fluoropolymer cathode materials but also fluorinated ingredients in the electrolyte can lead to the formation of various persistent PFASs. Potential products of the thermolysis of fluoropolymer binder (often PVDF or FEP) are: Short and long chain perfluoroalkyl acids (PFAAs); and CF4 (Zackrisson and Schellenberger, 2020). In the end-of-life stage the risks related to toxicity, fire and high voltage in the lithium-ion 42 It is understood, that batteries and accumulators according to Article 12 should be removed but in some applications, removal is not practically possible (permanently installed batteries) as such these are assumed to be treated within the WEEE. 157 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) life cycle become apparent and amplified. Lithium-ion batteries are a green technology but contain different hazardous substances, that can be emitted especially during e.g., fire events. These emissions are of high risks since chemical transformation processes are not well understood so far. Generally, the recycling and re-use of WEEE can contribute to the global distribution of PFASs, especially if they are sold as used equipment to developing countries without appropriate treatment capacities. The mechanism of extended producer responsibility (EPR) as laid down in the WEEE Directive additionally enables Member States to lay financial and/or organisational responsibility on producers of EEE concerning proper collection and treatment of WEEE. A recent report by the ECA (2021)indicated that currently only two Member States are on track to achieve the collection targets set for 2019 thereby putting the EU in danger of not meeting its ambitious targets for the collection of WEEE. It should also be noted that the WEEE Directive currently does not contain any explicit provisions or requirements e concerning PFASs. it End-of-Life-Vehicles (ELV) t c As cars have a long average lifespan, cars sold many years ago may enter the end-of-life stage today. Cars have an average lifetime of 17 up to 20 years (EC, 2019). As lower number o of cars were sold 20 years ago, the PFAS load entering waste stage from end-of-life vehicles n is lower than the PFAS tonnage (about 6 400 tonnes) put on the market today. The PFAS load, especially the fluoropolymer share in ELVs (usually around 12 years old), is significantly lower compared to modern cars put on the market. do In 2019, almost 16 million cars were put on the market according to ACEA. The Heinrich Bll Foundation's European Mobility Atlas 2021 mentions that every year, around 12 million cars leave European roads. Using Eurostat data for 2019, around 6.9 million ELVs were statistically - covered for EU27 + 1.6 million from the UK. This means that there are still large statistical gaps between the total number of ELV leaving the European roads and the number of ELVs n officially collected. io The quantity of PFASs used in vehicles in the EU corresponds to between 6 000 and t 14 500 tonnes per year (see also A.3.11.3). This tonnage will grow strongly as in modern a (electric) cars more PFASs are used. Plastics Europe mentioned in their report on fluoropolymer industry in Europe, that transport, as one of their key sectors, has the highest lic shares of fluoropolymer sales in 2015 with 15 500 tonnes (Wood, 2022). Within the U.S. transport is ranked as the second most important sector in terms of production value following b electronics (Fluoropolymer Industry, 2018). u As most PFAS-applications in vehicles are textiles and polymer applications, the relevant p fraction in which PFASs from ELV end up are non-ferrous materials from shredding also referred to as shredder heavy fraction (SHF) and the shredder light fraction (SLF). The SLF is - a mixed fraction and includes, for example, textiles, foams, plastics and plastic films as well e as broken glass, paint residues and wood (BDSV, 2012). Median values calculated based on r several literature sources indicate that a share of about 74% of plastics ends in the SLF. p Median values calculated for the SHF indicate a share of 4% of plastics (Martens, 2011; Ramboll Deutschland GmbH, 2020; Sander et al., 2020; Wilts et al., 2016). In the future, it is expected that the quantities of vehicles placed on the market will increase (Kuhnert et al., 2018). Next to that a shift to electric cars or hybrid electric cars is expected. In Germany, around 14% of all newly registered passenger cars in 2020 had an electrically powered engine (battery-electric, plug-in, fuel cell) (KBA, 2021). On the European market, the average share of new passenger plug-in electric cars lies at 11.4% in 2020 (Kane, 2021). For relevant waste streams, this means increasing quantities of SLF and SHF. Amduri (2020) estimated an increase to 1 - 2 kg PFASs/car in the future. With regards to disposal, data do not indicate if this refers to incineration without energy recovery or simply 158 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) landfilling. In several Member States, it is still allowed to dispose of SLF in landfills other countries require a pre-treatment of the SLF before landfilling (Mehlhart et al., 2018). Generally, neither the recycling process nor landfilling destroys the PFAS content within the relevant fractions. Both paths can contribute to the distribution of PFASs in the environment. The Heinrich Bll Foundation's European Mobility Atlas 2021 mentions that every year, around 12 million cars leave European roads due to total loss after an accident, economic write-off, non-compliance or a change in design preferences. Up to two thirds of vehicles leaving the European roads are handled in authorised recycling facilities. About one million cars are exported as used vehicles to non-EU countries. It is unclear how the other ca. 3 million cars are handled (Heinrich-Bll-Stiftung, 2021). ation - do not cite Figure A.22. A car's last journey. Source: European Mobility Atlas 2021. blic Landfilling u A considerable part of the European waste is still being landfilled, but percentages vary a lot p among the European member states (more landfilling in Central and Eastern Europe) as well - as in time (declining landfilling share) (CMS, 2013). The percentages also vary among the different waste types. re Many modern landfills are equipped with a plastic liner capturing the leachate. However, this p is not always the case for older landfills (Lang et al., 2017). In Europe the landfill directive (1999/31/EC) stipulates, that all newly constructed landfills need to be equipped with "a geological barrier and a bottom liner during the operational/active phase", however it is unclear how many landfills in Europe are currently equipped with liners. According to Eurostat 96% of the landfilled waste was non-hazardous waste with only 4% being hazardous, which is then deposited on the respective landfill. The exact number of landfills and landfill types is unknown, however according to Eurelco there are an estimated 500 000 (former) landfills in Europe with 90% preceding the EU-landfill directive 1999/31/EC. ECHA (2012) on the other hand provides default values for a landfill scenario stating that there are approximately (active) 8 400 landfills in Europe from which ~400 are for hazardous, 159 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) ~5 000 for non-hazardous and ~3 000 for inert waste. The data is however from 2006 and should be used with caution. According to Eurelco is can be stated with reasonable safety tha Europe host more than 500 000 (f) landfills43. Landfills have more or less a symbiotic relationship with Waste Water Treatment Plants (WWTP) as landfills send leachate to WWTP and WWTP send sludge to landfills. Incineration According to the Fluorpolymer Group (a subgroup of Plastics Europe) more than 50% of the fluoropolymers in the market stays in use for many years. Overall ~23 kt of fluoropolymer waste was disposed of in 2017 according to the Fluoropolymer Group of PlasticsEurope Incineration of PFAS containing waste is currently seen as the most effective treatment option e for (party) destroying PFASs. The fluorine in the PFASs will end up in either the bottom/fly it ash or the flue gas. Incineration has been used as a method of destroying other halogenated organic chemicals such as polychlorinated biphenyls (PCBs) and ozone-depleting substances c (ODSs). High temperatures and long residence times break the carbon-halogen bond, after t which the halogen can be scrubbed from the flue gas. PFAS compounds are however more difficult to break down due to fluorine's electronegativity. no The Confederation of European Waste-to-Energy Plants (CEWEP) reported 4992 waste-to- energy (WtE) plants which treated a total of 96 million tonnes of waste thermally in 201944. According to the waste incineration (WI) BREF there were 470 municipal solid waste o incinerators in Europe in 2019 with a total capacity of 87.44 million tonnes per year (JRC, d 2019). The WI BREF reported 121 hazardous waste incinerators in Europe in 2019 with a total capacity of 6.75 million tonnes of waste per year, however the exact incineration conditions are unknown. Table A.69 summarises this information. - Table A.69. Summary of numbers and capacity of European waste incinerators. n Source Number of non- Number of hazardous Capacity/incinerated io hazardous incinerators waste incinerators waste [million t] PRTR 472 t CEWEP 492 96 a WI-BREF 470 87.44 lic WI-BREF 121 6.75 b Recycling u Europe is striving to achieve a circular economy and to increase its circular material use rate. p Products from recycled materials are only possible if substances of concern, such as PFASs, - are avoided in products as much as possible. This is usually not the case in the typical e recycling processes of the considered waste streams. Hence, PFASs are often maintained in r the economic cycle and may pose an obstacle to produce safe products from recycled p materials. Especially paper & board, plastic packaging and WEEE waste streams are relevant from a recycling perspective. Sewage sludge from urban wastewater treatment Sewage sludge is generated in WWTP by separating undissolved particles from water, which is done in lagoons or basins. As WWTP receives waters from urban and industrial sources 43 https://eurelco.org/2018/09/30/data-launched-on-the-landfill-situation-in-the-eu28/#:~:text=With%20a%20reasonable%20safety%20level,the%20Landfill%20Directive%20(1999), date of access: 2022-12-16. 44 https://www.cewep.eu/waste-to-energy-plants-in-europe-in-2019/, date of access: 2022-12-20. 160 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) sludge can contain PFASs originating from the production and use phase of PFAS products (e.g. cosmetics). The most recent data was used to calculate the amount of sewage sludge for the EEA. Moreover, it must be noted, that the data reported within Eurostat on production does not align with the volumes treated as waste, which was also found by Bianchini et al. (2016) who highlighted the structural lack of homogeneity and reliability on the Eurostat data on sewage sludge. Generally, the total quantities fluctuate slightly but remain between 5.78 and 6.53 million tonnes per year since 2011. Within the EEA sewage sludge from urban wastewater treatment is disposed of or recovered (land application) in roughly equal proportions. Bianchini et al. (2016) reported, that due to the Landfill Directive (1999/31/EC) amounts of e sewage sludge disposed of in landfills will rapidly decrease in upcoming years as Member it States reduce the amount of biodegradable waste sent to landfills by 2016. c In Eastern Europe, an increasingly larger percentage of households connected to treatment t plants can be expected. Here, agricultural use of the sludge is still considered as the preferred disposal method. The reuse of biosolids as soil improver/fertilizer in arable crops represented o the most used disposal/recovery option in some European countries. This has led to n restrictions in the use of biosolids with Directive 86/278/EEC. However, an evaluation of the directive in 2014 has found shortcomings also with regards to contaminations such as PFASs. These are currently not regulated. Most countries in the EU have prohibited the use of o untreated sludge on land, while some Member States (France, Ireland, and the UK) permit d the use of untreated sludge (Collivignarelli et al., 2019). Currently, among the EU-27 countries France, Finland, Germany, Ireland, Italy and Spain have the highest share of biosolids recycled to land. - The sewage sludge mass flow (Appendix) indicates that a possible yearly total of 0.27 tonnes n of PFASs are not destroyed within the EEA. Especially the application on farm land poses a io risk, as PFASs can enter directly into the environment. This has been seen to cause massive problems in Raststatt Germany as wel as in Wisconsin, USA45. at Literature and measurement campaigns clearly show that precursors make a significant contribution to the total load of PFASs in WWTPs. WWTPs usually receive wastewater from lic both industry and households. PFAS concentrations are higher in wastewater with a high proportion of industrial wastewater. PFASs concentrations in industrial wastewater can be up b to a factor of 1 000 higher. Literature also shows that the quantities and type of PFASs depend u very much on the type of industry. Due to the large number of PFAS compounds and the p many use categories of these substances, tracing the origin of specific PFASs in wastewater is difficult (STOWA, 2021). STOWA measurements showed that PFAS concentrations in the - outgoing wastewater were often found to be higher than in the incoming wastewater. e According to the researchers there are both known and unknown PFAS compounds present in r the incoming wastewater. Currently, unknown PFAS compounds cannot be detected and p measured due to their instability. According to the researchers, these unstable, undetected PFAS precursors are partly converted into stable PFAS (where all available sites are occupied by fluorine atoms), which can be measured. This leads to the higher concentrations found in the treated wastewater. These findings confirm existing foreign research. Several of the analysed PFAS use waste streams have a high likelihood of adding PFASs into the waste streams and in cases where the PFASs are not destroyed, these waste streams can contribute to the global distribution of PFASs via recycling or other treatment options. Especially textile waste presents a high PFAS load in waste and a high share of PFASs not 45 https://www.theguardian.com/environment/2022/sep/19/us-states-toxic-sewage-sludge-pfasfarmers, date of access: 2022-12-16. 161 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) destroyed during its treatment. Similarly, the paper packaging applications of FCM can be seen as a possible source of PFASs into the environment due to the high share of recycling of paper. Further waste streams considered in the present investigation such as ELV and WEEE could grow strongly in the coming years. (Especially the market for electric vehicles, which contain more PFASs, likely will grow strongly). This will further contribute to the issue of the ubiquitous occurrence of PFASs. It is hard to estimate the effects of a total PFAS ban on the future PFAS concentration in sludges. As the sludge is generated in the WTTP, which receive waters from many different sources including landfills, it can be estimated, that PFASs will be present in sludge for many years following a PFAS ban. Additionally, sludge from urban WWTP presents a high risk as around half of the waste sludge is directly spread on arable land. Land application/composting ite Organic waste can be further reused via composting or through the application on land. In the case of sewage sludge, 50% is reused through these two methods, however these c methods are not suitable for the destruction of PFASs. As such it is assumed, that through t the use as compost and other land applications of organic waste, PFASs are not significantly destroyed in reasonable time frames, in contrast they can be considered as directly released pre-publication - do no to the environment. 162 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) A.4. Uses advised against by the registrants The analysis in this Annex XV dossier is based on substances that have been identified as being used in various applications. No review of registration dossiers for all the potentially relevant PFAS has been undertaken in terms of identifying any specific uses that are advised against by the registrants. cite not do n - licatio -pub pre 163 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendices to Annex A Appendix A.2. Manufacture, import and uses Table A.70. PFAS from the OECD and REACH registry database combined. Substances identified as fluorinated gases are indicated in bold. CAS No[1][2] PFAS Chemical Name REACH Midpoint category registered (OECD) volume band (tonnes per 19430-93-4. This is a monomer for a fluoropolymer 80793-17-5 355-04-4 n:2 fluorotelo mer olefins Hydroflu orocarbo ns (HFC) perfluor oalkanes 1-hexene, 3,3,4,4 5 5,6,6,6nonfluoro- Octane, 1,1,1,2,2,3,3,4,4 5 5,6,6-tridecafluoro- Pentane, 1,1,1,2,2,3,3,4 5 5 5undecafluoro-4- year) 100 - 1 000 not 0 - 10 100 - 1 000 cite 5 550 2043-57-4 do 80806-68-4 tion - 647-42-7 blica 34451-26-8 pre-pu 73609-36-6 n:2 fluorotelo mer iodides other fluorotelo merbased nonpolymers n:2 fluorotelo mer alcohol (trifluoromethyl)Octane, 1,1,1,2,2,3,3,4,4 5 5,6,6-tridecafluoro-8-iodo- 1-nonanol, 4,4 5 5,6,6,7,7,8,8,9,9,9-tridecafluoro- 1-octanol, 3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluoro- Intermediate use only Intermediate use only Intermediate use only n:2 fluorotelo mer-thiol derivative s #N/A 1-octanethiol, 3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluoro- Silane, dichloromethyl(3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl)- 0 - 10 10 - 100 / 85857-16-5 n:2 Silane, trimethoxy(3,3,4,4 5 fluorotelo mer 5,6,6,7,7,8,8,8tridecafluorooctyl)- 10 - 100 / silanes 375-72-4 perfluoroa 1-butanesulfonyl fluoride, lkanesulfo 1,1,2,2,3,3,4,4,4-nonafluoro- Intermediate nyl use only halides 101947-16-4, a n:2 PFOA precursor fluorotelo Silane, triethoxy(3,3,4,4 5 5,6,6,7,7,8,8,9,9,10,10,10- Confidential 164 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS category (OECD) Chemical Name mer silanes heptadecafluorodecyl)- REACH registered volume band (tonnes per year) Midpoint 144317-44-2 Perfluoroa Sulfonium, triphenyl-, lkane 1,1,2,2,3,3,4,4,4-nonafluoro-1- sulfonic acids butanesulfonate (1:1) Confidential (PFSAs) + salts 52299-25-9 perfluoroa Phosphinic acid, P,P- t 38565-52-5 no 297730-93-9 do 26650-09-9 n - 27619-89-2 licatio 17527-29-6 pre-pub 1228350-17-1 lkyl phosphini c acids fluorotelo mer epoxides hydrofluo roethers n:2 fluorotelo mer-thiol derivative s n:2 fluorotelo mer sulfonyl based compoun ds n:2 fluorotelo mer acrylates fluorotelo mer methacryl ates (other) bis(1,1,2,2,3,3,4,4,4nonfluorobutyl)- Oxirane, 2-(2,2,3,3,4,4 5 5,6,6,7,7,7-tridecafluoroheptyl)- Hexane, 3-ethoxy-1,1,1,2,3,4,4 5 5,6,6,6-dodecafluoro-2(trifluoromethyl)Thiocyanic acid, 3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluorooctyl ester 1-octanesulfonyl chloride, 3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluoro- 2-propenoic acid, 3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluorooctyl ester 2-propenoic acid, 2-methyl-, 4,4 5 5,6,6,7,7,8,8,9,9,9tridecafluorononyl ester 0 - 10 Intermediate use only 10 - 100 / confidential Intermediate use only Intermediate use only 100 - 1 000 0 - 10 307-35-7 perfluoroa 1-octanesulfonyl fluoride, lkane 1,1,2,2,3,3,4,4 5 5,6,6,7,7,8,8,8- Intermediate sulfonyl heptadecafluoro- use only halides 2144-53-8 n:2 2-propenoic acid, 2-methyl-, fluorotelo 3,3,4,4 5 5,6,6,7,7,8,8,8- mer tridecafluorooctyl ester 100 - 1 000 methacryl ates 56773-42-3 Perfluoroa Ethanaminium, N,N,N-triethyl-, 0 - 10 cite 165 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS Chemical Name REACH category registered (OECD) volume band (tonnes per year) lkane 1,1,2,2,3,3,4,4 5 5,6,6,7,7,8,8,8- sulfonic heptadecafluoro-1- acids octanesulfonate (1:1) (PFSAs) + salts 34454-97-2 Perfluoroa 1-butanesulfonamid, lkanesulfo 1,1,2,2,3,3,4,4,4-nonafluoro-Nnamidoet (2-hydroxyethyl)-N-methyl- 100 - 1 000 hanols 67584-55-8 perfluoroa 2-propenoic acid, 2- ot 34455-29-3 - do n 42532-60-5 n 756-12-7 tio 756-13-8 lica 132182-92-4 ub 1187-93-5 pre-p 62037-80-3 lkane sulfonyl (meth)acr ylates n:2 fluorotelo mer sulfonyl based compoun ds perfluoroa lkyl cyanide perfluoroa lkyl ketones perfluoroa lkyl ketone hydrofluo roethers perfluoroa lkyl ethers / alkenes Per- and polyfluoro ether carboxylic [methyl[(1,1,2,2,3,3,4,4,4nonfluorobutyl)sulfonyl]amino]eth yl ester 1-propanaminium, N(carboxymethyl)-N,N-dimethyl-3[[3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl)sulfonyl]amino] -, inner salt Propanenitrile, 2,3,3,3tetrafluoro-2-(trifluoromethyl)- 2-butanone, 1,1,1,3,4,4,4heptafluoro-3-(trifluoromethyl)- 3-pentanone, 1,1,1,2,2,4 5 5 5-nonafluoro-4(trifluoromethyl)Pentane, 1,1,1,2,2,3,4 5 5 5decafluoro-3-methoxy-4(trifluoromethyl)Ethene, 1,1,2-trifluoro-2(trifluoromethoxy)- Propanoic acid, 2,3,3,3tetrafluoro-2-(1,1,2,2,3,3,3heptafluoropropoxy)-, ammonium salt (1:1) 100 - 1 000 100 - 1 000 1 to < 10 1 - 10 100 - 1 000 + 10 - 100 100 - 1 000 10 - 100 acids (PFECAs) 90622-71-2 perfluoroa lkyl iodides Alkyl iodides, C6-18, perfluoro Intermediate use only 68391-08-2 n:2 Alcohols, C8-14, --perfluoro fluorotelo Intermediate mer use only alcohols Midpoint cite 550 166 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS Chemical Name REACH category registered (OECD) volume band (tonnes per year) 85631-54-5 n:2 2-Propenoic acid, --perfluoro- fluorotelo mer C8-14-alkyl esters 10 - 100 acrylates 375-50-8 perfluoroa lkyl iodides Butane, 1,1,2,2,3,3,4,4octafluoro-1 4-diiodo- Intermediate use only 375-80-4 perfluoroa lkyl iodides Hexane, 1,1,2,2,3,3,4,4 5 5,6,6dodecafluoro-1,6-diiodo- Intermediate use only 85995-91-1 ot 306-94-5 n 335-27-3 do 338-83-0 n - 382-26-3 tio 382-28-5 ublica 1800-91-5 pre-p 15290-77-4 n:2 fluorotelo mer iodides perfluoroa lkanes perfluor oalkanes perfluoroa lkyl amines Hydrofluo roethers other per - and polyfluoro alkyl ether based substance s n:2 fluorotel omer olefins Hydroflu orocarbo Alkyl iodides, C8-14, -perfluoro Naphthalene, 1,1,2,2,3,3,4,4,4a 5 5,6,6,7,7,8,8,8aoctadecafluorodecahydroCyclohexane, 1,1,2,2,3,3,4 5 5,6-decafluoro-4,6bis(trifluoromethyl)1-Propanamine, 1,1,2,2,3,3,3heptafluoro-N,Nbis(1,1,2,2,3,3,3heptafluoropropyl)Propane, 1,1,1,3,3-pentafluoro-3methoxy-2-(trifluoromethyl)Morpholine, 2,2,3,3 5 5,6,6octafluoro-4-(trifluoromethyl)- 1,9-Decadiene, 3,3,4,4 5 5,6,6,7,7,8,8-dodecafluoro- Cyclopentane, 1,1,2,2,3,3,4heptafluoro- Intermediate use only 0 - 10 0 - 10 1 000 to < 10 000 Intermediate use only 100 - 1 000 0 - 10 0 - 10 ns (HFC) 19190-61-5 Per- and Butanoic acid, 2,2,3,3,4,4- polyfluoro hexafluoro-4-[(1,2,2- ether trifluoroethenyl)oxy]-, methyl carboxylic ester 0 - 10 acids (PFECAs) esters 25628-08-4 Perfluoroa Ethanaminium, N,N,N-triethyl-, lkanesulfo 1,1,2,2,3,3,4,4,4-nonafluoro-1- 0 - 10 Midpoint cite 5 5 5 167 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS Chemical Name REACH category registered (OECD) volume band (tonnes per year) nic acids butanesulfonate (1:1) (PFSAs) + salts 34455-22-6 n:2 1-Octanesulfonamide, N-[3- fluorotelo (dimethylamino)propyl]-3,3,4,4 5 mer sulfonyl based 5,6,6,7,7,8,8,8-tridecafluoro- Intermediate use only compoun ds 59493-72-0 o not 96383-55-0 n - d 102061-82-5 licatio 103055-07-8 ub 130841-23-5 pre-p 161075-00-9 other per - and polyfluoro alkyl ether based substance s n:2 fluorotelo merbased nonpolymers Perfluoroa lkane sulfinic acids (PFSAs) + salts 1-Propanaminium, 3-[[4[(heptadecafluorononen-1yl)oxy]benzoyl]amino]-N,N,Ntrimethyl-, iodide (1:1) 2-Propenoic acid, 2-chloro-, 3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl ester 1-Butanesulfinic acid, 1,1,2,2,3,3,4,4,4-nonafluoro-, sodium salt (1:1) Benzamide, N-[[[2 5-dichloro-4(1,1,2,3,3,3hexafluoropropoxy)phenyl]amino] carbonyl]-2,6-difluoroBenzene, 1 4-dichloro-2(1,1,2,3,3,3-hexafluoropropoxy)5-nitro1-Propene, 1,1,2,3,3,3hexafluoro-, oxidized, polymd., reduced, fluorinated Confidential 10 - 100 Confidential Confidential Confidential 100 - 1 000 220133-51-7 Perfluoroa Sulfonium, dimethylphenyl-, lkane 1,1,2,2,3,3,4,4,4-nonafluoro-1- sulfonic acids butanesulfonate (1:1) Confidential (PFSAs) + salts 220689-12-3 Perfluoroa Phosphonium, tetrabutyl-, lkane 1,1,2,2,3,3,4,4,4-nonafluoro-1- 1 + / sulfonic butanesulfonate (1:1) confidential acids Midpoint cite 168 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS Chemical Name REACH category registered (OECD) volume band (tonnes per year) (PFSAs) + salts 332350-93-3 other Phosphonium, sulfonyl- triphenyl(phenylmethyl)-, salt based with 1,1,2,2,3,3,4,4,4- Confidential non- nonafluoro-N-methyl-1- polymers butanesulfonamide (1:1) 371771-07-2 Side- 1,2-Benzenedicarboxamide, N1- 874288-98-9 not 908020-52-0 - do 919005-14-4 tion 958445-54-0 ublica 1189052-95-6 pre-p 1190931-27-1 chain fluorinate d aromatics perfluoroa lkyl ether halides Per- and polyfluoro ether carboxylic acids (PFECAs) Per- and polyfluoro ether carboxylic acids (PFECAs) Per- and polyfluoro ether carboxylic acids (PFECAs) esters n:2 fluorotelo mer phosphon ic acids Per- and [1,1-dimethyl-2(methylsulfinyl)ethyl]-N2-[2methyl-4-[1,2,2,2-tetrafluoro-1(trifluoromethyl)ethyl]phenyl]Ethane, 1,2-dichloro-1[difluoro(trifluoromethoxy)metho xy]-1,2,2-trifluoroAcetic acid, 2,2-difluoro-2[1,1,2,2-tetrafluoro-2-(1,1,2,2,2pentafluoroethoxy)ethoxy]-, ammonium salt (1:1) Propanoic acid, 2,2,3-trifluoro-3[1,1,2,2,3,3-hexafluoro-3(trifluoromethoxy)propoxy]- Propanoic acid, 2,2,3-trifluoro-3[1,1,2,2,3,3-hexafluoro-3(trifluoromethoxy)propoxy]-, methyl ester Phosphonic acid, P-(3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl)-, sodium salt (1:1) Acetic acid, 2,2-difluoro-2-[[2,2,4 Intermediate use only Intermediate use only 10 - 100 Intermediate use only Intermediate use only 0 - 10 polyfluoro 5-tetrafluoro-5- ether (trifluoromethoxy)-1,3-dioxolan- carboxylic 4-yl]oxy]-, ammonium salt (1:1) 10 - 100 acids (PFECAs) 1190931-39-5 Per- and Acetic acid, 2,2-difluoro-2-[[2,2,4 polyfluoro ether carboxylic 5-tetrafluoro-5(trifluoromethoxy)-1,3-dioxolan4-yl]oxy]-, potassium salt (1:1) Intermediate use only acids Midpoint cite 169 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS category (OECD) Chemical Name REACH registered volume band (tonnes per year) (PFECAs) 1190931-41-9 Per- and polyfluoro ether carboxylic acids (PFECAs) Acetic acid, 2,2-difluoro-2-[[2,2,4 5-tetrafluoro-5(trifluoromethoxy)-1,3-dioxolan4-yl]oxy]- Intermediate use only 13846-22-5 perfluoroa Propane, 1,1,2,2,3,3-hexafluoro- lkyl 1,3-bis[(1,2,2- Intermediate ethers / trifluoroethenyl)oxy]- use only 203929-12-8 not 36097-07-1 do 428-59-1 n - 88992-45-4 atio 62880-93-7 ublic 76-19-7 p 754-12-1 pre- 29118-24-9 alkenes n:2 fluorotelo mer olefins n:2 fluorotelo mer-thiol derivative s perfluoroa lkyl epoxides n:2 fluorotelo mer-thiol derivative s n:2 fluorotelo mer-thiol derivative s Perfluor oalkane Perfluor oalkane Hydrochl orofluor oolefins 1-Hexene, 3,3,4,4 5 5,6,6octafluoro-6-iodo- 1-Butanethiol, 4-[(3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl)thio]- Oxirane, 2,2,3-trifluoro-3(trifluoromethyl)- 1-Propanaminium, 2-hydroxyN,N,N-trimethyl-3-[(3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl)thio]-, chloride (1:1) 1-Propanesulfonic acid, 2-methyl2-[[1-oxo-3-[(3,3,4,4 5 5,6,6,7,7,8,8,8tridecafluorooctyl)thio]propyl]ami no]-, sodium salt (1:1) Propane, 1,1,1,2,2,3,3,3octafluoro2,3,3,3-tetrafluoroprop-1-ene (E)-1,3,3,3-tetrafluoroprop-1ene Intermediate use only 0 - 10 100 - 1 000 10 - 100 10 - 100 100 - 1 000 1 000 to < 10 000 1 000 to < 10 000 102687-65-0 N/A (1E)-1-chloro-3,3,3trifluoroprop-1-ene 1 000 to < 10 000 357409-09-7 Hydroflu orocarbo ns 1,1,1,2tetrafluoroethane;hydrobromi de Not registered 406-58-6 Hydroflu orocarbo ns 1,1,1,3,3-pentafluorobutane Confidential 460-73-1 Hydroflu 1,1,1,3,3-Pentafluoropropane orocarbo 1 000+ Midpoint cite 450 4 500 4 500 4 500 unknown unknown 1 000 170 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS category (OECD) Chemical Name REACH registered volume band (tonnes per year) ns 374-27-6 Hydroflu oroolefin s 3,3,4,4,4-pentafluorobut-1ene 1 - 10 811-97-2 Hydroflu orocarbo ns Norflurane (HFC-134a) 10 000 to < 100 000 354-33-6 Hydroflu orocarbo ns Pentafluoroethane (HFC-125) 10 000 to < 100 000 t 138495-42-8 Hydroflu orocarb ons (S,S)-1,1,1,2,2,3,4 5 5 5decafluoropentane; reaction mass of: (R,R)-1,1,1,2,2,3,4 5 5 5-decafluoropentane no 677-56-5 Hydroflu orocarbo ns 1,1,1,2,2,3Hexafluoropropane (HFC236cb) do 420-46-2 Hydroflu orocarbo ns 1,1,1-trifluoroethane - 690-39-1 Hydroflu orocarbo ns 1,1,1,3,3,3-hexafluoropropane n SUBTOTAL OECD list Fluorinated gases Source: OECD, ECHA 2020 10 to < 100 / confidential Not registered 1 000 to < 10 000 100 - 1 000 tio Only the first 72 substances in the table (up to CAS no 76-19-7) appear in the OECD database of PFAS. lica There are also fluorinated gases not in the OECD list. Some important substances, including volume range, are presented below ub 116-15-4 Perfluori nated olefins Hexafluoropropene, HFC 1216 Not in the main OECD list - only appears as a "related chemical" 10 000 to < 100 000 -p 79-38-9 N/A Chlorotrifluoroethylene 1 000 to < 10 Not in the main OECD list - only 000 appears as a "related chemical" e 406-58-6 Hydroflu 1,1,1,3,3-pentafluorobutane, No info. r orocarbo HFC-365 mfc Production p ns capacity Solvay Taveaux: 15 000 t: Booten, CEMAC) 306-83 Hydrochl orofluor ocarbons 2,2-dichloro-1,1,1trifluoroethane, HCFC-123 Intermediate use only 204-075-2 Perfluor Octafluorocyclobutane oalkanes 10 000 to < 100 000 (import only) Midpoint 5 55 000 cite 55 000 55 unknown 4 500 450 131 080 55 000 5 500 15 000 2 000 55 000 171 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS category (OECD) Chemical Name REACH registered volume band (tonnes per year) Fluorinated gases not included in OECD fluorinated gas list SUBTOTAL Fluorinated gases both included or excluded from OECD fluorinated gas list Stakeholders input from the second stakeholder consultation (Manufactured in/sold in EEA (and UK)) 1064698-37-8 N/A 3M Fluorinert Liquid Fluid FC-40 100 to < 1 000 1093615-61- N/A 3M Fluorinert Liquid Fluid FC-770 10 to < 100 2 Reaction mass of 2,2,3,3 5 5,6,6- not 2187449-42-7 N/A octafluoro-4-(1,1,1,2,3,3,3heptafluoropropan-2yl)morpholine and 2,2,3,3 5 5,6,6-octafluoro-4(heptafluoropropyl)morpholine 3M Performance Fluid PF 5056 10 to < 100 tion - do 2176446-38-9 pre-publica 3709-71-5 Perfluoroa lkanes Perfluoror inated olefins Reaction mass of perfluoro(dimethyl - N Butylamine ) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N propylamine and 2,2,3,3 5 5,6,6, octafluoro-4(trifluoromethyl)morpholine and perfluoro-N-pentane 3M Performance Fluid PF 5058 Reaction mass of perfluoro(dimethyl - N Butylamine ) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N propylamine and 2,2,3,3 5 5,6,6, octafluoro-4(trifluoromethyl)morpholine and perfluoro-N-pentane 3M FA-188 Foam Blowing Additive (2E)-1,1,1,2,3,4,5,5,5Nonafluoro-4-(trifluoromethyl)-2pentene 10 to < 100 100 to < 1 000 Additive 375-03-1 Hydrofluo 1-methoxyheptafluoropropane roether No info 163702-08-7 Hydrofluo roether 2-(Difluoromethoxymethyl)1,1,1,2,3,3,3-heptafluoropropane >10 ton for reaction mass 163702-07-6 Hydrofluo 1,1,1,2,2,3,3,4,4-nonafluoro-4roether methoxy-butane >10 ton for reaction mass 163702-06-5 Hydrofluo 2-(difluoromethylethoxy)roether 1,1,1,2,3,3,3-heptafluorpropane No info Midpoint 127 000 258 530 550 5c5 ite 55 55 550 10 10 172 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) CAS No[1][2] PFAS category (OECD) Chemical Name 163702-05-4 Hydrofluo 1-Ethoxy-1,1,2,2,3,3,4,4,4roether nonafluorbutane Total fluorinated gases (based on stakeholder consultation) TOTAL Fluorinated gases manufactured/processed in EEA REACH registered volume band (tonnes per year) No info Midpoint > 1 285 259 815 [1] The first 72 substances (up to CAS no. 76-19-7) were identified by filtering the OECD database for "REACH Registered" substances and obtaining the registered volume data from the ECHA database. [2] The bold substances in this table have been identified as fluorinated gases in PFAS scope however e they are not included in the OECD database of PFAS. As discussed, the numbers for total fluorinated it gas volumes in this study were obtained from the stakeholder consultation and the total volume data provided in the EEA report. c It has been noted that there can be some ambiguity in the definition of "F-gas" (in or outside PFAS t scope). From a purely chemical and physical perspective, an F-gas could be considered as any substance o that contains at least one fluorine atom and is a gas at standard temperature and pressure. This is a n very wide definition and is likely the reason why some F-gas substances that meet this description (and do or do not meet the PFAS definition as well) do not appear in the OECD database. o Table A.71. Volume bands of PFASs non-polymers with unsaturated bonds. d CAS No Name Volume band/ (tonnes/ year) - 1187-93-5 Trifluoro(trifluoromethoxy)ethylene 100-1 000 1623-05-8 1,1,1,2,2,3,3-heptafluoro-3-[(trifluorovinyl)oxy]propane 100-1 000 n 1644-11-7 1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3[(trifluorovinyl)oxy]propane 1-10 io 10493-43-3 Trifluoro(pentafluoroethoxy)ethylene 1-10 t 13846-22-5 1,1,2,2,3,3-hexafluoro-1,3-bis[(trifluorovinyl)oxy]propane Not available - a intermediate use only lic 19190-61-5 Methyl 2,2,3,3,4,4-hexafluoro-4-[(1,2,2- 0 trifluoroethenyl)oxy]butanoate b 29514-94-1 1,1,2,2-tetrafluoro-2-[(trifluorovinyl)oxy]ethanesulfonyl fluoride 1-10 pu 442-390-9 1,1,2,2,3,3-hexafluoro-1-trifluoromethoxy-3trifluorovinyloxypropane 10-100 e- 700874-87-9 1-[Difluoro(trifluoromethoxy)methoxy]-1,2,2trifluoroethylene 10-100 r TOTAL p (rounded) 220 -2 200 Source: Wang et al. (2020), OECD database and the ECHA dissemination sites. 173 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.72. Volume bands of perfluoroethers non-polymers with saturated bonds. CAS No Name Volume band/ (tonnes/ year) 382-28-5 2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine 100-1 000 62037-80-3 Ammonium 2,3,3,3-tetrafluoro-2(heptafluoropropoxy)propanoate 10-100 144728-59-6 2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2- N/A tetrafluoroethanesulfonyl fluoride e 874288-98-9 1,2-dichloro-1-[difluoro(trifluoromethoxy)methoxy]-1,2,2- N/A trifluoroethane it 919005-14-4 2,2,3-trifluoro-3-[1,1,2,2,3,3-hexafluoro-3- N/A c (trifluoromethoxy)propoxy]propanoic acid ot 957209-18-6 2,3,3,4,4-pentafluoro-2,5-bis(1,1,1,2,3,3,3heptafluoropropan-2-yl)-5-methoxytetrahydrofuran 1-10 o n 161075-00-9 Hexafluoropropene, oxidized, oligomers, reduced, fluorinated 100-1 000 d Total (rounded) 210-2 100 - Source: Wang et al. (2020), OECD database and the ECHA dissemination sites. n Table A.73. A summary of annual imports of PFAS chemicals from third countries into EU-27 io (tonnes). Year at PFAS group 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 lic Fluoropolymers b (tonnes) Fluoropolymer - u YoY Growth (%) p Fluorinated gas - Volumes - (tonnes) e Fluorinated gas - r YoY Growth (%) p PFAA 22 194 7 005 31 122 40% 9 722 39% 29 644 -5% 12 249 26% 29 070 -2% 14 106 15% 32 004 10% 16 773 19% 29 706 -7% 13 970 -17% 33 072 11% 18 781 34% 38 202 16% 23 631 26% 46 008 20% 27 456 16% 36 149 -21% 19 191 -30% (precursors) and others PFAS 87 644 79 881 85 354 75 540 77 157 77 881 83 267 105 110 103 334 281 583 Volumes (tonnes) Other PFAS - YoY Growth (%) -9% 7% -11% 2% 1% 7% 27% 5% -6% Source: https://ec.europa.eu/eurostat/web/international-trade-in-goods/data/database, date of access: 2022-12-20. 174 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.74. A summary of annual exports of PFAS chemicals from EU-27 into third countries (tonnes). PFAS group Year Fluoropolymer - Volumes (tonnes) Fluoropolymer - YoY Growth (%) 29 535 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 28 469 -4% 26 595 -7% 23 323 -12% 27 360 17% t cite 26 546 no -3% 26 107 -2% 27 068 4% 30 167 11% 28 718 -5% Fluorinated gas - Volumes (tonnes) 9 559 7 459 7 116 7 415 8 507 12 360 18 242 16 443 13 660 10 371* o Fluorinated gas - YoY d Growth (%) -22% -5% 4% 15% 45% 48% -10% -17% -24% PFAA (precursors) and other PFAS - 90 728 98 378 128 659 133 519 131 424 115 358 99 810 122 130 127 711 131 866 - Volumes (tonnes) Other PFAS - YoY n Growth (%) 8% 31% 4% -2% -12% -13% 22% 5% 3% io Source: https://ec.europa.eu/eurostat/web/international-trade-in-goods/data/database, date of access: 2022-12-20. *Remark from stakeholder: The export figures shown above (Eurostat extract) are far too low as only export of bulk gases is presented. According to EEA pre-publicat the bulk export of F-gases was about 26 000 tonnes in 2019. An unknown number of F-gas volume in exported equipment must be added to this volume. 175 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) TULAC Food contact, packaging Consumer mixtures Lubricants, construction products Cosmetics Metal plating Ski waxes Appendix A.3.2. Fluoropolymer applications, including fluoroelastomers Table A.75. Non-exhaustive overview of common commercial FPs and their applications - part 1 of 2. cite Fluoropolymers ot Cross reference dossier o n Fluropolymers estimated use volumes d (ton/year) pre-publication - Key applications Table A.16 High: 109 544 Low: 33 091 Table A.18 0 High: 20 430* Low: 15 330* *Addressed as "polymeric PFAS, but main use are fluoropolymers. Table A.26 Table A.84 Range: 800 to 1 200* *Micropowder PTFE Table A.57 and A.3.15 High: 10 320 Low: 4 254 Table A.60 Table A.58 Table A.29 N/A Table A.27 and Table A.83 High: 960 Low: 960 Table A.31 and Table A.32 Table A.28 For PPE and felt fabrics for filtration For processing equipment As there are already nonPFAS alternatives on the market with satisfactory functionality For industrial or professional settings under harsh conditions As there are already nonPFAS alternatives/ non-PFAS coatings on the market with satisfactory For processing under harsh conditions A.3.8 N/A There is only total PFAS (polymeric and non-polymeric) volumes of 1.6 tonnes presented in the dossier in the summary of A.3.8. As there are already nonPFAS alternatives on the market with satisfactory functionality 176 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) TULAC Food contact, packaging Consumer mixtures Lubricants, construction products Cosmetics Metal plating Ski waxes Fluoropolymers Thermoplastics Polytetrafluoroethylene (PTFE) Sulfonated tetrafluoroethylene (PSEPVE) Perfluoro methyl alkoxy copolymer (MFA) Polychlorotrifluoroethylene (PCTFE) Fluorinated ethylene propylene (FEP) Linings Laminates Lubricants e.g Tapes Seals Cook Ware, lubricants for Filters Beverage cans, string Laminates Piping, gaskets, instruments as Waterproof & equipment, etc. in PTFE stain industrial micropowder repellent production of food clothing and food pre-publication Architectural & carpet coatings Fabrics ingredients are also lined/coated with PTFE. Seals for food process applications (Coffee machines, valves etc.) Scrappers Felt fabrics for filtration Non stick Packaging and barrier films Food processing and packaging equipment cite functionality t Lubricants: o Micro-powder n PTFE as solid additives o Construction dproducts: Resistant -components and coatings Micro beads or micropowder used in e.g leave-on products such as mascara and rinse-off products such as hair bleaches. Chemical processing such as Bulking glassfiber coatings Pipes Fittings Lubricants: Base oil Ski wax components 177 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) TULAC Food contact, packaging Consumer mixtures Lubricants, construction products Cosmetics Metal plating Ski waxes Fluoropolymers Polyvinyldifluoride (PVDF) Fluoroethylene vinyl ether (FEVE) Ethylene (E) copolymer of CTFE (ECTFE) Perfluoroalkoxy alkane (PFA) Ethylene copolymer of TFE (ETFE) THV (a semicrystalline three component terpolymer of the given monomers) Elastomers pre-publication - do not Bag liners Beverage tubings and hoses Conveyor beltings High strength films Food processing and packaging equipment Food processing and packaging equipment Food processing and packaging equipment Guitar strings and piano keys Fluid handling systems, valves, pumps and water piping. Resistant paints Architectural coatings. Architectural coatings Pipes and components Industrial and architectural coatings Building textiles Flexible and resistant coatings Multilayer barrier coatings cite 178 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) TULAC Food contact, packaging Consumer mixtures Lubricants, construction products Cosmetics Metal plating Ski waxes Fluoropolymers High fluorine terpolymers of VDF/HFP/TFE and VDF/PMVE/TFE VDF/PMVE/TFE perfluoro elastomers Ethylene/TFE/PMVE elastomers Vinylidene fluoridehexafluoropropylene copolymer (FKM) NOTE: PFAS production and Table A.81 Table A.81 Table A.81 Food packaging materials Food processing pre-publication equipment waste are not included in this table, since they are out - do not cite of scope concerning fluoropolymer uses and applications 179 Transport Medical devices Fluorinated gases Electroncics and semiconduc tors Energy Petroleum mining Other sectors/use s "This column include uses and ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.76. Non exhaustive overview of common commercial FPs and their applications - part 2 of 2. Fluoropolymers Cross reference dossier Fluropolymers estimated use volumes (ton/year) Key applications A.3.11, Table t A.41, Table o A.42 Table A.37, Table A.99 and Table A.105 Not relevant Table A.48 and Table A.49 Table A.54 do n Range: - 6 000 to 14 500 High: 12 032 Low: 3 233 n "Stakeholders io estimate of polymeric t PFAS where a the major lic volumes are fluoropolymers according to b stakeholders u (rounded numbers)" p For - equipment, e installations r and pcomponents Table A.40 For sensing and biomedical devices and implants Not relevant High: 4 615 Low: 1 560 Table A.50 Not relevant Electronic equipment and components for their maintained High: 2 920 Low: 2 592 Table A.55 Energy storage systems and components for their maintained cite A.3.16 and Table A.62 Range: 3 500 to 7 500 Table A.63 For processing under harsh conditions Some "other uses" are mentioned in Table A.83 N/A For processing under harsh conditions. 180 Transport Medical devices Fluorinated gases Electroncics and semiconduc tors Energy Petroleum mining Other sectors/use s "This column include uses and ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluoropolymers Thermoplastics Polytetrafluoroethylene (PTFE) that operate under harsh t conditions no Chemical processing pre-publication - do equipment Biomedical devices such as breathing air devices, medical ventilators and oxygen supply systems. functionality functionality Wire and cable insulation Semiconductor manufacturing Li ion batteries Membranes for hydrogen production and electrochemical processes Systems for storage, transport, and production of hydrogen cite Chemical processing industry Chemical processing industry Production of filter systems for industrial plants. 3D-printing Printing inks Processing aid in thermoplastics, thermossetting plastics and elastomers Antidrip additive in plastics Sealing components for radioactive waste processing systems 181 Transport Medical devices Fluorinated gases Electroncics and semiconduc tors Energy Petroleum mining Other sectors/use s "This column include uses and ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluoropolymers Sulfonated tetrafluoroethylene (PSEPVE) Perfluoro methyl alkoxy copolymer (MFA) Polychlorotrifluoroethylene (PCTFE) Fluorinated ethylene propylene (FEP) Polyvinylfluoride (PVF) a partial fluorinated fluoropolymer and therefore not a PFAS - do not Cryogenic seals Biologic applications Pharmaceutical packaging tion Medical components blica Flammability u lowering coatings of p airplane pre- interiors Semiconductor electronics Optoelectronic devices Electrical packaging Lighting Semiconductor processing Cable and wire Insulation Semiconductor wet bench equipment Membranes for hydrogen production and for electrochemical processes Systems for storage, transport, and production of hydrogen Wire and cable insulation. Electronic component such as photovoltaic module back sheets Solar panels cite Chemical processing equipment Fluid handling Chemical processing equipment 182 Transport Medical devices Fluorinated gases Electroncics and semiconduc tors Energy Petroleum mining Other sectors/use s "This column include uses and ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluoropolymers Polyvinyldifluoride (PVDF) Fluoroethylene vinyl ether (FEVE) Ethylene (E) copolymer of CTFE (ECTFE) Perfluoroalkoxy alkane not Flammability lowering coatings of o airplane n - d interiors Sensing and biomedical devices Membranes in cochlear implants and Catheters Food and pharmaceutical processing Adhesive for coating and lamination High purity semiconductors Wire and cable isolators Sensors Solar panels Energy storage devices such as Li ion batteries Separator in Electric Vehicle (EV) batteries licatio Coating and finishes pub Membranes pre- for fuel cells Medical devices Flame resistant wire and cable insulation Resistant cite Chemical Filaments for additive manufacturing for e.g 3D printing General chemical processing Production of filter systems for industrial plants. Pipe and pumping applications Industrial acids and corrosives storage Fluid handling 183 Transport Medical devices Fluorinated gases Electroncics and semiconduc tors Energy Petroleum mining Other sectors/use s "This column include uses and ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluoropolymers (PFA) Ethylene copolymer of TFE (ETFE) THV (a semicrystalline three component terpolymer of the given monomers) o not Automotive d and mass transit cabling - Fuel tubing and fittings. Seals Oxygen respirator components components and fittings Electrical insulation. Semiconductor manufacturing Wire and cable insulation Wet bench equipment Radomes pre-publication Fuel hoses Wire and cable insulation Optical fibres Solar panels Lighting cite processing equipment Chemical processing equipment Chemical processing equipment Production of filter systems for industrial plants. Chemical processing equipment Military and defence equipment (for instance munition, bullet proof vests) Greenhouse glass coatings Sealing components for radioactive waste processing systems Safety glass 184 Transport Medical devices Fluorinated gases Electroncics and semiconduc tors Energy Petroleum mining Other sectors/use s "This column include uses and ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Fluoropolymers Elastomers High fluorine terpolymers of VDF/HFP/TFE and VDF/PMVE/TFE VDF/PMVE/TFE perfluoro elastomers Ethylene/TFE/PMVE elastomers Vinylidene fluoridehexafluoropropylene copolymer (FKM) NOTE: PFAS production and t cite Table A.13 Table A.13 Table A.13 industrial Table A.13 industrial no Table A.13 Table A.13 ion - do Table A.102 Table A.13 Table A.13 Li ion batteries Table A.13 Industrial Table A.13 industrial Table A.13 industrial Table A.13 industrial Table A.13 industrial Table A.13 Sealing components for radioactive waste processing systems pre-publicat waste are not included in this table, since they are out of scope concerning fluoropolymer uses and application. 185 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) There is a column "other sectors/uses" in Table A.75 and Table A.76, where certain uses of fluoropolymers could not be allocated to any of the sectors specified in the dossier. These uses and applications may though be relevant to other sectors and applications not mentioned in the dossier. Some of these uses such as "Fluid handling and Chemical processing equipment" appear to be horizontal and can refer to any type of process industry that handles chemical processes and fluids in some form. There are a number of uses and applications for unspecified fluoropolymers for which limited information was available as shown below in Table A.77. Table A.77. Uses and applications for unspecified fluoropolymers for which limited information was available. Uses and applications for e unspecified fluoropolymers it for which limited information was available c Extrusion and moulding (non- stick) ot Professional cleaning and polishing o n Pyrotechnics ublication - d Artificial turfs (AT) Use description Remarks Extrusion and moulding processes for technical rubber parts and fittings Fluoropolymer coatings and components enable preventing corrosion and facilitating cleaning Fluorine containing oxidizers, primarily polymers, are extensively used in pyrotechnic compositions Unclear if and how FP would be used in AT Use of FP for plastics and rubbers processing is not covered in the dossier Use of FP in professional cleaning and polishing is not covered in the dossier Use of FP in pyrotechnics is not covered in the dossier Laura et al test results of total fluorine, suggest that the fluorine in synthetic AT materials (i.e., not including organic fill) consists mostly of non-extractable, non-PFAA precursors, such as fluoropolymers. It cannot be ruled out that contributions from inorganic fluorine species may occur in the turf that could not be extracted in water. -p Some thermoplastic fluoropolymers such as sulfonated tetrafluoroethylene (PSEPVE), e perfluoro methyl alkoxy copolymer (MFA) and a range of fluoroelastomers are not described in terms of uses but only mentioned in the dossier. pr Sectors mentioned in the dossier are named slightly differently in the literature sources found in the reference list. Examples are automotive and aerospace, that can be included in the transportation sector, that also covers other means of transportation than automotive and aerospace such as marine vessels. Polyvinylfluoride (PVF) is a partial fluorinated fluoropolymer and therefore not a PFAS, which could be an alternative fluoropolymer to polymeric PFAS such as PVDF and PTFE for certain applications in transport, electronics, and the energy sector. 186 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.3. Textiles, upholstery, leather, apparel and carpets Table A.78. Requirements/Standards relating to PPE (specific technical standards) - Industry Data commissioned by the EC (Wood, 2020). e Product Applicable Standard Function tested Scope Further details it TULAC category Surgical drapes and gowns Medical EN 13795 Mechanical resistance, microbiological Surgical drapes, As a medical device, c Medical applications applications purity and a barrier effect against liquids: gowns and clean textiles used in t Resistance to microbial penetration air suits, used as operating rooms Resistance to liquid penetration in medical devices have to be conform o reference to achieve a reasonable for patients, to the requirements n physiological comfort clinical staff and of the European equipment Medical Devices o Directive 2007/47/EC d (modified 93/42/EEC) - Protective textiles against Medical EN 14216 Maximum protection against infection over Medical infection infection applications blood and secretions rejection. High prevention surgery n hydrolyses stability (repeated 130 C hot blankets, surgery steam disinfection, often repeated laundry) protection aprons io etc. licat Protective clothing against b infective agent Medical applications EN 14126 Performance requirements and test methods for maximum protection against infections like Ebola PPE for workers in hospital laundries, Ebola -emergency -pu Awnings (Strong dynamic pre water-repellence) Outdoor technical textiles EN 20811 Determination of resistance to water penetration. Hydrostatic pressure test min. 200 cm ; 10 mbar/min All Textiles 187 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Applicable TULAC category Standard EN ISO 4920 Function tested Determination of resistance to surface wetting (spray test) AATCC 22 Water Repellency: Spray Test EN 29 865 ot EN ISO105n B04 o DIN 53931 Determination of water-repellency of fabrics by the Bundesmann rainshower test Colour fastness - Part B04: Colour fastness to artificial weathering: Xenon arc fading lamp test Determination Of The Resistance Of Textiles To Mildew; Growth Test d EN ISO - 12947 (1-4) Determination of the abrasion resistance of fabrics by the Martindale method n ASTM pre-publicatio D4032 Test Method for stiffness of fabric by circular bend procedure Scope cite Textile fabrics Not specified Textiles Textiles Textiles Textiles Not specified Further details Other Standards that are indirectly related to the use of FC 188 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Hand and arm protection Applicable Standard Function tested TULAC category PPE for industrial EN Specifies the requirements applicable to all and professional 420:2010- protective gloves relevant test methods use (other than 03 and the general requirements such as t sportswear) resistance of the glove material against water penetration. It shall be used in conjunction with specific product standards. lication - do no EN 388:2003 Protective gloves against mechanical risks ubEN pre-p 374:2003 Specifies the requirements for gloves to protect the user against chemicals and/or micro-organisms and defines terms to be used Scope cite Protective gloves Protective gloves Protective gloves Further details The standard deals with particular aspects of quality, health and safety. The standard is used in conjunction with specific product standards as a basis for the placing on the market of protective gloves under the Directive 89/686 / EEC for personal protective equipment. The use of protective gloves is not limited to individual sectors, but affects many areas of life and work in different branches. The standard is to apply in combination with DIN EN 420:2003-12 189 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Applicable Standard Function tested TULAC category EN This standard specifies thermal 407:2004 performance for protective gloves against heat and/or fire: a) Resistance to not EN o 511:2006 flammability b) Contact heat resistance c) Convective heat resistance d) Radiant heat resistance e) Resistance to small splashes of molten metal f) Resistance to large splashes of molten metal This standard applies to any gloves to protect the hands against convective and contact cold down to -50 C. n - d EN io 421:2010 This standard applies to gloves to protect from ionising radiation and radioactive contamination. licat EN 659 pre-pubEN 12477 Not specified Requirements such as burning behavior, contact heat and convective heat, small splashes Scope cite Protective gloves Protective gloves against cold Protective gloves Protective gloves for firefighters Gloves giving protection from manual metal welding Further details a. Resistance to convective cold b. Resistance to contact cold c. Penetration by water (0 or 1) 0 = water penetration 1 = no water penetration. To protect from radioactive contamination it is important that, the glove has to be liquid proof and it needs to pass penetration test EN 374 190 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Protective Clothing Applicable Standard Function tested TULAC category EN 50237 This standard applies to insulating gloves and mitts made of plastic or elastomer for use without over-gloves for mechanical t PPE for industrial o and professional n use (other than sportswear) EN 340 protection. Gloves for working at nominal voltages up to 7500 V. Requirements and test methods for protective clothing for fire-fighting pre-publication - do EN943 Part 1: Performance requirements for ventilated and non-ventilated 'gas-tight' (Type 1) and 'non-gas-tight' (Type 2) chemical protective suits Part 2: Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solid particles. Part 2: Performance requirements for "gas-tight" (Type 1) chemical protective suits for emergency Scope cite Gloves for Electricians Protective clothing The outer fabric is woven from 75% meta-aramid, 23% para-aramid and 2% antistatic fibres. The fabric is laminated with water vapour permeable membrane made of bi-component expanded PTFEfilm. Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solid particles Further details The European Standard specifies: Protective clothing, Clothing, Performance, Grades (quality), Ergonomics, Anthropometric characteristics, Fitness for purpose, Classification systems, Clothing sizes, Ageing (materials), Compatibility, Marking, Instructions for use 191 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Applicable TULAC category Standard Function tested teams (ET) not EN ISO o 6529 Determination of resistance of protective clothing materials to permeation by liquids and gases - d EN 14325 tion EN 368 Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblage Resistance of materials to penetration by liquids No degradation, > 80% run off and no penetration to the innermost surface ublica EN 31092 pre-p EN14605 Water-vaping resistance (Ret) Max 11 m2 Pa/W Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only e.g. maximum gasoline/chemical repellency for worker in the chemical industry, high Scope cite Protective clothing - Protection against chemicals Protective clothing - Protection against chemicals Protective clothing - Protection against liquids Polyamide fabric Protective clothing against liquid chemicals (acids) Further details e.g. PPE for police uniform, workers in chemistry parks, oil platforms, mineraloil industry etc. Confirmed by ocular inspection after use of: - petroleum products - inorganic acids 36% - inorganic bases 40% - alcohols - sodium hypochlorite 10% 192 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Applicable Standard Function tested TULAC category durability professional washing and dry cleaning. EN 13982 Part 1: Performance requirements for EN 13034 not chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing) Performance requirements for chemical protective suits offering limited protective o EN ISO pre-publication - d 11612 performance against liquid chemicals (Type 6 equipment) Protection against heat and flame Minimum performance requirements: A: Minimum protective performance with respect to flame spread (test method EN ISO 15052) B: Performance with respect to insulation against convective heat (test method EN ISO 9151) C: Performance with respect to insulation against heat radiated (test method EN ISO 6942) D: Performance with respect to insulation against aluminum spraying ( test method EN ISO 9185) E: Performance with respect to insulation against cast iron spraying (test method EN ISO 9185) F: Performance with respect to insulation against heat through contact (test method EN ISO 12127) Scope cite Protective clothing for use against solid particulates Protective clothing against liquid chemicals Clothing to protect against heat and flame e.g. oildrilling protective wear with maximum high oiland chemical (fracking) repellency, high durability against repeated laundry/ dry cleaning etc. Further details 193 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Applicable Standard Function tested TULAC category EN ISO This standard specifies minimum basic 11611 safety requirements and test methods for protective clothing including hoods (head), aprons, sleeves and gaiters (feet). pre-publication - do not ENISO343 Specifies the requirements and test methods for materials and the seams of clothing designed to give protection against precipitation (rain, snow), mist and ground moisture Scope cite Protective clothing for use in welding and allied processes Protective clothing - Protection against rain Further details This PPE protects against spatter, short contact time with flame, radiant heat from the arc, and minimizes the possibility of electrical shock by short-term, accidental contact with electrical conductors in normal conditions of welding. Test methods: EN ISO 15025, EN ISO 6942, EN ISO 9150 Value X stands for the waterproofing of the article. There are 3 classes derived from the amount of pressure the fabric can withstand: 3 is the highest (i.e. the most waterproof) and 1 is the lowest. Value Y stands for the breathability of the fabrics (plus all the layers used in the article). There are 3 classes for breathability. Class 1 = the lowest and 194 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Applicable TULAC category Standard Function tested pre-publication - do not EN14058 Articles are divided in three classes depending on their thermal resistance (insulation). With the test method two optional features can be tested: the water vapour resistance and thermal insulation. Scope cite Protective clothing - Garments for protection against cool environments Further details Class 3 = the highest Clothing certified with this standard includes: Thermal resistance Air permeability Penetration of water. Water vapour resistance Thermal insulation 195 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Other Protective clothing Applicable Standard Function tested TULAC category PPE for industrial EN 1073 This standard is for requirements and test and professional methods for ventilated protective clothing use (other than against particulate radioactive pre-publication - do not sportswear) contamination Scope cite Protective clothing against radioactive contamination Further details Protective clothing, Radiation protection, Radioactive materials, Contamination, Clothing, Particulate air pollutants, Industrial overalls, Protective suits, Performance testing, Splitting tests, Leak tests, Gas resistance tests, Water tightness tests, Dust-tightness tests, Perforating tests, Tear tests, Chemicalresistance tests, Abrasion resistant materials, Protective coatings, Breathing apparatus, Visors, Air, Gas flow, Flow measurement, Seams, Design, Occupational safety, Performance, Wear resistance, Strength of materials, Classification systems, Marking, Instructions for use, Testing conditions. 196 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Protective clothing for firefighters Applicable TULAC category Standard EN 50286 Function tested Not specified ot EN 61482 Determination of the arc rating of flame resistant materials for clothing - do n EN 1149-5 This European Standard specifies material and design requirements for electrostatic dissipative clothing, used as part of a total earthed system, to avoid incendiary discharges lication PPE for industrial and professional use (other than pre-pub sportswear) EN 469 (mentioned standards therein: EN ISO 24920, EN ISO 6530 Requirements: Flame spread (test method ISO 15025) Convective heat (test method EN 367) Radiant heat (test method ISO 6942) Heat resistance (test method ISO 17493) Water repellence, dimensional stability, resistance to chemicals Scope cite Electrical insulating protective clothing for work on lowvoltage installations Live working Protective clothing against the thermal hazards of an electric arc Protective clothing - Electrostatic properties PPE worn during structural firefighting to protect mainly against heat and flame. Further details These anti-static clothing are compliant and designed for use in an ATEX (EXplosive ATmosphere) working environment where a risk of explosion is possible, e.g. tank truck driver. 197 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Protective clothing for military Applicable Standard Function tested TULAC category PPE for industrial EN ISO The C-combat suit shall be water and oil and professional 14419 repellent, Oil repellence, min 5 and use (other than resistance to surface wetting, min 5 pre-publication - do not sportswear) EN 29865 EN ISO 4920 EN ISO 6330 according to EN 24920 (spray test). Both new and washed/dried materials shall be tested. Wash/dry procedure (three wash/dry cycles): The C-combat suit shall be possible to be washed in 60 C and then tumble dried of a maximum of 80 C for at least 3 times according to ISO 6330 with maintained protective ability. The Ccombat suit shall be water and oil repellent and be tested according to ISO 2811 (Determination of resistance to water penetration -hydrostatic pressure test.) The C-combat suit shall be able to be washed in 60 C for at least 3 times with no loss in protective ability. The C-combat suit shall be able to be dried in a tumble dryer in a temperature of a maximum of 80 C with no loss in protective ability The permeability of the C-combat suit shall not be lower than 40 mm/s when using a pressure drop of 100Pa according to SS-EN ISO 9237:1995 (Textiles - Determination of the permeability of fabrics to air) Water repellency, water absorption, after 3 washes (25%) Water repellency after 3 washes (min. 4) W Spray test-before wash/after 3 washes (min. 5/ min) 60 C 8.5 tumble dry Scope cite Protective C(hemical)-combat suit, Viscose FR PES Fabric PES Fabric Further details 198 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Protective clothing for police Protective clothing for fire fighters, police, military and chemical protection Protective / Safety footwear Applicable TULAC category Standard EN ISO 6350 Function tested Penetration and Repellency to Liquid chemicals PPE for industrial TLP 9004 Oil- and water-repellency, fuel repellency and professional use (other than t sportswear) o no PPE for industrial d and professional use (other than - sportswear) ublication PPE for industrial p and professional - use (other than pre sportswear) (mentioned standards therein: EN ISO 24920, EN ISO 14419, EN 228, EN ISO 6530 TL 83050020 TL 83050023, TL 8305-0302, TL 83050335, TL 8305-0336 (mentioned standards therein: EN 29865, EN ISO 14419) EN ISO 20345 Maximum oil- and water-repellency, fastness to repeated washing cycles (mentioned standards therein: EN 29865, EN ISO 14419 Maximum water-, oil-repellency after repeated washing. Maximum repellence concerning dangerous liquids, chemicals, blood etc. Scope cite Fabric Viscose FR PPE clothing for police Technical delivery condition uniform twill Technical delivery condition for uniform doubletwill, medium-fine twill and woven fabric PPE shoes Further details 199 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Ready made garments Impact from above with high energy droplets Protective clothing for agricultural workers Protective clothing for automobile (racing) drivers Fuel cells Applicable TULAC category Standard EN ISO 20346 Function tested EN ISO 20344 test methods, DIN EN 12568 test methods not Medical applications o PPE for industrial d and professional use (other than - sportswear) EN 455 EN 14360 Disposable medical protective footwear Maximum water repellency because of high dynamic energy at 150-200 Km speed of water droplets n PPE for industrial io and professional use (other than t sportswear) a Professional lic Sports clothing ISO 27065 FIAStandard 885 Performance requirements for protective clothing worn by operators applying liquid pesticide Maximum protection against fuel, heat and flame b Outdoor technical pre-pu textiles Safety Standards of Internationa l Electrotechnical Commission (IEC) Maximum resistance to hydrolysis und acid conditions e.g. treated non-woven carbon fibre separator in phosphoric acid conditions Scope cite Protective off shore jackets and trousers on boats and ships, protective motor cycle wear e.g. protective suits in agriculture application of pesticides e.g. outer garments, socks, shoes, balaclava hoods and gloves Certified carbon fibre nonwoven for fuel cell Further details 200 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Filters Roofing textiles Textile components of aircraft parts Textile components of automobile parts Textile components of automobile parts Applicable TULAC category Outdoor technical textiles Standard VDI 3677 Blatt 3:2012-11 Function tested Long-term temperature resistance, stability Outdoor technical t textiles DIBTCertified Maximum dynamic water repellency, maximum dirt repellency, UV-stability long lifecycle o no Outdoor technical textiles AirbusCertified Maximum release properties, air permeability - d Outdoor technical n textiles tio Outdoor technical pre-publica textiles AudiStandard LAH 893-80 AATCC TM 118-oil repellency: hydrocarbon resistance test Maximum repellency against dry soil and white spirit, heavy dynamic rain repellency, maximum performance because of high impact (> 200 km/h) of raindrops 96 hours fuel rejection ; maximum fuel rejection of e.g. non-woven engine compartment interior/cushion (safety feature in case of fire), strong oil/fuelrepellency of flame-retardant nonwoven/PU-foam motor compartment sound cushions. Scope cite Filters for wasted air/incineration plants Protective architecture textiles (Energy saving, UVprotection), e.g. lightweight textile roofing systems Membrane textiles for in mould injection processes of carbon fibre composite parts e.g. convertible tops non woven engine compartment interior/cushion (safety feature in case of fire), nonwoven/PUfoam motor compartment sound cushions Further details 201 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Product Textile components of automobile parts Applicable Standard Function tested TULAC category Outdoor technical Other- Repellency - resistance to wetting by oily textiles Automotive liquids, hydrophobicity Standards for Oil pre-publication - do not repellency Scope cite e.g. fuel, oil, coolant-repellent, inflammable nonwoven for safety cushion/sound absorbing automotive parts Further details 202 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.4. Food contact materials and packaging Table A.79. Summary of data used for estimating PFAS (surfactants) volume in Paper and Board Food Packaging. Geographical Data Source coverage Tonnes Total Paper and EU-27 & United Carton Board 6 169 000 (Cepi, 2020) Board (P&B) Kingdom (UK) Data from 2019 Packaging & Norway (NO) Wrapping 2 647 000 Consumption (That may be used in food & feed contact i.e. closest disaggregated categories to food packaging) Total organic UK Sum of above Case materials Other P&B packaging Total 95% of the 8 816 000 ite 28 369 000 c 4 166 000 t 41 351 000** no Range of fluorine Dinsmore (2020) fluorine content of o supermarket food packaging e.g. d popcorn bags, cookie bags, pizza - boxes, greaseproof n paper. Paper and io paperboard food t wrappers from fast food a restaurants lic Permitted concentrations of b PFAS in paper and board food u packaging US EU and US -p Estimate of the proportion of e total* paper r packaging that p contains PFAS Not specified (assumed EU) packaging had fluorine content content (mg/kg or g/tonne): Average = 537 Maximum = 1200 46% food contact papers and 20% paperboard samples have detectable fluorine EU(BfR): Range is: 0.5 - 1.2% 0.4 - 1.2% US FDA (dry weight) typically 0.5% CfE 0.4 - 1.0% Up to 1% (assume 0.5 - 1.0%) Schaider et al. (2017) (BfR, 2020; FDAUS, 2021) Estimate (see Table A.22) Total organic EU Oil-beading compostable: Strakov et al. fluorine content of 680 mg/kg TOF (2021) throwaway Oil-beading takeaway paper: packaging 480 mg/kg TOF Oil-spreading or soaking paper/board: 14.5 mg/kg TOF Notes: *Presumed to be packaging that may come into contact with food, rather than generic (packaging for non-food items) packaging; **Assumed to include feed and food contact P&B. 203 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.80. Substances (indicative list with some examples) used in FCM and packaging. Substance Abbrev CAS number Chemical Use Function / iation formula regulatory listing 2,3,3,3-tetrafluoro-2heptafluoropropoxy)propinoic acid; or perfluoro[2(npropoxy)propanoic acid] GenX, HFPODA, FRD903 13252-13-6 C6HF11O3 Consumer and industrial cookware PPA in Reg. 10/2011. Substitute for PFOA Polytetrafluoroethylene; a polymer of: tetrafluoroethylene (TFE) PTFE 9002-84-0 (C2F4)n pre-publication Silicone Rubber, fluorinated FKM, fluoroelastomers (1,1- Difluoroethylen hexafluoropropenpolymer ) Ethene, 1,1,2,2tetrafluoro-, homopolymer (PTFE) Ethylenetetrafluoroethylene copolymer (ETFE) FKM Perfluoroelastomer (FFKM) 64706-30-5 64706-30-65 PTFE: 9002-840; VDF-coHFP/FKM#1: 9011-17-0; FEP: 25067-112 - Tetrafluoroethylene- perfluoropropylene copolymer (FEP) Perfluoroalkyl(C6-C16) No data 65530-64-5 phosphates of bis(2- hydroxyethyl)amine or Diethanolamine salts of mono- and bis(1H,1H,2H,2H- do - NH2+(CH2C H2OH) (O)P(O-) (OCH2CH2 CnF2n+1)2 Cooking and Monomer baking equipment, coated rubber not citelisted in Reg 10/2011 Polymer for coating cookware, such as coatings on frying pans and articles for oven baking, and moulded articles for industrial use. Liquid No data processing equipment Rubber components Food, nonfood and feed packaging Additive 204 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Abbrev iation CAS number perfluoroalkyl(C8-C18) phosphates [mono- and di-PAP, FT] Chemical formula Use Function / regulatory listing Table A.81. PFAS that have been identified for all food contact and packaging use. Entries have been organised according to chemical groupings in this table. Source: see note at the end of the table. Substance Name* Perfluorooctanoic acid, ammonium salt Abbreviation PFOA CAS Number** 3825-26-1 Perfluorooctane sulfonic PFOS 1763-23-1 pre-publication acid Perfluoroheptanoic acid Perfluorohexanoic acid 2,3,3,3-tetrafluoro-2heptafluoropropoxy)propinoic acid; or perfluoro[2(npropoxy)propanoic acid] No data 375-85-9 (PFHxA) 307-24-4 GenX, HFPO-DA, FRD-903 13252-13-6 Hexafluoropropylene No data 116-15-4 Chemical Formula C8H4F15NO2 - do No data C7HF13 O2 C6HF11O2 C6HF11O3 C3F6 Use Consumer not cookware Industrial food processing and food transport equipment Food & feed packaging Food & feed packaging Food & feed packaging Food & feed packaging Consumer cookware Industrial food processing and food transport equipment Food & feed packaging Consumer cookware cite Function and Regulatory Listing PPA listed in Reg. 10/2011. No longer used. No longer used. No data No data PPA in Reg. 10/2011. Substitute for PFOA Monomer in Reg. 10/2011. Perfluoroalkyl vinyl ethers: Perfluoromethyl vinyl ether Perfluoroethyl vinyl ether Perfluoropropyl vinyl ether e.g. PFMVE PFEVE PFPVE e.g. 1187-93-5 10493-43-3 1623-05-8 C3F6O (PFMVE) C4F8O (PFEVE) C5F10O (PFPVE) Consumer cookware Monomers listed in Reg. 10/2011. Industrial food processing and food 205 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use transport equipment Function and Regulatory Listing Perfluoroalkyl phosphonic acids Perfluoroalkyl phosphinic acids Ammonium perfluoroalkyl carboxylate (PFPAs) (PFPiAs) No data 40143-768, 4014378-0, 52299-260, 6322555-8 40143-779, 4014379-1, 52299-271, 6322554-7 6130-43-4, 4149-60-4, 4234-23-5, 4288-72-6 pre-publication 1-Alkanol, 1H,1H,2H,2H- perfluoro-, 1-(hydrogen sulfate), ammonium salt (1:1) No data Chlorotrifluoroethylene No data 63225-569, 6322557-0, 63225-581, 6322559-2 79-38-9 Vinylidene fluoride No data 75-38-7 (Perfluorobutyl)ethylene No data Potassiumperfluorobutanes ulfonate Perfluoropolyether (PFPE) or Perfluoropolyether dicarboxylic acid, No data No data 19430-93-4 29420-49-3 76415-979, 6999162-4 No data No data NH4+ CnF2n+1CO O (4149- - do 60-4) No data ClCF=CF2 CH2CF2 C6H3F9 C4F9KO3S No data Non-food packaging Non-food packaging not Non-food P&B packaging Non-food packaging Coating for polyethylene film used e.g. for packaging toys cite and foodstuff. Coating for polyethylene film used e.g. for packaging toys and foodstuff. PFAS that have been patented for use in paper packaging for non-food articles Coating for polyethylene film used e.g. for packaging toys and foodstuff Consumer cookware Consumer cookware Consumer cookware Food & feed packaging Food & feed packaging Monomer Listed in 10/2011. (The monomer is not a PFAS, the polymer is a PFAS). Monomer Listed in 10/2011. (The monomer is not a PFAS, the polymer is a PFAS). Monomers listed in Reg. 10/2011. No data No data 206 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing ammonium salt Perfluoro-1,2- No data 306-98-9 dimethylcycloalkane 6:2-8:2 or 8:2-8:2-di No data No data polyfluoroalkyl phosphate ester (PAP) 8:2, 10:2, 12:2, 14:2 or No data No data 16:2 fluorotelomer alcohol (FTOH) and mono- phosphate or di-phosphate Phosphoric acid, mono- No data No data and bis(gamma, omega- perfluoroalkyl) esters, compounds with diethanolamine Pentanoic acid, 4,4-bis No data 71608-61-2 [(gamma-omega- perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine 3,3,4,4,5,5,6,6,7,7,8,8,8- No data 17527-29-6 tridecafluorooctyl acrylate, or methacrylate acetate pre-publication 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluorooctyl methacrylate, acetate and/or malate 1-Octanesulfonamide, Nethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7 ,8,8,8-heptadecafluoro Acrylic acid, ester with Nethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7 , 8,8,8-heptadecafluoro-N(2-hydroxyethyl)-1-octanesulfonamide N-(2-Hydroxyethyl) perfluorooctyl sulphonamide Acrylic acid, Nmethylperfluorooctanesulfo No data No data No data No data No data 2144-53-8 No data No data 1691-99-2 25268-77-3 namido-ethyl ester (Perfluorooctylsulfonylamin No data 68310-75-8 opropyl)trimethylammoniu m iodide 2-Propenoic acid, 2- No data 1893-52-3 amino]ethylester[ethyl[(tri decafluorohexyl)sulfonyl]- 2-Propanoic acid, 2- No data No data ((ethyl(pentadecafluorohep C8F16 No data No data No data No data o No data - d C12H9F13O2 No data No data No data No data No data No data No data Food & feed packaging Food & feed packaging No data No data Food & feed packaging Food & feed packaging not Food & feed packaging No data cite No data No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 207 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing tyl)-sulfonyl) amino)ethyl ester Acrylic acid, 2[methyl[(nonafluorobutyl) sulfonyl]ethylester amino] Ethanaminium, N,N,Ntriethyl-, salt with 1,1,2,2,3,3,4,4, 5,5,6,6,7,7,8,8,8heptadecafluoro-1octanesulfonicacid (1:1) 2,3,3,4,4,5,5-Heptafluoro1- pentene No data No data No data No data No data 1547-26-8 Perfluoro[(2-ethyloxy- No data No data ethoxy)acetic acid] pre-publication Perfluoro[(2-ethyloxy- ethoxy)acetic acid]], ammonium salt No data 908020-520 Sodium 4perfluorononyloxybenzenesulphonate Perfluoro[2-(poly(npropoxy))propanoic acid] or perfluoropolyether carboxylic acid Perfluoro acetic acid, substituted with the No data No data No data e.g. 59536-17-3 51798-33-5 329238-246 copolymer of perfluoro- 1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexa-fluoropropyloxy groups No data No data C5H3F7 - do C6HF11O4 C6HF11O4 (+ NH3) C15H4F19 NaO4S (C3F6O)n C6HF11O3 C3F6ClO[CF2CF(CF3)-O]n[CF(CF3)O]mCF2COOH Food & feed packaging No data Food & feed packaging No data Consumer not cookware Food & feed packaging Non-food packaging Industrial food processing and food transport equipment Consumer cookware cite Monomer Listed in 10/2011. Comonomer, in combination with the comonomers ethylene and tetrafluoroethylen e, in the manufacture of fluoropolymers. Temperature resistant polymer coating systems for frying, cooking and baking utensils Monomer and emulsifier (PPA) Listed in 10/2011. Consumer cookware Monomer and emulsifier (PPA) Consumer cookware Consumer cookware Industrial food processing and food transport equipment Monomer and emulsifier (PPA) Listed in 10/2011. PPA Listed in 10/2011. PPA in Reg. 10/2011 - specification: Up to 0.5 % w/w in the polymerisation of fluoropolymers that are processed at 208 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing 2H-perfluoro-[(5,8,11,14tetramethyl)tetraethyleneglycol ethyl propyl ether] No data 37486-69-4 perfluoro{acetic acid, 2[(5- methoxy-1,3dioxolan-4-yl)oxy]}, ammonium salt 3H-perfluoro-3-[(3methoxypropoxy)propanoic acid], ammonium salt Polytetrafluoroethylene; a polymer of: tetrafluoroethylene No data ADONA PTFE 119093127-1 958445-448 9002-84-0 116-14-3 pre-publication Polytrifluoroethylene No data No data Polychlorotrifluorethyene (PCTFE) 9002-83-9 Polyvinylidene fluoride PVDF 24937-79-9 No data No data No data - do (C2F4)n No data No data (C2H2F2)n Consumer cookware Consumer not cookware Consumer cookware temperatures at or above 340 C and are intended for use in repeated use articles PPA Listed in 10/2011. cite PPA Listed in 10/2011. PPA Listed in 10/2011. Consumer cookware Industrial food processing and food transport equipment Food & feed packaging Non-food packaging Non-food packaging Non-food packaging Industrial food processing and food transport equipment Monomer and PPA Listed in 10/2011. Additive (in micropowder form) for other plastics to get better nonsticking properties for these plastics. Food packaging foils. Food packaging films, pharmaceutical blister packaging. High barrier film. Used for solid and lined pipes, fittings, valves, pumps, tower packing, and tank and trailer linings for fluid-handling applications. 209 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing Vinylidene fluoridehexafluoropropene copolymer A dipolymer made from HFP and vinylidene fluoride (VF). No data No data 9011-17-0 9011-17-0 1478-61-1 VF and HFP copolymers No data 9011-17-0 VF, HFP and No data 25190-89-0 tetrafluoroethylene (TFE) pre-publication copolymers Poly (hexafluoropropyleneoxide) , polymer with 3-Nmethylaminopropylamine, N, N,dimethyldipropylenetria mine and poly (hexamethylenediisocyanat e) with a fluorine content of 59,1% No data No data Reaction product of No data No data hexamethylene-1,6- diisocyanate (homopolymer), transformed with 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluoro-1-octanol with a fluorine content of 48% (CH2CF2)x(CF2CFCF3)y No data No data do (CF2CF2)x- (CF2CFCF3)y- -(CF2CH2) No data No data Food & feed packaging No data Industrial food processing and food transport equipment not Industrial food processing and food transport equipment Industrial food processing and food transport equipment Food & feed packaging Food & feed packaging A fluoroelastomer designed for finished parts, which are compliant with cite the regulations of the U.S. Food and Drug Administration (FDA) 21 CFR 177. 2600(c)(4)(i). Monomers in Reg. 10/2011 Monomers in Reg. 10/2011 No data Food & feed packaging No data 210 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing Reaction product of No data 647-42-7 hexamethylene-1,6- diisocyanate (homopolymer), converted with 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluoro-1-octanol with a fluorine content of 48 % Hexane, 1,6-diisocyanato-, No data 357624-15- homopolymer, 8 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluoro-1-octanol- blocked Copolymer of 1,1- No data No data difluoroethylene, tetrafluoroethylene, trifluoro methyl trifluorovinyl ether and a halogenated alkene, optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert- pre-publication butylperoxy)hexane Hexane, 1,6-diisocyanato-, homopolymer, -[1-[[[3[[3 (dimethylamino)propyl]ami no]propyl]amino]carbonyl] -1,2,2,2-tetrafluoroethyl]-(1,1,2,2,3,3,3heptafluoropropoxy) poly[oxy[trifluoro(trifluoro methyl)-1,2-ethanediyl]]blocked No data Hexane, 1,6-diisocyanato-, homopolymer, -[1-[[[3[[3 (dimethylamino)propyl]ami no]propyl]amino]carbonyl] -1,2,2,2-tetrafluoroethyl]- No data 127910820-1 No data -(1,1,2,2,3,3,3- heptafluoropropoxy)poly[o xy[trifluoro(trifluoromethyl )-1,2-ethanediyl]] Other HFP copolymers HFP 116-15-4 e.g. with TFE No data No data No data - do No data No data C3F6 Food & feed packaging No data Food & feed packaging not Food & feed packaging cite No data No data Food & feed packaging No data Food & feed packaging No data Industrial food processing and food transport equipment Monomer in Reg. 10/2011 211 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing Copolymer of No data 116-15-4 hexafluoropropylene, TFE, (hexafluoro and perfluoroethyl vinyl propylene) ether 116-14-3 10493-43-3 (vinyl ether) A copolymer of propylene, No data 115-07-1 TFE, and 3,3,3- 116-14-3 trifluoropropene cured 677-21-4 with a salt of a quarternary (trifluoropr ammonium compound and opene) phenol, 4,4'-(2,2,2- trifluoro-1- (trifluoromethyl)ethylidene )bis- A copolymer of TFE and No data 116-14-3 trifluoromethyl 1187-93-5 trifluorovinyl ether, and (ether) optionally employing a halogenated alkene. 2-Propen-1-ol, reaction No data 464178-90- products with 3 pre-publication pentafluoroiodoethane-TFE telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine 1-Hexene, 3,3,4,4,5,5,6,6,6nonafluoro-, polymer with 1,1,2,2-tetrafluoroethene 2,3,3,4,4,5,5-Heptafluoro1-pentene polymer with ethene and TFE Perfluoroalkoxy alkanes (PFA); a copolymer of: Perfluoroalkyl vinyl ether, and tetrafluoroethene No data No data PFA 82606-24-4 94228-79-2 e.g. 26655-005, 1623-05-8 116-14-3 Perfluoroethylene FEP propylene, or Fluorinated Ethylene Propylene (FEP); is a copolymer of: Hexafluoropropene (see 25067-11-2 116-15-4 116-14-3 No data No data No data - do No data (C6H3F9.C2F4) x (C5H3F7.C2H4. C2F4)x C7F14O (C3F6.C2F4)n Food & feed packaging No data Food & feed packaging not Food & feed packaging No data cite No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Consumer cookware Industrial food processing and food transport equipment Consumer cookware Polymer. Non-stick coating for pans and facilitates cleaning of the cookware. Monomer in Reg. 10/2011. Polymer for coating cookware, such as frying pans and articles for oven baking, 212 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing above), andtetrafluoroethylene Silicone Rubber, fluorinated No data 64706-3065 Siloxanes and silicones, No data 1643944- methyl-phenyl, methyl- 25-5 pre-publication 3,3,3-trifluoropropyl Glycine, N,N-bis[2hydroxy-3-(2propenyloxy)propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethanetetrafluoroethylene telomer Glycine, N-ethyl-N[(heptadecafluorooctyl)sulf No data No data 220459-7012 2991-51-7 67584-51-4 onyl]-, potassium salt, or 67584-53-6 nonafluorobutyl or 67584-62-7 tridecafluorohexyl or pentadecafluoroheptyl Diphosphoric acid, No data 162492-15- polymers with ethoxylated 1 with reduced Me esters of phosphorou reduced polymerized s pentoxide oxidized TFE. This 1314-56-3 substance is also known or No data - do No data No data No data No data Industrial food processing not and food transport equipment Industrial food processing and food transport equipment Industrial food processing and food transport equipment Food & feed packaging moulded articles for industrial use, and for use in non-porous (very good chemical resistance) films with excellent abrasion cite resistance. Monomers 10/2011 in Reg. A silicone-based fluoroelastomer. Used as a lubricant, or a component of, bearing grease to lubricate facer roll bearings in paper and paperboard manufacturing. No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 213 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing as: phosphate esters of pyrophosph ethoxylated perfluoroether, oric acid prepared by reaction of 2466-09-3. ethoxylated perfluoroether diol. Diphosphoric acid, No data 200013-65- polymers with ethoxylated 6 reduced methyl esters of reduced polymerized oxidized TFE Diphosphoric acid, No data 200013-65- polymers with ethoxylated 6 (reduced reduced methyl esters of methyl reduced polymerized esters) oxidized TFE. Fomblin 162492-15- HC/P2-1000. This 1 substance is also known as (perfluoroet phosphate esters of her diol) ethoxylated perfluoroether, 1314-56-3 prepared by reaction of (pentoxide) ethoxylated perfluoroether diol with phosphorous 2466-09-3 pentoxide or (acid) pre-publication pyrophosphoric acid Diphosphoric acid, polymers with methyl esters reduced ethoxylates oxidized reduced polymerized tetrafluoro ethylene 2-propenoic acid, 2hydroxyethyl ester, polymer with -(1-oxo-2propen-1-yl)-hydroxypoly(oxy-1,2ethanediyl), -(1-oxo-2propen-1-yl)--[(1-oxo-2propen-1-yl)oxy]poly(oxy1,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 2- No data No data No data 101278370-8 propenoate 2-propenoic acid, 2- No data 1158951- methyl-, polymer with 2- 86-0 hydroxyethyl 2-methyl-2- propenoate, -(1-oxo-2- propen-1-yl)-- hydroxypoly(oxy-1,2- ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluorooctyl 2- No data No data do - No data (C11H7F13O2. C5H8O3. (C2H4O)nC6H 6O3.(C2H4O)n C3H4O2)x (C11H7F13O2. C6H10O3. C4H6O2.(C2H4 O)n C3H4O2)x.xN a Food & feed packaging No data Food & feed packaging not cite No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 214 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* propenoate, sodium salt Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing 2-propenoic acid, 2methyl-, 2-hydroxyethyl ester, polymer with 2propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 2methyl-2-propenoate, sodium salt 2-propenoic acid, 2methyl-, 2-hydroxyethyl ester polymer with 1ethyenyl-2-pyrrolidinone, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 2propenoate sodium salt No data No data 187820424-0 120645010-3 Phosphoric acid ester of No data 200013-65- ethoxylated perfluoropoly- 6 pre-publication etherdiol Diphosphate ester of Nethyl perfluorooctane sulfonamido ethanol (NEtFOSE) No data N,N',N''[phosphinylidynetris(oxyet hane-2,1-diyl)]tris[Nethylheptadecafluorooctane -1-sulphonamide] 1-Butanaminium, N,N,Ntributyl-, hexafluorophosphate(1-) No data No data N-Ethyl-N-(2- No data 162492-151 1314-56-3 2466-09-3 No data 2250-98-8 3109-63-5 67969-69-1 hydroxyethyl)perfluoroocta nesulfonamide phosphate, diammonium salt [SN-mono-PAP/PFPA] 1-Octanesulfonamide, N, No data 30381-98-7 N'-(phosphinicobis(oxy-2, 1-ethanediyl))bis(N, ethyl- 1,1,2,2,3,3,4,4,5,5,6,6,7,7 ,8,8,8-heptadecafluoro-, ammonium salt) (C12H9F13O2. C6H10O3. C3H4O2)xxNa (C11H7F13O2. C6H10O3. C6H9NO.C3H4 O2)xxNa - do No data No data No data No data No data No data Food & feed packaging No data not Food & feed packaging cite No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 215 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing Perfluoroalkyl(C6-C16) No data 65530-64-5 phosphates of bis(2- hydroxyethyl)amine or Diethanolamine salts of mono- and bis(1H,1H,2H,2H- perfluoroalkyl(C8-C18) phosphates [mono- and di-PAP, FT] Ethanol, 2,2-iminobis-, No data 65530-64-5 compd. with ,- [phosphinicobis (oxy-2,1- ethanediyl)]bis[- fluoropoly(difluoromethyle ne)] (1:1) Perfluoroalkyl substituted No data No data phosphate ester acids, ammonium salts formed by pre-publication the reaction of 2,2-bis[ ([gamma], [omega]perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide Ammonium bis(N-ethyl-2perfluoroalkylsulfonamido ethyl) phosphates, containing not more than 15% ammonium mono (Nethyl-2perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is more than 95% C8 and the salts have a fluorine content of 50.2% to 52.8% as determined on a solids No data No data basis Ammonium salts of esters No data No data from reaction with 2,2'-bis perfluoralkyl substituted phosphoric acid formates [(alfa, omega-perfluoro C4-C20 alkylthio) methyl] - 1,3-propanediol, polyphosphoric acid and ammonium hydroxide No data NH2+(CH2C H2OH) (O)P(O- )(OCH2CH2C nF2n+1)2 - do No data No data No data Food & feed packaging No data not Non-food P&B packaging Food & feed packaging cite PFAS that have been patented for use in paper packaging for non-food articles (US EPA 2016) No data Food & feed packaging No data Food & feed packaging No data 216 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Number** Ammonium-bis- (N-ethyl- No data No data 2- perfluoralkylsulfonamidoet hyl) phosphate cannot contain more than 15 % ammonium mono(N-ethyl- 2- perfluoralkylsulfonamidoet hyl) phosphate Ammonium bis (N-ethyl-2- No data No data perfluorooctansulfonamidet hyl) phosphate with maximum content of 15% ammonium mono (N-ethyl- 2- perfluorctansulfonamidethy l) phosphate Ammonium-bis- (N-ethyl- No data 1071022- 2- 26-8 perfluorooktansulfonamidet hyl) phosphate with maximum content of 15% ammonium mono (N-ethyl- pre-publication 2- perfluoroktansulfonamideth yl) phosphate Diethanolamine salts of mono- and bis (1H,1H,2H,2H perfluoroalkyl) phosphates where the alkyl group is even-numbered in the range C8-C18 and the salts have a fluorine content of 52.4% to 54.4% as determined on a solids basis. Diethanolamine single (1H,1H,2H,2H -perfluoroalkyl) phosphate and dual(1H,1H,2H,2H-perfluoroalkyl) phosphate. No data No data No data No data Diethanol amino salts of No data No data mono- and bis (1H, 1H, 2H, 2H-perfluoroalkyl) phosphates 2-Propenoic acid, 2- No data 1334473- methyl-, 2- 84-5 (dimethylamino)ethyl ester, polymer with 1- ethenyl-2-pyrrolidinone and Chemical Formula No data Use Food & feed packaging Function and Regulatory Listing No data No data do (C12H9F13O2. C10H19NO2. C4H6O2.C3H4 O2)x.xC2H4O2 - Food & feed packaging not Food & feed packaging cite No data No data No data Food & feed packaging No data No data Food & feed packaging No data No data Food & feed packaging No data (C11H7F13O2. C8H15NO2. C6H9NO)x.xC 2H4O2 Food & feed packaging No data 217 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 2propenoate, acetate CAS Chemical Number** Formula Use Function and Regulatory Listing 2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl ester, polymer with -(1-oxo-2propen-1-yl)-hydroxypoly(oxy-1,2ethanediyl) Butanedioic acid, 2methylene-, polymer with 2-hydroxyethyl, 2-methyl2-propenoate, 2-methyl-2propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 2methyl-2-propenoate, sodium salt No data No data 68228-00-2 134581752-8 2Butanedioic acid, 2- No data 1345817- methylene-, polymer with 52-8 pre-publication 2-hydroxyethyl 2-methyl- 2-propenoate, 2-methyl-2propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 2methyl-2-propenoate, sodium salt Perfluoropentanoic acid Perfluoropentadecanoic acid PFPeA PFPeDA 2706-90-3 and 141074-637 Copolymer of TFE, PFMVE and 1-Butene, 4-bromo3,3,4,4-tetrafluoro-, No data 105656-631 polymer with ethene, 1,1,2,2-tetrafluoroethene and 1,1,2-trifluoro-2- (trifluoromethoxy)ethene. intended to be cross-linked with triallylisocyanurate A copolymer of TFE and No data 26425-79-6 PFMVE modified with 1,3,5- (TFE and triallyl isocyanurate or PFMVE) 1,3,5-triallyl cyanurate and No data No data do (C12H9F13O2. C6H10O3. -C5H6O4.C4H6 O2)x.xNa No data (C4H3BrF4.C3 F6O.C2H4. C2F4)x No data Food & feed packaging No data Food & feed not packaging cite No data Food & feed packaging No data Industrial food processing and food transport equipment Industrial food processing and food transport equipment Food & feed packaging Perfluoropenta acids (PFPEs) are used as lubricants during production, processing, and packaging of food. Monomers in Reg. 10/2011 No data Industrial food processing and food Monomers in Reg. 10/2011 218 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing 3,3,4,4,5,5,6,6,7,7,8,8- dodecafluoro-1,9-diene, manufactured and characterised as further described in the notification A copolymer of TFE and No data 26425-79-6 perfluoromethylvinyl ether (PFMVE) modified with 1,3,5-triallyl isocyanurate (TAIC) and 3,3,4,4,5,5,6,6,7,7,8,8- dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification A copolymer of TFE and No data 26425-79-6 PFMVE \ modified with 3,3,4,4,5,5,6,6,7,7,8,8- dodecafluoro-1,9-diene and 1,3,5-triallyl cyanurate or 1,3,5-triallyl pre-publication isocyanurate A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing TFE, PFMVE and perfluoro-6,6dihydro-6-iodo-3-oxa-1hexane, and subsequent curing of the terpolymer with triallylisocyanurate and 2,5-dimethyl-2,5-di(tbutylperoxy)hexane No data A perfluorocarbon cured No data 116-14-3 (TFE) 1187-93-5 (PFMVE) 106108-229 (perfluoroalkane) 193018-530 (terpolymer ) 1025-15-6 (triallylisoc yanurate) 78-63-7 (hexane) 116-14-3 elastomer (PCE) produced 2599-84-0 by terpolymerizing TFE, , (vinyl perfluoro-2,5-dimethyl- ether) 3,6-dioxanonane vinyl 106108-22- ether, and perfluoro-6,6- 9 (hexene) dihydro-6-iodo-3-oxa-1- 106108-23- hexene, and subsequent 0 curing of the terpolymer (terpolymer with triallylisocyanurate ) and 2,5-dimethyl-2,5-di(t- 1025-15-6 No data No data - do No data C4F8O No data No data No data No data No data transport equipment Food & feed packaging not Food & feed packaging No data cite No data Industrial food processing and food transport equipment Food & feed packaging Monomers in Reg. 10/2011 Food & feed packaging No data 219 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* butylperoxy)hexane Abbreviation CAS Chemical Number** Formula 78-63-7 Use Function and Regulatory Listing Perfluorocarbon cured No data 1187-93-5 elastomers produced by (methyl polymerizing perfluoro vinyl (methyl vinyl ether) with ether) TFE and perfluoro(8-cyano 116-14-3 -5-methyl -3,6-dioxa -1- 69804-19-9 octene, followed by curing (per fluoro with trimethylallyl octene) isocyanurate and/or triallyl 6291-95-8 isocyanurate, and with 2,5 1025-15-6 -dimethyl -2,5-di (t- 78-63-7 butylperoxy) hexane and as further described in this notification A perfluorocarbon-cured No data 116-14-3 elastomer (PCE) produced (TFE) by terpolymerizing TFE 2599-84-0 perfluoro (2,5-dimethyl- (vinyl 3,6-dioxanone vinyl ether) ether) pre-publication and perfluoro (6,6-dihydro- 6-iodo- 3-oxa- 1-hexene) and subsequent curing of the terpolymer by crosslinking with triallylcyanurate and vulcanizing with 2,5dimethyl- 2,5-di (tbutylperoxy) hexane, as a 68% dispersion on finely divided silica 1,9Decadiene,3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-, polymer with TFE and trifluoro (trifluoromethoxy)ethene No data 106108-229 (perfluoro alkene) 106108-230 (terpolymer ) 101-37-1 (triallycyan urate) 78-63-7 (hexane) 190062-249 (trifluoro ethene) manufactured and characterized as further described in the notification. 3-cyclohexane-1-carboxylic No data No data acid, 6-((di-2- propenylamino)carbonyl)- ,(1R,6R), reaction products with pentafluoroiodoethane- No data - do No data No data No data Food & feed packaging No data not Industrial food processing and food transport equipment Food & feed packaging cite Monomers in Reg. 10/2011 Industrial food processing and food transport equipment Food & feed packaging Monomers in Reg. 10/2011 Food & feed packaging No data 220 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation tetrafluoroethylene telomer, ammonium salts CAS Chemical Number** Formula Use Function and Regulatory Listing Copolymer of 1,1- No data No data difluoroethylene, hexafluoropropene, TFE, and a halogenated alkene, optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert- butylperoxy)hexane 1-Propene,1,1,2,3,3,3- No data 25190-89-0 hexafluoro-polymer with (polymer 1,1-difluoroethene and TFE with ethene modified with triallyl and TFE) isocyanurate and 3,3,4,4,5,5,6,6,7,7,8,8- dodecafluoro-1,9-diene, manufactured and characterised as further described in the notification. Tetrafluoroethylene- No data 25190-89-0 hexafluoropropylene- pre-publication vinylidene fluoride copolymers Tetrafluoroethyleneethylene-3,3,4,4,5,5,6,6,6nonafluoro-1-hexene terpolymer Ethene, 1,1,2,2tetrafluoro-, polymer with 1,1,2-trifluoro-2(1,1,2,2,2pentafluoroethoxy)ethene Ethene, tetrafluoro-, polymer with 1,1difluoroethene and trifluoro(trifluoromethoxy)e thene modified with 1,3,5triallyl isocyanurate (TAIC) and No data No data No data 68258-85-5 31784-04-0 56357-87-0 3,3,4,4,5,5,6,6,7,7,8,8- dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification Poly(hexafluoro-propylene No data 25038-02-2 oxide) No data No data do (CF2CF2)x- (CF2CFCF3)y- -(CF2CH2) No data (CF2CF2)x(CF2CFOC2F5) y No data No data Food & feed packaging No data Industrial food not processing and food transport equipment Food & feed packaging cite Monomers 10/2011 in Reg. Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 221 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing A polymer produced from No data 116-14-3 TFE and 1,1,2,2- (TFE) tetrafluoro-2-((1,2,2- 29514-94-1 trifluoroethenyl)oxy) (fluoride) ethane sulfonyl fluoride. The polymer is hydrolysed and may optionally be further neutralized to its ammonium salt. Ethene, tetrafluoro-, No data 56357-87-0 polymer with 1,1- (ethene, difluoroethene and fluoro, trifluoro(trifluoromethoxy)e polymer thene modified with 1,3,5- mixture) triallyl isocyanurate (TAIC) and 3,3,4,4,5,5,6,6,7,7,8,8- dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification Fluorocarbon cured No data 116-14-3 pre-publication elastomer produced by copolymerizing TFE and propylene and subsequent curing of the copolymer with triallylisocyanurate and 2,2'bis-(t-butylperoxy) diisopropylbenzene. Fluorocarbon cured elastomer produced by copolymerizing tetrafluoroethylene and No data (TFE) 115-07-1 (propylene) 27029-05-6 (copolymer ) 1025-15-6 (triallylisoc yanurate) 25155-25-3 (2,2'bis-(tbutylperoxy ) diisopropyl benzen) 116-14-3 (TFE) 115-07-1 (propylene) propylene and subsequent curing of the copolymer 1025-15-6 with triallylisocyanurate (triallylisoc and 2,2'-bis(tert- yanurate) butylperoxy) 25155-25-3 diisopropylbenzene (benzene) No data No data - do No data No data Industrial food processing and food transport equipment Food & feed packaging Industrial food processing not and food transport equipment Monomers in Reg. 10/2011 cite Monomers 10/2011 in Reg. Industrial food processing and food transport equipment Food & feed packaging Monomers in Reg. 10/2011 Food & feed packaging No data 222 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing Fluorocarbon cured elastomer produced by copolymerizing TFE and propylene and subsequent curing with triallylisocyanurate or triallylcyanurate and 2,2'bis(tert-butylperoxy) diisopropylbenzene Ethylene tetrafluoroethylene copolymer No data ETFE 116-14-3 115-07-1 1025-15-6 101-37-1 (triallylcyan urate) 25155-25-3 25038-71-5 Chlorotrifluoroethylene ECTFE 79-38-9 Copolymer of TFE, PFMVE No data No data and 1-iodo-2-bromotetra- pre-publication fluoroethane intended to be cross-linked with triallylisocyanurate Copolymer perfluoroalkylacrylate No data No data Copolymers of 2(perfluoroctylsulfonylamino methyl) ethylmethacrylate, 2,3epoxypropylmethacrylate, ethoxyethylacrylate and methacryloylmethyltrimethylammoniumchlorid e Copolymers of 2perfluoroalkylethyl No data No data No data No data acrylate, 2-N,N- diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid2 Copolymer of No data No data 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluorooctylacrylate, 2-hydroxyethylacrylate, polyethylenglycolmonacryla (C6H3F9.C2H4. C2F4)x No data No data - do No data No data No data No data No data Food & feed packaging No data Industrial food processing not and food transport equipment Industrial food processing and food transport equipment Food & feed packaging cite Monomer 10/2011 in Reg. Monomer in Reg. 10/2011 No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 223 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Number** te and polyethylenglycoldiacrylate with a fluorine content of 35.4 - 45.1% Copolymer of 2(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl methacrylate, N-oxide, acetate Copolymer of 2dimethylaminoethylmethac rylate and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctylmethacryl ate, N-oxide, acetate, with a fluorine content of 45% No data No data 144052804-0 No data Copolymer with 2,2'- No data No data ethylendioxydiethyldimetha pre-publication crylat, 2-hydroxyethyl- methacrylate and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctylmethacryl ate, acetate and/or malate Copolymer with 2hydroxyethylmethacrylate, methacrylic acid, itaconic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctylmethacryl ate, sodium salt Copolymer with 2hydroxyethylmethacrylate, vinylpyrrolidon, acrylic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctylacrylate, sodium salt, with a fluorine No data No data No data No data content of 41.9% Chemical Formula Use Function and Regulatory Listing No data Food & feed packaging No data No data - do No data Food & feed not packaging Food & feed packaging cite No data No data No data Food & feed packaging No data No data Food & feed packaging No data Copolymer with methacrylic acid, 2hydroxyethylmethacrylate, polyethylenglycolmonacryla te and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctylacrylate, No data No data No data Food & feed packaging No data 224 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation sodium salt with a fluorine content of 45.1% CAS Chemical Number** Formula Use Function and Regulatory Listing Perfluoroalkyl acrylate No data 92265-81-1 copolymer (CAS Reg. No. 92265-81-1) containing 35 to 40 weight percent fluorine, produced by the copolymerization of ethanaminium,N,N,Ntrimet hyl-2-[(2-methyl-1-oxo-2- propenyl)-oxy]-, chloride; 2-propenoic acid, 2-methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl ester; and 2-propenoic acid, 2- (heptadecafluoro- octyl)sulfonyl] pre-publication methyl amino]ethyl ester Copolymers of 2perfluoroalkylethyl acrylate, 2-N,Ndiethylaminoethyl methacrylate, and glycidyl methacrylate. Copolymer of 2perfluoroalkylethyl acrylate, 2(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate Copolymer of perfluorohexylethyl methacrylate, 2-N,Ndiethylaminoethyl methacrylate, 2- No data No data No data 247047-616 479029-282 (2(dimethyla mino)ethyl methacrylat e 122527344-8 hydroxyethyl methacrylate, and 2,2'- ethylenedioxydiethyl dimethacrylate, malic acid salt Copolymer of No data 863408-20- perfluorohexylethyl 2 methacrylate, 2-N,N- diethylaminoethyl methacrylate, 2- No data - do No data No data (C14H22O6.C12 H9F13O2. C10H19NO2.C 6H10O3)x. xC4H6O5 (C14H22O6.C12 H9F13O2. C10H19NO2.C 6H10O3)x. xC2H4O2 Food & feed packaging not No data cite Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 225 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing hydroxyethyl methacrylate, and 2,2'- ethylenedioxydiethyl dimethacrylate, acetic acid salt Copolymer of No data 863408-20- perfluorohexylethyl 2 or methacrylate, 2-N,N- malic acid diethylaminoethyl salt methacrylate, 2- 1225273- hydroxyethyl methacrylate, 44-8 and 2,2'- ethylenedioxydiethyl dimethacrylate, acetic acid salt or malic acid salt. 2,3-Epoxypropyl No data 92265-81-1 methacrylate - 2- ethoxyethyl acrylate - N- methylperfluorooctane- sulfonamidoethyl acrylate - trimethylethanolammoniu m chloride methacrylate, copolymer pre-publication 2-(Perfluorooctyl sulfonyl aminomethyl) ethyl methacrylate, copolymer [copolymer of fluorinated (meth)acrylate polymers] Methacrylic acid, 2(dimethylamino)ethyl ester, polymers with gamma-omega-per- fluoroC8-14-alkyl acrylate, acetates, N-oxides Methacrylic acid, 2(dimethylamino)ethyl ester, polymers with gamma-omega-per- fluoroC8-14-alkyl acrylate, Noxides Perfluoroalkyl acrylate copolymers including: No data No data No data No data No data 479029-282 783306-310 152521-136, 90451- Perfluoroalkyl acrylate 86-8 copolymer (Foraperle 321) 2-Propenoic acid,2-methyl- 196316-34- , 2-(dimethylamino) ethyl 4 ester, polymers with g-w- perfluoro-C10-16-alkyl acrylate and vinyl acetate, acetates No data No data - do No data No data No data No data Food & feed packaging No data not Food & feed packaging cite No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data Food & feed packaging No data 226 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Function and Regulatory Listing Acetic salts of the No data No data copolymer of perfluoroalkylethylacrylate, vinyl acetate and dimethyl aminoethylmetacrylate 2-(Diethylamino)ethyl No data No data methacrylate - 2,3- epoxypropyl methacrylate - perfluoroalkyl(C4- C18)ethyl acryl 2-(Dimethylamino)ethyl No data No data methacrylate - perfluoroalkylethyl acrylate - vinyl acetate, copolymer Fluorinated polyurethane No data 328389-91- anionic resin prepared by 9 reacting perfluoropolyether (polyuretha diol, isophorone ne) diisocyanate, 2,2- 88645-29-8 dimethylolpropionic acid (diol) and triethylamine 4098-71-9 (diisocyana te) pre-publication 2-Propen-1-ol, reaction products with 1,1,1,2,2,3,3,4,4,5,5,6,6tridecafluoro-6iodohexane*, de-hydroiodinated, reaction products with epichlorohydrin and triethylenetetraamine with a fluorine content of 54 % 2-propen-1-ol, reaction products with 1,l,1,2,2,3,3,4,4,5,5,6,6tridecafluoro-6- No data No data 4767-03-7 (acid) 121-44-8 (triethylami ne) * 355-43-1 464178-947 iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine Piperazinium, 1- (2- No data 103555-98- hydroxyethyl) -1-methyl-4- 2 (perfluoro-1-oxoalkyl) -, chloride (1:1) No data No data No data No data do - No data No data Cl CnF2n+1C(O )NC4H8N+(C H3) CH2CH2OH Food & feed packaging No data Food & feed packaging No data Food & feed packaging not Food & feed packaging cite No data No data Food & feed packaging No data Food & feed packaging No data Non-food P&B packaging PFAS that have been patented for use in paper packaging for non-food articles 227 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Number** Poly(oxy-1,2-ethanediyl), -sulfo-[(perfluoroalkyl)oxy]-, sodium salt Poly(oxy-1,2-ethanediyl), -[2[[(pentadecafluoroheptyl) sulfonyl]propylamino]ethyl ]--hydroxy Poly(oxy-1,2-ethanediyl), -[[4-[(perfluoroalkyl)oxy] phenyl]methyl]--[[4[(nonadecafluorononyl)oxy ] phenyl]methoxy] Ethanol, 2-[2[(perfluoroalkyl)oxy]ethoxy ]-, dihydrogen phosphate, disodium salt No data No data No data No data 138226-343 138226-354 138226-365 138473-753 Ethanol, 2- No data 138473-76- [methyl(perfluoroalkyl)ami 4 no]-, hydrogen phosphate (ester), ammonium salt pre-publication Benzenesulfonic acid, 4- [(perfluoroalkyl)oxy]-, ammonium salt (1:1) Carbamic acid, [(perfluoroalkyl)sulfonyl]pr opyl-, sodium salt No data No data Glycine, N-ethyl-N(perfluoro-1-oxoalkyl)-, ammonium salt No data 1-Propanaminium, N(carboxymethyl)-N,Ndiethyl-3[propyl[(perfluoroalkyl)sulf onyl]amino]-, inner salt Poly(oxy-1,2-ethanediyl), -[2-[[(perfluoroalkyl) No data No data 138473-775 138473-786 138473-797 138473-800 138570-748 sulfonyl]propylamino]ethyl ]--[2-[[(perfluoroalkyl) sulfonyl]propylamino]ethox y]- Potassium perfluoroalkane No data 2795-39-3 sulfonate Chemical Formula Use NH4+ CnF2n+1OC6 H4SO3 Non-food P&B packaging CnF2n+1SO2 N(C3H7)CH2 CH2 (OCH2CH2)x OH CnF2n+1OC6 H4CH2(OCH 2CH2)x OCH2C6H4O CnF2n+1 2 Na+ CnF2n+1CH2 OCH2CH2O CH2CH2OPO 32 o NH4+ PO2 (OCH2CH2N d (CH3)CH2CH 2CnF2n+1)2 -NH4+ CnF2n+1OC6 H4SO3 Non-food P&B packaging Non-food P&B packaging not Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging Na+ CnF2n+1SO2 N(C3H7)COO NH4+ CnF2n+1C(O )N(C2H5)CH 2 COO CnF2n+1SO2 N(C3H7)CH2 CH2 CH2N+(C2H 5)2CH2COO CnF2n+1SO2 N(C3H7)O(C H2CH2 O)xCH2CH2N (C3H7)SO2C n F2n+1 K+ CnF2n+1SO3 Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging Function and Regulatory Listing cite 228 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Number** 1-Propanaminium, 3[[(perfluoroalkyl)sulfonyl]a mino]-N,N,N-trimethyl-, chloride (1:1) No data 38006-74-5 1-Alkanesulfonamide, No data 64264-44-4 perfluoro-N-[2- (phosphonooxy) ethyl]-N- propyl Ethanol, 2,2-iminobis-, No data 65530-63-4 compd. with -fluoro--[2- (phosphonooxy)ethyl]poly( difluoromethylene) (2:1)4a NH2+ (CH2CH2OH) CnF2n+1CH2 CH2OPO3H not specified 65530-63-4 1-Propanaminium, N- No data 90179-39-8 (carboxymethyl)-N,N- dimethyl-3-[(perfluoro-1- oxoalkyl)amino]-, inner salt pre-publication Piperazinium, 1-(2- hydroxyethyl)-1-methyl-4(perfluoro-1-oxoalkyl)-, chloride (1:1) No data Oxirane, 2[[(perfluoroalkyl)oxy]meth yl]- No data Poly(oxy-1,2-ethanediyl), -sulfo-[(perfluoroalkyl)oxy]-, sodium salt Poly(oxy-1,2-ethanediyl), -[2[[(pentadecafluoroheptyl) sulfonyl]propylamino]ethyl ]--hydroxy Poly(oxy-1,2-ethanediyl), No data No data No data 103555-982 122193-684 138226-343 138226-354 138226-36- -[[4-[(perfluoroalkyl)oxy] 5 phenyl]methyl]--[[4- [(nonadecafluorononyl)oxy ] phenyl]methoxy] Ethanol, 2-[2- No data 138473-75- [(perfluoroalkyl)oxy]ethoxy 3 ]-, dihydrogen phosphate, disodium salt Chemical Formula Use Cl CnF2n+1SO2 NHCH2CH2 CH2N+(CH3) 3 CnF2n+1SO2 N(C3H7)CH2 CH2OP (=O)(OH)2 NH2+ (CH2CH2OH) CnF2n+1CH2 CH2OPO3H CnF2n+1OC6 o H4CH2(OCH 2CH2)x d OCH2C6H4O CnF2n+1 -Cl CnF2n+1C(O )NC4H8N+(C H3) CH2CH2OH CnF2n+1CH2 CH2OCH2C2 OH3 (n =6) NH4+ CnF2n+1OC6 H4SO3 Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging not Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging CnF2n+1SO2 N(C3H7)CH2 CH2 (OCH2CH2)x OH CnF2n+1OC6 H4CH2(OCH 2CH2)x OCH2C6H4O CnF2n+1 2 Na+ CnF2n+1CH2 OCH2CH2O CH2CH2OPO 32 Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging Function and Regulatory Listing cite 229 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name* Abbreviation CAS Chemical Number** Formula Use Ethanol, 2[methyl(perfluoroalkyl)ami no]-, hydrogen phosphate (ester), ammonium salt Benzenesulfonic acid, 4[(perfluoroalkyl)oxy]-, ammonium salt (1:1) No data No data 138473-764 138473-775 NH4+ PO2 (OCH2CH2N (CH3)CH2CH 2CnF2n+1)2 NH4+ CnF2n+1OC6 H4SO3 Non-food P&B packaging Non-food P&B packaging Function and Regulatory Listing Carbamic acid, [(perfluoroalkyl)sulfonyl]pr e opyl-, sodium salt No data it Glycine, N-ethyl-Nc (perfluoro-1-oxoalkyl)-, ammonium salt No data ot 1-Propanaminium, N- No data n (carboxymethyl)-N,N- diethyl-3- [propyl[(perfluoroalkyl)sulf o onyl]amino]-, inner salt d PPA = polymer processing additive 138473-786 138473-797 138473-800 Na+ CnF2n+1SO2 N(C3H7)COO NH4+ CnF2n+1C(O )N(C2H5)CH 2 COO CnF2n+1SO2 N(C3H7)CH2 CH2 CH2N+(C2H 5)2CH2COO Non-food P&B packaging Non-food P&B packaging Non-food P&B packaging - *PFAS identified as being used in packaging from Glge et al. (2020), PFAS in Paper and Board for Food Contact (Trier et al., 2017), Per and polyfluoroalkyl substances (PFAS in food contact material (RIVM and Bokkers, 2019), Product - Chemical Profile for Food Packaging Containing Perfluoroalkyl or n Polyfluoroalkyl Substances (DTSC, 2020), BfR recommendations (BfR, 2020), US EPA food contact io database (FDA-US, 2021), some patents and individual EFSA opinion substance reports. t **CAS number where data available. lica Regulatory listing mainly refers to Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, but in some cases US EPA and other listing is specified. ub Table A.82. PFAS Positively Identified as Used/Were Used in Consumer Cookware. Source: see note below table. p Substance Name Abbreviation CAS Chemical Function and Listing in - Number** Formula EU Regulation e 10/2011 pr Perfluorooctanoic PFOA 3825-26-1 C8HF15O2 Listed in Reg. 10/2011. acid, ammonium salt Short-Chain PFAS. Emulsifier (PPA), but no current use. Previously used in manufacture of PTFE as a PPA. Listed in 10/2011 as only to be used in repeated-use articles, sintered at high temperatures. 230 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name Abbreviation CAS Number** Chemical Formula Function and Listing in EU Regulation 10/2011 2,3,3,3-tetrafluoro-2heptafluoropropoxy)propinoic acid; or perfluoro[2-(npropoxy)propanoic acid] GenX, HFPO-DA, FRD-903 13252-13-6 Hexafluoropropylene No data 116-15-4 Perfluoroalkyl vinyl e.g. e.g. ethers: PFMVE 1187-93-5 Perfluoromethyl vinyl PFEVE 10493-43-3 ether PFPVE 1623-05-8 Perfluoroethyl vinyl pre-publication ether Perfluoropropyl vinyl ether Chlorotrifluoroethylen e No data Vinylidene fluoride No data 79-38-9 75-38-7 (Perfluorobutyl)ethyle No data 19430-93-4 ne C6HF11O3 C3F6 C3F6O (PFMVE) o C4F8O d(PFEVE) C5F10O -(PFPVE) ClCF=CF2 CH2CF2 C6H3F9 PPA in Reg. 10/2011. Emulsifier. Replacement for PFOA in production of PTFE. For use as top layer for cooking, baking and roasting utensils, used at max temperature of e 230 C. it Monomer in Reg. 10/2011. c For use in temperature resistant polymer coating t systems for frying, ocooking and baking nutensils. Monomers listed in Reg. 10/2011. For use in temperature resistant polymer coating systems for frying, cooking and baking utensils and moulded articles for industrial use. Anti-stick coatings. For manufacturing of PTFE for use as top layer for cooking, baking and roasting utensils, used at max temperature of 230 C. Monomer Listed in 10/2011 (The monomer is not a PFAS, the polymer is a PFAS). Monomer Listed in 10/2011. (The monomer is not a PFAS, the polymer is a PFAS). Monomers listed in Reg. 10/2011. Co-monomer. For use in polymers, sintered at high temperatures. 231 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name Abbreviation CAS Number** Chemical Formula Function and Listing in EU Regulation 10/2011 2,3,3,4,4,5,5Heptafluoro-1pentene No data Perfluoro[(2-ethyloxyethoxy)acetic acid]], ammonium salt No data 1547-26-8 C5H3F7 908020-52-0 C6HF11O4 (+ NH3) Sodium 4- No data e.g. C15H4F19 perfluorononyloxybenzenesulphonate 59536-17-3 Perfluoro[2-(poly(n- No data 51798-33-5 pre-publication propoxy))propanoic acid] or perfluoropolyether carboxylic acid Perfluoro acetic acid, -substituted with the copolymer of perfluoro-1,2propylene glycol and perfluoro-1,1ethylene glycol, terminated with chlorohexafluoropropyloxy groups 2H-perfluoro[(5,8,11,14tetramethyl)tetraethyleneglycol No data No data 329238-24-6 37486-69-4 NaO4S do (C3F6O)n -C6HF11O3 C3F6ClO[CF2CF(CF3)O]n[CF(CF3)O]mCF2COOH No data ethyl propyl ether] perfluoro{acetic acid, 2-[(5- methoxy-1,3dioxolan-4-yl)oxy]}, ammonium salt No data 1190931-27-1 No data Monomer Listed in 10/2011. For fluoro-copolymers for their application as a PPA. Monomer and emulsifier (PPA) Listed in 10/2011. e For use in temperature it resistant polymer coating systems for frying, c cooking and baking utensils. t as FCM. oMonomer and emulsifier n(PPA) Only for use in coatings on kitchen utensils for cooking, baking, roasting etc. Monomer and emulsifier (PPA) Listed in 10/2011. For the emulsion polymerisation of FPs. PPA Listed in 10/2011. For FPs that are processed at temperatures at or above 340 C and are intended for use in repeated use articles. Listed in 10/2011 as FCM. PPA Listed in 10/2011. For use in FPs that are processed at temperatures at or above 300 C (in repeated use) or 360C (in single use) articles. PPA Listed in 10/2011. Emulsifier/ dispersing agent (PPA). For FPs processed at temperatures at or above 232 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Name Abbreviation CAS Number** Chemical Formula Function and Listing in EU Regulation 10/2011 370 C. 3H-perfluoro-3-[(3- ADONA 958445-44-8 No data PPA Listed in 10/2011. methoxy- Emulsifier for use in the propoxy)propanoic polymerisation of FPs acid], ammonium salt Polytetrafluoroethylen e; a polymer of: tetrafluoroethylene PTFE 9002-84-0 116-14-3 (C2F4)n pre-publication Perfluoroalkoxy PFA alkanes (PFA); a copolymer of: Perfluoroalkyl vinyl ether, and tetrafluoroethene Perfluoroethylene FEP propylene, or Fluorinated Ethylene Propylene (FEP); is a copolymer of: Hexafluoropropene (see above), and- tetrafluoroethylene e.g. 26655-00-5, 1623-05-8 116-14-3 25067-11-2 116-15-4 116-14-3 do - C7F14O (C3F6.C2F4 )n that are processed at temperatures at or above 190 C. ite Monomer c Listed in 10/2011. t Polymer for coating cookware, such as ocoatings on frying pans nand articles for oven baking, and moulded articles for industrial use. Temperature resistant polymer coating systems for frying, cooking and baking utensils. Non-stick baking paper, films, foil and cooking bags. Polymer. Non-stick coating for pans and facilitates cleaning of the cookware. Polymer for coating cookware, such as frying pans and articles for oven baking, moulded articles for industrial use, and for use in nonporous (very good chemical resistance) films with excellent abrasion resistance. Lower melting temperature than PTFE. Note: PFAS positively identified as used in packaging from Glge et al. (2020), PFAS in Paper and Board for Food Contact (Trier et al., 2017), Per and polyfluoroalkyl substances (PFAS in food contact material (RIVM and Bokkers, 2019), Product - Chemical Profile for Food Packaging Containing Perfluoroalkyl or Polyfluoroalkyl Substances (DTSC, 2020), BfR recommendations (BfR, 2020), US EPA food contact database (FDA-US, 2021) and individual EFSA opinion substance reports. **CAS number where available. PPA = polymer processing additive, 10/2011 is a reference to Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. 233 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.5. Metal plating and manufacture of metal products Table A.83. PFAS used (or patented) in metal plating processes and in the manufacture of metal products. Group/substance EU market (Tpa) Source Metal plating 3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic 10-100 (registration (Willand W., acid dossier, volume not 2022) (6:2 FTS) limited to the use of N,N,N,-triethylethanaminium 1,1,2,2,3,3,4,4,4nonafluorobutane-1-sulfonate (derivate of PFBS) Potassium 1,1,2,2-tetrafluoro-2(perfluorohexyloxo)ethane sulfonate (F-53) Potassium 2-(6-chloro-1,1,2,2,3,3,4,4 5 5,6,6dodecafluorohexyloxy)-1,1,2,2-tetrafluoroethane sulfonate (F-53B) Perfluoroalkyl phosphinic acids Perfluorohexanesulfonamides pre-publication 1-Alkanesulfonamide, N,N'-bis(2,3-dihydroxy propyl)- perfluoroTridecafluoroheptanamide Alkanamide, N,N-bis(2,3-dihydroxy propyl)-perfluoro N-Alkyl perfluoroalkane sulfonamides 1-Alkanesulfonamide, N,N'-[phosphonicobis(oxy2,1,ethanediyl)]bis[perfluoro-N-methyl) Fluorinated (meth)acrylate polymers Manufacture of metal products Potassium perfluorohexane-1-sulphonate Potassium undecafluorocyclohexanesulphonate 1-Propanaminium, 3-[[(perfluoroalkyl)sulfonyl]amino]N,N,N-trimethyl-, chloride (1:1) 1-Propanaminium, N-ethyl-3[[(perfluoroalkyl)sulfonyl]amino]-N,N-dimethyl-, ethyl sulfate (1:1) N-[3-(Dimethylamino)propyl]-N- metal plating) 1-10 (registration dossier, volume not ite limited to the use of metal plating) c Unknown - not t registered. (NEA, 2017) (KEMI, 2015; Wang et al., 2020) no 1-10 (registration o dossier, volume not dlimited to the use of metal plating) Unknown -Unknown Glge et al. (2020) Unknown Unknown Unknown Unknown Unknown Unknown Unknown Unknown Unknown Glge et al. (2020) Unknown [(perfluoroalkyl)sulfonyl]--alanine Cyclohexanecarboxamide, N-[3-(dimethyl Unknown amino)propyl]-1,2,2,3,3,4,4 5 5,6,6-undecafluoro- 1-Propanaminium, N-(2-carboxyethyl)-N,N-dimethyl- Unknown 3-[[(1,2,2,3,3,4,4 5 5,6,6- undecafluorocyclohexyl)carbonyl]amino]-, inner salt 1-Propanaminium, N-(2-carboxyethyl)-3-[[[1,2,2,3,3,4 Unknown 5 5,6, 6-decafluoro-4- (trifluoromethyl)cyclohexyl]carbonyl] amino]-N,N- dimethyl-, inner salt 234 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Group/substance EU market (Tpa) Source Poly(oxy-1,2-ethanediyl), -[2-[ethyl[(perfluoroalkyl) Unknown sulfonyl]amino]ethyl]--hydroxy N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2- 100-1 000 [[2-(trifluoromethyl)phenyl]azo] butyramide (registration dossier, volume not limited to the use of manufacture of metal products) 6:2 FTS 10-100 (registration dossier, volume not limited to the use of manufacture of metal products) 3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1- 10-100 (registration acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4- dossier, volume not chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide] limited to the use of manufacture of t metal products) o Reaction mass of ammonium(3,3,4,4 5 1-10 (registration n 5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen dossier, volume not phosphate and ammonium bis(3,3,4,4 5 limited to the use of 5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate manufacture of o metal products) d Polytetrafluoroethylene (PTFE) Unknown Polyvinylidene fluoride (PVDF) Unknown - Siloxanes and silicones, di-Me, Me 3,3,4,4 5 Unknown 5,6,6,7,7,8,8,8-tridecafluorooctyl Siloxanes and silicones, di-Me, Me 3-(1,1,2,2-tetra fluoro Unknown n ethoxy)propyl, Me 3,3,4,4 5 5,6,6,7,7,8,8,8- io tridecafluorooctyl t Hexafluoropropylene polymer (HFP) Unknown Polychlorotrifluoroethylene (PCTFE) Unknown a Ethylene tetrafluoroethylene copolymer (ETFE) Unknown lic Fluorinated ethylene propylene (FEP) Unknown Ethylene-chlorotrifluoroethylene copolymer (ECTFE) Unknown Perfluoralkoxy polymer (PFA) Unknown b Ethylene-tetrafluoroethylene-hexafluoro propylene Unknown u copolymer p Hexafluoropropylene-tetrafluoroethylene-vinylidene Unknown - fluoride copolymer (THV) Ethylene-hexafluoropropylene-perfluoropropyl vinyl Unknown e ether-tetrafluoroethylene copolymer r Hexafluoropropylene-perfluoropropyl vinyl ether-tetra Unknown p fluoroethylene-vinylidene fluoride copolymer cite Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoro ethoxy-) Unknown Pentane, 1,1,1,2,2,3,4 5 5 5-decafluoro- Unknown Cyclopentane, 1,1,2,2,3,3,4-heptafluoro- 1-10 (registration dossier, volume not limited to the use of manufacture of metal products) Fluororubber (FKM, FFKM, FPM) Unknown Fluorosilicone (FVMQ) Unknown 235 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.6. Consumer mixtures Table A.84. Examples for specific PFAs used for certain applications (Glge et al., 2020). Use Name CAS number General cleaning agents Potassium N-ethylperfluoroalkane- 67584-51-4 sulfonamido acetate 67584-52-5 67584-53-6 67584-62-7 2991-51-7 Ammonium (n:2) fluorotelomer 65530-71-4 phosphate monoester 3,3-Dichloro-1,1,1,2,2pentafluoropropane Methyl perfluoroalkyl ether Cleaning agents for Perfluoroalkylcarboxylic acids (PFCAs) dishes and glasses Glass cleaners Potassium N-ethyl perfluoroalkane- sulfonamide acetate Carpet and upholstery o cleaners Perfluoroalkylphosphonic acids (PFPAs) Perfluoroalkylphosphinic acids (PFPiAs) n - d Dry cleaning of metals, io glass, ceramics, etc. t Guitar strings and piano keys a Lubricants for string lic instruments Anti-fog agents pub Coating for Guitar strings e- Cleaning for optical r devices p Floor polish Ethyl perfluoroalkyl ether Polyvinylidene fluoride, PVDF PTFE micropowder Fluorotelomer alcohols (FTOHs) and fluorotelomer ethoxylates (FTEOs): 6:2FTOH; 8:2 FTOH; 10:2FTOH; 6:2FTEOs PTFE (polytetrafluoroethylene) / FEP (fluorinated ethylene propylene) /ETFE (ethylene tetrafluoroethylene) 1,1,1,2,2,3,4,5,5,5-Decafluoropentane Potassium N-ethylperfluoroalkane- 422-56-0 e 22410-44-2 it 375-03-1 163702-07-6 c 375-22-4 t 335-67-1 67584-53-6 o2991-51-7 n40143-76-8 40143-78-0 52299-26-0 40143-77-9 610800-34-5 1240600-40-1 1240600-41-2 40143-79-1 500776-81-8 163702-05-4 24937-79-9 9002-84-0 647-42-7 678-39-7 865-86-1 52440-44-4 9002-84-0 25067-11-2 25038-71-5 138495-42-8 67584-51-4 sulfonamidoacetate 67584-52-5 67584-53-6 67584-62-7 2991-51-7 236 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Products sampled in 2016 were analysed for PFBA, PFBS, PFHxA, PFHxS, PFOA, PFNA, PFDA, PFOS, 4:2 FTOH, 6:2 FTOH, 8:2 FTOH, 10:2 FTOH, 6:2 FTA, 8:2 FTA, 10:2 FTA, MeFOSA, EtFOSA, MeFOSE, EtFOSE; products sampled in 2014 were analysed for PFBA, PFBS, PFHxA, PFHxS, PFHpA, PFOA, PFNA, PFDA, PFOS, 4:2 FTOH, 6:2 FTOH, 8:2 FTOH, 4:2 FTS, 6:2 FTS, PFUnDa, PFDoDA, PFTriA, PFTeA, 6:2 diPAP, 6:2 mono-PAP, 8:2 diPAP, 8:2 mono-PAP. Errors in dealing with the units were corrected using Blom and Hanssen (2015). Blank cells symbolise that no PFAS could be detected (see Table A.85). Table A.85. Sum of PFAS and TOF content for several consumer mixtures (Borg and Ivarsson, 2017). Product Year of product Sum (PFAS) [g/l] Total organic Rinse aid 1 Rinse aid 2 Floor polish Furniture polish Car polish 1 Car polish 2 Dishwasher 1 Dishwasher 2 sampling 2016 2016 2016 2016 2014 2014 2014 2014 0.75 1.2 1 840 3 370 3 130 9 680 2.6 fluorine [g/l] <1 000 e 2 000 it 18 500 c <1 000 3 000 t8 000 o14 500 n<1 000 Waterproofing textiles - Wash in 2014 660 <1 000 do Table A.86. Measured PFAS content for several consumer mixtures(Blom and Hanssen, 2015; Borg and Ivarsson, 2017). Blank cells indicate that the PFAS in question could not be - detected. Product Year of PFBA PFHxA PFOA PFDA 6:2 8:2 n product [g/l] [g/l] [g/l] [g/l] FTOH FTOH sampling [g/l] [g/l] tio Rinse aid 1 Rinse aid 2 a Shoe wax lic Floor polish Furniture polish b Car wax 1 Car wax 2 u Car polish 1 p Car polish 2 - Dishwasher 1 e Dishwasher 2 r Waterproofing p textiles - Wash 2016 2016 2016 2016 2016 2016 2016 2014 2014 2014 2014 2014 0.47 1.12 0.75 0.75 0.53 0.59 1.4 2.8 0.47 0.509 0.555 0.47 1834 263 3 110 31 130 391 9 290 2.62 630 in 1 Waterproofing textiles - Wash 2014 680 in 2 237 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.87. Quantified PFAs content for a group of polishes and cleaners (Favreau et al., 2017). Samples were collected in 2012/2013 in Switzerland. In total, the product content was analysed regarding 41 different PFAS. Product 6:2 FTS N-EtFOSE 6:2 FTOH group Cleanser Polish Occurrence 0 out of 24 1 out of 18 Content [mg/kg] 0.1 Occurrence 1 out of 24 0 out of 18 Content [mg/kg] 1.2 - Occurrence above LOQ 1 out of 24 1 out of 18 Content [mg/kg] 4 26.0 Table A.88. Determined Fluorotelomers for cleaning products, waxes and sealants. e products were sampled in 2011 and 2013 in the USA (Liu et al., 2015). it Product group Product 6:2 FTOH 8:2 FTOH 10:2 FTOH number [mg/kg] [mg/kg] [mg/kg] c Commercial A1 carpet care liquid 3.28 2.95 1.46 t A2 105 o A3 0.194 Household n carpet/fabric- B1 care liquids and o foams d B2 0.372 Floor waxes and - wood/stone C1 1.59 1.4 sealants C2 4.01 0.442 n C3 24.2 6.91 io C4 331 92.4 C5 13.9 0.477 The licat Table A.89. Quantified PFAS in cleaners (Kotthoff et al., 2015). Six products were used for measuring PFAS except FTOHs and three products for FTOHs. The samples were collected in 2010 in Germany. b PFOA PFOS PFTeA 6:2 FTOH 8:2 FTOH 10:2 u [mg/kg] [mg/kg] [mg/kg] [mg/kg] [mg/kg] FTOH p [mg/kg] - Maximum concentration 0.0011 0.0016 0.0008 38.7 547.1 81.9 re Median 0.0007 0.0012 0 p concentration 38 63 22.6 238 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.90. Sum of 45 analysed PFAS and extractable organic fluorine (EOF) for several cleaning products sampled in 2021 in the Netherlands(Pancras, 2021). Product Sum (PFAS) [g/kg] Extractable organic fluorine [g/kg] Dishwash 1 0 590 Dishwash 2 6 10 000 Dishwash 3 4 1 200 Dishwash 4 7 630 Cleaning agent 1 5 4 600 Cleaning agent 2 5 470 Cleaning agent 3 6 250 Cleaning agent 4 8 Cleaning agent 5 16 Table A.91. Sum of 16 analysed PFAS and TOF for four online (Herkert et al., 2022). Product Sum (PFAS) [g/kg] Spray A Spray B Spray C Spray D 25 000 327 529 566 n - licatio -pub pre 460 150 ite different anti-fog sprays purchased c Total organic fluorine t [g/kg] 20 700 o 221 n 202 do190 239 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.7. Cosmetics -publication - do not cite Figure A.23. Functions of INCI names in cosmetics. Searched for 169 INCI names in total in the CosIng database, for 9 INCI names the function section was empty or "not reported" was given as information. Total function count surpasses 160, as several INCI names have several listed pre functions. 240 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.92. PFAS INCI names found in cosmetic products in the different databases. Shown are only the most frequent found PFAS among all databases and the top ten ranked PFAS within each database (CosmEthics, Kemiluppen and ToxFox), rank within database (the number of products in which the according PFAS was found). Note that a hyphen (-) equals not found in this database, grey cells represent the top 10 e ranked substances of all databases and/or within a database). it PFAS INCI names CAS No EC/List no Fluorinat Covered by any Rank Rank Rank ed existing or pending CosmEthics Kemiluppen ToxFox c carbons PFAS restriction (number of (number of (number of products) products) products) t PTFE 9002-84-0 618-337-2 fluoropoly No 1 (541) 1 (64) 1 (321) o mer n C9-15 fluoroalcohol 223239-92-7 - C9-C15 Existing, included in 3 (208) 3 (27) 3 (76) phosphate the PFOA restriction in POPs and the C9- o C14 PFCAs restriction d in REACH Perfluorodecalin 306-94-5 206-192-4 C10/fully No 6 (64) 5 (13) 4 (70) - F Perfluorooctyl triethoxysilane 51851-37-7 257-473-3 C6 Existing, included in 2 (232) 4 (14) - the n(3,3,4,4,5,5,6,6,7,7, io8,8,8- tridecafluorooctyl) t silanetriol and TDFAs a restriction in REACH lic Perfluorononyl dimethicone - - C9 Existing, included in 4 (111) 11.5 (5) 5 (60) the PFOA restriction in POPs and the C9- b C14 PFCAs restriction u in REACH Polyperfluoromethylisopropyl 69991-67-9 615-044-1 C4 No 8 (55) 7 (9) 6 (55) p ether - Octafluoropentyl methacrylate 355-93-1 206-596-0 C4 No 12 (31) 2 (31) - e Acetyl trifluoromethylphenyl 379685-96-8 609-497-4 C1 No r valylglycine p Methyl perfluorobutyl ether 163702-07-6 - C4 No 7 (63) 7 (9) - 11 (34) 7 (9) - Polyperfluoroethoxymethoxy - - C1+C2 No 9 (47) 11.5 (5) - 241 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PFAS INCI names CAS No EC/List no Fluorinat ed carbons Covered by any existing or pending PFAS restriction difluoroethyl PEG phosphate Ammonium C6-16 65530-72-5 685-094-7 C6-C16 Existing, included in perfluoroalkylethyl phosphate / 65530-71- / the PFOA restriction 4 / 65530- 809-881-3 in POPs and the C9- 70-3 / C14 PFCAs restriction 809-882-9 in REACH Methyl perfluoroisobutyl ether 163702-08-7 605-340-9 C4 No Trifluoropropyldimethyl/trimet - - C1 No hylsiloxysilicate Polyperfluoroisopropyl ether 25038-02-2 626-882-2 C3 No do Trifluoromethyl C1-4 alkyl dimethicone PEG-8 trifluoropropyl dimethicone copolymer HC yellow no. 13 Polysilicone-7 Polysilicone-10 * Included in the Cosmetics - - C1 No - - - C1 No n 10442-83-8 443-760-2 C1 io 146632-08-8 - C8 at - - unclear No* Existing, included in the PFOS restriction in POPs unclear pre-public Regulation provisions: Annex III/26 (EC, 2022). Rank Rank CosmEthics (number of e products) it 14 (25) Kemiluppen (number of products) 10 (6) not c 16 (23) 9 (7) 10 (42) 23.5 (1) 21.5 (7) 25 (6) 19 (2) - 30 (3) - - - - - - - Rank ToxFox (number of products) - 11 (1) 8 (7) 9 (2) 7 (16) 11 (1) 11 (1) 242 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.8. Ski wax Table A.93. Examples of PFAS-based ski waxes, applications and normalised prices from a review in 2020. Trade name Supplier Specific application (e.g ski, snowboard, glide wax, grip wax) Normalised price (/g, from supplier websites) Glider for skis 1,Swix HF7 Violet Swix Ski, glide 1.006 Swix vr 55 krystal line grip Swix Ski, glide, grip 0.38 wax silber-violet Glider 1, Swix LF6 Blue e Vauhti Quick HF Skin Care 80ml Red it SWIX FC10X CERA F/ c 7045951824131 SWIX FC7X CERA F/ t 7045951824117 o 5SKIGO C22 GUL/ 7393753630048 n TOKO JETSTREAM POWDER BLUE/7613186169350 o BRIKO MAPLUS FP4/ d 8028383990079 REX RACING SERVICE 63 Swix Vauhti Swix Swix Ski, glide Ski, snowboard, glide Ski Ski Skigo Ski TOKO Ski JETSTREAM BRIKO Ski MAPLUS rex Ski - VAUHTI FC LDR/ n 6419696087204 VAUHTI Ski io GALLIUM GIGA SPEED GALLIUM Ski MAXFLUOR / 4948575107853 t SWIX HF MARATHON/ Swix Ski 7045951580778 a SKIGO HF UNIVERSAL / lic 7393753630208 TOKO HF HOTWAX/ 4250423601612 SKIGO Ski TOKO Ski 0.23 0.34 4 4.5 2.33 3.8 1.8 4.3 5.4 6.33 1.93 1.22 0.68 ub Table A.94. Examples of fluorine-free waxes, applications and normalized prices from a p review in 2020. re- Trade Name Supplier Specific application (e.g ski, snowboard, glide wax, grip wax) Normalised price (/g, from supplier websites) BP77 Base prep Hard 900g p BP77 Base prep Hard 100g Swix Ski, snowboard, glide wax 0.09 0.08 BP88 Base Prep Medium,900g Swix Ski, snowboard, glide 0.11 BP88 Base Prep Medium, wax 0.11 180g BP99 Base Prep Soft, 180g Swix Ski, snowboard, glide 0.09 wax CH10X Yellow, 0 C/10C, Swix Ski, snowboard, glide 0.18 180, wax 0.14 CH10X Yellow, 0 C/10C, 0.09 60g CH10X Yellow, 0 C/10C, 900g 243 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Trade Name Supplier Specific application (e.g ski, snowboard, glide wax, grip wax) CH12X Combi, 54g Swix Ski, snowboard, glide CH12X Combi, 900g wax CH3X Cold Powder, 30g Swix Ski, snowboard, glide wax CH5X Turquoise, -8 C/- Swix Ski, snowboard, glide 14C, 180g wax CH5X Turquoise, -8 C/- 14C, 60g CH5X Turquoise, -8 C/- 14C, 900g CH7X Violet, -2 C/-8C, Swix Ski, snowboard, glide 180g wax CH7X Violet, -2 C/-8C, 60g CH7X Violet, -2 C/-8C, 900g CH8X Red, -4C/4C, 180g Swix Ski, snowboard, glide CH8X Red, -4C/4C, 60g wax CH8X Red, -4C/4C, 900g F4-100C Glidewax Liquid Swix Ski, snowboard, glide 100ml wax F4-80NC liquid 80ml F4-150C spray 150 ml F4-180 solid 180g o F4-60 solid 60g d F4-900 solid 900g F4-75C paste 75ml F6LNC Blue liquid glide,-6/- - 15,80ml F7LNC Violet liquid glide 1/- n 6,80ml F8LNC Red liquid glide 0/+10, io 80ml HS10 Yellow, 0C/+10C, t 180g a HS10 Yellow, 0C/+10C, 60g lic HS5 Turquoise, -10C/-18C, 180g HS5 Turquoise, -10C/-18C, b 60g u HS5 Turquoise, -10C/-18C, 900g p HS6 Blue, -6C/-12C, 180g - HS6 Blue, -6C/-12C, 60g HS6 Blue, -6C/-12C, 900g e HS6 Blue liquid 125 ml r Marathon White Fluor Free, p 40g Swix Swix Swix Swix Swix Swix Swix Ski, wax Ski, wax Ski, wax Ski, wax snowboard, snowboard, snowboard, snowboard, glide glide glide glide Ski, snowboard, glide wax Ski, snowboard, glide wax Ski, snowboard, glide wax Marathon Black Fluor Free, Swix Ski, snowboard, glide 180g wax Marathon Black Fluor Free, 40g N15 Swix Skin Care Swix Ski, snowboard, glide N15 Swix Skin Care Spray wax 150ml Normalised price (/g, from supplier websites) 0.17 0.08 0.91 0.15 0.17 n.a. 0.09 0.20 0.09 not0.09 0.20 0.09 0.14 0.15 0.09 0.14 0.20 cite 0.15 0.21 0.18 0.18 0.19 0.28 0.19 0.20 0.30 0.12 0.12 0.93 0.99 1.13 0.17 N19 Glide Wax For Skin Skis Swix Ski, snowboard, glide n.a. wax 244 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Trade Name Supplier Specific application (e.g ski, snowboard, glide wax, grip wax) Phantom DPS Ski, snowboard, glide wax Quick Wax mountainFl ow Ski, snowboard Fast Wax Nordic Ski waxes Natural Skiwax bar Natural Skiwax spray Natural Skiwax paste Natural Skiwax stick Natural Skiwax fluid Holmenkol Ski Green Ice Wax Green Ice Wax Ski, snowboard Purl Wax Purl Ski, snowboard Wend Mf non-fluoro race bar with meadowfoam 300g Wend Mf non-fluoro race bar with meadowfoam 100g Wend Ski, glide Fluoro-Free Competition Dominator Ski, snowboard, glide (FFC) Series wax ELITE Dominator o Start RG Race Glider Red Start d Start RG Race Glider purple Start - Start RG Race Glider blue Start Start RG Race Glider green Start ion Start RG Race Glider base Start t Universal yellow Solid Fluor Free pre-publica Universal Red Solid Fluor Free MAPLUS MAPLUS Ski, wax Ski, wax Ski, wax Ski, wax Ski, wax Ski, wax Ski, snowboard, snowboard, snowboard, snowboard, snowboard, snowboard, snowboard glide glide glide glide glide glide Ski, snowboard Normalised price (/g, from supplier websites) n.a. n.a. n.a. n.a. n.a. n.a. not0.34 0.39 n.a. n.a. cite n.a. n.a. n.a. n.a. n.a. n.a. n.a. 245 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.9. Applications of fluorinated gases Table A.95. Fluorinated gases currently in commercial use for Heating, Ventilation, Air Conditioning and Refrigeration (HVACR) and other e uses - Organised by HFC Code (Source: Stakeholder consultation and literature review carried out during the development of the restriction it proposal). Substance Code CAS number General use Sub-use Specific use c Fluoroform HFC-23 75-46-7 Refrigeration (in t (trifluoromethane) blend, see R- (Not in scope) 473A) o Difluoromethane HFC-32 75-10-5 Refrigeration Domestic and commercial air Split non-ducted units n (Not in scope) and heat pumps conditioning Domestic refrigeration oIndustrial refrigeration Transport refrigeration dElectronics cooling Water and space heating heat - pumps 1,1,1,2,2,3,4,5,5,5- HFC-43-10mee 138495-42-8 Solvents Precision & electronics n Decafluoropentane cleaning, commercial & io industrial cleaning and carrier solvent & lubricants tOther Immersion cooling of a electronics Pentafluoroethane HFC-125 354-33-6 Fire suppressant Total flooding agent Protection of high value lic assets and electrical equipment. Military b aircraft engine nacelles. 1,1,1,2-Tetrafluoroethane HFC-134a 811-97-2 Foam-blowing Rigid polyurethane foam Commercial refrigeration u agents (commercial refrigeration and p domestic appliances) - Rigid polyurethane boardstock Continuous panel e and panels production r Rigid polyurethane spray foam Open-cell spray foam p Propellants Consumer propellants Consumer products 246 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance 1,1,1-Trifluoroethane 1,1-Difluoroethane (Not in scope) 1,1,1,2,3,3,3Heptafluoropropane Code CAS number General use Sub-use Commercial and industrial ation - do not cite HFC-143a lic HFC-152a 420-46-2 75-37-6 pre-pub HFC-227ea 431-89-0 Refrigeration and heat pumps Commercial refrigeration Industrial refrigeration Transport refrigeration Domestic and commercial air conditioning Mobile air conditioning Other Electronics cooling Water and space heating heat pumps Heat pump clothes dryers Plasma coating of HDPE Used in blends (see below) Foam-blowing agents Propellants Cover gases Foam-blowing agents Rigid polyurethane spray foam Extruded polystyrene foam (XPS) Consumer propellants Magnesium casting Rigid polyurethane boardstock and panels Rigid polyurethane spray foam Rigid polyurethane pipe-in-pipe Specific use Technical uses where nonflammability and inhalation safety required - air dusters and lubricant aerosols Condensing unit systems, bottler coolers, ice cream cabinets, standalone plugin displays. Data centre cooling Refrigerated shipping containers Split non-ducted units - in areas with high ambient temperature, chillers New cars, air conditioning in trains Open cell spray foam XPS Consumer aerosols Rigid boardstock, continuous panel production Block foam 247 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance 1,1,1,3,3,3Hexafluoropropane 1,1,1,3,3Pentafluoropropane 1,1,1,3,3-Pentafluorobutane Code CAS number General use HFC-236fa 690-39-1 Fire suppressant Fire suppressant HFC-245fa 460-73-1 Foam-blowing agents pre-publication - HFC-365mfc 406-58-6 Refrigeration and heat pumps Solvents Foam-blowing Agents Sub-use Specific use and block foam e Polyurethane integral skin it Phenolic foam Total flooding agent & c streaming agent t Streaming agent o no Rigid polyurethane foam d(commercial refrigeration and manufacture/pipe insulation Protection of high value assets and electrical equipment. Protection of high value assets and electrical equipment. Onboard aircraft. Domestic appliances, commercial refrigeration domestic appliances) Rigid polyurethane boardstock Rigid boardstock, and panels continuous panel production Rigid polyurethane spray Foam Closed-cell spray foam Rigid Polyurethane pipe-in-pipe Block foam and block foam manufacture/pipe insulation Domestic and commercial air Chillers conditioning Solvent in aerosols; precision & electronics cleaning and commercial & industrial cleaning Rigid polyurethane foam (commercial refrigeration and domestic appliances) Rigid Polyurethane (PU) Boardstock and Panels Commercial refrigeration Rigid boardstock, continuous panel 248 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance 2-Bromo-3,3,3trifluoroprop-1-ene 1-Chloro-1,2,2,2tetrafluoroethane 1,1-Dichloro-1-fluoroethane (Not in scope) 3,3-Dichloro-1,1,1,2,2pentafluoropropane 1,1,-Difluoroethylene (Not in scope) 2,3,3,3-Tetrafluoropropene Code CAS number General use Solvents BTP, 2-BTP, Halotron BrX - HCFC-124 tion HCFC-141b 1514-82-5 2837-89-0 1717-00-6 Fire suppressant Fire suppressant Foam-blowing agents Solvents lica HCFC-225ca/cb 422-56-0 Solvents pub HFO-1132a pre- HFO-1234yf 75-38-7 754-12-1 Refrigeration (in blend, see R473A) Refrigeration and heat pumps Sub-use Specific use Rigid polyurethane spray Foam e Rigid polyurethane pipe-in-pipe it and block foam c Polyurethane integral skin t Phenolic foam no Solvent in aerosols; precision & electronics cleaning and ocommercial & industrial cleaning dStreaming agent production Closed-cell spray foam Block foam manufacture/pipe insulation Skin foams Phenolic boardstock production/phenolic block foams Niche applications aviation/military to replace halon 1211 Total flooding agent Support existing/legacy systems. Rigid polyurethane (PU) Rigid boardstock (believed Boardstock and Panels to be largely phased out) Solvent in aerosols; precision & Largely phased out. electronics cleaning and commercial & industrial cleaning Solvent in aerosols; precision & Largely phased out. electronics cleaning and commercial & industrial cleaning Domestic refrigeration Commercial refrigeration Domestic fridge/freezer Bottler coolers 249 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Trans-1,3,3,3Tetrafluoroprop-1-ene 1,3,3,3-Tetrafluoropropene Trans-1,1,1,4,4,4hexafluorobut-2-ene Cis-1,1,1,4,4,4-Hexafluoro2-butene Code CAS number General use HFO-1234ze(E) HFO-1234ze(E) 1645-83-6 29118-24-9 Other Refrigeration and heat pumps Foam-blowing agents ion - HFO-1336mzz(E) 66711-86-2 licat HFO-1336mzz(Z) 692-49-9 Propellants Refrigeration and heat pumps Refrigeration and heat pumps Foam-blowing agents re-pub Propellants p Solvents Sub-use Specific use Industrial refrigeration Mobile air conditioning e Domestic and commercial air it conditioning Plasma coating of HDPE c Domestic and commercial air t conditioning Rigid polyurethane foam o (commercial refrigeration and n domestic appliances) Rigid polyurethane spray foam oExtruded polystyrene foam (XPS) dConsumer propellants New cars Stationary air conditioning and chillers Stationary air conditioning and chillers Commercial refrigeration Open-cell spray foam Emerging use as XPS Non-flammable propellant and novelty aerosols Domestic refrigeration Domestic fried/freezer Commercial refrigeration Bottler coolers Industrial refrigeration Data centre cooling Heat pumps Steam production Domestic and commercial air Chillers conditioning Water and space heating heat pumps Rigid polyurethane foam Domestic appliances, (Commercial Refrigeration and commercial refrigeration Domestic Appliances) Rigid polyurethane (PU) Emerging use as rigid Boardstock and Panels boardstock Phenolic foam Emerging use as phenolic boardstock production/phenolic block foams Consumer propellants Solvent in aerosols; Precision & 250 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance 1-Chloro-2,3,3,3tetrafluoropropene (Z)-1-Chloro-2,3,3,3tetrafluoropropene Trans-1-chloro-3,3,3trifluoropropene Code CAS number General use HCFO-1224yd 3110-38-1 Refrigeration and heat pumps HCFO-1224yd(Z) 111512-60-8 Foam-blowing agents Refrigeration and heat pumps Solvents ion - HCFO-1233zd(E) 102687-65-0; Foam-blowing agents blicatRefrigeration u and heat pumps pre-p Solvents Sub-use Specific use electronics cleaning, commercial & industrial e cleaning and carrier solvent & it lubricants Domestic and commercial air c conditioning t Heat pumps Rigid polyurethane foam o (commercial refrigeration and n domestic appliances) Water and space heating heat opumps Solvent in aerosols; Precision & delectronics cleaning, Chillers Steam production commercial & industrial cleaning and carrier solvent & lubricants Rigid polyurethane foam (commercial refrigeration and domestic appliances) Rigid Polyurethane (PU Boardstock and Panels Phenolic foam Domestic and commercial air conditioning Heat pumps Solvent in aerosols; precision & electronics cleaning, commercial & industrial cleaning and carrier solvent & lubricants Domestic appliances, commercial refrigeration Emerging use as rigid boardstock Emerging use as phenolic boardstock production / phenolic block foams Chillers Steam production 251 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Methoxytridecafluoroheptene isomers Dodecafluoro-2-methyl-3pentanone 1,1,2,2-Tetrafluoro-1(2,2,2-trifluoroethoxy) ethane Methyl perfluoropropyl ether Methyl nonafluorobutyl ether + Methyl nonafluoroisobutyl ether 1-Ethoxy-nonafluorobutane 3-Methoxyperfluoro(2methylpentane) 3-Ethoxyperfluoro(2methylhexane) Hexafluoroisopropanol Code MPHE, SionTM CAS number No data General use Solvents FK-5-1-12 756-13-8 HFE-347pc-f2 406-78-0 Other Cover gases Fire Suppressant Solvents HFE-7000 375-03-1 Solvents HFE-449mccc/ 163702-08-7 Solvents HFE-449s1 (HFE-7100) 163702-07-6 tion - HFE-569mccc/ a HFE-569sf2 lic (HFE-7200) 163702-05-4 b HFE-7300 pu HFE-7500 132182-92-4 297730-93-9 pre- HFIP 920-66-1 Other Cover gas Solvents Solvents Cover gas Solvents Solvents Refrigerant Solvents Sub-use Specific use Precision & electronics cleaning, commercial & e industrial cleaning and carrier it solvent & lubricants Debinding agent, 3D printing c Magnesium casting t Local streaming agent o Precision & electronics n cleaning, commercial & industrial cleaning oCarrier solvent & lubricants Precision & electronics dcleaning, commercial & Methoxytridecafluoroheptene isomers industrial cleaning and carrier solvent & lubricants Immersion cooling of electronics Magnesium casting Cultural heritage paper preservation Precision & electronics cleaning, commercial & industrial cleaning and carrier solvent & lubricants Magnesium casting Commercial & industrial cleaning Electronics cooling, military applications 3D printing processing liquid 252 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance 2,3,3,3-tetrafluoro-2(trifluoromethyl)propanenitrile 1,1,1,3,4,4,4-heptafluoro-3(trifluoromethyl)-2butanone (E)-1,1,1,2,3,4,5,5,5nonafluoro-4(trifluoromethyl)- 2-pentene Perfluorohexane (n- and iso-) Perfluorotripropylamine (perfluamine) Perfluorotributylamine Perfluoro-N-propylmorpholine (mixture of isomers) Perfluoro-2-methylpentane 1,1,2,3,3,3Hexafluoropropene, oxidized, polymd. (Perfluoropolyether, PFPE) HFC Blend (HFC-125/143a/134a) Code C4-FN CAS number 42532-60-5 General use Insulating gas C5-FK 756-12-7 Insulating gas FA-188 3709-71-5 FC-72/PF-5060 1064697-81-9 Foam-blowing agents Solvents FC-3283 338-83-0 Solvents FC-40/FC-3284 n - FC-770 311-89-7 (1064698-37-8) Solvents Other 1093615-61-2 Solvents tio Flutec RC1 a Galden HT-55 lic /HT-70 355-04-4 69991-67-9 Foam-blowing agents Other pre-pub R-404A N/A Refrigeration and heat pumps Sub-use Specific use Electrical switchgear (high voltage) ite Electrical switchgear (medium voltage) t c Polyurethane foam, closed cell no Heat transfer agent Cultural heritage paper opreservation dHeat transfer agent Heat transfer agent Immersion cooling of electronics Heat transfer agent Rigid closed-cell PU/PIR insulation foam Immersion cooling of electronics Commercial refrigeration Transport refrigeration Centralised supermarket systems, Condensing unit systems. Ice cream cabinets / ice machines, standalone plug-in displays Refrigerated shipping containers, reefer ships 253 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance HFC Blend (HFC-32/125/134a) HFC Blend (HFC-32/125/134a) HFC Blend (HFC-32/125/134a) HFC Blend (HFC-32/125/134a) HFC Blend (HFC-32/125/134a) HFC Blend (HFC-32/HFC-125) Code CAS number General use R-407A N/A R-407C N/A Refrigeration and heat pumps Refrigeration and heat pumps n - R-407E N/A io R-407F N/A t R-407H N/A pre-publica R-410A N/A Refrigeration and heat pumps Refrigeration and heat pumps Refrigeration and heat pumps Refrigeration and heat pumps Sub-use Specific use Industrial refrigeration cite Commercial refrigeration t Transport refrigeration o Domestic and commercial air n conditioning oIndustrial refrigeration dMobile air conditioning Large-scale food storage and processing Condensing unit systems Reefer ships Self-contained units, Split non-ducted units, Multisplit units, Split ducted units, chillers Data centre cooling Trains Water and space heating heat pumps Heat pump clothes dryers Domestic and commercial air conditioning Commercial refrigeration Condensing unit systems Commercial refrigeration Condensing unit systems Commercial refrigeration Domestic and commercial air conditioning Domestic refrigeration Industrial refrigeration Transport refrigeration Condensing unit systems Self-contained units, Split non-ducted units, Multisplit units, Split ducted units, chillers Variable Refrigerant Flow (VRF) air conditioning system Data centre cooling 254 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance HFC Blend (HFC-125/134a/isobutane) HFC Blend (HFC-125/134a/ isobutane) HFC Blend (HFC-125/143a/propane/ isobutane) HFC Blend (HFC-125/143a/134a/ isobutane) HFC/HFO Blend (HFC-32/152a/HFO1234ze(E)) HFC/HFO Blend (HFC-32/HFO1234ze(E)/600)) HFC/HFO Blend HFC-32/125/HFO-1234ze HFC/HFO Blend (HFC-32/125/HFO-1234ze (E)) HFC/HFO Blend (HFC-32/125/134a HFO1234yf/ 1234ze(E)) HFC/HFO Blend (HFC-32 /125 /134a/HFO1234yf) HFC/HFO Blend (HFC-32/125/134a HFO1234yf) HFC/HFO Blend (HFC-134a/ HFO- Code CAS number General use R-422A N/A R-422D N/A R-428A N/A Refrigeration and heat pumps Refrigeration and heat pumps Refrigeration and heat pumps R-434A N/A Refrigeration and heat pumps R-444B N/A Air conditioning - R-446A N/A n R-447A N/A tio R-447B N/A lica R-448A N/A b R-449A (XP40) N/A -pu R-449B N/A pre R-450A N/A Air conditioning Air conditioning Air conditioning Refrigeration and heat pumps Refrigeration and heat pumps Refrigeration and heat pumps Refrigeration and heat pumps Sub-use Water and space heating heat pumps e Industrial refrigeration it Industrial refrigeration t c Industrial refrigeration no Industrial refrigeration oCommercial and industrial air dconditioning Specific use Large-scale food storage and processing Large-scale food storage and processing Large-scale food storage and processing Large-scale food storage and processing Ducted self-contained units Commercial and industrial air conditioning Ducted self-contained units Commercial and industrial air conditioning Commercial and industrial air conditioning Ducted self-contained units Ducted self-contained units Commercial refrigeration Condensing unit systems, standalone display cases Commercial refrigeration Heat pumps Commercial refrigeration Condensing unit systems, standalone display cases Condensing unit systems Commercial refrigeration Condensing unit systems 255 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance 1234ze(E)) HFC/HFO Blend (HFC-32/125/HFO-1234yf) HFC/HFO Blend (HFC-32/125/HFO-1234yf) HFC/HFO Blend (HFC-32/HFO-1234yf) HFC/HFO Blend (HFC-32/HFO-1234yf), HFC/HFO Blend (CO2/HFC-32/HFO-1234yf) HFC/HFO Blend (HFC-32/134a/HFO1234ze(E)) HFC/HFO Blend (HFC-32 /HFO1234yf/1234ze(E)) HFC/CO2 blend (CO2/HFC-32/HFC-125) HFC/HFO/CO2 Blend (CO2/HFC-23/HFC125/HFO-1132a) HFC Blend (HFC-125/143a) Code R-452A CAS number N/A General use Refrigeration and heat pumps R-452B N/A Air conditioning R-454A N/A Air conditioning R-454B N/A Air conditioning R-455A N/A - R-456A N/A n R-459A N/A tio R-469A N/A blica R-473A N/A pre-pu R-507A N/A Air conditioning Refrigeration and heat pumps Air conditioning Refrigeration Refrigeration Refrigeration and heat pumps Sub-use Specific use Commercial refrigeration e Transport refrigeration t cit Commercial and industrial air o conditioning n Commercial and industrial air conditioning oCommercial and industrial air conditioning dCommercial and industrial air Condensing unit systems New and retrofitted vehicles, low GWP replacement in refrigerated shipping containers Ducted self-contained units Ducted self-contained units Ducted self-contained units Ducted self-contained conditioning units Transport refrigeration Shipping containers Commercial and industrial air conditioning Transport and industrial refrigeration Transport and industrial refrigeration Industrial refrigeration Ducted self-contained units Ultra low-temperature applications such as reefers, chemical processes and environmental simulation Ultra low-temperature applications such as reefers, chemical processes and environmental simulation Large-scale food storage and processing 256 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance HFC/PFC Blend (HFC-23/PFC-116) HFC/HFO Blend (HFO-1234yf/HFC-134a) HFC/HFO Blend (HFO-1234yf/HFC-134a) HCO/HFO Blend HFO-1336mzz(Z) / trans-1,2 dichloroethene (1130(E)) HFC/HFO Blend (HFC-227ea/HFO1234ze(E)) Difluorochloromethane (HFC-22) 1-Chloro-1,2,2,2tetrafluoroethane (HCFC-124) 2,2-Dichloro-1,1,1trifluoroethane (HCFC-123) d-limonene 1,1,1,2-Tetrafluoroethane (HFC-134a) Pentafluoroethane (HFC-125) Code R-508B R-513A CAS number N/A N/A General use Refrigeration Refrigeration and heat pumps R-513B N/A Refrigeration and heat pumps R-514A N/A n - R-515B N/A tio HCFC Blend A, lica NAF-S-III 75-45-6 2837-89-0 b306-83-2 -pu HFC Blend B pre Halotron II, 5989-27-5 811-97-2 354-33-6 Refrigeration and heat pumps Refrgeration and heat pumps Fire suppressant Fire suppressant Sub-use Specific use Industrial refrigeration ite Domestic and commercial air conditioning c Transport refrigeration t Commercial refrigeration o Industrial refrigeration n Heat pumps doTransport refrigeration Ultra low-temperature vaccine preservation Chillers Refrigerated shipping containers Condensing units Ultra low-temperature vaccine preservation Low GWP replacement in refrigerated shipping containers Domestic and commercial air Chillers conditioning Domestic and commercial air conditioning Total flooding agent Chillers Support existing/legacy systems. Total flooding agent Support existing/legacy systems. 257 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance Code CAS number General use Sub-use Specific use Carbon Dioxide 124-38-9 The R notation used for blends in this table is a globally used commercial shorthand way Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). The R notation is a safety 2021). n - licatio -pub pre e of naming refrigerants established do not cit classification based on toxicity and by the flamma American bility data Society of (ASHRAE, 258 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.96. List of specific fluorinated gas substances identified in different commercial applications. Entry Substance Code Structure 1 Fluoroform (trifluoromethane) HFC-23 (not in scope) CHF3 2 Difluoromethane HFC-32 (not in scope) CH2F2 3 1,1,1,2,2,3,4,5,5,5- HFC-43-10mee CF3-CF2-CHF-CHF-CF3 Decafluoropentane 4 Pentafluoroethane HFC-125 CF3-CHF2 5 1,1,1,2-Tetrafluoroethane HFC-134a CF3-CH2F ite 6 1,1,1-Trifluoroethane HFC-143a CF3-CH3 c 7 1,1-Difluoroethane HFC-152a (not in scope) CHF2-CH3 t 8 1,1,1,2,3,3,3-Heptafluoropropane HFC-227ea CF3-CHF-CF3 no 9 1,1,1,3,3,3-Hexafluoropropane HFC-236fa CF3-CH2-CF3 o 10 1,1,1,3,3-Pentafluoropropane HFC-245fa CF3-CH2-CHF2 d 11 1,1,1,3,3-Pentafluorobutane HFC-365mfc CF3-CH2-CF2-CH3 - 12 1-Chloro-1,2,2,2-tetrafluoroethane HCFC-124 CHClF-CF3 n 13 1,1-Dichloro-1-fluoroethane HCFC-141b (not in scope) CCl2F-CH3 io 14 3,3-Dichloro-1,1,1,2,2- t pentafluoropropane a 15 1,1,-Difluoroethylene HCFC-225ca/cb CF3-CF2-CHCl2 HFO-1132a (not in scope) CH2=CF2 lic 16 1-Chloro-2,3,3,3- HFO-1224yd(Z) * tetrafluoropropene b 17 1-Chloro-3,3,3-trifluoro-1-propene HFO-1233zd(E) ** CHCl=CF-CF3 CHCl=CH-CF3 u 18 2,3,3,3-Tetrafluoropropene HFO-1234yf CH2=CF-CF3 -p 19 Trans-1,3,3,3-tetrafluoroprop-1- HFO-1234ze(E) *** eene r 20 1,3,3,3-Tetrafluoropropene HFO-1234ze(E) *** CHF=CH-CF3 CHF=CH-CF3 p21 Trans-1,1,1,4,4,4-hexafluorobut-2- HFO-1336mzz(E) CF3-CH=CH-CF3 ene 22 Cis-1,1,1,4,4,4-Hexafluoro-2- HFO-1336mzz(Z) CF3-CH=CH-CF3 butene 23 (Z)-1-Chloro-2,3,3,3- HCFO-1224yd * CHCl=CF-CF3 tetrafluoropropene 24 Trans-1-chloro-3,3,3- HCFO-1233zd(E) ** CHCl=CH-CF3 trifluoropropene 25 2-Bromo-3,3,3-trifluoroprop-1-ene BTP, 2-BTP, Halotron BrX CH2=CBr-CF3 259 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Entry Substance Code Structure 26 Methoxytridecafluoro-heptene isomers 27 Dodecafluoro-2-methyl-3- pentanone 28 1,1,2,2-Tetrafluoro-1-(2,2,2- trifluoroethoxy) ethane 29 Methyl perfluoropropyl ether MPHE, SionTM FK-5-1-12 (fluoroketone) HFE-347pc-f2 CF3-CF2-CF2CF=C(OCH3)-CF2-CF3 CF3-CF(CF3)-C(=O)-CF2CF3 CF3-CH2-O-CF2-CHF2 HFE-7000 CH3-O-CF2-CF2-CF3 30 Methyl nonafluorobutyl ether + HFE-449mccc/HFE-449s1 CH3-O-CF2-CF2-CF2-CF3 Methyl nonafluoroisobutyl ether (HFE-7100) 31 1-Ethoxy-nonafluorobutane HFE-569mccc/HFE-569sf2 CH3-CH2-O-CF2-CF2-CF2- e (HFE-7200) CF3 it 32 3-Methoxyperfluoro(2- HFE-7300 CF3-CF2-CF(OCH3)-CF- c methylpentane) (CF3)2 33 3-Ethoxyperfluoro(2-methylhexane) HFE-7500 CF3-CF(CF3)-CF(OCH2- tCH3)-CF2-CF2-CF3 o 34 Hexafluoroisopropanol HFIP CF3-CHOH-CF3 n 35 2,3,3,3-tetrafluoro-2- C4-FN (trifluoromethyl)- propanenitrile o 36 1,1,1,3,4,4,4-heptafluoro-3- C5-FK (trifluoromethyl)-2-butanone d 37 (E)-1,1,1,2,3,4,5,5,5-nonafluoro-4- FA-188 (trifluoromethyl)- 2-pentene - 38 Perfluorohexane (n- and iso-) FC-72/PF-5060 CF3-CF(CN)-CF3 (CF3)2-CF-C(=O)-CF3 CF3-CF=CF-CF-(CF3)2 CF3-(CF2)4-CF3 n 39 Perfluorotripropylamine io (perfluamine) 40 Perfluorotributylamine FC-3283 FC-40 (CF3-CF2-CF2)3N (CF3-CF2-CF2-CF2)3N at 41 Perfluoro-N-propylmorpholine lic (mixture of isomers) 42 Perfluoro-2-methylpentane FC-770 Flutec RC1 O-(CF2-CF2)2-N-CF2-CF2CF3 / O-(CF2-CF2)2-N-CF(CF3)2 CF3-CF2-CF2-CF-(CF3)2 b 43 1,1,2,3,3,3-Hexafluoropropene, Galden HT-55 / HT-70 CF2=CF-CF3, oxidized and u oxidized, polymerized polymerized pre-p (Perfluoropolyether, PFPE) 260 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.97. Intended applications of EU-28 total supply of fluorinated gases. Source data reported in the F-gas Report (EEA, 2020). Unit: tonnes. Intended Applications of e Bulk Supply it Refrigeration, air c conditioning and heating and heat transfer fluids t Foams, incl pre-blended o polyols n Aerosols Fire protection o Electrical Equipment d Semiconductor, - photovoltaics and other electronics manufacture Other or unknown n applications 2007 2008 2009 2010 2011 2012 2013 2014 61 377 58 720 58 678 65 964 61 045 58 574 58 999 95 688 14 286 15 284 11 709 11 503 9 234 9 090 649 1 197 127 11 131 491 1 422 301 8 425 531 969 184 9 547 1 677 1 290 265 7 808 2 508 1 344 243 8 526 8 202 10 950 1 451 1 362 169 9 690 1 385 1 419 71 12 967 8 954 1 858 622 1 057 1 861 2 219 2 185 1 501 1 437 1 684 1 132 6 402 2015 2016 74 023 78 016 9 572 9 421 818 745 715 10 157 8 728 585 813 755 1 485 997 2017 78 012 11 521 10 300 502 951 924 1 266 2018 68 676 11 083 9 109 324 640 897 1 450 tio Totals (including SF6)* a SF6 quantities 88 586 89 569 82 681 91 749 83 620 82 715 80 898 127 547 96 779 100 050 103 475 92 179 1 810 1 860 1 435 1 522 1 502 1 490 1 535 716 909 1 004 1 225 843 blic Totals (excluding SF6) 86 776 87 709 81 246 90 227 82 118 81 225 79 363 126 831 95 870 99 046 102 250 91 336 u Notes: *SF6 included in these figures but not separated out per application. SF6 is primarily used in electrical equipment because of its excellent electrical insulation properties and in the manufacture of semiconductors; it also has other medical uses and as a cover gas in magnesium casting for installations p using less than 850kg SF6/year until 2018 (sand casting may still be permitted). It is outside of the scope of this project however and therefore it has been pre- deducted. 2019 55 600 11 041 8 964 130 534 769 1 255 78 293 727 77 566 261 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.98. Estimation of quantities of Hydrofluoroolefins Used , as a Proportion of F-gases in Products and Equipment for EU-28. Source: EEA (2020). Intended Applications of Bulk Supply Usage data for F-gases Refrigeration, air conditioning and heating and heat transfer fluids Foams, incl pre-blended polyols Aerosols Fire protection Electrical Equipment 2016 78 016 10 157 8 728 585 813 2017 78 012 11 521 10 300 502 951 2018 68 676 not 11 083 9 109 324 640 cite2019 55 600 11 041 8 964 130 534 Semiconductor, photovoltaics and other electronics manufacture 755 924 897 o Other or unknown applications d Totals (including SF6)* - SF6 quantities n io Totals (excluding SF6) t a Usage data for unsaturated HFOs and lic HCFOs HFO & HCFO Proportion of total (%)* 997 100 050 1 004 99 046 6 305 6 1 266 103 475 1 225 102 250 13 400 13 1 450 92 179 843 91 336 17 767 19 pre-pub Notes: *HFOs are mainly used in mobile air conditioning and commercial refrigeration (stakeholder discussions). 769 1 255 78 293 727 77 566 18 350 24 262 PTFE P E P A PDMS PHA PET P P Silicone LCP Parylene PMMA PEK P I SU 8 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.10. Medical devices Table A.99. Medical implants and materials (Teo et al., 2016). Additions from stakeholder. not Anestesiology Epidural catheters Cardiovascular Pacemaker, implantable defibrillator/cardioverter, left ventricular assist device, heart valves, artificial blood vessels, cite catheters, suture material and pledgets Dental Dentures, dental implants, orthodontic wires, o dental instrumentation d Ear, nose, throat Cochlear implants, stapes implants, nasal implants for nose reconstruction - Gastroenterology Penile implants, neurostimulator in sacral and urology nerve stimulation, foley catheter, artificial urinary sphincter implant, hernia or vaginal n mesh io General and Synthetic blood vessels, breast implants, plastic surgery cheek, jaw and chin implants, lip implant, t titanium surgical implants, hip implant, clamps a for high frequency surgery lic Hematology and pathology Central venous access device, peripherally inserted central catheter b Neurology Implantable pulse generator for deep brain stimulation, neuroprosthetiocs, cognitive u protheses, catheters Opthalmic dexamethasone intravitreal implant, retinal p prothesis, artificial inocular lens, glaucoma - valve, fluocinolone ophthalmic implant, orbital e implant, catheters pr Orthopedic Orthopedic implants, medical splints 263 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.100. Main coatings reported during the CfE and additional stakeholder information. Product name CAS number SF-coat-AS-20280 2414599-48-9 SF-coat-SFE-X008 441049-46-2 AsahiGuard-AG-E082 746622-86-6 ETFE, PTFE, PCTFE 25038-71-5 / 9002-84-0 / 9002-83-9 Table A.101. Main applications of PFAS in technology (analytical, biological and laboratory) reported by stakeholders (RINA, 2021). e PTFE in wire and heat shrink, sensors, tubing/housing, gaskets, seals, O-rings, connectors, it coatings of device surfaces such as mixing equipment, tip fittings and diaphragm pumps. c F-Gases as a carrier for analytical testing, and the following gases R-134a, R-404A, R-407F, R- 410A, R-449A, R-452A, R-507A, R-508B and R-513A. ot FKM (Polymer of 1,1-difluoroethene / 1,1,2,3,3,3-hexafluoroprop-1-ene) and FFKM in O-rings, n sealing surfaces, seals, diaphragms, vacuum pumps, gauges and controllers. FFKO in vacuum pumps, gauges and controllers. do ETFE in diaphragms, hoses, valves, housings, pumps, sealing surface and seals. ECTFE in vacuum pumps, diaphragm pumps, tubes, seals, bushes, cables and valves. - FEP-encapsulated FFKM O-ring in vacuum pumps, gauges and controllers. ion FEP for non-reactive inert tubes/tubing, in liquid handling instruments, seals and bushes. t Fluoromethacrylate within pharmaceutical consumables and equipment as filters, hydrophobic a and oleophobic membranes, connectors, seals and spacer materials. lic PVDF for tubes, seals and bushes. b FPM and FFPM in O-rings in pumps. u Polychlorotrifluoroethylene PCTFE in laboratory equipment for liquid handling such as bottle top p dispensers, bottle top burettes, tubes, seals, and bushes. - PFA in non-reactive inert tubes/tubing, in liquid handling instruments and for seals. pre Perfluoro(tributylamine) as a reagent standard for mass spectroscopy. PFPE-oils (perfluoroalkyl ethers / alkanes + aromatics - more than 10 ether linkages) as a lubricant. 264 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.102. Polymers and elastomers used in medical devices (including medical device production). Polymer Abbreviation CAS number fluoroelastomers FKM Multiple nr's perfluoroelastomer FFKM polychlorotrifluoroethylene PCTFE 9002-83-9a polyvinylidene fluoride PVDF 9011-17-0 fluorosilicones fluorosilicone rubber polytetrafluorethene poly(tetrafluoroethylene-coperfluoro(propylvinyl ether)) poly(ethene-co-chlorotrifluoroethene) FVQM FVQM PTFE ECTFE 63148-56-1 64706-30-5 9002-84-0 not 26655-005 25101-45-5 cite tetrafluoroethylene-hexafluoropropene FEP o copolymer 25067-11-2 d poly(ethylene-co-tetrafluoroethylene) ETFE 25038-71-5 - 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and n tetrafluoroethene THV 25190-89-0 io 1-propene, 1,1,2,3,3,3-hexafluoro-, t polymer with 1,1-difluoroethene, a 1,1,1,2,2,3,3-heptafluoro-3- [(trifluoroethenyl)oxy]propane and lic tetrafluoroethene THVP 68182-34-3 b a main use as pharmaceutical packaging u Table A.103. List of additional p stakeholders). - PFAS substance e PTFE, PFA, FEP and some pr fluorinated surfactants uses of PFASs in medical devices (as mentioned by Additional uses Are used to make printed circuit boards and formed or moulded components. Printed circuit boards are used in many applications including medical equipment. Ethyl trifluoroacetate Used in crown structures to label antibodies. Hexafluoroisopropanol Used for QC for oligonucleotides. 2,2,2-Trifluoroethyl methacrylate Incorporated into intra ocular lenses. (TFEMA) Ethyl trifluoroacetate and ethyl Used as raw materials to synthetise 2-NTA and BFPP. (2-NTA pentafluoropropionate and BFPP are active molecules in are required for medical signal generation). PBSF (perfluoro-1-butanesulfonyl Surgical staples use a PBSF surfactant as a coating to fluoride) approximate skin for surgical or other acute wounds. 265 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) PFAS substance Additional uses C6-PFAS Filters used in intensive-care ventilators and breathing systems. Packaging of sterilised medical devices; they provide a permeable bacterium barrier. Single-use detergent-proof washbowls. Wound dressing. Perfluorohexyloctane (F6H8) + Sterile eye drops- non-active invasive medical device- for C14F13H17 (CAS nr 133331-77-8) ophthalmic use: for lubrication of dry, irritated eyes - stabilization of the tear film and relief of symptoms of dry eyes. PTFE and PET with fluorinated C6 based side-chain coatings t cite C6-Fluoretelomer-acrylateo copolymer n PFTE tion - do PFA or FEP a Fluorinated monomers: lic hexafluoroisopropyl methacrylate (CAS 3063-94-3) Trifluoroethyl methacrylate (CAS b 352-87-4) u Bis (hexafluoroisopropyl) itaconate (CAS 98452-82-5) p PFPE pre- Fluoropolymer Hydrophobic / oleophobic membranes. Are used for (sterile) venting of several medical devices, for example cell culture devices, analytical devices (e.g., PCR cartridges for Corona virus and other viruses and bacteria), blood tube systems for dialyzer systems, tube systems for eye surgery, microfluidic chips for "organ on a chip" pharmaceutical research systems, pharmaceutical packaging of liquids going into human body In Surgical gowns, to create a protective liquid barrier. Surface protection of rubber stoppers for pharmaceutical syringes and pharmaceutical vials Printed circuit boards are envisioned to enable wireless charging of medical implants. This will allow for fewer large scale invasive surgeries to the patient, substantially reducing patient risk. Heat sealing for intravenous bags. Filters for medical masks. This includes COVID-19 mask, which are used in extreme numbers: 29 - 91 billion per year globally (Muensterman et al., 2022) Medical splints coatings to ensure the proper healing of fractured bones. Polymer coating of aluminium MDI Are used in the manufacture of plastics used in the production of permeable contact lenses. Usually, material content varies typically between 4% and 60% as a percentage of the finished polymer. Medical and silicone tapes, wound dressings are single-use disposable medical/surgical supplies, some of which rely on PFPE-enabled release liners for their function. Polyimide films with fluoropolymer resin are used for cryogenic bags for long term storage of various blood and tissue components that will not be compromised during the preservation process. Orthodontic wires for aligning teeth Ostomy bags (filters), AED's, release liners. 266 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.104. Estimated fluorinated gas greenhouse warming potential (GWP) based on reported volumes of medical gases in the EU (responses to CfE and ECHA database) and assuming an emission factor of 0.1%. CAS number Substance GWP production volume (t/y) midpoint 811-97-2 HFC-134a 1 430 25 487 431-89-0 HFC-227ea 3 320 3 068 163702-08-7 163702-07-6 HFE7100 2 597 556 163702-06-5 163702-05-4 HFE7200 59 55 375-03-1 HFE7000 575 8 138495-42-8 HFC-43-10mee 1 640 5.5 57041-67-5 26675-46-7 28523-86-6 13838-16-9 151-67-7 76-19-7 76-16-4 355-25-9 115-25-3 75-73-0 desflurane isoflurane - sevoflurane enflurane n halothane io perfluoropropane (PFC-218) perfluoroethane (PFC-116) t perfluorobutane (PFC-3-1-10) a octafluorocyclobutane lic tetrafluoromethane pre-pub HFE7000 989 350 216 583 41 8 830 12 200 8 860 10 300 7 390 1 0.25 0.25 0.25 0.25 0.25 0.15 0.1 0.05 0.03 32 806 77.7% 9.4% 1.7% do0.2% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% 100% CO2 equivalents e (t/y) it 36 446 c10 186 t165 77.1% 21.6% 0.3% no3 <0.01% 3.2 1.6 0.2 0.1 0.1 0.1 0.0 1.3 1.2 0.4 0.3 0.1 47 252 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 267 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.105. Other polymeric PFASs (non-PTFE). Fluoropolymer Ethylenechlorotrifluoroethylene (ECTFE) cite Ethylenetetrafluoroethylene (ETFE) not Polyvinylidene fluoride (PVDF) Fluoromethacrylate - do Fluorinated ethylene propylene (FEP) Main properties which result in the uses Chemically and biologically inert/unreactive, non contaminating, flexible Chemically and biologically inert/unreactive Non-reactive inert chemically stable, flexible, thermally resistant Chemically and biologically inert/unreactive, durable, non-contaminating, flexible Chemically and biologically inert/unreactive, durable, non-contaminating, flexible, suitable for tubes Uses Laboratory, analytical and medical equipment, internal connection parts in vacuum pumps, diaphragm pumps, tubes, seals, bushes, cables and valves Laboratory, analytical and medical equipment, internal connection parts in chemical resistant vacuum pumps, chemical resistant diaphragm pumps, housing cover, diaphragms, hoses, valves Analytical instruments / measurement devices, tubes, seals, bushes Pharmaceutical consumables and equipment, tubes, seals and bushes. Liquid handling instrument parts in contact with media, water purification systems in dialysis Analytical instruments / measurement devices, tubes, for sealing applications, for laboratory liquid handling equipment tion Table A.106. Other uses of PFAS. a Uses lic Perfluoropolyether (PFPE) oils b Pentadecafuorooctanoic acid (PFOA) pu Tris(nonafluorobutyl)amine, Heptacosafluorotributylaminie (PFTBA), pre- fluorinert FC-43, Perfluorobutylamine Main properties for uses Low outgassing behaviour, high vacuum capable, UV-stability, inert/unreactive, in manufacturing of analytical equipment (and micro electronics) Non-implantable medical devices: Flexible medical endoscopes and video processors for image sensors for the chip lens. Analytical mass spectroscopy standard. Also used as solvent and blood substitute 268 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.15. Lubricants Table A.107. Examples of PFASs used in lubricant applications. CAS no Name(s) as specified in the Use in PFAS PFAS sources consulted lubricant type Sub group application 69991-67-9 1-Propene, 1,1,2,3,3,3-hexafluoro-, Base oil Polymeric PFPE Y oxidized, polymd. 69991-61-3 Ethene, 1,1,2,2-tetrafluoro-, oxidized, Base oil Polymeric PFPE Z polymd. 60164-51-4 113114-19-5 161075-14-5 370097-12-4 Poly[oxy[trifluoro(trifluoromethyl)1,2ethanediyl]], -(1,1,2,2,2pentafluoroethyl)-Oxetane, 2,2,3,3-tetrafluoro-, homoPolymer, fluorinated 1-Propene, 1,1,2,3,3,3-hexafluoro-, oxidized, Polymerized, reduced hydrolyzed 1-Propene, 1,1,2,3,3,3-hexafluoro-, Base oil Base oil Additive Additive Polymeric PFPE K ite Polymeric PFPE D c Polymeric PFPE not Polymeric PFPE-CO-NH2 oxidized, polymd., reduced, hydrolysed reaction products with ammonia 63148-56-1 Siloxanes and Silicones, Me 3,3,3- trifluoropropyl 9002-83-9 Polychlorotrifluoroethylene pre-publication 9002-84-0 67584-42-3a 51798-33-5 163702-05-4 163702-06-5 163702-07-6 163702-08-7 Poly(1,1,2,2-tetrafluoroethylene) (PTFE) Cycloalkanesulfonic acid, perfluoro(pentafluoroethyl)-, potassium salt (1:1) Poly[oxy[trifluoro(trifluoromethyl)1,2-ethane diyl]], -(1- carboxy1,2,2,2-tetrafluoroethyl)-[tetrafluoro (trifluoromethyl)ethoxy]Ethyl nonafluorbutyl ether OR Ethyl perfluoroalkyl ether Ethyl nonafluorisobutyl ether OR Ethyl perfluoroisobutyl ether Methyl nonafluorobutyl ether OR Methyl perfluoroalkyl ether Propane, 2-(difluoromethoxymethyl)1,1,1,2,3,3,3-heptafluoro- OR Methyl perfluoroisoalkyl ether o Base d oil/Additive Base -oil/Additive Additive Additive Additive (surfactant) Solvent Solvent Solvent Solvent Polymeric Polymeric Polymeric Nonpolymeric Polymeric Nonpolymeric Nonpolymeric Nonpolymeric Nonpolymeric Other Fluoropolymer Fluoropolymer Ionic PFPE-COOH Non-ionic Non-ionic Non-ionic Non-ionic aAlso used as anti-erosion/anti-corrosion additive in aviation hydraulic fluids 269 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Appendix A.3.17. Active substances in Plant Production Products (PPP), Biocidal Products (BP) and Medicinal Products (MP) e Table A.108. Non-exhaustive list of EU approved active substances for PPPs covered by the current PFAS definition. it Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program List no under REACH or proposed c Triflumoron/ tritosulfuron (ISO) 604- 142469- Withdrawn Skin Sens. 1B, H317 Active substance in biocidal and plant t (containing 0.02% 2-amino- 291-0 14-5 Aquatic Acute 1, H400 protection products 4-methoxy-6-(trifluormethyl)- Aquatic Acute 1, M- o 1,3,5-triazine); factor=10 n 1-[4-methoxy-6- Aquatic Chronic 1, H410 (trifluoromethyl)-1,3,5-triazin- Aquatic Chronic 1, M- o 2-yl]-3-[2- factor=10 (trifluoromethyl)benzenesulfony d l]urea (containing 0.02% 2- amino-4-methoxy-6- - (trifluoromethyl)-1,3,5-triazine) Isoxaflutole (ISO); 604- 141112- Adopted Repr. 2, H361d Active substance in plant protection n 5-cyclopropyl-1,2-oxazol-4-yl 222-4 29-0 Aquatic Acute 1, H400 products ,,- trifluoro-2-mesyl-p-tolyl Aquatic Acute 1, M- io ketone factor=10 t Aquatic Chronic 1, H410 Aquatic Chronic 1, M- a factor=100 lic Submitted re-pub Triflusulfuron-methyl; p methyl 2-((]([4- 603146-9 12653515-7 Adopted Repr. 2, H361d*** STOT RE 1, H372 Aquatic Acute 1, H400 Aquatic Acute 1, Mfactor=10 Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=100 Carc. 2, H351 Aquatic Acute 1, H400 Active substance in plant protection products 270 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name (dimethylamino)-6-(2,2,2trifluoroethoxy)-1,3,5-triazin-2yl]carbamoyl)[)sulfamoyl)-3methylbenzoate Trifloxystrobin( ISO); methyl (E)-methoxyimino(]((E)--[1-(,,-trifluoro-mtolyl)ethylideneaminooxy]-otolyl)[)acetate Tefluthrin (ISO); 2,3,5,6-tetrafluoro-4methylbenzyl (1RS,3RS)-3[(Z)-2-chloro-3,3,3trifluoroprop-1-enyl]-2,2dimethylcyclopropanecarboxylat e Pyroxsulam (ISO); N-(5,7dimethoxy[1,2,4]triazolo[1,5a]pyrimidin-2-yl)-2-methoxy-4(trifluoromethyl) pyridine-3sulfonamide Pyridalyl (ISO); 2,6-dichloro-4-(3,3dichloroallyloxy)phenyl 3-[5(trifluoromethyl)-2pyridyloxy]propyl ether EC / List no CAS no CLH status/status under REACH 604237-6 14151721-7 Adopted 616699-6 7953832-2 Adopted pre-publication 610- 007-6 42255608-9 Opinion adapted 605845-4 17910181-6 Opinion development Classification adopted or proposed Aquatic Acute 1, M- factor=100 Aquatic Chronic 1, H410 Aquatic Chronic 1, M- factor=10 Lact. Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic not Acute Tox. 2, H300 o Acute Tox. 2, H310 d Acute Tox. 1, H330 STOT RE 1, H372 Aquatic Acute 1, H400 -Aquatic Acute 1, M- factor=10 000 Aquatic Chronic 1, H410 Aquatic Chronic 1, M- factor=10 000 Skin Sens. 1, H317 Aquatic Acute 1, H400 Aquatic Acute 1, M- factor=100 Aquatic Chronic 1, H410 Aquatic Chronic 1, M- factor=100 Skin Sens. 1, H317 Repr. 2, H361d Aquatic Acute 1, H400 Aquatic Acute 1, M- factor=1000 Aquatic Chronic 1, H410 Aquatic Chronic 1, M- Regulatory Program cite Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 271 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Picolinafen (ISO); N-(4-fluorophenyl)-6-[3(trifluoromethyl)phenoxy]pyridi ne-2-carboxamide; 4-fluoro-6[(,,-trifluoro-mtolyl)oxy]picolinanilide Penthiopyrad (ISO); (RS)-N-[2-(1,3-dimethylbutyl)3-thienyl]-1-methyl-3(trifluoromethyl)pyrazole-4carboxamide Fluopyram (ISO); N-(](2-[3-chloro-5(trifluoromethyl)pyridin-2yl]ethyl)[)-2(trifluoromethyl)benzamide; Flonicamid (ISO); N-(cyanomethyl)-4(trifluoromethyl)pyridine-3carboxamide; Flutolanil (ISO); N-[3-(propan-2-yloxy)phenyl]2-(trifluoromethyl)benzamide; ,,-trifluoro-3-isopropoxy-otoluanilide EC / List no CAS no CLH status/status under REACH 604030-0 13764105-5 Submitted 606001-8 18367582-3 Adopted pre-publication 619- 797-7 65806635-4 Adopted 605127-0 15806267-0 Adopted 613921-3 6633296-5 Intention Classification adopted or proposed factor=100 not STOT RE 2, H373 Aquatic Acute 1, H400 Aquatic Acute 1, Mfactor=1000 Aquatic Chronic 1, H410 Aquatic Chronic 1, M- o factor=100 d Aquatic Acute 1, H400 Aquatic Acute 1, Mfactor=1 -Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=1 Aquatic Chronic 2, H411 Acute Tox. 4, H302 Aquatic Acute 1, Mfactor=1 Aquatic Chronic 1, Mfactor=10 Regulatory Program cite Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 272 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Flutianil (ISO); (2Z)-(]([2-fluoro-5(trifluoromethyl)phenyl]thio)[)[ 3-(2-methoxyphenyl)-1,3thiazolidin-2-ylidene]acetonitrile Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3(trifluoromethyl)phenyl]pyrrolidi n-2-one Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5(trifluoromethyl)-2pyridylmethyl]benzamide Flazasulfuron (ISO); 1-(4,6-dimethoxypyrimidin-2yl)-3-(3-trifluoromethyl-2pyridylsulfonyl)urea Diflufenican (ISO); N-(2,4-difluorophenyl)-2-[3(trifluoromethyl)phenoxy]-3pyridinecarboxamide Cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tertbutylphenyl)-2-cyano-3-oxo-3(,,-trifluoro-otolyl)propionate Benfluralin EC / List no 812888-4 CAS no 95864710-4 CLH status/status under REACH Adopted 262661-3 6121325-0 Adopted 607285-6 23911015-7 Adopted 600- 104040- Intention pre-publication 514-0 78-0 617446-2 8316433-4 Adopted 642974-5 40088207-7 Adopted 217465-2 1861-401 Opinion development Classification adopted or proposed Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=100 not Acute Tox. 4, H302 Skin Sens. 1, H317 Repr. 1B, H360Df Aquatic Acute 1, H400 Aquatic Chronic 1, H410 do Aquatic Acute 1, M-factor=1000 Aquatic Chronic 1, Mfactor=100 Aquatic Acute 1, H400 Aquatic Acute 1, Mfactor=1000 Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=100 Skin Sens. 1A, H317 Carc. 2, H351 Skin Irrit. 2, H315 Eye Irrit. 2, H319 Skin Sens. 1, H317 Carc. 2, H351 Repr. 2, H361d Regulatory Program cite Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 273 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Sulfoxaflor (ISO); [methyl(oxo)(](1-[6(trifluoromethyl)-3pyridyl]ethyl)[)-6sulfanylidene]cyanamide; Fluazinam (ISO); 3-chloro-N-[3-chloro-2,6dinitro-4(trifluoromethyl)phenyl]-5(trifluoromethyl)pyridin-2amine; Tembotrione (ISO); 2-(](2-chloro-4(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl) [)cyclohexane-1,3-dione; EC / List no CAS no CLH status/status under REACH 807366-8 94657800-3 Adopted pre-publication 616- 712-5 7962259-6 Adopted 608879-8 33510484-2 Adopted Classification adopted or proposed Lact., H362 STOT SE 2, H371 Aquatic Acute 1, H400 Aquatic Acute 1, M- not factor=10 Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=10 Acute Tox. 4, H302 Aquatic Acute 1, H400 Aquatic Acute 1, M- o factor=1 d Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=1 -Acute Tox. 4, H332 Skin Irrit. 2, H315 Eye Dam. 1, H318 Skin Sens. 1, H317 Repr. 2, H361 STOT SE 3, H335 Aquatic Acute 1, H400 Aquatic Acute 1, Mfactor=10 Aquatic Chronic 1, H410 Skin Sens. 1B, H317 STOT RE 2, H373 Aquatic Acute 1, H400 Aquatic Acute 1, Mfactor=100 Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=10 Regulatory Program cite Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 274 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Metaflumizone (ISO); 1-[[](Z)-[[]2-(4-cyanophenyl)1-[[]3(trifluoromethyl)phenyl]ethylide ne]amino]-1-[[]4(trifluoromethoxy)phenyl]urea Oxathiapiprolin (ISO); 1-(4-(](4-[[]5-(2,6difluorophenyl)-4,5-dihydro1,2-oxazol-3-yl]-1,3-thiazol-2yl)[)piperidin-1-yl)-2-[[]5methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]ethan-1-one Mefentrifluconazole; (2RS)-2-[4-(4-chlorophenoxy)2-(trifluoromethyl)phenyl]-1(1H-1,2,4-triazol-1-yl)propan2-ol; Bifenthrin (ISO); (2-methylbiphenyl-3-yl)methyl rel-(1R,3R)-3-[(1Z)-2-chloro3,3,3-trifluoroprop-1-en-1-yl]2,2dimethylcyclopropanecarboxylat e; Fipronil (ISO); ()-5-amino-1-(2,6-dichloro,,-trifluoro-para-tolyl)-4trifluoromethylsulfinyl-pyrazole3-carbonitrile EC / List no 604167-6 CAS no 13996849-3 CLH status/status under REACH Adopted 801263-1 100331867-9 Adopted - 1417782- Adopted 03-6 pre-publication 617- 373-6 8265704-3 notified 424610-5 12006837-3 registered Classification adopted or proposed Repr. 2, H361d Lact., H362 STOT RE 2, H373 t Aquatic Chronic 1, H410 do no Skin Sens. 1, H317 Aquatic Acute 1, H400 -Aquatic Acute 1, M- factor=1 Aquatic Chronic 1, H410 Aquatic Chronic 1, Mfactor=1 Regulatory Program cite Active substance products in plant protection Active substance in plant protection products Active substance in plant protection products Active substance in biocidal and plant protection products Active substance in biocidal and plant protection products 275 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Flufenoxuron; () 1-(4-(2-cloro-,,-ptrifluorotolyloxy)-2fluorophenyl)-3-(2,6difluorobenzolyl)urea Picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2((]([6-(trifluoromethyl)pyridin2yl]oxy)[)methyl)phenyl]acrylate Triflumizole (ISO); (1E)-N-[4-chloro-2(trifluoromethyl)phenyl]-1-(1Himidazol-1-yl)-2propoxyethanimine; (ISO) Prosulfuron N-[(4-methoxy-6-methyl-1,3,5triazin-2-yl)carbamoyl]-2(3,3,3trifluoropropyl)benzenesulfona mide or 1-(4-methoxy-6-methyl-1,3,5triazin-2-yl)-3-[2-(3,3,3trifluoropropyl)phenylsulfonyl]ur ea Haloxyfop-P (R)-2-(](4-[3-chloro-5(trifluoromethyl)- 2pyridyloxy]phenoxy)[)propanoic acid EC / List no 417680-3 CAS no 10146369-8 CLH status/status under REACH registered 601478-9 11742822-5 registered 614708-8 6869411-1 notified pre-publication 9412534-5 no CLH intention 9597729-0 no CLH intention Classification adopted or proposed not do - Regulatory Program cite Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 276 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Gamma-Cyhalothrin; (S)-a-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3trifluoropropenyl)-2,2dimethylcyclopropanecarboxylat e lambda-Cyhalothrin; [(R)-cyano-(3phenoxyphenyl)methyl] (1S,3S)-3-[(Z)-2-chloro-3,3,3trifluoroprop-1-enyl]-2,2dimethylcyclopropane-1carboxylate Tau-Fluvalinate; [cyano-(3phenoxyphenyl)methyl] (2R)-2[2-chloro-4(trifluoromethyl)anilino]-3methylbutanoate Tetraconazole; (+/-)-2-(2,4-Dichlorophenyl)-3(1H-1,2,4-triazole-1-ylpropyl)1,1,2,2-tetrafluorethyl ether Flufenacet; N-(4-Fluorophenyl)-N-(propan2-yl)-2-(]([5-(trifluoromethyl)1,3,4-thiadiazol-2yl]oxy)[)acetamide Beflubutamid; N-benzyl-2-[4-fluoro-3(trifluoromethyl)phenoxy]butan amide EC / List no CAS no 7670362-3 CLH status/status under REACH no CLH intention -; 415130-7 9146508-6 no CLH intention 102851- no CLH intention 06-9 pre-publication 11228177-3 no CLH intention 14245958-3 no CLH intention 11361408-7 no CLH intention Classification adopted or proposed not do - Regulatory Program cite Active substance products in plant protection Active substance in biocidal and plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 277 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Penoxsulam; 2-(2,2-difluoroethoxy)-N-(5,8dimethoxy-[1,2,4]triazolo[1,5c]pyrimidin-2-yl)-6(trifluoromethyl)benzenesulfona mide Cyflufenamid; N-[(Z)-N-(cyclopropylmethoxy)C-[2,3-difluoro-6(trifluoromethyl)phenyl]carboni midoyl]-2-phenylacetamide Acrinathrin; (S)-Cyano(3phenoxyphenyl)methyl (Z)(1R,3S)-2,2-dimethyl[2-(2,2,2trifluoro-1trifluoromethylethoxycarb onyl)vinyl]cyclopropanecarboxylate fluazifop-P; (2R)-2-(4-([5(trifluoromethyl)pyridin-2yl]oxy)phenoxy)propanoic acid Flubendiamide; 3-iodo-N'-(2-mesyl-1,1dimethylethyl)-N-(](4-[1,2,2,2tetrafluoro-1(trifluoromethyl)ethyl]-otolyl)[)phthalamide Flumetralin; N-(2-chloro-6-fluorobenzyl)-Nethyl-,,-trifluoro-2,6-dinitrop-toluidine; flumetralin (ISO) EC / List no CAS no 21971496-2 CLH status/status under REACH no CLH intention 18040960-3 no CLH intention 600147-6 10100706-1 no CLH intention pre-publication 617- 435-2 8306688-0 no CLH intention 608064-7 27245165-7 no CLH intention 613108-3 6292470-3 no CLH intention Classification adopted or proposed not do - Regulatory Program cite Active substance products in plant protection Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products Active substance in plant protection products 278 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Substance name Fluometuron; 1,1-Dimethyl-3-[3(trifluoromethyl)phenyl]urea EC / List no 218500-4 CAS no 2164-172 CLH status/status under REACH no CLH intention Oxyfluorfen; 255- 2-chloro-1-(3-ethoxy-4- 983-0 nitrophenoxy)-4- (trifluoromethyl)benzene *The approval of these substances is pending. 4287403-3 no CLH intention tion ublica pre-p Classification adopted or proposed not do - Regulatory Program cite Active substance in plant protection products Active substance in plant protection products 279 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table A.109. Non- exhaustive list of EU approved biocidal active substances covered by the current PFAS definition. Substance EC/List CAS no. BAS Product-type Approval name no. number start date Hexaflumuron; -; 86479- 1314 PT18-Insecticides, 01/04/2017 1-(3,5-dichloro- 401-400-1 06-3 acaricides and products 4-(1,1,2,2- to control other tetrafluoroethoxy arthropods )phenyl)-3-(2,6- difluorobenzoyl) urea Chlorfenapyr; 602-782-4 122453- 66 (ISO)4-bromo-2- 73-0 e (4-chlorophenyl)- it 1-ethoxy methyl- 5- c trifluoromethylpy t rrole-3- carbonitrile o Bifenthrin - 82657- 8 n 04-3 Fipronil -; 120068- 33 o 424-610-5 37-3 d Flocoumafen - lambdan Cyhalothrin; [(R)-cyano-(3- io phenoxyphenyl) t methyl] (1S,3S)- 3-[(Z)-2-chloro- a 3,3,3lic trifluoroprop-1- enyl]-2,2dimethylcyclopro b pane-1u carboxylate p Tralopyril -; 421-960-0 -; 415-130-7 - 9003508-8 9146508-6 12245429-9 34 41 1403 PT08-Wood preservatives, PT18-Insecticides, acaricides and products to control other arthropods 01/05/2015 PT08-Wood preservatives 01/02/2013 PT18-Insecticides, acaricides and products to control other arthropods PT14-Rodenticides 01/10/2013 01/10/2011 PT18-Insecticides, acaricides and products to control other arthropods 01/10/2013 PT21-Antifouling products 01/04/2015 e- Table A.110. Non- exhaustive list of active pharmaceutical ingredients (APIs) following current r PFAS definition, authorised as medicinal products. p Type of registration API CASNR CH NH CV NV A126a WHO- Orpha ATC EML n alpelisib 1217486-61-7 x L01XX apalutamide 956104-40-8 x L02BB aprepitant 170729-80-3 x x A04AD bendroflumethiazide 73-48-3 x C03AA C03AB C03EA benfluorex 23602-78-0 x A10BX bicalutamide 90357-06-5 x x x L02BB cangrelor 163706-06-7 x B01AC 280 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Type of registration API CASNR CH NH CV NV A126a WHO- Orpha ATC EML n celecoxib 169590-42-5 x x x C08CA L01XX M01AH cinacalcet 226256-56-0 x H05BX desflurane 57041-67-5 x N01AB dexfenfluramine 3239-44-9 x A08AA doravirine 1338225-97-0 x J05AG dutasteride 164656-23-9 x G04CA efavirenz 154598-52-4 x x elexacaftor 2216712-66-0 x enzalutamide 915087-33-1 x fenfluramine 458-24-2 x flecainide 54143-55-4 fluoxetine 54910-89-3 x x flunixin 38677-85-9 fluphenazine 69-23-8 fluvoxamine 54739-18-3 x fosaprepitant 172673-20-0 x fosnetupitant 1703748-89-3 x fulvestrant 129453-61-8 x gemcitabine 95058-81-4 glecaprevir 1365970-03-1 x pre-publication isoflurane ivosidenib lansoprazole ledipasvir leflunomide letermovir lomitapide maraviroc mefloquine netupitant nilotinib nilutamide nitisinone penfluridol perflutren 26675-46-7 x 1448347-49-6 x 103577-45-3 x 1256388-51-8 x 75706-12-6 x x 917389-32-3 x 182431-12-5 x 376348-65-1 x 53230-10-7 290297-26-6 x 641571-10-0 x 63612-50-0 x 104206-65-7 x 26864-56-2 x 76-19-7 x x x x x x o x dx - x x x x x nxxot citeG04CB J05AG R07AXa L02BB A08AA C01BC N06AB QM01AG N05AB N06AB A04ADb A04ADb L02BA x L01BC J05AP x N01AB x L01XX A02BC A02BD J05AP L04AA x J05AX x C10AX J05AX x P01BC P01BF A04ADb x L01XE L02BB A16AX N05AG V08DA ponatinib 943319-70-8 x L01XE regorafenib 755037-03-7 x L01XE rolapitant 552292-08-7 x A04AD sevoflurane 28523-86-6 x x N01AB silodosin 160970-54-7 x G04CA siponimod 1230487-00-9 x L04AA sitagliptin 486460-32-6 x A10BH sorafenib 284461-73-0 x L01XE tafluprost 209860-87-7 x S01EE telotristat 1033805-22-9 x A16AX teriflunomide 163451-81-8 x L04AA 281 ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Type of registration API CASNR CH NH CV NV A126a WHO- Orpha ATC EML n tezacaftor 1152311-62-0 x R07AX tipranavir 174484-41-4 x J05AE travoprost 157283-68-6 x S01EE trifluoperazine 117-89-5 x N05AB upadacitinib 1310726-60-3 x L04AA vinflunine 162652-95-1 x L01CA voxilaprevir 1535212-07-7 x J05AP a No ATC code is available, based on similarity with tezacaftor and ivacaftor, the code R07AX was tentatively assigned. b No ATC code available, based on similarity with aprepitant and rolapitant the code A04AD was tentatively e assigned. it List of abbreviations: CH=centralised authorisation for human health, c NH=decentralised registration for human health (mutual recognition), t CV=centralised authorisation for veterinary purposes, NV=decentralised registration for veterinary purposes (mutual recognition), o A126a=registration in Article 126a. n WHO-EML=list of essential medicines of the World Health Organisation (WHO, 2019), ATC = Anatomical Therapeutic Chemical (ATC) Classification System up to the chemical-therapeutic-pharmacological subgroup (level 4)46. 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