Document 6bXL2M4w2vVpZp1qyqNXeXKw3

Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 Claigan PFAS Submission #5 PFAS Derogations and Justifications Derogations needed for PFAS applications necessary for society without effective substitutes Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 1 of 100 Table of Contents Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 Table of Contents 2 1. Summary 17 2. Summary of Derogations Requested 19 3. Related documents 25 3.1. Claigan PFAS Submission #1 - PFAS in Articles 25 3.2. Claigan PFAS Submission #2 - PFOA in Articles 25 3.3. Claigan PFAS Submission #3 - PFAS in Drinking Water 25 3.4. Claigan PFAS Submission #4 - PFAS Substitutes and Alternatives 25 4. Definitions 26 4.1. Text for derogation 26 4.2. Alternative text 26 4.3. Uses and Functionality 26 4.4. Substitutes / Alternatives 26 4.5. Forever Chemicals 26 4.6. Number of companies affected 27 4.7. Annual Tonnage 27 4.8. Timeline Requested 27 5. C2 - Fluoropolymer and Perfluoropolyether Release Agents 27 5.1. Text for derogation 27 5.2. Alternative text 27 5.3. Use and Functionality 27 5.4. Substitutes / Alternatives 28 5.5. Forever Chemicals 28 5.6. Number of companies affected 28 5.7. Annual Tonnage 28 5.8. Timeline Requested 28 6. C3a - PTFE Anti-Drip Additive 29 6.1. Text for derogation 29 6.2. Alternative text 29 6.3. Use and Functionality 29 6.4. Substitutes / Alternatives 29 6.5. Forever Chemicals 29 6.6. Number of companies affected 30 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 2 of 100 6.7. Annual Tonnage 6.8. Timeline Requested 7. C3b - PFBS as a Clarity Additive 7.1. Text for derogation 7.2. Alternative text 7.3. Use and Functionality 7.4. Substitutes / Alternatives 7.5. Forever Chemicals 7.6. Number of companies affected 7.7. Annual Tonnage 7.8. Timeline Requested 8. C4a - PTFE and ETFE for electrical insulation 8.1. Text for derogation 8.2. Alternative text 8.3. Use and Functionality 8.4. Substitutes / Alternatives 8.5. Forever Chemicals 8.6. Number of companies affected 8.7. Annual Tonnage 8.8. Timeline Requested 9. C4b - Fluoroelastomers for electrical insulation 9.1. Text for derogation 9.2. Alternative text 9.3. Use and Functionality 9.4. Substitutes / Alternatives 9.5. Forever Chemicals 9.6. Number of companies affected 9.7. Annual Tonnage 9.8. Timeline Requested 10. C5a - Fluoropolymers in invasive / implantable devices 10.1. Text for derogation 10.2. Alternative text 10.3. Use and Functionality 10.4. Substitutes / Alternatives 10.5. Forever Chemicals 10.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 30 30 30 30 30 30 31 31 31 31 31 31 31 31 31 32 32 32 32 32 33 33 33 33 33 33 34 34 34 34 34 34 34 35 35 35 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 3 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 10.7. Annual Tonnage 35 10.8. Timeline Requested 36 11. C5b - Fluoroelastomers in invasive / implantable devices 36 11.1. Text for derogation 36 11.2. Alternative text 36 11.3. Use and Functionality 36 11.4. Substitutes / Alternatives 37 11.5. Forever Chemicals 37 11.6. Number of companies affected 37 11.7. Annual Tonnage 37 11.8. Timeline Requested 38 12. C6a - PTFE additive to plastics for wear reduction 38 12.1. Text for derogation 38 12.2. Alternative text 38 12.3. Use and Functionality 38 12.4. Substitutes / Alternatives 38 12.5. Forever Chemicals 39 12.6. Number of companies affected 39 12.7. Annual Tonnage 39 12.8. Timeline Requested 39 13. C6b - PTFE, ETFE, and PCTFE for low friction parts and chemical inertness 39 13.1. Text for derogation 39 13.2. Alternative text 39 13.3. Use and Functionality 39 13.4. Substitutes / Alternatives 40 13.5. Forever Chemicals 40 13.6. Number of companies affected 40 13.7. Annual Tonnage 40 13.8. Timeline Requested 41 14. C7 - PTFE, ETFE, PFA, PVDF, and FEP as a wire insulator. 41 14.1. Text for derogation 41 14.2. Alternative text 41 14.3. Use and Functionality 41 14.4. Substitutes / Alternatives 41 14.5. Forever Chemicals 42 14.6. Number of companies affected 42 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 4 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 14.7. Annual Tonnage 42 14.8. Timeline Requested 42 15. C8a - Fluoroacrylic coatings for fabrics for safety reasons 43 15.1. Text for derogation 43 15.2. Alternative text 43 15.3. Use and Functionality 43 15.4. Substitutes / Alternatives 43 15.5. Forever Chemicals 43 15.6. Number of companies affected 44 15.7. Annual Tonnage 44 15.8. Timeline Requested 44 16. C8b - Fluoroacrylic coatings for fabrics for protection of medical devices 44 16.1. Text for derogation 44 16.2. Alternative text 44 16.3. Use and Functionality 44 16.4. Substitutes / Alternatives 45 16.5. Forever Chemicals 45 16.6. Number of companies affected 45 16.7. Annual Tonnage 45 16.8. Timeline Requested 45 17. C9 - PTFE and PVDF filter membranes 46 17.1. Text for derogation 46 17.2. Alternative text 46 17.3. Use and Functionality 46 17.4. Substitutes / Alternatives 46 17.5. Forever Chemicals 47 17.6. Number of companies affected 47 17.7. Annual Tonnage 47 17.8. Timeline Requested 47 18. C10 - PTFE Additive in Grease 48 18.1. Text for derogation 48 18.2. Alternative text 48 18.3. Use and Functionality 48 18.4. Substitutes / Alternatives 48 18.5. Forever Chemicals 48 18.6. Number of companies affected 48 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 5 of 100 18.7. Annual Tonnage 18.8. Timeline Requested 19. C11 - PTFE coatings for cookware 19.1. Text for derogation 19.2. Alternative text 19.3. Use and Functionality 19.4. Substitutes / Alternatives 19.5. Forever Chemicals 19.6. Number of companies affected 19.7. Annual Tonnage 19.8. Timeline Requested 20. C11b - PTFE coatings for chemical containers 20.1. Text for derogation 20.2. Alternative text 20.3. Use and Functionality 20.4. Substitutes / Alternatives 20.5. Forever Chemicals 20.6. Number of companies affected 20.7. Annual Tonnage 20.8. Timeline Requested 21. C12a - Fluoroelastomers for seals 21.1. Text for derogation 21.2. Alternative text 21.3. Use and Functionality 21.4. Substitutes / Alternatives 21.5. Forever Chemicals 21.6. Number of companies affected 21.7. Annual Tonnage 21.8. Timeline Requested 22. C12b - Fluoroelastomers for seals in water and food contact 22.1. Text for derogation 22.2. Alternative text 22.3. Use and Functionality 22.4. Substitutes / Alternatives 22.5. Forever Chemicals 22.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 48 49 49 49 49 49 50 50 50 50 50 51 51 51 51 51 51 51 51 52 52 52 52 52 53 53 53 53 54 54 54 54 54 55 55 55 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 6 of 100 22.7. Annual Tonnage 22.8. Timeline Requested 23. C13 - PTFE tape for sealing 23.1. Text for derogation 23.2. Alternative text 23.3. Use and Functionality 23.4. Substitutes / Alternatives 23.5. Forever Chemicals 23.6. Number of companies affected 23.7. Annual Tonnage 23.8. Timeline Requested 24. C13b - PTFE Tape for Friction Reduction 24.1. Text for derogation 24.2. Alternative text 24.3. Use and Functionality 24.4. Substitutes / Alternatives 24.5. Forever Chemicals 24.6. Number of companies affected 24.7. Annual Tonnage 24.8. Timeline Requested 25. C14 - Fluorosilicone release paper 25.1. Text for derogation 25.2. Alternative text 25.3. Use and Functionality 25.4. Substitutes / Alternatives 25.5. Forever Chemicals 25.6. Number of companies affected 25.7. Annual Tonnage 25.8. Timeline Requested 26. C16 - Fluorocoating of seals 26.1. Text for derogation 26.2. Alternative text 26.3. Use and Functionality 26.4. Substitutes / Alternatives 26.5. Forever Chemicals 26.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 55 56 56 56 56 56 56 56 57 57 57 58 58 58 58 58 58 59 59 59 59 59 60 60 60 60 61 61 61 61 61 61 61 62 62 62 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 7 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 26.7. Annual Tonnage 62 26.8. Timeline Requested 62 27. C17 - PTFE/PFA coating of metal for environmental resistance 62 27.1. Text for derogation 62 27.2. Alternative text 62 27.3. Use and Functionality 62 27.4. Substitutes / Alternatives 63 27.5. Forever Chemicals 63 27.6. Number of companies affected 63 27.7. Annual Tonnage 63 27.8. Timeline Requested 63 28. C18 - Fluorocoating of metal for wear resistance 64 28.1. Text for derogation 64 28.2. Alternative text 64 28.3. Use and Functionality 64 28.4. Substitutes / Alternatives 64 28.5. Forever Chemicals 64 28.6. Number of companies affected 65 28.7. Annual Tonnage 65 28.8. Timeline Requested 65 29. C19 - Fluoropolymers in hoses 65 29.1. Text for derogation 65 29.2. Alternative text 65 29.3. Use and Functionality 65 29.4. Substitutes / Alternatives 66 29.5. Forever Chemicals 66 29.6. Number of companies affected 66 29.7. Annual Tonnage 66 29.8. Timeline Requested 66 30. C20 - Fluoropolymers in/on labels 67 30.1. Text for derogation 67 30.2. Alternative text 67 30.3. Use and Functionality 67 30.4. Substitutes / Alternatives 67 30.5. Forever Chemicals 67 30.6. Number of companies affected 67 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 8 of 100 30.7. Annual Tonnage 30.8. Timeline Requested 31. C21 - Fluoropolymers tubing 31.1. Text for derogation 31.2. Alternative text 31.3. Use and Functionality 31.4. Substitutes / Alternatives 31.5. Forever Chemicals 31.6. Number of companies affected 31.7. Annual Tonnage 31.8. Timeline Requested 32. C22 - Heat transfer fluids 32.1. Text for derogation 32.2. Alternative text 32.3. Use and Functionality 32.4. Substitutes / Alternatives 32.5. Forever Chemicals 32.6. Number of companies affected 32.7. Annual Tonnage 32.8. Timeline Requested 33. C23a - PVDF and PTFE in batteries 33.1. Text for derogation 33.2. Alternative text 33.3. Use and Functionality 33.4. Substitutes / Alternatives 33.5. Forever Chemicals 33.6. Number of companies affected 33.7. Annual Tonnage 33.8. Timeline Requested 34. C23b - Fluoropolymers in capacitors 34.1. Text for derogation 34.2. Alternative text 34.3. Use and Functionality 34.4. Substitutes / Alternatives 34.5. Forever Chemicals 34.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 67 68 68 68 68 68 69 69 70 70 70 70 70 70 70 70 71 71 71 71 71 71 71 71 71 72 72 72 72 72 72 72 72 73 73 73 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 9 of 100 34.7. Annual Tonnage 34.8. Timeline Requested 35. C24 - Lubrication of internal wires 35.1. Text for derogation 35.2. Alternative text 35.3. Use and Functionality 35.4. Substitutes / Alternatives 35.5. Forever Chemicals 35.6. Number of companies affected 35.7. Annual Tonnage 35.8. Timeline Requested 36. C25 - Surfactant in assays 36.1. Text for derogation 36.2. Alternative text 36.3. Use and Functionality 36.4. Substitutes / Alternatives 36.5. Forever Chemicals 36.6. Number of companies affected 36.7. Annual Tonnage 36.8. Timeline Requested 37. C26 - PTFE Coating of Rubber for Biotechnology 37.1. Text for derogation 37.2. Alternative text 37.3. Use and Functionality 37.4. Substitutes / Alternatives 37.5. Forever Chemicals 37.6. Number of companies affected 37.7. Annual Tonnage 37.8. Timeline Requested 38. C27 - Products for Training or Simulation 38.1. Text for derogation 38.2. Alternative text 38.3. Use and Functionality 38.4. Substitutes / Alternatives 38.5. Forever Chemicals 38.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 73 73 73 73 73 73 74 74 74 74 74 74 74 74 74 75 75 75 75 75 75 75 76 76 76 76 76 76 76 77 77 77 77 77 77 77 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 10 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 38.7. Annual Tonnage 77 38.8. Timeline Requested 78 39. C28 - Fluorinated polyethylene for chemical storage 78 39.1. Text for derogation 78 39.2. Alternative text 78 39.3. Use and Functionality 78 39.4. Substitutes / Alternatives 78 39.5. Forever Chemicals 79 39.6. Number of companies affected 79 39.7. Annual Tonnage 79 39.8. Timeline Requested 79 40. C29 - ePTFE seals 79 40.1. Text for derogation 79 40.2. Alternative text 79 40.3. Use and Functionality 79 40.4. Substitutes / Alternatives 80 40.5. Forever Chemicals 80 40.6. Number of companies affected 80 40.7. Annual Tonnage 80 40.8. Timeline Requested 80 41. C31a - Fluoro acrylate side chain coatings for antismudge 80 41.1. Text for derogation 80 41.2. Alternative text 80 41.3. Use and Functionality 81 41.4. Substitutes / Alternatives 81 41.5. Forever Chemicals 81 41.6. Number of companies affected 82 41.7. Annual Tonnage 82 41.8. Timeline Requested 82 42. C31b - Fluorosilicone and nano fluoro coatings for antismudge 82 42.1. Text for derogation 82 42.2. Alternative text 82 42.3. Use and Functionality 82 42.4. Substitutes / Alternatives 83 42.5. Forever Chemicals 83 42.6. Number of companies affected 83 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 11 of 42.7. Annual Tonnage 42.8. Timeline Requested 43. C32a - Fluoropolymer seals and spacers 43.1. Text for derogation 43.2. Alternative text 43.3. Use and Functionality 43.4. Substitutes / Alternatives 43.5. Forever Chemicals 43.6. Number of companies affected 43.7. Annual Tonnage 43.8. Timeline Requested 44. C32b - PFA seals 44.1. Text for derogation 44.2. Alternative text 44.3. Use and Functionality 44.4. Substitutes / Alternatives 44.5. Forever Chemicals 44.6. Number of companies affected 44.7. Annual Tonnage 44.8. Timeline Requested 45. C33 - PVDF and ETFE in circulation systems 45.1. Text for derogation 45.2. Alternative text 45.3. Use and Functionality 45.4. Substitutes / Alternatives 45.5. Forever Chemicals 45.6. Number of companies affected 45.7. Annual Tonnage 45.8. Timeline Requested 46. C34 - PTFE for security protection of labels 46.1. Text for derogation 46.2. Alternative text 46.3. Use and Functionality 46.4. Substitutes / Alternatives 46.5. Forever Chemicals 46.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 83 83 84 84 84 84 84 84 85 85 85 85 85 85 85 85 86 86 86 86 86 86 86 86 87 87 87 87 87 88 88 88 88 88 89 89 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 12 of 46.7. Annual Tonnage 46.8. Timeline Requested 47. C35 - Fluoroacrylate and PFA coatings for semiconductors 47.1. Text for derogation 47.2. Alternative text 47.3. Use and Functionality 47.4. Substitutes / Alternatives 47.5. Forever Chemicals 47.6. Number of companies affected 47.7. Annual Tonnage 47.8. Timeline Requested 48. C36 - Fluoro sprays for industrial lubrication 48.1. Text for derogation 48.2. Alternative text 48.3. Use and Functionality 48.4. Substitutes / Alternatives 48.5. Forever Chemicals 48.6. Number of companies affected 48.7. Annual Tonnage 48.8. Timeline Requested 49. C37 - Fluoro ionic fluids in capacitors 49.1. Text for derogation 49.2. Alternative text 49.3. Use and Functionality 49.4. Substitutes / Alternatives 49.5. Forever Chemicals 49.6. Number of companies affected 49.7. Annual Tonnage 49.8. Timeline Requested 50. C38 - PFPE lubricants for harsh environments 50.1. Text for derogation 50.2. Alternative text 50.3. Use and Functionality 50.4. Substitutes / Alternatives 50.5. Forever Chemicals 50.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 89 89 89 89 89 90 90 90 91 91 91 91 91 91 91 92 92 92 92 92 93 93 93 93 93 93 94 94 94 94 94 94 94 95 95 95 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 13 of 50.7. Annual Tonnage 50.8. Timeline Requested 51. C40 - Pefluorocarboxylates in PFA 51.1. Text for derogation 51.2. Alternative text 51.3. Use and Functionality 51.4. Substitutes / Alternatives 51.5. Forever Chemicals 51.6. Number of companies affected 51.7. Annual Tonnage 51.8. Timeline Requested 52. C41 - Perfluorosulfonates in Fluoroelastomers 52.1. Text for derogation 52.2. Alternative text 52.3. Use and Functionality 52.4. Substitutes / Alternatives 52.5. Forever Chemicals 52.6. Number of companies affected 52.7. Annual Tonnage 52.8. Timeline Requested 53. C43 - PVDF in ferroelectric films 53.1. Text for derogation 53.2. Alternative text 53.3. Use and Functionality 53.4. Substitutes / Alternatives 53.5. Forever Chemicals 53.6. Number of companies affected 53.7. Annual Tonnage 53.8. Timeline Requested 54. C44 - Fluoroether for degreasing applications 54.1. Text for derogation 54.2. Alternative text 54.3. Use and Functionality 54.4. Substitutes / Alternatives 54.5. Forever Chemicals 54.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 95 95 95 95 95 95 96 96 96 96 96 97 97 97 97 97 97 98 98 98 98 98 98 98 99 99 99 99 99 99 99 99 99 100 100 100 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 14 of 54.7. Annual Tonnage 54.8. Timeline Requested 55. C45 - HFO for Insulating Foam 55.1. Text for derogation 55.2. Alternative text 55.3. Use and Functionality 55.4. Substitutes / Alternatives 55.5. Forever Chemicals 55.6. Number of companies affected 55.7. Annual Tonnage 55.8. Timeline Requested 56. C46 - PTFE as a high temperature manufacturing aid or tool 56.1. Text for derogation 56.2. Alternative text 56.3. Use and Functionality 56.4. Substitutes / Alternatives 56.5. Forever Chemicals 56.6. Number of companies affected 56.7. Annual Tonnage 56.8. Timeline Requested 57. C48 - Fluorocoatings for optical components 57.1. Text for derogation 57.2. Alternative text 57.3. Use and Functionality 57.4. Substitutes / Alternatives 57.5. Forever Chemicals 57.6. Number of companies affected 57.7. Annual Tonnage 57.8. Timeline Requested 58. C50 - Fluorosilicone as a surfactant in semiconductors 58.1. Text for derogation 58.2. Alternative text 58.3. Use and Functionality 58.4. Substitutes / Alternatives 58.5. Forever Chemicals 58.6. Number of companies affected Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 100 100 100 100 100 100 101 101 101 101 101 101 101 101 101 102 102 102 102 102 102 102 102 102 103 103 103 103 103 103 103 103 104 104 104 104 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 15 of 58.7. Annual Tonnage 58.8. Timeline Requested 59. C51 - F2 gas fluorinated plastics in capacitors 59.1. Text for derogation 59.2. Alternative text 59.3. Use and Functionality 59.4. Substitutes / Alternatives 59.5. Forever Chemicals 59.6. Number of companies affected 59.7. Annual Tonnage 59.8. Timeline Requested 60. C52 - PTFE additive in die attach paste 60.1. Text for derogation 60.2. Alternative text 60.3. Use and Functionality 60.4. Substitutes / Alternatives 60.5. Forever Chemicals 60.6. Number of companies affected 60.7. Annual Tonnage 60.8. Timeline Requested Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 104 104 104 104 104 104 105 105 105 105 105 105 105 105 105 105 106 106 106 106 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 16 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 1. Summary This report is submission #5 of 5 by Claigan Environmental Inc. (Claigan) on behalf of the EU PFAS Restriction Submission Project ("PFAS Submission Project"). The PFAS submission project is made up of dozens of companies from a wide range of industries (consumer, professional, industrial, medical, oil and gas, laboratory equipment, textiles, electronic components, and retail sales.) The PFAS Submission Project is focused primarily on the needs of complex products (articles.) Claigan is both a restricted materials consultancy and a high-volume restricted materials testing laboratory. Each of the PFAS Submission Project submissions is based on contributions from all major sectors of industry and 2023 PFAS testing data from complex products. This report (#5) is a detailed itemization and justification of each derogation of PFAS uses that are necessary for the functioning of society and do not have adequate replacements. These derogations are application-based, as opposed to industry-based. The reason for the use of a PFAS material is normally performance related and not necessarily related to any one industry segment. Many different industries have common critical performance characteristics. The derogations below are based on Feedback from a wide range of industries A review of substitutes (see Claigan EU PFAS Submission Project Report #4) and the availability of adequate substitutes Detailed testing data of the polymers themselves and PFAS additives / degradation products commonly found in those materials (Claigan EU PFAS Submission Project Reports #1 and #2) Risk of harm to the environment (Claigan EU PFAS Submission Project Report #3) Socio-economic impact Important note - due to the short timeline of the EU PFAS Restriction Consultation, each justification is only in brief. Each justification can be further elaborated upon, if needed. Important comment - Fluoropolymers and fluoroelastomers in industrial and medical applications should NOT be restricted in haste. In many cases, 13.5 years were requested in the derogations below based on the recommendation for materials currently without suitable replacements. However, unlimited-duration derogations for fluoropolymers in any industrial and medical applications is recommended until viable and proven alternatives are developed. The risk to humans and the environment due to material substitution is significant in these applications. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 17 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 In a number of industrial or scientific cases, such as piezo/ferroelectric PVDF, identification of a suitable replacement material would require a scientific breakthrough of Nobel prize significance. September 21 2023 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 18 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 2. Summary of Derogations Requested Note - some derogations have been removed (example - c1) as it was either a duplicate of a more specific derogation, or it did not meet the justification requirements. Derogation Timeline Requested c2 13.5 Years c3a 13.5 Years c3b 13.5 Years c4a 13.5 Years c4b 13.5 Years c5a 13.5 Years c5b 13.5 Years Derogation PFAS Polymers PFAS Polymers PFAS Polymers PFAS Polymers PFAS Polymers and Non-Polymers PFAS Polymers and Non-Polymers PFAS Polymers and Non-Polymers Tonnage per Year Text for Derogations 100-1,000 tons Fluoropolymer and perfluoropolyether (PFPE) release agents used in manufacturing processes of plastic and rubber parts including foam. 100-1,000 tons PTFE used as an additive drip agent in plastics to meet flammability safety requirements 10-100 tons PFBS (and its salts) for the purposes of plastic clarity in flame retarded polymers under 1,000 ppm of the plastic 100-1,000 tons PTFE, ETFE, FEP, and PFA used for electrical insulation purposes except wiring. 10-100 tons Fluorosilicone, amorphous fluoro resins, and fluoroelastomers (including perfluoroelastomers) for electrical insulation purposes except wiring. 100-1,000 tons Fluoropolymers in invasive, implantable, fluid, and gas contacting applications in medical devices. 0-10 tons Maximum of 2ppm C4-C14 perfluoroalkyl carboxylates in fluoropolymers in invasive, implantable, fluid, and gas contacting applications in medical devices. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 19 of 100 c6a c6b c7 c8a c8a c9 c10 c11a c11b c12a 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years PFAS Polymers 100-1,000 tons PFAS Polymers PFAS Polymers PFAS Polymers and Non-Polymers 100-1,000 tons 100-1,000 tons 10-100 tons PFAS Polymers and Non-Polymers 0-10 tons PFAS Polymers and Non-Polymers 10-100 tons PFAS Polymers PFAS Polymers PFAS Polymers 10-100 tons 100-1,000 tons 100-1,000 tons PFAS Polymers and Non-Polymers 100-1,000 tons Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 PTFE as an additive up to 25% in plastics for the purposes reduced friction and wear PTFE, ETFE, and PCTFE for professional, industrial, or high temperature applications (>150C) requiring reduced friction, or chemical inertness. PTFE, ETFE, PFA, PVDF, and FEP as a wire insulator. Fluoroacrylic coatings necessary for chemical safety for fabrics. Maximum of 5ppm sum of C4-C18 perfluoroalkyl carboxylates. Fluoroacrylic coatings on fabrics necessary for the protection or storage of portable medical devices or laboratory equipment. Maximum of 5ppm sum of C4-C18 perfluoroalkyl carboxylates. PTFE and PVDF membranes for gas and aqueous filtration, or particle retention. Maximum of 20ppm of C4-C14 perfluoroalkyl carboxylates PTFE as a lubricant additive under 30% concentration not in contact with drinking water. PTFE as a fused coating on cookware PTFE as a coating for chemical containers Fluoroelastomers (including perfluoroelastomers), fluorosilicone, and amorphous fluoro resins as a sealing material in situations requiring chemical resistance, oil resistance, oxidation resistance, decompression resistance, high temperature (over 150C), or low temperature (<-20C). Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 20 of 100 c12b c13a c13b c14 c16 c17 c18 c19 c20 c21 c22 13.5 Years 13.5 Years 13.5 Years 6.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 6.5 Years 13.5 Years 13.5 Years PFAS Polymers and Non-Polymers 10 to 100 tons PFAS Polymers and Non-Polymers PFAS Polymers and Non-Polymers 100-1,000 tons 100-1,000 tons PFAS Polymers 0-10 tons PFAS Polymers 10-100 tons PFAS Polymers 10-100 tons PFAS Polymers 10-100 tons PFAS Polymers 10-100 tons PFAS Polymers 0-10 tons PFAS Polymers and Non-Polymers PFAS Non-Polymers 100-1,000 tons 10-100 tons Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 Fluoroelastomers (including perfluoroelastomers), fluorosilicone, and amorphous fluoro resins as a sealing material for drinking water or food contact if compliant with EU drinking water directives and regulations. PTFE tape for moisture insulation, or joining of fluid or gas components. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates for 6.5 years PTFE tape for reduction of friction. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates for 6.5 years Fluorosilcone release paper and residual fluorosilicone on adhesive products. Fluorocoating of rubber, metal, and plastic seals in professional or industrial applications where chemical resistance is required PTFE and PFA coating of metal for environmental or temperature resistance not in contact with food or drinking water PTFE, FEP, and PFA coating of metal for low friction and wear resistance in machinery or tools PTFE, PFA, FEP, and TFE copolymers in hoses in chemical, pump, or valve applications. Fluorocoatings on labels on products (excluding textiles) necessary for environmental resistance PTFE, PFA, FEP, PVDF, ETFE, and fluoroelastomer (including perfluoroelastomer) tubing not in contact with drinking water. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates Heat transfer fluids for industrial applications Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 21 of 100 c23a c23b c24 c25 c26 c27 c28 c29 c31a 13.5 Years 13.5 Years 6.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 13.5 Years 6.5 Years Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 PFAS Polymers 1,000-10,000 tons PFAS Polymers PFAS Polymers PFAS Polymers and Non-Polymers 10-100 tons 10-100 tons 0-10 tons PFAS Polymers PFAS Polymers and Non-Polymers PFAS Polymers and Non-Polymers PFAS Polymers and Non-Polymers 0-10 tons 0-10 tons 10-100 tons 10-100 tons PFAS Polymers and Non-Polymers 10-100 tons PVDF and PTFE as the cathode binder in lithium batteries PVDF, PTFE, TFE, and sulfonated PTFE as a binder or spacer in capacitors PTFE and fluorosilicone lubricants for internal wires Surfactants in emulsion based bio-assays and dry-chemistry assays PTFE foil coating of rubber for biotechnology or chromatography purposes Products used for education or training purposes may use derogations applicable to products they are simulating. Fluorinated polyethylene for chemical storage and handling. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates ePTFE as a gasket / seal material in professional applications. Maximum of 5ppm of C4-C14 perfluoroalkyl carboxylates Fluoro acrylics for antismudge and antireflective coatings for plastics. Maximum of 1ppm of C4-C6 perfluoroalkyl carboxylates. Maximum of 1ppm of C7-C14 perfluoroalkyl carboxylates. c31b c32a c32b 13.5 Years 13.5 Years 13.5 Years PFAS Polymers 10-100 tons PFAS Polymers PFAS Polymers and Non-Polymers 100-1,000 tons 10-100 tons Fluorosilicone and nano-fluorocoatings for antismudge and antireflective coatings for plastics and glass. PTFE, PCTFE, PVDF, FEP, and TFE (including copolymers) as a sealing or spacer material. PFA as a sealing or spacer material in professional applications. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 22 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 c33 13.5 Years PFAS Polymers 10-100 tons PVDF and ETFE as a component in fluid or gas systems PFAS Polymers and PTFE in coatings of labels for security or tamper evidence. c34 13.5 Years Non-Polymers 0-10 tons Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates. Fluoroacrylic and PFA coatings (and solvents) for encapsulation of capacitors or semiconductor components. Maximum of 2ppm of PFAS Polymers and C4-C14 perfluoroalkyl carboxylates and 10ppm residual c35 13.5 Years Non-Polymers 0-10 tons fluoroethers PTFE and fluorosilicone sprays for maintaining lubrication in c36 13.5 Years PFAS Polymers 100-1,000 tons industrial equipment. PFAS Polymers and c37 13.5 Years Non-Polymers 0-10 tons Ionic fluoro fluids as electrolytes in capacitors or batteries Perfluorinated polyether (PFPE) as a lubricant for harsh c38 13.5 Years PFAS Polymers 10-100 tons environments PFAS Polymers and Maximum of 5ppm of C4-C14 perfluoroalkyl carboxylates in c40 13.5 Years Non-Polymers 0-10 tons derogated applications of PFA Maximum of 10 ppm 6:2 FTS, 5ppm C4-C6 perfluoroalkyl PFAS Polymers and carboxylates, and 10 ppm bisphenol AF in derogated applications c41 13.5 Years Non-Polymers 0-10 tons of fluoroelastomers and perfluoroelastomers c43 13.5 Years PFAS Polymers 0-10 tons PVDF polymers and PVDF terpolymers for ferroelectric films. PFAS Polymers and c44 6.5 Years Non-Polymers 10-100 tons Fluoroethers for degreasing applications Residual hydrofluoroolefins used as blowing agents for insulating c45 13.5 Years PFAS Polymers 10-100 tons foam internal to products Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 23 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 PTFE as a manufacturing aid or tool for high temperature (> 150C) c46 13.5 Years PFAS Polymers 0-10 tons applications PFAS Polymers and Fluorocoatings on laser fibers, laser fiber components, and fibers c48 13.5 Years Non-Polymers 0-10 tons for optical purposes including light guidance. PFAS Polymers and Fluorosilicone used as a surfactant or anti-foaming agent in c50 13.5 Years Non-Polymers 0-10 tons semiconductor materials c51 13.5 Years PFAS Polymers 0-10 tons F2 gas fluorinated plastics in capacitors and microchips c52 13.5 Years PFAS Polymers 0-10 tons PTFE filled die attach material for semiconductor devices Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 24 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 3. Related documents 3.1. Claigan PFAS Submission #1 - PFAS in Articles 3.1.1. Comprehensive 2023 testing data regarding locations and uses of PFAS in articles. 3.2. Claigan PFAS Submission #2 - PFOA in Articles 3.2.1. 2022 and 2023 test data regarding PFOA (and other perfluorocarboxylates and perfluorosulfonates in articles) 3.3. Claigan PFAS Submission #3 - PFAS in Drinking Water 3.3.1. Evaluation of recent news articles and related science papers on PFAS in drinking water and in human blood. 3.4. Claigan PFAS Submission #4 - PFAS Substitutes and Alternatives 3.4.1. A review of the pros and cons of fluoropolymers and their potential substitutes. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. Page 25 of 100 Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 4. Definitions 4.1. Text for derogation 4.1.1. The simple text to include in the derogation of REACH restriction for PFAS 4.2. Alternative text 4.2.1. Alternative text (if applicable) for the derogation. 4.3. Uses and Functionality 4.3.1. A longer explanation of the use and details of the requested derogation. 4.4. Substitutes / Alternatives 4.4.1. An evaluation of availability of effective, validated, and available substitutes 4.4.2. Due to the short timeline for submission to the consultation, the explanation of alternatives for each requested derogation is brief. Further details can be provided in each situation. 4.4.3. In most applications, once the material properties are reviewed, the justification of the use is fairly obvious due to temperature, safety, or environmental conditions. 4.4.4. See Claigan EU PFAS Submission Report #4 - Comparison of Substitutes for further details. 4.5. Forever Chemicals 4.5.1. Risk of perfluorocarboxylates (PFOA family) and perfluorosulfonates (PFOS family) in the use. 4.5.1.1. Plus explanation, if relevant, for fluorinated salts that are not classified vPvB or PBT substances. 4.5.2. A detailed explanation for each material is in Claigan EU PFAS Submission #2 - PFOA in Products and Claigan EU PFAS Submission #4 - Comparison of Alternatives. 4.6. Number of companies affected 4.6.1. Estimate of the number of companies affected. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 26 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 4.6.1.1. Note - number of companies is a misleading statistic as companies are of different order of magnitude of sizes and a straight count can be misleading. 4.7. Annual Tonnage 4.7.1. Expected annual tonnage of the PFAS substance imported into or manufactured for use in the EU each year. 4.8. Timeline Requested 4.8.1. 6.5 years - Substitutes available but replacement and re-qualification of the related products will take time 4.8.2. 13.5 years - Substitutes are not currently available and are not expected to be available in the near future. 5. C2 - Fluoropolymer and Perfluoropolyether Release Agents 5.1. Text for derogation 5.1.1. Fluoropolymer and Perfluoropolyether (PFPE) release agents used in 5.2. manufacturing processes of plastic and rubber parts including foam. Alternative text 5.2.1. n/a 5.3. Use and Functionality 5.3.1. Fluoropolymer and PFOE release agents are commonly used in the molds for rubber, plastic, and foams materials. The most common applications of mold release agents are in the manufacturing of o-rings, gaskets, and foam. Roughly 25% of o-rings / gaskets in physical products have residual release agents on the surface above 100 ppm fluorine. 5.3.2. Without effective release agents, the rubber, plastic, or foam part would adhere partially to the mold and suffer defects. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 27 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 5.4. Substitutes / Alternatives 5.4.1. Silicone mold release agents would be a suitable replacement for PFAS release agents in most applications, however the use of PFAS release agents are so prevalent in manufacturing that the conversion and requalification process will take years. 5.5. Forever Chemicals 5.5.1. None expected. 5.5.1.1. Due to the low concentration of fluorocoating, no measurable PFAS forever chemicals over 25 ppb is expected. 5.6. Number of companies affected 5.6.1. 10,000+ 5.7. Annual Tonnage 5.7.1. 100-1,000 tons per annum. 5.8. Timeline Requested 5.8.1. 13.5 years - Substitutes available but replacement and re-qualification of the related products will take significant time. 6.5 years would not be sufficient time as it would take years to find all the occurrences even in an individual product let alone a product family. 5.8.2. Roughly of all gaskets and seals use fluoro release agents in their manufacturing process and there is currently no universal effective and accepted test method for its detection. 5.8.3. Unlike the removal of Pb during RoHS, the test standards for low concentration of this material are still not widely adopted or even have basic consensus. Combustion Ion Chromatography (CIC) was heralded as a measured tool for fluorine concentration but is unable to detect mold release agents on the surface of plastics and rubbers. Until widespread adoption of WDXRF (years away), the simple matter of detecting this substance in products is not easily possible. 5.8.4. Supported by document [Draft] PFOA in articles 2023 (#2) section 5 and document [Draft] PFAS alternative and substitutes (#4) section 4 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 28 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 6. C3a - PTFE Anti-Drip Additive 6.1. Text for derogation 6.1.1. PTFE used as an additive drip agent in plastics to meet flammability safety requirements 6.2. Alternative text 6.2.1. n/a 6.3. Use and Functionality 6.3.1. To meet UL94 and similar EU flame retardancy standards, a plastic cannot `drip' molten plastic when exposed to flame. Many plastics, such as ABS or PC, drip molten plastic when exposed to flame creating both a safety hazard to the user and potentially causing the fire to spread. 6.3.2. PTFE, when added to plastic, creates a `webbing' during burning - trapping the plastic and preventing dripping of the plastic. 6.3.3. The use of PTFE anti-drip agents is very common in products requiring high flame retardancy, in particular electronics. Plastic parts that normally contain anti-drip agents are plastic housing of electronic products. 6.4. Substitutes / Alternatives 6.4.1. There are currently no effective replacements for PTFE as an anti-drip additive. Virtually all electronics use PTFE anti-drip agents in one or more parts. Restriction of PTFE anti-drip agents would create a significant safety risk for electronics and require the redesign and re-qualification of safety of virtually every electronic product on the EU market. 6.5. Forever Chemicals 6.5.1. None expected. 6.5.1.1. Pure unirradiated PTFE powder used as an anti-drip additive does not contain forever chemicals and has no expectation of degrading into forever chemicals. 6.5.1.1.1. Even in the rare case of an uncontrolled burn, the degradation products are not forever chemicals (no perfluorocarboxylates or perfluorosulfonates). See https://www.fluoridealert.org/wpcontent/pesticides/teflon.decomposition.prod.htm. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 29 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 6.6. Number of companies affected 6.6.1. 10,000+ 6.7. Annual Tonnage 6.7.1. 100-1,000 tons per annum. 6.8. Timeline Requested 6.8.1. 13.5 years - Wide spread use, no suitable replacement, no forever chemicals, and substitution creates a significant safety risk. 7. C3b - PFBS as a Clarity Additive 7.1. Text for derogation 7.1.1. PFBS (and its salts) for the purposes of plastic clarity in flame retarded 7.2. polymers under 1,000 ppm of the plastic. Alternative text 7.2.1. n/a 7.3. Use and Functionality 7.3.1. Flame retardant additives to transparent polycarbonate (and similar materials) tends to create a hazy or opaqueness 7.3.2. The addition of trace levels of PFBS (or its salts) maintains the transparency of the plastic. 7.3.3. Transparency and flame retardancy are critical criteria for a number of applications including electronic displays or construction materials. 7.4. Substitutes / Alternatives 7.4.1. There are currently no effective replacements for PFBS as a clarifying additive for flame retardant transparent plastics. 7.5. Forever Chemicals 7.5.1. None expected. 7.5.1.1. Note - PFBS would be present in the product <1,000 ppm. However PFBS is not currently classified as a vPvB or PBT chemical in the EU. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 30 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 7.6. Number of companies affected 7.6.1. 100 - 1,000 7.7. Annual Tonnage 7.7.1. 10 - 100 tons per annum. 7.8. Timeline Requested 7.8.1. 13.5 years - Wide spread use, low concentration use, replacement. and no suitable 8. C4a - PTFE and ETFE for electrical insulation 8.1. Text for derogation 8.1.1. PTFE, ETFE, FEP, and PFA used for electrical insulation purposes except wiring. 8.2. Alternative text 8.2.1. n/a 8.3. Use and Functionality 8.3.1. PTFE, ETFE, and similar fluoropolymers have very low dielectric constants which makes both materials excellent electrical insulators. 8.3.2. These materials are primarily used in connectors and electronic components for electrical insulation. The most visually obvious uses are the white `ring' inside a coaxial connector or the white centre core of a wireless router antenna. 8.3.3. PTFE and ETFE spacers include any application that requires electrical insulation including spacers / separators in batteries or capacitors. 8.3.4. Due to the volume of use and different critical properties, PTFE and ETFE wire insulation is covered in a different derogation request. 8.4. Substitutes / Alternatives 8.4.1. No other material has equivalent dielectric constant / electrical insulation capability. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 31 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 8.4.2. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of performance and biocompatibility of alternatives. 8.5. Forever Chemicals 8.5.1. None expected in initial material nor is material expected to degrade into forever chemicals. 8.5.1.1. The exception is PFA which can have a small amount of perfluorocarboxlates from degradation of its C-O-C side chain bond. PFA can be made without perfluorocarboxylate degradation, but it will take time to replace. There is a separate derogation request for phase out of perfluorocarboxylates in PFA. 8.5.1.2. PFA represents <1% of fluoropolymers in dielectrics / insulators. 8.6. Number of companies affected 8.6.1. 10,000+ companies 8.7. Annual Tonnage 8.7.1. 100 - 1,000 tons per annum. 8.8. Timeline Requested 8.8.1. 13.5 years - Wide spread use, no forever chemicals, and no suitable replacement. 9. C4b - Fluoroelastomers for electrical insulation 9.1. Text for derogation 9.1.1. Fluorosilicone, amorphous fluoro resins, and fluoroelastomers (including 9.2. perfluoroelastomers) for electrical insulation purposes except wiring. Alternative text 9.2.1. n/a 9.3. Use and Functionality 9.3.1. Fluoroelastomers (and similar materials) have low dielectric constants which makes both materials good electrical insulators. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 32 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 9.3.2. PTFE and ETFE have limited flexibility and fluoroelastomers are required to meet both the electrical insulation and flexibility requirements. 9.3.3. Common products using fluoroelastomers for electrical insulation would be electronic products such as hard drives. The use in hard drives (among very many other electronics applications) affects a large number of companies. 9.3.4. Fluorosilicone, amorphous fluoro resins, fluoroelastomers (FKM), and perfluoroelastomers (FFKM) have very similar performance and materials characteristics and are recommended to be covered under the same derogation. 9.4. Substitutes / Alternatives 9.4.1. No other material has equivalent dielectric constant / electrical insulation capability with flexibility 9.4.2. Fluoroelastomer use is more specialized and lower volume than PTFE and ETFE for the same purpose. 9.5. Forever Chemicals 9.5.1. Fluoroelastomers and perfluoroelastomers require a sulfonated fluorotelomer surfactant as part of their emulsion polymerization manufacturing process. The resulting 6:2 FTS, and short chain perfluorocarboxylates are covered in derogation request c41a. 9.5.2. All of the fluorosulfonates or fluorocarboxyles present are short chain chemicals and none are classified vPvB or PBT substances. 9.6. Number of companies affected 9.6.1. 10,000+ companies 9.7. Annual Tonnage 9.7.1. 10 - 100 tons per annum. 9.8. Timeline Requested 9.8.1. 13.5 years - Wide spread use, no forever chemicals, and no suitable replacement. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 33 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 10. C5a - Fluoropolymers in invasive / implantable devices 10.1. Text for derogation 10.1.1. Fluoropolymers in invasive, implantable, fluid, and gas contacting 10.2. applications in medical devices. Alternative text 10.2.1. n/a 10.3. Use and Functionality 10.3.1. Fluoropolymers are very low friction, hydrophobic, oleophobic (oil resistance) and very biocompatible making them ideal for medical devices. 10.3.2. Uses include an almost infinite number of implantable or invasive applications such as tubing, wiring, protective coatings, bearings, and a wide assortment of fluid and gas components. 10.3.3. Unlike other products, implantable and invasive medical devices undergo rigorous chemical safety testing which include PFOA and similar chemicals. Each implantable or invasive device is tested for PFOA (and similar) extractables and reviewed for toxicology. 10.3.3.1. Note - the testing described above only applies to invasive or implantable medical devices. Medical devices that are not implantable or invasive do not undergo the same testing (neither does IVD medical devices). These devices would have requirements for PFAS materials for their continued function, but the applications would overlap with other applications for other industries. 10.4. Substitutes / Alternatives 10.4.1. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of performance and biocompatibility of alternatives. 10.4.2. No other material has the same performance requirements (low friction, high biocompatibility) as fluoropolymer materials. In the cases where forever chemicals are present in fluoropolymers in medical devices, the Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 34 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 material was chosen for very specific performance criteria (such as flexibility) not available with standard PTFE. 10.5. Forever Chemicals 10.5.1. Due to the use of irradiated PTFE, expanded PTFE (ePTFE), and PFA in medical devices - the full range of perfluorocarboxylates (PFOA family) are present at >100 ppb per chemical in ~25% of PFAS uses in medical devices. 10.5.2. Any approval of fluoropolymers for implantable / invasive applications will need approval for perfluorocarboxylates (PFOA family). Due to material performance requirements, perfluorocarboxylates are currently unavoidable in implantable and invasive devices. 10.6. Number of companies affected 10.6.1. 1,000+ companies 10.7. Annual Tonnage 10.7.1. 100 - 1,000 tons per annum. 10.8. Timeline Requested 10.8.1. 13.5 years - No suitable replacements, high human safety risk, and length re-qualification required 11. C5b - Fluoroelastomers in invasive / implantable devices 11.1. Text for derogation 11.1.1. Fluorosilicone, amorphous fluoro resins, and fluoroelastomers (including perfluoroelastomers) for electrical insulation purposes except wiring. 11.2. Alternative text 11.2.1. n/a 11.3. Use and Functionality 11.3.1. Fluoroelastomers (FKM) and perfluoroelastomers (FFKM) are low friction, hydrophobic, oleophobic (oil resistance) and very biocompatible making Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 35 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 them ideal for medical devices. Fluoroelastomers have more rubber characteristics than fluoropolymers such as PTFE, and are needed for medical applications requiring a rubber over a plastic. 11.3.2. Uses include a large range of biocompatible rubber applications in medical devices including seals, strain relief, and other applications requiring a biocompatible rubber over a plastic. 11.3.3. Unlike other products, implantable and invasive medical devices undergo rigorous chemical safety testing which includes PFOA and similar chemicals. Each implantable or invasive device is tested for PFOA (and similar) extractables and reviewed for toxicology. 11.3.3.1. Note - this testing only applies to invasive or implantable medical devices. Medical devices, not implantable or invasive, do not undergo the same testing (neither does IVD medical devices). These devices would have requirements for PFAS materials for their continued function, but the applications would overlap with other applications for other industries. 11.3.4. This derogation includes four (4) different similar fluororubbers (fluorosilicone, amorphous fluoro resin, fluoroelastomer (FKM), and perfluoroelastomer (FFKM). 11.4. Substitutes / Alternatives 11.4.1. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of performance and biocompatibility of alternatives. 11.4.2. No other rubber material has the same performance requirements (low friction, high biocompatiblity) as fluoropolymer materials. 11.4.3. For example - Silicone rubber averages 100x higher concentrations of forever chemicals (D4, D5, and D6 - which are EU classified PBTs) than fluoroelastomers, is likely subject to REACH restriction in the near future in the EU (due to D4, D5, and D6 monomers restriction proposed under POP), has much higher friction, and has poor resistance to oils. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 36 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 11.5. Forever Chemicals 11.5.1. Fluoroelastomers and perfluoroelastomers require a fluorinated surfactant for emulsion polymerization and bisphenol AF for crosslinking. These materials cannot currently be made reliably without these manufacturing aids. 11.5.2. Any approval of fluoroelastomers for implantable / invasive applications will need approval of 6:2 FTS fluorotelomer sulfonates (and substances that degrade into 6:2 FTS), and approval for a low concentration of short chain perfluorocarboxylates that degrade from 6:2 FTS (C4 to C7 perfluorocarboxylates). Approval will also be required for low concentrations of residual bisphenol AF crosslinking additives. 11.6. Number of companies affected 11.6.1. 100-1,000 companies 11.7. Annual Tonnage 11.7.1. 10 - 100 tons per annum. 11.8. Timeline Requested 11.8.1. 13.5 years - No suitable replacements, high human safety risk, and length re-qualification required. 12. C6a - PTFE additive to plastics for wear reduction 12.1. Text for derogation 12.1.1. PTFE as an additive up to 25% in plastics for the purpose to reduce friction and wear 12.2. Alternative text 12.2.1. PTFE as an additive in plastics for the purpose to reduce friction and wear 12.3. Use and Functionality 12.3.1. The addition of PTFE powder to standard plastics such as nylon reduces the coefficient of friction of the plastic by up to 60%. 12.3.2. Used in a wide range of plastic components that turn against the surface of another plastic or metal. PTFE added plastics are commonly used in Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 37 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 fluid, gas, machinery, and electronics applications. Fluid and gas uses are generally (but not exclusively) valves and similar components with potential for wear, plastic gears in machinery (including consumer products), and connectors (with a turn lock type function) in electronics. 12.4. Substitutes / Alternatives 12.4.1. No other additives are as effective to safely reduce the coefficient of friction of plastics. Restriction of PTFE additives in plastics for friction reduction would reduce the lifetime of many products, resulting in products going to waste or landfall sooner and more often. 12.4.2. In addition, PTFE added plastics extend product life/service intervals thereby reducing potential fluid and gas releases/exposures. They also reduce power consumption compared to non-PTFE added counterparts. 12.5. Forever Chemicals 12.5.1. None expected. Unirradiated PTFE powder has no forever chemicals. 12.5.2. Irradiated PTFE powder is not needed and would be restricted by current PFOA and long chain perfluorocarboxylate restrictions (POP and REACH) in the EU. 12.6. Number of companies affected 12.6.1. 10,000+ companies 12.7. Annual Tonnage 12.7.1. 1000+ tons per annum. 12.8. Timeline Requested 12.8.1. 13.5 years - No suitable replacements and no forever chemicals or risk to drinking water / humans. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 38 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 13. C6b - PTFE, ETFE, and PCTFE for low friction parts and chemical inertness 13.1. Text for derogation 13.1.1. PTFE, ETFE, and PCTFE for professional, industrial, or high temperature 13.2. applications (>150C) requiring reduced friction, or chemical inertness. Alternative text 13.2.1. PTFE, ETFE, and PCTFE for applications requiring reduced friction or chemical inertness in machinery (including consumer and professional 13.3. applications). Use and Functionality 13.3.1. The use of PTFE, ETFE, and PCTFE as a material for parts requiring low friction or chemical inertness in products. 13.3.2. The uses are parts that require either low friction (such as plastic gears or bearings) or have a role in hostile chemical environments (a bracket in a chemical bath, brushes in a chemical environment, or wafer cassette for semiconductor manufacturing) other than as a seal. PTFE in seals are covered in another derogation request as that application is more specific. 13.3.3. Consumer applications at temperatures exceeding 150C would be included in this derogation. Potentially compromising high temperature safety in a household would not be recommended without significant review and validation. 13.3.4. The text of the derogation here is limited to non-consumer products unless high temperature is required, however due to the low risk of these materials, an alternative text to extend to consumer products under the same conditions is included. 13.4. Substitutes / Alternatives 13.4.1. No other materials have the same low friction and chemical inertness properties as PTFE, ETFE and PCTFE at regular temperatures and at high temperature (150C). 13.4.2. PTFE and PCTFE extend product life/service intervals thereby reducing potential chemical releases/exposures. They also can reduce power consumption compared to non-PTFE/PCTFE counterparts. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 39 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 13.4.3. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of friction, chemical resistance, and temperature resistance. 13.5. Forever Chemicals 13.5.1. None expected. Unirradiated PTFE powder has no forever chemicals. 13.5.2. Irradiated PTFE powder is not needed for this application and would be restricted by current PFOA and long chain perfluorocarboxylate restrictions (POP and REACH) in the EU. 13.6. Number of companies affected 13.6.1. 1,000-10,000 companies 13.7. Annual Tonnage 13.7.1. 100-1,000 tons per annum. 13.8. Timeline Requested 13.8.1. 13.5 years - No suitable replacements and no forever chemicals or risk to drinking water / humans. 14. C7 - PTFE, ETFE, PFA, PVDF, and FEP as a wire insulator. 14.1. Text for derogation 14.1.1. PTFE, ETFE, PFA, PVDF, and FEP as a wire insulator. 14.2. Alternative text 14.2.1. n/a 14.3. Use and Functionality 14.3.1. Fluoropolymers are commonly used as wire insulation. These materials have excellent electrical insulation and temperature resistance properties. 14.3.2. These materials are very important wire insulators in high density/temperature environments such as complex electronics (examples - laptops, computers, cell phones) or heating products (examples - ovens, furnaces) Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 40 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 14.3.3. With the move to chlorine free wiring, and the reduction of PVC wiring (and associated phthalate risks), PTFE (and other fluoropolymer wiring) has been the common choice. 14.3.4. Most PTFE (and similar) wiring is internal wiring with very limited exposure to humans or drinking water. 14.4. Substitutes / Alternatives 14.4.1. Silicone has similar temperature resistance to PTFE (and similar) wire insulators, but 14.4.1.1. Requires greater thickness, and is not suitable for dense applications, 14.4.1.2. Contains, on average, more than 100X more forever chemicals than even PFA wire insulation, 14.4.1.3. Is likely to be subject to REACH Restriction due to its constituent monomers (D4, D5, and D6), and 14.4.1.4. Does not hold its shape to the same manner as PTFE (and similar) insulation. 14.4.2. PVC is commonly used in wire applications, however it is not suitable in applications requiring high temperature, reduced friction, or outgassing of substances. PVC is known for outgassing or leaking of hazardous chemicals, and is not suitable for many high performance environments. 14.4.3. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of forever chemicals and temperature resistance. 14.5. Forever Chemicals 14.5.1. None expected for PTFE, FEP, PVDF, and ETFE wire insulation. 14.5.2. PFA wire insulation will commonly contain ~100 ppb for each perfluorocarboxylate (PFOA family) due to degradation of the C-O-C bond in the fluoro side chain. A specific PFA perfluorocarboxylate related derogation is included later in this report. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 41 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 14.6. Number of companies affected 14.6.1. 10,000+ companies 14.7. Annual Tonnage 14.7.1. 1,000+ tons per annum. 14.8. Timeline Requested 14.8.1. 13.5 years - No suitable replacements, very limited human exposure, and wide usage. 15. C8a - Fluoroacrylic coatings for fabrics for safety reasons 15.1. Text for derogation 15.1.1. Fluoroacrylic coatings necessary for chemical safety for fabrics. Maximum 15.2. of 5ppm sum of C4-C18 perfluoroalkyl carboxylates. Alternative text 15.2.1. n/a 15.3. Use and Functionality 15.3.1. Fluoroacrylates are acrylic polymers with side chain fluorocarbons attached by an ester bond (which includes the weak C-O-C bond subject to degradation with time). 15.3.2. Fluoroacrylate coatings are common for the chemical resistance of fabrics. No other air permeable coatings have the same resistance to water, acids, bases, and oils. 15.3.3. For situations where it is required for the fabric to protect the user from chemicals and air permeability, there are no safe replacements for fluoroacrylate coatings. 15.3.4. The use here is limited to fabrics that provide chemical safety protection to the user and not for general consumer wear. 15.4. Substitutes / Alternatives 15.4.1. No other air permeable coatings have the same resistance to water, acids, bases, and oils. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 42 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 15.4.2. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of water resistance, oil resistance, and chemical resistance. 15.5. Forever Chemicals 15.5.1. Fluoroacrylates >100 ppb for each perfluorocarboxylate (PFOA family) due to degradation of the C-O-C bond in the fluoro side chain. These chemicals will be present after manufacturing and will continue to accumulate as the weak (low energy of bond dissociation) C-O-C bond of the fluoro side chain fractures producing additional perfluorocarboxylates. 15.5.2. For this usage to continue, fluoroacrylates need to be permitted at least 5 ppm of perfluorocarboxylates. 15.6. Number of companies affected 15.6.1. 100-1,000 companies 15.7. Annual Tonnage 15.7.1. 10 - 100 tons per annum. 15.8. Timeline Requested 15.8.1. 13.5 years - No suitable replacements and significant safety risks if use is restricted. 16. C8b - Fluoroacrylic coatings for fabrics for protection of medical devices 16.1. Text for derogation 16.1.1. Fluoroacrylic coatings on fabrics necessary for the protection or storage of portable medical devices or laboratory equipment. Maximum of 5ppm 16.2. sum of C4-C18 perfluoroalkyl carboxylates. Alternative text 16.2.1. n/a Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 43 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 16.3. Use and Functionality 16.3.1. Fluoroacrylates are acrylic polymers with side chain fluorocarbons attached by an ester bond (which includes the weak C-O-C bond subject to degradation with time). 16.3.2. Fluoroacrylate coatings are common for the chemical resistance of fabrics. No other air permeable coatings have the same resistance to water, acids, bases, and oils. 16.3.3. Sensitive devices such as medical devices or laboratory equipment, in particular portable versions, require strong environmental protection for rugged conditions. Environmental damage could lead to an error with a medical or measuring device, potentially creating harm. 16.3.4. This derogation request is intended to encompass the medical / laboratory devices plus any accessories or reagents. Environmental damage to either risks human harm. 16.4. Substitutes / Alternatives 16.4.1. No other air permeable coatings have the same resistance to water, acids, bases, and oils. 16.4.2. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of water resistance, oil resistance, and chemical resistance. 16.5. Forever Chemicals 16.5.1. Fluoroacrylates >100 ppb for each perfluorocarboxylate (PFOA family) due to degradation of the C-O-C bond in the fluoro side chain. These chemicals will be present after manufacturing and will continue to accumulate as the weak (low energy of bond dissociation) C-O-C bond of the fluoro side chain fractures producing additional perfluorocarboxylates. 16.5.2. For this usage to continue, fluoroacrylates need to be permitted at least 5 ppm of perfluorocarboxylates. 16.6. Number of companies affected 16.6.1. 10-100 companies Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 44 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 16.7. Annual Tonnage 16.7.1. 0 - 10 tons per annum. 16.8. Timeline Requested 16.8.1. 13.5 years - No suitable replacements, low volume application, and significant safety risks if use is restricted. 17. C9 - PTFE and PVDF filter membranes 17.1. Text for derogation 17.1.1. PTFE and PVDF membranes for gas and aqueous filtration, or particle 17.2. retention. Maximum of 20ppm of C4-C14 perfluoroalkyl carboxylates Alternative text 17.2.1. PTFE (including ePTFE) and PVDF membranes for gas and aqueous filtration, or particle retention. Maximum of 20ppm of C4-C14 17.3. perfluoroalkyl carboxylates Use and Functionality 17.3.1. Filter membranes which allow gas permeability, but also filter fluids, are very common in medical, laboratory, and industrial applications (but can also be used in specialized consumer applications which require gas permeability with chemical filtration). 17.3.2. PTFE and PVDF filter membranes are strongly hydrophobic and oleophobic while allowing air to pass through. These membranes are also very acid and alkali resistant, allowing a wide range of specialized applications. 17.3.3. PTFE and PVDF filter membranes are normally expanded materials with a fabric-like structure. This derogation request is designed to include PVDF, PTFE, and the expanded form of ePTFE. ePTFE share the same CAS number, but are different materials from a structural and residual chemicals perspective. 17.3.4. In a number of cases, the legislated test method in EU member states requires fluoropolymer permeable membranes. 17.3.5. Membranes can also be used to hold particles (such as dye) internally and repel other fluids with its hydrophobic nature. This is very similar to its filtration function, repelling fluid due to strong hydrophobic and oleophobic properties, but stores the particles (dye) instead of letting it pass through. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 45 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 17.4. Substitutes / Alternatives 17.4.1. No other material has the same gas permeability while being hydrophobic, oleophobic, acid resistance, and alkali resistant. PTFE and PVDF membranes also have the advantages of maintaining their performance characteristics even at elevated temperatures. 17.4.2. Although it is theoretically possible to develop a porous gas permeable polyethylene frit for some applications, this would be a long project and is risky regarding tightness and reproducibility of the gas transfer. 17.4.3. See Claigan PFAS Submission #4 - comparison of substitutes for a full material by material comparison of forever chemicals and temperature resistance. 17.5. Forever Chemicals 17.5.1. ePTFE normally contains a concentration of ~100 ppb of each of the perfluorocarboxylates (PFOA family). The source of perfluorocarboxylates in ePTFE is not clear, but consistent in ePTFE materials. The likely source is irradiation of the original PTFE powder to `rubberize' the PTFE to make it more conducive to stretching (expansion) into ePTFE. Irradiation of the initial powder would produce low concentrations of each perfluorocarboxylate chain length as PTFE fragments fractured by radiation from the original long polymer chain will react with oxygen forming perfluorocarboxylates. 17.6. Number of companies affected 17.6.1. 100 - 1,000 companies 17.7. Annual Tonnage 17.7.1. 10 to 100 tons per annum. 17.8. Timeline Requested 17.8.1. 13.5 years - No suitable replacements, very limited human exposure, and very technical/scientific applications. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 46 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 18. C10 - PTFE Additive in Grease 18.1. Text for derogation 18.1.1. PTFE as a lubricant additive under 30% concentration not in contact with 18.2. drinking water. Alternative text 18.2.1. PTFE as a lubricant additive for professional applications. 18.3. Use and Functionality 18.3.1. PTFE in mineral oil or silicone oil grease has superior lubrication properties compared to mineral or silicone oil alone. 18.3.2. PTFE added grease is used in a very wide range of applications, primarily for machinery or other moving parts when lubrication for an extended time period is required. 18.3.3. PTFE added grease has both consumer and professional applications. 18.4. Substitutes / Alternatives 18.4.1. No other material has the same impact as a low friction additive to mineral or silicone oil than PTFE. 18.5. Forever Chemicals 18.5.1. None expected 18.5.2. Unirradiated PTFE does not normally contain perfluorocarboxylates and is not expected to degrade into perfluorocarboxlates. 18.5.2.1. Irradiated PTFE would not normally be used as an additive in grease, and would be regulated by current POP and REACH restrictions for long chain perfluorocarboxylates. 18.6. Number of companies affected 18.6.1. 10,000+ companies 18.7. Annual Tonnage 18.7.1. 10 to 100 tons per annum. 18.8. Timeline Requested 18.8.1. 13.5 years - No suitable replacements and very low risk to human health (no forever chemicals). Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 47 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 19. C11 - PTFE coatings for cookware 19.1. Text for derogation 19.1.1. PTFE as a fused coating on cookware 19.2. Alternative text 19.2.1. n/a 19.3. Use and Functionality 19.3.1. PTFE has been used as a fused polymer coating on cookware metals for decades. These coatings are very different from the fluoroacrylate coatings on paper food contact packaging, which are based on side chain fluoropolymers weakly adhered to acrylic polymer backbones. Fused polymer coatings are pure PTFE powder heated and cured to the surface of the metal, without the weak / degradation bonds of fluoroacrylates. 19.3.2. Contrary to popular belief, PTFE on cookware 19.3.2.1. Does not contain forever chemicals (such as PFOA), and 19.3.2.2. Does not degrade into forever chemicals over time or at end-of-life. 19.3.3. PTFE has superior performance (low friction, hydrophobic, and oleophic) over all other polymers. 19.3.4. Ceramic coatings can achieve the same performance at a higher cost, but do not provide any chemical safety advantages. Ceramic coatings are also prosecuting in food contacting materials for heavy metals in California Proposition 65 very commonly (averaging over 10 prosecutions per month). 19.4. Substitutes / Alternatives 19.4.1. No other polymers have the same low friction, temperature resistance, hydrophobic and oleophobic properties, and chemical safety as PTFE fused coatings. 19.4.2. Ceramics have similar performance characteristics and provide chemical safety risks greater than fused PTFE coatings. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 48 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 19.5. Forever Chemicals 19.5.1. None expected 19.5.2. Contrary to popular belief, fused PTFE coatings for cookware have not contained forever chemicals (PFOA family) for decades, and do not have a chemical structure that degrades into perfluorocarboxylates. 19.5.2.1. A good reference is "Determination of perfluorooctanoic acid (PFOA) extractable from the surface of commercial cookware under simulated cooking conditions by LC/MS/MS" 2005. 19.5.2.1.1. Claigan's 2023 testing of cookware agreed with the results above (`non detect' for perfluorocarboxlates). 19.5.3. See Claigan Submission #3 - PFAS in Drinking Water for further explanation. 19.6. Number of companies affected 19.6.1. 10,000+ companies 19.7. Annual Tonnage 19.7.1. 10 to 100 tons per annum. 19.8. Timeline Requested 19.8.1. 13.5 years - No suitable replacements and very low risk to human health (no forever chemicals). 20. C11b - PTFE coatings for chemical containers 20.1. Text for derogation 20.1.1. PTFE as a coating for chemical containers 20.2. Alternative text 20.2.1. n/a 20.3. Use and Functionality 20.3.1. PTFE is an effective coating for chemical containers, whether portable or industrial. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 49 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 20.3.2. PTFE is hydrophobic, oleophobic, acid resistant, alkali resistant, and maintains its characteristics over a wide temperature range. These properties are critical for chemical containers. 20.3.3. This derogation request is for PTFE coatings for containers or vessels that can hold chemical substances with safety or corrosion risks. 20.4. Substitutes / Alternatives 20.4.1. No other polymers have equivalent hydrophobic and oleophobic properties, and chemical safety over a range of temperatures as PTFE. 20.4.2. Ceramics have similar performance characteristics but could only be used to coat metal vessels. Ceramic coatings are more difficult to coat completely without gaps in larger containers, creating leakage or degradation risk. 20.5. Forever Chemicals 20.5.1. None expected. Unirradiated PTFE does not normally contain perfluorocarboxylates and does not further degrade into perfluorocarboxylates over time. 20.6. Number of companies affected 20.6.1. 100 - 1,000 companies 20.7. Annual Tonnage 20.7.1. 10 to 100 tons per annum. 20.8. Timeline Requested 20.8.1. 13.5 years - No suitable replacements, is a specialized use, replacement creates a safety risk, and is a very low risk to human health (no forever chemicals). 21. C12a - Fluoroelastomers for seals 21.1. Text for derogation 21.1.1. Fluoroelastomers (including perfluoroelastomers), fluorosilicone, and amorphous fluoro resins as a sealing material in situations requiring Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 50 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 chemical resistance, oil resistance, oxidation resistance, decompression 21.2. resistance, high temperature (over 150C), or low temperature (<-20C). Alternative text 21.2.1. Fluoroelastomers - FKM (including perfluoroelastomers - FFKM), 21.3. fluorosilicone, and amorphous fluoro resin as a sealing material. Use and Functionality 21.3.1. Fluoroelastomers (and similar materials) are important chemical resistant sealing materials for environments requiring acid resistance, alkali resistance, water resistance, oil resistance, and/or high temperature performance. 21.3.2. Without sealing materials that can function in these harsh environments, there is a strong risk for equipment or product failure and shorter periods between required servicing.. 21.3.3. Fluoroelastomer seals are used in a very wide range of applications including oil and gas, electronics, medical devices, laboratory equipment, and any other application that requires a rubber seal with strong temperature resistance. 21.3.4. Note 1 - fluoroelastomers are commonly called FKM from their ASTM standard, or by a common trade name of `Viton'. 21.3.5. Note 2 - perfluoroelastomers are commonly called FFKM from their ASTM standard, or by a common trade name of `Kalrez'. 21.4. Substitutes / Alternatives 21.4.1. No other rubbers have equivalent hydrophobic and oleophobic properties, oxidation resistance, and chemical safety over a range of low and high temperatures as fluoroelastomers. Fluoroelastomers are also very resistant to explosive decompression. 21.4.2. Fluoroelastomer use can extend product life/service intervals thereby reducing potential chemical releases/exposures. Alternative materials would need to be replaced monthly, as they begin to leak. 21.4.3. PTFE has similar environmental properties, but is a plastic and is not suitable for applications requiring the conformity of a `rubber' seal. Fluoroelastomers also have a higher coefficient of friction than PTFE and create a superior `seal' in most applications. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 51 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 21.4.4. See Claigan PFAS Submission #4 - for a detailed list of specific performance advantages of fluoroelastomers, perfluoroelastomers, and fluorosilicones. 21.5. Forever Chemicals 21.5.1. Any approval of fluoroelastomers or perfluoroelastomers will need approval of 6:2 FTS fluorotelomer sulfonates (and substances that degrade into 6:2 FTS), and approval of a low concentration of short chain perfluorocarboxylates that degrade from 6:2 FTS (C4 to C7 perfluorocarboxylates). Additionally, approval will be required for low concentrations of residual bisphenol AF crosslinking additives. 21.5.2. A separate derogation for the necessary fluoroadditives from the manufacturing process of fluoroelastomers and perfluoroelastomers is included in a separate derogation request. 21.6. Number of companies affected 21.6.1. 10,000+ companies 21.7. Annual Tonnage 21.7.1. 10,000+ tons per annum. 21.8. Timeline Requested 21.8.1. 13.5 years - No suitable replacements, specialized uses, and replacement creates a safety risk. 22. C12b - Fluoroelastomers for seals in water and food contact 22.1. Text for derogation 22.1.1. Fluoroelastomers (including perfluoroelastomers), fluorosilicone, and amorphous fluoro resins as a sealing material for drinking water or food 22.2. contact if compliant with EU drinking water directives and regulations. Alternative text 22.2.1. N/A Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 52 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 22.3. Use and Functionality 22.3.1. Fluoroelastomers (and similar materials) are important chemical resistant sealing materials for drinking water equipment and food processing equipment. 22.3.2. Public, residential and industrial water supply systems are typically designed for long life (at least several decades) and access for maintenance and repair is limited. Components in particular have to meet high mechanical requirements such as sliding or sealing must function trouble-free for a long time without maintenance. The inherent stability of fluoropolymers also reliably prevents harmful substances from migrating into drinking water. Drinking water components are certified to ACS, DVGW and DWI (as well as others), which require testing for chemical substance migration and cytotoxic parameters as well as functionality within the product. Water treatment protects people and the environment every day. The known water treatment methods have proven to be energy efficient and reliable, but are directly dependent on the use of fluoropolymers. These are used, dismantled and disposed of by professional personnel. 22.3.3. The recast EU drinking water directive regulates the sum of PFAS in drinking water at 0.1 ug/L PFAS. This regulation would effectively restrict perfluorocarboxylates and perfluorosulfonates that could be present in 22.4. fluoroelastomers. Substitutes / Alternatives 22.4.1. No other rubbers have equivalent hydrophobic and oleophobic properties, UV resistance, and chemical safety over a range of temperatures as fluoroelastomers. 22.4.2. The most common alternatives are not chemically compatible for direct contact for long exposure time (years). 22.4.3. PTFE has similar environmental properties, but is a plastic and is not suitable for applications requiring the conformity of a `rubber' seal. Fluoroelastomers also have a higher coefficient of friction than PTFE and create a superior `seal' in most applications. 22.4.4. See Claigan PFAS Submission #4 - for a detailed list of specific performance advantages of fluoroelastomers, perfluoroelastomers, and fluorosilicones. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 53 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 22.5. Forever Chemicals 22.5.1. None would be allowed. All applicable forever chemicals would be restricted under EU drinking water regulation. 22.5.2. The separate derogation request for 6:2 FTS, perfluorocarboxylates, and bisphenol AF would not be applicable to these materials if not in compliance with the PFAS restrictions of the recast EU drinking water regulation. 22.6. Number of companies affected 22.6.1. 100 to 1,000 companies 22.7. Annual Tonnage 22.7.1. 10 to 100 tons per annum. 22.8. Timeline Requested 22.8.1. 13.5 years - No suitable replacements, and hazardous PFAS strictly regulated in these materials by the recast EU drinking water regulation. 23. C13 - PTFE tape for sealing 23.1. Text for derogation 23.1.1. PTFE tape for moisture insulation, or joining of fluid or gas components. 23.2. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates for 6.5 years Alternative text 23.2.1. N/A 23.3. Use and Functionality 23.3.1. PTFE tape is one of the most commonly used sealing materials for fluid or gas components. PTFE tape is hydrophobic and oleophobic, providing strong resistance to any fluid or gas it is sealing against. 23.3.2. PTFE tape has more of a rubber-like property than standard PTFE and is useful in applications that require conforming and sealing uneven features (such as pipe threads). 23.3.3. PTFE tape is used in a wide range of consumer, professional, industrial, and medical applications requiring a seal from moisture (on an uneven surface), or joining of fluid or gas components. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 54 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 23.3.4. PTFE tape is also used to reduce the friction between moving parts, but 23.4. that application is different and is listed in a separate derogation. Substitutes / Alternatives 23.4.1. No other tape materials have the same hydrophobic and oleophobic properties as PTFE tape. 23.5. Forever Chemicals 23.5.1. The majority of extruded PTFE tape contains a concentration of ~100 ppb of each of the perfluorocarboxylates (PFOA family). The source of perfluorocarboxylates in PTFE tape is not clear, but is present in the majority of PTFE tapes. The likely source is irradiation of the original PTFE powder to `rubberize' the PTFE to make it easier to extrude and calender into tape. Irradiation of the initial powder would produce low concentrations of each perfluorocarboxylate chain length as fragments fracture by radiation from the original long polymer chain reacting with oxygen forming perfluorocarboxylates. 23.5.2. Extruded PTFE tape can be manufactured without perfluorocarboxylates, but it is so prevalent (even with the current EU POP and REACH restrictions for long chain perfluorocarboxylates) that it will take time to replace all of its uses in products. 23.5.2.1. To allow for the time it will take to identify which tapes contain perfluorocarboxylates, replace the materials, and requalify the products - a phase in period of 6.5 years is recommended for the complete removal of perfluorocarboxylate in PTFE tape. 23.5.2.2. Note - the cause of the generation of perfluorocarboxylates is related to the manufacturing process, and not expected to further increase with time as PTFE does not have a structure conducive to degradation into perfluorocarboxylates. 23.6. Number of companies affected 23.6.1. 10,000+ companies 23.7. Annual Tonnage 23.7.1. 100-1,000 tons per annum. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 55 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 23.8. Timeline Requested 23.8.1. 13.5 years (PTFE Tape) - No suitable replacements, specialized uses, does not require forever chemicals, and replacement creates a safety risk. 23.8.2. 6.5 years (perfluorocarboxylates in PTFE tape up to 2 ppm) - The use of long chain fluorocarboxylated PTFE tape is very common in all levels of products and will take time to replace and requalify the products involved. 24. C13b - PTFE Tape for Friction Reduction 24.1. Text for derogation 24.1.1. PTFE tape for reduction of friction. Maximum of 2ppm of C4-C14 24.2. perfluoroalkyl carboxylates for 6.5 years Alternative text 24.2.1. N/A 24.3. Use and Functionality 24.3.1. PTFE tape is used to reduce friction between moving parts. 24.3.2. PTFE tape conforms easily to uneven surfaces and is needed for applications on imperfect surfaces. PTFE tape has more of a rubber-like property than standard PTFE and is useful in applications that require conforming and sealing uneven features. 24.3.3. PTFE tape for friction reduction is used in a wide range of consumer, professional, industrial, and medical applications requiring low friction between two or more components. 24.3.4. PTFE tape is also used to seal fluid and gas components, but that 24.4. application is different and is listed in a separate derogation. Substitutes / Alternatives 24.4.1. No other tape materials have as low friction as PTFE tape and the ability to conform to uneven surfaces. 24.4.2. Replacement of PTFE tape in a low friction application will affect product performance issues and reduced lifetime of the product - causing earlier disposal or replacement of the product using the PTFE tape. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 56 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 24.5. Forever Chemicals 24.5.1. The majority of extruded PTFE tape contains a concentration of ~100 ppb of each of the perfluorocarboxylates (PFOA family). The source is not clear, but contained in the majority of PTFE tapes. The likely source is irradiation of the original PTFE powder to `rubberize' the PTFE to make it easier to extrude and calender into tape. Irradiation of the initial powder would produce low concentrations of each perfluorocarboxylate chain length as fragments fracture by radiation from the original long polymer chain react with oxygen forming perfluorocarboxylates. 24.5.2. Extruded PTFE tape can be manufactured without perfluorocarboxylates, but it is so prevalent (even with the current EU POP and REACH restrictions for long chain perfluorocarboxylates) that it will take time to replace all of its uses in products. 24.5.2.1. To allow for the time it will take to identify which tapes contain perfluorocarboxylates, replace the materials, and requalify the products - a phase in period of 6.5 years is recommended for the complete removal of perfluorocarboxylate in PTFE tape. 24.5.2.2. Note - the cause of the generation of perfluorocarboxylates is related to the manufacturing process, and not expected to further increase with time as PTFE does not have a structure conducive to degradation in to perfluorocarboxylates. 24.6. Number of companies affected 24.6.1. 1,000 - 10,000 companies 24.7. Annual Tonnage 24.7.1. 100-1,000 tons per annum. 24.8. Timeline Requested 24.8.1. 13.5 years (PTFE Tape) - No suitable replacements, specialized use, does not require forever chemicals, and replacement creates a product lifetime reduction. 24.8.2. 6.5 years (perfluorocarboxylates in PTFE tape up to 2 ppm) - The use of long chain fluorocarboxylated PTFE tape is very common in all levels of products and will take time to replace and requalify the products involved. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 57 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 25. C14 - Fluorosilicone release paper 25.1. Text for derogation 25.1.1. Fluorosilcone release paper and residual fluorosilicone on adhesive 25.2. products. Alternative text 25.2.1. N/A 25.3. Use and Functionality 25.3.1. Fluorosilicone release paper is the most commonly used backing paper for stickers or similar materials. 25.3.2. This derogation includes fluorosilicone release paper and potential residue from the fluorosilicone release paper on the back of stickers (retention by the adhesive contacting the release paper). 25.3.3. Fluorosilicone has very low friction (and therefore adhesion) allowing stickers and other parts with adhesive to be placed on a roll or sheet to be peeled off for application. 25.3.4. Some fluorosilicone seems to remain adhered to the sticker adhesive, and is measurable above 100 ppm fluorine in the adhesive. As long as fluorosilicone release paper is allowed, it also needs to be allowed as a residual in the adhesive of stickers or similar parts such as silicone thermal pads in electronics. 25.3.4.1. Note - it is possible that, in some cases, the residual fluorine is from a fluorobased surfactant used to reduce the surface tension and improve the adhesion. Work is ongoing to separate the two 25.4. uses as they look virtually identical with standard test methods. Substitutes / Alternatives 25.4.1. Fluorosilicone release paper can be replaced by a number of materials including silicone (non-fluorinated) release paper, but fluorosilicone release paper is so common that it will take time for all the uses (in particular contamination of the adhesive of stickers) to be replaced. 25.5. Forever Chemicals 25.5.1. No fluorinated forever chemicals expected. Fluorosilicone does not normally contain perfluorocarboxylates and perfluorosulfonates, and do not Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 58 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 have a structure expected to degrade into fluorinated forever chemicals over time. 25.5.2. The base silicone polymer is a risk for D4, D5, and D6 forever chemical like any siloxane based silicone rubber. Fluorosilicone release paper (and its silicone replacement) are at risk of being regulated for residual D4, D5, and D6 forever chemicals. 25.6. Number of companies affected 25.6.1. 10,000+ companies 25.7. Annual Tonnage 25.7.1. 10 - 100 tons per annum. 25.8. Timeline Requested 25.8.1. 6.5 years - Can be replaced by other materials, but it will take time to replace all of its uses and its residual content in sticker adhesives for stickers that were originally on fluorosilicone release paper. 26. C16 - Fluorocoating of seals 26.1. Text for derogation 26.1.1. Fluorocoating of rubber, metal, and plastic seals in professional or industrial applications where chemical resistance or reduced friction is 26.2. required Alternative text 26.2.1. N/A 26.3. Use and Functionality 26.3.1. Standard rubber seals (of nitrile, silicone, or SBR rubber) or metal seals do not have the low friction properties or chemical resistance of PTFE. 26.3.2. Fluorocoating or encapsulation of rubber, such as nitrile rubber, provides chemical resistance to the rubber that the rubber does not normally possess and provides a reduced friction to the rubber. 26.3.3. Fluorocoating of metals provides a similar reduced friction and chemical resistance. For example, steel (even stainless steel) is vulnerable to Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 59 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 acids and has very high friction. A fluorocoating protects the metal seals from environmental conditions. 26.3.4. Fluorocoated rubber is very common in medical and pharmaceutical applications including plungers / stoppers in syringes. Fluorocoated metal seals are rarer, but requirements in professional applications 26.4. require acid resistance or other environmental resistance. Substitutes / Alternatives 26.4.1. No other coating material provides the same environmental protection to rubber and metal seals. 26.5. Forever Chemicals 26.5.1. None expected. No fluorinated forever chemical above 25 ppb is expected in the coated. 26.6. Number of companies affected 26.6.1. 1,000-10,000 companies 26.7. Annual Tonnage 26.7.1. 10 - 100 tons per annum. 26.8. Timeline Requested 26.8.1. 13.5 years - No suitable replacements, specialized uses, and low risk to human health. 27. C17 - PTFE/PFA coating of metal for environmental resistance 27.1. Text for derogation 27.1.1. PTFE and PFA coating of metal for environmental or temperature 27.2. resistance not in contact with food or drinking water Alternative text 27.2.1. N/A 27.3. Use and Functionality 27.3.1. PTFE and PFA have excellent acid, alkali, water, and oil resistance. Many metals do not have good acid, water, or alkali resistance. PTFE or PFA coating of the metal improves the environmental resistance of the metal. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 60 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 27.3.2. PTFE coatings are also used on metal parts in marine environments to protect against environmental (salt) and chemical corrosion. They can also reduce friction/power consumption, provide anti-galling properties, and other wear related issues. 27.3.3. Improved environmental resistance is needed for metals likely to be exposed to outdoor or chemical conditions (in particular at higher temperatures). 27.3.4. This derogation request is for uses not in contact with food or drinking water. Related coatings are handled under a separate derogation. 27.4. Substitutes / Alternatives 27.4.1. No other coating materials provide the same environmental protection to metals. 27.4.2. Replacement PTFE and PFA environmental coatings for metals will reduce the corrosion resistance (in particular over temperature) of many metals resulting in failure of these metals and/or reduced product lifetime (resulting in more products entering end of life disposal sooner). 27.5. Forever Chemicals 27.5.1. None expected in fused PTFE nor is PTFE expected to degrade into forever chemicals. 27.5.2. PFA often (but not always) contains perfluorocarboxylates and further degrades into perfluorocarboxylates (PFOA family). The presence and degradation potential is covered under a separate derogation request for perfluorocarboxylates in PFA. 27.6. Number of companies affected 27.6.1. 1,000-10,000 companies 27.7. Annual Tonnage 27.7.1. 10 - 100 tons per annum. 27.8. Timeline Requested 27.8.1. 13.5 years - No suitable replacements, specialized uses, does not include food or drinking water applications, and is low risk to human health. 27.8.1.1. Note - the potential for perfluorocarboxylates in PFA is addressed in another derogation request in this report and is unlikely to be needed in the long term. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 61 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 28. C18 - Fluorocoating of metal for wear resistance 28.1. Text for derogation 28.1.1. PTFE, FEP, and PFA coating of metal for low friction and wear resistance 28.2. in machinery or tools Alternative text 28.2.1. N/A 28.3. Use and Functionality 28.3.1. Most metals have very high coefficients of frictions. Metal components in a potential friction situation with another metal have reduced functionality and greatly increased wear. 28.3.2. Examples include gears and shafts in machinery, but can involve any applications with moving metals parts. 28.3.3. Coating (as opposed to lubrication) of metal parts provides much longer 28.4. (less temporary) wear resistance than lubrication alone. Substitutes / Alternatives 28.4.1. No other coating materials provide equivalent reduced friction as PTFE or PFA for metals. 28.4.2. Replacement PTFE, FEP, and PFA environmental coatings will greatly reduce the performance of some machinery, increase wear, and reduce lifetimes on metal components. 28.4.3. Liquid lubricants can be used, but they are temporary in nature, and the most effective lubricants for low friction in metal parts contain PTFE powder and are covered by another derogation request. 28.5. Forever Chemicals 28.5.1. None expected in fused PTFE (or FEP) nor is PTFE (or FEP) expected to degrade into forever chemicals. 28.5.2. PFA often (but not always) contains perfluorocarboxylates and further degrades into perfluorocarboxylates (PFOA family). The presence and degradation potential is covered under a separate derogation request for perfluorocarboxylates in PFA. 28.6. Number of companies affected 28.6.1. 10,000+ companies Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 62 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 28.7. Annual Tonnage 28.7.1. 10 - 100 tons per annum. 28.8. Timeline Requested 28.8.1. 13.5 years - No suitable replacements, specialized uses, extends the lifetime of products, and is low risk to human health. 28.8.1.1. Note - the potential for perfluorocarboxylates in PFA is addressed in another derogation request in this report and is unlikely to be needed in the long term. 29. C19 - Fluoropolymers in hoses 29.1. Text for derogation 29.1.1. PTFE, PFA, FEP, and TFE copolymers in hoses in chemical, pump, or 29.2. valve applications. Alternative text 29.2.1. N/A 29.3. Use and Functionality 29.3.1. PTFE (and similar fluoropolymers such as PFA, FEP, and TFE copolymers) provide a wide range of chemical resistances to hoses (including braided hose) to transport chemicals. 29.3.1.1. This derogation request is for hoses and similar that require chemical resistance. Fluoropolymer tubing, which does not normally transport chemicals, is covered under a separate derogation request. 29.3.2. PTFE based polymers are acid resistant, alkali resistant, oil resistant, and can withstand high temperatures. In equipment that may have to transport corrosive or similar liquids (or gasses), PTFE related fluoropolymers provide the necessary functionality. 29.3.3. PTFE hoses have exceptional chemical compatibility, resistance to moisture and temperature, and handle high pressures. 29.3.4. Without PTFE based hoses, safe chemical handling in the EU will no longer be possible. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 63 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 29.4. Substitutes / Alternatives 29.4.1. No other polymer that can be formed into hoses or braided to transport chemicals, or having the resistance to the same range of chemicals and temperatures. 29.4.2. See Claigan PFAS Submission #4 - Comparison of Alternatives - for a detailed list of specific performance advantages of PTFE based polymers over other potential polymers. 29.5. Forever Chemicals 29.5.1. None expected in unirradiated PTFE, FEP, or TFE based copolymers. 29.5.2. PFA often (but not always) contains perfluorocarboxylates and further degrades into perfluorocarboxylates (PFOA family). The presence and degradation potential is covered under a separate derogation request for perfluorocarboxylates in PFA. 29.6. Number of companies affected 29.6.1. 10,000+ companies 29.7. Annual Tonnage 29.7.1. 1,000+ tons per annum. 29.8. Timeline Requested 29.8.1. 13.5 years - No suitable replacements, specialized uses, and is necessary for the processing of chemicals in the EU. 29.8.1.1. Note - the potential for perfluorocarboxylates in PFA is addressed in another derogation request in this report and is unlikely to be needed in the long term. 30. C20 - Fluoropolymers in/on labels 30.1. Text for derogation 30.1.1. Fluorocoatings on labels of products (excluding textiles) necessary for environmental resistance. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 64 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 30.2. Alternative text 30.2.1. N/A 30.3. Use and Functionality 30.3.1. Paper and polyester labels degrade in weather conditions such as rain, sun, or humidity. 30.3.2. By fluorocoating the surface of the label, the label can resist water, oil, and other environmental conditions. In many cases, these labels contain safety information that would create safety issues if subject to aging. 30.3.3. Fluorocoated labels are used in a wide range of applications including outdoor products, but can include an electronic product that requires the 30.4. label to withstand humidity and high temperature (such as a hard drive). Substitutes / Alternatives 30.4.1. Most polymers do not have the water resistance and oil/stain resistance of fluoropolymers. 30.4.1.1. PVC has nearly equivalent water and oil resistance, but has risks of other regulated substances (such as phthalates) and does not withstand temperature ranges as well as fluoropolymers. 30.5. Forever Chemicals 30.5.1. None expected. 30.5.1.1. This does not include fluoroacrylic coatings that would create perfluorocarboxylates (PFOA family) regulated under POP or REACH. 30.6. Number of companies affected 30.6.1. 10,000+ companies 30.7. Annual Tonnage 30.7.1. 10 - 100 tons per annum. 30.8. Timeline Requested 30.8.1. 13.5 years - No suitable replacements, require for safety warnings on products, and does not provide a risk to human health. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 65 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 31. C21 - Fluoropolymers tubing 31.1. Text for derogation 31.1.1. PTFE, PFA, FEP, PVDF, ETFE, and fluoroelastomer (including perfluoroelastomer) tubing not intended for drinking water. Maximum of 31.2. 2ppm of C4-C14 perfluoroalkyl carboxylates Alternative text 31.2.1. Two (2) derogations 31.2.1.1. PTFE, PFA, FEP, ETFE, and PVDF tubing not in contact with drinking water. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates 31.2.1.2. Fluoroelastomer tubing not in contact with drinking water. 31.2.2. Fluoroelastomers have a separate perfluorosulfonate risk from the 31.3. irradiated PTFE/PVDF or PFA perfluoroalkyl carboxylate risk. Use and Functionality 31.3.1. PTFE (and similar) tubing is used in a very wide range of applications either to transport fluid or to provide protection to another material. 31.3.2. PTFE tubing is common for fluid transportation in laboratory and medical equipment. Fluoropolymer tubing is non-reactive with virtually all fluids and does not affect the quality of the liquid or gas being transported. 31.3.3. Fluoropolymer tubing is widely used in electronics to protect wiring or other components. This tubing is not specifically wire insulation, but it is commonly used in tube or heat shrink form in applications requiring high temperature resistance. For example - the leads of most transformers in electronics are protected by PTFE tubes. 31.3.4. PTFE, PFA, FEP, ETFE, and PVDF are all used in tubing applications but each has a separate advantage for specific applications. PTFE is only for tubing with less flexibility requirements. PVDF is used in applications requiring a lower density than PTFE. PFA, FEP, ETFE, and fluoroelastomers are used in chemical environments specific to their performance advantages (PFA - flexibility and chemical resistance. FEP - complex shapes. ETFE - high tension applications. Fluoroelastomers - 31.4. high flexibility environment). Substitutes / Alternatives 31.4.1. No other polymer is as effective as a tubing material in applications in either 31.4.1.1. High temperature applications (electronics) or Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 66 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 31.4.1.2. Transportation of fluid and gasses (with no reactivity with the transported fluids). 31.4.2. Polyurethane and PVC tubing can be used in some applications, but have poor resistance to acids and bases, can release chemicals (isocyanates or phthalates) into the fluid, and have poor temperature stability. 31.5. Forever Chemicals 31.5.1. PTFE and PVDF tubing is often irradiated, in particular if used as heat shrink. 31.5.1.1. Irradiated PTFE and PVDF will contain a range of perfluorocarbooxylates up to a maximum of ~2 ppm C4-C14 perfluorocarboxylates. These perfluorocarboxylates are created during the irradiation process of the powder for the tubing and are not expected to further degrade into additional perfluorocarboxylates. 31.5.2. PFA often (but not always) contains perfluorocarboxylates because of its weak C-O-C side chain bond. The majority of PFA polymers (but not all as a shorter side chain will not produce the measurable perfluorocarboxylates) contain up to ~2 ppm perfluorocarboxylates. 31.5.3. Fluoroelastomers normally contain short chain fluorosalts such as 6:2 FTS and C4 to C7 perfluorocarboxylates. This is related to a necessary processing aid in their emulsion manufacturing process. The details are covered under a separate derogation request. 31.6. Number of companies affected 31.6.1. 10,000+ companies 31.7. Annual Tonnage 31.7.1. 100 to 1,000 tons per annum. 31.8. Timeline Requested 31.8.1. 13.5 years - No suitable replacements, required for fluid transport or temperature performance reasons, substitution would affect the majority of electronics on the EU market, and not in contact with drinking water. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 67 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 32. C22 - Heat transfer fluids 32.1. Text for derogation 32.1.1. Heat transfer fluids for industrial applications 32.2. Alternative text 32.2.1. Heat transfer fluids for professional and industrial applications 32.3. Use and Functionality 32.3.1. Fluoro heat transfer liquids are used in a range of industrial applications to transport the heat from part of the machinery or equipment to another. 32.3.2. Fluoro heat transfer fluids are commonly used in semiconductor manufacturing, data centers, and in the military/aerospace industry. 32.3.3. These applications are very specialized with tremendous heat generation 32.4. / transfer requirements. Substitutes / Alternatives 32.4.1. No other fluids have equivalent heat capacity to transfer heat sufficiently in machinery. Replacement with other fluids would create safety and performance issues in industrial applications such as semiconductor manufacturing, data centers, and military/aerospace. 32.5. Forever Chemicals 32.5.1. None expected. Fluoro heat transfer fluids are commonly built on chemical structures of F, C, and N without the oxygen bonds that degrade into perfluorocarboxylates. 32.6. Number of companies affected 32.6.1. 100 to 1,000 companies 32.7. Annual Tonnage 32.7.1. 100 to 1,000 tons per annum. 32.8. Timeline Requested 32.8.1. 13.5 years - No suitable replacements, specialized industrial applications, low exposure to the public, and no expectation of forever chemicals. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 68 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 33. C23a - PVDF and PTFE in batteries 33.1. Text for derogation 33.1.1. PVDF and PTFE as the cathode binder in lithium batteries 33.2. Alternative text 33.2.1. Fluoropolymers in lithium batteries 33.3. Use and Functionality 33.3.1. Fluoropolymers (primarily PVDF) are the standard binding agent in lithium batteries. 33.3.2. The cathode binder in lithium ion batteries is commonly PVDF and necessary for the functioning of high density lithium batteries. 33.3.3. Lithium batteries with fluoropolymer binders are used in virtually every lithium battery application from electric vehicles, to portable batteries, to 33.4. medical and life safety devices. Substitutes / Alternatives 33.4.1. No other polymer has the temperature resistance and chemical resistance of fluoropolymers. Other polymers could not maintain the rigorous performance requirements of a binder in a high density lithium battery. 33.4.2. Pb acid batteries have similar performance to lithium batteries, but can release Pb at the end of life and have a weight that makes them unusable for mobile applications including electrical vehicles. 33.5. Forever Chemicals 33.5.1. None expected. Unirradiated PVDF and PTFE does not contain perfluorocarboxylates and does have the C-O-C bond that leads to degradation of perfluorocarboxylates with time. 33.6. Number of companies affected 33.6.1. 10,000+ companies 33.7. Annual Tonnage 33.7.1. 1,000+ tons per annum. 33.8. Timeline Requested 33.8.1. 13.5 years - No suitable replacements, fundamental to mobile electronics, and necessary for electric vehicles. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 69 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 34. C23b - Fluoropolymers in capacitors 34.1. Text for derogation 34.1.1. PVDF, PTFE, TFE, and sulfonated PTFE as a binder or spacer in 34.2. capacitors Alternative text 34.2.1. Fluoropolymers in capacitors 34.3. Use and Functionality 34.3.1. High performance capacitors, in particular ultra/super capacitors, require fluoropolymers as either a binder, or as an electric insulator in capacitors. 34.3.2. Fluorobinders in high performance capacitors enable the energy density required in compact / dense electronics. 34.3.3. Fluoropolymers have electric insulation performance that separates different elements of the capacitor. 34.3.4. Fluoropolymer binders and spacers are common in capacitors and are 34.4. used in a wide range of electronic products. Substitutes / Alternatives 34.4.1. No other polymer has the temperature resistance and dielectric insulation properties of fluoropolymers. 34.5. Forever Chemicals 34.5.1. None expected. Unirradiated PVDF and PTFE does not contain perfluorocarboxylates and does have the C-O-C bond that leads to degradation of perfluorocarboxylates with time. 34.6. Number of companies affected 34.6.1. 10,000+ companies 34.7. Annual Tonnage 34.7.1. 100 to 1,000 tons per annum. 34.8. Timeline Requested 34.8.1. 13.5 years - No suitable replacements, temperature and electrical insulation advantages over other materials, fundamental to electronics, and similar to the necessary fluoropolymers in lithium batteries. 35. C24 - Lubrication of internal wires 35.1. Text for derogation 35.1.1. PTFE and fluorosilicone lubricants for internal wires Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 70 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 35.2. Alternative text 35.2.1. Fluoro lubricants for internal wires 35.3. Use and Functionality 35.3.1. Hookwires inside cables are commonly lubricated with either a fluorosilicone or PTFE lubricant. 35.3.2. Lubrication of the internal wires reduces friction and wear of the cable, improving the flexibility and lifetime of the cable. Hookup wires inside cables have fluoro lubricants on their hook wires in roughly 25% of cables. 35.3.2.1. See Claigan PFAS Submission #1 - PFAS in Articles for further details. 35.3.3. The amount of lubricant on a wire is ~100 ppm fluorine. 35.3.4. Note - in some cases the fluoro lubricants on the hookup / internal wires are from fluoro lubricants on the manufacturing equipment and may not be present intentionally. 35.4. Substitutes / Alternatives 35.4.1. Fluoro lubricants, except in high temperature environments, are replaceable lubricants. 35.4.2. Note - in some cases the fluoro lubricants on the hookup / internal wires are from fluoro lubricants on the manufacturing equipment and may not be present intentionally. 35.5. Forever Chemicals 35.5.1. None expected. The trace amount of fluoro lubricant on a wire ~ 100 ppm and no forever chemicals would be measurably present in the wire. 35.6. Number of companies affected 35.6.1. 10,000+ companies 35.7. Annual Tonnage 35.7.1. 10 to 100 tons per annum. 35.8. Timeline Requested 35.8.1. 6.5 years - Substitutes are readily available but the use is so common (~25% of all cables) that it will take years to identify and replace all the occurrences. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 71 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 36. C25 - Surfactant in assays 36.1. Text for derogation 36.1.1. Surfactants in emulsion based bio-assays and dry-chemistry assays 36.2. Alternative text 36.2.1. Surfactants in laboratory assays 36.3. Use and Functionality 36.3.1. Fluoro based surfactants are commonly used as the surfactants in specialized bio-assays and dry chemistry assays. 36.3.2. Fluoro based surfactants are useful for membrane protein stabilization in subsequent purification steps as they do not strip natural lipids and other co-factors from the proteins. In addition, the bulky fluorinated tails can not penetrate into the interior and disrupt structure. Fluorinated surfactants often decrease non-specific aggregation and are thought to result in improved distribution. 36.3.3. Without fluoro based surfactants, many specialized laboratory or medical measurements would not be possible or, at least, not with the same accuracy. 36.4. Substitutes / Alternatives 36.4.1. Replacement of fluoro-based surfactants would take years of research and validation, and - in many cases - not be possible. 36.5. Forever Chemicals 36.5.1. The fluorosurfactants would commonly degrade into perfluorocarboxylates or perfluorosulfonates, depending on their structure. 36.6. Number of companies affected 36.6.1. 10 to 100 companies 36.7. Annual Tonnage 36.7.1. 0 - 10 tons per annum. 36.8. Timeline Requested 36.8.1. 13.5 years - A very technical and highly specialized use. Replacement would take years of research and validation, and would likely reduce test performance and have little health advantage to society. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 72 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 37. C26 - PTFE Coating of Rubber for Biotechnology 37.1. Text for derogation 37.1.1. PTFE foil coating of rubber for biotechnology or chromatography 37.2. purposes Alternative text 37.2.1. Fluoropolymer coatings for biotechnology or chromatography purposes 37.3. Use and Functionality 37.3.1. Fluorocoating of rubber for biotechnology or chromatography is common to provide the low reactivity / low friction of PTFE to rubber. 37.3.2. This application is similar in nature to fluorocoating of rubber seals for medical and pharmaceutical purposes, but this derogation request includes applications of rubber in biotechnology and chromatography beyond rubber seals. 37.3.3. Chromatography and biotechnology require low reactivity of materials, and a PTFE coating imparts chemical and resistance, and biocompatibility to silicone or nitrile rubber. 37.4. Substitutes / Alternatives 37.4.1. No other polymer has as low reactivity and low friction as PTFE. Specialized biotechnology or chromatography applications require the highest possible performance for measurement accuracy and consistency. 37.5. Forever Chemicals 37.5.1. None expected. Unirradiated PTFE does not contain perfluorocarboxylates (PFOA family) and is not expected to degrade over time into perfluorocarboxylates. 37.6. Number of companies affected 37.6.1. 10 to 100 companies 37.7. Annual Tonnage 37.7.1. 0 - 10 tons per annum. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 73 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 37.8. Timeline Requested 37.8.1. 13.5 years - A very technical and highly specialized use. Replacement would take years of research and validation, and would likely reduce test performance and have little health advantage to society. 38. C27 - Products for Training or Simulation 38.1. Text for derogation 38.1.1. Products used for education or training purposes may use derogations applicable to products they are simulating. 38.2. Alternative text 38.2.1. N/A 38.3. Use and Functionality 38.3.1. Professional, medical, industrial, military, and aerospace applications often have simulators or other training aids to train or familiarize users with specific tasks. 38.3.2. The simulator or training aid may not be technically classified as a medical device or aerospace product, but it should be able to use any derogations available to the product it is simulating. 38.3.3. If a simulator or training aid is unable to use the same materials as the product it is simulating, gaps in design and training are possible. For example, an aircraft `joystick' is made of PTFE, it would not make sense for the simulator's joystick to be made from another material because it does not benefit from a specific aircraft related derogation. 38.3.4. This is a very low volume but necessary usage. 38.4. Substitutes / Alternatives 38.4.1. The alternative is a different product design from the actual product from its simulator or training aid. 38.5. Forever Chemicals 38.5.1. None expected. Unirradiated PTFE does not contain perfluorocarboxylates (PFOA family) and is not expected to degrade over time into perfluorocarboxylates. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 74 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 38.6. Number of companies affected 38.6.1. 10 to 100 companies 38.7. Annual Tonnage 38.7.1. 0 - 10 tons per annum. 38.8. Timeline Requested 38.8.1. 13.5 years - A very low volume usage that does not reasonably change the volume of fluorochemical for any application as the simulator or training aid would generally be expected to be much lower volume than the application or product it is simulating. 39. C28 - Fluorinated polyethylene for chemical storage 39.1. Text for derogation 39.1.1. Fluorinated polyethylene for chemical storage and handling. Maximum of 39.2. 2ppm of C4-C14 perfluoroalkyl carboxylates Alternative text 39.2.1. Fluorinated polyethylene for chemical purposes. Maximum of 2ppm of 39.3. C4-C14 perfluoroalkyl carboxylates Use and Functionality 39.3.1. Polyethylene is not resistant to all types of chemicals. In laboratory or chemical environments, fluorinated polyethylene is used for the storage of chemicals. 39.3.2. Fluorinated polyethylene is polyethylene that has been exposed to fluorine gas. The fluorine gas replaces some of the hydrogens in polyethylene creating a fluorinated polyethylene. 39.3.3. Fluorinated polyethylene is a chemical and UV resistance version of polyethylene and is widely used as a container or vessel for chemical storage or transport. Most laboratories or universities have some fluorinated polyethylene containers. 39.4. Substitutes / Alternatives 39.4.1. PFA fluoropolymer has similar performance as fluorinated polyethylene, but is more flexible and not suitable for most applications of fluorinated polyethylene. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 75 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 39.4.1.1. PFA also often contains low concentrations of perfluorocarboxylates. 39.5. Forever Chemicals 39.5.1. Fluorinated polyethylene often contains a wide range of perfluorocarboxylates (PFOA family) due to the reaction of polyethylene and fluorine in an oxygen environment. Some of the polyethylene chains are fractured creating low concentrations of perfluorocarboxylates. 39.6. Number of companies affected 39.6.1. 100 to 1,000 companies 39.7. Annual Tonnage 39.7.1. 10 to 100 tons per annum. 39.8. Timeline Requested 39.8.1. 13.5 years - A very specialized usage with limited public exposure. Restricted to chemical handling and storage. Replacement would create a safety hazard for workers. 40. C29 - ePTFE seals 40.1. Text for derogation 40.1.1. ePTFE as a gasket / seal material in professional applications. Maximum of 5ppm of C4-C14 perfluoroalkyl carboxylates 40.2. Alternative text 40.2.1. ePTFE as a gasket / seal material. Maximum of 5ppm of C4-C14 perfluoroalkyl carboxylates 40.3. Use and Functionality 40.3.1. Expanded PTFE (ePTFE), like other fluoropolymers, is an excellent seal material for fluids. 40.3.2. ePTFE seals are listed as a separate derogation request as it commonly contains perfluorocarboxylates (PFOA family) and the derogation request is limited to professional uses. 40.3.3. At high and low temperatures such as industrial, commercial and even residential HVAC, refrigeration & cryogenic applications It is particularly Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 76 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 well suited for field service repairs due to its conformability and for applications requiring fast sealing/repeated use. 40.4. Substitutes / Alternatives 40.4.1. Other polymers do not have the chemical and temperature resistance or range of fluoropolymers. 40.4.2. ePTFE, unlike PTFE, is compressible and is useful for applications that require the performance of a fluoropolymer and compressibility. 40.5. Forever Chemicals 40.5.1. ePTFE commonly contains perfluorocarboxylates (PFOA family), likely from irradiation of the original powder to allow for expansion into a fibre. The perfluorocarboxylates are related to the manufacturing process, and ePTFE does not have the C-O-C bond that would lead to further degradation over time. 40.6. Number of companies affected 40.6.1. 100 to 1,000 companies 40.7. Annual Tonnage 40.7.1. 10 to 100 tons per annum. 40.8. Timeline Requested 40.8.1. 13.5 years - A specialized use for compressible fluoropolymer seals. Derogation requested is limited to professional applications that require specialized performance of ePTFE. 41. C31a - Fluoro acrylate side chain coatings for antismudge 41.1. Text for derogation 41.1.1. Fluoroacrylates for antismudge and antireflective coatings for plastics and glass. Maximum of 1ppm of C4-C6 perfluoroalkyl carboxylates. 41.2. Maximum of 1ppm of C7-C14 perfluoroalkyl carboxylates for 6.5 years Alternative text 41.2.1. N/A Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 77 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 41.3. Use and Functionality 41.3.1. Side chain fluoropolymers are fluoropolymers such as fluorosilicone or fluoroacrylates that have a backbone of a non-fluorinated polymer (such as silicone or acrylic) with a side chain connected fluoro chain. 41.3.2. A side chain fluoropolymer bonds with a glass or plastic using its backbone chain of silicone or acrylic, and imparts fluoropolymer properties to the material with the side chain fluoro chain. These coatings are available in both standard and nano-coating form. 41.3.3. Side chain fluoropolymers are used as anti-smudge, anti-fingerprint, and anti-reflective coatings on surfaces. 41.3.4. This derogation request is only for fluoroacrylate and excludes fabric using fluoro side chain polymers for environmental or other uses. 41.3.5. Fluorosilicone and similar nano-coatings for the same purpose are covered in a separate derogation request. 41.4. Substitutes / Alternatives 41.4.1. Other anti-fingerprint coatings exist, such as parylene, but they do not adhere to plastic substrates as effectively as fluoropolymer side chain polymers and have lower thermal stability. 41.4.2. Fluoroacrlates are generally replaceable with non perfluorocarboxylate containing fluorosilicones or nanofluoropolymers. 41.5. Forever Chemicals 41.5.1. Fluoroacrylates contain a range of perfluorocarboxylates due to the weak C-O-C bond between the fluoro side chain and the base acrylic polymer. Fracturing of that bond during manufacturing and over time creates perfluorocarboxylates (PFOA family). 41.5.2. Fluorosilicones side chains are not attached to the base silicone polymer with weak C-O-C bonds, do not normally degrade into perfluorocarboxylates, and are covered under a separate derogation reqeust 41.5.3. Fluoro acrylate polymers are very commonly used, and a phase out is required. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 78 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 41.6. Number of companies affected 41.6.1. 1,000 to 10,000 companies 41.7. Annual Tonnage 41.7.1. 10 to 100 tons per annum. 41.8. Timeline Requested 41.8.1. 6.5 years (long chain perfluorocarboxylates) - widely used but replaceable with nonperfluorocarboxylate (non-PFOA family) contains fluorosilicones and nanocoatings. 42. C31b - Fluorosilicone and nano fluoro coatings for antismudge 42.1. Text for derogation 42.1.1. Fluorosilicone and nano-fluorocoatings for antismudge and antireflective 42.2. coatings for plastics and glass. Alternative text 42.2.1. N/A 42.3. Use and Functionality 42.3.1. Side chain fluoropolymers are fluoropolymers such as fluorosilicone or fluoroacrylates that have a backbone of a non-fluorinated polymer (such as silicone or acrylic) with a side chain connected fluoro chain. 42.3.2. A side chain fluoropolymer bonds with a glass or plastic using its backbone chain of silicone or acrylic, and imparts fluoropolymer properties to the material with the side chain fluoro chain. These coatings are available in both standard and nano-coating form. 42.3.3. Side chain fluoropolymers are used as anti-smudge, anti-fingerprint, and anti-reflective coatings on surfaces. 42.3.4. This derogation request is only for fluorosilicone and nanofluorocoatings that do not contain perfluorocarboxylates (PFOA family) and do not degrade into perfluorocarboxylates. 42.3.5. Fluorosilicone and similar nano-coatings for the same purpose are covered in a separate derogation request. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 79 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 42.4. Substitutes / Alternatives 42.4.1. Other anti-fingerprint coatings exist, such as parylene, but they do not adhere to plastic substrates as effectively as fluoropolymer side chain polymers and have lower thermal stability. 42.5. Forever Chemicals 42.5.1. Fluoroacrylates contain a range of perfluorocarboxylates due to the weak C-O-C bond between the fluoro side chain and the base acrylic polymer. Fracturing of that bond during manufacturing and over time creates perfluorocarboxylates (PFOA family). 42.5.2. Fluorosilicones side chains are not attached to the base silicone polymer with weak C-O-C bonds, do not normally degrade into perfluorocarboxylates, and are covered under a separate derogation reqeust 42.5.3. Fluoro acrylate polymers are very commonly used, and a phase out is required. 42.6. Number of companies affected 42.6.1. 1,000 to 10,000 companies 42.7. Annual Tonnage 42.7.1. 10 to 100 tons per annum. 42.8. Timeline Requested 42.8.1. 13.5 years - widely used, very low concentration, not easily replaceable with other materials, and no forever chemicals. 43. C32a - Fluoropolymer seals and spacers 43.1. Text for derogation 43.1.1. PTFE, FEP, PCTFE, PVDF, and TFE (including copolymers) as a sealing or spacer material. 43.2. Alternative text 43.2.1. N/A Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 80 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 43.3. Use and Functionality 43.3.1. PTFE (and similar) polymers are commonly used as sealing materials in products. PTFE seals are used in fluid applications, gas applications, and applications requiring protection from humidity. 43.3.2. PTFE seals are very common in fluid and gas components due to their acid resistance, alkali resistance, oil resistance, temperature resistance, and low weight. Virtually all fluid or gas transportation or storage equipment (consumer or professional) has at least one fluoropolymer seal. 43.3.3. PTFE seals are common in electronics for humidity protection. Moisture sensitive equipment with high operating temperature, such as hard drives, commonly use fluoropolymer seals for humidity protection. 43.3.4. In addition, PTFE seals extend product life/service intervals thereby reducing potential fluid and gas releases/exposures. 43.3.5. This derogation is intended to include PTFE as the main sealing material or as a reinforcement to another sealing material. 43.4. Substitutes / Alternatives 43.4.1. Other polymers do not have the wide range of environmental resistance as fluoropolymers and do not have the temperature resistance necessary for dense electronics. 43.4.2. In most applications, alternative sealing materials were tested, and no materials and closure systems showed positive results. 43.5. Forever Chemicals 43.5.1. None expected. Unirradiated PTFE, FEP, PCTFE, PVDF, and TFE copolymers do not perfluorocarboxylates and do not have the C-O-C bond that would lead to degradation into perfluorocarboxylates over time. 43.6. Number of companies affected 43.6.1. 10,000+ companies 43.7. Annual Tonnage 43.7.1. 100 to 1,000 tons per annum. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 81 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 43.8. Timeline Requested 43.8.1. 13.5 years - Other polymers cannot meet the performance capability of fluoropolymer seals, replacement would introduce safety and performance risks to both fluid/gas applications and to electronics, replacement would reduce the life expectancy of electronics, and this usage has no expectation of perfluorocarboxylates being generated. 44. C32b - PFA seals 44.1. Text for derogation 44.1.1. PFA as a sealing or spacer material in professional applications. 44.2. Alternative text 44.2.1. PFA as a sealing or spacer material, or 44.2.2. Include PFA in the above PTFE (and similar) derogation 44.3. Use and Functionality 44.3.1. PFA seals are used in professional applications that require extreme chemical resistance or flexibility advantages not available with standard PTFE. 44.3.2. PFA seals are used in the food, chemical, and petrochemical industries in applications requiring resistance to cold-flow and compression or require an adaptive seal. 44.4. Substitutes / Alternatives 44.4.1. Other polymers do not have the wide range of environmental resistance as fluoropolymers and do not have temperature resistance necessary for dense electronics. 44.4.2. PTFE and similar fluoropolymers do not have the flexibility and adaptability of PFA. 44.5. Forever Chemicals 44.5.1. PFA commonly (but not always) has perfluorocarboxylates from fracturing of the side chain fluoro chain attached to the PFA fluoropolymer 44.5.2. A separate derogation request for perfluorocarboxylates is included in this report. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 82 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 44.6. Number of companies affected 44.6.1. 100 to 1,000 44.7. Annual Tonnage 44.7.1. 10 to 1000 tons per annum. 44.8. Timeline Requested 44.8.1. 13.5 years - A specialized performance seal for professional/industrial uses. Replacement of PFA in specialized applications that require its chemical and temperature resistance with its adaptive properties (due to higher flexibility than other fluoropolymers) is not possible at this time. 45. C33 - PVDF and ETFE in circulation systems 45.1. Text for derogation 45.1.1. PVDF and ETFE as a component in fluid or gas systems 45.2. Alternative text 45.2.1. PVDF and ETFE as a component in fluid or gas systems for professional, 45.3. industrial, medical, or pharmaceutical applications. Use and Functionality 45.3.1. PVDF and ETFE are commonly used as a component in fluid or gas systems. PVDF is an excellent material for connectors in fluid systems. PVDF has advantages in high temperature tolerances that make it very useful for industrial or heating applications. ETFE has similar advantages to PVDF, but has high tensile strength. 45.3.2. PVDF and ETFE have excellent water, acid, alkali, and UV resistance and is commonly used for connectors, pipe fittings, flanges, pipes, and other components in fluid or gas systems. 45.3.3. The use of PVDF or ETFE in fluid or gas systems is related to (depending on the application) chemical resistance, temperature resistance, salt water resistance, UV resistance, tensile strength, and/or abrasion resistance. 45.4. Substitutes / Alternatives 45.4.1. The only other polymer with similar properties is PTFE. PTFE is higher density and has less abrasion resistance than PVDF. PVDF is preferred in Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 83 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 industrial or heating applications for piping. ETFE has higher tensile strength than PTFE and can be used under harsher conditions that PTFE. 45.5. Forever Chemicals 45.5.1. None expected. PVDF and ETFE does not normally contain any perfluorocarboxylates or perfluorosulfonates. 45.6. Number of companies affected 45.6.1. 10,000+ 45.7. Annual Tonnage 45.7.1. 1,000+ tons per annum. 45.8. Timeline Requested 45.8.1. 13.5 years - No other polymers have the equivalent performance in fluid and gas applications, low risk to human health, and widely used. 46. C34 - PTFE for security protection of labels 46.1. Text for derogation 46.1.1. PTFE in coatings of labels for security or tamper evidence. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates. 46.2. Alternative text 46.2.1. PTFE in coatings of products for security or tamper evidence. Maximum of 2ppm of C4-C14 perfluoroalkyl carboxylates 46.3. Use and Functionality 46.3.1. PTFE is used, not only as a label coating for environmental resistance, but also for security protection such as tamper evidence. 46.3.2. PTFE coating of a label or similar product protects the label from tampering. Removal of the PTFE is not achievable with simple chemicals and would require abrasion. The abrasion would easily show the tampering. 46.3.3. Unirradiated and irradiated PTFE is used in this application. Irradiated PTFE material film is also used in the label in order to provide evidence that the label seal has been damaged/broken by an "attacker". The soft PTFE material is left on the product showing it to be "Void". Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 84 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 46.3.4. This is a relatively specialized low volume but necessary use of PTFE. 46.4. Substitutes / Alternatives 46.4.1. For security - no other polymer provides the same tamper proof properties (chemical resistance) as PTFE as a coating. Use of another polymer would reduce the security of devices especially those for financial transactions or personal identification. 46.4.2. For tamper evidence - PTFE material film (plus an adhesive) is used in the label in order to provide evidence. Other plastics do not have the combination of chemical resistance and visibility of tampering than irradiated (soft) PTFE. 46.5. Forever Chemicals 46.5.1. Unirradiated PTFE - None expected. PTFE coatings would not normally contain perfluorocarboxylates (PFOA family) and do not have the C-O-C bond that results in degradation into perfluorocarboxylates. 46.5.2. Irradiated PTFE - Irradiated PTFE normally contains a concentration of ~100 ppb of each of the perfluorocarboxylates (PFOA family). These perfluorocarboxylates are created during the original manufacturing process of the specialized security film. Since PTFE does not contain a fragile C-O-C bond, no further degradation is expected over time. 46.6. Number of companies affected 46.6.1. 10 to 100 46.7. Annual Tonnage 46.7.1. 0 to 10 tons 46.8. Timeline Requested 46.8.1. 13.5 years - Specialized low volume use, no reasonable alternatives, required for security and financial transactions, and limited risk to human health. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 85 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 47. C35 - Fluoroacrylate and PFA coatings for semiconductors 47.1. Text for derogation 47.1.1. Fluoroacrylic coatings and PFA (and solvents) for encapsulation of capacitors or semiconductor components. Maximum of 2ppm of C4-C14 47.2. perfluoroalkyl carboxylates and 10ppm residual fluoroethers Alternative text 47.2.1. Fluoroacrylic coatings and PFA (and solvents) for capacitor and semiconductor manufacturing. Maximum of 2ppm of C4-C14 47.3. perfluoroalkyl carboxylates and 10ppm residual fluoroethers Use and Functionality 47.3.1. Thin fluoroacrylate coatings (often using fluoroether solvents) are commonly used for encapsulation / water protection of capacitors and semiconductors. 47.3.2. These very thin coatings on very small parts protect the capacitor or semiconductor device from water and other environmental contaminants, reducing the risk of failure and prolonging the lifetime of the device. 47.3.3. This application of fluoroacrylates or PFA is at very small concentrations and may not even be detectable by most laboratories test methods after application. 47.3.4. This derogation includes perfluoroethers used to manufacture the fluoroacrylate film. Perfluoroethers are a common solvent for fluoroacrylates. 47.4. Substitutes / Alternatives 47.4.1. No other thin coating provides the hydrophobic and oleophobic protection of fluoroacrylates while being able to adhere to acrylic and similar substrates. 47.5. Forever Chemicals 47.5.1. Fluoroacrylates and PFA normally contain perfluorocarboxylates from the fracturing of the C-O-C connecting the fluoro side chain to the acrylic or fluoro polymer backbone. However, the overall concentration of the fluoroacrylate or PFA coating on the device may be so small/thin, that the perfluorocarboxylates would not be measurable in the final device. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 86 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 47.5.2. The application of fluoroacrylates on capacitors and semiconductors often requires a small amount of perfluoroethers as a solvent. A small concentration of perfluoroethers would be expected in the final coating, however the coating would be so small/thin that the fluoroethers would likely be not detectable with standard test methods. 47.6. Number of companies affected 47.6.1. 10,000+ 47.7. Annual Tonnage 47.7.1. 0 to 10 tons 47.8. Timeline Requested 47.8.1. 13.5 years - Specialized use internal to electronics, very low human exposure, very low annual tonnage, reduces the potential for failure of electronic products, and prolongs the life of electronic devices. 48. C36 - Fluoro sprays for industrial lubrication 48.1. Text for derogation 48.1.1. PTFE and fluorosilicone sprays for maintaining lubrication in industrial equipment. 48.2. Alternative text 48.2.1. PTFE and fluorosilicone lubricants for maintaining lubrication in machinery. 48.3. Use and Functionality 48.3.1. Metal (and some plastic) parts have very high coefficients of frictions. PTFE and fluorosilicone sprays are capable of dramatically reducing the friction of metal parts with only a thin layer applied. 48.3.2. Fluorosprays are very commonly used on metal parts in contact with other metal parts such as gears, shafts, and bearings. Without a fluoro spray, the metal parts would have very high friction and wear. 48.3.3. Fluid lubrication is not possible in all situations, and a thin layer of PTFE or fluorosilicone is necessary for lubrication. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 87 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 48.3.4. Note - one side effect of the use of fluorolubricants on machinery is that some of the lubricants can be expected (especially fluorosilicone) to migrate to products contacting machinery during their manufacturing process. Manufacturers will need to take care not to allow fluoro lubricants on their machinery to contaminate products they contact. 48.4. Substitutes / Alternatives 48.4.1. No other spray is as effective in low concentrations and thickness in achieving reducing friction. 48.4.2. Silicone spray is less effective than fluoro sprays and often contains D4, D5, and D6 forever chemicals (also regulated in the EU with further restriction expected). Silicone lubricants stay `wet', apply thicker, do not have good high temperature resistance, and are less effective on moving parts. 48.4.3. Fluoroacrylates require specific plastic substances to adhere and normally contain perfluorocarbonxylates (and are not included in the scope of this derogation request). 48.5. Forever Chemicals 48.5.1. None expected. PTFE dry sprays and fluorosilicone sprays are not expected to have any measurable forever chemicals. 48.5.2. PTFE powder in dry spray is not expected to contain perfluorocarboxylates (PFOA) and does not contain the C-O-C bond that degrades into perfluorocarboxylates. 48.5.3. Fluorosilicone may contain trace amounts of D4, D5, and D6, but the thickness of the layer will normally reduce the concentration of those chemicals in the part below measurement detection. 48.6. Number of companies affected 48.6.1. 10,000+ 48.7. Annual Tonnage 48.7.1. 100 to 1,000 tons Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 88 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 48.8. Timeline Requested 48.8.1. 13.5 years - Necessary for the proper functioning of machinery, low risk to human health, wide spread use, and no equivalent alternatives. 49. C37 - Fluoro ionic fluids in capacitors 49.1. Text for derogation 49.1.1. Ionic fluoro fluids as electrolytes in capacitors or batteries 49.2. Alternative text 49.2.1. Ionic fluoro fluids as electrolytes in electrical storage devices. 49.3. Use and Functionality 49.3.1. Ionic fluoro fluids (alternatively fluoro ionic fluids, or FILs) have a specialized use as electrolytes in capacitors and batteries. 49.3.2. FILs have chemical/biological inertness, easy recovery and recyclability, low surface tension, extreme surface activity, high gas solubility, negligible vapour pressure, null flammability, and high thermal stability. 49.3.3. FILs are used in lithium, sodium, magnesium, and zinc batteries as they are non-volatile, non-flammable, and high ionic conductivity. 49.3.4. FILs improve both the performance and safety of batteries and capacitors. 49.3.5. Note - Fluorohydrogenate ionic liquids, one of the most common FIL in capacitors, are very simply structures without a C-O-C and may be removed from the definition of PFAS in the future (as they generally only have one fully fluorinated carbon) 49.4. Substitutes / Alternatives 49.4.1. Other ionic fluids can be used, but these fluids do not exhibit either/or the performance or flammability resistance of FILs. 49.5. Forever Chemicals 49.5.1. None expected. FILs are a large range of chemicals, the commonly used FILs do not have a C-O-C bond that leads to degradation into perfluorocarboxylates (PFOA family). Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 89 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 49.5.2. This derogation request does not include a provision for perfluorocarboxylates, and any FIL that degrades into perfluorocarboxylates would be regulated under the long chain perfluorocarbonxylate restrictions of the EU POP and REACH Regulations. 49.6. Number of companies affected 49.6.1. 100 to 1,000 companies 49.7. Annual Tonnage 49.7.1. 10 to 100 tons 49.8. Timeline Requested 49.8.1. 13.5 years - Necessary for the safety and performance of high energy density capacitors and batteries, replacement would impact electric vehicles, and low risk to human health. 50. C38 - PFPE lubricants for harsh environments 50.1. Text for derogation 50.1.1. Perfluorinated polyether (PFPE) as a lubricant for harsh environments 50.2. Alternative text 50.2.1. Perfluorinated polyether (PFPE) as a lubricant in professional and 50.3. industrial applications. Use and Functionality 50.3.1. Perfluorinated polyethers (PFPE) are used in harsh environments requiring high reliability. 50.3.2. PFPE operates effectively between -70C and 300C, does not exhibit oxidation, and has low losses from evaporation. PFPE enables longer relubrication intervals and may be suitable for the lifetime of the application. 50.3.3. PFPE's low evaporation losses make it suitable for high and ultra vacuum environments. 50.3.4. Harsh environments can include high temperature, corrosive, solvent, 50.4. natural gas, high vacuum, or equivalent hard environments. Substitutes / Alternatives 50.4.1. Silicone oil does not have the temperature range of PFPE and is not suitable for contact with some plastics. PFPE can handle a higher temperature range and is compatible with a wider range of rubbers. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 90 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 50.5. Forever Chemicals 50.5.1. None expected. PFPE can theoretically degrade into C3 or shorter perfluorocarboxylates, but there is no record of that situation being measured in practice. Note - Standard testing for perfluorocarboxylates is for C4 perfluorocarbxylates and longer. 50.6. Number of companies affected 50.6.1. 100 to 1,000 companies 50.7. Annual Tonnage 50.7.1. 10 to 100 tons 50.8. Timeline Requested 50.8.1. 13.5 years - No equivalent replacement and intended for harsh environments with very limited human exposure such as machinery in a vacuum. 51. C40 - Pefluorocarboxylates in PFA 51.1. Text for derogation 51.1.1. Maximum of 5ppm of C4-C14 perfluoroalkyl carboxylates in derogated 51.2. applications of perfluoroalkoxy alkane (PFA) Alternative text 51.2.1. C4-C14 perfluoroalkyl carboxylates in derogated applications of 51.3. perfluoroalkoxy alkane (PFA). Use and Functionality 51.3.1. This derogation request is for perfluorocarboxylates in approved derogations of PFA. 51.3.2. Perfluoroalkoxy alkane (PFA) polymers have C-O-C connected fluoro side chains. These C-O-C bonds break during manufacturing and further degrade over time creating perfluorocarboxylates. 51.3.3. The length of the side chain does vary amongst different PFA. For very short side chains (single fully fluorinated carbons), measurable Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 91 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 perfluorocarboxylates are not created. For PFA polymers with longer side chains, a range of short and long chain perfluorocarboxylates are created. 51.3.4. The majority of tested PFA materials in articles measured ~100 ppb of each of C4 to C14 perfluorocarboxylates (PFOA family). But not all 51.4. tested PFA contained perfluorocarboxylates. Substitutes / Alternatives 51.4.1. PFA commonly has perfluorocarboxylates but does not have to. It will take time to identify and replace perfluorocarboxylate forming PFA as both perfluorocarboxylate containing and non-containing PFA are described as the same polymer and PFA is very widely used in many industries (consumer, professional, medical, and industrial). 51.5. Forever Chemicals 51.5.1. PFA have fluorinated side chains connected by a C-O-C bond. Those side chains can degrade into perfluorocarboxylates through cleavage of the CO-C bond. 51.5.2. A separate derogation request for perfluorocarboxylates in PFA polymers is included in this report. 51.6. Number of companies affected 51.6.1. 10,000+ companies 51.7. Annual Tonnage 51.7.1. 0 to 10 tons (perfluorocarboxylates. Likely <1 tonne per annum) 51.8. Timeline Requested 51.8.1. 6.5 years - Perfluorcarboxylates are in the majority of PFA polymers but are not required for PFA polymers. However, perfluorocarboxylates are common in the majority of PFA polymers and it will take time to identify and replace perfluorocarboxylates containing PFA with nonperfluorocarboxylate containing PFA. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 92 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 52. C41 - Perfluorosulfonates in Fluoroelastomers 52.1. Text for derogation 52.1.1. Maximum of 10 ppm 6:2 FTS, 5ppm C4-C6 perfluoroalkyl carboxylates, and 10 ppm bisphenol AF in derogated applications of fluoroelastomers 52.2. and perfluoroelastomers Alternative text 52.2.1. 6:2 FTS, C4-C6 perfluoroalkyl carboxylates, and bisphenol AF in 52.3. derogated applications of fluoroelastomers and perfluoroelastomers Use and Functionality 52.3.1. This derogation request is for perfluorosulfonates, perfluorocarboxylates, and bisphenol AF crosslinker in approved derogations of fluoroelastomers (including perfluoroelastomers). 52.3.2. The manufacturing process for fluoroelastomers used a C6 (6 carbon fluorine chain) based fluorotelomer sulfonate surfactant for emulsion polymerization. The surfactant degrades into 6:2 fluorotelomer sulfonate (6:2 FTS - a short chain fluorotelomer sulfonate). Over time 6:2 FTS degrades into C4-C7 perfluorocarboxylates (short chain members of the PFOA family). Any approved derogation for fluoroelastomers would need a derogation for the degradation products of the surfactant for manufacturer fluoroelastomers. 52.3.3. Fluoroelastomers are crosslinked rubber that commonly use bisphenol AF as the crosslinker. Any approved derogation for fluoroelastomers would 52.4. need a derogation for residual bisphenol AF. Substitutes / Alternatives 52.4.1. There are currently no alternatives for the fluorotelomer sulfonate surfactants used for emulsion polymerization of fluoroelastomers. The principal manufacturers of fluoroelastomers are researching alternatives but there is currently no reasonably feasible alternative. 52.5. Forever Chemicals 52.5.1. 6:2 FTS and C4-C7 perfluorocarboxylates as degradation products of the fluorotelomer sulfonate surfactant manufacturing aid. 52.5.2. Residual bisphenol AF as the crosslinking agent. 52.6. Number of companies affected 52.6.1. 10,000+ companies Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 93 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 52.7. Annual Tonnage 52.7.1. 0 to 10 tons (perfluorocarboxylates and perfluorosulfonates. tonne per annum) Likely <1 52.8. Timeline Requested 52.8.1. 13.5 years - No current replacements for the emulsion surfactant and crosslinkers for fluoroelastomers. Fluoroelastomers have specialized uses and derogation of the degradation products of their manufacturing aids is needed for their continued use. 53. C43 - PVDF in ferroelectric films 53.1. Text for derogation 53.1.1. PVDF polymers and PVDF terpolymers for ferroelectric films. 53.2. Alternative text 53.2.1. PVDF polymers and PVDF terpolymers for ferroelectric films in actuators 53.3. and micro sensors. Use and Functionality 53.3.1. PVDF based polymers (PVDF polymers and PVDF terpolymers) are used for ferroelectric films in actuators and micro sensors. 53.3.2. PVDF films have ferroelectric and piezoelectric properties that make them very useful for actuators and micro sensors. 53.3.3. PVDF films have the advantages of a stable molecular dipole moment, compact crystal structure, conformational flexibility, and minimal steric hindrance. Ferroelectric polymers, either PVDF or P(VDF-TrFE), have 53.4. large piezoelectric coefficients and high electrical outputs. Substitutes / Alternatives 53.4.1. Specialized PVDF films have the highest dielectric constant of polymers, are new innovations, and are not replaceable with other materials. 53.5. Forever Chemicals 53.5.1. None expected. PVDF and PVDF terpolymers do not contain perfluorocarboxlates and do not have a chemical structure conducive to degradation into perfluorocarboxylates. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 94 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 53.6. Number of companies affected 53.6.1. 10 to 100 companies 53.7. Annual Tonnage 53.7.1. 0 to 10 tons 53.8. Timeline Requested 53.8.1. 13.5 years - Very specialized low volume use with little risk to human health. 54. C44 - Fluoroether for degreasing applications 54.1. Text for derogation 54.1.1. Fluoroethers for degreasing applications 54.2. Alternative text 54.2.1. N/A 54.3. Use and Functionality 54.3.1. Fluoroethers for vapour solvent degreasing of machined parts is widely used. 54.3.2. Fluoroethers have high solvency strength, low nonvolatile residue and low surface tension. Fluorinated solvents provide excellent cleaning performance. 54.3.3. Fluoroethers are critical for comprehensive cleaning of metal machined parts particularly for the medical and pharmaceutical industries. 54.3.4. Without fluorethers, residue and contamination on machine parts will be 54.4. common on machined parts. Substitutes / Alternatives 54.4.1. Chlorinated and brominated solvents can be used to degrease metal parts, they have higher greenhouse gas and environmental emissions; and reduced solvency power - resulting in most environmental hazards and would reduce part quality. 54.5. Forever Chemicals 54.5.1. None expected. Fluoroethers are not expected to degrade into perfluorocarboxylates. Fluoroethers themselves have short half lifes in the environment and are not bioaccumulants of their own. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 95 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 54.6. Number of companies affected 54.6.1. 1,000 to 10,000 companies 54.7. Annual Tonnage 54.7.1. 100 to 1,000 tons 54.8. Timeline Requested 54.8.1. 13.5 years - Necessary for reduced greenhouse gas emissions, reduced contaminants on medical devices, degrade in the environment, and have low risk to human health. 55. C45 - HFO for Insulating Foam 55.1. Text for derogation 55.1.1. Hydrofluoroolefins used as blowing agents for insulating spray foam 55.2. internal to products. Alternative text 55.2.1. Hydrofluoroolefins used as blowing agents for spray foam. 55.3. Use and Functionality 55.3.1. Hydrofluorolefins (HFO) are a low greenhouse gas blowing agent for insulating foam. 55.3.2. HFO blowing agents are not flammable, have zero ozone depletion potential (ODP), and have low global warming potential (GWP). 55.3.3. HFOs are technicallyc2 PFAS, but most only have one fully fluorinated carbon and may not qualify as a PFAS in update definitions that require 55.4. chains for at least two fully fluorinated carbons. Substitutes / Alternatives 55.4.1. HFOs are the environmentally friendly replacements for hydrofluorocarbons (HFCs). To meet greenhouse gas emissions targets, companies need to continue to use and convert to HFOs. 55.5. Forever Chemicals 55.5.1. None expected. HFOs do not have C-O-C bonds that lead to degradation into perfluorocarboxylates. 55.6. Number of companies affected 55.6.1. 10 to 100 companies Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 96 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 55.7. Annual Tonnage 55.7.1. 100 to 1,000 tons 55.8. Timeline Requested 55.8.1. 13.5 years - Necessary for reducing greenhouse gasses, and no expected risk to human health. 56. C46 - PTFE as a high temperature manufacturing aid or tool 56.1. Text for derogation 56.1.1. PTFE as a manufacturing aid or tool for high temperature (> 150C) 56.2. applications Alternative text 56.2.1. N/A 56.3. Use and Functionality 56.3.1. PTFE has high temperature tolerance and is commonly used in manufacturing processes as a tool or aid. 56.3.2. Numerous manufacturing processes involve high temperatures (such as soldering) and PTFE is commonly used as a holder or tool for the process. 56.3.3. Examples of PTFE as a high temperature manufacturing aid is a holder for parts during soldering, cutting jig, or insertion tool. Many of the applications covered in this derogation are custom and specialized for a 56.4. specific manufacturing process. Substitutes / Alternatives 56.4.1. Metals are too thermally conductive for most high temperature manufacturing processes. Other polymers either do not have the temperature resistance of PTFE (example - polyethylene) or are difficult to machine into custom tools (example - PEEK). 56.5. Forever Chemicals 56.5.1. None expected. Unirradiated PTFE does not perfluorocarboxylates and does not have C-O-C bonds that degradation into perfluorocarboxylates. contain lead to 56.6. Number of companies affected 56.6.1. 1,000 to 10,000 companies Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 97 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 56.7. Annual Tonnage 56.7.1. 1,000 - 10,000 tons 56.8. Timeline Requested 56.8.1. 13.5 years - Alternative materials do not have the necessary high temperature resistance and machinability, this derogation is limited to professional applications, and no expected risk to human health. 57. C48 - Fluorocoatings for optical components 57.1. Text for derogation 57.1.1. Fluorocoatings on laser fibers, laser fiber components, and fibers for 57.2. optical purposes including light guidance. Alternative text 57.2.1. N/A 57.3. Use and Functionality 57.3.1. Optical fibers and optical fiber based components commonly use fluoroacrylate coatings for guiding light for use in industrial, medical, defense, instrumentation, telecommunication and sensing markets. 57.3.2. UV curable coatings based on fluorinated polymers (amorphous fluoropolymers) are used in the connecting optical fibres or fiber based components to maintain light guidance along a chain of fiber and fiber based compoonents making a device. 57.3.3. For optical components, light guidance needs to be maintained with high reliability and precise optical matching to avoid losses and transmit light between beam forming between components. 57.3.4. These applications generally require fluoropolymers coating applied to glass typically in tens of micrometer thickness to accept and deliver high numerical aperture light. 57.3.5. This derogation includes both the fluorocoating and potential residual 57.4. perfluoroethers solvents that may be present in the final film. Substitutes / Alternatives 57.4.1. Alternative materials are not as transparent to visible light and have poorer optical matching properties. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 98 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 57.5. Forever Chemicals 57.5.1. None expected. The amount of amorphous fluoropolymer is not sufficient for measurable perfluorocarboxylates in the final device even for a potential degradation product. 57.6. Number of companies affected 57.6.1. 100 to 1,000 57.7. Annual Tonnage 57.7.1. 0 to 10 tons 57.8. Timeline Requested 57.8.1. 13.5 years - Alternative materials do not have same performance / light compatibility, no expected risk to human health, and is a low volume application. 58. C50 - Fluorosilicone as a surfactant in semiconductors 58.1. Text for derogation 58.1.1. Fluorosilicone used as a surfactant or anti-foaming agent in 58.2. semiconductor materials Alternative text 58.2.1. N/A 58.3. Use and Functionality 58.3.1. Semiconductor manufacturing is a very precise industry and requires specialized inert fluorosilicones for anti-foaming during manufacturing. 58.3.2. The fluorosilicone surfactants are used in a manufacturing step for a microscopic material internal to a semiconductor device. 58.3.3. The resulting chemical is only used in the manufacturing of the product and will not be present above 50 ppm oxrganic fluorine in the final 58.4. product. Substitutes / Alternatives 58.4.1. Other surfactants are not as effective for this high precision application or as inert. In semiconductor manufacturing this surfactant cannot react without other materials. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 100 Page 99 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 58.5. Forever Chemicals 58.5.1. None. The fluorosilicone surfactant is not a forever chemical, contains no forever chemical, and is not expected to degrade into forever chemicals. 58.6. Number of companies affected 58.6.1. 10 to 100 58.7. Annual Tonnage 58.7.1. 0 to 10 tons 58.8. Timeline Requested 58.8.1. 13.5 years - No present in the final product, very specialized application, and very controlled and treated waste stream. 59. C51 - F2 gas fluorinated plastics in capacitors 59.1. Text for derogation 59.1.1. F2 gas fluorinated plastics in capacitors and microchips 59.2. Alternative text 59.2.1. N/A 59.3. Use and Functionality 59.3.1. A microlayer of fluorinated material is created in capacitors and semiconductor devices by F2 gas fluorination (usually plasma fluorination) of a plastic such as polyethylene or polyphenylene sulfide 59.3.2. The thin layer has amorphous fluorinated alkane molecules. 59.3.3. This very thin internal fluorinated layer provides specialized capacitance 59.4. curves and is useful in specialized applications. Substitutes / Alternatives 59.4.1. Thin fluorinated plastics provide capacitance performance advantages not available in other materials. 59.5. Forever Chemicals 59.5.1. None expected. The fluorination occurs mostly in argon and is not expected to create the perfluorocarboxylates generally seen in fluorination of plastics in air. 59.6. Number of companies affected 59.6.1. 100 to 1,000 Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 101 Page 100 of Claigan Environmental Inc. 10 Brewer Hunt Way, Suite 200 Kanata, ON, Canada, K2K 2B5 59.7. Annual Tonnage 59.7.1. 0 to 10 tons 59.8. Timeline Requested 59.8.1. 13.5 years - Alternative materials do not have the same performance, no expected risk to human health, internal to electronics, and is a low volume application. 60. C52 - PTFE additive in die attach paste 60.1. Text for derogation 60.1.1. PTFE filled die attach material for semiconductor devices 60.2. Alternative text 60.2.1. N/A 60.3. Use and Functionality 60.3.1. PTFE added to die attach paste in semiconductor component for improved thermal performance. 60.3.2. The additive of PTFE to the die attach paste reduces `popcorning' for 60.4. repeat solder re-flows of the component. Substitutes / Alternatives 60.4.1. No other polymer powder is as chemically inert and have as high temperature resistance as PTFE powder. 60.5. Forever Chemicals 60.5.1. None expected. perfluorocarboxylates perfluorocarboxylates. Unirradiated and is not PTFE does expected to not contain degrade into 60.6. Number of companies affected 60.6.1. 1,000 to 10,000 60.7. Annual Tonnage 60.7.1. 0 to 10 tons 60.8. Timeline Requested 60.8.1. 13.5 years - Alternative materials do not have the same performance, no expected risk to human health, internal to electronics, and is a low volume application. Document is UNCONTROLLED if printed. Claigan PFAS Submission #5 - PFAS Derogations and Justifications Prepared by Claigan Environmental Inc. 101 Page 101 of