68. Linear and branched perfluorocarboxylic acids of the general formula CnF2n+1-C(= O)OH, where n = 8, 9, 10, 11, 12 or 13 (C9-C14 PFCA), including their salts and any combination thereof;
Any C9-C14 PFCA-related substance having a perfluoro group of the general formula CnF2n+1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12 or 13, including their salts and any combination thereof;
Any C9-C14 PFCA-related substance having a perfluoro group of the general formula CnF2n+1- not directly attached to another carbon atom as one of the structural elements, where n = 9, 10, 11, 12, 13 or 14, including their salts and any combination thereof. The following substances are excluded: CnF2n+1-X, where X = F, Cl or Br, and n = 9, 10, 11, 12, 13 or 14, including their salts and any combination thereof, CnF2n+1-C(= O)OX’, where n> 13 and X’ = any group, including its salts. | From 25 February 2023, the substance shall not be manufactured or placed on the market as a substance. From 25 February 2023, it shall not be used in or placed on the market: (a) as an ingredient in a substance; (b) in a mixture; or (c) in an article, unless the total concentration of C9-C14 PFCAs and their salts in the substance, mixture or article is less than 25 ppb or the total concentration of C9-C14 PFCA-related substances is less than 260 ppb. As a derogation from paragraph 2, when C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances are present in a substance as a transport quarantine intermediate, their total concentration limit is 10 ppm, provided that the conditions of points (a) to (f) of Article 18(4) of this Regulation are met. The Commission shall review this restriction no later than 25 August 2023. Paragraph 2 shall be effective from July 4, 2023, for: oil- and water-repellent textiles used to protect workers from hazardous liquids that endanger their health and safety; the manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of: high-performance, corrosion-resistant gas filtration membranes, water filtration membranes, and medical textile membranes; industrial waste heat exchange equipment; industrial sealants that can prevent the leakage of volatile organic compounds and PM 2.5 particles. As an exemption from paragraph 2, the use of C9-C14 PFCAs, their salts, and C9-C14 PFCA-related substances shall be permitted until July 4, 2025, in: lithography or etching processes in semiconductor manufacturing; photographic coatings applied to films; invasive and implantable medical devices; and firefighting foams for liquid fuel smoke suppression and liquid fuel fires (Class B fires) installed in systems, including mobile and fixed systems, subject to the following conditions: containing or may contain C9-C14 PFCAs, their salts, and C9-C14 PFCA-related substances. Firefighting foams containing PFCA-related substances must not be used for training personnel; firefighting foams that contain or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances must not be used for testing unless all releases are controlled; from January 1, 2023, the use of firefighting foams that contain or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances will only be permitted in locations where all releases can be controlled; stocks of firefighting foams that contain or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances must be managed in accordance with Article 5 of Regulation (EU) 2019/1021. Paragraph 2(c) does not apply to articles placed on the market before February 25, 2023. Paragraph 2 does not apply to the coating of cans of pressurized metered-dose inhalers before August 25, 2028. Paragraph 2(c) shall apply from December 31, 2023, to: (a) semiconductors themselves; and (b) semiconductors incorporated into semi-finished and finished electronic equipment. Paragraph 2(c) shall apply from December 31, 2030, to semiconductors used in spare or replacement parts for electronic equipment placed on the market before December 31, 2023. Until August 25, 2024, the concentration limit referred to in paragraph 2 shall be 2,000 ppb for the sum of C9-C14 PFCAs in fluoroplastics and fluoroelastomers containing perfluoroalkoxy groups. From August 25, 2024, the total concentration limit for C9-C14 PFCAs in fluoroplastics and fluoroelastomers containing perfluoroalkoxy groups shall be 100 ppb. During the manufacture and use of fluoroplastics and fluoroelastomers containing perfluoroalkoxy groups, all emissions of C9-C14 PFCAs shall be avoided or, if this is not possible, reduced to the maximum extent technically and practicable. This exemption does not apply to finished products referred to in paragraph 2. The Commission shall review this exemption no later than August 25, 2024. The concentration limit for the sum of the C9-C14 PFCAs referred to in paragraph 2 shall be 1000 ppb if these substances are present in PTFE micronized powders produced by ionizing radiation or thermal degradation, and in mixtures and finished products containing PTFE micronized powders for industrial or professional use. During the manufacture and use of PTFE micronized powders, all emissions of C9-C14 PFCAs shall be avoided or, if this is not possible, reduced to the maximum extent technically and practically feasible. The Commission shall review this exemption no later than August 25, 2024. For the purposes of this entry, C9-C14 PFCA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be converted into C9-C14 PFCAs. |
