On 5 August 2021, the European Commission has published Regulation (EU) 2021/1297 to amend Entry 68 of Annex XVII to REACH Regulation (EC) No 1907/2006, adding restrictions on perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances. The regulation shall apply from 25 February 2023, unless specified.

C9-C14 PFCAs, their salts and C9-C14 PFCA- related substances can occur as unintended by-products during the manufacture of perfluorinated and polyfluorinated substances containing a carbon chain of less than nine carbon atoms, such as perfluorooctanoic acid (PFOA). Furthermore, it is possible that companies may consider the use of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances as substitutes for PFOA, its salts and related substances in the future. Therefore, the European Commission has restricted these substances, prevent future possible manufacturing and use resulting in increasing releases into the environment.

Following is a summary of the regulation:
1. The substances shall not be manufactured, or placed on the market on their own from 25 February 2023.
2. The substances shall not, from 25 February 2023, be used in, or placed on the market in:
(a) Another substance, as a constituent;
(b) A mixture;
(c) An article,

Except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts, or 260 ppb for the sum of C9-C14 PFCA-related substances.

The restriction shall not apply to articles placed on the market before 25 February 2023.

The Commission approved to apply the restrictions at a later time on the following products:
(a) Textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety (from 4 July 2023);
(b) Manufacture of polytetrafluoroethylene (PTFE) and polyinylidene fluoride (PVDF) for the production of (i) high-performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles, (ii) industrial waste heat exchanger equipment, (iii) industrial sealants capable of preventing leakage of volatile organic compounds and PM2.5 particulates (from 4 July 2023);
(c) Can coating for pressurised metered-dose inhalers (after 25 August 2028);
(d) (i) Semiconductors on their own; (ii) semiconductors incorporated in semi-finished and finished electronic equipment (from 31 December 2023);
(e) Semiconductors used in spare or replacement parts for finished electronic equipment placed on the market before 31 December 2023 (from 31 December 2030);

Also, some time-limited exemptions are provided for the use of C9-C14 PFCAs, their salts and C9-C14 PFCAs-related substances in:
(a) Photolithography or etch processes in semiconductor manufacturing (until 4 July 2025);
(b) Photographic coatings applied to films (until 4 July 2025);
(c) Invasive and implantable medical devices (until 4 July 2025);
(d) Fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, subject to specific conditions (until 4 July 2025).

Specially, the concentration limit for the sum of C9-C14 PFCAs, their salts and C9-C14 PFCA related substances, present in a substance to be used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of the REACH Regulation are met for the manufacturing of fluorochemicals with a perfluoro carbon chain length equal to or shorter than 6 atoms, shall be 10 ppm.

The concentration limit for the sum of C9-C14 PFCAs in fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups, shall be:
(a) 2000 ppb (Until 25 August 2024);
(b) 100 ppb (From 25 August 2024).

The concentration limit for the sum of C9-C14 PFCAs present in PTFE micro powders produced by ionising irradiation or by thermal degradation, as well as in mixtures and articles for industrial and professional uses containing PTFE micro powders, shall be 1000 ppb.

Note:

• “C9-C14 PFCAs” means linear and branched perfluorocarboxylic acids of the formula CnF2n+1-C(=O)OH where n = 8, 9, 10, 11, 12, or 13.
• “C9-C14 PFCA-related substances” are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to C9-C14 PFCAs, either having:
  (1) A perfluoro group with the formula CnF2n+1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof; or
  (2) A perfluoro group with the formula CnF2n+1- that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.
  The following substances are excluded:
  (1) CnF2n+1-X, where X = F, Cl, or Br where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof;
  (2) CnF2n+1-C(=O)OX' where n > 13 and X' = any group, including salts.

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