Regulation (EU) 2024/2462, published in the Official Journal of the European Union on September 20, 2024, amends Annex XVII of the REACH Regulation (Regulation (EC) 1907/2006). It introduces restrictions on undecafluorohexanoic acid (PFHxA), its salts, and PFHxA-related substances, which are part of the PFAS group, including their use in cosmetic products.

• The restriction concerns Undecafluorohexanoic acid (PFHxA), its salts, and PFHxA-related substances;
  • having a linear or branched perfluoropentyl group with the formula C₅F₁₁- directly attached to another carbon atom as one of the structural elements; or
  • having a linear or branched perfluorohexyl group with the formula C₆F₁₃-.

• The following substances are excluded from this designation:
  • C₆F₁₄;
  • C₆F₁₃-C(=O)OH, C₆F₁₃-C(=O)O-X′ or C₆F₁₃-CF₂-X′ (where X′ = any group, including salts);
  • any substance having a perfluoroalkyl group C₆F₁₃- directly attached to an oxygen atom at one of the non-terminal carbon atoms
• PFHxA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed into PFHxA.
• The restriction concerns, among others, textiles, leather, furs, and hides in clothing and related accessories for the general public, footwear, paper, and cardboard used as food-contact materials within the scope of Regulation No 1935/2004, mixtures for the general public, and cosmetic products.
• It prohibits the presence of these substances in the above products at a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1 000 ppb for the sum of PFHxA-related substances.
• The restriction shall not apply to substances having a perfluoroalkyl group C₆F₁₃- directly attached to a sulphur atom that are prohibited in Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council.
• It will apply from 10 October 2026 for cosmetic products. Note that this restriction shall not apply to cosmetics that were placed on the market before 10 October 2026.

Background

Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances have a combination of hazardous properties. PFHxA by far exceeds the ‘very persistent’ criterion set out in point 1.2.1 of Annex XIII to Regulation (EC) No 1907/2006, is mobile in the aquatic environment and has potential adverse effects on human health and the environment. PFHxA itself is not registered or used in the Union. Several PFHxA-related substances as well as the ammonium salt of PFHxA are registered in the Union with tonnage bands from 1 to more than 100 tonnes per annum. PFHxA-related substances and the ammonium salt of PFHxA are widely used in many sectors, with large quantities used in paper and cardboard for use as food contact materials, in textiles and in firefighting foams. The continued use of PFHxA salts and PFHxA-related substances in particular in wide dispersive uses will lead to an increasing environmental stock and further environmental and human exposure.

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