SG 145/24
The European Union (EU) has issued legislation to regulate undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances. The restrictions will be implemented in phases, starting April 10, 2026.
On September 20, 2024, the EU issued Regulation (EU) 2024/2462 (the Regulation) to regulate PFHxA, its salts and PFHxA-related substances in a wide variety of products.
The regulation contains, among other things, several important provisions. It:
- Creates new entry 79 to Annex XVII of Regulation (EC) No. 1907/2006 (Registration, Evaluation, Authorization and Restriction of Chemicals, Annex XVII of REACH, consolidated version to June 2024)
- Defines PFHxA, its salts and PFHxA-related substances as either:
- Having a linear or branched perfluoropentyl moiety with the formula C5F11- directly attached to another carbon atom as one of the structural elements
- Having a linear or branched perfluorohexyl group with the formula C6F13-.
- Excludes several substance designations, including those with a perfluoroalkyl group C6F13-directly attached to an oxygen atom at one of the non-terminal carbon atoms
- Exempts certain products (see Table 1 below)
Highlights of the Regulation are summarized in Table 1.
| Scope | Requirement¹ | Effective date |
| < 25 ppb (sum of PFHxA and its salts) and < 1,000 ppb (sum of PFHxA-related substances) | April 10, 2026 |
| < 25 ppb (sum of PFHxA and its salts) and < 1,000 ppb (sum of PFHxA-related substances) | October 10, 2026² (mixtures and articles that were placed on the market before this date are exempt) |
| < 25 ppb (sum of PFHxA and its salts) and < 1,000 ppb (sum of PFHxA-related substances) | October 10, 2027² (articles that were placed on the market before this date are exempt) |
| < 25 ppb (sum of PFHxA and its salts) and < 1,000 ppb (sum of PFHxA-related substances) | October 10, 2029 |
Table 1
¹Exempts substances with a perfluoroalkyl group, C6F13-directly attached to a sulphur atom as these are prohibited under Annex I to Regulation (EU) 2019/1021 on persistent organic pollutants (POP, consolidated version to August 2023)
²Exempts the following:
- Personal protective equipment falling under risk category III (Regulation (EU) 2016/425, Annex I, points (a), (c) to (f), (h) and (l))
- Medical devices (Regulation (EU) 2017/745, consolidated version to July 2024)
- In vitro diagnostic medical devices (Regulation (EU) 2017/746, consolidated version to July 2024)
- Textiles used as construction textiles
Through a global network of laboratories and highly trained specialists, SGS offers a comprehensive suite of services to help our customers comply with their obligations under REACH, from initial REACH registration to consulting, testing, auditing and verification services to support ongoing compliance. Contact us or visit our website to find out more. In the end, it’s only trusted because it’s tested.
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