October 7, 2024
On September 20, 2024, the European Commission (EC) has adopted Commission Regulation (EU) 2024/2462 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances.
The new measures aim to protect human health and the environment by restricting the use of undecafluorohexanoic acid (‘PFHxA') and PFHxA related substances.
The restriction will ban the sale and use of PFHxA in consumer textiles, such as rain jackets; food packaging, like pizza boxes; consumer mixtures such as waterproofing sprays; cosmetics like skin care products; and in some firefighting foam applications like for training and testing, without compromising safety.
The Commission has adopted new measures under the REACH Regulation - the EU chemicals legislation - to protect human health and the environment by restricting the use of undecafluorohexanoic acid (‘PFHxA') and PFHxA ‑related substances.
These substances are a sub-group of per- and polyfluoroalkyl substances (‘PFAS') and are very persistent and mobile in water, and their use in certain products poses an unacceptable risk to human health and the environment.
The restriction will ban the sale and use of PFHxA in:
- Consumer textiles, such as rain jackets,
- Food packaging, like pizza boxes,
- Consumer mixtures such as waterproofing sprays,
- Cosmetics like skin care products, and in
- Some firefighting foam applications like for training and testing, without compromising safety.
It does not affect other applications of PFHxA, for example in semiconductors, batteries or fuel cells for green hydrogen.
This restriction will be the new entry 79 of Annex XVII of REACH, and it is an important step forward in reducing PFAS emissions, since PFHxA is often used as substitution for another already banned PFAS (perfluorooctanoic acid, or ‘PFOA'). It is based on the scientific assessment of European Chemicals Agency (ECHA)'s Committees and has successfully passed the scrutiny of the European Parliament and the Council.
The PFHxA restriction will formally enter into force 20 days after publication in the Official Journal on October 10, 2024. It will take effect after transitional periods of between 18 months and 5 years, depending on the use, allowing time for replacement by safer alternatives.
Specifically:
- April 10, 2026: fire-fighting foams for training, testing and public fire services.
- October 10, 2026: textiles, leather, furs and hides in clothing and related accessories for the general public; footwear for the general public; paper and cardboard used as food contact materials within the scope of Regulation (EC) No 1935/2004; mixtures for the general public; cosmetic products as defined in Regulation (EC) No 1223/2009.
- October 10, 2027: textiles, leather, furs and hides in products other than clothing and related accessories for the general public.
- October 10, 2029: firefighting foams for civil aviation.
The limits to respects are:
- Sum of PFHxA and its salts: < 25 ppb;
- Sum of PFHxA related substances: < 1000 ppb
Undecafluorohexanoic acid (PFHxA), its salts are covered by the following definitions:
(a) having a linear or branched perfluoro pentyl group with the formula C5F11- directly attached to another carbon atom as one of the structural elements; or
(b) having a linear or branched perfluorohexyl group with the formula C6F13-.
The following substances are excluded from this designation:
(a) C6F14;
(b) C6F13-C(=O)OH, C6F13-C(=O)O-X′ or C6F13-CF2-X′ (where X′ = any group, including salts);
(c) any substance having a perfluoroalkyl group C6F13- directly attached to an oxygen atom at one of the non-terminal carbon atoms.
For the purposes of this entry, PFHxA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to PFHxA.
To achieve the conformity, companies should test these substances together with other restricted PFAS in EU. We invite you to visit this webpage for more details.
UL Solutions can help you navigate PFAS regulations and mitigate compliance risks with our broad portfolio of chemical management and advisory services.
We partner with you on the development of a Restricted Substance List (RSL) to reduce the risk of non-compliant goods to the market, and we offer support and training to help you stay ahead of regulatory changes and upcoming restrictions for PFAS.
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