Attention! Annex XVII of EU REACH Regulation adds PFHxA control requirements

On 20 September 2024, the Official Journal of the European Union published (EU) 2024/2462, amending Annex XVII of REACH by adding the control requirements of Article 79 on Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The specific revisions are as follows:

In Annex XVII to Regulation (EC) No 1907/2006 (REACH) , the following entry is added:

Substance

79.

Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances:

(a)having a linear or branched perfluoropentyl 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.

Conditions of restriction

1.Shall not, from 10 October 2026 be placed on the market, or used, in 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, measured in homogeneous material, in the following:

(a)textiles, leather, furs and hides in clothing and related accessories for the general public;

(b)footwear for the general public;

(c)paper and cardboard used as food contact materials within the scope of Regulation (EC) No 1935/2004;

(d)mixtures for the general public;

(e)cosmetic products as defined in Article 2(1), point (a), of Regulation (EC) No 1223/2009.

2.Shall not, from 10 October 2027 be placed on the market, or used, in 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, measured in homogeneous material, in textiles, leather, furs and hides, other than in clothing and related accessories referred to in paragraph 1, for the general public.

3.Paragraphs 1 and 2 shall not apply to the following:

(a)personal protective equipment intended to protect users against risks within the scope of risk category III, points (a), (c) to (f), (h), and (l) of Annex I to Regulation (EU) 2016/425;

(b)devices within the scope of Regulation (EU) 2017/745;

(c)devices within the scope of Regulation (EU) 2017/746;

(d)textiles used as construction textiles.

4.Shall not, from 10 April 2026 be placed on the market, or used, in 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, in:

(a)firefighting foams and firefighting foam concentrates for training and for testing, except functional testing of the firefighting systems provided that all releases are contained;

(b)firefighting foams and firefighting foam concentrates for public fire services, except where those services intervene at industrial fires at establishments covered by Directive 2012/18/EU of the European Parliament and of the Council and they use the foams and the equipment for that purpose only.

5.Shall not, from 10 October 2029 be placed on the market, or used, in firefighting foams and firefighting foam concentrates for civil aviation (including in civilian airports) in 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.

6.Paragraphs 1, 2, 4 and 5 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.

7.By way of derogation from paragraph 1, that paragraph shall not apply to articles and mixtures which were placed on the market before 10 October 2026.

8.By way of derogation from paragraph 2, that paragraph shall not apply to articles which were placed on the market before 10 October 2027.

9.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.

Uses
Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances are a class of substances in PFAS, which are widely used in paper and cardboard of food contact materials, clothing textiles and fire fighting foam, and have potential hazards to human beings and the environment.

Original link:https://eur-lex.europa.eu/eli/reg/2024/2462/oj#ntr2-L_202402462EN.000101-E0002