EU REACH | PFAS
October 9, 2024 | Written by GreenSoft Technology, Inc.
New PFAS Restricted Under EU REACH Annex XVII
PFHxA added to EU REACH Annex XVII, restriction effective October 2026 for most products
On September 20, the European Commission approved and published an amendment to the EU REACH Regulation adding a new restriction under Annex XVII.
Amendment (EU) 2024/2462 adds Entry 79 to EU REACH Annex XVII restricting undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances.
The amendment enters into force on October 10, 2024. The effective date of the restrictions ranges from October 2026 to October 2029 depending on product type, as seen in the table below.
In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:
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.
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 (*1) 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 (*2).
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.
The full text of the amendment can be found online here.
GreenSoft can help with EU REACH compliance
Restricted substances under EU REACH are typically added twice per year, resulting in affected companies needing to re-evaluate their product compliance and possibly re-collect substance data from their suppliers.
GreenSoft Technology helps manage this process for companies, including coverage for the SCIP Database, by performing data collection, data validation, substance calculations and report generation as part of our EU REACH data services.
Learn more about how our Data Services help your company with EU REACH compliance by contacting us.