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EU: REACH Annex XVII restriction on PFHxA was published

SEPTEMBER 2024 - HARDLINES, SOFTLINES

On 20 September 2024, the Official Journal of the European Union (OJEU) published Regulation (EU) 2024/24621, which added a new restriction on undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances under Annex XVII to REACH regulation as entry 79.

PFHxA belongs to the group of per- and polyfluoroalkyl substances (PFAS), known for its expectational resistant to chemical, thermal and biological degradation. PFAS substances have a variety of applications such as water, oil and grease repellent treatments for carpets, furniture and clothing. They can also be found in Teflon products, semiconductors and fire-fighting foam.

In 2019, Germany submitted a dossier to the European Chemicals Agency (ECHA) proposing to restrict PFHxA, its salts and PFHxA-related substances under REACH Annex XVII. After two public consultations launched by ECHA, the agency submitted its final opinions to the EC. Considering the dossier submitted by Germany and the opinions of ECHA, the EC concluded that the use and market placement of PFHxA, its salts, and PFHxA-related in certain mixtures and articles pose an unacceptable risk to human health and the environment. Therefore, this risk should be addressed on an EU-wide basis.

The new restriction will enter into force on 10 October 2024. However, transitional periods ranging from 18 months to 5 years will apply to various product categories. 

Table A. Restriction on PFHxA, its salts and PFHxA-related substances

Target Substance Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances
Scope of restriction
  • Textiles, leather, furs and hides in products 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;
  • fire-fighting foams for training, testing, public fire services and civil aviation.
Limit
  • Sum of PFHxA and its salts: < 25 ppb;
  • Sum of PFHxA related substances: < 1000 ppb
Date of application
  • 10 April 2026: fire-fighting foams for training, testing and public fire services;
  • 10 October 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;
  • 10 October 2027: textiles, leather, furs and hides in products other than clothing and related accessories for the general public;
  • 10 October 2029: fire-fighting foams for civil aviation.

 

 

 

HOW DOES THIS IMPACT YOU AND YOUR BUSINESS?

CONTACT US TO DISCUSS.

TÜV SÜD has dedicated experts to assist you in the development of consumer products and meeting applicable regulations. Through a global network of laboratories, TÜV SÜD offers a wide range of services that includes chemical tests, physical or mechanical tests as well as inspections to ensure the compliance of your products in target markets. 

For enquiries, please contact us at  [email protected].

 

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