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EU: REACH Annex XVII C9-C14 PFCAs restriction has been published

AUGUST 2021 - ELECTRICAL AND ELECTRONICS, HARDLINES, SOFTLINES, TOYS AND CHILDREN'S PRODUCTS

On 5 August 2021, the European Union’s restriction on C9-C14 perfluorocarboxylic acids (PFCAs), their salts and related substances was published in the Official Journal as Regulation (EU) No 2021/12971 . This replaces the Annex XVII entry 68 to REACH Regulation. 

C9-C14 PFCAs are bioaccumulative and belong to the most persistent chemical substances known. These were found as unavoidable by-products during the production of per- and polyfluoroalkyl substances (PFAS) with carbon chain less than 9 carbon atoms and they are potentially used as substitutes for PFOA. A variety of commercial applications use PFAS for example, water, oil and grease repellent treatments for carpets, furniture and clothing. It can be found in teflon products, semiconductors and fire-fighting foam. C9-C14 PFCAs (PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFTDA ) have been added to the Candidate List as substances of very high concern (SVHCs) under REACH.

Germany and Sweden proposed this restriction back in 2017. Taking into account the Annex XV dossier and the opinions of European Chemicals Agency’s committees, the European Commission considers that the risk to human health from the placing on the market or use of C9-C14 PFCAs, their salts and related substances is unacceptable, and the risk needs to be addressed on a Union wide basis. REACH Annex XVII should be amended accordingly. The highlight of the restriction can be found in Table A.

The new restriction will apply from 25 February 2023, and some applications can enjoy longer transition periods.

Table A.  Restriction on C9-C14 PFCAs

Scope of restriction

Substances, mixtures and articles  
Requirement

[Effective from 25 February 2023]

  • Substances: Not used (Not detected);
  • As constituents in other substances, mixtures, articles: 
    1.     Sum of C9-C14 PFCAs and their salts: < 25 ppb; or
    2.     Sum of C9-C14 PFCAs-related substances: < 260 ppb;
  • Present in a substance to be used as a transported isolated intermediate: < 10 ppm for sum of C9-C14 PFCAs, their salts and related substances;
  • Present in PTFE micro powders, as well as in mixtures and articles for industrial and professional uses containing PTFE micro powders: < 1000 ppb for sum of C9-C14 PFCAs;
  • Fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups: < 2000 ppb for sum of C9-C14 PFCAs.

    [Effective from 25 August 2024]
    Fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups: < 100 ppb for sum of C9-C14 PFCAs.

    Longer transition periods are granted to certain industry and professional applications e.g. fire-fighting foam, photographic coatings and semiconductors, etc. Details can be referred to legal text.
Exemption
Articles placed on the market before 25 February 2023

 

 

[1]  Legal text – Regulation (EU) No. 2021/1297

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