The EU has added C9-C14 PFCAs and C9-C14 PFCA-related substances under ANNEX XVII of REACH. The new law will become effective on February 25, 2023.

SAFEGUARDS | Consumer ProductsNO. 113/21

 SG 11321 Chemical

On August 5, 2021, the European Union (EU) published Regulation (EU) 2021/1297 to replace entry 68 to Annex XVII of Regulation (EC) 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH, consolidated version to July 2021) in relation to ‘Restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures and articles.’ 

The new law regulates perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances – a family of substances that occur as unintentional by-products during the manufacture of perfluorinated and polyfluorinated substances containing a carbon chain of less than nine carbon atoms, such as perfluorooctanoic acid (PFOA), or as potential substitutes for PFOA, its salts and PFOA-related substances.   

The following C9-C14 PFCAs are in the Candidate List of substances of very high concern (SVHCs):

  • Perfluorononan-1-oic acid (PFNA) and its sodium and ammonium salts 
  • Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
  • Henicosafluoroundecanoic acid (PFUnDA)
  • Tricosafluorododecanoic acid (FPDoDA)
  • Pentacosafluorotridecanoic acid (PFTrDA)
  • Heptacosafluorotetradecanoic acid (PFTDA).

Highlights of new entry 68 to Annex XVII of REACH in the new law are summarized in Table 1. 

Regulation (EU) 2021/1297 Amending Annex XVII to REACH as regards Perfluorocarboxylic Acids Containing 9 to 14 Carbon Atoms in the Chain (C9-C14 PFCAs), their Salts and C9-C14 PFCA-Related Substances

Substance

Scope

Requirement5

Effective Date

  • C9-C14 PFCAs1, including their salts and any combinations thereof

  • C9-C14 PFCA-related substances2, 3, 4, including their salts and any combinations thereof

  • Substances on their own

  • Prohibited

February 25, 2023 (manufacture or placed on the market)

  • As a constituent of another substance

  • Mixtures

  • Articles

  • < 25 ppb (sum of C9-C14 PFCAs and their salts)

  • < 260 ppb (sum of C9-C14 PFCA-related substances)

February 25, 2023 (use or placed on the market)

1Linear and branched perfluorocarboxylic acids with the formula CnF2n+1-C(O)OH where n = 8, 9, 10, 11, 12 or 13
2Having a perfluoro group with the formula CnF2n+1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12 or 13
3Having a perfluoro group with the formula CnF2n+1- that is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements
4The following substances are excluded:

  • CnF2n+1-X, where X = F, Cl, or Br; n = 9, 10, 11, 12, 13 or 14, including any combinations thereof

  • CnF2n+1-C(O)OX’, where n > 13 and X’ = any group, including salts

5Certain derogations apply

Table 1

SGS keeps interested parties informed about the latest developments relating to the REACH regulation. Our expertise, combined with consultancy services and experience in consumer product supply chains, provides a central point of contact for global solutions. In the end, it’s only trusted because it’s tested. Discover more on our website, read our brochure and contact us if you would like to learn more about how SGS can support your REACH compliance activities. 

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Hingwo Tsang
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