EU Proposes to Regulate C9-C14 Perfluorocarboxylic Acids Under Annex XVII of REACH

On August 3, 2020 the World Trade Organization (WTO) circulated a draft regulation from the European Union (EU) to announce its intention to regulate perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C₉-C₁₄ PFCAs), their salts and related substances – a family of substitutes for perfluorooctanoic acid (PFOA), its salts and related substances. The draft regulation and Annex, attached to WTO document number 20-5375, places certain restrictions/prohibitions on these substances with multiple derogations.  

According to the definitions, C₉-C₁₄ PFCAs and their related substances have the following meaning:

• Linear and branched C₉-C₁₄ PFCAs having the formula C_nF_2n+1-C(O)OH, where n = 8, 9, 10, 11, 12 or 13:
  • C₉-PFCA (perfluorononan-1-oic acid, PFNA, CAS 375-95-1)
  • C₁₀-PFCA (nonadecafluorodecanoic acid, PFDA, CAS 335-76-2)
  • C₁₁-PFCA (henicosafluoroundecanoic acid, PFUnDA, CAS 2058-94-8)
  • C₁₂-PFCA (tricosafluorododecanoic acid, FPDoDA, CAS 307-55-1)
  • C₁₃-PFAC (pentacosafluorotridecanoic acid (PFTrDA, CAS 72629-94-8)
  • C₁₄-PFCA (heptacosalfluorotetradecanoic acid, PFTDA, CAS 376-06-7)
• C₉-C₁₄ PFCA-related substances having a perfluoro group (C_nF_2n+1- where n = 8, 9, 10, 11, 12 or 13) directly attached to another carbon atom, including any combinations thereof
• C₉-C₁₄ PFCA-related substances having a group (C_nF_2n+1- where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements) not directly attached to another carbon atom, including any combinations thereof

The following substances are excluded from the meaning:

• C_nF_2n+1-X, where X is F, Cl or Br and n = 9, 10, 11, 12, 13 or 14, including any combinations thereof
• C_nF_2n+1-C(O)OX’ where X’ is any group and n > 13, including salts

The six C₉-C₁₄ PFCAs, including the ammonium and sodium salts of PFNA and PFDA, are also in the Candidate List of substances of very high concern (SVHCs).

The draft regulation would replace entry 68 to Annex XVII of REACH on PFOA, its salts and PFOA-related substances – the European Commission is planning to delete entry 68 to Annex XVII of REACH as these substances are now regulated under the POP recast Regulation.

Per the WTO document, the changes would be:

• Adopted in Q1 of 2021
• Entered into force 20 days from its publication in the Official Journal of the EU (OJEU)
• Effective 18 months after the date of entry into force, potentially second half of 2022

Highlights of the draft regulation are summarized in Table 1.

Table 1 

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