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The EU has published a draft revision to replace entry 68 to Annex XVII of REACH. If approved, the new restrictions may become effective in the second half of 2022.

SAFEGUARDS | Consumer ProductsNO. 121/20

 SG 12120 Scientists

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 CnF2n+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 (CnF2n+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 (CnF2n+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:

  • CnF2n+1-X, where X is F, Cl or Br and n = 9, 10, 11, 12, 13 or 14, including any combinations thereof
  • CnF2n+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 (SafeGuardS 97/17 and 96/20).

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.

WTO Document Number 20-5375, August 3, 2020
Entry 68 to Annex XVII of REACH
Substance Scope* Requirement Effective Date
  • C9-C14 PFCAs, including their salts, and any combinations thereof
  • C9-C14 PFCA-related substances
  • Substances on their own
  • Constituent of another substance
  • Mixtures
  • Articles

Prohibited (substances on their own)

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

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

Potentially second half of 2022
*Certain derogations apply

Table 1 

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