EU Proposes Regulations on C9-C14 PFCAs Under REACH

The European Union (EU) has published a draft proposal that, if approved, would regulate perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and related substances.

C9-C14 PFCAs are a family of substitutes for perfluorooctanoic acid (PFOA), its salts and related substances. According to the definitions, C9-C14 PFCAs and their related substances have the following meanings:

• Linear and branched C9-C14 PFCAs having the formula CnF2n+1-C(O)OH, where n = 8, 9, 10, 11, 12 or 13:
o C9-PFCA (perfluorononan-1-oic acid, PFNA, CAS 375-95-1)
o C10-PFCA (nonadecafluorodecanoic acid, PFDA, CAS 335-76-2)
o C11-PFCA (henicosafluoroundecanoic acid, PFUnDA, CAS 2058-94-8)
o C12-PFCA (tricosafluorododecanoic acid, FPDoDA, CAS 307-55-1)
o C13-PFAC (pentacosafluorotridecanoic acid (PFTrDA, CAS 72629-94-8)
o 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 perfluoro 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

It should be noted, 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 relates to substances on their own, constituents of another substance, mixtures, and articles, although some derogations do apply. According to the draft revision, the requirements are:
• Substances on their own – prohibited
• C9-C14 PFCAs and their salts (sum) – < 25 ppb
• C9-C14 PFCA-related substances (sum) – < 260 ppb

If approved 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 the current entry 68 to Annex XVII of REACH as these substances are now regulated under the POP recast Regulation.

The proposal was circulated by the World Trade Organization (WTO) on August 3, 2020, attached to WTO document number 20-5375. According to the document, the draft revision will be adopted in Q1 of 2021. It will then enter into force 20 days after its publication in the Official Journal of the EU (OJEU) and it will come into effect eighteen months later. This means the restrictions could potentially be effective from the second half of 2022.

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