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:

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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

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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

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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

  • Substances
    on their own – prohibited
  • C9-C14
    PFCAs and their salts (sum) – < 25 ppb
  • C9-C14
    PFCA-related substances (sum) – < 260 ppb

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

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Hingwo Tsang

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