EU Regulates C9-C14 Perfluorocarboxylic Acids (PFCA) under REACH

26 Oct 2022

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.

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In 2021, the European Commission published Commission Regulation (EU) 2021/1297, updating Entry 68 of Annex XVII, which restricts perfluorocarboxylic acids containing 9 – 14 carbons in the chain (C₉-C₁₄ PFCAs), their salts and their related substances.

PFCA

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 shown below:

Effective Date	Restriction Details
25 February 2023	Shall not be manufactured, or placed on the market as substances on their own Shall not be used in, or placed on the market in: another substance, as a constituent; a mixture; an article, except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances
Definitions: Linear and branched perfluorocarboxylic acids of the formula CnF2n +1-C(= O)OH where n = 8, 9, 10, 11, 12, or 13 (C₉-C₁₄ PFCAs), including their salts, and any combinations thereof; Any C₉-C₁₄ PFCA-related substance having a perfluoro group with the formula CnF2n +1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof; Any C₉-C₁₄ PFCA-related substance having a perfluoro group with the formula CnF2n +1- that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.

Effective Date

Restriction Details

25 February 2023

Shall not be manufactured, or placed on the market as substances on their own
Shall not be used in, or placed on the market in:
- another substance, as a constituent;
- a mixture;
- an article,

except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances

Definitions:

Linear and branched perfluorocarboxylic acids of the formula CnF2n +1-C(= O)OH where n = 8, 9, 10, 11, 12, or 13 (C₉-C₁₄ PFCAs), including their salts, and any combinations thereof;
Any C₉-C₁₄ PFCA-related substance having a perfluoro group with the formula CnF2n +1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof;
Any C₉-C₁₄ PFCA-related substance having a perfluoro group with the formula CnF2n +1- that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.

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