EU Amended REACH Annex XVII with New Restrictions on PFCAs

On 2021-08-04, the European Commission published the Regulation (EU) 2021/1297, amending Annex XVII to Regulation (EC) No 1907/2006 (REACH) -- as regards perfluorocarboxylic acids (PFCAs) containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances.

Significance of this Amendment:

Linear and branched perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances currently mainly occur in the European Union as unintended by-products during the manufacture of perfluorinated and polyfluorinated substances containing a carbon chain of less than 9 carbon atoms, such as perfluorooctanoic acid (PFOA).  Furthermore, it is possible that companies may consider the use of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances as substitutes for PFOA, its salts and related substances in the future, especially after the Union Law restrictions on PFOA become applicable.  Thus, it is necessary to prevent future possible manufacturing and use resulting in increasing releases into the environment.

Major Changes:

In Annex XVII, entry 68 is replaced, including the following significant restrictions:

1. Shall not be manufactured, or placed on the market as substances on their own from 2023-02-25.
2. Shall not, from 2023-02-25, be used in, or placed on the market in:

          (a) another substance, as a constituent;
          (b) a mixture;
          (c) 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.

Effective Date:

These restrictions will be applicable as of 2023-02-25.

References:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R1297&qid=1628207104080

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