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Product Stewardship

New restriction on perfluorinated substances

The restriction nr. 68 on pefluorocarboxylic acids C9-C14, their salts and C9-C14 PFCA-related substances is applicable as of February 2023

A new restriction for the placing on the market of pefluorocarboxylic acids C9-C14, their salts and C9-C14 PFCA-related substances has been introduced in Annex XVII of REACH Regulation.

Fluorinated substances are lately kept under review by che EuropeanXfor their health and environmental impacts; the restriction is in particular about:

  • 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;
  • 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;
  • 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.

Some substances are already part of the Candidate List (CL), like PFNA and PFDA because of the reproductive toxicity and the PBT profile. Other substances, like PFUnDA and il PFDoDA are in CL for the vPvB danger.

Fluorinated substances are actually mostly present as not intentional added by-product in the manufacturing process (Eg Pentadecafluorooctanoic acid, PFOA), but it cannot be excluded to be used in future as substitutes of PFOA and fluorinated with less than 9 carbons.

The restriction of PFCA C9-C14 and related substances takes effect on the 25th of February 2023 prohibiting:

  • manufacturing or placing on the market as substances;
  • placing on the market and use 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.

The restriction include some derogations, such as:

  • the concentration limit for C9-C14 PFCAs, their salts and C9-C14 PFCA related substances, shall be 10 ppm where they are present in a substance to be used as a transported isolated intermediate;
  • Longer deadlines and different concentration limit depending on the sector of use.

We highly recommend the companies impacted by the restriction to evaluate its applicability in order to be ready to face the changement by February 2023. Given the complexity of the regulation we suggest to read the text for a detailed examination of all the provisions.


Source: Official journal of the European Union

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