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EU Revises REACH ANNEX XVII Restricting C9-C14 PFCAS

Per- and polyfluoroalkyl substances (PFAS) is a chemical family widely used in the industrial and consumer goods due to their properties of water repellence and anti-grease.  However, they are classified as persistent organic pollutants, which can be accumulated in organisms and human bodies causing long-time damage to humans and the environment. In recent years, the restriction of PFAS in many countries and regions has become more stringent, and the enforcement agencies have also strengthened the enforcement actions where more PFAS substances are restricted under relevant regulations. 

Perfluoro carboxylic acids (PFCAs) is one category of per-fluorinated substances, which have attracted the attention of relevant parties.

On August 5, 2021, the European Commission published (EU) 2021/1297, revising REACH Annex XVII by replacing Entry 68 with the restriction of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances, which will enter into force 20 days after its publication in the official journal of the European Union.

Previously, the EU published regulation (EU) 2020/2096 in 2020 to remove the restricted requirements on PFOA in Entry 68 of Annex XVII due to its inclusion in POPs Regulation.

Highlights of (EU) 2021/1297 are listed as following:

  • Linear and branched perfluoro carboxylic acids of the formula CnF2n+1-C(=O)OH (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 below structure, including heir salts and any combinations thereof:
    • Having a perfluoro group with the formula CnF2n+1- (n=8, 9, 10, 11, 12, or 13) directly attached to another carbon atom.
      o    Having a perfluoro group with the formula CnF2n+1- (n=9, 10, 11, 12, 13 or 14) that it is not directly attached to another carbon atom.
  • Shall not be manufactured or placed on the market as substances on their own from February 25, 2023.
  • From February 25, 2023, shall not be used in, or placed on the market, unless 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 concentration limit shall be 10 ppm for the sum of C9-C14 PFCAs, their salts and C9-C14 PFCA related substances, where they are present in a substance to be used as a transported isolated intermediate, provided that the conditions fulfilling the strictly controlled conditions set out in REACH regulation for the manufacturing of fluorochemicals with a perfluoro carbon chain length equal to or shorter than 6 atoms.
  1. The following substances are excluded from this entry:
    •    CnF2n+1-X, where X=F, Cl, or Br, where n=9, 10, 11, 12, 13 or 14, including any combinations thereof,
    •    CnF2n+1-C(= O)OX' where n> 13 and X'=any group, including salts
2.    The regulation set detailed deadlines for certain applications of C9-C14 PFCAs, their salts and C9-C14-PFCA-related substances
Through our global network of laboratories and highly trained specialists, SGS offers a one-stop-shop for services to ensure that your production and distribution systems support your compliance with REACH legislation.

Please contact our Customer Service Team for more information!

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