In August 2020, the European Commission has drafted a regulation to amend Entry 68 of Annex XVII to REACH Regulation (EC) No 1907/2006, which is the entry currently restricting perfluorooctanoic acid (PFOA), its salts and related substances.

The purpose of amending the entry is to prevent the manufacture, placing on the market and use of potential substitutes for PFOA, namely perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and related substances.

In short, the Commission intends to restrict C9-C14 PFCAs, their salts and related substances in the following ways:

1. The substances shall not be manufactured or placed on the market as substances on their own.
2. The substances shall not be used in or placed on the market in:
   1. Another substance as a constituent;
   2. A mixture;
   3. An article,

Except if the concentration is < 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 Commission proposes to apply the restrictions at a later time on the following products:

1. Textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety (from 4 July 2023);
2. Manufacture of polytetrafluoroethylene (PTFE) and polyinylidene fluoride (PVDF) for the production of (i) High-performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles, (ii) industrial waste heat exchanger equipment, (iii) industrial sealants capable of preventing leakage of volatile organic compounds and PM2.5 particulates (from 4 July 2023);
3. Semiconductors; and semiconductors incorporated in semi-finished and finished electronic equipment (from 31 December 2023);

Also, some time-limited exemptions are provided for the use of C9-C14 PFCAs, their salts and related substances in:

1. Photolithography or etch processes in semiconductor manufacturing (until 4 July 2025);
2. Photographic coatings applied to films (until 4 July 2025);
3. Invasive and implantable medical devices (until 4 July 2025);
4. Fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, subject to specific conditions (until 4 July 2025).

Note:

• “C9-C14 PFCAs”means linear and branched perfluorocarboxylic acids of the formula CnF2n+1-C(=O)OH where n = 8, 9, 10, 11, 12, or 13.
• “C9-C14 PFCA-related substances”are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to C9-C14 PFCAs, either having:
  1. A perfluoro group with the formula CnF2n+1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including any combinations thereof; or
  2. 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 any combinations thereof.
• The following substances are excluded:
  1. CnF2n+1-X, where X = F, Cl, or Br where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof;
  2. CnF2n+1-C(=O)OX' where n > 13 and X' = any group, including salts.

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