PFCAs banned from 23 february onwards

The European Commission has published REGULATION (EU) 2021/1297 of 4 August 2021 amending Annex XVII to REACH restricting perfluorocarboxylic acids (PFCAs) containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and substances from 23 February 2023 onwards, although some uses have been granted longer transition periods.

The decision responds to a restriction proposal submitted by German and Swedish authorities in 2017.

Reasons for the restriction proposal

The main reason argued in the proposal was to prevent a switch by industry using PFOA-based substances to longer chain PFCAs (‘C9-14 chemistry’) to fulfil the same role in the end products now that the restriction for PFOA, (salts and PFOA-related substances) has become effective.

In the text of the proposal, was exposed why the use of these substances would be equally harmful to human and environmental health due to some of their properties:

  • 1. A number of other PFAS are on the REACH Candidate List of substances of very high concern (SVHC). Certain PFAS are toxic for reproduction and can harm the development of foetuses, also have been demonstrated to cause cancer. On the other hand, some PFAS are suspected of interfering with the human endocrine (hormonal) system but testing in this area is ongoing. C9-C14 PFASs are bioaccumulative and belong to the most persistent chemical substances known, due to its carbon-fluorine bonds.
  • 2. PFASs do not undergo any further abiotic or biotic degradation under environmentally relevant conditions. They have a high-water solubility leading to relatively high mobility in water bodies and between different environmental compartments, and they can also be transported over long distances via the atmosphere and aquatic environment. As a result, they are found ubiquitously in the environment, even in remote areas, as well as in human body fluids.

Due to these properties, they are very likely to cause severe and irreversible adverse effects to the environment and to human health if their releases are not minimised.

ECHA´S final decision

The Committee of Risk Assessment (RAC) and the Committee for Socio Economic Analysis (SEAC) stated in their joint opinion on the restriction proposal that “Per- and polyfluoroalkyl substances (PFASs) are emerging pollutants of the 21st century.” Due to their outstanding properties - they provide water, oil, and grease repellency and are very stable − certain PFASs have been used in a variety of consumer products, as non-stick pans, cellphones and sun lotion, but their potential risk to human and environmental health is equally important.

That is why their conclusion of the Dossier Submitter’s risk assessment is that “a restriction on a Union-wide basis is justified to reduce the release of these substances into the environment and to prevent any future manufacturing, placing on the market and use”, supporting the restriction proposal.

So, taking into account the Annex XV dossier and the opinions of RAC and SEAC, the Commission finally published REGULATION (EU) 2021/1297 restricting the manufacture, use or placing on the market of linear and/or branched C9-C14 PFCAs, their salts and C9-C14 PFCA- related substances on their own, as a constituent of other substances, in mixtures and in articles, considering them “an unacceptable risk to human health and the environment”.

The application of the restriction will come into force in February 2023, but longer deferrals or overall exemptions should apply to address the cases of specific sectors.