Eurofins Tech Watch: PFAS restriction proposal - the largest substances ban project ever in Europe

Thursday, February 16, 2023

On 13 January 2023, a proposal to limit the use of PFAS (Per- and polyfluoroalkyl substances) in the EU was submitted to the ECHA (European Chemical Agency) by five European authorities (Denmark, Germany, the Netherlands, Norway, and Sweden).

The collaboration proposed to limit the use of PFAS (Per- and polyfluoroalkyl substances) in the EU, after extensively studying PFAS, their uses, and the risks they pose to humans and the environment over the past three years. This stage involved the consultation of scientific literature and various requests for information from relevant businesses, public authorities, and organisations.

On 7 February 2023, this new restriction proposal was published by ECHA. The restriction proposal seeks to ban both the use and production of PFAS in order to reduce the risks these substances pose to humans and the environment.

PFAS is a group of synthetically produced chemicals that are widely used in society. Common to all PFASs is that they break down very slowly in the environment and they have negative health and environmentally damaging properties. More than 10,000 different types of PFAS exist.

They are available in a range of everyday products and give products water and dirt-repellent properties, among others. They are, therefore, used in many consumer products, for example for the impregnation of textiles, in food packaging, in non-slip coatings in frying pans, in coolants for refrigerators and air conditioners, in ski lubrication, electronic devices, and paints. PFAS are also used in industrial activities such as in chrome plating, as foam suppressors, and in fluorine-containing plastic materials.

Hereinafter the main stages in the process of banning the use of PFAS will be:

• The first stage, ECHA's Scientific Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will initially discuss at their meetings in March 2023 whether the submitted restriction proposal complies with the legal requirements under REACH. After that, the committees will start the scientific examination of the proposal.
• The next stage is a six-month public consultation which is expected to start on 22 March 2023. Anyone may submit information or state an opinion about the proposal.
• Afterwards, two ECHA scientific committees – the Risk Assessment Committee (RAC) and the Socio-Economic Assessment Committee (SEAC) – will present their opinions which are to be completed within 12 months according to the REACH Regulation.
• Finally, the European Commission will draft a definitive proposal for a Member State vote. The ban is subsequently expected to enter into force in 2025.?

Summary of the restriction proposal:

Per- and polyfluoroalkyl substances (PFASs) are defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).

Conditions of restriction:

1. Shall not be manufactured, used or placed on the market as substances on their own;
2. Shall not be placed on the market in:

• another substance, as a constituent;
• a mixture,
• an article

in a concentration of or above:

• 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFASs excluded from quantification)
• 250 ppb for the sum of PFASs measured as the sum of targeted PFAS analysis, optionally with prior degradation of precursors (polymeric PFASs excluded from quantification)
• 50 ppm for PFASs (polymeric PFASs included). If total fluorine exceeds 50 mg F/kg the manufacturer, importer or downstream user shall upon request provide to the enforcement authorities proof for the fluorine measured as content of either PFASs or non-PFASs.

1. Paragraphs 1 and 2 shall apply 18 months from entry into force of the restriction.

A number of derogations, reporting requirements and management plans implementation have been also provided in the conditions of restriction (Paragraphs 4 to 9). For further information on these, please consult the complete Annex XV restriction report on the ECHA website.

For more information, consult the ECHA’s website?here .