On 22 March 2023, ECHA (European Chemicals Agency) has launched a public consultation on restricting PFASs (Per- and Polyfluoroalkyl Substances) in Annex XVII of the EU REACH Regulation (EC) 1907/2006.

Proposed Restriction

The proposed restriction would prevent the manufacturing, use and place on the market of PFASs as substances on their own, and prevent the place on the market of substances, mixtures and articles containing PFASs in a concentration of or above:

1. 25 ppb (0.025 mg/kg) for any PFAS as measured with targeted PFAS analysis (polymeric PFASs excluded from quantification), or
2. 250 ppb (0.25 mg/kg) for the sum of PFASs measured as sum of targeted PFAS analysis, optionally with prior degradation of precursors (polymeric PFASs excluded from quantification), or
3. 50 ppm (50 mg/kg) for PFASs (polymeric PFASs included). 

If total fluorine (F) exceeds 50 mg/kg, the manufacturer, importer or downstream user shall upon request provide to the enforcement authorities a proof for the fluorine measured as content of either PFASs or non-PFASs.

Proposed Application Date

18 months from entry into force of the restriction.

Exemption

Derogations have been proposed for many industrial and professional applications.

Definition

Per- and polyfluoroalkyl substances (PFASs): 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).

A substance that only contains the following structural elements is excluded from the scope of the restriction: CF₃-X or X-CF₂-X’, where X = -OR or -NRR’ and X’ = methyl (-CH₃), methylene (-CH₂-), an aromatic group, a carbonyl group (-C(O)-), -OR’’, -SR’’ or -NR’’R’’’; and where R/R’/R’’/R’’’ is a hydrogen (-H), methyl (-CH₃), methylene (-CH₂-), an aromatic group or a carbonyl group (-C(O)-).

The public consultation on this proposed restriction will last for 6 months, until 25 September 2023. ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Assessment Committee (SEAC) will check the comments. ECHA will send the joint opinion of the Committees to the European Commission, which will, together with EU Member States, decide on whether to include the proposed restriction in Annex XVII of the REACH Regulation.

To prepare for the implementation of these requirements, manufacturers and importers are recommended to review the ingredients of their products, with respect to the presence of fluorine (F) and its content. An actual test on total fluorine (F) content can be a helpful indicator when the ingredient information is not precise, or the presence of impurities in raw materials is not clear.

If fluorine (F) is found in the sample, it may be due to the presence of PFASs. Confirmation tests to identify the exact source of the fluorine are then recommended. 

Intertek is capable of providing you with testing and consultation services on total fluorine (F) content and PFASs content.

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