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Annex XVII of the EU REACH regulation is officially revised to restrict the use

Date:2024-09-25 16:55:29 Classification :【Statute】 Visits:
On September 20, 2024, the European Union issued Official Journal (EU) 2024/2462, adding new restrictions on perfluorohexanoic acid (PFHxA), its salts and related substances in Appendix XVII of the REACH regulation. The revised proposal was announced in February this year pass. At this point, Annex XVII of the EU REACH Regulation has been added to item 79, and the regulation will take effect 20 days after the date of publication in the Official Journal of the European Union.


Source: eur-lex.europa.eu

▋Substance definition
✅Perfluorohexanoic acid (PFHxA) and its salts and related substances*:
(a) Contains straight-chain or branched perfluoropentyl (C5F11-), directly connected to another carbon atom as one of the structural elements;
or (b) substances containing linear or branched perfluorohexyl (C6F13-).
* PFHxA-related substances are substances that are considered to have the potential to degrade or convert to PFHxA based on their molecular structure.

❌The following substances do not fall within the scope of the definition:
(a) Perfluorohexane (C6F14);
(b) C6F13-C(=O)OH, C6F13-C(=O)O-X' or C6F13-CF2-X' (X' refers to any group, including salts);
(c) Any substance containing a perfluorohexyl group (C6F13-) directly bonded to an oxygen atom on a non-terminal carbon atom.


▋Properties and applications
PFHxA substances have a variety of hazardous properties, and their persistence far exceeds the "vP (very persistent high persistence)" standard stipulated in point 1.2.1 of Appendix XIII of the REACH regulation. They are also mobile in the aquatic environment and are harmful to human health. and the environment have potential adverse effects.
PFHxA itself is not registered or used in the EU, but several PFHxA-related substances and PFHxA ammonium salts have been registered in the EU and are widely used in food contact materials, textiles, fire-fighting foams, etc., with annual production or import volumes ranging from 1 to 100 tons. above.



▋New terms
In order to control the release of PFHxA and prevent its accumulation in the environment, the European Union has proposed restricting the use of PFHxA substances in cosmetics and other products.
From October 10, 2026, the content of PFHxA in cosmetics must meet the following limits before they can be placed on the EU market or used:
(a) The total concentration of PFHxA and its salts is <0.025 mg/kg;
(b) The total concentration of PFHxA-related substances is <1 mg/kg.


▋Scope of control


**The above provisions do not apply to substances containing perfluoroalkyl C6F13-directly connected to a sulfur atom that are banned in Annex I of Regulation (EU) 2019/1021.

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