EU Proposed Amendment to REACH Regulation to Restrict PFHxA, Its Salts and PFHxA-related Substances
In June 2023, the European Commission has proposed a regulation to amend the Annex XVII to the EU REACH Regulation (EC) No 1907/2006, by adding a new restriction entry of undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances.
The proposed regulation is scheduled to be adopted and published in fourth quarter of 2023. Transition periods of 18 months to five years are granted for different products. Details are shown below:
Restriction
The proposed restriction would prevent the use and place on the market of products in which PFHxA, its salts and PFHxA-related substances are in a concentration equal to or greater than:
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Products
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Limits in homogeneous
material
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Transition period
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- Textiles, leather, furs and hides in clothing and related accessories for the general public;
- Footwear for the general public;
- Paper and cardboard used as food contact materials within the scope of the EU FCM Regulation (EC) No 1935/2004;
- Mixtures for the general public;
- Cosmetic products as defined in Article 2(1), point (a), of the EU Cosmetics Regulation (EC) No 1223/2009
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- Sum of PFHxA and its salts: 25 ppb (0.025 mg/kg), and
- Sum of PFHxA-related
substances: 1000 ppb (1 mg/kg)
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24 months
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Textiles, leather, furs and hides, other than in clothing and related accessories referred above, for the general public
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36 months
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- Fire-fighting foams for training and for testing (except functional testing of the firefighting systems);
- Fire-fighting foams for municipal fire services
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18 months
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Fire-fighting foams for civil aviation
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5 years
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Exemption
- Substances having a perfluoroalkyl group C6F13- directly attached to a sulphur atom; or
- Articles placed on the market before 24 months from the date of entry into force of this regulation.
Definition
“Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances” means:
- having a linear or branched perfluoropentyl group with the formula C5F11- directly attached to another carbon atom as one of the structural elements; or
- having a linear or branched perfluorohexyl group with the formula C6F13-.
The following substances are excluded from this designation:
- C6F14;
- C6F13-C(=O)OH, C6F13-C(=O)O-X′ or C6F13-CF2-X′ (where X′ = any group, including salts);
- any substance having a perfluoroalkyl group C6F13- directly attached to an oxygen atom at one of the non-terminal carbons.
“PFHxA-related substances” are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to PFHxA.
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