欧盟提议修订REACH法规以限制全氟己酸(PFHxA)及其盐类和相关物质

EU Proposed Amendment to REACH Regulation to Restrict PFHxA, Its Salts and PFHxA-related Substances

2023-07-06 Reading format 中文 Subscribe +

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:

Products	Limits in homogeneous material	Transition period
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	Sum of PFHxA and its salts: 25 ppb (0.025 mg/kg), and Sum of PFHxA-related substances: 1000 ppb (1 mg/kg)	24 months
Textiles, leather, furs and hides, other than in clothing and related accessories referred above, for the general public		36 months
Fire-fighting foams for training and for testing (except functional testing of the firefighting systems); Fire-fighting foams for municipal fire services		18 months
Fire-fighting foams for civil aviation		5 years

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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