欧盟批准修订REACH法规以限制全氟己酸(PFHxA)及其盐类和相关物质

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

2024-09-25 Reading format 中文 Subscribe +

Targeted audience	EU/EEA manufacturers, EU/EEA importers and their upstream providers
Products concerned	Certain consumer products (mixtures, articles)
Key industries concerned with this insight	Textile products, FCM (food contact materials), cosmetics
Application date	10 October 2026 (10 October 2027 for textiles, leather, furs and hides for the general public, other than in clothing and related accessories; 10 April 2026 for firefighting foams and firefighting foam concentrates for training or for testing, or certain public fire services; 10 October 2029 for firefighting foams and firefighting foam concentrates for civil aviation)
Main content or requirements	On 20 September 2024, the European Commission amended Annex XVII to the EU REACH Regulation by adding a new restriction entry, Entry 79, to restrict undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances content in certain consumer products placed on the EU market. For textiles, leather, furs and hides, footwear, mixtures for the general public, as well as paper and cardboard used as food contact materials, and cosmetic products, the limits for the sum of PFHxA and its salts, and for the sum of PFHxA-related substances, are 25 ppb and 1000 ppb, respectively. The application dates depend on the product category. The application date for major products is 10 October 2026.
Reference	http://data.europa.eu/eli/reg/2024/2462/oj

On 20 September 2024, the European Commission approved and published Regulation (EU) 2024/2462 to amend Annex XVII to the EU REACH Regulation (EC) No 1907/2006, by adding a new restriction entry, Entry 79, on undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances.

The amendment shall enter into force on 10 October 2024. Transition periods of 18 months to five years are granted for different products. Details are shown below:

Restriction

The restriction would prevent the use and place on the EU 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	Application Date
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)	10 October 2026 (24 months)
Textiles, leather, furs and hides, other than in clothing and related accessories referred to above, for the general public		10 October 2027 (36 months)
Certain firefighting foams and firefighting foam concentrates for training or for testing Certain firefighting foams and firefighting foam concentrates for public fire services		10 April 2026 (18 months)
Firefighting foams and firefighting foam concentrates for civil aviation		10 October 2029 (5 years)

Exemption

Substances having a perfluoroalkyl group C₆F₁₃- directly attached to a sulphur atom;
Articles and mixtures placed on the market before 10 October 2026 (10 October 2027, for whose application date is 10 October 2027);
Personal protective equipment intended to protect users against risks within the scope of risk category III, points (a), (c) to (f), (h), and (l) of Annex I to EU PPE Regulation (EU) 2016/425;
Devices within the scope of EU Regulation (EU) 2017/745;
Devices within the scope of EU Regulation (EU) 2017/746; or
Textiles used as construction textiles.

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 carbon atoms.

“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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