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EU proposes to amend REACH regulations to limit perfluorohexanoic acid (PFHxA), its salts, and related substances


Time:

2023-07-14

EU proposes to amend REACH regulations to limit perfluorohexanoic acid (PFHxA), its salts, and related substances

In June 2023, the European Commission proposed to amend Annex XVII of the EU REACH Regulation (EC) No 1907/2006, adding new restrictions on perfluorohexanoic acid (PFHxA), its salts, and PFHxA related substances.


The proposed regulations are planned to be adopted and released in the fourth quarter of 2023. The proposed regulations propose a transitional period of 18 months to 5 years for different products. The details are as follows:


limit

The proposed regulation aims to limit the use of perfluoroaxoic acid (PFHxA), its salts, and PFHxA related substances in the following products, and to limit the market placement of these products when the concentration of the substance is equal to or above the limit value:

 

 

Product Limits in Mean Material Transition period

1. Textiles, leather, fur, and animal skins in clothing and related accessories for the general public;

2. Footwear for the general public;

3. Paper and cardboard used in food contact within the scope of the EU Food Contact Materials (FCM) Regulation (EC) No 1935/2004;

4. Mixtures for the general public;

5. Cosmetics as defined in Article 2, Paragraph 1, Point a of the European Union Cosmetics Regulation (EC) No 1223/2009

1. Sum of concentrations of PFHxA and any of its salts: 25 ppb (0.025 mg/kg), and

2. Sum of concentrations of all PFHxA related compounds: 1000 ppb (1 mg/kg)

24 months
Textiles, leather, fur, and animal skins for the general public (except for the aforementioned clothing and related accessories) 36 months

1. Firefighting foam for training and testing (except for functional test of fire protection system);

2. Firefighting foam for municipal fire protection

18 months
Firefighting foam for civil aviation 5 years

 

Exemption
1. Substances containing perfluoroalkyl C6F13- directly connected to a sulfur atom; or
2. Articles that have been placed on the market 24 months prior to the effective date of this regulation.

 

Definition
Perfluorohexanoic acid (PFHxA), its salts, and PFHxA related substances refer to:
a. Containing a straight or branched perfluoroapentyl C5F11 directly connected to another carbon atom as one of its structural elements; or
b. Contains a straight or branched perfluorohexyl C6F13-.

 

Excluding the following substances:
a. C6F14;
b. C6F13-C (=O) OH, C6F13-C (=O) O-X ′ or C6F13-CF2-X ′ (when X ′=any functional group, including salts);
c. A substance containing a perfluoroalkyl C6F13- directly connected to an oxygen atom on a non terminal carbon atom.
"PFHxA related substances" refer to substances that are considered to be likely to degrade or convert into perfluorohexanoic acid (PFHxA) according to their molecular structure.

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