On August 8, 2023, the European Commission published the Commission Regulation (EU) 2023/1608 to amend the European Union Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs), by listing perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds in Annex I to the EU POPs Regulation. The Regulation will come into effect on the 20th day following its publication in the Official Journal and will be applicable in all Member States. The specific revisions are as follows:
In Part A of Annex I to Regulation (EU) 2019/1021, the following entry is added:
‘Perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds
“Perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds” means the following:
(i) perfluorohexane sulfonic acid, including any of its branched isomers;
(ii) its salts; and
(iii) PFHxS-related compounds which, for the purposes of the Convention, are any substance that contains the chemical moiety C6F13S- as one of its structural elements and that degrades to PFHxS.
355-46-4 and others
206-587-1 and others
Specific exemption on intermediate use or other specification
1. For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFHxS or any of its salts equal to or below 0.025 mg/kg (0.0000025% by weight) where they are present in substances, mixtures or articles.
2. For the purposes of this entry, Article 4(1), point (b), shall apply to the sum of concentrations of all PFHxS-related compounds equal to or below 1 mg/kg (0.0001% by weight) where they are present in substances, mixtures or articles.
3. For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFHxS, its salts, and PFHxS-related compounds equal to or below 0.1 mg/kg (0.00001% by weight) where it is present in concentrated firefighting foam mixtures that are to be used or are used in the production of other firefighting foam mixtures. This exemption will be reviewed and assessed by the Commission no later than August 28, 2026.
Perfluorohexane sulfonic acid (PFHxS) is a group of per- and polyfluoroalkyl substances (PFAS). As a substitute for perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA), PFHxS is extensively used in various products such as firefighting foams, metal plating, textiles, leather, polishing agents, cleaning/detergent, coatings, as well as electronics and semiconductor manufacturing. PFHxS is, as a result of its long-range environment migration, likely to lead to significant adverse impacts on human health and the environment. In 2017, PFHxS and its salts were listed as substances of very high concern (SVHC) by the European Chemicals Agency (ECHA). In June 2022, PFHxS, its 147 salts, and related compounds were also added to Annex A of the Stockholm Convention with no exemptions.
Persistent Organic Pollutants (POPs) refer to organic pollutants that exhibit characteristics of persistence, bioaccumulation, semi-volatility, and high toxicity, whether they are naturally occurring or synthetically produced. POPs have the ability to undergo long-range migration through various environmental media such as air, water, and living organisms, posing significant threats to human health and ecological environments.
The European Union’s regulation on Persistent Organic Pollutants (POPs), published in 2019, is designed to manage substances listed in the Annex of the Stockholm Convention. Its primary objectives are:
- Prohibiting or strictly restricting the production, placing on the market, and use of POPs;
- Reducing emissions of POPs from industrial by-products;
- Ensuring safe storage of restricted POPs; and
- Ensuring environmentally sound disposal of waste containing or contaminated by POPs.
The management of PFAS substances is becoming increasingly stringent worldwide. Relevant companies should closely monitor the latest regulatory policies and stay ahead of cutting-edge technologies to ensure compliance and the safety of their products.
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