Date: 2023-08-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2023/1608 of 30 May 2023 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds (Text with EEA relevance)
Executive Summary:
This Commission Delegated Regulation (EU) 2023/1608 amends Annex I to Regulation (EU) 2019/1021, incorporating perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds into the list of substances. It sets limit values for PFHxS as unintentional trace contaminants. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment of Annex I to Regulation (EU) 2019/1021:**
* PFHxS, its salts, and PFHxS-related compounds are added to Part A of Annex I.
* **Limit Values for PFHxS:**
* 0.025 mg/kg for PFHxS (including its salts) in substances, mixtures, or articles.
* 1 mg/kg for individual or combined PFHxS-related compounds in substances, mixtures, or articles.
* 0.1 mg/kg for PFHxS, its salts and PFHxS-related compounds present in concentrated firefighting foam mixtures.
* **Exemptions and Review:**
* Article 4(1)(b) applies to concentrations at or below the specified limit values.
* The exemption for firefighting foam mixtures will be reviewed by the Commission by August 28, 2026.
Impact Analysis:
**Manufacturers, Importers, and Suppliers of Substances, Mixtures, and Articles:**
* Impact: Need to ensure that PFHxS, its salts, and PFHxS-related compounds as unintentional trace contaminants in their products do not exceed the specified limit values.
* Action Required: Review product composition, implement monitoring and testing procedures, and adjust manufacturing processes as needed to comply with the new limits.
**Firefighting Foam Manufacturers and Users:**
* Impact: Need to comply with the limit value of PFHxS, its salts and PFHxS-related compounds present in concentrated firefighting foam mixtures, and be aware of the upcoming review of this exemption.
* Action Required: Monitor PFHxS levels, explore alternatives, and prepare for potential stricter limits after the Commission's review.
**European Commission:**
* Impact: Responsible for enforcing the regulation and reviewing the exemption for firefighting foam mixtures.
* Action Required: Monitor compliance, conduct the review of the firefighting foam exemption by August 28, 2026, and consider potential revisions to the concentration limits.
**Member States:**
* Impact: Responsible for ensuring the regulation is applied and enforced.
* Action Required: Incorporate the regulation into national law and conduct checks and controls to verify compliance.
Key Entities Referenced
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Regulation EU 2019/1021: A regulation of the European Parliament and of the Council on persistent organic pollutants.
European Parliament: One of the legislative branches of the European Union.
Council of the European Union: A legislative body of the European Union consisting of government ministers from each member state.
perfluorohexane sulfonic acid PFHxS: A persistent organic pollutant being added to Annex I of Regulation EU 2019/1021.
Stockholm Convention on Persistent Organic Pollutants: An international environmental treaty aiming to eliminate or restrict the production and use of persistent organic pollutants (POPs).
Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants: An international agreement focused on reducing air pollution, specifically persistent organic pollutants, across national boundaries.
Ursula VON DER LEYEN: The President of the European Commission.
L 198/24 EN Official Journal of the European Union 8.8.2023
COMMISSION DELEGATED REGULATION (EU) 2023/1608
of 30 May 2023
amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as
regards the listing of perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019on persistent
organic pollutants(1), and in particular Article 15(1) thereof,
Whereas:
(1) Regulation (EU) 2019/1021 implements the commitments of the Union under the 2001 Stockholm Convention on
Persistent Organic Pollutants(2)(‘the Convention’) and under the Protocol to the 1979 Convention on Long Range
Transboundary Air Pollution on Persistent Organic Pollutants(3)(‘the Protocol’).
(2) Annex A to the Convention contains a list of chemicals. Each Party to the Convention is required to prohibit the
chemicals on the list and/or take the legal and administrative measures necessary to eliminate their production, use,
import and export.
(3) The Conference of the Parties to the Convention has, pursuant to Article 8(9) of the Convention, decided in its tenth
meeting from 6to 17 June 2022to amend Annex A to the Convention in order to include perfluorohexane sulfonic
acid (‘PFHxS’), its salts and PFHxS-related compounds in that Annex without any specific exemption.
(4) Part A of Annex I to Regulation (EU) 2019/1021, which contains a list of the substances listed in the Convention and
in the Protocol as well as substances listed only in the Convention, should therefore also be amended to include
PFHxS, its salts and PFHxS-related compounds.
(5) In order to reinforce the application and enforcement in the Union of Article 3 of Regulation (EU) 2019/1021, a
limit value should be set for PFHxS, its salts and PFHxS-related compounds occurring as an unintentional trace
contaminant in substances, mixtures and articles. That limit value should be set at 0,025 mg/kg for PFHxS including
its salts, and at 1 mg/kg for the individual PFHxS-related compounds or a combination of those compounds. For the
use in firefighting foams where those limit values cannot currently be met, higher concentration limits should be
established, subject to review by the Commission within 3 years after entry into force with a view to lowering the
limits.
(6) Regulation (EU) 2019/1021 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EU) 2019/1021 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
(1) OJ L 169, 25.6.2019, p. 45.
(2) OJ L 209, 31.7.2006, p. 3.
(3) OJ L 81, 19.3.2004, p. 37.8.8.2023 EN Official Journal of the European Union L 198/25
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 May 2023.
For the Commission
The President
Ursula VON DER LEYENL 198/26 EN Official Journal of the European Union 8.8.2023
ANNEX
In Part A of Annex I to Regulation (EU) 2019/1021, the following entry is added:
Specific exemption on intermediate use or other
Substance CAS No EC No
specification
‘Perfluorohexane sulfonic acid (PFHxS), its 355-46-4 206-587-1 1. For the purposes of this entry, Article 4(1),
salts and PFHxS-related compounds and others and others point (b), shall apply to concentrations of
PFHxS or any of its salts equal to or below
“Perfluorohexane sulfonic acid (PFHxS), its
0,025 mg/kg (0,0000025 % by weight)
salts and PFHxS-related compounds” means
where they are present in substances, mix
the following:
tures or articles.
(i) perfluorohexane sulfonic acid, includ
2. For the purposes of this entry, Article 4(1),
ing any of its branched isomers;
point (b), shall apply to the sum of con
(ii) its salts; centrations of all PFHxS-related com
pounds equal to or below 1 mg/kg
(iii) PFHxS-related compounds which, for
(0,0001 % by weight) where they are pre
the purposes of the Convention, are
sent in substances, mixtures or articles.
any substance that contains the chemical
moiety C F S- as one of its structural 3. For the purposes of this entry, Article 4(1),
6 13
elements and that degrades to PFHxS. point (b), shall apply to concentrations of
PFHxS, its salts and PFHxS-related com
pounds equal to or below 0,1 mg/kg
(0,00001 % by weight) where it is present
in concentrated firefighting foam mix
tures that are to be used or are used in
the production of other firefighting foam
mixtures. This exemption shall be re
viewed and assessed by the Commission
no later than 28 August 2026.’