# L_2023198EN.01002401.xml

| 8.8.2023 | EN | Official Journal of the European Union | L 198/24 |
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8.8.2023

EN

Official Journal of the European Union

L 198/24

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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 2019 on 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’). |
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(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. |
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(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 6 to 17 June 2022 to 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. |
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(3)

The Conference of the Parties to the Convention has, pursuant to Article 8(9) of the Convention, decided in its tenth meeting from 6 to 17 June 2022 to 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. |
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(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. |
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(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, |
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(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.

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 LEYEN

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(1)  
  OJ L 169, 25.6.2019, p. 45.

1

(2)  
  OJ L 209, 31.7.2006, p. 3.

2

(3)  
  OJ L 81, 19.3.2004, p. 37.

3

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ANNEX

In Part A of Annex I to Regulation (EU) 2019/1021, the following entry is added:

| Substance | CAS No | EC No | Specific exemption on intermediate use or other specification |
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| ‘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; |

Substance

CAS No

EC No

Specific exemption on intermediate use or other specification

‘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; |
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(ii)

its salts;

| (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. |
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(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

| 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. |
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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. |
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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 shall be reviewed and assessed by the Commission no later than 28 August 2026.’ |
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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 shall be reviewed and assessed by the Commission no later than 28 August 2026.’

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