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Document Ares(2023)958923

COMMISSION DELEGATED REGULATION (EU) …/... 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 PHFxS-related compounds

Please be aware that this draft act does not constitute the final position of the institution.

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE DELEGATED ACT

The objective of Regulation (EU) 2019/1021 is to protect human health and the environment from persistent organic pollutants (‘POPs’) by prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the market and use of substances subject to the Stockholm Convention on POPs (‘the Convention’). At the tenth Conference of the Parties to the Stockholm Convention, which took place in Geneva, Switzerland in June 2022, it was decided to include perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds in Annex A to the Convention. That decision should be reflected in Annex I to Regulation (EU) 2019/1021.

This delegated act implements decision SC-xx to list perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds in Annex A, in accordance with Article 15(1) of Regulation (EU) 2019/1021.

2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

An expert group (the 'POPs CA meeting') was consulted on the draft delegated act on [insert date] and comments were taken into account. The group is composed of all the relevant stakeholders - representatives of Member States, of the European Chemicals Agency, the chemicals industry and the civil society.

A public consultation was carried out for the draft act from [insert date] to [insert date] [summarise comments received and replies]

3.LEGAL ELEMENTS OF THE DELEGATED ACT

The delegated act amends the list of chemicals in Annex I on the basis of developments under the Convention, as required by Article 15(1) of Regulation (EU) 2019/1021.

COMMISSION DELEGATED REGULATION (EU) …/...

of XXX

amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorohexane sulfonic acid (PFHxS), its salts and PHFxS-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’).

(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.

(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.

It shall apply from xx

Done at Brussels,

   For the Commission

   The President
   Ursula VON DER LEYEN
   

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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

‘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; 

(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.

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 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 [… PO: please insert the date 3 years after entry into force of this amending Regulation]’.

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