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 twelfth meeting of the Conference of the Parties to the Stockholm Convention, which took place in Geneva, Switzerland from 28 April to 9 May 2025, it was decided to include long-chain perfluorocarboxylic acids, their salts and related compounds in Annex A to the Convention with certain specific exemptions. This decision should be reflected in Annex I to Regulation (EU) 2019/1021.

This delegated act implements decision SC-12/12 to list perfluorocarboxylic acids (C9-21 PFCAs), their salts and related compounds in Annex A, in accordance with Article 15(1) of Regulation (EU) 2019/1021.

A subgroup of C9-21 PFCAs (C9-14 PFCAs) is already restricted in the EU under Regulation (EU) 1907/2006 (REACH), in entry 68 of Annex XVII. It is proposed to include in Annex I to the POPs Regulation the group of C9-21 PFCAs, as covered in the listing in the Convention, which also covers the subgroup already restricted in entry 68 of Annex XVII to REACH. The exemptions included in entry 68 of Annex XVII have expired, except the exemption for can coating for pressurised metered-dose inhalers, granted in entry 68 until 25 August 2028, and the exemption for semiconductors used in replacement parts for finished electronic equipment placed on the market before 31 December 2023, which is granted in entry 68 until 31 December 2030. The exemption for can coating for pressurised metered-dose inhalers is no longer needed, as confirmed by the relevant stakeholder. It is proposed to include in Annex I to the POPs Regulation the exemption for finished electronic equipment until 31 December 2030.

Concerning the Unintentional Trace Contaminant (UTC) limits, it is proposed to use the concentration limits specified in entry 68.

2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

Experts designated by each Member State were consulted in the relevant expert group (the ‘POPs CA meeting’) on the draft delegated act and comments were taken into account.

Relevant stakeholders, including the chemicals industry and the civil society, also took part in the discussions on the listing of long-chain perfluorocarboxylic acids, their salts and related compounds in Annex I to the POPs Regulation in the 'POPs CA meeting' and comments were taken into account.

A public consultation on the draft act was carried out through the public feedback mechanism portal and the comments have been taken into account as follows.

3.LEGAL ELEMENTS OF THE DELEGATED ACT

The delegated act amends the list of chemicals in Annex I based on developments under the Convention, as required by Article 15(1) of Regulation (EU) 2019/1021. The legal basis for the delegated act is 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 long-chain perfluorocarboxylic acids, their salts and 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 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 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 twelfth meeting held from 28 April to 9 May 2025 to amend Annex A to the Convention to include long chain perfluorocarboxylic acids, their salts and related compounds in that Annex with specific exemptions. The Union supported the inclusion of long chain perfluorocarboxylic acids, their salts and related compounds in Annex A with specific exemptions as decided in Council Decision (EU) 2025/868 4 .

(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 long chain perfluorocarboxylic acids, their salts and related compounds.

(5)A group of long chain perfluorocarboxylic acids, their salts and related compounds is already restricted in entry 68 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 5  with regard to its manufacture, placing on the market and use, subject to certain derogations, some of which already expired. The derogation for can coating for pressurised metered-dose inhalers laid down in paragraph 7 of entry 68 is no longer needed because long chain perfluorocarboxylic acids are no longer used in that application, as confirmed by the relevant stakeholder. The derogation for semiconductors used in spare or replacement parts for finished electronic equipment granted, by way of a deferred application, in paragraph 9 of entry 68 until 30 December 2030 for finished electronic equipment placed on the market before 31 December 2023 is still needed in the Union and should therefore be included in Part A of Annex I to Regulation (EU) 2019/1021.

(6)To reinforce the application and enforcement of Article 3(1) of Regulation (EU) 2019/1021 in the Union, a limit value should be set for long chain perfluorocarboxylic acids, their salts and related compounds occurring as unintentional trace contaminants in substances, mixtures and articles. The limit values should be the same as those set out in entry 68 of Annex XVII to Regulation (EC) No 1907/2006. However, concerning polytetrafluoroethylene micropowders, the limit value should apply only for those micropowders that are transported or treated for the purpose to reduce the concentration of long-chain perfluorocaboxylic acids and their salts below the limit of 0,025 mg/kg, in order to ensure consistency with the entry for perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Part A of Annex I to Regulation (EU) 2019/1021.

(7)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,

   For the Commission

   The President
   Ursula VON DER LEYEN    


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

‘Long chain perfluorocarboxylic acids (C9-21 PFCAs), their salts and related compounds

“Long chain perfluorocarboxylic acids (C9-21 PFCAs), their salts and related compounds” means the following:

(I)linear and branched perfluorocarboxylic acids of the formula CnF2n+1COOH where 8 ≤ n ≤ 20 (C9-21 PFCAs);

(II)their salts

(III)compounds related to C9-21 PFCAs, which are any substances that have the potential to degrade or to be transformed to C9-21 PFCAs, including any substances that contain the perfluorinated alkyl moiety CnF2n+1 (where 8 ≤ n ≤ 20) as one of the structural elements. 

The following compounds are not included as compounds related to C9-21 PFCAs: CnF2n+1X, where X = F, Cl or Br.

[1] 375-95-1,

[2] 335-76-2,

[3] 2058-94-8,

[4] 307-55-1,

[5] 72629-94-8,

[6] 376-06-7,

[7] 141074-63-7,

[8] 67905-19-5,

[9] 57475-95-3,

[10] 16517-11-6,

[11] 133921-38-7,

[12] 68310-12-3,

and others

[1] 206-801-3,

[2] 206-400-3,

[3] 218-165-4,

[4] 206-203-2,

[5] 276-745-2,

[6] 206-803-4,

[7] -

[8] 267-638-1,

[9] -

[10] 240-582-5,

[11] -

[12] 269-701-9,

and others

1. For the purposes of this entry, Article 4(1), point (b), shall apply to the sum of concentrations of C9-21 PFCAs and their 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 C9-21 PFCAs related compounds equal to or below 0,26 mg/kg (0,000026 % by weight) where they are present in substances, mixtures or articles.

3. By way of derogation from paragraphs 1 and 2, for the purposes of this entry, Article 4(1), point (b), shall apply to the sum of concentrations of C9-21 PFCAs, their salts and related compounds, equal to or below 10 mg/kg (0,001 % by weight) where they are present in a substance to be used as a transported isolated intermediate within the meaning of Article 3, point 15(c), of Regulation (EC) No 1907/2006 and fulfilling the strictly controlled conditions set out in Article 18(4), first subparagraph, points (a) to (f), of that Regulation for the production of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms.

4. By way of derogation from paragraph 1, for the purpose of this entry, Article 4(1), point (b) shall apply to the sum of concentrations of C9-21 PFCAs equal to or below 0,1 mg/kg (0,00001 % by weight) where they are present in fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups. This unintentional trace contaminant level shall not apply to articles.

All emissions of C9-21 PFCAs that are unintentionally formed during the production and use of fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups shall be avoided and, if not possible, reduced as far as technically and practically possible.

5. By way of derogation from paragraph 1, for the purpose of this entry, Article 4(1), point (b), shall apply to the sum of concentrations of C9-21 PFCAs and their salts equal to or below 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene micropowders that are transported or treated for the purpose to reduce the sum of concentrations of C9-21 PFCAs and their salts below the limit of 0,025 mg/kg (0,0000025 % by weight).

6. The placing on the market and use of C9-21 PFCAs, their salts and related compounds shall be allowed until 30 December 2030 in semiconductors used in spare parts for, and the repair of, the following:

(a) electronic equipment placed on the market before 31 December 2023 for combustion-engine powered vessels;

(b) electronic equipment placed on the market before 31 December 2023 for land-based motor vehicles that have ceased mass production.

7. Articles containing C9-C21 PFCAs, their salts and related compounds, already in use in the Union before 31 December 2023, may continue to be used.’.