Commission Delegated Regulation (EU) 2025/1399 of 5 May 2025 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds
Date: 2025-05-05
Institutions: Directorate-General for Environment, European Commission
Subjects: environmental protection, fluorine, intermediate goods, international convention, market approval, organic acid, organic pollution, pollution control measures, protocol to an agreement, public health








L_202501399EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1399


14.7.2025







            COMMISSION DELEGATED REGULATION (EU) 2025/1399
of 5 May 2025
         
amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorooctanoic acid (PFOA), its salts and PFOA-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).












(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, taking into account applicable specific exemptions laid down in that Annex.












(3)


Commission Delegated Regulation (EU) 2020/784 (4) amended Annex I to Regulation (EU) 2019/1021 to include perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (‘PFOA entry’). Subsequently, the PFOA entry has been amended by Commission Delegated Regulations (EU) 2021/115 (5) and (EU) 2023/866 (6).












(4)


Annex I to Regulation (EU) 2019/1021 contains a specific exemption for the use of PFOA, its salts and PFOA-related compounds in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, subject to certain conditions. That exemption expires on 4 July 2025. Member States and stakeholders have reported difficulties for operators to comply with the deadline. This could be due to the difficulties in measuring PFOA-related compounds in the foams and underestimation of the volumes of foams containing PFOA-related compounds. The specific exemption should therefore be extended until 3 December 2025, which is the maximum extension possible under the Convention.












(5)


In point 1 of the PFOA entry in Annex I to Regulation (EU) 2019/1021, the unintentional trace contaminant (UTC) limit is set at 0,025 mg/kg for PFOA or any of its salts, where they are present in substances, mixtures and articles. In point 2 of that entry, the UTC limit is set at 1 mg/kg for any individual PFOA-related compound or a combination of PFOA-related compounds, where they are present in substances, mixtures or articles. As recent analytical data from several Member States have shown that PFOA or its salts and PFOA-related compounds can be present in higher concentrations as unintentional trace contaminants in fire-fighting foams and fire-fighting foam concentrates for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, a specific UTC limit should be set at 1 mg/kg for PFOA or any of its salts and at 10 mg/kg for any individual PFOA-related compound or combination of PFOA-related compounds in such foams and foam concentrates for a period of three years. That period of time will allow operators sufficient time to substitute foams and foam concentrates containing PFOA or any of its salts and PFOA-related compounds above the current UTC limits.












(6)


When removing foams containing PFOA, its salts and PFOA-related compounds from the fire-fighting systems, some of these substances can remain inside the system even after it has been cleaned and could contaminate the new foams that are installed. It is therefore appropriate to set a UTC limit for PFOA, its salts and PFOA-related compounds in fluorine-free fire-fighting foams installed after cleaning of the fire-fighting system to replace foams containing PFOA, its salts and PFOA-related compounds. That limit should be set at 10 mg/kg for the sum of PFOA, its salts and PFOA-related compounds.












(7)


To ensure clarity on the foams, concentrates or solutions covered in Annex I to Regulation (EU) 2019/1021, a definition is added clarifying that the term ‘Fire-fighting foam’ covers any mixture to fight fires with foam as well as firefighting foam concentrates and firefighting foam solutions to produce the foam.












(8)


Article 3 of Regulation (EU) 2019/1021 prohibits the manufacturing, placing on the market and use of substances listed in Annex I to that Regulation whether on their own, in mixtures or in articles. In this regard, it should be clarified that articles that contain PFOA, its salts and PFOA-related compounds and that are produced or placed on the market under an exemption laid down in that Annex I to that Regulation and that were already in use on the expiry date of the relevant exemption, are allowed to continue to be used after that date.












(9)


Points 3 and 10 of the PFOA entry set out an obligation for the Commission to review the UTC limits for PFOA, its salts and PFOA-related compounds with regard to certain medical devices and substances to be used as a transported isolated intermediate. There is currently no information supporting a change in such limits. Considering that the Commission can amend the PFOA entry if new information becomes available, the review clauses should be deleted.












(10)


The first column of the PFOA entry, under point (v), refers to ‘Perfluorooctane sulfonic acid and its derivatives (PFOS)’. As the wording of the first column of PFOS entry has been changed to ‘Perfluorooctane sulfonic acid (PFOS), its salts and PFOS-related compounds’, the reference in the PFOA entry should be changed 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, 5 May 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 169, 25.6.2019, p. 45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj.

(2)  Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 1, ELI: http://data.europa.eu/eli/dec/2006/507/oj).

(3)  Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L 81, 19.3.2004, p. 35, ELI: http://data.europa.eu/eli/dec/2004/259/oj).

(4)  Commission Delegated Regulation (EU) 2020/784 of 8 April 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (OJ L 188 I, 15.6.2020, p. 1, ELI: http://data.europa.eu/eli/reg_del/2020/784/oj).

(5)  Commission Delegated Regulation (EU) 2021/115 of 27 November 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (OJ L 36, 2.2.2021, p. 7 ELI: http://data.europa.eu/eli/reg_del/2021/115/oj).

(6)  Commission Delegated Regulation (EU) 2023/866 of 24 February 2023 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (OJ L 113, 28.4.2023, p. 5, ELI: http://data.europa.eu/eli/reg_del/2023/866/oj).




ANNEX

1.   

In Annex I, Part A, to Regulation (EU) 2019/1021, in the table, entry ‘Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds’, first column, point (v), ‘perfluorooctane sulfonic acid and its derivatives (PFOS) as listed in this Annex’ is replaced by ‘perfluorooctane sulfonic acid (PFOS), its salts and PFOS-related compounds as listed in this Annex’.



2.   
In Annex I, Part A, to Regulation (EU) 2019/1021, in the table, entry ‘Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds’, the fourth column is amended as follows:






(1)


in point 3, the second sentence is deleted;










(2)


the following points 4a and 4b are inserted:






‘4a.


For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of PFOA or any of its salts equal to or below 1 mg/kg (0,0001 % by weight) and to concentrations of any individual PFOA-related compound or combination of PFOA-related compounds equal to or below 10 mg/kg (0,001 % by weight) where they are present in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems. This limit value shall apply until 3 August 2028.










4b.


For the purposes of this entry, Article 4(1), point (b), shall apply to the sum of the concentration of PFOA, its salts and PFOA-related compounds equal to or below 10 mg/kg (0,001 % by weight) where they are present in fluorine-free fire-fighting foam and originate from fire-fighting equipment which has undergone cleaning in accordance with the best available techniques.’;














(3)


in point 6, the date ‘4 July 2025’ is replaced by ‘3 December 2025’;










(4)


at the end of point 6, the following sentence is added:

                        ‘
                        “firefighting foam” means any mixture to fight fires with foam and includes but is not limited to firefighting foam concentrates and firefighting foam solutions to produce the foam.’;










(5)


in point 10, the second sentence is deleted;










(6)


the following point 11 is added:






‘11.


Articles containing PFOA, its salts or PFOA-related compounds already in use in the Union before or on the date of expiry of the relevant exemption laid down in points 5(a) to (d) may continue to be used.’.












ELI: http://data.europa.eu/eli/reg_del/2025/1399/oj
ISSN 1977-0677 (electronic edition)