Commission Delegated Regulation (EU) 2025/1482 of 24 July 2025 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the persistent organic pollutants tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether
Date: 2025-07-24
Institutions: Directorate-General for Environment, European Commission
Subjects: bromine, dangerous substance, international convention, market approval, organic chemical, organic pollution, pollution control measures, protocol to an agreement, public health, toy industry




L_202501482EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1482


28.10.2025







            COMMISSION DELEGATED REGULATION (EU) 2025/1482
of 24 July 2025
         
amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the persistent organic pollutants tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether
(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)


Pursuant to Article 3(1) of Regulation (EU) 2019/1021, the manufacturing, placing on the market and use, whether on their own, in mixtures or in articles, of substances listed in Annex I to that Regulation are prohibited, subject to Article 4 of that Regulation.












(3)


Tetrabromodiphenyl ether (tetraBDE), pentabromodiphenyl ether (pentaBDE), hexabromodiphenyl ether (hexaBDE), heptabromodiphenyl ether (heptaBDE) and decabromodiphenyl ether (decaBDE) (together ‘listed polybrominated diphenyl ethers’, ‘listed PBDE’) are listed in Annex I to Regulation (EU) 2019/1021 with an unintentional trace contaminant (UTC) limit value of 500 mg/kg for the sum of the concentrations of the five substances where they are present in mixtures or articles. That UTC limit value is subject to review by the Commission.












(4)


Regulation (EU) 2022/2400 of the European Parliament and of the Council (4) reduces the concentration limit in waste for the sum of tetraBDE, pentaBDE, hexaBDE, heptaBDE and decaBDE to 500 mg/kg as of 10 June 2023, to 350 mg/kg from 30 December 2025 and to 200 mg/kg from 30 December 2027.












(5)


The manufacturing, placing on the market and use of PBDE in the Union have been largely phased out. However, due to past and current recycling activities the substances occur in products made from recovered materials, including products for the general public.












(6)


Particular attention should be given to childcare products and toys in view of potential exposure to listed PBDE contained in them. To address the situation where listed PBDE may be present unintentionally in childcare products and toys manufactured from recovered material, it is justified to set an unintentional trace contaminant limit value for them.












(7)


Taking into account the objective of Regulation (EU) 2019/1021 to protect human health and the environment from persistent organic pollutants by prohibiting, phasing out as soon as possible, or restricting their manufacturing, placing on the market and use, the fact that listed PBDE occur mainly in products from recovered materials, and the limit of detection of relevant determination methods, different UTC limit values should be set for mixtures and articles made from or containing listed PBDE-containing recovered material and other mixtures and articles. Food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council (5) should be excluded from this Regulation as listed PBDE should in principle not be present in food contact materials in accordance with Commission Regulations (EU) No 10/2011 (6) and (EU) 2022/1616 (7).












(8)


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, 24 July 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)  Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 3, ELI: http://data.europa.eu/eli/convention/2006/507/oj).

(3)  Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L 81, 19.3.2004, p. 37, ELI: http://data.europa.eu/eli/prot/2004/259/oj).

(4)  Regulation (EU) 2022/2400 of the European Parliament and of the Council of 23 November 2022 amending Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants (OJ L 317, 9.12.2022, p. 24, ELI: http://data.europa.eu/eli/reg/2022/2400/oj).

(5)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI: http://data.europa.eu/eli/reg/2004/1935/oj).

(6)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1, ELI: http://data.europa.eu/eli/reg/2011/10/oj).

(7)  Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (OJ L 243, 20.9.2022, p. 3, ELI: http://data.europa.eu/eli/reg/2022/1616/oj).




ANNEX
Annex I to Regulation (EU) 2019/1021 is amended as follows:






(1)


in Part A, in the table, in the entry ‘Tetrabromodiphenyl ether C12H6Br4O’, point 2 in the fourth column is replaced by the following:






‘2.


For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:






(a)


10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council (*1);










(b)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;










(c)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council (*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.









(*1)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI: http://data.europa.eu/eli/reg/2004/1935/oj)."
                        

(*2)  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, ELI: http://data.europa.eu/eli/dir/2009/48/oj).’;"
                        










(2)


in Part A, in the table, in the entry ‘Pentabromodiphenyl ether C12H5Br5O’, point 2 in the fourth column is replaced by the following:






‘2.


For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:






(a)


10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;










(b)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;










(c)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;


















(3)


in Part A, in the table, in the entry ‘Hexabromodiphenyl ether C12H4Br6O’, point 2 in the fourth column is replaced by the following:






‘2.


For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:






(a)


10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;










(b)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;










(c)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;


















(4)


in Part A, in the table, in the entry ‘Heptabromodiphenyl ether C12H3Br7O’, point 2 in the fourth column is replaced by the following:






‘2.


For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:






(a)


10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;










(b)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;










(c)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;


















(5)


in Part A, in the table, in the entry ‘Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE)’, point 2 in the fourth column is replaced by the following:






‘2.


For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:






(a)


10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;










(b)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;










(c)


by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.














(*1)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI: http://data.europa.eu/eli/reg/2004/1935/oj).

(*2)  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, ELI: http://data.europa.eu/eli/dir/2009/48/oj).’;’



ELI: http://data.europa.eu/eli/reg_del/2025/1482/oj
ISSN 1977-0677 (electronic edition)