Commission Delegated Regulation (EU) 2025/1930 of 15 May 2025 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards Dechlorane Plus

Official Journal EN of the European Union L series 2025/1930 25.9.2025 COMMISSION DELEGATED REGULATION(EU) 2025/1930 of 15 May 2025 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards Dechlorane Plus (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 eleventh meeting held from 1 to 12 May 2023 to amend Annex A to the Convention to include Dechlorane Plus in that Annex with specific exemptions. The Union supported the inclusion of Dechlorane Plus in Annex A with specific exemptions as stipulated in Council Decision (EU) 2023/1006(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 Dechlorane Plus. (4) In 2022, the European Chemicals Agency’s Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) (the ‘committees’) adopted their opinions(5)on a restriction dossier from Norway for Dechlorane Plus under Regulation (EC) No 1907/2006 of the European Parliament and of the Council(6). The opinions support a restriction of manufacture and use of Dechlorane Plus, with certain derogations for specific uses. Those derogations are included in the list of specific exemptions granted under the Convention by Decision SC-11/10 of the (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) Council Decision (EU) 2023/1006 of 25 April 2023 on the position to be taken on behalf of the European Union at the eleventh meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants as regards the proposals for amendments of Annex A to that Convention (OJ L 136, 24.5.2023, p. 55, ELI: http://data.europa.eu/eli/dec/2023/1006/oj). (5) https://echa.europa.eu/documents/10162/d4e88790-cfe2-c934-7ea4-489e1602d6c2. (6) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). ELI: http://data.europa.eu/eli/reg_del/2025/1930/oj 1/5EN OJ L, 25.9.2025 Conference of the Parties and should be granted as exemptions also under Regulation (EU) 2019/1021 since they are still needed in the Union. This concerns, among others, spare parts for land-based motor vehicles, such as cars, motorcycles, agricultural and construction motor vehicles and industrial trucks, including motor vehicles covered by Regulations (EU) 2018/858(7), (EU) No 167/2013(8)and (EU) No 168/2013(9)of the European Parliament and of the Council. (5) The Convention includes exemptions for the use of Dechlorane Plus that are not recommended in the committees’ opinions. This includes use of that substance for the purpose of spare parts for outdoor power equipment, medical devices, in vitro diagnostic devices and instruments for analysis, measurements, control, monitoring, testing, production and inspection as well as for the repair of certain articles. Considering that the volume of Dechlorane Plus used in spare parts and for the repair of articles is small and taking into account the importance of maintaining articles already in use, such exemptions should be included in Regulation (EU) 2019/1021. (6) The maximum duration of the exemptions should be five years, with the possibility to extend for an additional period of five years, in accordance with Article 4(4) of the Convention. This is especially relevant for the exemptions for medical imaging applications and radiotherapy devices and installations, for which the committees’ opinions supported a duration of seven and 10 years, respectively. The Commission should review the need for a prolongation of the specific exemptions at the latest by 1 April 2028 in order to prepare for the Conference of the Parties that is expected to be held in May 2029, since a potential extension of the specific exemptions for this substance under the Convention will have to be decided at that Conference of the Parties. (7) 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 Dechlorane Plus and that are produced or placed on the market under an exemption laid down in 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. (8) Furthermore, in line with Decision SC-11/10, the exemption covering the placing on the market and use of Dechlorane Plus for the purposes of spare parts for certain vehicles, certain machines, for the purposes of marine, garden, forestry and outdoor power equipment, for the purposes of aerospace, space and defence applications and for the purposes of certain instruments is granted until the end of the service life of the relevant product or until 31 December 2043, whichever comes earlier, or, with regard to spare parts for the purposes of medical devices and in vitro diagnostic devices, until the end of the service life of the relevant product. The service life of products in defence, aerospace and space applications may go beyond 2043. The placing on the market and use of spare parts for such applications, present in the territory of the Union before or on the date of the expiry of the relevant exemption, should therefore be allowed even after that date. (9) 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 Dechlorane Plus occurring as an unintentional trace contaminant in substances, mixtures and articles. (10) Considering that laboratories need to improve analysis accuracy and to ensure uniform and adequate application of analytical methods, the unintentional trace contaminant limit should be set at 1 000 mg/kg. 30 months after the entry into force of this Regulation, that limit should be 1 mg/kg. (7) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1, ELI: http:// data.europa.eu/eli/reg/2018/858/oj). (8) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1, ELI: http://data.europa.eu/eli/reg/2013/167/oj). (9) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52, ELI: http://data.europa.eu/eli/reg/2013/168/oj). 2/5 ELI: http://data.europa.eu/eli/reg_del/2025/1930/ojEN OJ L, 25.9.2025 (11) 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, 15 May 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_del/2025/1930/oj 3/5EN OJ L, 25.9.2025 ANNEX In Part A of Annex I to Regulation (EU) 2019/1021, the following entry is added: Specific exemption on intermediate use or other Substance CAS No EC No specification ‘Dechlorane Plus 13560-89-9 236-948-9 1. For the purposes of this entry, Article 4(1), point (b), shall apply to concentrations of Dechlorane “Dechlorane Plus” includes its 135821-03-3 Plus: syn-isomer and anti-isomer 135821-74-8 (a) equal to or below 1 000 mg/kg (0,1 % by weight) where they are present in substances, mixtures or articles until 15 April 2028; (b) equal to or below 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles after 15 April 2028. 2. By way of derogation, the placing on the market and use of Dechlorane Plus shall be allowed for the following purposes: (a) aerospace, space and defence applications, until 26 February 2030; (b) medical imaging applications, until 26 February 2030; (c) radiotherapy devices and installations, until 26 February 2030; (d) spare parts for, and the repair of, any of the following: (i) land-based motor vehicles; (ii) stationary industrial machines for use in agriculture, forestry and construction; (iii) marine, garden, forestry and outdoor power equipment other than that covered under (ii); (iv) aerospace, space and defence applications; (v) instruments for analysis, measurements, control, monitoring, testing, production and inspection; where Dechlorane Plus was initially used in their production, until the end of their service life or until 31 December 2043, whichever comes earlier: (e) spare parts for, and the repair of, any of the following: (i) medical devices and accessories for medical devices within the scope of Regulation (EU) 2017/745; 4/5 ELI: http://data.europa.eu/eli/reg_del/2025/1930/ojEN OJ L, 25.9.2025 Specific exemption on intermediate use or other Substance CAS No EC No specification (ii) in vitrodiagnostic medical devices and accessories for in vitrodiagnostic medical devices within the scope of Regulation (EU) 2017/746; where Dechlorane Plus was initially used in their production, until the end of their service life. 3. The Commission shall assess the need for a prolongation of the specific exemptions in points (a), (b) and (c) of paragraph 2 at the latest by 1 April 2028. 4. Articles containing Dechlorane Plus already in use in the Union before or on the date of expiry of the relevant exemption laid down in paragraph 2(a) to (d) may continue to be used. 5. Placing on the market and use of spare parts containing Dechlorane Plus referred to in paragraph 2, point (d)(iv) that are present in the territory of the Union before or on 31 December 2043 shall be allowed.’ ELI: http://data.europa.eu/eli/reg_del/2025/1930/oj 5/5