(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 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.

(11)

Regulation (EU) 2019/1021 should therefore be amended accordingly,