BAKGRUNN (fra Kommisjonsforslaget)

Regulation (EC) No 396/2005 establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002, in particular the need to ensure a high level of consumer protection and harmonised Union provisions relating to maximum levels (MRLs) of pesticide residues in or on food and feed of plant and animal origin. It recognises that, for food and feed produced outside the Union, different agricultural practices as regards the use of plant protection products may be legally applied, sometimes resulting in pesticide residues differing from those resulting from uses legally applied in the Union. Therefore, it provides for the possibility to apply for the setting of MRLs for imported products (i.e., import tolerances) by providing a comprehensive scientific dossier that take these uses and the resulting residues into account, which is evaluated by a Member State and the European Food Safety Authority (EFSA). Also, MRLs set at international level by the Codex Alimentarius Commission are also considered when MRLs are set, taking into account the corresponding good agricultural practices.

For the active substance thiacloprid, the EFSA Conclusions on the peer review 1 identified areas of critical concern in relation to the contamination of groundwater with metabolites of thiacloprid with respect to one or more representative uses that satisfy the approval criteria provided in Article 4 of Regulation (EC) No 1107/2009. As a consequence, the approval of the substance was not renewed by Commission Implementing Regulation (EU) 2020/23 2 . In addition, thiacloprid is classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council as toxic for reproduction category 1B.

Member States had to withdraw authorisations for plant protection products containing thiacloprid as active substance by 3 August 2020. The maximum grace period allowed to be given by a Member State in accordance with Article 46 of Regulation (EC) No 1107/2009 expired on 3 February 2021.

In accordance with Article 14(1)(a) and in conjunction with Article 17 of Regulation (EC) No 396/2005, following the non-renewal of thiacloprid, the Commission drafted a Regulation to lower its MRLs to the limit of quantification (LOQ). Nevertheless, some exceptions are possible for certain import tolerances and Codex MRLs (CXLs), in particular where those were recently reviewed and were found safe by EFSA3. Those MRLs were kept according to Article 3(2), point (g) and Article 14 (2), points (a), (c) and (e) of Regulation (EC) No 396/2005.

The Commission proposed a draft Regulation to the Member States, that was thoroughly discussed in the Standing Committee on Plants, Animals, Food and Feed in its meetings on 13-14 February 2023, 10-11 May 2023 and 18-19 September 2023.