Explanatory Memorandum to COM(2023)739 - Amendment of Annex II to Regulation 396/2005 as regards maximum residue levels for thiacloprid in or on certain products - Main contents
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| dossier | COM(2023)739 - Amendment of Annex II to Regulation 396/2005 as regards maximum residue levels for thiacloprid in or on certain products. |
|---|---|
| source | COM(2023)739  |
| date | 24-11-2023 |
•Reasons for and objectives of the proposal
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.
•Consistency with existing policy provisions in the policy area
The followed approach is consistent with the provisions of Regulation (EC) No 396/2005.
2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
•Legal basis
In line with the favourable Reasoned Opinion adopted by EFSA and based on Article 14(1)(a) and Article 49 (2) of Regulation (EC) No 396/2005, a draft Commission Regulation was prepared and submitted to the SCoPAFF (see chapter 1). According to Article 45 i of that Regulation the regulatory procedure with scrutiny applies according to Article 5a of Council Decision 1999/468.
•Choice of the instrument
The above mentioned draft Commission Regulation proposing the revision of the MRLs for thiacloprid was submitted to the Standing Committee on Plants, Animals, Food and Feed, on 18-19 September 2023, for an opinion. The Committee did not deliver an opinion on the draft Commission Regulation, as a qualified majority was not reached neither for nor against the proposed measures.
Consequently, pursuant to Article 5a of Council Decision 1999/468/EC in conjunction with Article 45 i of Regulation (EC) No 396/2005, the Commission is submitting to the Council and the Parliament a draft Council Regulation relating to the measures to be taken. The Council shall act on the proposed measure by a qualified majority within one month of referral to it. If the Council opposes the measure by a qualified majority, the measure shall not be adopted. If the Council envisages adopting the measure, it shall without delay submit it to the European Parliament. In the absence of an opinion of the Council, the Regulation is sent back to the Commission who shall without delay submit it for scrutiny to the European Parliament. If the Parliament does not oppose the measure, the latter shall be adopted by the Commission. If the Parliament opposes the measure it shall not be adopted by the Commission.
3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
No ex-post evaluations, stakeholder consultations and impact assessment are foreseen for this implementing Regulation in the context of Regulation (EC) No 396/2005.
The Regulation has no budgetary impact.
5.OTHER ELEMENTS
•Detailed explanation of the specific provisions of the proposal
This Regulation intends to lower all the existing MRLs for thiacloprid to the LOD following the non-renewal of its approval with the exception of some MRLs based on uses in non- EU countries. The MRLs for thiacloprid in papayas and tea corresponds to import tolerances that were confirmed to be safe for consumers by EFSA in 2023 3 . The MRLs for thiacloprid in in tree nuts, quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), plums, strawberries, blackberries, dewberries, other small fruits and berries, kiwis, potatoes, tomatoes, aubergines/eggplants, melons, watermelons, rice, wheat, animal (swine, bovine, sheep, horse, poultry, and other farm animals) products from tissues (muscle, liver, kidney and edible offal), milk and eggs correspond to CXLs that were considered safe for consumers3.