Explanatory Memorandum to COM(2023)499 - Amendment of Annexes II and V to Regulation 396/2005 as regards maximum residue levels for tricyclazole in or on certain products - Main contents
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| dossier | COM(2023)499 - Amendment of Annexes II and V to Regulation 396/2005 as regards maximum residue levels for tricyclazole in or on certain ... |
|---|---|
| source | COM(2023)499  |
| date | 30-08-2023 |
•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). The Commission can set the MRL applied for, provided that safety for European Consumers has been demonstrated using the same criteria as for domestic products.
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy received an application to set an import tolerance for the active substance tricyclazole in rice.
On 26 April 2018, Italy sent a report with its evaluation of that application to EFSA.
On 18 January 2023, EFSA adopted a favourable Reasoned Opinion on the evaluation of the safety of the proposed modified MRL for tricyclazole in rice 1 . The Commission therefore proposed a draft Regulation to the Member States in the Standing Committee for Plants, Animals, Food and Feed (SCoPAFF) to modify the relevant Union MRL accordingly.
•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) 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 modification of the MRL for tricyclazole in rice was submitted to the Standing Committee on Plants, Animals, Food and Feed, on 11 May 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, 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 two months 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 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 provides for a modification of the existing MRL for tricyclazole in rice, raising it from the limit of determination established at 0.01 mg/kg to a level of 0.09 mg/kg, based on a scientific opinion by EFSA. In doing so, the MRLs for tricyclazole, which are currently established in Annex V of Regulation (EC) No 396/2005, will be moved to Annex II of that same Regulation.