Considerations on 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 ... |
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| document | COM(2023)499  |
| date | August 30, 2023 |
(2)An application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 for tricyclazole used in Brazil on rice was submitted. The applicant states that the authorised uses of that substance on such crop in Brazil lead to residues exceeding the MRL provided for in Regulation (EC) No 396/2005 and that a higher MRL is necessary to avoid trade barriers for the importation of that crop.
(3)In accordance with Article 8 of Regulation (EC) No 396/2005, this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.
(4)The European Food Safety Authority ('the Authority') assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRL 3 . It forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public.
(5)The Authority concluded that, for the product concerned, all requirements with respect to completeness of data submission were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance, which was not previously available and was only provided with the application concerned. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.
(6)Based on the reasoned opinion of the Authority and taking into account the factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is appropriate to conclude that the proposed modification to the MRL fulfils the requirements of that Article.
(7)Regulation (EC) No 396/2005 should therefore be amended accordingly.
(8)The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. The measures provided for in this Regulation should therefore be adopted by the Council.