(fra kommisjonsforordningen)

(1) For imazalil, mandipropamid, propaquizafop, quizalofop-P-ethyl and quizalofop-Ptefuryl, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For carbofuran, MRLs were set in Annex II and Part B of Annex III to that Regulation. 

(2) On 30 November 2024, the Codex Alimentarius Commission revoked some Codex maximum residue limits (‘CXLs’) for the active substance carbofuran. For the only one of those revoked CXLs that was implemented in the Union, concerning cotton seeds, the European Food Safety Authority (‘the Authority’) evaluated alternative authorised good agricultural practices (‘GAPs’) to identify a fall-back MRL proposal and published a scientific report. 

(3) In its report, the Authority recommended lowering the MRL for carbofuran in cotton seeds at the current limit of determination (‘LOD’), since carbofuran is not approved in the Union and no import tolerances have been requested for carbofuran on cotton seeds. Moreover, the MRLs for carbofuran on all other products are currently set at the product-specific LODs. It is, therefore, appropriate to delete the MRLs currently set for carbofuran in Annex II and Part B of Annex III to Regulation (EC) No 396/2005 and to set MRLs for carbofuran on all products at the product-specific LODs in Annex V to that Regulation. 

(4) The Authority assessed the MRLs for imazalil in accordance with Article 12 of Regulation (EC) No 396/2005 in 2017 but identified some information as unavailable for certain products. In 2018, it updated its reasoned opinion4 following new information submitted by the applicant related to the toxicological profiles of metabolites R014821, FK-722 and FK-284. The Authority identified some information gaps on: residue trials for peppers, courgettes and melons; toxicological data on metabolites R014821, FK-722 and FK-284; and storage stability data. The available information was nevertheless sufficient for the Authority to propose tentative MRLs. Since those MRLs were safe for consumers, they were set in Annex II to Regulation (EC) No 396/20055 , specifying the date by which the missing information was to be submitted to the Authority in support of the proposed MRLs. 

(5) Subsequently, the applicant submitted information to address part of the data gaps identified and in parallel submitted a request to modify the existing MRLs for imazalil in citrus fruits in accordance with Article 6 of Regulation (EC) No 396/2005. 

(6) The Authority assessed the application and the further information submitted and concluded in its reasoned opinion6 that the data gap concerning the toxicological profile of metabolites R014821, FK-772 and FK-284 was addressed. The data gap on storage stability was addressed. 

(7) The data gaps on residue trials were not addressed in the case of melons. The Authority concluded that the EU critical GAP on melons submitted in the MRL review is not sufficiently supported by data and noted that the alternative Codex MRL of 2 mg/kg has been withdrawn in 2019. No import tolerances have been requested for imazalil on melons. Therefore, the MRLs laid down in Annex II to Regulation (EC) No 396/2005 for imazalil on melons should be lowered to the LOD. The data gaps on residue trials were not addressed either in the case of peppers. Therefore, the MRLs laid down in Annex II to Regulation (EC) No 396/2005 for imazalil on peppers should stay at the LOD. 

(8) As regards the application concerning citrus fruits, the Authority concluded that the submitted information was sufficient to derive an MRL for the whole group of citrus fruits. It is, therefore, appropriate to set the MRLs for imazalil on citrus fruits in Annex II to Regulation (EC) No 396/2005 at the level recommended by the Authority, at which it identified no risk for consumers. 

(9) An application requesting a modification of the existing MRLs for imazalil in cucumbers, courgettes and gherkins was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005. 

(10) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report and the supporting dossier to the Authority. 

(11) The Authority assessed the application and the evaluation report and gave a reasoned opinion on the proposed MRLs . It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. 

(12) The Authority concluded that the data submitted in support of the application were found appropriate to derive or confirm the MRL proposal for cucumbers, courgettes and gherkins. The Authority also concluded that the confirmatory data requirement as regards additional residue trials on courgettes has been met. The data gap on the toxicological information for the metabolites has been addressed. The Codex MRL for cucumbers and gherkins has been revoked in 2019. Therefore, it is appropriate to set the MRLs for these commodities in Annex II of Regulation (EC) No 396/2005 at the levels recommended by the Authority. 

(13) In light of the review carried out for the MRLs for imazalil and of the outcomes of the applications for MRLs concerning imazalil in certain commodities, the respective footnotes requiring the submission of additional information on imazalil should be deleted from Annex II to Regulation (EC) No 396/2005. 

(14) On 12 July 2019, the Codex Alimentarius Commission adopted a new Codex maximum residue level (‘CXL’) for the active substance imazalil in bananas. 

(15) On 2 December 2023, the Codex Alimentarius Commission adopted new CXLs for the active substance mandipropamid. 

(16) In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council, where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts thereof would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of the Union food law, or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with Article 13, point (e), of that Regulation, the Union is to promote consistency between international technical standards and Union food law while ensuring that the high level of protection adopted in the Union is not reduced.

(17) til (34) utelatt her.