(Utkast) Kommisjonsforordning (EU) …/… om endring av vedlegg II, III og V til europaparlaments- og rådsforordning (EF) nr. 396/2005 med hensyn til øvre grenseverdier for rester av ametoktradin, cyflumetofen, diflufenikan og milbemektin i eller på visse produkter
Grenseverdier for rester av plantevernmidler i næringsmidler: ametoktradin, cyflumetofen, diflufenikan og milbemektin
Utkast til kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering og publisert i EUs komitologiregister 29.10.2026
Bakgrunn
(fra kommisjonsforordningen)
(1) For the active substances ametoctradin, cyflumetofen, diflufenican and milbemectin, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.
(2) As regards cyflumetofen, an application requesting a modification of the existing MRLs was submitted for sweet peppers/bell peppers pursuant to Article 6(1) of Regulation (EC) No 396/2005. As regards milbemectin, such an application was submitted for cherries (sweet).
(3) The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports prepared by the evaluating Member States, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs. It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public.
(4) As regards those applications, the Authority concluded that the data were appropriate to derive or confirm the MRL proposals for the commodities under assessment. It is therefore appropriate to set the requested MRLs for cyflumetofen in sweet peppers/bell peppers and for milbemectin in cherries (sweet) in Annex II to Regulation (EC) No 396/2005 at the levels recommended by the Authority.
(5) As regards ametoctradin, tentative MRLs were set by Commission Regulation (EU) 2021/1110 for barley, oat, rye, wheat, hops, bovine muscle, bovine fat, bovine liver, bovine kidney, equine muscle, equine fat, equine liver, equine kidney, swine muscle, swine fat, swine liver, swine kidney, sheep muscle, sheep fat, sheep liver, sheep kidney, goat muscle, goat fat, goat liver, goat kidney, poultry muscle, poultry fat, poultry liver, poultry kidney, milk and bird eggs. These tentative MRLs were set until 7 July 2023, pending the submission of information on analytical methods, residue trials on primary and rotational crops, storage stability and feeding studies, based on the Authority’s reasoned opinion.
(6) In 2023, the applicant submitted the requested confirmatory data concerning ametoctradin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. The Authority evaluated the submitted confirmatory data and published a reasoned opinion. The Authority concluded that the data gaps identified during the MRL review for all commodities were addressed, that the existing tentative MRLs were confirmed and that for some livestock products the MRLs could be increased.
(7) It is, therefore, appropriate to increase the MRLs for swine liver, swine edible offals (other than liver and kidney), bovine liver, bovine kidney, bovine edible offals (other than liver and kidney), sheep liver, sheep kidney, sheep edible offals (other than liver and kidney), goat liver, goat kidney, goat edible offals (other than liver and kidney), equine liver, equine kidney, equine edible offals (other than liver and kidney) and to maintain the existing MRLs for barley, oat, rye, wheat, hops, bovine muscle, bovine fat, equine muscle, equine fat, swine kidney, swine muscle, swine fat, sheep muscle, sheep fat, goat muscle, goat fat, poultry muscle, poultry fat, poultry liver, poultry kidney, milk and bird eggs, and delete the respective footnotes requiring the submission of information from Annex II to Regulation (EC) No 396/2005.
(8) As regards diflufenican, tentative MRLs were set by Commission Regulation (EU) 2015/603 for wheat, rye, oat, barley and products of animal origin. These tentative MRLs were set until 17 April 2017, pending the submission of information on storage stability, residue trials, analytical methods and the northern outdoor Good Agricultural Practice, based on the Authority’s reasoned opinion.
(9) In 2018, the applicant submitted the requested confirmatory data concerning diflufenican in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. The Authority evaluated the submitted confirmatory data and published a reasoned opinion. The Authority concluded that the consumer risk assessment was not finalised, but that part of the data gaps were addressed, and the additional information was assessed. The Authority proposed no changes to the existing MRLs for wheat, rye, oat, barley and products of animal origin since a sufficient number of valid residue field trials for the representative use on cereals and the analytical method for enforcement of diflufenican in products of animal origin were provided.
(10) It is, therefore, appropriate to maintain the existing MRLs for wheat, rye, barley and products of animal origin, and delete the footnotes requiring the submission of information from Annex II to Regulation (EC) No 396/2005.
(11) Regulation (EC) No 396/2005 should therefore be amended accordingly.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,