(fra kommisjonsforordningen)

(1) Commission Regulation (EU) No 37/2010 sets out the pharmacologically active substances and their classification regarding maximum residue limits (‘MRLs’) in foodstuffs of animal origin.

(2) Commission Regulation (EU) 2018/7823 provides that chemical-unlike biological substances for which it is concluded that a standard MRL evaluation is not required are to be published by the European Medicines Agency (‘Agency’) in a list of such substances.

(3) The following five chemical-unlike biological substances were included in the list published by the Agency: (i) bovine casein hydrolysate (bCNH), produced from sodium caseinate hydrolysed with trypsin, heat treated, for intramammary use in cows, (ii) probiotic components including bacteria and yeasts, (iii) recombinant bovine IL-8 (His-tag) for intrauterine use in cattle at a dose of up to 1,000 μg per animal, (iv) stem cells and (v) varroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA).

(4) Regulation (EU) 2018/782 was amended by Commission Regulation C(2025) 850 providing that chemical-unlike biological substances are to be evaluated by the Agency in order to determine whether a ‘no MRL required’ classification is appropriate.

(5) On 13 September 2024, the Commission requested the Agency to provide scientific advice on whether, a classification as ‘no MRL required’ is appropriate for the five chemical-unlike biological substances included by the Agency in the list of chemical-unlike biological substances considered as not requiring an MRL evaluation.

(6) On 15 January 2025, the Agency, based on the opinion of the Committee for Veterinary Medicinal Products, concluded that the five chemical-unlike biological substances do not pose a risk to public health and that the classification thereof as ‘no MRL required’ is appropriate.

(7) Those substances should therefore be included in table 1 of the Annex to Regulation (EU) No 37/2010.

(8) Regulation (EU) No 37/2010 should therefore be amended accordingly.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,