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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Councilnote, and in particular Article 14 thereof,Whereas:
(1)Commission Regulation (EU) No 37/2010note sets out the pharmacologically active substances and their classification regarding maximum residue limits (‘MRLs’) in foodstuffs of animal origin.
(2)Commission Regulation (EU) 2018/782note 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 Agencynote: (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 1000 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 (EU) 2025/1101note 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 Agencynote, 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,
HAS ADOPTED THIS REGULATION:
Article 1#
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
In Table 1 of the Annex to Regulation (EU) No 37/2010, the following entry is inserted in alphabetical order:
Pharmacologically active Substance | Marker residue | Animal Species | MRL | Target Tissues | Other Provisions(according to Article 14(7) of Regulation (EC) No 470/2009) | Therapeutic ClassificationBovine casein hydrolysate (bCNH), produced from sodium caseinate hydrolysed with trypsin, heat treated – chemical-unlike biological substance | NOT APPLICABLE | Bovine | No MRL required | NOT APPLICABLE | For intramammary use only | NO ENTRYProbiotic components including bacteria and yeasts – chemical-unlike biological substance | NOT APPLICABLE | All food producing species | No MRL required | NOT APPLICABLE | NO ENTRY | NO ENTRYRecombinant bovine IL-8 (His-tag) – chemical-unlike biological substance | NOT APPLICABLE | Bovine | No MRL required | NOT APPLICABLE | For intrauterine use only at a dose of up to 1000 μg per animal | NO ENTRYStem cells – chemical-unlike biological substance | NOT APPLICABLE | All food producing species | No MRL required | NOT APPLICABLE | NO ENTRY | NO ENTRYVarroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA) – chemical-unlike biological substance | NOT APPLICABLE | Bees | No MRL required | NOT APPLICABLE | NO ENTRY | NO ENTRY
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