28.5.2013   

EN

Official Journal of the European Union

L 141/4

(1)

The maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009.

(2)

Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2).

(3)

An application for the establishment of MRLs for double stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israel Acute Paralysis Virus for bees has been submitted to the European Medicines Agency.

(4)

The Committee for Medicinal Products for Veterinary Use has recommended that for this pharmacologically active substance a standard pharmacological and toxicological approach, including the setting of a level of acceptable daily intake, is not appropriate and that there is no need to establish an MRL, applicable to honey, for double stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israel Acute Paralysis Virus for bees.

(5)

According to Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to always consider the use of MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. The Committee for Medicinal Products for Veterinary Use has concluded that the extrapolation to other food producing species cannot be supported for this substance.

(6)

Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the substance double stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israel Acute Paralysis Virus for bees while establishing the absence of the need to establish a MRL, applicable to honey.

(7)

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