欧盟Eurlex法规详细信息

18.3.2015   

EN

Official Journal of the European Union

L 74/18

(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 is to 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 (2).

(3)

Barium selenate is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for bovine and ovine species with ‘no MRL required’ status.

(4)

In accordance with Article 11 of Regulation (EC) No 470/2009, an application for a review of the opinion on barium selenate has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use (‘CVMP’) confirmed its initial recommendation that there is no need to establish an MRL for barium selenate for bovine and ovine species. However, the CVMP concluded that because of the fact that the depletion of the substance and its residue selenium from an injection site is extremely slow, there is a risk that consumption of an injection site would lead to an intake of selenium greater than the established safe level. Therefore, to ensure that consumers' exposure to selenium is not above the established tolerable upper intake level, the CVMP recommended that barium selenate used in veterinary medicinal products should not be administered by injection.

(6)

In accordance with Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using 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 CVMP recommended the extrapolation of the existing ‘no MRL required’ status for barium selenate in relation to bovine and ovine species to all food producing species.

(7)

The entry for barium selenate in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

(8)

It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with this Regulation.

(9)

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