(1)

In accordance with Regulation (EC) No 470/2009, the Commission is to establish, by way of a Regulation, maximum residue limits (‘MRLs’) 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.

(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding maximum residue limits (MRLs) in foodstuffs of animal origin.

(3)

Bambermycin is already included in that table as an allowed substance for rabbits, for oral use only. The existing entry has a ‘no MRL required’ classification.

(4)

In accordance with Article 3 of Regulation (EC) No 470/2009, on 3 December 2019, Huvepharma N.V. submitted an application for the extension of the existing entry for bambermycin to chicken tissues to the European Medicines Agency (‘Agency’).

(5)

On 18 March 2021, the Agency, through the opinion of the Committee for Medicinal Products for Veterinary Use (‘the CVMP’), concluded that the establishment of an MRL for bambermycin in chicken tissues was not necessary and recommended a ‘no MRL required’ classification.

(6)

On 5 May 2021, the Commission requested the Agency to reconsider its opinion of 18 March 2021 with a view to establishing MRLs in order to facilitate official controls and enforcement of legislative provisions by competent authorities.

(7)

On 15 July 2021, the Agency, based on the opinion of the Committee, having considered the application and the request from the Commission, recommended the establishment of numerical MRLs for bambermycin for use in chicken, applicable to muscle, skin and fat in natural proportions, liver and kidney, however not for use in animals from which eggs are produced for human consumption.

(8)

According to Article 5 of Regulation (EC) No 470/2009, the 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.

(9)

The Agency concluded that the extrapolation of the MRLs for bambermycin from chicken tissues to the tissues of other poultry species is appropriate, but not to poultry eggs.

(10)

In view of the Opinion of the Agency it is considered appropriate to establish the recommended MRL for bambermycin in chicken tissues and to extrapolate it to other poultry species, but not to poultry eggs.

(11)

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

(12)

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