Commission Implementing Regulation (EU) 2022/634 of 13 April 2022 amending Regulation (EU) No 37/2010 as regards the classification of the substance bambermycin with respect to its maximum residue limit in foodstuffs of animal origin (Text with EEA relevance)

• Published date: 19 April 2022
• Subject Matter: Veterinary legislation
• Official Gazette Publication: Official Journal of the European Union, L 117, 19 April 2022

19.4.2022 EN Official Journal of the European Union L 117/29

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/634

of 13 April 2022

amending Regulation (EU) No 37/2010 as regards the classification of the substance bambermycin with respect to its maximum residue limit in foodstuffs of animal origin

(Text with EEA relevance)

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 Council (1), and in particular Article 14, in conjunction with Article 17 thereof,

Having regard to the opinion of the European Medicines Agency formulated on 15 July 2021 by the Committee for Medicinal Products for Veterinary Use,

Whereas:

(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

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