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of 8 February 2019
amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit
(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 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 19 July 2018 by the Committee for Medicinal Products for Veterinary Use,
Whereas:
(1) Article 17 of Regulation (EC) No 470/2009 requires that 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 established in a Regulation.
(2) Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
(3) The substance ovotransferrin is not included in that table.
(4) An application for the establishment of MRLs for ovotransferrin in chicken tissues and eggs has been submitted to the European Medicines Agency (‘EMA’).
(5) The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended that the establishment of an MRL for ovotransferrin in chicken is not necessary for the protection of human health.
(6) According to Article 5 of Regulation (EC) No 470/2009, the EMA 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.
(7) The EMA has considered that the extrapolation of the ‘no MRL required’ classification for ovotransferrin from chicken tissue to the tissue of other poultry species is appropriate.
(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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 February 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 152, 16.6.2009, p. 11.
(2) 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 (OJ L 15, 20.1.2010, p. 1).
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, an entry for the following substance is inserted in alphabetical order:
|
Pharmacologically active substance |
Marker residue |
Animal Species |
MRLs |
Target Tissues |
Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009) |
Therapeutic Classification |
|
‘Ovotransferrin |
NOT APPLICABLE |
Chicken |
No MRL required |
NOT APPLICABLE |
For inhalation use only |
Anti-infectious agent’ |
|
All poultry except chicken |
No MRL required |
NOT APPLICABLE |
For inhalation use only Not for use in animals from which eggs are produced |
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