COMMISSION IMPLEMENTING REGULATION (EU) 2015/1492
of 3 September 2015
amending Regulation (EU) No 37/2010 as regards the substance
‘tylvalosin’
(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
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 (hereinafter ‘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)
Tylvalosin is currently included in that table as an allowed substance,
for porcine and poultry species, applicable to muscle, skin and fat, liver and
kidney in porcine species and to skin and fat and liver in poultry species,
excluding animals producing eggs for human consumption.
(4)
An application for the extension of the existing entry for tylvalosin to
chicken eggs has been submitted to the European Medicines Agency (hereinafter
‘EMA’).
(5)
The EMA, based on the opinion of the Committee for Medicinal Products for
Veterinary Use has recommended the establishment of a MRL for chicken
eggs.
(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 MRLs for tylvalosin
from chicken eggs to eggs of other poultry species is appropriate.
(8)
Regulation (EU) No 37/2010 should therefore be amended accordingly.
(9)
It is appropriate to grant the stakeholders concerned a reasonable period
of time to take measures that may be required to comply with the new MRL.
(10)
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.
It shall apply from 3 November 2015.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.
Done at Brussels, 3 September 2015.
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, the entry for the
substance ‘tylvalosin‘ is replaced by the following:
Pharmacologically active substance
|
Marker residue
|
Animal species
|
MRL
|
Target tissues
|
Other provisions (according to Article 14(7) of Regulation (EC)
No 470/2009)
|
Therapeutic classification
|
‘Tylvalosin
|
Tylvalosin
|
Porcine
|
50 μg/kg
50 μg/kg
50 μg/kg
50 μg/kg
|
Muscle
Skin and fat
Liver
Kidney
|
NO ENTRY
|
Anti-infectious agents/Antibiotics’
|
Poultry
|
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