Commission Regulation (EC) No 1353/2007 of 20 November 2007 amending Annex I to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards Monensin, Lasalocid and Tylvalosin (Text with EEA relevance)
Date: 2007-11-20
Institutions: European Commission
Subjects: cattle, foodstuff, material of animal origin, poultry, swine, veterinary drug, veterinary legislation

L 303/6

EN

Official Journal of the European Union

21.11.2007

COMMISSION REGULATION (EC) No 1353/2007

of 20 November 2007

amending Annex I to Council Regulation (EEC) No 2377/90 laying down a Community procedure
for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of
animal origin, as regards Monensin, Lasalocid and Tylvalosin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 2377/90 of
26 June 1990 laying down a Community procedure for the
establishment of maximum residue
veterinary
medicinal products in foodstuffs of animal origin (1), and in
particular Article 2 thereof,

limits of

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

Whereas:

(1)

(2)

(3)

All pharmacologically active substances used in the
Community in veterinary medicinal products intended
should be evaluated in
for
accordance with Regulation (EEC) No 2377/90.

food-producing animals

An application for establishing maximum residue limits
for Monensin, an antibiotic and anticoccidial belonging
to the group of ionophores, has been submitted to the
European Medicines Agency. On the basis of the rec-
ommendation of the Committee for Medicinal Products
for Veterinary Use, this substance should be added in
Annex I to Regulation (EEC) No 2377/90 for bovine
species (muscle, fat, liver, kidney and milk).

The substance Lasalocid is currently included in Annex I
to Regulation (EEC) No 2377/90 for poultry for muscle,
skin and fat, liver and kidney and in Annex III to Regu-
lation (EEC) No 2377/90 for poultry from which eggs
are produced for human consumption, awaiting vali-
dation of analytical method. Those scientific studies
have been now completed and the analytical method
has been validated by the Committee for Medicinal
Products for Veterinary Use. Lasalocid belongs to the
ionophores having anticoccidial
group of antibiotic

(1) OJ L 224, 18.8.1990, p. 1. Regulation as

(EC) No 1323/2007 (OJ

last amended by
L 294,

Commission Regulation
13.11.2007, p. 11).

properties. Consequently, Lasalocid should be added in
Annex I to Regulation (EEC) No 2377/90 for poultry
from which eggs are produced for human consumption,
under the new point 1.2.16, while the Lasalocid entry
to Regulation
2.4.4
under
(EEC) No 2377/90 should be deleted.

of Annex

point

I

(4)

(5)

(6)

(7)

substance Acetylisovaleryltylosin,

an antibiotic
The
belonging to the group of macrolides
is currently
included in Annex I to Regulation (EEC) No 2377/90
for porcine and poultry species. A change to the Inter-
this active
national Non-proprietary Name (INN) of
substance has been notified to the European Medicines
Agency. The substance’s name Acetylisovaleryltylosin
should be replaced by the new INN, Tylvalosin.

Regulation (EEC) No 2377/90 should therefore be
amended accordingly.

An adequate period should be allowed before the appli-
cability of this Regulation in order to enable Member
States to make any adjustment which may be necessary
in the light of this Regulation to the authorisations to
place the veterinary medicinal products concerned on the
market which have been granted in accordance with
Directive 2001/82/EC of the European Parliament and
the Council of 6 November 2001 on the
of
Community
to veterinary medicinal
products (2) to take account of the provisions of this
Regulation.

relating

code

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

opinion

of

HAS ADOPTED THIS REGULATION:

Article 1

Annex I
accordance with the Annex to this Regulation.

to Regulation (EEC) No 2377/90 is amended in

(2) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

21.11.2007

EN

Official Journal of the European Union

L 303/7

This Regulation shall enter into force on the third day following its publication in the Official Journal of the
European Union.

Article 2

It shall apply from 20 January 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 November 2007.

For the Commission

Günter VERHEUGEN
Vice-President

L 303/8

EN

Official Journal of the European Union

21.11.2007

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