Commission Regulation (EC) No 1518/2005 of 19 September 2005 amending Annexes I and III 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 acetylisovaleryltylosin and fluazuron   (Text with EEA relevance)
Date: 2005-09-19
Institutions: European Commission
Subjects: market approval, veterinary drug, veterinary legislation

20.9.2005

EN

Official Journal of the European Union

L 244/11

COMMISSION REGULATION (EC) No 1518/2005

of 19 September 2005

amending Annexes I and III 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 acetylisovaleryltylosin and fluazuron

(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 and the third paragraph of Article 4 thereof,

limits of

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

Whereas:

(1)

(2)

All pharmacologically active substances which are used
within the Community in veterinary medicinal products
intended for administration to food-producing animals
should be evaluated in accordance with Regulation
(EEC) No 2377/90.

skin and fat and for

Acetylisovaleryltylosin has been included in Annex I to
Regulation (EEC) No 2377/90 for porcine species for
muscle, skin and fat,
liver and kidney. That substance
has also been included in Annex III to that Regulation
for poultry species
for
excluding animals from which eggs are produced for
human consumption, awaiting completion of scientific
studies. These studies have now been completed and
acetylisovaleryltylosin should therefore be inserted in
Annex I to that Regulation for poultry species.

liver,

(3)

(4)

(5)

(6)

An application for establishing of maximum residue
limits for ‘fluazuron’ has been submitted.
In order to
allow for the completion of scientific studies for bovine
species, fluazuron should be included in Annex III to that
Regulation.

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

An adequate period should be allowed before the applic-
ability 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 marketing author-
accordance with Directive
isations
the
2001/82/EC of
Council of 6 November 2001 on the Community code
relating to veterinary medicinal products (2).

the European Parliament and of

granted

in

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

opinion

of

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and III to Regulation (EEC) No 2377/90 are amended
in accordance with the Annex to this Regulation.

Article 2

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

It shall apply from 19 November 2005.

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

Done at Brussels, 19 September 2005.

For the Commission

Günter VERHEUGEN
Vice-President

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

(EC) No 1356/2005 (OJ

last amended by
L 214,

Commission Regulation
19.8.2005, p. 3).

(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).

L 244/12

EN

Official Journal of the European Union

20.9.2005

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