Commission Regulation (EC) No 1299/2005 of 8 August 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 phenoxymethylpenicillin, phoxim, norgestomet and thiamphenicol   (Text with EEA relevance)
Date: 2005-08-08
Institutions: European Commission
Subjects: animal product, food safety, foodstuff, foodstuffs legislation, health policy, pharmaceutical product, veterinary drug

L 206/4

EN

Official Journal of the European Union

9.8.2005

COMMISSION REGULATION (EC) No 1299/2005

of 8 August 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
regards phenoxymethylpenicillin, phoxim, norgestomet and
foodstuffs of animal origin, as

thiamphenicol

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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 estab-
lishment of maximum residue limits of veterinary medicinal
products in foodstuffs of animal origin (1), and in particular
Article 2 and the third paragraph of Article 4 thereof,

(5)

Norgestomet has been included in Annex III to Regu-
lation (EEC) No 2377/90 for bovine awaiting completion
scientific studies. These studies have now been
of
be
should
completed
inserted in Annex I to that Regulation.

norgestomet

therefore

and

The substance thiamphenicol is included in Annex I to
Regulation (EEC) No 2377/90 for bovine and chicken
excluding animals from which eggs are produced for
human consumption.
the
completion of scientific studies for the extension to
cover
be
thiamphenicol
species,
included in Annex III to that Regulation.

to allow for

In order

porcine

should

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 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.

Phenoxymethylpenicillin has been included in Annex I to
Regulation (EEC) No 2377/90 for porcine for muscle,
liver and kidney. The entry should be extended for
these target tissues and in addition for skin and fat to
poultry excluding animals from which eggs are produced
for human consumption.

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

and

(6)

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

(7)

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 authorisations
granted in accordance with Directive 2001/82/EC of the
European Parliament and of the Council of 6 November
2001 on the Community code relating to veterinary
medicinal products (2).

(8)

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

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

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

last amended by
Commission Regulation (EC) No 1148/2005 (OJ L 185, 16.7.2005,
p. 20).

(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).

9.8.2005

EN

Official Journal of the European Union

L 206/5

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 8 October 2005.

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

Done at Brussels, 8 August 2005.

For the Commission

Günter VERHEUGEN
Vice-President

L 206/6

EN

Official Journal of the European Union

9.8.2005

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EN

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