Commission Regulation (EC) No 1101/2004 of 10 June 2004 amending Annexes I and II 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
Date: 2004-06-10
Institutions: European Commission
Subjects: animal product, food safety, health control, market approval, veterinary drug, veterinary inspection

12.6.2004

EN

Official Journal of the European Union

L 211/3

COMMISSION REGULATION (EC) No 1101/2004

of 10 June 2004

amending Annexes I and II 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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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), as last amended by
Commission Regulation (EC) No 546/2004 (2) and in particular
Articles 6, 7 and 8 thereof;

Whereas:

In accordance with Regulation (EEC) No 2377/90,
maximum residue limits must be established progres-
sively for all pharmacologically active substances which
are used within the Community in veterinary medicinal
products intended for administration to food-producing
animals.

Maximum residue limits should be established only after
the examination within the Committee for Veterinary
information
Medicinal Products of all
the substance
concerning the safety of
concerned for the consumer of
foodstuffs of animal
residues on the industrial
origin and the impact of
processing of foodstuffs.

residues of

relevant

the

In the case of veterinary medicinal products intended for
use in laying birds,
lactating animals or honey bees,
maximum residue limits must also be established for
eggs, milk or honey.

Tulathromycin should be inserted into Annex I to Regu-
lation (EEC) No 2377/90.

Diclazuril should be inserted into Annex II to Regulation
(EEC) No 2377/90.

An adequate period should be allowed before the entry
into force of this Regulation in order to allow Member
States to make any adjustment which may be necessary
to the authorisations to place the veterinary medicinal
products concerned on the market which have been
granted in accordance with Directive 2001/82/EC (3), as
amended by Directive 2004/28/EC (4) of
last
the
European Parliament
to take
and of
account of the provisions of this Regulation.

the Council

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

opinion

of

(6)

(7)

(8)

(9)

In establishing maximum residue limits for residues of
veterinary medicinal products in foodstuffs of animal
origin,
it is necessary to specify the animal species in
which residues may be present, the levels which may
be present
tissues
obtained from the treated animal (target tissue) and the
nature of the residue which is relevant for the monitoring
of residues (marker residue).

relevant meat

in each of

the

For the control of residues, as provided for in appropriate
Community legislation, maximum residue limits should
usually be established for the target tissues of liver or
kidney. However,
the liver and kidney are frequently
removed from carcasses moving in international trade,
and maximum residue limits
should therefore also
always be established for muscle or fat tissues.

HAS ADOPTED THE FOLLOWING REGULATION :

Article 1

Annexes I and II to Regulation (EEC) No 2377/90 are hereby
amended as set out in the Annex hereto.

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 the sixtieth day following its publication.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 87, 25.3.2004, p. 13.

(3) OJ L 311, 28.11.2001, p. 1.
(4) OJ L 136, 30.4.2004, p. 58.

(1)

(2)

(3)

(4)

L 211/4

EN

Official Journal of the European Union

12.6.2004

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

Done at Brussels, 10 June 2004.

For the Commission

Erkki LIIKANEN
Member of the Commission

12.6.2004

EN

Official Journal of the European Union

L 211/5

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