Commission Regulation (EC) No 1646/2004 of 20 September 2004 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(Text with EEA relevance)
Date: 2004-09-20
Institutions: European Commission
Subjects: animal health, animal product, product safety, veterinary drug, waste

21.9.2004

EN

Official Journal of the European Union

L 296/5

COMMISSION REGULATION (EC) No 1646/2004

of 20 September 2004

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

(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), 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
origin and the impact of
residues on the industrial
processing of foodstuffs.

residues of

relevant

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,
should therefore also
and maximum residue limits
always be established for muscle or fat tissues.

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.

Albendazole, Febantel, Fenbendazole, Oxfendazole, Thia-
bendazole, Oxyclozanide, Amitraz, Cypermethrin, Delta-
methrin and Dexamethasone should be inserted into
Annex I 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) of
to take
the European Parliament 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
it is necessary to specify the animal species in
origin,
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

HAS ADOPTED THE FOLLOWING REGULATION:

Article 1

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

In view of the reduced availability of veterinary medicinal
products for certain food-producing species (2), maximum
residue limits may be established by methods of extra-
polation from maximum residue limits set
for other
species on a strictly scientific basis.

Article 2

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

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

(EC) No 1101/2004 (OJ

last amended by
L 211,

Commission Regulation
12.6.2004, p. 3).

It shall apply from the sixtieth day following its publication.

(2) Availability of veterinary medicinal products Communication from
the Commission to the Council and the European Parliament
COM(2000) 806 final.

(3) 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).

(1)

(2)

(3)

(4)

L 296/6

EN

Official Journal of the European Union

21.9.2004

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

Done at Brussels, 20 September 2004.

For the Commission

Olli REHN
Member of the Commission

21.9.2004

EN

Official Journal of the European Union

L 296/7

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L 296/8

EN

Official Journal of the European Union

21.9.2004

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