Commission Regulation (EC) No 2908/2000 of 29 December 2000 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)
Date: 2000-12-29
Institutions: European Commission
Subjects: animal product, pharmaceutical legislation, public health, veterinary drug, waste

L 336/72

EN

Official Journal of the European Communities

30.12.2000

COMMISSION REGULATION (EC) No 2908/2000

of 29 December 2000

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,

Having regard to the Treaty establishing the European
Community,

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 2535/2000 (2), and in partic-
ular Articles 6, 7 and 8 thereof,

Whereas:

(1)

(2)

(3)

(4)

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.

the relevant
residues of

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 in each of the relevant meat tissues obtained
from the treated animal (target tissue) and the nature of
the residue which is relevant
for the monitoring of
residues (marker residue).

For the control of residues, as provided for in appro-
priate Community legislation, maximum residue limits
should usually be established for the target tissues of
the liver and kidney are
liver or kidney. However,
frequently removed from carcasses moving in inter-
trade, and maximum residue limits should
national

(5)

(6)

(7)

(8)

therefore also always be established for muscle or fat
tissues.

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

Difloxacin, flunixin, halofuginone and toltrazuril should
be inserted into Annex I to Regulation (EEC) No 2377/
90.

Calcium glycerophosphate
Annex II to Regulation (EEC) No 2377/90.

should be

inserted into

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 Council Directive 81/
851/EEC (3), as last amended by Commission Directive
2000/37/EC (4), to take account of the provisions of this
Regulation.

(9)

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

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
Communities.

It shall apply from the 60th day following its publication.

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

Done at Brussels, 29 December 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 291, 18.11.2000, p. 9.

(3) OJ L 317, 6.11.1981, p. 1.
(4) OJ L 139, 10.6.2000, p. 25.

A. Annex I to Regulation (EEC) No 2377/90 is amended as follows

ANNEX

1.

Anti-infectious agents

1.2. Antibiotics

1.2.3. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Difloxacin

Difloxacin

Bovine

Porcine

400 µg/kg
100 µg/kg
1 400 µg/kg
800 µg/kg
400 µg/kg
100 µg/kg
800 µg/kg
800 µg/kg

Muscle
Fat
Liver
Kidney
Muscle
Skin and fat
Liver
Kidney

Not for use in animals from which milk is produced
for human consumption’

2.

Anti-parasitic agents

2.4. Agents acting against protozoa

2.4.1. Triazinetrione derivatives

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Toltrazuril

Toltrazuril sulfone

Porcine

100 µg/kg
150 µg/kg
500 µg/kg
250 µg/kg

Muscle
Skin and fat
Liver
Kidney’

2.4.2. Quinazolone derivatives

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Halofuginone

Halofuginone

Bovine

10 µg/kg
25 µg/kg
30 µg/kg
30 µg/kg

Muscle
Fat
Liver
Kidney

Not for use in animals from which milk is produced
for human consumption’

.

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4.

Anti-inflammatory agents

4.1. Non-steroidal anti-inflammatory agents

4.1.2. Fenamate group derivates

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Flunixin

Flunixin

Equidae

10 µg/kg
20 µg/kg
100 µg/kg
200 µg/kg

Muscle
Fat
Liver
Kidney’

B. Annex II to Regulation (EEC) No 2377/90 is amended as follows.

1.

Inorganic chemicals

Pharmacologically active substance(s)

Animal species

Other provisions

‘Calcium glycerophosphate

All food producing species’

L

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