Commission Regulation (EC) No 1322/2001 of 29 June 2001 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 (Text with EEA relevance)
Date: 2001-06-29
Institutions: European Commission
Subjects: chemical product, health policy, manufactured feedingstuffs, material of animal origin, veterinary drug

L 177/52

EN

Official Journal of the European Communities

30.6.2001

COMMISSION REGULATION (EC) No 1322/2001

of 29 June 2001

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

(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 807/2001 (2), and in partic-
ular Articles 6, 7 and 8 thereof,

Whereas:

(1)

(2)

(3)

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).

(4)

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

liver or kidney. However,
the liver and kidney are
frequently removed from carcases moving in inter-
national
trade, and maximum residue limits should
therefore also 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.

Florfenicol should be inserted into Annex I to Regula-
tion (EEC) No 2377/90.

In order to allow for the completion of scientific studies,
the duration of the validity of the provisional maximum
residue limits previously defined in Annex III to Regula-
tion (EEC) No 2377/90 should be extended for cefa-
lonium, morantel and metamizole.

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

(5)

(6)

(7)

(8)

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and III 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 June 2001.

For the Commission

Erkki LIIKANEN

Member of the Commission

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 118, 27.4.2001, p. 6.

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

1.

Anti-infectious agents

1.2. Antibiotics

1.2.5. Florfenicol and related compounds

ANNEX

Pharmacologically active
substance

‘Florfenicol

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Sum of florfenicol and its
metabolites measured as
florfenicol-amine

Fin fish

1 000 µg/kg

Muscle
and
proportions’

skin

in

natural

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

1.

Anti-infectious agents

1.2. Antibiotics

1.2.4. Cephalosporins

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cefalonium

Cefalonium

Bovine

10 µg/kg

Milk

Provisional MRLs expire on 1.1.2003’

2.

Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.3. Tetrahydropyrimides

Pharmacologically active
substance

‘Morantel

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Bovine, ovine

Sum of residues which may
be hydrolysed to N-methyl-
1,3-propanediamine
and
expressed
as morantel
equivalents

Porcine

100 µg/kg
100 µg/kg
800 µg/kg
200 µg/kg
100 µg/kg

100 µg/kg
100 µg/kg
800 µg/kg
200 µg/kg

Muscle
Fat
Liver
Kidney
Milk

Muscle
Skin and fat
Liver
Kidney

Provisional MRLs expire on 1.7.2003’

.

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5.

Anti-inflammatory agents

5.1. Nonsteroidal anti-inflammatory agents

5.1.3. Pyrazolone derivatives

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Metamizole

4-Methylaminoantipyrin

Bovine, porcine, equidae

200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg

Muscle
Fat
Liver
Kidney

Provisional MRLs expire on 1.7.2003.
Not for use in animals from which milk is produced
for human consumption’

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