Commission Regulation (EC) No 1553/2001 of 30 July 2001 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: 2001-07-30
Institutions: European Commission
Subjects: animal product, veterinary drug, veterinary legislation, waste

L 205/16

EN

Official Journal of the European Communities

31.7.2001

COMMISSION REGULATION (EC) No 1553/2001

of 30 July 2001

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,

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 1322/2001 (2), and in par-
ticular 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
concerning the safety of
the substance
foodstuffs of animal
concerned for the consumer of
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
for the monitoring of
the residue which is relevant
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
liver or kidney. However,
the liver and kidney are
frequently removed from carcasses moving in inter-

(5)

(6)

(7)

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.

Cefapirin, clavulanic acid and moxidectin 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 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.

(8)

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

Annex I to Regulation (EEC) No 2377/90 is 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, 30 July 2001.

For the Commission

Frederik BOLKESTEIN

Member of the Commission

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 177, 30.6.2001, p. 52.

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

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

ANNEX

1.

1.2.

Anti-infectious agents

Antibiotics

1.2.2.

Cephalosporins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cefapirin

Sum of
desacetylcephapirin

cephapirin and

Bovine

50 µg/kg
50 µg/kg
100 µg/kg
60 µg/kg

Muscle
Fat
Kidney
Milk’

1.2.13.

Beta-lactamase inhibitors

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Clavulanic acid

Clavulanic acid

Bovine

Porcine

2.

2.3.

Antiparasitic agents

Agents acting against endo- and ectoparasites

2.3.1.

Avermectins

100 µg/kg
100 µg/kg
200 µg/kg
400 µg/kg
200 µg/kg

100 µg/kg
100 µg/kg
200 µg/kg
400 µg/kg

Muscle
Fat
Liver
Kidney
Milk

Muscle
Skin and fat
Liver
Kidney’

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Moxidectin

Moxidectin

Bovine

40 µg/kg

Milk’

.

.

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