Commission Regulation (EC) No 2162/2001 of 7 November 2001 amending Annexes I, II 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: 2001-11-07
Institutions: European Commission
Subjects: animal product, food inspection, foodstuff, health control, veterinary drug, waste

8.11.2001

EN

Official Journal of the European Communities

L 291/9

COMMISSION REGULATION (EC) No 2162/2001

of 7 November 2001

amending Annexes I, II 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 1879/2001 (2), and in partic-
ular Articles 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
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-
trade, and maximum residue limits should
national
therefore also always be established for muscle or fat
tissues.

(5)

(6)

(7)

(8)

(9)

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.

Cefacetrile, deltamethrin and imidocarb should be
inserted into Annex I to Regulation (EEC) No 2377/90.

Ammonium lauryl sulphate, bronopol, calcium panto-
thenate and menthae arvensis aetheroleum should be
inserted into Annex II to Regulation (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 kana-
mycin.

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.

(10)

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

Article 2

This Regulations 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.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 258, 27.9.2001, p. 11.

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

L 291/10

EN

Official Journal of the European Communities

8.11.2001

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

Done at Brussels, 7 November 2001.

For the Commission

Erkki LIIKANEN

Member of the Commission

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

ANNEX

1.

Anti-infectious agents

1.2. Antibiotics

1.2.2. Cephalosporins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cefacetrile

Cefacetrile

Bovine

125 µg/kg

Milk

For intramammary use only’

2.

Antiparasitic agents

2.2. Agents acting against ectoparasites

2.2.3. Pyrethroids

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Deltamethrin

Deltamethrin

Fin fish

10 µg/kg

Muscle and skin in natural
proportions’

2.4. Agents acting against protozoa

2.4.3. Carbanilides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Imidocarb

Imidocarb

Bovine

300 µg/kg
50 µg/kg
2 000 µg/kg
1 500 µg/kg
50 µg/kg

Muscle
Fat
Liver
Kidney
Milk’

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

2.

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

‘Ammonium lauryl sulphate

All food-producing species

Bronopol

Fin fish

Calcium pantothenate

All food-producing species’

.

.

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6.

Substances of vegetable origin

Pharmacologically active substance(s)

Animal species

Other provisions

‘Menthae arvensis aetheroleum

All food-producing species’

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

1.

Anti-infectious agents

1.2. Antibiotics

1.2.5. Aminoglycosides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Kanamycin

Kanamycin

Rabbits

Bovine, ovine

Porcine, chicken

100 µg/kg
100 µg/kg
600 µg/kg
2 500 µg/kg

100 µg/kg
100 µg/kg
600 µg/kg
2 500 µg/kg
150 µg/kg

100 µg/kg
100 µg/kg
600 µg/kg
2 500 µg/kg

Muscle
Fat
Liver
Kidney

Muscle
Fat
Liver
Kidney
Milk

Muscle
Skin and Fat
Liver
Kidney

Provisional

MRLs

expire

on

1.1.2004’

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