Commission Regulation (EC) No 1478/2001 of 18 July 2001 amending Annexes I, II and III of 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: 2001-07-18
Institutions: European Commission
Subjects: animal product, food inspection, health control, veterinary drug, veterinary legislation, waste

L 195/32

EN

Official Journal of the European Communities

19.7.2001

COMMISSION REGULATION (EC) No 1478/2001

of 18 July 2001

amending Annexes I, II and III of 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 partic-
ular 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 Community 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).

(1)

(2)

(3)

(4)

(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.

Bacitracin (bovine, milk), rafoxanide, coumafos, cyroma-
zine and doramectin (deer including reindeer) should be
inserted into Annex I to Regulation (EEC) No 2377/90.

Amprolium and tiludronic acid, disodium salt 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 pipera-
zine.

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 THIS REGULATION:

Article 1

Annexes I,
hereby amended as se out in the Annex hereto.

II and III to Regulation (EEC) No 2377/90 are

For the control of residues, as provided for in appro-
priate Community legislation, maximum residue limits
should usually be established for the taget tissues of liver
or kidney. However, the liver and kidney are frequently
removed from carcasses moving in international trade,
and maximum residue limits
should therefore also
always be established for muscle or fat tissues.

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.

(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.

19.7.2001

EN

Official Journal of the European Communities

L 195/33

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

Done at Brussels, 18 July 2001.

For the Commission

Erkki LIIKANEN

Member of the Commission

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

ANNEX

1.

1.2.

Anti-infectious agents

Antibiotics

1.2.12. Polypeptides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Bacitracin

Sum of bacitracin A, baci-
tracin B, and bacitracin C

Bovine

100 µg/kg

Milk’

2.

2.1.

Antiparasitic agents

Agents acting against endoparasites

2.1.1.

Salicylanilides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Rafoxanide

Rafoxanide

Bovine

Ovine

2.2.

Agents acting against ectoparasites

2.2.1. Organophosphates

30 µg/kg
30 µg/kg
10 µg/kg
40 µg/kg

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

Muscle
Fat
Liver
Kidney

Muscle
Fat
Liver
Kidney

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

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Coumafos

Coumafos

Bees

100 µg/kg

Honey’

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2.2.6.

Triazine derivatives

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cyromazine

Cyromazine

Ovine

300 µg/kg
300 µg/kg
300 µg/kg
300 µg/kg

Muscle
Fat
Liver
Kidney

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

2.3.

Agents acting against endo- and ectoparasites

2.3.1. Avermectins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Doramectin

Doramectin

Deer, including reindeer

20 µg/kg
100 µg/kg
50 µg/kg
30 µg/kg

Muscle
Fat
Liver
Kidney’

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

2.

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

‘Amprolium

Tiludronic acid, disodium salt

Poultry

Equidae

For oral use only

For intravenous use only’

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

2.

2.1.

Antiparasitic agents

Agents acting against endoparasites

2.1.5.

Piperazine derivatives

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Piperazine

Piperazine

Porcine

400 µg/kg
800 µg/kg
2 000 µg/kg
1 000 µg/kg

Muscle
Skin and fat
Liver
Kidney

Provisional MRLs expire on 1.7.2003’

Chicken

2 000 µg/kg

Eggs

.

.

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