Commission Regulation (EC) No 1960/2000 of 15 September 2000 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: 2000-09-15
Institutions: European Commission
Subjects: animal product, consumer protection, pharmaceutical legislation, veterinary drug

16.9.2000

EN

Official Journal of the European Communities

L 234/5

COMMISSION REGULATION (EC) No 1960/2000

of 15 September 2000

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 1295/2000 (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
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.

Spectinomycin, dicyclanil and tylosin should be inserted
into Annex I to Regulation (EEC) No 2377/90.

In order to allow for the completion of scientific studies
deltamethrin should be inserted into Annex III to Regu-
lation (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 dihydro-
streptomycin, gentamicin, neomycin (including framy-
cetin) and streptomycin.

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

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.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 146, 21.6.2000, p. 11.

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

L 234/6

EN

Official Journal of the European Communities

16.9.2000

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

Done at Brussels, 15 September 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission

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

ANNEX

1.

1.2.

Anti-infectious agents

Antibiotics

1.2.4. Macrolides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Tylosin

Tylosin A

Poultry

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

Muscle
Skin and fat
Liver
Kidney
Eggs’

1.2.10. Aminoglycosides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Spectinomycin

Spectinomycin

Bovine

Porcine, chicken

300 µg/kg
500 µg/kg
1 000 µg/kg
5 000 µg/kg
200 µg/kg
300 µg/kg
500 µg/kg
1 000 µg/kg
5 000 µg/kg

Muscle
Fat
Liver
Kidney
Milk
Muscle
Skin and fat
Liver
Kidney’

.

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2.

Antiparasitic agents

2.2.

Agents acting against ectoparasites

2.2.5.

Pyrimidines derivatives

Pharmacologically active
substance(s)

‘Dicyclanil

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Sum of dicyclanil and 2, 4, Ovine
6-triamino-pyrimidine-5-
carbonitrile

200 µg/kg
50 µg/kg
400 µg/kg
400 µg/kg

Muscle
Fat
Liver
Kidney

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

B. 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

‘Dihydrostreptomycin

Dihydrostreptomycin

Bovine, ovine

Porcine

Gentamicin

Gentamicin

Bovine
Bovine, porcine

500 µg/kg
500 µg/kg
500 µg/kg
1 000 µg/kg
200 µg/kg
500 µg/kg
500 µg/kg
500 µg/kg
1 000 µg/kg

Muscle
Fat
Liver
Kidney
Milk
Muscle
Skin and fat
Liver
Kidney

100 µg/kg
50 µg/kg
50 µg/kg
200 µg/kg
750 µg/kg

Milk
Muscle
Fat
Liver
Kidney

Provisional MRLs expire on 1.6.2002

Provisional MRLs expire on 1.6.2002

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Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Neomycin
framycetin)

(including Neomycin B

Bovine, porcine, chicken

Streptomycin

Streptomycin

Bovine, ovine

Bovine
Chicken

Porcine

500 µg/kg
500 µg/kg
500 µg/kg
5 000 µg/kg
500 µg/kg
500 µg/kg

500 µg/kg
500 µg/kg
500 µg/kg
1 000 µg/kg
200 µg/kg
500 µg/kg
500 µg/kg
500 µg/kg
1 000 µg/kg

Muscle
Fat
Liver
Kidney
Milk
Eggs

Muscle
Fat
Liver
Kidney
Milk
Muscle
Skin and fat
Liver
Kidney

2.

Antiparasitic agents

2.2. Agents acting against ectoparasites

2.2.3. Pyrethroids

Provisional MRLs expire on 1.6.2002

Provisional MRLs expire on 1.6.2002’

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Deltamethrin

Deltamethrin

Fin fish

10 µg/kg

Muscle
proportions

and

skin

in

natural

Provisional MRLs expire on 1.1.2002’

.

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