Commission Regulation (EC) No 2728/98 of 17 December 1998 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: 1998-12-17
Institutions: European Commission
Subjects: animal product, food inspection, public health, veterinary drug, veterinary legislation, waste

L 343/8

EN

Official Journal of the European Communities

18. 12. 98

COMMISSION REGULATION (EC) No 2728/98

of 17 December 1998

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,

honey bees, maximum residue limits must also be estab-
lished for eggs, milk or honey;

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 establishment of maximum residue limits of veter-
inary medicinal products in foodstuffs of animal origin (1),
as last amended by Commission Regulation (EC) No
2692/98 (2), and in particular 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;

Whereas maximum residue limits should be established
only after the examination within the Committee for
Veterinary Medicinal Products of all the relevant informa-
tion concerning the safety of residues of the substance
concerned for the consumer of foodstuffs of animal origin
and the impact of residues on the industrial processing of
foodstuffs;

Whereas, in establishing maximum residue limits for re-
sidues 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);

Whereas, for the control of residues, as provided for in
appropriate Community legislation, maximum residue
limits should usually be established for the target tissues
of liver or kidney; whereas, however, the liver and kidney
are frequently removed from carcases moving in inter-
national trade, and maximum residue limits should there-
fore also always be established for muscle or fat tissues;

Whereas enrofloxacin and ivermectin should be inserted
into Annex I to Regulation (EEC) No 2377/90;

Whereas hyperici oleum, eucalypti aetheroleum, sodium
2-methyl-2-phenoxy-propanoate, nonivamide, nicoboxil,
methyl nicotinate, mecillinam, 8-hydroxyquinoline and
diethylene glycol monoethyl ether should be inserted into
Annex II to Regulation (EEC) No 2377/90;

Whereas, 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 Regulation (EEC) No 2377/90 should be extended for
enrofloxacin;

Whereas a period of 60 days 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 Directive 93/40/EEC (4),
to take account of the provisions of this Regulation;

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

Article 2

Whereas, in the case of veterinary medicinal products
lactating animals or
intended for use in laying birds,

This Regulation shall enter into force on the 60th day
following its publication in the Official Journal of the
European Communities.

(1) OJ L 224, 18. 8. 1990, p. 1.
(2) OJ L 338, 15. 12. 1998, p. 5.

(3) OJ L 317, 6. 11. 1981, p. 1.
(4) OJ L 214, 24. 8. 1993, p. 31.

18. 12. 98

EN

Official Journal of the European Communities

L 343/9

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

Done at Brussels, 17 December 1998.

For the Commission

Martin BANGEMANN

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

1.2.3. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Enrofloxacin

Sum of enrofloxacin and
ciprofloxacin

Bovine

Rabbits

Porcine

Poultry

Not for use in animals from which
eggs are produced for human con-
sumption

100 lg/kg Muscle
100 lg/kg
300 lg/kg
200 lg/kg Kidney
100 lg/kg Milk

Fat
Liver

100 lg/kg Muscle
100 lg/kg
200 lg/kg
300 lg/kg Kidney

Fat
Liver

100 lg/kg Muscle
100 lg/kg
200 lg/kg
300 lg/kg Kidney

Skin + fat
Liver

100 lg/kg Muscle
100 lg/kg
200 lg/kg
300 lg/kg Kidney

Skin + fat
Liver

2.

2.3.

Antiparasitic agents

Agents acting against endo- and ectoparasites

2.3.1. Avermectins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Ivermectin

22,23-Dihydro-aver-
mectin B1a

Deer, including reindeer

20 lg/kg Muscle
100 lg/kg
50 lg/kg
20 lg/kg Kidney

Fat
Liver

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

2.

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

8-Hydroxyquinoline

All mammalian food producing species

For topical use in new-born animals only

Diethylene glycol monoethyl ether

Mecillinam

Methyl nicotinate

Nicoboxil

Nonivamide

Bovine, porcine

Bovine

Bovine, equidae

Equidae

Equidae

Sodium 2-methyl-2-phenoxy-propanoate

Bovine, porcine, caprine, equidae

6.

Substances of vegetable origin

For intra-uterine use only

For topical use only

For topical use only

For topical use only

Pharmacologically active substance(s)

Animal species

Other provisions

Eucalypti aetheroleum

Hyperici oleum

All food producing species

All food producing species

For topical use only

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

1.

1.2.

Anti-infectious agents

Antibiotics

1.2.06. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Enrofloxacin

Sum of enrofloxacin and Ovine
ciprofloxacin

100 lg/kg Muscle
100 lg/kg
300 lg/kg
200 lg/kg Kidney

Fat
Liver

Provisional MRLs expire on 1 July 1999

1
8

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1
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