Commission Regulation (EC) No 2535/2000 of 17 November 2000 amending Annex I 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: 2000-11-17
Institutions: European Commission
Subjects: animal product, pharmaceutical legislation, public health, veterinary drug, waste

18.11.2000

EN

Official Journal of the European Communities

L 291/9

COMMISSION REGULATION (EC) No 2535/2000

of 17 November 2000

amending Annex I 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 2391/2000 (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
the residue which is relevant
for the monitoring of
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
the liver and kidney are
liver or kidney. However,

(5)

(6)

(7)

frequently removed from carcasses moving in inter-
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.

Prednisolone should be inserted into Annex I to Regula-
tion (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 Directive 93/40/EEC (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 of 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 sixtieth day following its publication.

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

Done at Brussels, 17 November 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 276, 28.10.2000, p. 5.

(3) OJ L 317, 6.11.1981, p. 1.
(4) OJ L 214, 24.8.1993, p. 31.

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

ANNEX

5.

Corticoides

5.1. Glucocorticoids

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Prednisolone

Prednisolone

Bovine

4 µg/kg
4 µg/kg
10 µg/kg
10 µg/kg
6 µg/kg

Muscle
Fat
Liver
Kidney
Milk’

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