Commission Regulation (EC) No 2391/2000 of 27 October 2000 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: 2000-10-27
Institutions: European Commission
Subjects: animal product, pharmaceutical legislation, public health, veterinary drug, waste

28.10.2000

EN

Official Journal of the European Communities

L 276/5

COMMISSION REGULATION (EC) No 2391/2000

of 27 October 2000

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 2338/2000 (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
concerning the safety of
the substance
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 carcases 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.

Dicyclanil, tilmicosin, flumethrin and clenbuterol hydro-
chloride should be inserted into Annex I to Regulation
(EEC) No 2377/90, without prejudice to other provi-
sions of Community law, in particular Council Directive
96/22/EC (3).

Butafosfan should be inserted into Annex II to Regula-
tion (EEC) No 2377/90.

In order to allow for the completion of scientific studies,
phoxim should be inserted into Annex III to Regulation
(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 (4), as last amended by Directive 93/40/EEC (5),
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,
hereby amended as set out in the Annex hereto.

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

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.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 269, 21.10.2000, p. 21.

(3) OJ L 125, 23.5.1996, p. 3.
(4) OJ L 317, 6.11.1981, p. 1.
(5) OJ L 214, 24.8.1993, p. 31.

L 276/6

EN

Official Journal of the European Communities

28.10.2000

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

Done at Brussels, 27 October 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.

Anti-infectious agents

1.2. Antibiotics

1.2.4. Macrolides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Tilmicosin

Tilmicosin

Bovine

50 µg/kg

Milk’

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

‘Flumethrin

Flumethrin (sum of trans-Z Ovine
isomers)

10 µg/kg
150 µg/kg
20 µg/kg
10 µg/kg

Muscle
Fat
Liver
Kidney

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

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
150 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’

.

2
8
1
0
2
0
0
0

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

L

2
7
6
/
7

3.

Agents acting on the nervous system

3.2. Agents acting on the automatic nervous system

3.2.2. β2 sympathomimetic agents

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Clenbuterol
chloride

hydro-

Clenbuterol

Bovine

Equidae

0,1 µg/kg
0,5 µg/kg
0,5 µg/kg
0,05 µg/kg
0,1 µg/kg
0,5 µg/kg
0,5 µg/kg

Muscle
Liver
Kidney
Milk
Muscle
Liver
Kidney’

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

2.

Organic chemicals

Pharmacologically active substance(s)

Animal species

Other provisions

‘Butafosfan

Bovine

For intravenous use only’

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

2.

Antiparasitic agents

2.2. Agents acting against ectoparasites

2.2.4. Organophosphates

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Phoxim

Phoxim

Ovine

50 µg/kg
400 µg/kg
50 µg/kg

Muscle
Fat
Kidney

Provisional MRLs expire on 1.7.2001; not for use in
animals from which milk is produced for human
consumption’

L

2
7
6
/
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

.

2
8
1
0
2
0
0
0

.