Commission Regulation (EC) No 2338/2000 of 20 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: 2000-10-20
Institutions: European Commission
Subjects: animal product, pharmaceutical legislation, veterinary drug, waste

21.10.2000

EN

Official Journal of the European Communities

L 269/21

COMMISSION REGULATION (EC) No 2338/2000

of 20 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 1960/2000 (2), and in partic-
ular Articles 6, 7 and 8 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

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
foodstuffs of animal
concerned for the consumer of
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
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.

In the case of veterinary medicinal products intended for
lactating animals or honey bees,
use in laying birds,
maximum residue limits must also be established for
eggs, milk or honey.

(6)

(7)

(8)

(9)

Erythromycin,
flumequine, marbofloxacin, paromo-
mycin, pirlimycin, tiamulin and tilmicosin should be
inserted into Annex I to Regulation (EEC) No 2377/90.

fructus, standardised extracts and prepara-
Anisi stellati
tions thereof, Cinchonae cortex, standardised extracts and
preparations thereof, Cinnamoni cassiae cortex, standar-
dised extracts and preparations thereof, Cinnamomi ceyla-
nici cortex, standardised extracts and preparations thereof,
Condurango cortex, standardised extracts and preparations
thereof, decoquinate,
standardised
Frangulae
extracts and preparations thereof, Gentianae radix, stan-
dardised extracts and preparations thereof, sodium boro-
formiate and sodium propionate should be inserted into
Annex II to Regulation (EEC) No 2377/90.

cortex,

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 colistin,
josamycin and oxyclozanide.

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,
amended as set out in the Annex.

II and III to 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 234, 16.9.2000, p. 5.

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

L 269/22

EN

Official Journal of the European Communities

21.10.2000

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

Done at Brussels, 20 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.

1.2.

Anti-infectious agents

Antibiotics

1.2.3. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Flumequine

Flumequine

Bovine
Turkey

Marbofloxacin

Marbofloxacin

Bovine

Porcine

50 µg/kg
400 µg/kg
250 µg/kg
800 µg/kg
1 000 µg/kg

150 µg/kg
50 µg/kg
150 µg/kg
150 µg/kg
75 µg/kg
150 µg/kg
50 µg/kg
150 µg/kg
150 µg/kg

Milk
Muscle
Skin and fat
Liver
Kidney

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

.

2
1
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
6
9
/
2
3

1.2.4. Macrolides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Erythromycin

Erythromycin A

Chiken

Bovine

Ovine

Porcine

Tilmicosin

Tilmicosin

Rabbits

200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
150 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
40 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg
200 µg/kg

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

50 µg/kg
50 µg/kg
1 000 µg/kg
1 000 µg/kg

Muscle
Fat
Liver
Kidney’

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

1.2.8.

Pleuromutilines

Pharmacologically active
substance(s)

‘Tiamulin

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Sum of metaboilites that
may be hydrolysed to 8-α-
hydroxymutilin

Rabbits

100 µg/kg
500 µg/kg

Muscle
Liver’

L

2
6
9
/
2
4

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
1
1
0
2
0
0
0

.

1.2.9.

Lincosamides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Pirlimycin

Pirlimycin

Bovine

100 µg/kg
100 µg/kg
1 000 µg/kg
400 µg/kg
100 µg/kg

Muscle
Fat
Liver
Kidney
Milk’

1.2.10. Aminoglycosides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Paromomycin

Paromomycin

Bovine

Porcine, rabbits

Chicken

500 µg/kg
1 500 µg/kg
1 500 µg/kg
500 µg/kg
1 500 µg/kg
1 500 µg/kg
500 µg/kg
1 500 µg/kg
1 500 µg/kg

Muscle
Liver
Kidney
Muscle
Liver
Kidney
Muscle
Liver
Kidney

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

1. Inorganic chemicals

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

for use in animals

Not
produced for human consumption’

from which eggs are

Pharmacologically active substance(s)

Animal species

Other provisions

‘Sodium propionate

2. Organic compounds

All food producing species’

Pharmacologically active substance(s)

Animal species

Other provisions

‘Decoquinate

Bovine, ovine

For oral use only. Not for use in animals from which milk is
produced for human consumption’

Sodium boroformiate

All food producing species

.

2
1
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
6
9
/
2
5

6. Substances of vegetable origin

Pharmacologically active substance(s)

Animal species

Other provisions

‘Anisi stellati fructus, standardised extracts and preparations thereof

All food producing species

Cinchonae cortex, standardised extracts and preparations thereof

All food producing species

Cinnamomi cassiae cortex, standardised extracts and preparations
thereof

All food producing species

Cinnamomi ceylanici cortex, standardised extracts and preparations
thereof

All food producing species

Condurango cortex, standardised extracts and preparations thereof

All food producing species

Frangulae cortex, standardised extracts and preparations thereof

All food producing species

Gentianae radix, standardised extracts and preparations thereof

All food producing species’

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

1.

Anti-infectious agents

1.2. Antibiotics

1.2.2. Macrolides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Josamycin

Josamycin

Chicken

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

Muscle
Fat
Liver
Kidney
Eggs

Provisional MRLs expire on 1.7.2002’

L

2
6
9
/
2
6

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
1
1
0
2
0
0
0

.

1.2.9. Polymyxins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Colistin

Colistin

Bovine, ovine
Bovine, ovine, porcine, chicken,
rabbits

Chicken

50 µg/kg
150 µg/kg
150 µg/kg
150 µg/kg
200 µg/kg
300 µg/kg

Milk
Muscle
Fat
Liver
Kidney
Eggs

Provisional MRLs expire on 1.7.2002’

2.

Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.1. Phenol derivatives including salicylanides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Oxyclozanide

Oxyclozanide

Bovine

Ovine

20 µg/kg
20 µg/kg
500 µg/kg
100 µg/kg
10 µg/kg
20 µg/kg
20 µg/kg
500 µg/kg
100 µg/kg

Muscle
Fat
Liver
Kidney
Milk
Muscle
Fat
Liver
Kidney

Provisional MRLs expire on 1.7.2002’

.

2
1
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
6
9
/
2
7