Commission Regulation (EC) No 1181/2002 of 1 July 2002 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: 2002-07-01
Institutions: European Commission
Subjects: animal product, consumer protection, food safety, foodstuff, pharmaceutical product, veterinary drug, veterinary inspection

2.7.2002

EN

Official Journal of the European Communities

L 172/13

COMMISSION REGULATION (EC) No 1181/2002

of 1 July 2002

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 869/2002 (2) and in particular
Articles 6, 7 and 8 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

In accordance with Regulation (EEC) No 2377/90, maxi-
mum residue limits must be established progressively 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
Medicinal Products of all the relevant information con-
cerning 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 food-
stuffs.

In establishing maximum residue limits for residues of
veterinary medicinal products in foodstuffs of animal ori-
gin, 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 resi-
due which is relevant for the monitoring of residues
(marker residue).

the

In view of
reduced availability of veterinary
medicinal products for certain food-producing species (3),
maximum residue limits may be established by methods
of extrapolation from maximum residue limits set for
other species on a strictly scientific basis.

For the control of residues, as provided for in appropri-
ate Community legislation, maximum residue limits
should usually be established for the target tissues of

(6)

(7)

(8)

liver or kidney. However, the liver and kidney are fre-
quently removed from carcasses moving in international
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, max-
imum residue limits must also be established for eggs,
milk or honey.

Trimethoprim, Neomycin (including framycetin), Paro-
momycin, Spectinomycin, Colistin, Danofloxacin, Diflox-
acin, Enrofloxacin, Flumequine, Erythromycin, Tilmico-
sin, Tylosin, Florfenicol, Lincomycin and Oxyclozanide
should be inserted into Annex I 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 Directive 2001/82/EC (4) of
the European Parliament and of the Council to take ac-
count of the provisions of this Regulation.

(9)

The measures provided for in this Regulation are in ac-
cordance 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.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 137, 25.5.2002, p. 10.
(3) Availability of veterinary medical products Communication from
the Commission to the Council and the European Parliament
COM(2000) 806 final.

It shall apply from the sixtieth day following its publication.

(4) OJ L 311, 28.11.2001, p. 1.

L 172/14

EN

Official Journal of the European Communities

2.7.2002

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

Done at Brussels, 1 July 2002.

For the Commission

Erkki LIIKANEN

Member of the Commission

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

ANNEX

1.

1.1.

Anti-infectious agents

Chemotherapeutics

1.1.2.

Diamino pyrimidine derivatives

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Trimethoprim

Trimethoprim

food producing

All
except equidae

species

Equidae

(1) For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.
(2) For fin fish this MRL relates to “muscle and skin in natural proportions”.’

50 µg/kg
50 µg/kg
50 µg/kg
50 µg/kg
50 µg/kg

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

Fat (1)
Muscle (2)
Liver
Kidney
Milk

Muscle
Fat
Liver
Kidney

for use in animals

Not
produced for human consumption

from which eggs are

1.2.

Antibiotics

1.2.3.

Quinolones

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Danofloxacin

Danofloxacin

food producing

species
All
except bovine, ovine, caprine
and poultry

Bovine, ovine, caprine

Poultry

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

200 µg/kg
100 µg/kg
400 µg/kg
400 µg/kg
30 µg/kg

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

Muscle (1)
Fat (2)
Liver
Kidney

Muscle
Fat
Liver
Kidney
Milk

Muscle
Skin and fat
Liver
Kidney

for use in animals

Not
produced for human consumption

from which eggs are

.

.

2
7
2
0
0
2

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

1
7
2
/
1
5

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Difloxacin

Difloxacin

food producing

species
All
except bovine, ovine, caprine
and poultry

Bovine, ovine, caprine

Porcine

Poultry

Enrofloxacin

Sum of enrofloxacin and
ciprofloxacin

food producing

All
species
except bovine, ovine, caprine,
porcine, rabbits and poultry

Bovine, ovine, caprine

Porcine, rabbits

Poultry

300 µg/kg
100 µg/kg
800 µg/kg
600 µg/kg

400 µg/kg
100 µg/kg
1 400 µg/kg
800 µg/kg

400 µg/kg
100 µg/kg
800 µg/kg
800 µg/kg

300 µg/kg
400 µg/kg
1 900 µg/kg
600 µg/kg

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

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

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

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

Muscle (1)
Fat
Liver
Kidney

Muscle
Fat
Liver
Kidney

Muscle
Skin and fat
Liver
Kidney

Muscle
Skin and fat
Liver
Kidney

Muscle (1)
Fat
Liver
Kidney

Muscle
Fat
Liver
Kidney
Milk

Muscle
Fat (2)
Liver
Kidney

Muscle
Skin and fat
Liver
Kidney

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

for use in animals

Not
produced for human consumption

from which eggs are

L

1
7
2
/
1
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
7
2
0
0
2

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Flumequine

Flumequine

food producing

species
All
except bovine, ovine, caprine,
porcine, poultry and fin fish

Bovine, porcine, ovine, caprine

Poultry

Fin fish

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

200 µg/kg
300 µg/kg
500 µg/kg
1 500 µg/kg
50 µg/kg

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

600 µg/kg

Muscle
Fat
Liver
Kidney

Muscle
Fat (2)
Liver
Kidney
Milk

Muscle
Skin and fat
Liver
Kidney

Muscle
proportion

and

skin

in

natural

for use in animals

Not
produced for human consumption

from which eggs are

(2) For fin fish this MRL relates to “muscle and skin in natural proportions”.
(1) For porcine species this MRL relates to “skin and fat in natural proportions”.’

1.2.4.

Macrolides

Pharmacologically active
substanceactiva

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Erythromycin

erythromicyin A

All food producing species

Tilmicosin

Tilmicosin

food producing

All
except poultry

species

Poultry

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

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

75 µg/kg
75 µg/kg
1 000 µg/kg
250 µg/kg

Muscle (1)
Fat (2)
Liver
Kidney
Milk
Eggs

Muscle (1)
Fat (2)
Liver
Kidney
Milk

Muscle
Sin and fat
Liver
Kidney

for use in animals

Not
produced for human consumption

from which eggs are

.

.

2
7
2
0
0
2

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

1
7
2
/
1
7

Pharmacologically active
substanceactiva

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Tylosin

Tylosin A

All food producing species

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

Fat (3)
Muscle (1)
Liver
Kidney
Milk
Eggs

(1) For fin fish this MRL relates to a “muscle and skin in natural proportions”.
(2) For procine species this MRL relates to “skin and fat in natural proportions”.
(3) For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.’

1.2.5.

Florfenicol and related compounds

Pharmacologically active
substance

‘Florfenicol

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Sum of florfenicol and its
metabolites measured as
florfenicol-amine

food producing

species
All
except bovine, ovine, caprine,
porcine, poultry and fin fish

Bovine, ovine, caprine

Porcine

Poultry

Fin fish

100 µg/kg
200 µg/kg
2 000 µg/kg
300 µg/kg

200 µg/kg
3 000 µg/kg
300 µg/kg

300 µg/kg
500 µg/kg
2 000 µg/kg
500 µg/kg

100 µg/kg
200 µg/kg
2 500 µg/kg
750 µg/kg

1 000 µg/kg

Muscle
Fat
Liver
Kidney

Muscle
Fat
Kidney

Muscle
Skin and fat
Liver
Kidney

Muscle
Skin and fat
Liver
Kidney

Muscle
and
proportions’

skin

in

natural

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

L

1
7
2
/
1
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
7
2
0
0
2

1.2.9.

Lincosamides

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Lincomycin

Lincomicyn

All food producing species

50 µg/kg
100 µg/kg
500 µg/kg
1 500 µg/kg
150 µg/kg
50 µg/kg

Fat (1)
Muscle (2)
Liver
Kidney
Milk
Eggs

(1) For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.
(2) For fin fish this MRL relates to “muscle and skin in natural proportions”.’

1.2.10. Aminoglycosides

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Neomycin
framycetin)

(including Neomycin B

All food producing species

Paromomycin

Paromomycin

All food producing species

Spectinomycin

Spectinomycin

food producing

All
except ovine

species

500 µg/kg
500 µg/kg
500 µg/kg
5 000 µg/kg
1 500 µg/kg
500 µg/kg

Fat (1)
Muscle (2)
Liver
Kidney
Milk
Eggs

500 µg/kg
1 500 µg/kg
1 500 µg/kg

Muscle (2)
Liver
Kidney

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

Fat (1)
Muscle (2)
Liver
Kidney
Milk

Not for use in animals from which milk or eggs are
produced for human consumption

for use in animals

Not
produced for human consumption

from which eggs are

.

.

2
7
2
0
0
2

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

L

1
7
2
/
1
9

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Ovine

300 µg/kg
500 µg/kg
2 000 µg/kg
5 000 µg/kg
200 µg/kg

Muscle
Fat
Liver
Kidney
Milk

(1) For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.
(2) For fin fish this MRL relates to “muscle and skin in natural proportions”.’

1.2.14.

Polymyxins

Pharmacologically active
substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Colistin

Colistin

All food producing species

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

Fat (1)
Muscle (2)
Liver
Kidney
Milk
Eggs

(1) For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.
(2) For fin fish this MRL relates to “muscle and skin in natural proportions”.’

2.

2.1.

Antiparasitic agents

Agents acting against endoparasites

2.1.4.

Phenol derivatives including salicylanides

L

1
7
2
/
2
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

Pharmacologically active
substance

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

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

.

.

2
7
2
0
0
2