Commission Regulation (EC) No 807/2001 of 25 April 2001 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: 2001-04-25
Institutions: European Commission
Subjects: animal product, food inspection, foodstuff, health control, health risk, marketing, veterinary drug, waste

L 118/6

EN

Official Journal of the European Communities

27.4.2001

COMMISSION REGULATION (EC) No 807/2001

of 25 April 2001

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 750/2001 (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
liver or kidney. However,
the liver and kidney are
frequently removed from carcasses moving in inter-
national
trade, and maximum residue limits should
therefore also always be established for muscle or fat
tissues.

(6)

(7)

(8)

(9)

maximum residue limits must also be established for
eggs, milk or honey.

Cefoperazone, cyhalothrin,
lincomycin, nafcillin, neto-
tiamulin and cyfluthrin should be
bimin, phoxim,
inserted into Annex I to Regulation (EEC) No 2377/90.

‘Linear alkyl benzene sulphonic acids with alkyl chain
lengths ranging from C9 to C13, containing less than
2,5 % of chains longer than C13’ should be inserted into
Annex II to Regulation (EEC) No 2377/90.

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 ceface-
trile, oxolinic acid and permethrin.

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 THE FOLLOWING REGULATION:

Article 1

Annexes I,
hereby amended as set out in the Annex hereto.

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.

(5)

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

It shall apply from the 60th day following its publication.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 109, 19.4.2001, p. 35.

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

27.4.2001

EN

Official Journal of the European Communities

L 118/7

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

Done at Brussels, 25 April 2001.

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

1.2.1. Penicillins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Nafcillin

Nafcillin

Bovine

300 µg/kg
300 µg/kg
300 µg/kg
300 µg/kg
30 µg/kg

Muscle
Fat
Liver
Kidney
Milk

For intramammary use only’

1.2.2. Cephalosporins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cefoperazone

Cefoperazone

Bovine

50 µg/kg

Milk’

1.2.8. Pleuromutilines

Pharmacologically active
substance(s)

‘Tiamulin

1.2.9. Lincosamides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

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

Turkey

100 µg/kg
100 µg/kg
300 µg/kg

Muscle
Skin and fat
Liver’

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Lincomycin

Lincomycin

Ovine

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

Muscle
Fat
Liver
Kidney
Milk

L

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2
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4
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0
0
1

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Porcine

Chicken

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

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

Muscle
Skin and fat
Liver
Kidney

Muscle
Skin and fat
Liver
Kidney
Eggs’

2.

Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.3. Benzimidazoles and pro-benzimidazoles

Pharmacologically active
substance(s)

‘Netobimin

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Turkey

Sum of albendazole oxide,
albendazole sulphone and
albendazole
2-aminosul-
phone, expressed as alben-
dazole

100 µg/kg
100 µg/kg
1 000 µg/kg
500 µg/kg
100 µg/kg

Muscle
Fat
Liver
Kidney
Milk

For oral use only’

2.2.

Agents acting against ectoparasites

2.2.1. Organophosphates

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Phoxim

Phoxim

Ovine

Porcine

50 µg/kg
400 µg/kg
50 µg/kg

20 µg/kg
700 µg/kg
20 µg/kg
20 µg/kg

Muscle
Fat
Kidney

Muscle
Skin and fat
Liver
Kidney

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

.

.

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2.2.3. Pyrethroids

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cyhalothrin

Cyhalothrin
isomers)

(sum

of

Bovine

Cyfluthrin

Cyfluthrin (sum of isomers)

Bovine

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

2.

Organic compounds

500 µg/kg
50 µg/kg

50 µg/kg
10 µg/kg

50 µg/kg
10 µg/kg
10 µg/kg
20 µg/kg

Fat
Kidney

Milk
Muscle

Fat
Liver
Kidney
Milk

Further provisions in Council Directive 94/29/EC are
to be observed’

Pharmacologically active substance(s)

Animal species

Other provisions

‘Linear alkyl benzene sulphonic acids with alkyl chain lengths
ranging from C
9 to C13, containing less than 2,5 % of chains
longer than C

13

Bovine

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

For topical use only’

1.

Anti-infectious agents

1.2.

Antibiotics

1.2.4. Cephalosporins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cefacetrile

Cefacetrile

Bovine

125 µg/kg

Milk

Provisional MRLs expire on 1.1.2002
For intramammary use only’

1.2.6. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Oxolinic acid

Oxolinic acid

Bovine

100 µg/kg
50 µg/kg

Muscle
Fat

150 µg/kg

Liver

150 µg/kg

Kidney

Provisional MRLs expire on 1.1.2003
Not for use in animals from which milk is produced
for human consumption’

L

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.

.

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4
2
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0
1

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Porcine

Chicken

Fin fish

100 µg/kg
50 µg/kg
150 µg/kg
150 µg/kg

100 µg/kg
50 µg/kg
150 µg/kg
150 µg/kg
50 µg/kg

300 µg/kg

Muscle
Skin and fat
Liver
Kidney

Muscle
Skin and fat
Liver
Kidney
Eggs

Muscle
proportions

and

skin

in

natural

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

‘Permethrin

Permethrin
isomers)

(sum

of

Chicken, porcine

Bovine, caprine

50 µg/kg
500 µg/kg
50 µg/kg
50 µg/kg

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

Muscle
Skin and fat
Liver
Kidney

Muscle
Fat
Liver
Kidney
Milk

Provisional MRLs expire on 1.1.2003

Provisional MRLs expire on 1.1.2003

provisions

Further
Commission Directive
98/82/EC are to be observed (OJ L 290, 29.10.1998,
p. 25)

in

Chicken

50 µg/kg

Eggs

Provisional MRLs expire on 1.1.2003’

.

.

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