Commission Regulation (EC) No 804/1999 of 16 April 1999 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 originText with EEA relevance
Date: 1999-04-16
Institutions: European Commission
Subjects: animal product, food inspection, veterinary drug, veterinary legislation, waste

L 102/58

EN

Official Journal of the European Communities

17. 4. 1999

COMMISSION REGULATION (EC) No 804/1999

of 16 April 1999

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,

honey bees, maximum residue limits must also be estab-
lished for eggs, milk or honey;

Having regard to the Treaty establishing the European
Community,

Whereas lincomycin and ceftiofur should be inserted into
Annex I to Regulation (EEC) No 2377/90;

Having regard to Council Regulation (EEC) No 2377/90
of 26 June 1990 laying down a Community procedure for
the establishment of maximum residue limits of veter-
inary medicinal products in foodstuffs of animal origin (1),
as last amended by Commission Regulation (EC) No 508/
1999 (2) and in particular Articles 6, 7 and 8 thereof,

Whereas, 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;

Whereas maximum residue limits should be established
only after the examination within the Committee for
Veterinary Medicinal Products of all the relevant informa-
tion concerning 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
foodstuffs;

Whereas, in establishing maximum residue limits for resi-
dues 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 resi-
dues (marker residue);

Whereas, for the control of residues, as provided for in
appropriate Community legislation, maximum residue
limits should usually be established for the target tissues
of liver or kidney; whereas, however, the liver and kidney
are frequently removed from carcases moving in inter-
national trade, and maximum residue limits should there-
fore also always be established for muscle or fat tissues;

Whereas melissae aetheroleum,
centellae asiaticae
extractum, strychnine, 1-methyl-2-pyrrolidone, etamsy-
late, enilconazole and cefacetrile should be inserted into
Annex II to Regulation (EEC) No 2377/90;

Whereas, in order to allow for the completion of scientific
studies, oxolinic acid, cefacetrile and thiamphenicol
should be inserted into Annex III to Regulation (EEC) No
2377/90;

Whereas, 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 Regulation (EEC) No 2377/90 should be extended for
nafcillin and cephapirin;

Whereas a period of 60 days 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;

Whereas 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, II and III to Regulation (EEC) No 2377/90 are
hereby amended as set out in the Annex hereto.

Article 2

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

This Regulation shall enter into force on the 60th day
following its publication in the Official Journal of the
European Communities.

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 60, 9.3.1999, p. 16.

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

17. 4. 1999

EN

Official Journal of the European Communities

L 102/59

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

Done at Brussels, 16 April 1999.

For the Commission

Martin BANGEMANN

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

1.2.2. Cephalosporins

Pharmacologically active
substance(s)

‘Ceftiofur

1.2.9. Lincosamides

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Sum of
residues
all
retaining the betalactam
expressed as
structure
desfuroylceftiofur

Bovine

Porcine

1 000 lg/kg Muscle

2 000 lg/kg

Fat

2 000 lg/kg

Liver

6 000 lg/kg Kidney

100 lg/kg Milk, not for

intramammary
use

1 000 lg/kg Muscle

2 000 lg/kg

Fat

2 000 lg/kg

Liver

6 000 lg/kg Kidney'

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Lincomycin

Lincomycin

Bovine

100 lg/kg Muscle

50 lg/kg

Fat

500 lg/kg

Liver

1 500 lg/kg Kidney

150 lg/kg Milk'

L
1
0
2
/
6
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

1
7

.

4

.

1
9
9
9

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

2.

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

‘1-Methyl-2-pyrrolidone

Cefacetrile

Enilconazole

Etamsylate

Strychnine

6.

Substances of vegetable origin

Equidae

Bovine

For intramammary use only and for all tissues except milk

Bovine, equidae

For topical use only

All food producing species

Bovine

For oral use only at dose to 0,1 mg/kg bw'

Pharmacologically active substance(s)

Animal species

Other provisions

‘Centellae asiaticae extractum

All food producing species

For topical use only'

Melissae aetheroleum

All food producing species

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

Anti-infectious agents
Antibiotics

1.
1.2.
1.2.4. Cephalosporins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Cefacetrile

Cefacetrile

Bovine

125 lg/kg Milk

Cephapirin

Sum of cephapirin and
desacetylcephapirin

Bovine

50 lg/kg Muscle
50 lg/kg
50 lg/kg
100 lg/kg Kidney
10 lg/kg Milk

Fat
Liver

Provisional MRLs expire on 1.1.2001
For intramammary use only

Provisional MRLs expire on 1.1.2001'

1
7

.

4

.

1
9
9
9

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
0
2
/
6
1

1.2.6. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Oxolinic acid

Oxolinic acid

Bovine

100 lg/kg Muscle

Provisional MRLs expire on 1.1.2001'

Porcine

Chicken

50 lg/kg

Fat

150 lg/kg

Liver

150 lg/kg Kidney

100 lg/kg Muscle

50 lg/kg

Skin + fat

150 lg/kg

Liver

150 lg/kg Kidney

100 lg/kg Muscle

50 lg/kg

Skin + fat

150 lg/kg

Liver

150 lg/kg Kidney

50 lg/kg

Eggs

Fin fish

300 lg/kg Muscle and skin

in natural
proportions

1.2.10. Penicillins

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Nafcillin

Nafcillin

Bovine

300 lg/kg Muscle

Provisional MRLs expire on 1.1.2001'

300 lg/kg

Fat

300 lg/kg

Liver

300 lg/kg Kidney

30 lg/kg Milk

L
1
0
2
/
6
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

1
7

.

4

.

1
9
9
9

1.2.11. Florfenicol and related compounds

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Thiamphenicol

Thiamphenicol

Ovine

Porcine

Fin fish

Provisional MRLs expire on 1.1.2001'

50 lg/kg Muscle
50 lg/kg
50 lg/kg
50 lg/kg Kidney

Fat
Liver

50 lg/kg Muscle
50 lg/kg
50 lg/kg
50 lg/kg Kidney

Skin + fat
Liver

50 lg/kg Muscle and skin

in natural
proportions

1.2.13. Lincosamides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Lincomycin

Lincomycin

Ovine

Porcine

Chicken

Provisional MRLs expire on 1.1.2001'

100 lg/kg Muscle
50 lg/kg
500 lg/kg

Fat
Liver

1 500 lg/kg Kidney
150 lg/kg Milk

100 lg/kg Muscle
50 lg/kg
500 lg/kg

Skin + fat
Liver

1 500 lg/kg Kidney

100 lg/kg Muscle
50 lg/kg
500 lg/kg

Skin + fat
Liver

1 500 lg/kg Kidney

50 lg/kg

Eggs

1
7

.

4

.

1
9
9
9

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e
E
u
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p
e
a
n
C
o
m
m
u
n
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t
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s

L
1
0
2
/
6
3