Commission Regulation (EC) No 2560/98 of 27 November 1998 amending Annexes I and II 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: 1998-11-27
Institutions: European Commission
Subjects: animal product, food inspection, public health, veterinary drug, veterinary legislation, waste

L 320/28

EN

Official Journal of the European Communities

28. 11. 98

COMMISSION REGULATION (EC) No 2560/98

of 27 November 1998

amending Annexes I and II 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,

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
1191/98 (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 re-
sidues 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 re-
sidues (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 valnemulin should be inserted into Annex I to
Regulation (EEC) No 2377/90;

Whereas cinnamomi cassiae aetheroleum, copper hepta-
noate, copper methionate, copper oxide, copper sulphate,
alfaprostol, dicopper oxide, rifaximin, angelicae radix
aetheroleum, anisi aetheroleum, copper gluconate, caryo-
phylli aetheroleum, cinnamomi ceylanici aetheroleum,
citri aetheroleum,
coriandri
aetheroleum, foeniculi aetheroleum, menthae piperitae
aetheroleum, myristicae aetheroleum, rosmarini aethero-
leum, thymi aetheroleum and carvi aetheroleum should
be inserted into Annex II to Regulation (EEC) No 2377/
90;

citronellae aetheroleum,

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 and II 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 165, 10. 6. 1998, p. 6.

(3) OJ L 317, 6. 11. 1981, p. 1.
(4) OJ L 214, 24. 8. 1993, p. 31.

28. 11. 98

EN

Official Journal of the European Communities

L 320/29

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

Done at Brussels, 27 November 1998.

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

1.2.8. Pleuromutilines

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Valnemulin

Valnemulin

Porcine

50 lg/kg Muscle
500 lg/kg
100 lg/kg Kidney'

Liver

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

1.

Inorganic chemicals

Pharmacologically active substance(s)

Animal species

Other provisions

‘Copper chloride

Copper gluconate

Copper heptanoate

Copper methionate

Copper oxide

Copper sulphate

Dicopper oxide

2.

Organic compounds

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species'

Pharmacologically active substance(s)

Animal species

Other provisions

‘Alfaprostol

Rifaximin

Rabbits

All mammalian food producing species

For topical use only'

L
3
2
0
/
3
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

2
8

.

1
1

.

9
8

6.

Substances of vegetable origin

Pharmacologically active substance(s)

Animal species

Other provisions

‘Angelicae radix aetheroleum

Anisi aetheroleum

Carvi aetheroleum

Caryophylli aetheroleum

Cinnamomi cassiae aetheroleum

Cinnamomi ceylanici aetheroleum

Citri aetheroleum

Citronellae aetheroleum

Coriandri aetheroleum

Foeniculi aetheroleum

Menthae piperitae aetheroleum

Myristicae aetheroleum

Rosmarini aetheroleum

Thymi aetheroleum

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

All food producing species

For use in newborn animals only'

2
8

.

1
1

.

9
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

L
3
2
0
/
3
1