Commission Regulation (EC) No 998/1999 of 11 May 1999 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: 1999-05-11
Institutions: European Commission
Subjects: animal product, antibiotic, foodstuff, homeopathic product, veterinary drug, waste

L 122/30

EN

Official Journal of the European Communities

12. 5. 1999

COMMISSION REGULATION (EC) No 998/1999

of 11 May 1999

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,

maximum residue limits
always be established for muscle or fat tissues;

should therefore also

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 997/
1999 (2), and in particular Articles 6 and 8 thereof,

(1) Whereas, in accordance with Regulation (EEC) No
2377/90, maximum residue limits must be estab-
lished progressively for all pharmacologically active
substances which are used within the Community
in veterinary medicinal products
intended for
administration to food-producing animals;

(2) Whereas maximum residue limits should be estab-
lished only after
the examination within the
Committee for Veterinary Medicinal Products of all
the relevant information concerning the safety of
residues of
the
consumer of foodstuffs of animal origin and the
impact of residues on the industrial processing of
foodstuffs;

the substance concerned for

(3) Whereas, 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);

(5) Whereas, in the case of veterinary medicinal prod-
ucts intended for use in laying birds,
lactating
animals or honey bees, maximum residue limits
must also be established for eggs, milk or honey;

(6) Whereas danofloxacin should be inserted into
Annex I to Regulation (EEC) No 2377/90;

(7) Whereas

tiaprost,

convallaria majalis, atropa
belladonna, aqua levici and adonis vernalis
should be inserted into Annex II to Regulation
(EEC) No 2377/90;

(8) 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 adjust-
ment which may be necessary to the authorisations
to place
veterinary medicinal products
concerned on the market which have been granted
in
81/
accordance with Council Directive
851/EEC (3), as last amended by Directive 93/
40/EEC (4), to take account of the provisions of this
Regulation;

the

(9) Whereas the measures provided for in this Regula-
tion 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.

(4) 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
and
carcarses moving in international

trade,

Article 2

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) See page 24 of this Official Journal.

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

12. 5. 1999

EN

Official Journal of the European Communities

L 122/31

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

Done at Brussels, 11 May 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

1.2.3. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Danofloxacin

danofloxacin

Bovine

200 lg/kg
100 lg/kg
400 lg/kg
400 lg/kg
30 lg/kg

Muscle
Fat
Liver
Kidney
Milk'

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

2.

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

‘Tiaprost

Bovine, ovine, porcine, equidae'

4.

Substances used in homeopathic veterinary medicinal products

Pharmacologically active substance(s)

Animal species

Other provisions

‘Adonis vernalis

All food producing species

For use in homeopathic veterinary medicinal products
prepared according to homeopathic pharmacopoeias, at
concentrations in the products not exceeding one part per
hundred only

Acqua levici

All food producing species

For use in homeopathic veterinary medicinal products
prepared according to homeopathic pharmacopoeias only

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Pharmacologically active substance(s)

Animal species

Other provisions

Atropa belladonna

All food producing species

Convallaria majalis

All food producing species

For use in homeopathic veterinary medicinal products
prepared according to homeopathic pharmacopoeias, at
concentrations in the products not exceeding one part per
hundred only

For use in homeopathic veterinary medicinal products
prepared according to homeopathic pharmacopoeias, at
concentrations in the products not exceeding one part per
thousand only'

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