Commission Regulation (EC) No 1568/98 of 17 July 1998 amending Annexes I, II, III and IV 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: 1998-07-17
Institutions: European Commission
Subjects: animal product, food inspection, public health, veterinary drug, veterinary legislation, waste

22. 7. 98

EN

Official Journal of the European Communities

L 205/1

I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 1568/98

of 17 July 1998

amending Annexes I, II, III and IV 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 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 res-
idues 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 res-
idues (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 carcasses moving in inter-

national trade, and maximum residue limits should there-
fore also always be established for muscle or fat tissues;

Whereas, in the case of veterinary medicinal products
intended for use in laying birds,
lactating animals or
honey bees, maximum residue limits must also be estab-
lished for eggs, milk or honey;

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

Whereas pyrethrum extract, hamamelis virginiana, chry-
purpurea,
santhemi
tanninum and natamycin should be inserted into Annex
II to Regulation (EEC) No 2377/90;

cinerariifolii

echinacea

flos,

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

Whereas it appears that maximum residue limits cannot
be established for aristolochia spp. and preparations
thereof because residues, at whatever limit, in foodstuffs of
animal origin might constitute a hazard to the health of
the consumer; whereas aristolochia spp. and preparations
thereof should be inserted into Annex IV to Regulation
(EEC) No 2377/90;

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,

(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.

L 205/2

EN

Official Journal of the European Communities

22. 7. 98

HAS ADOPTED THE FOLLOWING REGULATION:

Article 2

Article 1

Annexes I, II, III and IV of Regulation (EEC) No 2377/90
are hereby amended as set out in the Annex hereto.

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

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

Done at Brussels, 17 July 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

22. 7. 98

EN

Official Journal of the European Communities

L 205/3

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