Commission Regulation (EC) No 203/2008 of 4 March 2008 amending Annex 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, as regards gamithromycin (Text with EEA relevance)
Date: 2008-03-04
Institutions: European Commission
Subjects: animal product, food inspection, foodstuffs legislation, health control, veterinary drug, waste

L 60/18

EN

Official Journal of the European Union

5.3.2008

COMMISSION REGULATION (EC) No 203/2008

of 4 March 2008

amending Annex 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, as regards gamithromycin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 2377/90 of
26 June 1990 laying down a Community procedure for the
establishment of maximum residue
veterinary
medicinal products in foodstuffs of animal origin (1), and in
particular the third paragraph of Article 4 thereof,

limits of

Having regard to the opinion of
the European Medicines
Agency formulated by the Committee for Medicinal Products
for Veterinary Use,

Whereas:

(1)

(2)

All pharmacologically active substances used in the
Community in veterinary medicinal products intended
for
should be evaluated in
accordance with Regulation (EEC) No 2377/90.

food-producing animals

daily

intake

An application for establishing maximum residue limits
(hereinafter MRLs)
for gamithromycin, an antibiotic
belonging to the group of macrolides, has been
submitted to the European Medicines Agency.
In its
first opinion the Committee for Medicinal Products for
Veterinary Use (hereinafter CVMP) established an overall
acceptable
(hereinafter ADI) of 370
μg/person as the basis for the MRL calculation. It was
based on the microbiological ADI. MRLs for kidney and
liver were fixed at 100 respectively 200 μg/kg. The
applicant introduced an appeal against the first opinion,
disagreeing with the established microbiological ADI as
well as with the MRLs set by the CVMP for liver and
kidney. He requested to change the overall ADI to 600
μg/person, which corresponded to the toxicological ADI.
Furthermore, he requested that, if the overall ADI should
not be changed to 600 μg/person, the CVMP consider
reducing the MRLs for kidney and liver by half. Having
the CVMP agreed in its final
considered the appeal,
opinion to change the microbiological ADI and, thus,

to amend the overall ADI for gamithromycin to 600
μg/person. CVMP decided that provisional maximum
residue limits should be established for gamithromycin.
As a consequence, it is found appropriate to insert that
substance in Annex III to Regulation (EEC) No 2377/90
for bovine species, for fat,
liver and kidney, excluding
animals producing milk for human consumption. The
provisional maximum residue limits will expire on
1 July 2009.

Regulation (EEC) No 2377/90 should therefore be
amended accordingly.

An adequate period should be allowed before the appli-
cability of this Regulation in order to enable Member
States to make any necessary adjustment in the light of
this Regulation to the authorisations
to place the
veterinary medicinal products concerned on the market
which have been granted in accordance with Directive
the
2001/82/EC of
Council of 6 November 2001 on the Community code
relating to veterinary medicinal products (2).

the European Parliament and of

The measures provided for in this Regulation are in
accordance with
Standing
the
the
Committee on Veterinary Medicinal Products,

opinion

of

(3)

(4)

(5)

HAS ADOPTED THIS REGULATION:

Article 1

Annex III
accordance with the Annex to this Regulation.

to Regulation (EEC) No 2377/90 is amended in

Article 2

This Regulation shall enter into force on the third day following
the European
that of
Union.

its publication in the Official

Journal of

It shall apply from 5 May 2008.

(1) OJ L 224, 18.8.1990, p. 1. Regulation as

last amended by
Commission Regulation (EC) No 61/2008 (OJ L 22, 25.1.2008,
p. 8).

(2) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

5.3.2008

EN

Official Journal of the European Union

L 60/19

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

Done at Brussels, 4 March 2008.

For the Commission

Günter VERHEUGEN
Vice-President

L 60/20

EN

Official Journal of the European Union

5.3.2008

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