Commission Regulation (EC) No 61/2008 of 24 January 2008 amending Annex 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, as regards dinoprostone (Text with EEA relevance )
Date: 2008-01-24
Institutions: European Commission
Subjects: animal product, food inspection, foodstuffs legislation, health control, veterinary drug, waste

L 22/8

EN

Official Journal of the European Union

25.1.2008

COMMISSION REGULATION (EC) No 61/2008

of 24 January 2008

amending Annex 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, as regards dinoprostone

(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 Article 3 thereof,

limits of

Having regard to the opinions 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

The substances dinoprost tromethamine and dinoprost
to Regulation (EEC) No
are included in Annex II
2377/90 in the category of organic compounds, for all
mammalian species. A request has been made to the
Committee for Medicinal Products for Veterinary Use
(CVMP) to examine whether the assessments performed
and conclusions reached for dinoprost tromethamine and
dinoprost
also apply to dinoprostone. The CVMP
considered that given the structural similarity of dino-
prostone and dinoprost, and the fact that dinoprostone
safety
to
is
assessments performed for dinoprost tromethamine and
dinoprost also apply to dinoprostone. Consequently, the
there is no need to establish
CVMP concluded that

rapidly metabolised

dinoprost,

the

maximum residue limits for this substance. Following
the conclusions of the CVMP, it is considered appropriate
to include a new entry in Annex II, in the category of
organic compounds, for dinoprostone, for all mammalian
species.

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 adjustment which may be necessary
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 2001/82/EC of
the European Parliament
the Council of 6 November 2001 on the
and of
Community
to veterinary medicinal
products (2).

relating

code

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 II
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
its publication in the Official Journal of the European Union.

It shall apply from 25 March 2008.

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

Done at Brussels, 24 January 2008.

For the Commission

Günter VERHEUGEN
Vice-President

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

(EC) No 1353/2007 (OJ

last amended by
L 303,

Commission Regulation
21.11.2007, p. 6).

(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).

25.1.2008

EN

Official Journal of the European Union

L 22/9

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