Commission Regulation (EC) No 2232/2004 of 23 December 2004 amending Annexes I, II and 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 altrenogest, beclomethasone dipropionate, cloprostenol, r-cloprostenol, sorbitan sesquioleate and toltrazurilText with EEA relevance
Date: 2004-12-23
Institutions: European Commission
Subjects: animal product, chemical product, foodstuff, pharmaceutical legislation, veterinary drug

24.12.2004

EN

Official Journal of the European Union

L 379/71

COMMISSION REGULATION (EC) No 2232/2004

of 23 December 2004

amending Annexes I, II and 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 altrenogest, beclomethasone dipropionate, cloprostenol, r-
cloprostenol, sorbitan sesquioleate and toltrazuril

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

2377/90 for bovine, porcine and equine species. Those
entries should be extended to cover caprine species.

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 estab-
lishment of maximum residue limits of veterinary medicinal
products in foodstuffs of animal origin (1), and in particular
Articles 2 and 3 and the third paragraph of Article 4 thereof,

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

Whereas:

All pharmacologically active substances which are used
within the Community in veterinary medicinal products
intended for administration to food-producing animals
should be evaluated in accordance with Regulation
(EEC) No 2377/90.

The substance altrenogest was included,
in accordance
with Council Directive 96/22/EC of 29 April 1996
concerning the prohibition on the use in stockfarming
of certain substances having a hormonal or thyrostatic
action and of beta-agonists, and repealing Directives
81/602/EEC, 88/146/EEC and 88/299/EEC (2), in Annex
III to Regulation (EEC) No 2377/90 for porcine species
pending
zootechnical
and
completion of scientific studies. These studies have now
been completed and altrenogest should therefore be
inserted in Annex I to that Regulation.

equidae

only

use

for

(1)

(2)

(3)

(4)

The substance beclomethasone dipropionate should be
included in Annex II to Regulation (EEC) No 2377/90
for equidae but only for inhalation use.

The substances cloprostenol and r-cloprostenol have
to Regulation (EEC) No
been included in Annex II

(9)

(5)

(6)

(7)

(8)

The substance sorbitan sesquioleate is closely related to
sorbitan trioleate, which is included in Annex II to Regu-
lation (EEC) No 2377/90 for all food producing species.
Other sorbitan esters are authorised as food additives
under Directive 95/2/EC of
the European Parliament
and Council of 20 February 1995 on food additives
other than colours and sweeteners (3) and are therefore
included in Annex II to Regulation (EEC) No 2377/90 for
all food producing species. The sorbitan esters concerned
are sorbitan monostearate (E491), sorbitan tristearate
(E492), sorbitan monolaurate (E493), sorbitan mono-
oleate
(E495).
sorbitan sesquioleate should therefore also be included
in that Annex II for all food producing species.

and sorbitan monopalmitate

(E494)

The substance toltrazuril is included in Annex I to Regu-
lation (EEC) No 2377/90 for chickens,
turkeys, and
porcine species.
In order to allow for the completion
of scientific studies for the extension to cover bovine
species, toltrazuril should be included in Annex III to
that Regulation, but not for animals from which milk
is produced for human consumption.

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

An adequate period should be allowed before the applic-
ability 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 marketing author-
accordance with Directive
isations
2001/82/EC of
the
Council of 6 November 2001 on the Community code
relating to veterinary medicinal products (4).

the European Parliament and of

granted

in

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

opinion

of

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

(EC) No 1875/2004 (OJ

last amended by
L 326,

Commission Regulation
29.10.2004, p. 19).

(2) OJ L 125, 23.5.1996, p. 3. Directive as last amended by Directive
2003/74/EC of the European Parliament and of the Council
(OJ
L 262, 14.10.2003, p. 17).

(3) OJ L 61, 18.3.1995, p. 1. Directive as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(4) 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).

L 379/72

EN

Official Journal of the European Union

24.12.2004

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I,
amended in accordance with the Annex to this Regulation.

to Regulation (EEC) No 2377/90 are

II and III

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 22 February 2005.

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

Done at Brussels, 23 December 2004.

For the Commission

Günter VERHEUGEN
Vice-President

24.12.2004

EN

Official Journal of the European Union

L 379/73

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L 379/74

EN

Official Journal of the European Union

24.12.2004

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