Commission Regulation (EC) No 1323/2007 of 12 November 2007 amending Annex I 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 firocoxib Text with EEA relevance
Date: 2007-11-12
Institutions: European Commission
Subjects: chemical product, equidae, health policy, material of animal origin, veterinary drug

13.11.2007

EN

Official Journal of the European Union

L 294/11

COMMISSION REGULATION (EC) No 1323/2007

of 12 November 2007

amending Annex I 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 firocoxib

(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 2 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)

(3)

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 substance firocoxib is included in Annex III to Regu-
lation (EEC) No 2377/90 for Equidae for muscle, fat, liver
and kidney. These provisional maximum residue limits
(hereinafter MRLs) expired on 1 July 2007. Additional
data were provided and assessed leading the Committee
for Medicinal Products for Veterinary Use (hereinafter
CVMP) to recommend that MRLs for Firocoxib should
be set as definitive and consequently included in Annex I
to Regulation (EEC) No 2377/90 for Equidae for muscle,
fat, liver and kidney.

The CVMP’s recommendation is based on a provisional
estimation of the substance and its residues that can be
ingested daily over a lifetime without any appreciable
health risk to exposed individuals (hereinafter ‘ADI’).
The
established temporary Acceptable Daily Intake
(ADI) has been determined by applying a different
methodology to the usual approach used for establishing

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

(EC) No 1064/2007 (OJ

last amended by
L 243,

Commission Regulation
18.9.2007, p. 3).

to ensure

ADI of veterinary medicine. However a higher safety
factor has been applied to compensate for this use in
for
order
there
supposing that
the level
proposed for use present a hazard for the health of the
consumer.

the residues of Firocoxib at

are no grounds

that

It is therefore proposed to include Firocoxib in Annex I
of Regulation (EEC) No 2377/90 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 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 and
the Council of 6 November 2001 on the
of
to veterinary medicinal
Community
products (2) to take account of the provisions of this
Regulation.

relating

code

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

opinion

of

(4)

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

Annex I
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 12 January 2008.

(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).

L 294/12

EN

Official Journal of the European Union

13.11.2007

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

Done at Brussels, 12 November 2007.

For the Commission

Günter VERHEUGEN
Vice-President

13.11.2007

EN

Official Journal of the European Union

L 294/13

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