Commission Regulation (EC) No 500/2007 of 7 May 2007 amending Regulation (EC) No 1463/2004 as regards the introduction of a maximum residue limit for the feed additive Sacox 120 microGranulate , belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)
Date: 2007-05-07
Institutions: European Commission
Subjects: animal nutrition, fattening, food additive, foodstuffs legislation, poultry

8.5.2007

EN

Official Journal of the European Union

L 118/3

COMMISSION REGULATION (EC) No 500/2007

of 7 May 2007

amending Regulation (EC) No 1463/2004 as regards the introduction of a maximum residue limit
for the feed additive ‘Sacox 120 microGranulate’, belonging to the group of coccidiostats and other
medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 13(3) thereof,

Whereas:

(1)

(EC) No

The additive salinomycin sodium (Sacox 120 microGra-
nulate) was authorised under certain conditions
in
accordance with Council Directive 70/524/EEC (2).
1463/2004 (3)
Commission
Regulation
for use for
authorised that additive for 10 years
chickens for fattening,
linking the authorisation to the
person responsible for putting that additive into circu-
lation. That additive was notified as an existing product
on the basis of Article 10 of Regulation (EC) No
1831/2003. Since all
the information required under
that provision was submitted, that additive was entered
into the Community Register of Feed Additives.

(the Authority). The holder of the authorisation of the
additive salinomycin sodium (Sacox 120 microGranulate)
has submitted an application which proposes changing
the authorisation by introducing a
the conditions of
(MRL) as evaluated by the
maximum residue limit
Authority.

In its opinion adopted on 30 June 2004 (4),
the
Authority proposed to establish an MRL of 5 μg/kg for
the active substance concerned. It may be necessary to
review that MRL in the light of the results of a future
evaluation of
that active substance by the European
Agency for the Evaluation of Medicinal Products.

Regulation (EC) No 1463/2004 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(3)

(4)

(5)

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 1463/2004 is replaced by the
text in the Annex to this Regulation.

(2)

Regulation (EC) No 1831/2003 provides for the possi-
bility of modifying the authorisation of an additive
further to a request from the holder of the authorisation
and an opinion of the European Food Safety Authority

Article 2

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

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

Done at Brussels, 7 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(2) OJ L 270, 14.12.1970, p. 1. Directive as

(EC) No 1800/2004 (OJ

last amended by
L 317,

Commission Regulation
16.10.2004, p. 37).

(3) OJ L 270, 18.8.2004, p. 5. Regulation as amended by Regulation

(EC) No 249/2006 (OJ L 42, 14.2.2006, p. 22).

(4) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on a request from the Commission
on the re-evaluation of coccidiostat Sacox® 120 microGranulate in
accordance with article 9G of Council Directive 70/524/EEC.
Adopted on 30 June 2004 The EFSA Journal (2004) 76, p. 1-49.

L 118/4

EN

Official Journal of the European Union

8.5.2007

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