Commission Regulation (EC) No 1095/2008 of 6 November 2008 amending Regulation (EC) No 109/2007 as regards the terms of the authorisation of the feed additive monensin sodium (Coxidin) (Text with EEA relevance)
Date: 2008-11-06
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, market approval, poultry, veterinary drug

7.11.2008

EN

Official Journal of the European Union

L 298/3

COMMISSION REGULATION (EC) No 1095/2008

of 6 November 2008

amending Regulation (EC) No 109/2007 as regards the terms of the authorisation of the feed
additive monensin sodium (Coxidin)

(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:

The additive monensin sodium (Coxidin) was authorised
under certain conditions in accordance with Regulation
(EC) No 1831/2003. Commission Regulation (EC) No
109/2007 (2) authorised that additive for ten years for
use for chickens for fattening and turkey,
linking the
authorisation to the holder of authorisation for putting
that additive into circulation.

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
(‘the Authority’).

(1)

(2)

(3)

authorisation by reducing the withdrawal period before
slaughter and by establishing the final Maximum Residue
Limits (MRLs).

In its opinion adopted on 18 June 2008 (3),
the
Authority concluded, after re-assessing human exposure,
that a one-day withdrawal time for Coxidin for chickens
for fattening and turkeys could be set. No new data was
provided by the holder of the authorisation which would
allow the Authority to propose a final MRL.

Regulation (EC) No 109/2007 should therefore be
amended accordingly.

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

opinion

the

the

of

(4)

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 109/2007 is replaced by the
Annex to this Regulation.

the authorisation of

The holder of
the feed additive
monensin sodium (Coxidin) has submitted an application
the
with which it proposes changing the terms of

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, 6 November 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 29.
(2) OJ L 31, 6.2.2007, p. 6.

(3) Scientific Opinion of

the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) on a request from the
European Commission on the withdrawal period for Coxidin for
chickens and turkeys for fattening and the re-examination of the
provisional Maximum Residue Limit. The EFSA Journal (2008) 731,
1-14.

L 298/4

EN

Official Journal of the European Union

7.11.2008

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