Commission Regulation (EC) No 1096/2008 of 6 November 2008 amending Regulation (EC) No 1356/2004 as regards the terms of the authorisation of the feed additive Elancoban , belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)
Date: 2008-11-06
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, laying poultry, market approval, poultry, veterinary drug

7.11.2008

EN

Official Journal of the European Union

L 298/5

COMMISSION REGULATION (EC) No 1096/2008

of 6 November 2008

amending Regulation (EC) No 1356/2004 as regards the terms of the authorisation of the feed
additive ‘Elancoban’, belonging to the group of coccidiostats and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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

Regulation

The
additive monensin sodium (Elancoban G100,
Elancoban 100, Elancogran 100, Elancoban G200,
Elancoban 200) was authorised under certain conditions
in accordance with Council Directive 70/524/EEC (2).
1356/2004 (3)
Commission
authorised that additive for
for use for
chickens for fattening, chickens reared for laying and
turkeys,
authorisation to the person
responsible for putting that additive into circulation.
That additive was notified as an existing product
in
accordance with 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.

ten years

linking

the

The holder of the authorisation of the additive monensin
sodium (Elancoban G100, Elancoban 100, Elancogran
100, Elancoban G200, Elancoban 200) has submitted
an application with which it proposes changing the
terms of the authorisation by reducing the withdrawal
period before slaughter.

In its opinion adopted on 18 June 2008 (4),
the
Authority concluded, after re-assessing human exposure,
that a one-day withdrawal time for Elancoban G100,
Elancoban 100, Elancogran 100, Elancoban G200 and
Elancoban 200 for chickens
fattening, chickens
reared for laying and turkeys could be set.

for

Regulation (EC) No 1356/2004 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 1356/2004 is replaced by the
Annex to this Regulation.

(2)

Regulation (EC) No 1831/2003 provides for the possi­
bility to modify the authorisation of an additive further
to a request from the holder of the authorisation and an
opinion of
Safety Authority
European Food
the
(‘the 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, 6 November 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 29.
(2) OJ L 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC)

No 1831/2003.

(3) OJ L 251, 27.7.2004, p. 6.

(4) 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 Elancoban for
chickens for fattening, chickens reared for laying and turkeys for
fattening. The EFSA Journal (2008) 730, 1-16.

L 298/6

EN

Official Journal of the European Union

7.11.2008

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