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)

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
,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1831/2003 of the 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) 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). Commission Regulation (EC) No 1356/2004 (3) authorised that additive for ten years for use for chickens for fattening, chickens reared for laying and turkeys, linking the 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.
(2) Regulation (EC) No 1831/2003 provides for the possibility to modify 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’).
(3) 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.
(4) 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 for fattening, chickens reared for laying and turkeys could be set.
(5) Regulation (EC) No 1356/2004 should therefore be amended accordingly.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,