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)
Commission Regulation (EC) No 1096/2008of 6 November 2008amending 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 nutritionOJ L 268, 18.10.2003, p. 29., 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/EECOJ L 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC) No 1831/2003.. Commission Regulation (EC) No 1356/2004OJ L 251, 27.7.2004, p. 6. 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 2008Scientific 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., 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,HAS ADOPTED THIS REGULATION:
Article 1The Annex to Regulation (EC) No 1356/2004 is replaced by the Annex to this Regulation.
Article 2This 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 CommissionAndroulla VassiliouMember of the CommissionANNEX
Coccidiostats and other medicinal substances
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(Trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationProvisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 757Eli Lilly and Company LimitedMonensin sodium(Elancoban G100, Elancoban 100, Elancogran 100, Elancoban G200, Elancoban 200)Active substanceC36H61O11Nasodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis, ATCC 15413 in granular form.Factor composition:Monensin A: not less than 90 %Monensin A + B: not less than 95 %Additive compositionGranular monensin (dried fermentation product) equivalent to Monensin activity 10 % w/wMineral oil 1-3 % w/wLimestone granular 13-23 % w/wRice hulls or limestone granular qs 100 % w/wGranular monensin (dried fermentation product) equivalent to Monensin activity 20 % w/wMineral oil 1-3 % w/wRice hulls or limestone granular qs 100 % w/wChickens for fattening—100125Use prohibited at least one day before slaughter.Indicate in the instructions for use:"Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances"30.7.201425 μg/kg monensin sodium of wet skin + fat8 μg/kg monensin sodium of wet liver, wet kidney and wet muscle.
Chickens reared for laying16 weeks100120
Turkeys16 weeks60100