Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive «Elancoban» in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Modified by
  • Commission Regulation (EC) No 108/2007of 5 February 2007amending Regulation (EC) No 1356/2004 as regards the conditions for authorisation of the feed additive Elancoban, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance), 32007R0108, February 6, 2007
  • 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), 32008R1096, November 7, 2008
  • Commission Implementing Regulation (EU) 2019/138of 29 January 2019amending Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013 as regards the name of the holder of the authorisation for feed additives(Text with EEA relevance), 32019R0138, January 30, 2019
Commission Regulation (EC) No 1356/2004of 26 July 2004concerning the authorisation for 10 years of the additive Elancoban in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Article 1Chapter I of Annex B to Directive 70/524/EEC is amended as follows:The additive monensin sodium, belonging to the group "Coccidiostats and other medical substances", shall be deleted.
Article 2The additive Elancoban belonging to the group "Coccidiostats and other medical substances", as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.
Article 3A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of monensin sodium.
Article 4This Regulation shall enter into force on the third day following that of 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.ANNEX
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 757Elanco GmbHMonensin 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
Article 1Chapter I of Annex B to Directive 70/524/EEC is amended as follows:The additive monensin sodium, belonging to the group "Coccidiostats and other medical substances", shall be deleted.
Article 2The additive Elancoban belonging to the group "Coccidiostats and other medical substances", as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.
Article 3A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of monensin sodium.
Article 4This Regulation shall enter into force on the third day following that of 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.ANNEX
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 757Elanco GmbHMonensin 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