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), 307R0108, February 6, 2007
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) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffsOJ L 270, 14.12.1970, p. 1. Regulation as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1)., and in particular Article 9g(5)(b) thereof,Whereas:(1)In accordance with Directive 70/524/EEC, coccidiostats included in Annex I to that Directive before 1 January 1988 were provisionally authorised as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation. The monensin sodium product, Elancoban, is an additive belonging to the group "Coccidiostats and other medicinal substances" listed in Chapter I of Annex B to Directive 70/524/EEC.(2)The person responsible for putting into circulation Elancoban submitted an application for authorisation and a dossier, according to Article 9g(2) and (4) of that Directive.(3)Article 9g(6) of Directive 70/524/EEC allows the automatic extension of the period of authorisation of the additives concerned until the Commission takes a decision in case of, for reasons beyond the control of the authorisation holder, no decision may be taken on the application before the expiry date of the authorisation. This provision is applicable to the authorisation of Elancoban. On 26 April 2001, the Commission requested the Scientific Committee for Animal Nutrition for a full risk evaluation and this request was consequently transferred to the European Food Safety Authority. Several requests for additional information were made during the re-evaluation process making it impossible to complete the re-evaluation within the time limits required by Article 9g.(4)The Scientific Panel on Additives and Products or Substances used in Animal Feed attached to the European Food Safety Authority has delivered a favourable opinion with regard to the safety and to the efficacy of Elancoban for chickens for fattening, for chickens reared for laying and for turkeys.(5)The re-evaluation of Elancoban carried out by the Commission showed that the relevant conditions laid down in Directive 70/524/EEC are satisfied. Elancoban should therefore be authorised for 10 years as an additive linked to the person responsible for putting it into circulation and included in Chapter I of the list referred to Article 9t(b) of that Directive.(6)As the authorisation for the additive is now linked to a person responsible for putting it into circulation, and replaces the previous authorisation which was not linked to any specific person, it is appropriate to delete the latter authorisation.(7)Since there are no safety reasons for withdrawing the product monensin sodium from the market immediately, it is appropriate to allow a transitional period of six months for the disposal of existing stocks of the additive.(8)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 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 757Eli Lilly and Company LimitedMonensin sodium (Elancoban G100, Elancoban 100, Elancogran 100, Elancoban G200, Elancoban 200)Active substanc:C36H61O11Nasodium 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 composition:Granular 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 three days 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 monensin sodium/kg of wet skin + fat.8 μg monensin sodium/kg of wet liver, kidney and muscle.
Chickens reared for laying16 weeks100120
Turkeys16 weeks60100