Commission Regulation (EC) No 1463/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive «Sacox 120 microGranulate» in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Modified by
  • Commission Regulation (EC) No 249/2006of 13 February 2006amending Regulations (EC) No 2430/1999, (EC) No 937/2001, (EC) No 1852/2003 and (EC) No 1463/2004 as regards the terms of the authorisation of certain additives in feedingstuffs belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance), 32006R0249, February 14, 2006
  • Commission Regulation (EC) No 500/2007of 7 May 2007amending Regulation (EC) No 1463/2004 as regards the introduction of a maximum residue limit for the feed additive Sacox 120 microGranulate, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance), 32007R0500, May 8, 2007
  • Commission Implementing Regulation (EU) 2017/1145of 8 June 2017on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives(Text with EEA relevance), 32017R1145, June 29, 2017
  • Commission Implementing Regulation (EU) 2017/1914of 19 October 2017concerning the authorisation of salinomycin sodium (Sacox 120 microGranulate and Sacox 200 microGranulate) as a feed additive for chickens for fattening and chickens reared for laying and repealing Regulations (EC) No 1852/2003 and (EC) No 1463/2004 (holder of authorisation Huvepharma NV)(Text with EEA relevance), 32017R1914, October 20, 2017
Commission Regulation (EC) No 1463/2004of 17 August 2004concerning the authorisation for 10 years of the additive Sacox 120 microGranulate 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 salinomycin sodium, belonging to the group "Coccidiostats and other medical substances", is deleted.
Article 2The additive Sacox 120 microGranulate 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 salinomycin 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 authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 766Huvepharma NV BelgiumSalinomycin sodium 120 g/kg(Sacox 120 microGranulate)Additive composition:Salinomycin sodium ≥ 120 g/kgSilicon dioxide 10-100 g/kgCalcium carbonate 350-700 g/kgActive substance:Salinomycin sodium,C42H69O11Na,CAS number: 55 721-31-8,Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (DSM 12217)Related impurities:< 42 mg elaiophylin/kg salinomycin sodium.< 40 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodiumChickens for fattening—6070Use prohibited at least one day before slaughter.Indicate in the instructions for use:"Dangerous for equines and turkeys";"This feedingstuff contains an ionophore:simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated"21.8.20145 μg of Salinomycin/kg for all wet tissues
Article 1Chapter I of Annex B to Directive 70/524/EEC is amended as follows:The additive salinomycin sodium, belonging to the group "Coccidiostats and other medical substances", is deleted.
Article 2The additive Sacox 120 microGranulate 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 salinomycin 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 authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 766Huvepharma NV BelgiumSalinomycin sodium 120 g/kg(Sacox 120 microGranulate)Additive composition:Salinomycin sodium ≥ 120 g/kgSilicon dioxide 10-100 g/kgCalcium carbonate 350-700 g/kgActive substance:Salinomycin sodium,C42H69O11Na,CAS number: 55 721-31-8,Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (DSM 12217)Related impurities:< 42 mg elaiophylin/kg salinomycin sodium.< 40 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodiumChickens for fattening—6070Use prohibited at least one day before slaughter.Indicate in the instructions for use:"Dangerous for equines and turkeys";"This feedingstuff contains an ionophore:simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated"21.8.20145 μg of Salinomycin/kg for all wet tissues