
Article 1 
The provisional authorisations of the additives listed in Annex I to this Regulation are replaced by authorisations granted to the person responsible for putting the additive in circulation, inserted in the second column of Annex I.
Article 2 
The provisional authorisations of the additives listed in Annex II to this Regulation are replaced by provisional authorisations granted to the person responsible for putting the additive into circulation, inserted in the second column of Annex II.
Article 3 
This Regulation shall enter into force on the seventh day of its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I

Registration number of additive Name and registration number of person responsible for putting additive into circulation Additive (trade name) Composition, chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorisation Maximum Residue Limits(MRLs)
mg of active substance/kg of complete feedingstuff

. . . . .
E 764 Huvepharma nv Halofuginone hydrobromide 6 g/kg(Stenorol) Additive composition:
 Halofuginone gydrobromide: 6 g/kg
 Gelatine: 13,2 g/kg
 Starch: 19,2 g/kg
 Sugar: 21,6 g/kg
 Calcium carbonate: 940 g/kgActive substance:
 Halofuginone hydrobromide,
 C16H17BrClN3O3, HBr
 DL-trans-7-bromo-6-chloro-3-(3-(3-hydroxy-2-piperidy)acetonyl)quinazolin-4(3H)-one hydrobromide,
 CAS number: 64924-67-0Related impurities:
 Cis-isomer of halofuginone: < 1,5 % Chickens for laying 16 weeks 2 3 — 30.9.2009 





ANNEX II

Registration number of additive Name and registration number of person responsible for putting additive into circulation Additive (trade name) Composition, chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorisation
mg of active substance/kg of complete feedingstuff
26 Hoechst Roussel Vet GmbH Salinomycin sodium 120 g/kg(Sacox 120) Additive composition:
 Salinomycin sodium ≥ 120 g/kg
 Silicium dioxide 10-100 g/kg
 Calcium carbonate: 350-700 g/kgActive substance:
 Salinomycin sodium, C42H69O11Na,
 CAS number: 53003-10-4,
 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 sodium Rabbits for fattening — 20 25 Use prohibited at least five days before slaughterIndicate in the instructions for use:'Dangerous for equines''This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated' 30.9.2000
Chickens reared for laying 12 weeks 30 50 Indicate in the instructions for use:'Dangerous for equines''This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated' 30.9.2000
27 Janssen Animal Health B.V.B.A. Diclazuril 0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril 0,2 g/100 g(Clinacox 0,2 % Premix) Additive composition:
 Diclazuril: 0,5 g/100 g
 Soybean meal: 99,25 g/100 g
 Polyvidone K 30: 0,2 g/100 g
 Sodium hydroxyde: 0,0538 g/100 g
 Diclazuril: 0,2 g/100 g
 Soybean meal: 39,7 g/100 g
 Polyvidone K 30: 0,08 g/100 g
 Sodium hydroxide: 0,0215 g/100 g
 Wheat middlings: 60 g/100 gActive substance:
 Diclazuril, C17H9Cl3N4O2,
 (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,
 CAS number: 101831-37-2Related impurities:
 Degradation compound (R064318): ≤ 0,2 %
 Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually
 Total impurities: ≤ 1,5 % Turkeys 12 weeks 1 1 Use prohibited at least five days before slaughter 30.9.2000
Chickens reared for laying 16 weeks 1 1 — 30.9.2000
28 Roche Vitamins Europe Ltd Maduramicin ammonium alpha 1 g/100 g(Cygro 1 %) Additive composition:
 Maduramicin ammonium alpha: 1 g/100 g
 Benzyl alcohol: 5 g/100 g
 Corn cob grits qs 100 gActive substance:
 Maduramicin ammonium alpha,
 C47H83O17N,
 CAS number: 84878-61-5,
 ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis (ATCC 31585) (NRRL 12515)Related impurities:
 Maduramicin ammonium beta: < 10 % Turkeys 16 weeks 5 5 Use prohibited at least five days before slaughterIndicate in the instructions for use:'Dangerous for equines''This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated' 30.9.2000


