
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and other medicinal substances’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2 
This 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, 5 October 2010.
For the Commission
The President
José Manuel BARROSO
ANNEX

Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Coccidiostats and other medicinal substances
5 1 774 Phibro Animal Health SA Belgium Nicarbazin 250 g/kg 
 Additive composition
Nicarbazin: 250 g/kg
Stearic acid: 126 ± 5 % g/kg
Polysorbate 20: 13,90 ± 10 % g/kg
Wheat middling to 100 %
 Active substance
Nicarbazin, C19H18N6O6.
CAS number: 330-95-0
equimolecular complex of 1,3-bis(4-nitrophenyl) urea and 4,6-dimethylpyrimidin-2-ol, in granular form
Related impurities: p-nitroaniline: ≤ 0,3 % Chickens for fattening — 125 125 
1. Use prohibited at least one day before slaughter.

2. Nicarbazin shall not be mixed with other coccidiostats except narasin.

3. The additive shall be incorporated in compound feed in form of a premixture.

4. From 26 October 2013 the p-nitroaniline content shall be ≤ 0,1 %.

5. A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation.
 26 October 2020 
 15 000 μg of dinitrocarbanilide (DNC)/kg of fresh liver;
 6 000 μg of DNC/kg of fresh kidney;
 4 000 μg of DNC/kg for fresh muscle and fresh skin/fat.