Scientific Opinion on safety and efficacy of Clinacox® 0.5% (diclazuril) for chickens for fattening

Clinacox® 0.5% (containing 0.5 % diclazuril) is intended to be used as a coccidiostat for chickens for fattening. Feeding 1 mg diclazuril/kg feed was safe for chickens for fattening (margin of safety of at least 25) and effective in controlling coccidiosis. Ingested diclazuril is absorbed and biotransformed to a limited extent, the parent compound being the main metabolite and marker substance. Diclazuril is not genotoxic or carcinogenic, and no major concern appeared in reproductive/developmental studies. The NOEL in a chronic mouse study was 2.9 mg/kg bw/day, yielding an ADI of 0.029 mg/kg bw. The maximum theoretical consumer exposure would be 13 % of the ADI when no withdrawal period is applied. MRLs are set at 1.5, 1.0, 0.5 and 0.5 mg/kg liver, kidney, muscle and skin/fat, respectively. No safety concern would arise for workers handling Clinacox® 0.5%. The use of Clinacox® 0.5% in chickens for fattening at the recommended dose does not pose a risk for the environment.