Scientific Opinion on the safety and efficacy of Coxiril® (diclazuril) as a feed additive for chickens for fattening

Coxiril®, containing 0.5 % diclazuril, is intended for use in the control of coccidiosis in chickens for fattening at a dose range of 0.8 to 1.2 mg diclazuril/kg complete feed. The highest proposed use level (1.2 mg diclazuril/kg feed) is considered safe for chickens for fattening, although the value of the tolerance study is limited owing to weaknesses in the design. However, none of the parameters measured showed an adverse effect of the three-fold use level of diclazuril. Diclazuril has no substantial antibacterial activity. Diclazuril from Coxiril® is considered toxicologically equivalent to the other currently authorised diclazuril. The use of Coxiril® at the highest proposed use level of 1.2 mg diclazuril/kg complete feed in chickens for fattening is safe for the consumer since Maximum Residue Limits are not exceeded. Coxiril® is considered non-irritant to eyes and skin. It is not a potential skin sensitiser. User exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. Based on a Phase I assessment, the use of diclazuril in chickens for fattening at the high use level does not pose a risk to the environment. Diclazuril from Coxiril® has the potential to control coccidiosis in chickens for fattening at a minimum dose of 0.8 mg/kg complete feed. This conclusion is derived from literature data, and from recent studies (five floor pen studies, two field trials and two sensitivity tests) performed with Coxiril®.