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

Abstract

The additive Clinacox® 0.5% is a coccidiostat containing 0.5 % of the active substance diclazuril. The recommended dose of 1 mg diclazuril/kg feed was shown to be safe for the target animal with a margin of safety of at least 12. Diclazuril does not have antibacterial properties and consequently no microbial risk for the target species or induction of cross-resistance to clinically relevant antibiotics is expected. The toxicological studies submitted have been previously assessed by the FEEDAP Panel and no new data was found which would require reconsideration of the previous opinion and its conclusion on an ADI of 0.029 mg diclazuril/kg bw (corresponding to 1.7 mg diclazuril/person/day). Therefore, the basis of the assessment of consumer safety is unchanged and the former conclusions remain: compliance with the ADI is achieved without applying a withdrawal period and therefore in principle no MRLs need to be established. The MRL's previously proposed and enforced at the EU level ensure the protection of the consumer regarding the use of Clinacox® 0.5 % at the dose proposed for use in turkeys for fattening. No safety concern would arise for workers handling Clinacox® 0.5 % provided that appropriate protective measures are taken. The use of diclazuril at the dose proposed for turkeys for fattening does not pose a risk for the environment. The results of a battery study and three floor pen studies with recent field isolates and one field trial provided evidence that 1 mg diclazuril/kg complete feed remains effective in controlling coccidiosis in turkeys for fattening.