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

Abstract

Coxiril®, containing 0.5 % diclazuril, is intended for use in the control of coccidiosis in guinea fowl at concentrations between 0.8 and 1.2 mg diclazuril/kg complete feed. Since diclazuril from Coxiril® is considered safe for turkeys for fattening with a margin of safety of 12‐fold the intended dose, this conclusion can be extrapolated to guinea fowl, which is a physiologically similar minor species. Diclazuril at a level of 1.2 mg/kg complete feed is therefore safe for guinea fowl. The safety for the consumer of diclazuril when used as a feed additive for chickens for fattening and turkeys for fattening has been established. The FEEDAP Panel proposed that the same Maximum Residue Limits (MRLs) be applied as established in chickens and turkeys for fattening. A withdrawal time is not considered necessary. In the absence of data on residues of diclazuril in eggs, no conclusion on the potential exposure of the consumer can be made. No specific safety concerns related to the user or the environment were identified in the opinions on Coxiril® for chickens and turkeys for fattening, and the same applies to the use of Coxiril® in guinea fowl, since the conditions of use are similar. Based on the results of one study, in which guinea fowl were artificially infected with Eimeria numidia and Eimeria grenieri, and considering the established efficacy of the additive at the proposed use level compared with other Eimeria species, the FEEDAP Panel concludes that 0.8 mg diclazuril/kg feed has the potential to control coccidiosis in guinea fowl.

Assessment of the feed additive consisting of diclazuril (Clinacox® 0.5%) for chickens for fattening and chickens reared for laying for the renewal of its authorisation (Elanco GmbH)

“…EFSA issued seven other opinions on the same additive consisting of diclazuril from a different applicant (EFSA FEEDAP Panel, 2014a , 2014b , 2014c , 2015 , 2018a , 2018b , 2023a , 2023b ).…”

Scientific Opinion on the safety and efficacy of Coxiril®(diclazuril) for rabbits for fattening and breeding

“…Finally, an opinion on re-evaluation of safety and efficacy of Clinacox ® 0.5 % for chickens reared for laying was adopted in 2013 (EFSA FEEDAP Panel, 2013). EFSA adopted in 2014 three opinions on the safety and efficacy of Coxiril ® (diclazuril) for chickens for fattening (EFSA FEEDAP Panel, 2014a), for turkeys for fattening (EFSA FEEDAP Panel, 2014b) and for guinea fowl (EFSA FEEDAP Panel, 2014c).…”