Coxiril® (diclazuril) for chickens for fattening

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and the efficacy of Coxiril® (diclazuril) in 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 since the specifications of the European Pharmacopoeia (Ph. Eur. 7, 2011) are respected. A residue study of Coxiril® in chickens for fattening demonstrated compliance with the Maximum Residue Limits for diclazuril without applying a withdrawal period. Consequently, Coxiril® at the highest dose proposed for use (1.2 mg diclazuril/kg complete feed) is safe for the consumer.



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.



The use of diclazuril in chickens for fattening at the highest 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 performed with Coxiril® (five floor pen studies, two field trials and two sensitivity tests).