Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the Maximum Residue Limits for Clinacox 0.5 % (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying

Clinacox 0.5 % is a feed additive belonging to the category of coccidiostats that contains diclazuril as the active substance. It is already authorised as a coccidiostat at Community level for turkeys for fattening, chickens for fattening and chickens reared for laying. EFSA has been requested by the European Commission to set maximum residue limits (MRLs) in chicken and turkey tissues. A specific and major diclazuril impurity and/or metabolite has been identified in rabbit fat which has not been found to occur in laboratory animals. It cannot be ruled out that the accumulation in fat of this lipophilic impurity/metabolite might occur in other species, including the chicken and turkey. The safety of this compound has not been established. Provided the safety issues relating to this impurity/metabolite are satisfactorily addressed then the FEEDAP Panel would be in a position to complete the safety assessment for the consumer which provides the basis for MRLs.