Safety of ‘Clinacox 0.5%’ (diclazuril) used in rabbits for fattening and breeding

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to complete its former opinion on the safety and efficacy of Clinacox 0.5% based on diclazuril for rabbits for fattening and breeding. The Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP) assessed the supplementary information supplied by the applicant on the diclazuril impurity/metabolite R070016 and concluded that the compound is devoid of genotoxic activity. Consequently, the FEEDAP Panel is in a position to adopt the already proposed ADI for diclazuril (1.7 mg diclazuril per person per day). Consumer exposure to diclazuril residues from edible tissues of rabbits amounts to 19 % of the ADI after a one-day withdrawal. As data for a shorter withdrawal time was not provided, the FEEDAP Panel considers a withdrawal period of one day appropriate. The FEEDAP Panel proposes the following MRL values for rabbit tissues: 2.5, 1, 0.15 and 0.3 mg diclazuril kg-1 wet tissue for the liver, kidney, muscle and fat, respectively. Those MRLs are in line with highest measured residues and ensure consumer safety (the worst case calculation representing 28 % of the ADI). A suitable analytical method in terms of specificity and sensitivity (LOQ of 0.05 mg kg-1 wet tissue liver, kidney and muscle, 0.1 mg kg-1 fat) is available for the determination of diclazuril residues in tissues at the MRL level.