Scientific Opinion on the safety and efficacy of diclazuril (Clinacox 0.5 %) as feed additive for chickens reared for laying

Clinacox 0.5 % is a feed additive containing 0.5 % diclazuril and is used to control coccidiosis in poultry. The previous conclusion on the safety of diclazuril in chickens for fattening at the use level of 1 mg/kg complete feed is extended to chickens reared for laying. Chickens reared for laying are in a similar physiological stage as chickens for fattening. The use level proposed for diclazuril in feed is the same for both categories of birds. Consequently, the metabolic fate and residue status of this additive described for chickens for fattening can be extrapolated to chickens reared for laying. Feeding diclazuril at 1 mg/kg complete feed to chickens reared for laying for the first 16 weeks of life would result in negligibly low or absent residues of diclazuril in the first eggs for production. Therefore, maximum residue levels (MRLs) for eggs are not necessary. The previous assessment of consumer safety for the use of diclazuril in chickens for fattening is confirmed and extended to chickens reared for laying. The same MRLs for tissues as already established can be applied. Clinacox has a low irritation potential for the eye and skin. Skin sensitisation was not observed. Considering the particle size (particle of respirable size) and dusting potential, exposure by inhalation cannot be excluded, although workers’ exposure has been calculated to be low in comparison with the ADI. In the absence of any data on respiratory toxicity, a hazard from inhalation of dust cannot be entirely excluded and appropriate protective measures should be taken. The use of Clinacox at 1 mg/kg complete feed does not pose a risk to the terrestrial or aquatic environment. One mg diclazuril/kg complete feed is effective in controlling coccidiosis in chickens reared for laying.