Safety and efficacy of Coxiril(®) (diclazuril) for chickens reared for laying

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 efficacy of Coxiril(®) (diclazuril) for chickens reared for laying. Coxiril(®), containing 0.5% diclazuril, is intended for the prevention of coccidiosis in chickens reared for laying at a dose range of 0.8–1.2 mg diclazuril/kg of complete feed up to a maximum age of 12 weeks. Derived from data already assessed for chickens and turkeys for fattening, diclazuril from Coxiril(®) is safe for chickens reared for laying up to 1.2 mg/kg complete feed when applied until 12 weeks of age. The FEEDAP Panel extended its previous assessment of consumer safety for the use of diclazuril from Coxiril(®) in chickens for fattening to chickens reared for laying. No measurable diclazuril residues were found in the first eggs laid from chickens reared for laying fed diclazuril from Coxiril(®) at 1.2 mg/kg complete feed until 12 weeks of age. Coxiril(®) was considered as a non‐irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril(®), as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril(®) in chickens reared for laying at the highest proposed feed concentration would not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril(®) cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. Derived from data already assessed for chickens for fattening, diclazuril from Coxiril(®) has the potential to control coccidiosis in chickens reared for laying at a minimum concentration of 0.8 mg/kg complete feed.