Safety and efficacy of Coxiril® (diclazuril) for pheasants

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

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® for pheasants. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in pheasants at a dose range of 1.0–1.2 mg/kg of complete feed. Diclazuril from Coxiril® is considered safe for pheasants at a level of 1.2 mg/kg complete feed. The conclusion was made by extrapolating the results of a tolerance study with turkeys for fattening. The FEEDAP Panel considered that the residues in pheasant tissues and eggs would be of the same magnitude as those measured in the physiologically similar major species chickens and turkeys for fattening. The use of diclazuril at a maximum concentration of 1.2 mg/kg complete fed for pheasants would be safe for the consumer, provided that the maximum residue limits (MRLs) established for poultry would not be exceeded. The conclusions on the safety of the additive for the target species and the consumer are made under the provision that Coxiril® is not fed to laying birds. Coxiril® is 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 pheasants does not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of the additive in acid soil cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. The FEEDAP Panel concluded that diclazuril from Coxiril® at a minimum dose of 1 mg/kg complete feed has the potential to control coccidiosis in pheasants.

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(FEEDAP), EFSA: Safety and efficacy of Coxiril® (diclazuril) for pheasants. 2018.

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