Scientific Opinion on the safety and efficacy of Clinacox® 0.5% (diclazuril) for guinea fowl

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Mézes, M.

The safety and efficacy of Clinacox® 0.5%, containing 0.5 % diclazuril as active substance, at a use level of 1 mg (0.9–1.1 mg) similar in chickens for fattening, has recently been evaluated by the FEEDAP Panel. Since the guinea fowl is a physiologically similar minor species to the chicken for fattening, and 1 mg diclazuril was considered safe for chickens for fattening with a wide margin of safety, the same dose is considered safe for guinea fowl. Likewise, no specific metabolism and residue studies are required to establish the consumer safety. Consequently, the FEEDAP Panel proposes to apply the same MRLs for tissues (1.5, 1.0, 0.5 and 0.5 mg/kg liver, kidney, muscle and skin/fat, respectively) and the same zero-day withdrawal time for guinea fowl as those established in chickens for fattening. No safety concerns related to the user or the environment have been identified in the opinion on Clinacox® 0.5% in chickens for fattening, and the same applies to the use of the product in guinea fowl. Based on the uniform results of two studies with artificial Eimeria numidae and Eimeria grenieri infection indicating that these guinea fowl-specific strains are sensitive to diclazuril and considering the established efficacy of the additive at the proposed use level in the major species chickens for fattening, the FEEDAP Panel concludes that 1 mg diclazuril/kg feed is effective in controlling coccidiosis in guinea fowl.

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(FEEDAP), EFSA / Mézes, M.: Scientific Opinion on the safety and efficacy of Clinacox® 0.5% (diclazuril) for guinea fowl. 2010.

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