PMID- 32625832 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200928 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 16 IP - 3 DP - 2018 Mar TI - Safety and efficacy of Coxiril((R)) (diclazuril) for pheasants. PG - e05196 LID - 10.2903/j.efsa.2018.5196 [doi] LID - e05196 AB - 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((R)) for pheasants. Coxiril((R)), 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((R)) 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((R)) is not fed to laying birds. Coxiril((R)) is considered as a non-irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril((R)), as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril((R)) 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((R)) at a minimum dose of 1 mg/kg complete feed has the potential to control coccidiosis in pheasants. CI - (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. CN - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) FAU - Rychen, Guido AU - Rychen G FAU - Aquilina, Gabriele AU - Aquilina G FAU - Azimonti, Giovanna AU - Azimonti G FAU - Bampidis, Vasileios AU - Bampidis V FAU - Bastos, Maria de Lourdes AU - Bastos ML FAU - Bories, Georges AU - Bories G FAU - Chesson, Andrew AU - Chesson A FAU - Cocconcelli, Pier Sandro AU - Cocconcelli PS FAU - Flachowsky, Gerhard AU - Flachowsky G FAU - Kolar, Boris AU - Kolar B FAU - Kouba, Maryline AU - Kouba M FAU - Lopez-Alonso, Marta AU - Lopez-Alonso M FAU - Lopez Puente, Secundino AU - Lopez Puente S FAU - Mantovani, Alberto AU - Mantovani A FAU - Mayo, Baltasar AU - Mayo B FAU - Ramos, Fernando AU - Ramos F FAU - Saarela, Maria AU - Saarela M FAU - Villa, Roberto Edoardo AU - Villa RE FAU - Wallace, Robert John AU - Wallace RJ FAU - Wester, Pieter AU - Wester P FAU - Brantom, Paul AU - Brantom P FAU - Halle, Ingrid AU - Halle I FAU - van Beelen, Patrick AU - van Beelen P FAU - Holczknecht, Orsolya AU - Holczknecht O FAU - Vettori, Maria Vittoria AU - Vettori MV FAU - Gropp, Jurgen AU - Gropp J LA - eng PT - Journal Article DEP - 20180322 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC7009574 OTO - NOTNLM OT - Coxiril(R) OT - coccidiostats OT - diclazuril OT - efficacy OT - pheasants OT - safety EDAT- 2018/03/22 00:00 MHDA- 2018/03/22 00:01 PMCR- 2018/03/22 CRDT- 2020/07/07 06:00 PHST- 2020/07/07 06:00 [entrez] PHST- 2018/03/22 00:00 [pubmed] PHST- 2018/03/22 00:01 [medline] PHST- 2018/03/22 00:00 [pmc-release] AID - EFS25196 [pii] AID - 10.2903/j.efsa.2018.5196 [doi] PST - epublish SO - EFSA J. 2018 Mar 22;16(3):e05196. doi: 10.2903/j.efsa.2018.5196. eCollection 2018 Mar.