Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brantom Paul, Halle Ingrid, van Beelen Patrick, Holczknecht Orsolya, Vettori Maria Vittoria, Gropp Jürgen
EFSA J. 2018 Mar 22;16(3):e05196. doi: 10.2903/j.efsa.2018.5196. eCollection 2018 Mar.
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.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就Coxiril对雉鸡的安全性和有效性发表科学意见。Coxiril含有0.5%的地克珠利，旨在以1.0 - 1.2毫克/千克全价饲料的剂量范围预防雉鸡球虫病。饲料中地克珠利含量为1.2毫克/千克时，Coxiril中的地克珠利对雉鸡被认为是安全的。该结论是通过对育肥火鸡的耐受性研究结果进行外推得出的。FEEDAP小组认为，雉鸡组织和蛋中的残留量与生理上相似的主要品种肉鸡和育肥火鸡中测得的残留量相当。如果不超过为家禽设定的最大残留限量（MRLs），以最高浓度1.2毫克/千克全价饲料使用地克珠利对雉鸡来说对消费者是安全的。关于该添加剂对目标物种和消费者安全性的结论是在不将Coxiril喂给产蛋鸡的前提下得出的。Coxiril被认为对眼睛和皮肤无刺激性。它不是潜在的皮肤致敏剂。由于正常操作导致使用者吸入Coxiril，不太可能引起呼吸道或全身毒性。在中性/碱性土壤（pH≥7）中，在雉鸡中使用Coxiril中的地克珠利对环境没有风险。由于与地克珠利随时间潜在积累相关的高度不确定性，无法对在酸性土壤中使用该添加剂产生的风险得出最终结论。FEEDAP小组得出结论，饲料中地克珠利含量至少为1毫克/千克时，Coxiril中的地克珠利有控制雉鸡球虫病的潜力。
