Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Gropp Jürgen, Rychen Guido, Holczknecht Orsolya, Vettori Maria Vittoria
EFSA J. 2021 Mar 12;19(3):e06457. doi: 10.2903/j.efsa.2021.6457. eCollection 2021 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 efficacy of amprolium hydrochloride (COXAM ) for chickens for fattening and chickens reared for laying. COXAM is a coccidiostat intended to be used to control coccidiosis in chickens for fattening and chickens reared for laying up to 12 weeks of age at a dose of 125 mg amprolium hydrochloride (HCl)/kg complete feed. In its former opinion, the FEEDAP Panel was not in the position to conclude on the efficacy of COXAM for chickens for fattening and chickens reared for laying due to insufficient number of positive and significant effects on relevant parameters in one of the anticoccidial sensitivity tests (ASTs) evaluated. In the present submission, an additional AST has been provided by the applicant. In this study, challenge by an inoculum of low pathogenicity indicated the coccidiostatic potential of amprolium HCl based on the reduction of intestinal lesions. Considering the results of three floor pen trials and two ASTs described and assessed in a previous EFSA opinion and taking into account the newly submitted AST, the FEEDAP Panel concludes that COXAM is efficacious in controlling coccidiosis in chickens for fattening at a dose of 125 mg amprolium HCl/kg complete feed. This conclusion is extended to chickens reared for laying.
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)被要求就盐酸氨丙啉(COXAM)对育肥鸡和蛋鸡的功效发表科学意见。COXAM是一种抗球虫药,旨在用于控制育肥鸡和蛋鸡的球虫病,剂量为每千克全价饲料含125毫克盐酸氨丙啉(HCl),适用至12周龄。在其先前的意见中,FEEDAP专家小组无法就COXAM对育肥鸡和蛋鸡的功效得出结论,因为在所评估的一项抗球虫敏感性试验(AST)中,对相关参数的阳性和显著影响数量不足。在本次提交的材料中,申请人提供了一项额外的AST。在这项研究中,用低致病性接种物进行攻毒试验,根据肠道病变的减少情况表明了盐酸氨丙啉的抗球虫潜力。考虑到先前欧洲食品安全局(EFSA)意见中描述和评估的三项地面围栏试验和两项AST的结果,并考虑到新提交的AST,FEEDAP专家小组得出结论,COXAM以每千克全价饲料含125毫克盐酸氨丙啉的剂量,对控制育肥鸡的球虫病有效。这一结论也适用于蛋鸡。