Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Gropp Jürgen, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Martelli Giovanna, Renshaw Derek, Glandorf Boet, Herman Lieve, Kärenlampi Sirpa, Aguilera Jaime, López-Gálvez Gloria, Mantovani Alberto
EFSA J. 2018 May 17;16(5):e05269. doi: 10.2903/j.efsa.2018.5269. eCollection 2018 May.
Fumonisin esterase produced from a genetically modified strain of is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated-dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non-irritant to skin and eyes and is not considered a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10 U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panel on Additives and Products or Substances used in Animal Feed FEEDAP) considers the additive efficacious for all poultry and all pigs.
由转基因菌株产生的伏马菌素酯酶旨在降解猪和家禽饲料中的伏马菌素霉菌毒素污染物。生产菌株及其重组基因不存在于最终产品中。申请人选择300 U/kg饲料作为可能的上限。该浓度对仔猪、肉鸡、火鸡和产蛋母鸡显示是安全的；因此，该添加剂对这些类别是安全的。这一结论扩展到所有猪、产蛋鸡和种用火鸡，并外推到所有其他生长和产蛋的家禽品种以及小型猪品种。未检测到致突变性或遗传毒性的证据，重复剂量口服毒性研究也未发现毒性证据；残留评估未发现任何问题。因此，该添加剂对消费者而言被认为是安全的。该添加剂吸入无毒，呼吸道暴露可能较低；然而，不能排除通过呼吸道致敏的风险。该添加剂对皮肤和眼睛无刺激性，不被认为是皮肤致敏剂。按照建议的使用条件在饲料中使用该添加剂后，预计对环境没有风险。如对育肥鸡、产蛋母鸡和断奶仔猪的研究所表明的，当以10 U/kg全价饲料的最低推荐剂量使用时，该添加剂有能力降解适销质量饲料中的伏马菌素污染物。由于可以合理假定该添加剂在其适用的动物物种中的作用方式相同，动物饲料添加剂及产品或物质专家委员会（FEEDAP）认为该添加剂对所有家禽和所有猪均有效。
