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, Cocconcelli Pier Sandro, Glandorf Boet, Prieto Maradona Miguel, Saarela Maria, Brozzi Rosella
EFSA J. 2021 Apr 30;19(4):e06535. doi: 10.2903/j.efsa.2021.6535. eCollection 2021 Apr.
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 the additive consisting of PTA-6507, NRRL B-50013 and NRRL B-50104 (trade name: Enviva PRO 202 GT) for turkeys for fattening. The product under assessment is based on viable spores of three strains originally identified as which, in the course of the current assessment, were reclassified as . The bacterial species is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established. The active agents do not harbour acquired antimicrobial resistance genes and lack toxigenic potential and the capacity to produce aminoglycosides. Following the QPS approach, the three bacterial strains are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, Enviva PRO 202 GT is also considered safe for the target species, consumers and the environment. Enviva PRO 202 GT is non-irritant to skin and eyes and is not a dermal sensitiser. Due to the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. In a previous opinion, it was concluded that Enviva PRO 202 GT has a potential to be efficacious as a zootechnical additive in chickens for fattening at the recommended level of 7.5 × 10 CFU/kg complete feed. It is considered that conclusions on efficacy of Enviva PRO 202 GT in chickens for fattening can be extrapolated to turkeys for fattening. Therefore, the FEEDAP Panel concludes that Enviva PRO 202 GT has the potential to be efficacious in turkeys for fattening at 7.5 × 10 CFU/kg complete feed.
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)被要求就由PTA - 6507、NRRL B - 50013和NRRL B - 50104(商品名:Enviva PRO 202 GT)组成的添加剂对育肥火鸡的安全性和有效性发表科学意见。所评估的产品基于最初鉴定为的三种菌株的活孢子,在当前评估过程中,这些菌株被重新分类为。该细菌物种被认为适用于安全性评估的合格假定安全性(QPS)方法。已确定了活性剂的身份。活性剂不携带获得性抗菌抗性基因,缺乏产毒潜力和产生氨基糖苷类的能力。按照QPS方法,假定这三种细菌菌株对目标物种、消费者和环境是安全的。由于预计添加剂的其他成分不会引起担忧,因此Enviva PRO 202 GT也被认为对目标物种、消费者和环境是安全的。Enviva PRO 202 GT对皮肤和眼睛无刺激性,不是皮肤致敏剂。由于活性剂的蛋白质性质,该添加剂应被视为呼吸道致敏剂。在先前的意见中,得出结论认为Enviva PRO 202 GT在育肥鸡中作为动物技术添加剂在推荐水平7.5×10CFU/kg全价饲料下具有有效潜力。据认为,关于Enviva PRO 202 GT在育肥鸡中的有效性结论可外推至育肥火鸡。因此,FEEDAP小组得出结论,Enviva PRO 202 GT在7.5×10CFU/kg全价饲料下对育肥火鸡具有有效潜力。 (注:原文中部分菌株名称缺失,翻译时保留原文格式)