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, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brozzi Rosella, Saarela Maria
EFSA J. 2018 Apr 20;16(4):e05199. doi: 10.2903/j.efsa.2018.5199. eCollection 2018 Apr.
Following a request from the European Commission, the EFSA 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 EB15 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of intended for use in feed at the proposed dose of 5 × 10 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 10 CFU/L. The additive exists in two forms, EB15 and EB15 10, which contain the bacterium in concentrations of 1.25 × 10 CFU/g additive and 1.25 × 10 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. . is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂和产品或物质专家小组（FEEDAP）被要求就EB15 10对断奶仔猪和小型猪种的安全性和有效性发表科学意见。该添加剂是一种制剂，含有一种菌株的活孢子，拟以5×10⁶CFU/kg全价饲料的剂量用于饲料中，并以1.7×10⁶CFU/L的剂量用于饮用水中。该添加剂有两种形式，EB15和EB15 10，分别含有浓度为1.25×10⁹CFU/g添加剂的细菌。当用于提供相同剂量时，这两种制剂被认为是等效的。欧洲食品安全局认为，该菌株适合采用安全合格假定（QPS）方法来确定安全性。活性剂符合QPS安全评估方法的要求。因此，可以假定该添加剂对目标动物、来自经处理动物的产品消费者和环境是安全的。鉴于活性剂的蛋白质性质，该添加剂应被视为潜在的呼吸道致敏剂。由于缺乏数据，FEEDAP小组无法就该添加剂对皮肤和眼睛的刺激性潜力或其皮肤致敏性得出结论。提供的证据不足以得出该添加剂对断奶仔猪或小型断奶猪种有效性的结论。
