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. 2017 May 26;15(5):e04855. doi: 10.2903/j.efsa.2017.4855. eCollection 2017 May.
PB6 is a feed additive based on viable spores of a strain of . EFSA has already issued several opinions on the safety and efficacy of the additive when used in the feed for a number of avian and porcine species/categories. The applicant is now seeking authorisation for use in sows in order to have benefits in piglets. In the course of previous assessments, no evidence of a toxigenic potential or resistance to relevant antibiotics was found. Consequently, the strain of in the additive, following the qualified presumption of safety approach to safety assessment, is presumed safe for target animals including sows and their offspring, consumers and the environment. In a previous assessment, it was also concluded that the additive is not a skin/eye irritant or a skin sensitiser and that there were no concerns on respiratory sensitisation. The use of the additive with feed for sows is considered unlikely to introduce hazards for users of the product not already considered. Five studies are described in which groups of sows given the additive for a minimum period from the last 3 weeks of pregnancy, throughout farrowing and lactation, until weaning of piglets were compared with a control group. In only two of five studies, there was a significant beneficial effect seen in terms of piglet performance. However, when data from the four similar were pooled and analysed, significant increases in weaned weight and average daily gain were indicated for piglets from sows given the additive. Consequently, the FEEDAP Panel concludes that PB6 when added to diets of sows from 3 weeks before parturition until weaning of piglets at a dose of 1 × 10 CFU/kg complete feed has the potential to improve the growth of piglets from birth to weaning.
PB6是一种基于某菌株活孢子的饲料添加剂。欧洲食品安全局（EFSA）已就该添加剂在多种禽类和猪类物种/类别饲料中的安全性和有效性发布了多项意见。申请人现寻求批准其用于母猪，以便使仔猪受益。在之前的评估过程中，未发现有产毒潜力或对相关抗生素耐药的证据。因此，根据安全性评估的合格假定安全方法，该添加剂中的菌株被假定对包括母猪及其后代、消费者和环境在内的目标动物是安全的。在之前的一项评估中，还得出结论，该添加剂不是皮肤/眼睛刺激物或皮肤致敏剂，并且不存在呼吸道致敏问题。认为将该添加剂与母猪饲料一起使用不太可能给尚未考虑到的产品使用者带来危害。文中描述了五项研究，其中将在从怀孕最后3周开始、整个分娩和哺乳期间直至仔猪断奶的最短时间内给母猪投喂该添加剂的组与对照组进行了比较。在五项研究中只有两项显示，在仔猪性能方面有显著的有益效果。然而，当汇总并分析四项相似研究的数据时，发现给母猪投喂该添加剂后，其仔猪的断奶体重和平均日增重有显著增加。因此，饲料添加剂和动物营养产品专家委员会得出结论，当以1×10CFU/kg全价饲料的剂量在分娩前3周直至仔猪断奶期间添加到母猪日粮中时，PB6有提高仔猪从出生到断奶生长速度的潜力。
