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 Jan 11;15(1):e04674. doi: 10.2903/j.efsa.2017.4674. eCollection 2017 Jan.
Levucell SB is a feed additive consisting of viable cells of a strain of currently authorised as a zootechnical additive for piglets and sows. The applicant is now seeking authorisation as a zootechnical additive (other zootechnical additive) for use with chickens for fattening and minor poultry species. The EFSA FEEDAP Panel in a previous opinion concluded that the additive fulfilled the requirements for the qualified presumption of safety (QPS) approach to safety assessment and thus could be presumed safe for the target species, consumers and the environment. Since the additive which is the subject of the present application has the same formulations as that considered previously, following the QPS approach, the same conclusions on target animal consumer and environmental safety apply when used with poultry. The use of the additive with diets for the new target species is considered unlikely to introduce hazards for users of the product not already considered in the previous assessment. When used with poultry feed, the additive is intended to aid the reduction of carcass contamination with enteropathogens and so improve the quality of poultry products. Five studies were submitted with chickens fed diets with or without the additive and then (in four studies) artificially challenged with . The fifth study relied on the natural incidence of . The prevalence of contamination was estimated by examining the carcass directly and/or by detection in caecal, cloacal or faecal samples. Considering overall the results of the five studies, there is evidence that the addition of Levucell SB to diets at a dose of 2 × 10 CFU/kg feed can aid the reduction of carcass contamination with spp.. This conclusion can be extrapolated to minor avian species for fattening when used at the same dose, but not to minor poultry species for laying.
乐菌素SB是一种饲料添加剂，由一种目前已被批准作为仔猪和母猪畜牧技术添加剂的菌株的活细胞组成。申请人现寻求批准其作为畜牧技术添加剂（其他畜牧技术添加剂）用于育肥鸡和小型家禽品种。欧洲食品安全局动物饲料添加剂和产品（FEEDAP）小组在先前的一份意见中得出结论，该添加剂符合安全评估的合格假定安全性（QPS）方法的要求，因此可以假定对目标物种、消费者和环境是安全的。由于本申请所涉及的添加剂与先前考虑的添加剂具有相同的配方，按照QPS方法，当与家禽一起使用时，关于目标动物、消费者和环境安全的相同结论适用。与新目标物种的日粮一起使用该添加剂被认为不太可能给先前评估中未考虑的产品使用者带来危害。当与家禽饲料一起使用时，该添加剂旨在帮助减少胴体被肠道病原体污染，从而提高家禽产品的质量。提交了五项研究，研究中给鸡饲喂含或不含该添加剂的日粮，然后（四项研究中）用[病原体名称未给出]进行人工攻毒。第五项研究依赖于[病原体名称未给出]的自然发生率。通过直接检查胴体和/或通过检测盲肠、泄殖腔或粪便样本估计[病原体名称未给出]污染的发生率。综合考虑这五项研究的结果，有证据表明，以2×10⁸CFU/kg饲料的剂量将乐菌素SB添加到日粮中可以帮助减少胴体被[病原体名称未给出]属污染。当以相同剂量使用时，这一结论可以外推至育肥的小型禽类品种，但不适用于产蛋的小型家禽品种。
