Bampidis Vasileios, Azimonti Giovanna, Bastos Maria De Lourdes, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Kos Durjava Mojca, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto, Woutersen Ruud, Chesson Andrew, Cocconcelli Pier Sandro, Wallace Robert John, Rychen Guido, Brozzi Rosella, Saarela Maria
EFSA J. 2018 Jul 24;16(7):e05385. doi: 10.2903/j.efsa.2018.5385. eCollection 2018 Jul.
Levucell SC is the trade name for a feed additive based on viable cells of a strain . The product is currently authorised for use in feed for horses, lambs, dairy sheep, dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell SC as a zootechnical additive for dairy ewes and dairy goats. is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to establishing safety for the target species, consumers and the environment. The identity of the strain present in the additive was established. Accordingly, this strain is presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell SC is considered safe for the target species, consumers of products from animals fed the additive and the environment. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. Furthermore, according to the information provided in the technical dossier, no new evidence has been identified that would make the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reconsider the previous conclusions on the safety of the product for target species, consumers and the environment under the authorised conditions of use.
乐菌素SC是一种基于特定菌株活细胞的饲料添加剂的商品名。该产品目前被批准用于马、羔羊、奶羊、奶山羊、奶牛和育肥牛的饲料中。本意见涉及乐菌素SC作为奶羊和奶山羊饲养技术添加剂授权的续期。欧洲食品安全局认为其适用于采用合格安全推定（QPS）方法来确定对目标物种、消费者和环境的安全性。已确定添加剂中存在的菌株的特性。因此，假定该菌株对目标物种、食用添加该添加剂饲料的动物的产品消费者以及环境是安全的。由于预计添加剂的其他成分不会引起担忧，所以乐菌素SC被认为对目标物种、食用添加该添加剂饲料的动物的产品消费者以及环境是安全的。申请人提供的数据表明，目前市场上的添加剂符合授权条件。此外，根据技术档案中提供的信息，未发现新的证据会使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）重新考虑先前关于该产品在授权使用条件下对目标物种、消费者和环境安全性的结论。
