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 Edoardo, Woutersen Ruud, Brozzi Rosella
EFSA J. 2019 Mar 21;17(3):e05639. doi: 10.2903/j.efsa.2019.5639. eCollection 2019 Mar.
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 and dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell SC as a zootechnical additive for lambs and horses. 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 also 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 FEEDAP Panel reconsider the previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Levucell SC is an eye irritant.
乐维塞尔 SC 是一种基于特定菌株活细胞的饲料添加剂的商品名。该产品目前已获批准用于马、羔羊、奶羊、奶山羊、奶牛和育肥牛的饲料中。本意见涉及乐维塞尔 SC 作为羔羊和马的畜牧学添加剂授权的续期。欧洲食品安全局认为其适用于采用合格假定安全（QPS）方法来确定对目标物种、消费者和环境的安全性。已确定了添加剂中存在的菌株的身份。因此，假定该菌株对目标物种、食用添加该添加剂的动物产品的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，乐维塞尔 SC 也被认为对目标物种、食用添加该添加剂的动物产品的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饲料添加剂和动物营养产品专家小组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、使用者和环境安全性的结论。乐维塞尔 SC 是一种眼刺激物。
