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 Puente Secundino, López-Alonso Marta, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brozzi Rosella, Saarela Maria
EFSA J. 2017 Jul 19;15(7):e04944. doi: 10.2903/j.efsa.2017.4944. eCollection 2017 Jul.
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 Levucell SC for dairy cows, cattle for fattening, all minor ruminant species and camelids. The additive consists of viable cells of a strain of and is sold in three formulations. The FEEDAP Panel considers that the three available formulations are equivalent when used to deliver the same dose. The active agent fulfils the requirements of the qualified presumption of safety approach to the assessment of safety and since no concerns are expected from other components, Levucell SC can be presumed safe for target animals, consumers of products from treated animals and the environment. Levucell SC is not a skin irritant or sensitiser but is an eye irritant. Inhalation exposure is unlikely. Encapsulation is not expected to introduce hazards for users. The FEEDAP Panel is not in the position to conclude on the efficacy of Levucell SC for dairy cows, minor dairy ruminant species or dairy camelids. Levucell SC has a potential to improve the performance of cattle raised for fattening when supplied at a minimum dose of 8 × 10 CFU/head and day which would approximate to 6 × 10 CFU/kg complete feed. This conclusion is extended to minor ruminant species and camelids reared for meat production at the same minimum dose of 6 × 10 CFU/kg complete feed.
应欧盟委员会的要求，动物饲料添加剂和产品或物质专家小组（FEEDAP）被要求就乐菌素SC对奶牛、育肥牛、所有小型反刍动物和骆驼科动物的安全性和有效性发表科学意见。该添加剂由一种菌株的活细胞组成，有三种剂型出售。FEEDAP小组认为，当使用相同剂量时，三种可用剂型是等效的。活性剂符合安全性评估的合格假定方法的要求，并且由于预计其他成分不会引起担忧，因此可以假定乐菌素SC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。乐菌素SC不是皮肤刺激物或致敏剂，但却是眼部刺激物。吸入暴露不太可能发生。预计包囊化不会给使用者带来危害。FEEDAP小组无法就乐菌素SC对奶牛、小型反刍动物或骆驼科动物的有效性得出结论。当以最低剂量8×10CFU/头·天供应时，乐菌素SC有提高育肥牛性能的潜力，这相当于每千克全价饲料6×10CFU。这一结论扩展到以相同最低剂量每千克全价饲料6×10CFU饲养用于肉类生产的小型反刍动物和骆驼科动物。
