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, Aguilera Jaime, Brozzi Rosella, Saarela Maria
EFSA J. 2018 Jul 11;16(7):e05339. doi: 10.2903/j.efsa.2018.5339. eCollection 2018 Jul.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the renewal of the authorisation of Actisaf Sc47 as a zootechnical additive for lambs for fattening, minor dairy ruminants, horses and pigs for fattening. In 2006, 2007 and 2008, the FEEDAP Panel adopted opinions on the safety and efficacy of Actisaf Sc47 when used in lambs for fattening, minor dairy ruminants, horses and pigs for fattening. Actisaf Sc47 is the trade name for a feed additive based on viable cells of CNCM I-4407 with no carrier. It is currently authorised for use in sows, piglets, pigs for fattening, cattle for fattening, calves for rearing, dairy cows, dairy buffaloes, lambs for fattening, dairy sheep, dairy goats, horses, rabbits for fattening and non-food producing rabbits. Actisaf Sc47 is marketed in three forms: standard, powder and HR. All of them are authorised with a declared minimal concentration of viable yeast cells in the additive of 5 × 10 CFU/g. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. In previous opinions, Actisaf Sc47 was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Additionally, it was not found to be a skin or eye irritant. No new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of Actisaf Sc47. Therefore, the Panel considers that the additive Actisaf SC47 remains safe under the approved conditions for lambs for fattening, minor dairy ruminants, horses and pigs for fattening, the consumer, user and the environment.
应欧盟委员会要求,动物饲料添加剂及产品或物质专家小组(FEEDAP)被要求就Actisaf Sc47作为育肥羔羊、小型反刍奶畜、马和育肥猪的动物技术添加剂重新授权事宜发表科学意见。2006年、2007年和2008年,FEEDAP专家小组就Actisaf Sc47用于育肥羔羊、小型反刍奶畜、马和育肥猪时的安全性和有效性发表了意见。Actisaf Sc47是一种基于CNCM I - 4407活细胞且无载体的饲料添加剂的商品名。它目前被授权用于母猪、仔猪、育肥猪、育肥牛、育肥犊牛、奶牛、奶水牛、育肥羔羊、奶羊、奶山羊、马、育肥兔和非食用兔。Actisaf Sc47有三种销售形式:标准型、粉剂型和HR型。所有这些形式均被授权,添加剂中宣称的活酵母细胞最低浓度为5×10CFU/g。申请人提供的数据表明,目前市场上的该添加剂符合授权条件。在之前的意见中,Actisaf Sc47被假定对目标物种、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。此外,未发现其为皮肤或眼睛刺激性物质。未发现新的证据会使FEEDAP专家小组重新考虑之前关于Actisaf Sc47安全性的结论。因此,专家小组认为,在批准的条件下,添加剂Actisaf SC47对育肥羔羊、小型反刍奶畜、马和育肥猪、消费者、使用者及环境而言仍然是安全的。