Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Anguita Montserrat, Galobart Jaume, Innocenti Matteo Lorenzo, Ortuño Jordi, Firmino Joana P
EFSA J. 2024 Apr 15;22(4):e8728. doi: 10.2903/j.efsa.2024.8728. eCollection 2024 Apr.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of BioCell® for calves, and, consequently, for other ruminants for fattening or rearing. The applicant provided three additional efficacy trials in veal calves to support the efficacy of BioCell® for ruminants for fattening or rearing. The three studies showed positive effects of the supplementation with the additive at 1.7 × 10 colony forming unit (CFU)/kg complete feed on the performance of veal calves. Considering the previously submitted studies in dairy cows and the new submitted trials, the FEEDAP Panel concluded that the additive has the potential to be efficacious for all ruminants at the proposed condition of use: 4.0 × 10 CFU/kg complete feed for dairy ruminants and 4.0 × 10 CFU/kg complete feed for ruminants for fattening and rearing.
应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求就DBVPG 48 SF（BioCell®）作为马、猪和反刍动物的动物营养饲料添加剂的安全性和有效性发表科学意见。在之前的一份意见中，动物饲料添加剂和产品或物质专家小组（FEEDAP）得出结论，该添加剂在马、奶牛和所有猪的拟用条件下具有有效的可能性。然而，该专家小组无法就BioCell®对犊牛以及因此对其他育肥或饲养反刍动物的有效性得出结论。申请人提供了三项关于犊牛的额外有效性试验，以支持BioCell®对育肥或饲养反刍动物的有效性。这三项研究表明，在全价饲料中添加1.7×10菌落形成单位（CFU）/千克的添加剂对犊牛的生产性能有积极影响。考虑到之前提交的奶牛研究和新提交的试验，FEEDAP专家小组得出结论，该添加剂在拟用条件下对所有反刍动物都有有效的可能性：奶牛全价饲料中为4.0×10 CFU/千克，育肥和饲养反刍动物全价饲料中为4.0×10 CFU/千克。
