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, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Brantom Paul, Dierick Noël, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Innocenti Matteo Lorenzo, Navarro-Villa Alberto, Ortuño Jordi, Pizzo Fabiola, Revez Joana
EFSA J. 2023 Apr 20;21(4):e07971. doi: 10.2903/j.efsa.2023.7971. eCollection 2023 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. The product, manufactured in three formulations (microsphere, micropellet and powder), is intended for use in complete feed at a minimum inclusion level of 3 × 10 CFU/kg complete feed for horses, 4 × 10 CFU/kg complete feed for dairy cows and minor dairy species, 4 × 10 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species and 6 × 10 CFU/kg complete feed for sows and minor porcine species for reproduction. is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was conclusively established and, therefore, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive, in any formulation, is not irritant to the eyes and skin but should be considered a respiratory sensitiser. The Panel cannot conclude on the skin sensitisation potential of the additive. The Panel 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 the additive for calves, and neither for cattle for fattening, minor growing and fattening ruminants.
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。该产品有三种制剂形式（微球、微丸和粉剂），拟用于全价饲料，马的最低添加水平为每千克全价饲料3×10⁶CFU，奶牛和小型奶牛品种为每千克全价饲料4×10⁶CFU，犊牛、育肥牛、小型生长育肥反刍动物、仔猪、育肥猪和小型猪品种为每千克全价饲料4×10⁶CFU，母猪和用于繁殖的小型猪品种为每千克全价饲料6×10⁶CFU。欧洲食品安全局认为该产品适用于安全性评估的合格假定方法。该菌株的身份已得到最终确定，因此，添加剂在动物营养中的使用被认为对目标物种、消费者和环境是安全的。该添加剂无论何种制剂形式，对眼睛和皮肤均无刺激性，但应被视为呼吸道致敏原。专家小组无法就该添加剂的皮肤致敏潜力得出结论。专家小组得出结论，该添加剂在提议的马、反刍动物和所有猪的使用条件下有产生效果的潜力。然而，专家小组无法就该添加剂对犊牛以及育肥牛、小型生长育肥反刍动物的有效性得出结论。
