Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon Durjava Mojca, 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, Anguita Montserrat, Galobart Jaume, Ortuño Jordi, Brozzi Rosella
EFSA J. 2022 Apr 29;20(4):e07245. doi: 10.2903/j.efsa.2022.7245. eCollection 2022 Apr.
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 safety and efficacy of Probiotic Lactina, a feed additive consisting of NBIMCC 8270, NBIMCC 8242, NBIMCC 8269, ssp. NBIMCC 8250, ssp. NBIMCC 8244 and NBIMCC 8253, for chickens for fattening and suckling and weaned rabbits. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species and concluded that the additive is presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on its dermal sensitisation potential due to the lack of data. Moreover, the data provided in the previous assessment were not sufficient to conclude on the efficacy of the additive in the target species. In the current assessment, the applicant provided supplementary information to address these flaws. Based on the new studies, the Panel concluded that Probiotic Lactina is irritant to skin and eyes. In the absence of data, no conclusions could be reached on its sensitisation potential. Due to the absence of appropriate data, no conclusions could be drawn on the efficacy of Probiotic Lactina for chickens for fattening and suckling/weaned rabbits.
应欧盟委员会的要求,动物饲料添加剂及产品或物质专家小组(FEEDAP)被要求就益生菌Lactina(一种由NBIMCC 8270、NBIMCC 8242、NBIMCC 8269、ssp. NBIMCC 8250、ssp. NBIMCC 8244和NBIMCC 8253组成的饲料添加剂)对育肥鸡以及哺乳和断奶兔的安全性和有效性发表科学意见。在之前的一份意见中,FEEDAP专家小组评估了该产品在这些目标动物中的安全性和有效性,并得出结论认为该添加剂对目标动物、消费者和环境被假定为安全的。关于对使用者的安全性,由于缺乏数据,专家小组无法就该添加剂对皮肤和眼睛的刺激性潜力或其皮肤致敏潜力得出结论。此外,之前评估中提供的数据不足以就该添加剂在目标动物中的有效性得出结论。在本次评估中,申请人提供了补充信息以解决这些缺陷。基于新的研究,专家小组得出结论认为益生菌Lactina对皮肤和眼睛有刺激性。由于缺乏数据,无法就其致敏潜力得出结论。由于缺乏适当的数据,无法就益生菌Lactina对育肥鸡以及哺乳/断奶兔的有效性得出结论。