Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, 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, Cocconcelli Pier Sandro, Pettenati Elisa, Anguita Montserrat, Brozzi Rosella
EFSA J. 2023 Mar 13;21(3):e07856. doi: 10.2903/j.efsa.2023.7856. eCollection 2023 Mar.
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 a feed additive consisting of CNCM I-3698 and sp. CNCM I-3699 intended to be used as a technological additive (functional group: silage additives) in forage for all species. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 10 Viable Forming Units (VFU)/g additive. However, in that opinion the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address these gaps. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I-3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. The additive is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive. The Panel reiterated its previous conclusions that no conclusions can be drawn on the efficacy of the additive to improve the ensiling process of forage.
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）被要求就一种饲料添加剂的安全性和有效性发表科学意见，该添加剂由CNCM I - 3698和sp. CNCM I - 3699组成，拟用作所有物种饲料的技术添加剂（功能组：青贮饲料添加剂）。在之前的意见中，该添加剂被描述为含有两种菌株的活但不可培养细胞，比例为1:1，添加剂中总乳酸菌计数至少为5×10个活形成单位（VFU）/克。然而，在该意见中，专家小组无法完全表征该添加剂，也无法就其皮肤/眼部刺激性或致敏潜力得出结论。在当前评估中，申请人提供了补充信息以填补这些空白。用于区分和单独定量构成添加剂的两种菌株的拟议方法仍然存在局限性。因此，专家小组得出结论，现有数据不足以完全表征该添加剂。专家小组无法就菌株CNCM I - 3699的分类鉴定得出结论，因此也无法就其是否符合安全合格假定（QPS）方法的适用资格得出结论。因此，基于QPS方法先前关于该添加剂安全性的结论无法得到确认。专家小组无法就该添加剂对目标物种、消费者和环境的安全性得出结论。该添加剂对皮肤无刺激性。专家小组无法就该添加剂的眼部刺激性或皮肤致敏潜力得出结论。专家小组重申其先前的结论，即无法就该添加剂改善饲料青贮过程的功效得出结论。
