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 Puente Secundino, López-Alonso Marta, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brantom Paul, Dierick Noël Albert, Aguilera Jaime, Anguita Montserrat
EFSA J. 2018 Apr 24;16(4):e05224. doi: 10.2903/j.efsa.2018.5224. eCollection 2018 Apr.
A total of 11 enzymes were assessed including alpha-amylase, endo-1,4-beta-glucanase, endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase as silage additives for all animal species. These enzymes are obtained by fermentation of bacterial or fungi non-genetically modified production strains. Throughout information regarding the production strains of each product were provided, including the origin and history of modifications and allowing their identification. The identification was conclusive for 8 of 10 production strains. For three of the strains, more information/data would still be required in order to conclude. Three of the amylases are produced by bacterial strains that belong to a species that is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. The identity of the strains has been established and the qualifications were met, and consequently, those products were regarded as safe. For the products derived from fungal strains, the strains or resulting products were tested for the presence of secondary metabolites which could be of toxicological concern. These were found to be below the limits of detection or the strain not capable of producing them. Considering all the information provided by the applicant, the Panel concluded that these products can be regarded as safe for the target species, consumer and the environment. In the absence of data, the Panel could not conclude on the skin and eye irritancy or skin sensitisation potential of the products under evaluation. These products should be considered to have the potential to be a respiratory sensitiser. For some of the products under evaluation, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that they have a potential to improve the characteristic of the silage material; for some other products, the Panel could not conclude on their efficacy.
共评估了11种酶，包括α-淀粉酶、内切-1,4-β-葡聚糖酶、内切-1,4-β-木聚糖酶和内切-1,3(4)-β-葡聚糖酶，作为所有动物物种的青贮添加剂。这些酶是通过细菌或真菌非转基因生产菌株发酵获得的。提供了关于每种产品生产菌株的详细信息，包括其来源、修饰历史及可进行识别。对10个生产菌株中的8个的识别是确凿的。对于其中3个菌株，仍需要更多信息/数据才能得出结论。其中3种淀粉酶由属于欧洲食品安全局（EFSA）认为适用于安全性评估的合格假定方法的一个物种的细菌菌株产生。菌株的身份已确定且符合相关条件，因此，这些产品被视为安全。对于源自真菌菌株的产品，对菌株或所得产品进行了可能引起毒理学关注的次生代谢物检测。结果发现这些次生代谢物低于检测限，或者该菌株不具备产生它们的能力。考虑到申请人提供的所有信息，专家小组得出结论，这些产品对目标物种、消费者和环境可被视为安全。由于缺乏数据，专家小组无法就所评估产品的皮肤和眼睛刺激性或皮肤致敏潜力得出结论。这些产品应被视为有成为呼吸道致敏原的可能性。对于一些所评估的产品，动物饲料添加剂及产品或物质专家小组（FEEDAP）得出结论，它们有改善青贮材料特性的潜力；对于其他一些产品，专家小组无法就其功效得出结论。
