據(jù)了解，該3′-唾液酸乳糖是由大腸桿菌BL21 (DE3)的衍生菌株生產(chǎn)的。經(jīng)過評估，專家小組得出結(jié)論，在提議的使用條件下，3′-唾液酸乳糖作為新型食品是安全的。部分原文報道如下：

 

　　Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 3’-sialyllactose (3’-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3’-SL, but it also contains d-lactose, 3’-sialyllactulose, sialic acid, N-acetyl-d-glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow-on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3’-SL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3’-SL from human milk in infants on a body weight basis. The intake of 3’-SL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3’-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3’-SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.

 

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