据了解,?-唾液酸乳糖钠盐是由大肠杆菌W (ATCC 9637)的衍生菌株(大肠杆菌NEO3)生产的。经过评估,专家小组得出结论,在提议的使用条件下?-唾液酸乳糖钠盐作为新型食品是安全的。部分原文报道如下:
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 (sodium salt), but it also co
ntains sialic acid, d-glucose, d-lactose, 3-sialyllactulose and 6-sialyllactose sodium salts and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli NEO3) of E. coli W (ATCC 9637). The information provided on the identity, 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 special medical purposes and food supplements (FS). The target population is the general population. The applicant applies for the same uses and use levels as already assessed for 3-SL sodium salt produced by a genetically modified strain of E. coli K-12 DH1, with the exception for the use in FS, which is proposed to be higher (from 0.5 to 1.0 g/day) in individuals from 3 years of age. Since the NF as a food ingredient would be co
nsumed at the same extent as the already assessed 3-SL sodium salt, no new estimates of the intakes have been carried out. The Panel notes that the maximum daily intake of 3-SL from the proposed use of the NF in FS for individuals from 3 years of age (1.0 g/day) is lower than the estimated highest mean daily intake of 3-SL in breastfed infants. FS are not intended to be used if other sources of 3-SL are co
nsumed on the same day. The Panel co
ncludes that the NF is safe under the proposed co
nditions of use.
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