经过评估,专家小组得出结论,在建议的使用条件?'-岩藻糖基乳糖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 the safety of the extension of use of 2-fucosyllactose (2-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient in several food categories, including infant formula (IF) and follow-on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF and FOF. EFSA estimated the anticipated daily intake of the NF from the proposed extension of use, including the already authorised co
nditions of use in other food categories. Additionally, a new intake estimate limited to the already authorised co
nditions of use of the NF was carried out following EFSA's current approach. The estimated daily intake of the NF from high co
nsumption of IF alone at the proposed maximum use level in infants < 16 weeks of age is similar to the estimated natural highest mean daily intake of 2-FL from human milk in breastfed infants. The estimated highest P95 daily intakes of the NF from the proposed extension of use in IF and FOF (including the authorised uses in other food categories) and from the already authorised co
nditions of use, are comparable and both higher than the estimated natural highest mean daily intake of 2-FL from human milk in infants and to a lesser extent in young children. The Panel co
nsiders that the proposed extension of use of the NF in IF and FOF o
nly marginally affects the highest P95 daily intake estimate from the authorised co
nditions of use, and therefore does not affect the safety of the NF. The Panel co
ncludes that the NF, 2-FL, is safe under the proposed co
nditions of use.
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