Safety of 3-FL (3-Fucosyllactose) as a novel food pursuant to Regulation (EU) 2015/2283.
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on 3-fucosyllactose (3-FL) as a novel food (NF)pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milkoligosaccharide (HiMO) 3-FL but also contains D-lactose and its monomers, L-fucose and a smallfraction of other related saccharides. The NF is produced by fermentation with a genetically modifiedstrain ofEscherichia coliK-12. The information provided on the manufacturing process, compositionand specifications of the NF does not raise safety concerns. The applicant intends to add the NF in avariety of foods, including infant and follow-on formula, foods for infants and toddlers, foods forspecial medical purposes and food supplements. The target population is the general population,except for food supplements for which the target population is individuals above 1 year of age. Theanticipated daily intake of 3-FL from the NF at the maximum proposed use levels is unlikely to exceedthe intake level of breastfed infants on a body weight basis. The intake of 3-FL in breastfed infants ona body weight basis is expected to be safe also for other population groups. In infants below 1 year ofage, a possible exceedance of a natural intake was observed, but the degree of this exceedance is notconsidered of safety concern in view of the wide range of 3-FL concentrations in human milk. Foodsupplements are not intended to be used if other foods with the added NF (as well as human milk foryoung children) are consumed on the same day. The Panel concludes that the NF is safe under theproposed conditions of use.
Domaines
Sciences du Vivant [q-bio]
Fichier principal
EFSA Journal - 2021 - - Safety of 3‐FL 3‐Fucosyllactose as a novel food pursuant to Regulation EU 2015 2283.pdf (2.55 Mo)
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