Safety of 3-FL (3-Fucosyllactose) as a novel food pursuant to Regulation (EU) 2015/2283

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-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3-FL but also contains D-lactose and its monomers, L-fucose and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli K-12. 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 in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special 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. The anticipated daily intake of 3-FL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake of 3-FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. In infants below 1 year of age, a possible exceedance of a natural intake was observed, but the degree of this exceedance is not considered of safety concern in view of the wide range of 3-FL concentrations in human milk. Food supplements are not intended to be used if other foods with the added NF (as well as human milk for young children) are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.