EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Statement on the safety of lacto-N-neotetraose and 2'-O-fucosyllactose as novel food ingredients in food supplements for children

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on the safety of lacto-N-neotetraose and 2'‑O-fucosyllactose as novel food ingredients in food supplements for children (excluding infants). In July 2015, the Panel concluded that LNnT and 2’-FL are safe for infants and for young children when added to infant, follow-on and young-child formulae under specific conditions of use; and for adults when added to foods at the uses and use levels proposed by the applicant, which include food supplements at a maximum intended daily intake of 1.5 g for LNnT and 3 g for 2’-FL. The applicant also intends to include LNnT and 2’-FL in food supplements for children, with maximum daily intake levels of 0.6 g for LNnT and 1.2 g for 2’-FL for toddlers (1–3 years of age), and maximum daily intake levels of 1.5 g for LNnT and 3 g for 2’-FL for children (4–18 years of age). In this scientific assessment, maximum daily intakes from food supplements for toddlers, children and teenagers are presented and two scenarios are calculated in which the maximum daily intakes from food supplements are added to the mean and 95th percentile intake estimates from all foods in which LNnT and 2’-FL are intended to be added. The Panel concludes that LNnT and 2’-FL are safe for the proposed use in food supplements at the maximum use levels proposed for toddlers (1–3 years of age) of 0.6 g/day for LNnT and 1.2 g/day for 2’-FL (alone or in combination) and for children (4‑18 years of age) of 1.5 g for LNnT and 3 g for 2’-FL (alone or in combination). However, in children of 1‑10 years of age the combined intakes from all foods in which the NFIs are intended to be added and from food supplements could result in intake levels which were reported to cause mild gastrointestinal symptoms in adults.