Statement on the safety of lacto-N-neotetraose and 2'-O-fucosyllactose as novel food ingredients in food supplements for children

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(11):4299 [12 pp.].
doi
10.2903/j.efsa.2015.4299
Panel members at the time of adoption
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Novel Foods: Tara Dean, Karl-Heinz Engel, Marina Heinonen, Inge Mangelsdorf, Rosangela Marchelli, Harry McArdle, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Yolanda Sanz, Josef Schlatter and Hendrik van Loveren for the support provided to this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
Question Number
EFSA-Q-2015-00594
EFSA-Q-2015-00595
Adopted
28 October 2015
Published
13 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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. 

Summary

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 (NFIs) 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 (4-10 years of age) and teenagers (11-18 years of age).

In this scientific assessment, maximum daily intakes from food supplements for toddlers, children and teenagers are presented and two scenarios for each population group are calculated in which the maximum daily intakes from food supplements are added to the mean and 95th percentile intake estimates (on a per kg body weight basis) from all foods in which LNnT and 2’-FL are intended to be added.

For children at the considered age from 1 to 18 years, daily intakes from food supplements at the proposed maximum levels would be below the 95th percentile daily intakes estimated for LNnT and 2’FL from all proposed foods intended to contain these NFIs, which were already considered safe by the Panel in July 2015.

In children of 1–10 years of age the combined intakes from all proposed foods, which are intended to contain the NFI, plus food supplements, could result in intake levels which were reported to cause mild gastrointestinal symptoms in adults.

However, the Panel notes that the intake estimates are based on the conservative assumptions that all proposed food items consumed by an individual actually contain the NFI at the maximum specified level of use and that in addition to such intakes these ingredients are also consumed from food supplements at the maximum proposed intake levels.

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. 

Keywords
lacto-N-neotetraose, 2'-O-fucosyllactose, food supplements, novel foods
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Number of Pages
12