Safety of lacto‐N‐tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

lacto‐N‐tetraose, LNT, human milk oligosaccharide, HMO, novel food, safety
First published in the EFSA Journal
3 décembre 2019
30 octobre 2019
Scientific Opinion


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 lacto‐N‐tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed by LNT, but also containing d‐lactose and other oligosaccharides such as para‐lacto‐N‐hexaose‐2 (para‐LNH‐2), lacto‐N‐triose II and a small fraction of other carbohydrates. It 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 intake of LNT from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring LNT in breastfed infants on a body weight basis. The intake of other carbohydrate‐type compounds structurally related to LNT is considered of no safety concern. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations.

Panel members at the time of adoption

Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti.
Panel on Nutrition, Novel Foods and Food Allergens
nda [at]
EFSA Journal 2019;17(12):5907
Question Number
On request from
European Commission following an application by Glycom A/S