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

Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, K. Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, F Cubadda, KH Engel, T Frenzel, Marina Heinonen, R MarchelliM Neuhauser-Berthold, M Poulsen, Y Sanz, JR Schlatter, H van Loveren, P Colombo, Helle Katrine Knutsen

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Abstract

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.

Original languageEnglish
Article numbere05907
Number of pages27
JournalEFSA Journal
Volume17
Issue number12
DOIs
Publication statusPublished - 3 Dec 2019

Keywords

  • HMO
  • human milk oligosaccharide
  • lacto-N-tetraose
  • LNT
  • novel food
  • safety

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    Turck, D., Castenmiller, J., De Henauw, S., Hirsch‐Ernst, K. I., Kearney, J., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Engel, KH., Frenzel, T., Heinonen, M., ... Knutsen, H. K. (2019). Safety of lacto-N-tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 17(12), [e05907]. https://doi.org/10.2903/j.efsa.2019.5907