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

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 carbohydratetype 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.

Changes in HMO Concentrations throughout Lactation: Influencing Factors, Health Effects and Opportunities

“…Today, HMOs are classified as novel foods by many food regulation authorities requiring a mandatory food safety assessment. So far, eight HMOs (2′-FL [ 92 ], 3-FL, LNnT, DFL, LNT [ 93 ], 6′-SL and 3′-SL [ 94 ]) have being positively assessed and approved by the European Food Safety Authority (EFSA). The combination of 2′-FL and LNnT or DFL [ 92 , 95 ] was also regarded as safe for infants up to one year of age when added to infant and follow-on formulae, based on the scientific and technical information provided.…”

Safety of lacto‐N‐neotetraose (LNnT) produced by derivative strains of E. coli BL21 as a novel food pursuant to Regulation (EU) 2015/2283

“…In addition, the Panel noted that with identical (LNnT synthetically produced) or similar HiMO (LNT, the regioisomer of LNnT, obtained by microbial fermentation), the stability of the respective NFs was at least 24 months (EFSA NDA Panel, 2015aPanel, , 2019.…”

Safety of the extension of use of 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283

“…These NF applications make reference to the proprietary data cited for 2’‐FL/DFL mixture (EFSA NDA Panel, 2019a ) and for LNT (EFSA NDA Panel, 2019b ).…”

“… a Values estimated considering the average concentration of 2’‐FL and DFL (81 and 11% w/w DM, respectively) in the NF (EFSA NDA Panel, 2019a ). b Values estimated considering the average concentration of LNT (78% w/w DM) in the NF (EFSA NDA Panel, 2019b ). …”

“…LNT is included in the EU Union list of authorised NFs ((EU) 2017/2470 2 ) when produced by fermentation with a genetically modified strain of E. coli K‐12 DH1. A scientific opinion on the safety of LNT as a NF has been published in 2019 (EFSA NDA Panel, 2019b ).…”