Safety of lacto-N-tetraose (LNT) produced by a derivative strain (Escherichia coli K-12 MG1655 INB_LNT_01) of E. coli K-12 MG1655 (ATCC 700926) 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 mainly composed of the human-identical milk oligosaccharide (HiMO) LNT, but it also contains lacto-N-triose II, d-lactose, LNT-fructose isomer and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain (Escherichia coli K-12 MG1655 INB_LNT_01) of E. coli K-12 MG1655 (ATCC 700926). LNT when produced by fermentation with genetically modified strains of E. coli K-12 DH1 or E. coli BL21 is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while the target population, conditions of use and consequently the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate-type compounds structurally related to LNT is also considered of no safety concern. In line with other HiMOs, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake of the NF. Given that the NF would be consumed to the same extent as the already authorised LNT, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. The Panel concludes that the NF is safe under the proposed conditions of use.