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

• Published in: EFSA journal 2020-11, Vol.18 (11), p.e06305-n/a
• Main Authors: Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Kearney, John, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Maradona, Miguel Prieto, Schlatter, Josef Rudolf, van Loveren, Henk, Colombo, Paolo, Knutsen, Helle Katrine
• Format: Article
• Language: English
• Subjects: Allergens; Breast milk; Carbohydrates; change in specifications; Children; Dietary supplements; E coli; Fermentation; Food; Food allergies; food for specific groups; Gene expression; Genetic modification; HiMO; human milk oligosaccharide; Lactose; lacto‐N‐neotetraose; Life Sciences; LNnT; Manufacturing industry; Microorganisms; Milk; novel food; Novel foods; Nutrition; Oligosaccharides; RNA polymerase; Safety; Scientific Opinion; Specifications; Strains (organisms); Yeasts
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2020.6305

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 the change in the production process and specifications of lacto‐N‐neotetraose (LNnT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) LNnT but also contains lactose, lacto‐N‐triose II (LNT II), para‐lacto‐N‐neo‐hexaose (para‐LNnH) and other related carbohydrates. The NF is produced by fermentation with two genetically modified strains of Escherichia coliBL21. LNnT when chemically synthesised or produced by microbial fermentation using another E. coli strain (K‐12) is already authorised and included in the EU list of NFs. This application is limited to a change in the manufacturing process and specifications while target population, uses and use levels and consequently the anticipated intake do not change. The information provided on the manufacturing process, including the absence of DNA from the producing microorganisms, composition, identity and specifications of the NF do not raise safety concerns. Particularly, the proposed changes in the specifications are limited to a slightly higher ash content and limits for the presence of yeast and moulds, while specifications for methanol and LNnT fructose isomer have been removed. Food supplements are not intended to be used if other foods with the added NF or breast milk for young children are consumed on the same day. The Panel concludes that lacto‐N‐neotetraose (LNnT) as a NF when produced by fermentation with two genetically modified strains of E. coliBL21 is safe under the proposed conditions of use.