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

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela MarchelliMonika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Henk van Loveren, Paolo Colombo, Helle Katrine Knutsen

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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 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 coli BL21. 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. coli BL21 is safe under the proposed conditions of use.

Original languageEnglish
Article numbere06305
Number of pages11
JournalEFSA Journal
Volume18
Issue number11
DOIs
Publication statusPublished - 19 Nov 2020

Keywords

  • lacto-N-neotetraose
  • LNnT
  • human milk oligosaccharide
  • HiMO
  • novel food
  • change in specifications
  • food for specific groups

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