Safety of lacto-N-neotetraose (LNnT) produced by derivative strains of E. coli BL21 as a novel food pursuant to Regulation (EU) 2015/2283 - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 2020

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

Jacqueline Castenmiller
  • Fonction : Auteur
Stefaan de Henauw
  • Fonction : Auteur
Karen Ildico Hirsch-Ernst
  • Fonction : Auteur
John Kearney
  • Fonction : Auteur
Alexandre Maciuk
  • Fonction : Auteur
Inge Mangelsdorf
  • Fonction : Auteur
Harry J. Mcardle
  • Fonction : Auteur
Androniki Naska
  • Fonction : Auteur
Carmen Pelaez
  • Fonction : Auteur
Kristina Pentieva
  • Fonction : Auteur
Alfonso Siani
  • Fonction : Auteur
Frank Thies
  • Fonction : Auteur
Sophia Tsabouri
  • Fonction : Auteur
Marco Vinceti
  • Fonction : Auteur
Francesco Cubadda
  • Fonction : Auteur
Thomas Frenzel
  • Fonction : Auteur
Marina Heinonen
  • Fonction : Auteur
Rosangela Marchelli
  • Fonction : Auteur
Monika Neuhauser-Berthold
  • Fonction : Auteur
Morten Poulsen
  • Fonction : Auteur
Miguel Prieto Maradona
  • Fonction : Auteur
Josef Rudolf Schlatter
  • Fonction : Auteur
Henk van Loveren
  • Fonction : Auteur
Paolo Colombo
  • Fonction : Auteur
Helle Katrine Knutsen
  • Fonction : Auteur

Résumé

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.
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hal-04387728 , version 1 (11-01-2024)

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Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen Ildico Hirsch-Ernst, John Kearney, et al.. 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 Journal, 2020, EFSA Journal, 18, pp.e06305. ⟨10.2903/j.efsa.2020.6305⟩. ⟨hal-04387728⟩

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