Open AccessSafety of lacto‐ N ‐neotetraose (LNnT) produced by derivative strains of E. coli BL21 as a novel food pursuant to Regulation (EU) 2015/2283
Author(s) -
Turck Dominique,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst 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,
Hein Marina,
Marchelli Rosangela,
NeuhäuserBerthold Monika,
Poulsen Morten,
Maradona Miguel Prieto,
Schlatter Josef Rudolf,
van Loveren Henk,
Colombo Paolo,
Knutsen Helle Katrine
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6305
Subject(s) - food science , population , lactose , fermentation , chemistry , european commission , microbiology and biotechnology , medicine , business , biology , european union , environmental health , economic policy
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 ( LN nT) as a novel food ( NF ) pursuant to Regulation ( EU ) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (Hi MO ) LN nT but also contains lactose, lacto‐ N ‐triose II ( LNT II ), para‐lacto‐ N ‐neo‐hexaose (para‐ LN nH) and other related carbohydrates. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL 21. LN nT 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 NF s. 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 LN nT 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 ( LN nT) as a NF when produced by fermentation with two genetically modified strains of E. coli BL 21 is safe under the proposed conditions of use.