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A new source of lacto-N-tetraose recognized as a safe novel food by EFSA

Lacto-n-tetraose is a human milk oligosaccharide. A synthetic form of this ingredient is already authorized in Europe for a use in many food products. EFSA has been asked to evaluate the safety of a new source of lacto-N-tetraose, obtained by using by using genetically modified Escherichia coli BL21(DE3) strain.

In its opinion, EFSA notes that the manufacturing process, composition and specifications on the novel food does not raise safety concerns. Notably, the absence of both DNA and viable cells in the product has been demonstrated in accordance with EFSA requirements.

Despite the fact that lacto-N-tetraose has already been recognized as safe by EFSA, the applicant (Chr. Hansen A/S, Denmark) has provided a full panel of toxicity studies, including a bacterial reverse mutation test, one in vitro micronucleus test, a 7-day repeated dose oral toxicity study and a 90-day repeated dose oral toxicity study. All these studies have demonstrated the safety of the novel food.

Therefore, based on the data presented in the application, EFSA recognized that lacto-N-tetraose obtained by using GMO E. coli is safe under the proposed conditions of use, which are close to the conditions of use of the synthetic lacto-N-tetraose.

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernandez E and Knutsen HK, 2022. Scientific Opinion on the safety of lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coliBL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022;20(5):7242.