Lacto-N-triose II Receives Positive Novel Food Safety Assessment from EFSA

At the request of the European Commission, the European Food Safety Authority (EFSA) assessed the safety of LNTri II as a novel food.

The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) LNTri II, but it also contains d-glucose, d-galactose, d-lactose and lacto-N-triitol. The NF is produced by fermentation with a genetically modified strain (Kluyveromyces lactis DSM 709-2-02) of K. lactis DSM 70799.

The applicant intends to use the novel food in a range of food categories, including infant formula, follow-on formula, food supplements, and foods for special medical purposes, with the general population as the target population.

In line with other HiMOs, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake of the NF. The anticipated daily intake from its use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. The anticipated daily intake from the NF as a food ingredient at the maximum proposed use levels exceeds the intake level of breastfed infants on a body weight basis in infants and children.

Taking all available evidence into consideration, the Panel concluded that consumption of LNTri II at the proposed uses and use levels does not raise safety concerns. Therefore, lacto-N-triose II is considered safe under the proposed conditions of use.

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