Peer-reviewed article
Safety of lacto-N-triose II as a novel food pursuant to Regulation (EU) 2015/2283.
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Bohn T, Cámara M et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This document is a regulatory safety assessment of a food additive (lacto-N-triose II) for use in infant formula and other foods. It evaluates whether the substance is safe for consumption based on chemical composition and intake comparisons with naturally occurring levels in breast milk. The assessment concludes the additive is safe at proposed use levels.
Key points
- The substance is a human-identical milk oligosaccharide produced through fermentation
- Safety assessment compares intake from the novel food to natural intake levels in breastfed infants
- Proposed use includes infant formula, follow-on formula, food supplements, and medical foods
- Anticipated daily intake from infant formula use is similar to natural intake in breastfed infants
- Panel concluded the novel food is safe under proposed conditions of use
Limitations
This is a technical regulatory assessment focused on chemical safety rather than effectiveness or impact on child health outcomes. It does not evaluate whether the intervention actually improves child nutrition or well-being.
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 lacto-N-triose II (LNTri II) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. 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 information on the identity, production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant formula (IF), follow-on formula (FOF), food supplements (FS) and food for special medical purposes (FSMP). The target population is the general 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. Of note, higher exposure can be obtained from LNTri II as it is a by-product in the already authorised HiMOs (e.g. Lacto-N-tetraose). In addition, the natural intake estimate does not consider the formation of LNTri II at gastrointestinal level by gut microbiota fermentation or acid hydrolysis. The Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns and concludes that the NF is safe under the proposed conditions of use.