The European Food Safety Authority (EFSA) has concluded that lacto-N-triose II (LNTri II), a human-identical milk oligosaccharide (HiMO) produced via fermentation with a genetically modified strain of Kluyveromyces lactis, is safe for use as a novel food ingredient in a range of products including infant formula, follow-on formula, food supplements, and foods for special medical purposes. The opinion, adopted on 1 July 2026 and published on 22 July 2026, covers the general population as the target group. The assessment, requested by the European Commission following an application by Shandong Henglu Biotechnology Co., Ltd, found that the proposed uses and use levels do not raise safety concerns, despite noting that anticipated daily intake for infants and children may exceed natural intake levels from breast milk on a body weight basis.
The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) based its safety evaluation primarily on a comparison between the intake of breastfed infants and the estimated intake from the novel food. The anticipated daily intake from use in infant formula is similar to the estimated natural mean highest daily intake in breastfed infants. However, for infants and children, the intake from the novel food as a food ingredient at maximum proposed use levels exceeds that of breastfed infants on a body weight basis. The panel also noted that higher exposure could occur because LNTri II is a by-product in already authorised HiMOs such as lacto-N-tetraose, and that natural intake estimates do not account for LNTri II formation at the gastrointestinal level by gut microbiota fermentation or acid hydrolysis. Despite these considerations, the panel concluded that consumption at the proposed levels is safe.
The opinion adds to a series of positive EFSA assessments on HiMOs since 2015, including 2'-fucosyllactose, lacto-N-tetraose, and 3-fucosyllactose, among others. The applicant has requested data protection under Article 26 of Regulation (EU) 2015/2283 for proprietary data submitted in support of the application. The European Commission will now consider the opinion in its decision on whether to authorise the novel food for the EU market.