The European Commission has authorized lacto-N-tetraose (LNT) produced through microbial fermentation using a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) as a novel food in the European Union. The authorization was granted under Regulation (EU) 2026/397, which amends the Union list of authorized novel foods established by Commission Implementing Regulation (EU) 2017/2470.
The application was submitted on 15 October 2023 by Inbiose N.V. under Article 10(1) of Regulation (EU) 2015/2283 on Novel Foods. The company requested authorization to market LNT produced via microbial fermentation for use in the same food categories and at the same maximum levels as previously authorized LNT. In October 2025, the applicant modified the request to exclude food supplements intended for young children.
Following a request from the Commission, the European Food Safety Authority conducted a safety assessment of the ingredient. Based on the evaluation of the production process, composition, toxicological data, allergenicity assessment, and other scientific evidence, the Commission concluded that the novel food meets the safety requirements established under the EU novel food framework.
The authorized ingredient must be labelled as “lacto-N-tetraose.” The regulation also establishes maximum permitted levels for its use in various food categories. These include 1.0 g/L in pasteurised or sterilised milk products and beverages, 10 g/kg in fermented milk products and cereal bars, 0.8 g/L in infant formula, 0.6 g/L in follow-on formula, 5 g/kg in processed cereal-based foods and milk-based products, and 2.0 g/day in food supplements for the general population. For total diet replacement foods for weight control, the permitted levels are 2.0 g/L in beverages and 20 g/kg in other products. Foods for special medical purposes may contain the ingredient according to the specific nutritional requirements of the intended population.
Specific labelling conditions apply to food supplements containing LNT, including statements that they should not be consumed by children under three years of age and should not be used on the same day as other foods containing added LNT.
The authorization also grants five years of data protection for the applicant’s proprietary scientific evidence. As a result, only Inbiose N.V. is authorized to place this specific LNT on the EU market until 16 March 2031, unless another applicant obtains authorization without relying on the protected data or with the agreement of the original applicant.
Consumer News Region