Safety Assessment of 3-Fucosyllactose (3-FL) as a Novel Food for Use in Food and Food Supplements (RP2001)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application from Inbiose N.V., Belgium (“the applicant”) for the authorisation of 3-fucosyllactose (3-FL) as a novel food in April 2023. The novel food is intended to be used as a source of the human identical milk oligosaccharide, 3-FL, and is manufactured by microbial fermentation using a genetically modified strain of Escherichia coli K-12 and then refined to yield the purified powder. This new application is seeking to use the novel food within the following food categories: dairy products and analogues, bakery wares, cereals, foods for special groups, beverages, and food supplements. Food supplements are not intended to be used if other foods with added 3-FL or breast milk are consumed in the same day. The FSA and FSS in their evaluation of the application reviewed the safety dossier and supplementary information provided by the applicant. The FSA and FSS did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the change in the conditions of use to extend the food is safe and not putting consumers at a nutritional disadvantage. The FSA and FSS concluded that the applicant had provided sufficient information to assure that 3-FL was safe under the intended conditions of use. The anticipated intake levels and the intended use in food and food supplements was not considered to be nutritionally disadvantageous. The safety assessment represents the opinion of the FSA and FSS.