Safety Assessment on the Change to Conditions of Use of the Novel Food 3-Fucosyllactose (3-FL) Produced Using a Derivative Strain of Escherichia Coli BL21 (DE3) to Increase the Permitted Use Levels (RP2363)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application in December 2025 from Chr. Hansen A/S, Denmark (“the applicant”) for the authorisation of a change of conditions of use for 3-fucosyllactose (3-FL) produced using a genetically modified strain of Escherichia coli BL21 (DE3). The novel food, 3-fucosyllactose (3-FL), is a Human identical Milk Oligosaccharide (HiMO) and is manufactured by microbial fermentation using a genetically modified strain of Escherichia coli BL21 (DE3). The novel food was previously assessed by GB and received a positive opinion for use in the following categories: foods for infants and young children (infant formula and follow-on formula, baby foods and processed cereal-based foods, milk-based drinks, foods for special medical purposes and food supplements) and foods for other children, adolescents and adults (foods for special medical purposes and food supplements) (FSA and FSS, 2024). The change in the conditions of use seek to increase the maximum use levels of 3-FL within all authorised food categories. No other changes have been requested. 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 extension of use to increase specified use levels of the novel 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 the change in conditions of use for 3-FL produced using a genetically modified strain of Escherichia coli BL21 (DE3) was safe under the intended change to use levels. The anticipated intake levels and the intended use levels in foods was not considered to be nutritionally disadvantageous. The safety assessment represents the opinion of the FSA and FSS.