Safety Assessment: Outcome of the assessment of 3-fucosyllactose (3-FL) as a novel food

The novel food is 3-FL which is intended to be used as a source of human identical milk oligosaccharides. 3-FL is manufactured by microbial fermentation using a genetically modified strain of Escherichia coli K-12, and then refined to yield the purified novel food. This new application is seeking to use the novel food within the food following categories: dairy products and analogues, bakery wares, foods for special groups, beverages, and also as a food supplement. Food supplements are not intended to be used if other foods with added 3-FL or breast milk are consumed the same day. To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. The Committee concluded that the applicant had provided sufficient information to assure the novel food, 3-FL, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods and food supplements was not considered to be nutritionally disadvantageous and does not mislead consumers. The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinion of the FSA and FSS.