Safety Assessment of 2’-Fucosyllactose (2’-FL) as a Novel Food for Use in Food and Food Supplements (RP1476)

Abstract

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application from Kyowa Hakko Bio Company Ltd, Japan (“the applicant”) for the authorisation of 2’-fucosyllactose (2’-FL) as a novel food in March 2022. The novel food is intended to be used as a source of human identical milk oligosaccharide, 2’-FL, and is manufactured by microbial fermentation using a genetically modified strain of Escherichia coli W, 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, table-top sweeteners, foods for special groups, beverages, and food supplements. Food supplements are not intended to be used if other foods with added 2’-FL or breast milk are consumed the same day. The intended uses and use levels for the novel food are the same as those that have already been authorised for 2’-FL produced by fermentation with genetically modified strains of E. coli BL21 (DE3), E. coli K-12 DH1, and Corynebacterium glutamicum ATCC 13032. However, this application is also seeking to use 2’-FL as a food supplement for infants, which is not currently authorised. 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 views of the Committee were taken into account by the FSA and FSS who concluded that the applicant had provided sufficient information to assure the novel food, 2-FL, was safe under the proposed conditions of use. The anticipated intake levels and the intended use in food and food supplements was not considered to be nutritionally disadvantageous. This safety assessment represents the opinion of the FSA and FSS.