Assessment of 3-Fucosyllactose (3-FL) as a Novel Food for Use in Food and Food Supplements (RP2106)

Chr. Hansen, Denmark (“the applicant”) submitted a novel food application for the authorisation of 3-fucosyllactose (3-FL) as a novel food to each nation of Great Britain in September 2023. The novel food is intended to be used as a source of human identical milk oligosaccharide, 3-FL, and is manufactured by microbial fermentation using a genetically modified strain of Escherichia coli BL21 (DE3), and then refined to yield the purified powder. This new application is seeking to use the novel food within the following food categories: food for special medical purposes and food supplements for the general population including those for vulnerable groups (pregnant and breastfeeding women, and the elderly); food for infants and young children including infant formula and follow-on formula. Food supplements are not intended to be used if other foods with added 3-FL or breast milk are consumed the same day. This novel food had its application for authorisation assessed by the European Food Safety Authority (EFSA) which was published in May 2022. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have reviewed the information available, including the EFSA opinion, and confirmed that 3-FL was safe under the proposed conditions of use. The anticipated intake levels and proposed use in food and food supplements was not considered to be nutritionally disadvantageous. This safety assessment represents the opinion of the FSA and FSS.