EFSA Concludes 3-Fucosyllactose (3-FL) is Safe as a Novel Food for Extended Uses

The European Food Safety Authority (EFSA) has published a scientific opinion confirming the safety of 3-Fucosyllactose (3-FL) as a novel food for extended uses under Regulation (EU) 2015/2283. 3-FL is a human-identical milk oligosaccharide naturally present in human breast milk and produced via microbial fermentation using a genetically modified Escherichia coli K-12 strain. It was already authorized for several food categories in the EU, and this application sought to extend its use to foods for special medical purposes (FSMP) for infants and young children, food supplements for the same age groups, and to increase the maximum permitted use levels in infant and follow-on formula. EFSA’s NDA Panel reviewed its identity, production process, composition, anticipated intake, nutritional, toxicological, and allergenic data and found no safety concerns under the proposed new uses and levels. The production microorganism and final product purity were also deemed acceptable. This conclusion clears the way for broader use of 3-FL in infant and medical nutrition products within the EU.