EU Evaluates Safety of 2'-Fucosyllactose as a Novel Food Ingredient

The European Food Safety Authority (EFSA) recently reported on the safety of 2'-fucosyllactose (2’-FL) as a novel food ingredient. Produced by a genetically modified strain of E. coli W (ATCC 9637), the ingredient is mainly composed of the human-identical milk oligosaccharide (HiMO) 2’-FL, along with other related saccharides.

2'-fucosyllactose

Credit: Wikipedia

The expert panel concluded that 2′-fucosyllactose is safe as a novel food under the proposed conditions of use, including as a food supplement for infants at the use level of 1.2g/day. The resulting estimated intake in infants from the proposed use in food supplements is within the natural intake of 2’-FL in breastfed infants.

The Panel noted that the available intake estimate is not recent and decided to perform a new intake estimate according to the current EFSA approach. The highest P95 daily intake of the NF from the use as a food ingredient is higher than the estimated natural highest mean daily intake in breastfed infants and marginally higher in young children.

The applicant applies for the same use and use levels as already authorized for 2’-FL and included in the Union list of NFs, with the general population as the target population. The information provided on the identity, manufacturing process, composition, and specifications of the NF does not raise safety concerns.

Overall, the Panel concluded that the NF is safe under the proposed conditions of use. This assessment is an important step in evaluating the safety and suitability of 2’-fucosyllactose as a novel food ingredient.