EFSA Greenlights Broader Use of 3-Fucosyllactose in 4 Key Food Categories for 2025

On April 29, 2025, the European Food Safety Authority (EFSA) issued a pivotal scientific opinion confirming the safety of expanding the use of 3-Fucosyllactose (3-FL) in multiple food products. This decision follows a request from the European Commission regarding the ingredient’s extended applications under EU Regulation 2015/2283.

Produced using a genetically engineered strain of E. coli BL21 (DE3), 3-FL is already approved for use in infant formulas, follow-on formulas, and other food items. The latest request sought to increase maximum use levels in infant formula, follow-on formula, food for special medical purposes (FSMP), and food supplements (FS).

EFSA conducted detailed intake assessments to evaluate the potential exposure to 3-FL under the proposed usage scenarios. Findings showed that even under high consumption patterns, the estimated intake in infants younger than 16 weeks remained lower than the natural average levels found in breastfed infants. When combining the proposed and already approved uses, the estimated 95th percentile intake was slightly higher but still fell within the natural safe range of 3-FL from human milk.

EFSA also confirmed that the same conclusions apply to FSMP and FS categories, assuring that the broader application of 3-FL poses no safety risks under the new usage limits. This conclusion further strengthens the case for its expanded inclusion in medical nutrition and dietary supplements in the EU.

This approval marks a significant step toward wider acceptance of 3-FL, an oligosaccharide that mimics compounds found naturally in human breast milk and plays a vital role in infant gut health and immune support.