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Updated: Jul 15, 2026

Analysis of Fucosylated Human Milk Trisaccharides in Biotechnological Context Using Genetically Encoded Biosensors
Published on: April 13, 2019
A comprehensive safety evaluation of approved 2'-fucosyllactose for human nutritional applications in China
Jiangge Zheng1, Huali Wang1, Wenfeng Liu1
1Division III, China National Center for Food Safety Risk Assessment, Beijing, China.
Background:
2'-Fucosyllactose (2'-FL), as a significant human milk oligosaccharide, plays a crucial role in infant formula products. This study aims to provide a scientific basis for the safe application of 2'-FL by systematically evaluating its physicochemical properties, production strain safety, toxicological data, and population exposure levels.
Methods:
This study characterizes the physicochemical properties of 2'-FL, evaluates the safety of its production strain, and conducts a series of toxicological assessments, including an acute oral toxicity test, genotoxicity tests, a 90-day subchronic toxicity test, and a teratogenicity test. Additionally, an exposure assessment of 2'-FL was conducted by integrating usage level data with food consumption data.
Result:
The production strain for 2'-FL is recognized as safe, and all the results of toxicological experiments show negative or no observed adverse effects. Exposure assessment data further confirm that infant and young child populations exposed to 2'-FL remain within established safety limits under the specified usage levels. Consequently, the use of 2'-FL as a food ingredient is considered safe.
Discussion:
The safety and technological necessity of 2'-FL constitute the scientific basis for its approval as a novel nutritional additive authorized for use in infant formula products.