Frontiers in Toxicology · Published 2026-06-22 · DOI 10.3389/ftox.2026.1836564
Jiangge Zheng, Huali Wang, Wenfeng Liu, Zhongzhou Chen, Jiyue Zhang, Jianbo Zhang
Background2′-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.MethodsThis 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.ResultThe 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.DiscussionThe 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.
Abstract from DOAJ. Public domain (CC0 1.0).
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Zheng, J., Wang, H., Liu, W., et al. (2026). A comprehensive safety evaluation of approved 2′-fucosyllactose for human nutritional applications in China. Frontiers in Toxicology. https://doi.org/10.3389/ftox.2026.1836564