Safety evaluation of the human-identical milk monosaccharide, l-fucose

•A subchronic dietary toxicity study preceded by an in utero phase was conducted on l-fucose in Sprague–Dawley rats.•No maternal toxicity or adverse effects on development in offspring were observed at a maternal dietary level of up to 1%.•No adverse effects were observed at doses of up to 516 and 665mg/kgbw/day in F1 males and females, respectively.•l-Fucose was non-genotoxic in a series of genotoxicity tests.•The results of these studies support the safe use of l-fucose in infant formula and as a food ingredient.