It is the most abundant human milk oligosaccharide in breast milk, playing a crucial role in infant immune system development, gut microbiota regulation, and pathogen infection suppression. It was first approved by the US FDA and the EU for use in infant nutrition foods (infant formula stage 1/2, as well as infant formula, also known as stage 3), dietary supplements, formula foods for special medical purposes, and milk based ingredients or similar products for young children only. At the same time, it has also been approved for use in traditional foods (such as dairy products, baked goods, beverages, coffee, tea, and other foods and beverages).

In China, it has been approved for use in infant formula, formulated milk powder (limited to children's milk powder only), and special medical use infant formula.