Global Compliance Perspective on HMOs: Approvals and Applications in India

Human milk oligosaccharides (HMOs) are the third most abundant solid nutrient in breast milk, following only lactose and lipids. HMOs form a variety of complex structures through different combinations of five basic components – glucose, galactose, N-acetylglucosamine, L-fucose, and N-acetylneuraminic acid – and possess multiple functions, including regulating the gut microbiota, establishing the intestinal barrier, boosting immunity, and enhancing cognitive development.

The Food Safety and Standards Authority of India (FSSAI) stipulates that non-specific foods or food ingredients – that is, food products or raw materials that have not undergone standardization and do not fall under the specific food categories listed in the Food Safety and Standards Regulations – can be submitted for approval under the Regulations. Several HMO manufacturers have already had their products approved in India following the submission of applications in accordance with the regulations. This section lists only the approved HMO ingredients (six items) and does not include infant formula products approved for HMO addition (eight items).

The table below shows the approved HMO ingredients published by the FSSAI, effective until January 15, 2026.

Status of Approved HMOs in India

*DSM is actively leading the way in securing market access for HMOs in India. The company has already successfully obtained approval for the three HMOs listed above, while applications for LNT, 3’-SL, and 6’-SL are currently underway. According to information on DSM’s official website, the FSSAI has approved the use of 2’-FL in infant nutrition products for infants under 6 months of age, with a maximum level of 1.2 g/L.

The above reflects the current use of HMOs in India. In addition, several HMO products have already obtained market access in regions such as Europe, the United States, Australia & New Zealand, and Singapore. Their regulatory status can be found in the above-linked previous articles from the “Global Compliance Perspective on HMOs” series.

The HMO market is expanding rapidly. Beyond their application in infant formula, HMOs are increasingly being incorporated into conventional foods. North America and Europe currently represent the largest global markets for HMOs, while the Asia-Pacific region is experiencing rapid growth. As companies focus on HMO development, it is essential to closely monitor global market dynamics in order to adjust regulatory strategies in a timely manner.

Note: Data in this article is current as of December 31, 2025, and is sourced from publicly available information on the FSSAI’s official website. It is provided for reference only.

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