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Press Release | Ghent, 6 July 2021
Inbiose applies for FDA GRAS approval of four new Human Milk Oligosaccharides

Inbiose, a leading biotech company active in the development of Human Milk Oligosaccharides (HMOs), is pleased to announce that it has submitted its application for a Generally Recognized as Safe (GRAS) approval by the US Food & Drug Administration (FDA) of four HMOs, specifically 6’-Sialyllactose (6’SL), 3-Sialyllactose (3’SL), Lacto-N-Tetraose (LNT) and Lacto-N-neoTetraose (LNnT). Inbiose will also file for Novel Food approval of these HMOs by the European Commission (EFSA) in the coming weeks and is preparing a global regulatory roll-out. Inbiose expects to obtain regulatory approval for these HMOs in 2022 and is currently organizing its industrial production for timely deliveries to customers in infant nutrition, dietary supplements and functional food and beverages. Product samples are available for interested parties that wish to develop innovative products with these HMOs.

“Over the years, Inbiose has earned itself a solid reputation of technological leadership in the development of HMOs. I am really proud of our team that has allowed us to take the regulatory step on our way to the market. The approval of these HMOs in the US and EU will mark the beginning of a whole new range of advanced HMOs produced by Inbiose” said Prof. Soetaert, CEO and Chairman of Inbiose.


Professor Soetaert, CEO and Chairman of Inbiose

Inbiose has been developing a wide range of human-identical milk oligosaccharides that can be industrially produced by sustainable fermentation processes. Inbiose is currently developing its next generation HMOs that will permit infant formula to better replicate the composition of breast milk. HMOs are the newest ingredients for premium infant formula and industry watchers expect this market to reach €500m by 2025 and grow further to well over € 1bn. The HMO market goes beyond infant nutrition as recent scientific studies have demonstrated that HMOs may play an important role as bio-active ingredients for improved immunity, gut health, learning ability and brain health of the general population.

About Inbiose

Inbiose is a Belgium-based biotech company focused on the research, development and commercialization of specialty carbohydrates, including human milk oligosaccharides. Our unique proprietary technology platform “GlycoActives®” enables cost-effective manufacturing of a wide range of specialty carbohydrates by sustainable fermentation processes.

For more information, please send e-mail to businessdevelopment@inbiose.com or contact Wim Soetaert at +32 474 51 47 91 or Paul Decraemer at +32 475 43 20 35