Inbiose applies for FDA GRAS approval of four new fermentation-produced HMOs

By Jim Cornall

- Last updated on GMT

Prof. Wim Soetaert, CEO and chairman of Inbiose. Pic: Inbiose
Prof. Wim Soetaert, CEO and chairman of Inbiose. Pic: Inbiose

Related tags Breast milk HMO HMOs Fermentation

Belgian biotech company Inbiose, which develops human milk oligosaccharides (HMOs), has submitted its application for a Generally Recognized as Safe (GRAS) approval by the US Food & Drug Administration (FDA) of four HMOs.

The HMOs are 6'-Sialyllactose (6'SL), 3-Sialyllactose (3'SL), Lacto-N-Tetraose (LNT) and Lacto-N-neoTetraose (LNnT).

Inbiose said it 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 deliveries to customers in infant nutrition, dietary supplements and functional food and beverages.

"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. Wim 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 more than €1bn.

The HMO market goes beyond infant nutrition as recent scientific studies have demonstrated HMOs may play an important role as bio-active ingredients for improved immunity, gut health, learning ability and brain health of the general population.

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