dsm-firmenich announces approval in India for human milk oligosaccharide

In an April 11, 2025, press release, dsm-firmenich announced that its 2'-FL (2'-O-Fucosyllactose) human milk oligosaccharide (HMO) had received approval by the Food Safety and Standards Authority of India (FSSAI) as a functional ingredient for infant nutrition. Marketed as Glycare 2FL, the HMO had received approval for use of up to 1.2 g/L of the reconstituted formula per day for infants up to six months old.

“With a robust portfolio of eight HMOs, and more under development, we’re leading market access for HMOs,” stated Purvesh Shah, senior manager of regulatory affairs APAC, HNC, dsm-firmenich, in the press release. “This regulatory win—in a region with the fastest-growing global economy—will help early life nutrition brands address rising demand for innovative, science-backed infant nutrition solutions. And with hypoallergenic formats of Glycare 2FL available, there is an opportunity to cater to the needs of more infants in this region.” Nearly one-fifth of the world’s births occur in India annually, the press release noted.

After lipids and lactose, HMOs are the most abundant component in human milk, the press release explained, and 2’-FL is the most abundant fucosylated HMO, helping formulators better match human breastmilk. It also noted health benefits associated with HMOs, including promoting beneficial bacteria for gut health, and supporting immune health, cognitive development, and reducing risk of allergies.

“Securing our first HMO approval in India marks a significant milestone for dsm-firmenich and underscores our position as a global leader in early life nutrition innovation,” stated Srilatha Sreepathy, director of regulatory affairs APAC, HNC. “This achievement reflects our ability to navigate complex regulatory environments, thanks to the persistent dedication of our regulatory affairs team. As we continue to uncover the potential benefits of HMOs, approvals like this will pave the way for new research and product innovation opportunities for early life nutrition and beyond.”

As noted in the press release, dsm-firmenich has HMO approvals and registrations for HMO-containing products in more than 165 countries.