dsm-firmenich, a global innovator in health, nutrition and beauty, has announced the approval of its human milk oligosaccharide (HMO), 2′-O-Fucosyllactose (2′-FL)—commercially known as GLYCARE® 2FL—as a functional ingredient for early life nutrition in India. This regulatory milestone marks a new opportunity to enhance infant health, as well as support HMO innovation in the region, with GLYCARE® 2FL representing dsm-firmenich’s first HMO approval in India.
The Food Safety and Standards Authority of India (FSSAI) approved GLYCARE® 2FL for use in nutritional products for infants up to six months old at a maximum level of 1.2 g/L of reconstituted formula per day. HMOs are the third most abundant solid component in human milk, after lipids and lactose. As the most abundant fucosylated HMO, 2’-FL enables formulators to bring the composition of formula milk closer to that of breastmilk, the gold standard in infant nutrition.
Growing evidence shows that HMOs have important health benefits during early life. In particular, 2’-FL plays a vital role in infant gut health by promoting the growth of beneficial bacteria, like bifidobacteria. Emerging science suggests that 2’-FL may support a healthy immune system, potentially reducing the incidence of infections and illnesses like diarrhea, while also benefiting cognitive development and lowering the risk of allergies in infants. With India home to nearly one fifth of the world’s annual child births, the approval of GLYCARE® 2FL opens doors to advancing infant health in this region.
“With a robust portfolio of eight HMOs, and more under development, we’re leading market access for HMOs,” Purvesh Shah, Senior Manager of Regulatory Affairs APAC, HNC, dsm-firmenich remarked. “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.”
The approval of GLYCARE® 2FL as a functional ingredient in India is testament to dsm-firmenich’s continuous commitment to improving access to HMOs worldwide—adding to its list of HMO approvals and HMO-containing product registrations across more than 165 countries.
Srilatha Sreepathy, Director of Regulatory Affairs APAC, HNC, dsm-firmenich added: “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. 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.”
