dsm-firmenich poised to enhance infant health in India following HMO solution approval

dsm-firmenich has been given the green light for 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.

The company hails this as a “regulatory milestone” that boosts infant health and supports regional HMO innovation. Glycare 2FL is dsm-firmenich’s first HMO approval in India.

 The Food Safety and Standards Authority of India (FSSAI) approved the solution for use in nutritional products for infants up to six months old at a maximum daily dose of 1.2 g/L of reconstituted formula. 

Health benefits

The company notes that 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 breast milk.

 Growing evidence shows that HMOs have essential 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. 

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. 

India is home to almost one-fifth of the world’s annual childbirths, so the approval of Glycare 2FL is expected to advance infant health in this region.

 “With a robust portfolio of eight HMOs and more under development, we’re leading market access for HMOs,” says Purvesh Shah, senior manager of regulatory affairs APAC, HNC at dsm-firmenich. 

“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.”

First approval in India

The approval of Glycare 2FL as a functional ingredient in India is a testament to dsm-firmenich’s continuous commitment to improving access to HMOs worldwide. It adds 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, adds: “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.”