Innovative HMO ingredients by dsm-firmenich get FSANZ green light for infant nutrition

17 Jan 2024 --- Four more human milk oligosaccharide (HMO) ingredients by the health, nutrition and beauty company dsm-firmenich have been cleared for use in infant formula by the Food Standards Australia New Zealand (FSANZ).

“We were the first company to bring 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs to Australia and New Zealand,” says Christoph Röhrig, head of the HMO regulatory division at dsm-firmenich. “But the approval of these additional four ingredients opens up even more avenues for pioneering advancements in the realm of early life nutrition — ultimately extending the reach of our HMOs’ unique health benefits to more infants globally.”

“Australia and New Zealand are important markets as FSANZ opinions are highly valued by regulatory authorities in other countries — particularly in Asia-Pacific — and therefore support market access to these HMOs in other regions,” adds Maryse Darch, regulatory and scientific affairs manager at dsm-firmenich.

FSANZ confirms dsm-firmenich’s HMOs for infants promote beneficial gut microbiota, have anti-pathogenic effects, suppress inflammation and support immune responses and antigenic memory.The Swiss HMOs manufacturer is the first to apply for and obtain approval for the four evaluated ingredients — GlyCare 2’-fucosyllactose/difucosyllactose (2’-FL/DFL), GlyCare lacto-N-tetraose (LNT), GlyCare 6’-sialyllactose (6’-SL) sodium salt and GlyCare 3’-sialyllactose (3’-SL) sodium salt.

FSANZ ruling
The food safety authority concludes that dsm-firmenich’s ingredients pose “no public health and safety concerns associated with incorporating these HMOs as nutritive substances in infant formula products, either individually or in combination, at the specified levels.”

The company has been granted a 15-month exclusive use period for all four GlyCare HMO products, commencing on the date of gazettal in the two countries. 

Dsm-firmenich states that there is scientifically-backed evidence that the ingredients soon to be introduced on the Australian and New Zealand markets offer specific health benefits and pave the way for early-life nutrition solutions that closely resemble human breast milk’s function and chemical composition.

“Dsm-firmenich is committed to delivering safe and innovative infant nutrition solutions — and this latest development is a significant stride toward achieving that goal,” Röhrig comments. 

The FSANZ’s evaluation further confirms dsm-firmenich’s health benefits claims of the HMOs for infants, verifying that the GlyCare 2’-FL/DFL, LNT, 6’-SL sodium salt and 3’-SL sodium salt promote beneficial gut microbiota, have anti-pathogenic effects, suppress inflammation and support immune responses and antigenic memory when added to infant formula.

“We have also received approval for the same six HMO products (2”-FL, LNnT, 2’-FL/DFL, LNT, 6’-SL sodium salt and 3’-SL sodium salt) in other markets, including the EU, US, Singapore and Thailand,” Darch asserts.

Late last year, dsm-firmenich’s HMOs received approval to enter the Chinese infant nutrition market from the nation’s relevant authorities.

“These approvals unlock new commercialization opportunities in over 160 markets globally for infant formula products with HMO blends that include HMOs from all three structural classes found in breastmilk — fucosylated, neutral core and sialylated,” she explains.

 By Milana Nikolova