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DSM-Firmenich receives approval for HMOs in infant formula in Australia and New Zealand
Rafaela Sousa

Rafaela Sousa

17 January 2024

DSM-Firmenich receives approval for HMOs in infant formula in Australia and New Zealand

DSM-Firmenich has received approval for four more human milk oligosaccharide (HMO) ingredients to be used as nutritive substances in infant formula products in Australia and New Zealand. The approval was obtained through the company's HMO supplier, Glycom A/S, following DSM-Firmenich's application to the Food Standards Australia New Zealand (FSANZ). It marks DSM-Firmenich as the first HMO manufacturer to apply for and secure approval for these four HMOs in the region. The four HMO ingredients evaluated by FSANZ were 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 concluded that there were "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". Additionally, a 15-month use period has been granted for all four GlyCare HMO products, starting from the date of the official announcement. The evaluation also looked into the possible health benefits of the HMOs for infants. It confirmed there is "well-founded" evidence that adding these HMOs to infant formula has several positive effects, including promoting healthy gut bacteria, anti-pathogenic effects, reducing inflammation and supporting immune responses and anti-genic memory. Christoph Röhrig, head of HMO Regulatory at DSM-Firmenich, commented: “DSM-Firmenich is passionately committed to delivering safe and innovative infant nutrition solutions – and this latest development is a significant stride towards achieving that goal". "We were the first company to bring 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs to Australia and New Zealand. 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.” Maryse Darch, regulatory and scientific affairs manager at DSM-Firmenich, added: “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". "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. 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.”

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