Kaiseraugst (Switzerland), Heerlen (Netherlands) - January 15, 2024
dsm-firmenich, a leading innovator in health, nutrition and beauty, is delighted to announce that it has gained approval for an additional four human milk oligosaccharide (HMO) ingredients for use as nutritive substances in infant formula products in Australia and New Zealand. The approval follows the company’s successful application – submitted by Glycom A/S* – to the Food Standards Australia New Zealand (FSANZ). dsm-firmenich is the first HMO manufacturer to apply and obtain approval for the four HMOs in this region.
Not only does the landmark approval authorize the use of additional science-backed ingredients with unique health benefits, but it paves the way for a new era of early life nutrition solutions that are more closely matched to the function and composition of breastmilk. The four dsm-firmenich 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. Furthermore, a 15-month exclusive use period has been granted for all four GlyCare™ HMO products, commencing on the date of gazettal.
The FSANZ assessment also included an evaluation of the potential health benefits of the HMOs for infants. It verified that there is well founded evidence that the HMOs elicit multiple positive effects when added to infant formula – including the promotion of beneficial gut microbiota, anti-pathogenic effects, suppression of inflammation and support of immune responses and anti-genic memory.
Christoph Röhrig, Head of HMO Regulatory at dsm-firmenich comments: “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.”
“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 & Scientific Affairs Manager at dsm-firmenich. “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.”
To learn more about dsm-firmenich’s industry-leading HMO portfolio and the promising science-based benefits of these unique ingredients, visit: https://www.dsm.com/human-nutrition/en/products/hmos/hmos-for-early-life.html
*Glycom A/S is ultimately controlled by dsm-firmenich AG, registered in Kaiseraugst, Switzerland.
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.
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