DSM 3-FL HMO approved for use in the US and Australia

Royal DSM, a global science-based company active in Health, Nutrition and Bioscience, has recently announced that its newly developed human milk oligosaccharide (HMO) – 3-fucosyllactose (3-FL) – has been approved as an ingredient in food applications in the US and Australia.

These latest regulatory approvals strengthen DSM position as a leading end-to-end partner in the HMO space and open new opportunities for early life nutrition and conventional food innovation in the US and dietary supplement developments in Australia.

The US Food and Drug Administration (FDA) has issued a “no questions letter” in response to DSM affiliate, Glycom A/S notification, that its 3-FL HMO – marketed as GlyCare™ 3FL 9000 or 9001 – is Generally Recognized as Safe (GRAS) for use in a number of early life nutrition applications and conventional foods (GRAS Notice No. 1037).[1] Notably, the maximum permitted use level of DSM’s 3-FL HMO is 0.75 g/L in non-exempt term infant formula and 0.90 g/L in formula and drinks for young children as consumed – nearly twice as high as the maximum use level that is GRAS in the US for other 3-FL ingredients in the same food categories. The greater use level was authorized by the FDA as a result of DSM’s recent analysis of HMO concentrations in global pooled (secretor and non-secretor) human milk by lactation stage.[2] It has previously been demonstrated that 3-FL concentrations increase over the course of lactation, whereas concentrations of most other HMOs decrease over time. However, DSM’s review specifically reports that 3-FL concentrations are already increased two-fold from colostrum to three-month mature milk. Thus higher levels of DSM’s 3-FL in infant nutrition products were determined to be GRAS as these provide formula-fed infants with nutrition that is closer to the composition of breast milk over the course of lactation, independent of secretor status.

In Australia, the Therapeutic Goods Administration (TGA) has included 3-FL in the latest update to its Therapeutic Goods (Permissible Ingredients) Determination. This permits the use of 3-FL as a complementary medicine ingredient in listed medicines, such as dietary supplements. Specifically, 3-FL has been recommended for oral use at a maximum daily dose of 2g for infants and young children aged 0-3 years and 5g for individuals 4 years of age and older. As the first HMO manufacturer to apply for the addition of 3-FL to listed medicines in the country, DSM has secured exclusivity for this use for a period of 2 years.

HMOs are a unique component of human breast milk with important benefits for immunity, gut health and potentially cognitive development. DSM’s science-backed GlyCare™ HMO portfolio is available for use in more than 160 countries worldwide. Following the successful authorization of its first manufactured HMOs, 2’-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT) in several markets globally, DSM has since launched difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose sodium salt (3′-SL) and 6’-sialyllactose sodium salt (6′-SL). At present, all 6 HMO products have secured market authorization as new ingredients in foods in 6 markets including the EU, UK, US, Russia, Israel and Singapore. 3-FL will be DSM’s 7th HMO ingredient to gain international authorization.

Christoph Röhrig, Head of HMO Regulatory at DSM said, “At DSM, we’re always looking for new ways to support the health of people globally, whether that’s through quality ingredients, innovative solutions or cutting-edge technologies. HMOs are a powerful emerging ingredient capturing increasing attention across the health and nutrition space – especially in the infant nutrition market. There are more than 150 identified HMOs in human breast milk and what’s interesting is that the science behind these unique nutrients is only just emerging. The discoveries have been incredibly positive so far, but there is still a lot to be uncovered regarding the potential health benefits and applications of HMOs – which is extremely exciting! Consequently, it’s anticipated that HMO solutions will continue to breakthrough onto the market as the industry learns more about the role these ingredients play in human health.”

Marta Mikš, Senior Regulatory & Scientific Affairs Manager at DSM added, “As a leader in HMO research, development and manufacture, DSM is continuously looking at how it can pioneer advancements in the space and expand its HMO offering. 3-FL is a highly abundant HMO in human breast milk and was therefore an important ingredient for us to develop and add to our growing portfolio. The approval of 3-FL in these 2 important markets is another positive step towards delivering the benefits of HMOs to the global population.”

DSM continues to champion regulatory developments in the HMO landscape; holding the largest number of approvals worldwide and with scope to expand. Mikš said that this is made possible by spearheading research in the field through its HMO Donation Program to advance the industry’s knowledge of HMOs and their relevance for human health.”

[1] Non-exempt term infant formula (at a maximum use level of 0.75 g/L as consumed); formula and drinks for young children (at a maximum use level of 0.90 g/L as consumed); foods for infants and young children (at a maximum use level of 6.25 g/kg); and a variety of conventional foods (at maximum use levels ranging from 1.25-25 g/kg or g/L).

[2] Soyyilmaz et al. The Mean of Milk: a review of human milk oligosaccharide concentrations throughout lactation. Nutrients, 2021.

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