DSM’s 3-FL ingredient approved in US and Australia

Published: 14-Feb-2023

It has previously been demonstrated that 3-FL concentrations increase over the course of lactation

Royal DSM has 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 for DSM strengthen its 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 Glycom A/S*’s notification, delivered on behalf of DSM, that its 3-FL HMO – marketed as GlyCare 3FL 9000 or 9001 – is Generally Recognised as Safe (GRAS) for use in a number of early life nutrition applications and conventional foods, 

The maximum permitted use level of DSM’s 3-FL HMO is 0.75g/L in non-exempt term infant formula and 0.90g/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 authorised 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. 

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 have 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 2 g for infants and young children aged 0-3 years and 5 g 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 two years.

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

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 authorisation 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 six HMO products have secured market authorization as new ingredients in foods in six markets, including the European Union, United Kingdom, United States, Russia, Israel and Singapore. 3-FL will be DSM’s seventh HMO ingredient to gain international authorisation.

“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,” said Christoph Röhrig, Head of HMO Regulatory at DSM. “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. 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 two important markets is another positive step towards delivering the benefits of HMOs to the global population.

“But our progress doesn’t stop here. We continue to champion regulatory developments in the HMO landscape; holding the largest number of approvals worldwide and with scope to expand. We make this possible by spearheading research in the field through our HMO Donation Program to advance the industry’s knowledge of HMOs and their relevance for human health.”                                                             

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