Expanding early life innovation with 3-FL HMO ingredient approvals

Summary

• dsm-firmenich has achieved approval of its latest HMO ingredient – GlyCare™ 3FL – for food applications and dietary supplements in the US and Australia.
• Backed by a team of scientists and regulatory experts, dsm-firmenich is pioneering innovation in the HMO space to make these unique oligosaccharides found in breast milk available to infants worldwide.
• Read on to find out what dsm-firmenich’s latest regulatory win for its 3-fucosyllactose (3-FL) ingredient means for early life nutrition advancements.

To ensure formula-fed babies have the best possible start in life, when breastfeeding is not possible or chosen, it is important to bring infant formula as close as possible to the composition and function of human breast milk – the gold standard for infant nutrition. As the third most abundant solid component in human milk after lipids and lactose,¹ human milk oligosaccharides (HMOs) are a collection of complex carbohydrate structures that play an important role in infant nutrition. Since their discovery, increasing evidence has demonstrated the potential benefits of HMOs in multiple areas of infant health such as digestive health, immunity and cognitive development.

dsm-firmenich breaks into new markets with 3-FL HMO

dsm-firmenich has achieved another regulatory milestone in the HMO space with the approval of its newly-developed HMO ingredient, 3-fucosyllactose (3-FL) – marketed as GlyCare™ 3FL 9000 or 9001 – for use in food applications and dietary supplements in the US and Australia. 

The US Food and Drug Administration (FDA) issued a “no questions letter” in response to dsm-firmenich’s Generally Recognized as Safe (GRAS) Notice submitted to the Agency for the use of 3-FL in a number of early life nutrition applications and conventional foods (GRN 1037). The GRAS determination supports the use of higher concentrations of dsm-firmenich’s 3-FL HMO compared to other HMO ingredients on the market, with the maximum use level of dsm-firmenich’s 3-FL HMO that has been notified as GRAS in the US in formula and drinks being 0.75 g/L. The safety of the higher concentration was supported by dsm-firmenich’s recent review of the concentration of HMOs in global pooled human milk throughout lactation.²

Australia is the second market where dsm-firmenich has gained market access for 3-FL, with the Therapeutic Goods Administration (TGA) adding the ingredient to the Therapeutic Goods (Permissible Ingredients) Determination list. This move permits the use of 3-FL as a complementary medicine ingredient for use in non-prescription medicines such as dietary supplements. As the first manufacturer to apply for 3-FL approval within this category, dsm-firmenich has also been granted two years exclusivity for use of the ingredient in complementary medicines in this region.

What is 3-FL?

3-FL is a highly abundant, α1-3 fucosylated HMO in human milk. Unlike most HMOs, 3-FL has been shown to increase during lactation, meaning the proportion of 3-FL compared to other HMOs will likely increase as breast-fed infants progress in the early developmental stages.³ Indeed, research indicates that 3-FL has a critical role in early development as it is found in amniotic fluid and cord blood as well as milk.^4,5

Pre-clinical and preliminary studies have been instrumental in demonstrating the possible functional benefits of 3-FL. Evidence indicates that 3-FL supports the growth of beneficial bacteria in the gut, including bifidobacteria.^6,7,8 Other exciting avenues of 3-FL research have shown that it could support immunity by preventing harmful microbes from attaching to cells in the gut.⁹ Additional studies have indicated the role of 3-FL in supporting gastric motility, integrity and barrier function.^10,11,12 This growing body of evidence suggests that 3-FL is a strong candidate for supporting infant development and gut health in particular.

Leading the way in HMO approvals and innovation

dsm-firmenich is a renowned partner in the HMO market, holding the largest number of approvals worldwide and offering a broad portfolio of commercially-available HMOs to more than 160 countries. 3-FL joins dsm-firmenich’s portfolio of authorized HMOs including 2’-fucosyllactose (2'-FL), lacto-N-neotetraose (LNnT), difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose sodium salt (3'-SL) and 6’-sialyllactose sodium salt (6'-SL) – all of which have received approval as new food ingredients in the European Union, United Kingdom, United States, Israel and Singapore.