On February 14, DSM announced that its newly developed human milk oligosaccharide (HMO) 3-Fucosyllactose (3-FL) had been approved as a food ingredient in the United States and Australia.
FDA Approved 3-FL Ingredient
It is reported that Glycom, a supplier of breast milk oligosaccharides, filed an application with the FDA for 3-FL HMO as a food ingredient on behalf of DSM. Now the FDA has issued a “no question” response to Glycom, confirming that the 3-FL HMO sold as GlyCare 3FL9000 or 9001 is certified GRAS (safe) and can be used in early life nutrition and traditional food.
DSM’s 3-FL HMO has a maximum allowable use level of 0.75g/L in a non-exempt term infant formula and a maximum allowable use level of 0.90g/L in infant formula and beverages. It is almost double the maximum use of other 3-FL ingredients in the same food category as determined by US GRAS.
Besides the US, DSM’s 3-FL is also approved in Australia.
Incorporated 3-FL Into Australian Therapeutic Supplies
Australia’s Therapeutic Goods Administration (TGA) has included 3-FL in its latest update, Therapeutic Goods (Allowed Ingredients), allowing 3-FL as a complementary pharmaceutical ingredient to listed medicines, such as dietary supplements.
3-FL is recommended for oral use, with a maximum daily dose of 3 grams for infants aged 0-2 and a maximum daily dose of 4 grams for people aged 5 and over.
As the first HMO manufacturer to apply to add 3-FL to a drug marketed in Australia, DSM has been granted exclusivity for this use for two years. Currently, DSM’s GlyCare HMO portfolio is available in more than 160 countries worldwide.
These two latest regulatory approvals will reinforce DSM’s significant position in the HMO space and open up new opportunities for early-life nutrition and traditional food innovation in the US and dietary supplement development in Australia.
It is worth noting that DSM has a very extensive layout in the direction of HMO. Following the successful licensing of its first produced HMOs, namely 2′-Fucosyllactose (2′-FL) and Lactose-N-Neotetraose (LNnT), in several markets worldwide, DSM has since launched Eryan Decosyllactose (DFL), Lactose-N-Tetraose (LNT), 3′-Sialyllactose sodium salt (3′-SL) and 6′-Sialyllactose sodium salt (6′-SL).
At present, all six HMO products have obtained marketing authorization for new food ingredients in six markets, including the European Union, the United Kingdom, the United States, Russia, Israel, and Singapore. 3-FL will be DSM’s seventh HMO ingredient to receive international authorization.
HMOs are unique components of human breast milk that have important benefits for immunity, gut health, and potentially cognitive development. As an emerging ingredient, HMOs will attract increasing attention throughout the health and nutrition sector, especially in the infant nutrition market. Currently, there are more than 150 identified HMOs in breast milk.
Currently, many domestic companies focus on the R&D and production of HMO raw materials. For example, Yixi Biology is a technology and product R&D company focusing on synthetic biology. In November 2022, its HMOs successfully entered the formal production stage, and in 2023, it may fully bloom in terms of production capacity and applications.
Although foreign countries are moving faster than domestic HMOs, they have also made progress on the enterprise and regulatory sides. On February 10, the National Center for Food Safety Risk Assessment announced the solicitation of 5 new food additives, including 2′-Fucosyllactose, which means 2′-Fucosyllactose (2′-FL) is isolated from Approval is only one step away, and this year may usher in greater progress in regulations.