Exclusive benefit: Australia approves use of DSM’s 3-FL for the first time

By Tingmin Koe

- Last updated on GMT

Australia has approved the use of DSM’s 3-fucosyllactose in dietary supplements. ©Getty Images
Australia has approved the use of DSM’s 3-fucosyllactose in dietary supplements. ©Getty Images

Related tags Dsm 3-fucosyllactose TGA

Australia’s Therapeutic Goods Administration (TGA) has approved for the first time the use of 3-fucosyllactose (3-FL) as a complementary medicine ingredient in listed medicines, such as dietary supplements.

The 3-FL approved is made by DSM and the company will enjoy a two-year exclusivity for supply this ingredient for listed medicines use in the country.

The ingredient has been recommended for oral use at a maximum daily dose of two grams for infants and young children aged zero to three.

For children aged four and above, as well as adults, the maximum oral dose is five grams per day. 

“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,” ​the company said.

Together with 2-fucosyllactose (2’-FL), 3-FL is one of the more well-known human oligosaccharides (HMOs) commonly added to infant formula.

“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,”​ Marta Mikš, senior regulatory & scientific affairs manager at DSM said. 

Aside from infant nutrition, companies are also starting to explore the use of HMOs in dietary supplements. One example is H&H, which launched in year 2021 ProBOOST + VIT D, Australia’s first kids supplement containing 2’-FL​ and claims to “support healthy immune system, growth, and development.”​  In this case, it was German firm BASF that has secured the two-year market exclusivity status from TGA to supply 2’-FL for use as a prebiotic in supplements.

Research has shown​ that different probiotics bacteria feed on different types of HMOs – which serves as prebiotics – for growth and colonisation in the human gut.

“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,”​ said Christoph Röhrig, head of HMO regulatory at DSM.

Aside from Australia, DSM’s 3-FL also secured the Generally Recognised as Safe (GRAS) status in the US and can be used in early life nutrition applications and conventional foods.

In the US, the maximum permitted use of DSM’s 3-FL is 0.75g/L in non-exempt term infant formula – meaning formulas intended for use by healthy term infants – and  0.90 g/L in formula and drinks for young children.

DSM’s HMO portfolio in APAC

So far, DSM’s HMOs are approved in two APAC countries, namely Australia and Singapore.

In Singapore, DSM has secured market authorisation for six of its HMOs as new ingredients in foods.

These are 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).

Other than Singapore, these HMOs have also secured market authorisation in the EU, UK, US, Russia, and Israel.

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