The public consultation will end on July 23, 2025.
3-FL is said to offer potential health benefits such as increasing the beneficial gut bacteria Bifidobacterium and also produces anti-pathogenic effects.
The HMO is also considered unique among other HMOs as it is present in the breastmilk of all women regardless of their secretor status and its concentration level increases throughout lactation.
The FSANZ is considering the approval of 3-FL for use as a nutritive substance in infant formulas following an application by Glycom A/S - a subsidiary of dsm-firmenich AG.
The company has also requested an exclusive use permission under the brand name ‘GlyCare’ for a period of 15 months if approved.
The 3-FL from Glycom A/S is produced using the genetically modified source organism known as Escherichia coli K-12.
The FSANZ said it has so far found no public health or safety concerns with the proposed use of 3-FL in infant formulas.
“FSANZ’s safety assessment concluded there are no public health and safety concerns associated with the addition of 3-FL synthesised from the applicant’s GM E. coli K-12 to infant formula products up to 80 mg/100 kJ.”
With the final approval, 3-FL could be used as an optional nutritive substance in infant formula products up to the specified permitted amount of 80 mg/100 kJ.
However, the approval would only apply to the Australian market. In Australia, the HMO is already approved for use as a complementary medicine ingredient by the Therapeutic Goods Administration (TGA).
Currently, the HMO is permitted for use as a novel food ingredient, including in infant formula and follow-on formula at a level of 1.75 g/L in the European Union (EU).
In the UK, it is permitted for use in infant formula and follow-on formula at a maximum level of 2.0 g/L.
In the US, it has received the Generally Recognised as Safe (GRAS) status for use in infant formula at a level of 0.75 g/L in non-exempt formula for term infants, in addition to a variety of other food uses.
Glycom A/S building up HMOs approvals in Oceania
This is not the first HMO application by Glycom A/S in the Oceania region.
Last year, its four HMOs have been approved by the FSANZ, including the most commonly-used 2′-fucosyllactose (2′-FL) in infant formulas, as well as lacto-N-tetraose (LNT), 6′-sialyllactose (6′-SL) sodium salt, and 3′-siallylactose (3′-SL) sodium salt.
These HMOs were also granted exclusivity for infant formula use in ANZ for 15 months from the date of gazettal.
Two other HMOs, namely 2’-FL/lacto-N-neotetraose (LNnT) and 2’-FL/difucosyllactose (DFL), have also been approved for use in infant formulas by the FSANZ.
Clinical trial findings
Infant formulas containing 0.24 to 0.8 g/L of 3-FL in combination with other HMOs were found to be safe, well tolerated and did not affect growth, said the FSANZ.
The regulator concluded based on results from three clinical studies involving infants.
One of the studies was conducted by Abbott Nutrition.
Findings published in Nutrients in 2022 found that an infant formula containing five HMOs, including 3-FL, could support normal growth, gastrointestinal (GI) tolerance and safe use in healthy term infants.
The amount of 3-FL used in the infant formula was 0.8 g/L, while the amount that could be found in human milk is between 0.023 and 6.08 g/L.
