The 2’-FL is produced by microbial fermentation using a genetically modified (GM) bacteria strain known as Corynebacterium glutamicum – which is not yet listed as a permitted source organism for producing 2’-FL under the Australia New Zealand Food Standards Code (the Code).
The public consultation, which ends on March 22 (Friday), 6pm Canberra time, is meant to assess the possibility of adding the strain into the Code.
The FSANZ said in its announcement that the strain has a long history of use and posed no risks to human health.
“C. glutamicum has a long history of documented use for the production of biomolecules, including food additives, and poses no risks to human health. No safety concerns arising from the gene donors were identified.
“Characterisation of the production strain confirmed the expression plasmid carrying the introduced genes was both genetically stable and fully functional,” it said.
It also said that the strain was a non-pathogenic bacterium widely used in industrial amino acid production and has been studied for more than 60 years since its discovery as a glutamate-secreting bacterium.
For example, in the European Union, it has been granted qualified presumption of safety status for producing amino acids and other food ingredients such as flavouring compounds.
In addition, data has shown that 2'-FL from C. glutamicum is chemically identical to 2'-FL naturally present in human breast milk and can therefore be expected to undergo the same metabolic pathways.
“The applicant’s 2′-FL is chemically and structurally identical to the naturally occurring substance present in human milk and other 2′-FL already assessed and permitted by FSANZ,” said FSANZ CEO Dr Sandra Cuthbert.
The FSANZ previously permitted the use of 2’-FL from different source organisms for use as nutritive substances in infant formulas.
An example is 2’-FL produced via microbial fermentation using the GM Escherichia coli (E. coli) K12 production strain SCR6.
If approved, 2’-FL produced using Corynebacterium glutamicum could be used at the same levels as those produced using other approved strains – which is 96mg/kJ or 2.4g/L.
“The availability and use of 2'-FL from C. glutamicum as an alternative source for this HMO ingredient is expected to promote healthy market competition, which will ultimately benefit Australian and New Zealand consumers,” said the regulator, adding that AP Technologies’ 2’-FL was of high purity, containing no less than 94 per cent 2’-FL.
Approvals in eight countries
AP Technologies has so far received approvals for its 2’-FL in eight countries, with India the latest to permit the use of the ingredient in infant formulas, according to the company’s update in January.
The company’s 2’-FL is so far approved for infant nutrition use in the US, Europe, South Korea, Thailand, Vietnam, Malaysia, and Singapore.
Aside from ANZ, it also said it was interested in receiving approvals from China, Japan, the UK, and Mexico.
Other HMOs that the company produces are 3-FL (3-Fucosyllactose), LNT (Lacto-N-Tetraose), LNnT (Lactose-N-netetraose), LNFP (Lacto-N-FucoPentose), 3’-SL (3’-Sialic Lactose), and 6’-SL (6’-Sialic Lactose).
The company is also behind the supplement brand Momstamin which produces HMOs-based supplements for both adults and children.
