For infant formula: FSANZ seeks public comment on use of 2’-FL produced via new GM strains

By Tingmin Koe

- Last updated on GMT

Human milk oligosaccharide is one of the popular ingredients used in infant formula. ©Getty Images
Human milk oligosaccharide is one of the popular ingredients used in infant formula. ©Getty Images

Related tags New zealand Fsanz Infant formula

Regulator Food Standards Australia New Zealand is seeking public comment on the use of 2’-O-fucosyllactose (2’-FL) produced using new genetically modified (GM) strains in infant formula products.

A human milk oligosaccharide (HMO), FSANZ approved 2’-FL for voluntary use in infant formula products and formulated supplementary foods for young children in Dec 2019.

The approved 2’-FL is produced via microbial fermentation using genetically-modified Escherichia ​coli (E. coli) K12 production strain SCR6.

This time round, the 2’-FL in question is also produced via microbial fermentation – but using E. coli BL21 strains.  

The public comment​ was conducted in response to an application was made by Denmark-based bioscience company Chr. Hansen A/S.

The public comment will also assess if the 2’-FL in question can be used in a wider range of infant formula products, including follow-on formula and infant formula products for special dietary uses.

The FSANZ has completed a pre-market assessment of the 2’-FL in question and has proposed to permit the voluntary addition of the 2’-FL to infant formula products at a maximum level of 2.4g/L.

“The Australian New Zealand Food Standards Code (the Code) already permits the addition of 2'FL to infant formula products.

"However, this permission does not apply to the applicant's 2ʹ-FL, which has a different source and specifications.

"FSANZ's safety and risk assessment found no safety concerns with the addition of this particular 2′-FL to infant formula products at the level requested,”​ said FSANZ interim CEO Dr Sandra Cuthbert.

The FSANZ develops food standards for both Australia and New Zealand. The public comment will end on Jan 31.

Existing approvals

Other than 2’-FL, another HMO known as Lacto-N-neotetraose (LNnT) has been approved by the FSANZ for use in infant formula products.

The FSANZ had made the approval in Dec 2019 after assessing the applications made by Glycom A/S – a biotech firm based in Denmark and is part of DSM.

The approval has allowed 2’-FL to be added alone or in combination with Lacto-N-neotetraose (LNnT) in infant formula products.

The HMOs were produced via microbial fermentation using E.coli​ K12 production strains SCR6 and MP572.


In Australia, 2’-FL was approved by the Therapeutic Goods Administration (TGA) for use as a prebiotic in dietary supplements​ last year.

The application was made by German functional ingredient supplier BASF and the company was given a two-year market exclusivity status.

Health and nutrition giant H&H then went on to launch Australia’s first kids supplement containing 2’-FL. The ingredient functions as a prebiotic in the product known as ProBOOST + VIT D.

Human milk oligosaccharides have attracted a high level of interest from the health and nutrition industry in recent years.

Japan’s Morinaga Milk Industry pointed out​ the role of HMOs in healthy gut microbiota development while firms such as Nestle and Abbott are studying HMOs’ composition in breastmilk and their benefit for infant growth.

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