,Food Standards Australia New Zealand (FSANZ) has opened a public consultation on an application to amend the Australia New Zealand Food Standards Code to permit additional human-identical milk oligosaccharides (HiMO) produced from new genetically modified (GM) Escherichia coli BL21 strains for use as optional nutritive substances in infant formula products, together with proposed new maximum permitted levels.
HiMO are non-digestible carbohydrates naturally present in human breast milk and are known to support infant growth and development by helping protect against harmful bacteria, supporting immune function, and promoting beneficial gut microbiota similar to that of breastfed infants.
The Code already permits 3-fucosyllactose (3-FL), lacto-N-tetraose (LNT), 3?-sialyllactose (3?-SL) sodium salt, and 6?-sialyllactose (6?-SL) sodium salt as optional nutritive substances in infant formula. The current application seeks approval for these same HiMO when produced from GM E. coli BL21, a production organism previously assessed by FSANZ. Notably, FSANZ has already approved 2?-fucosyllactose (2?-FL) derived from this GM strain for use in infant formula products.
In addition, the applicant is requesting a 15-month exclusive use permission for each HiMO under its brand and has proposed new maximum levels for these substances, including those already permitted. FSANZs safety assessment found no public health or safety concerns for 2?-FL, 3-FL, 3?-SL sodium salt, and 6?-SL sodium salt at the proposed maximum levels, confirming that HiMO from the new GM sources are chemically, structurally, and functionally equivalent to those naturally found in human milk.
However, FSANZ concluded that safety could not be established for lacto-N-tetraose (LNT) at the maximum level requested, as this level exceeded concentrations naturally present in human milk. As a result, FSANZ has proposed a lower maximum level for LNT in the draft variation to the Code. No numerical maximum limits are specified in the consultation notice, with the exact values detailed in the supporting assessment documents for Application A1339.
FSANZ reiterates that breastfeeding remains the recommended source of infant nutrition, while recognizing the need for safe and nutritionally adequate infant formula for infants who are not breastfed. All infant formula products sold in Australia must comply with the composition and safety requirements set out in the Food Standards Code.
The proposed amendments apply in Australia only, as infant formula regulation in New Zealand is managed separately by the New Zealand Government.
Stakeholders are invited to submit comments via the FSANZ Consultation Hub. Submissions close at 11:59 pm (Canberra time) on 6 March 2026. All feedback received will be reviewed by FSANZ and published following the close of the consultation period.
Consumer News Region