Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to permit human-identical milk oligosaccharides (HiMO) produced from new genetically modified (GM) source organisms for use as nutritive substances in infant formula products at new maximum amounts.
HiMO are non-digestible carbohydrates that naturally occur in human milk. The Australia New Zealand Food Standards Code (the Code) permits HiMO to be used as optional nutritive substances in infant formula products. Evidence shows they can support infant growth and development by helping protect against harmful bacteria, supporting immune function and promoting the development of beneficial gut microorganisms similar to those 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 nutritive substances in infant formula products. This application seeks to amend the Code to include 3-FL, LNT, 3′-SL sodium salt and 6′-SL sodium salt sourced from GM strains of Escherichia coli BL21 in infant formula products.
FSANZ has previously assessed and approved the applicant’s 2′-fucosyllactose (2′-FL) produced from GM E. coli BL21, for use as a nutritive substance in infant formula products.
The application also requests a 15-month exclusive use permission for each HiMO under the applicant’s brand and proposes new maximum amounts for these HiMO and others already permitted for use in infant formula products.
Our 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 levels. HiMO from these new GM sources are chemically, structurally and functionally the same as the HiMO naturally found in human milk. However, safety could not be established for LNT at the maximum level (ML) requested, as this level exceeded naturally occurring amounts. A lower ML for LNT has therefore been proposed in the draft variation.
While breastfeeding is recommended as the primary source of nutrition for infants, a safe and nutritious substitute for breast milk is needed for infants who are not breastfed. All commercially produced infant formula products available in Australia must comply with the composition and safety requirements outlined in the Code.
These standards apply in Australia only. The New Zealand Government is responsible for maintaining infant formula product regulations in New Zealand.
To have your say on this application, visit the FSANZ Consultation Hub. Submissions close at 11.59pm (Canberra time) 6 March 2026.
What happens to my feedback?
FSANZ will consider all feedback received through this submission process before deciding on whether to approve the application.
Submissions will be published to our website as soon as possible at the end of the public comment period.
More information
- How to make a submission
- Read the assessment documents: A1339 - 2′-FL, 3-FL, LNT, 3′-SL, and 6′-SL from GM Escherichia coli BL21 for use as nutritive substances in infant formula products
- Infant formula products
Media contact
- 0401 714 265 (Australia)
- media@foodstandards.gov.au