Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to permit 2′-fucosyllactose (2′-FL) produced from a new genetically modified (GM) source organism for use as a nutritive substance in infant formula products.
2ʹ-FL is a non-digestible carbohydrate that naturally occurs in human milk. The Australia New Zealand Food Standards Code (the Code) permits 2ʹ-FL to be used as an optional nutritive substance in infant formula products. Evidence shows it can support infant growth and development by helping to protect against harmful bacteria and promoting beneficial gut microorganisms similar to those of breastfed infants.
The Code already permits 2′-FL from several GM sources for use in infant formula products. This application seeks to extend existing permissions to include 2′-FL sourced from GM Escherichia coli BL21 containing the gene for alpha-1,2-fucosyltransferase from Akkermansia muciniphila. The application also requests a 15-month exclusive use permission under the brand name ‘Synbilac’.
Our safety assessment found no public health or safety concerns. The 2′-FL from this new GM source is chemically, structurally and functionally the same as the 2′-FL naturally found in human milk.
While breastfeeding is recommended as the best 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) 12 February 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: A1340 - 2'-FL from GM Escherichia coli BL21 (gene donor: Akkermansia muciniphila) for use as a nutritive substance in infant formula products
- Infant formula products
Media contact
- 0401 714 265 (Australia)
- media@foodstandards.gov.au