Published
Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to permit the use of a nutritive substance in infant formula products.
The substance, 3-fucosyllactose (3-FL), is a type of human-identical milk oligosaccharide (HiMO) made using a genetically modified source organism.
The application seeks approval to use the synthesised 3-FL in infant formula products. FSANZ has found it is chemically, structurally and functionally the same as the naturally occurring 3-FL found in human milk.
3-FL offers potential health benefits for infants including increasing beneficial gut bacteria, such as Bifidobacterium, and anti-pathogenic effects.
Our safety assessment found no public health or safety concerns with the proposed use. While breastfeeding is recommended, 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 Australia New Zealand Food Standards 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 about this application, visit the FSANZ Consultation Hub. Submissions close at 11:59pm (Canberra time) Wednesday 23 July 2025.