Call for comment on new source of human-identical milk oligosaccharide in infant formula

Published

Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to permit a new genetically modified source organism to produce a human-identical milk oligosaccharide used in infant formula products.  

2ʹ-fucosyllactose (2ʹ-FL) is a non-digestible carbohydrate that naturally occurs in human milk. It is used as a nutritive substance in infant formula products at levels consistent with those found in human milk.  

FSANZ’s safety assessment concluded there were no public health and safety concerns associated with the applicant’s 2ʹ-FL. The 2ʹ-FL is chemically, structurally and functionally the same as the naturally occurring substance found in human milk and other 2ʹ-FL already assessed and permitted by FSANZ.

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 on this application, visit the FSANZ Consultation Hub. Submissions close at 11:59pm (Canberra time) 18 November 2025.

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. 

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