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

Published

Date: 10/10/2023

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

2′-fucosyllactose (2ʹ-FL) is a non-digestible carbohydrate, or oligosaccharide, found naturally in human milk. It can be used as a nutritive substance in infant formula products at levels consistent with those found in human milk. 

FSANZ CEO Dr Sandra Cuthbert said FSANZ's safety assessment concluded there were no public health and safety concerns associated with the application.

“The applicant's 2′-FL is chemically and structurally identical to the naturally occurring substance present in human milk and other 2′-FL already assessed and permitted by FSANZ," she said.

Dr Cuthbert said while breastfeeding was the recommended way to feed infants, this option was not always available to parents.

“Infant formula products provide a safe and nutritious substitute for human milk where required," she said.

“All commercially produced infant formula products available in Australia and New Zealand must comply with the composition and safety requirements outlined in the Australia New Zealand Food Standards Code."

For more information about the application and to access assessment documents, visit the FSANZ call for comment page. Submissions close 6pm (AEST time) 21 November 2023.

What happens to my feedback?

Submissions will be published to our website as soon as possible after the end of the public comment period.

FSANZ will consider all feedback received through this submission process before deciding on whether to approve the application.

FSANZ's decision will be notified to ministers responsible for food regulation who can ask for a review or agree that the standard should become law.

More information:

Media contact: