Call for comment on the addition of four human identical milk oligosaccharides in infant formula

Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to allow four human identical milk oligosaccharides in infant formula products (IFP).​

FSANZ CEO Dr Sandra Cuthbert said the Application is seeking to amend the Australia New Zealand Food Standards Code (the Code) to permit the voluntary addition of the substances: a mixture of 2′-fucosyllactose (2′-FL) and difucosyllactose (DFL) (2′-FL/DFL); lacto-N-tetraose (LNT); 6′-sialyllactose sodium salt (6′-SL); and 3′-sialyllactose sodium salt (3′-SL).

 “Breastfeeding is the recommended way to feed infants however safe and nutritious formula substitutes are needed for infants who are not breastfed,” Dr Cuthbert said.

 “The four substances are naturally present in human milk and their addition to infant formula will support development of products that better reflect the profile of human milk.

 “FSANZ’s safety assessment identified no health or safety concerns with the substances which were found to play a positive role in supporting infant growth and development by promoting a healthy gut microbiota.” 

 If approved, the current infant formula permissions in the Code will be expanded, allowing the four substances to be used individually or in combination up to maximum permitted amounts.

Given the number of human identical milk oligosaccharides the amendment will permit, FSANZ is also proposing to remove an existing prohibition on the use of inulin-type fructans (ITF) and/or galacto-oligosaccharides in IFP with lacto-N-neotetraose (LNnT) to provide regulatory clarity and allow for greater flexibility in combinations of oligosaccharides in IFP.

 The period for comment closes at 6pm (Canberra time) 7 July 2023.

What happens to my feedback?

We will publish all submissions to our website as soon as possible at the end of the public comment period.

All feedback will be considered by FSANZ before making a decision on whether to approve the application/proposal.

Our decision will be notified to ministers responsible for food regulation who can ask for a review or agree to include the amendment in the Code.

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