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Public feedback on substance used in baby formula

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Food Standards Australia New Zealand (FSANZ) is calling for feedback on an application to allow synthesised 3-fucosyllactose (3-FL) to be used in infant formula products.

3-FL is a nutritive substance, a type of human-identical milk oligosaccharide (HiMO), made from a genetically modified source organism.

To provide a safe and nutritious substitute for infants who are not breastfed, FSANZ is collecting comments to ensure commercially produced infant formula products in Australia comply with safety requirements.

FSANZ has found that the synthesised 3-FL alternative is chemically, structurally, and functionally identical to the naturally occurring 3-FL found in human milk. The 3-FL substitute offers potential health benefits for infants, including increased gut bacteria and anti-pathogenic effects.

While FSANZ’s safety assessment found no public health or safety concerns with the proposed use, the Australia New Zealand Food Standards Code requires all safety requirements to be met.

To ensure public safety, applications received will directly support health outcomes by enabling consumers to make more informed purchasing decisions. Rigorous processes will help prevent potential risks and possible recalls in the food sector.

These standards apply in Australia only. The New Zealand Government is responsible for maintaining infant formula product regulations in New Zealand.

Anyone interested in having a say about this application can visit the FSANZ Consultation Hub.

Submissions close on 23 July 2025.

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