Food Standards Australia New Zealand (FSANZ) is seeking public comment on an application to approve a new genetically modified source organism to produce a human-identical milk oligosaccharide for use in infant formula products.
2ʹ-fucosyllactose (2ʹ-FL) is a non-digestible carbohydrate naturally present in human milk. It is used as a nutritive substance in infant formula at levels consistent with those found in human milk.
FSANZ’s safety assessment found no public health or safety concerns associated with the applicant’s 2ʹ-FL. The substance is chemically, structurally and functionally the same as the 2ʹ-FL that occurs naturally in human milk and as other 2ʹ-FL ingredients already assessed and approved by FSANZ.
While breastfeeding remains the recommended source of nutrition for infants, a safe and nutritious alternative is essential for those who are not breastfed. All infant formula products sold in Australia must meet the composition and safety requirements set out in the Australia New Zealand Food Standards Code.
These standards apply only in Australia. The New Zealand Government is responsible for maintaining infant formula product regulations in New Zealand.
To comment on the application of genetically modified source organism to produce a human-identical milk in infant formula products, visit the FSANZ Consultation Hub. Submissions close on 18 November 2025.