Call for comment on a new source of 2′-FL in infant formula products

Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to permit 2′-fucosyllactose (2′-FL) produced from a new genetically modified (GM) source organism for use as a nutritive substance in infant formula products.

2ʹ-FL is a non-digestible carbohydrate that naturally occurs in human milk. The Australia New Zealand Food Standards Code (the Code) permits 2ʹ-FL to be used as an optional nutritive substance in infant formula products.

The Code already permits 2′-FL from several GM sources for use in infant formula products. This application seeks to extend existing permissions to include 2′-FL sourced from GM Escherichia coli BL21 containing the gene for alpha-1,2-fucosyltransferase from Akkermansia muciniphila. The application also requests a 15-month exclusive use permission under the brand name ‘Synbilac’.

FSANZ’s safety assessment found no public health or safety concerns. It said the 2′-FL from this new GM source is chemically, structurally and functionally the same as the 2′-FL naturally found in human milk.

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

Submissions are open until 11.59 pm (Canberra time) on 12 February 2026.

To find out more, visit here.

Image credit: iStock.com/Olga Yastremska