A1340 - 2′-FL from GM Escherichia coli BL21 (gene donor: Akkermansia muciniphila) for use as a nutritive substance in infant formula products

Overview

FSANZ has assessed an application made by Suzhou Yixi Biotech Co., Ltd. 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. This 2′-FL is sourced from Escherichia coli BL21 containing the gene for alpha-1,2-fucosyltransferase from Akkermansia muciniphila. FSANZ has prepared a draft food regulatory measure. 

FSANZ has provided public notification and welcomes your submission to assist with consideration of the application.

Consultation papers

The consultation documents and a copy of the application can be accessed from the A1340 webpage on the FSANZ website. Please read these documents before preparing your submission.

Why your views matter

FSANZ invites and welcomes public and stakeholder input into standard setting processes. Your views will help us ensure food standards continue to protect public health and safety while supporting an effective, transparent and accountable regulatory framework for industry and food authorities.

How to make a submission

The Consultation Hub is FSANZ's platform for public consultation. We have set up an online survey response form to assist you in completing your submission. Please refer to the consultation documents in preparing your submission. Once you begin, you can save your progress and complete your submission before the consultation closes on 12 February 2026 at 11:59pm Australian Eastern Daylight Savings Time (AEDT).