A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) for use in infant formula products.

Overview

FSANZ has assessed an application made by Cataya Bio (Shanghai) Company Limited to permit a new genetically modified (GM) source organism for the production of 2′-fucosyllactose (2′-FL) to be used as a nutritive substance in infant formula products. The applicant’s 2′-FL is sourced from Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum. 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 A1334 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 18 November 2025 at 11:59pm Australian Eastern Daylight Savings Time (AEDT).