FSANZ Regulatory Updates: Cataya Bio’s 2'-FL Completes Codex Amendment

According to the Amendment No. 250 to the Australia New Zealand Food Standards Code published by the Food Standards Australia New Zealand (FSANZ) on June 9, 2026, several standards and schedules of the Australia New Zealand Food Standards Code have been revised.

Proposal A1334 - Use of 2'-fucosyllactose (2′-FL) derived from genetically modified Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) in infant formula products

FSANZ has assessed an application made by Cataya Bio (Shanghai) Company Limited to amend the Australia New Zealand Food Standards Code to permit the use of 2′-fucosyllactose produced from a genetically modified source organism, Corynebacterium glutamicum containing the gene for alpha-1,2-fucosyltransferase from Corynebacterium urealyticum, as a nutritive substance in infant formula products.

The corresponding amendments cover the compositional requirements, relevant definitions, purity requirements, and the schedule for genetically modified foods for infant formula products. Previously, FSANZ had approved HMO ingredients for infant formula, such as 3-FL (3-fucosyllactose) approved in January 2026.

CIRS suggests that infant formula companies can assess the feasibility of using 2′-FL derived from genetically modified Corynebacterium glutamicum as an allowed ingredient based on the new regulations. They should evaluate whether existing product labels, technical documents, and registration materials need to be updated and timely adjust their market access strategies for Australia and New Zealand.

About CIRS 

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.