FSANZ Released New Guidance Clarifying the Definitions of GM Food

The Food Standards Australia New Zealand (FSANZ) has issued updated guidance clarifying the definitions of Genetically Modified (GM) Food and Novel DNA under the Australia New Zealand Food Standards Code (the Code). The guidance also includes practical examples to help food businesses determine whether their products fall within the definition of GM food.

The Guidance is used to:

• Explains how the definitions of genetically modified food and novel DNA in the Australia New Zealand Food Standard Code (the Code) may apply. 
• Supports consistent interpretation of those definitions by food developers and regulatory agencies.

Four Categories of Foods Classified as GM Foods

Under the Code, genetically modified food means a food that:

(a) is any of the following:

(i) an organism that contains novel DNA;

(ii) food derived from an organism that contains novel DNA;

(iii) cells that contain novel DNA;

(iv) food derived from cells that contain novel DNA;

(b) is not any of the following:

(i) a substance used as a food additive;

(ii) a substance used as a processing aid;

(iii) a substance used to:

(A) support the growth and viability of cells during cell culture; or

(B) process cells during cell culture;

(iv) food that is derived from part of a grafted plant, where that part does not contain novel DNA or novel protein;

(v) food derived from a null segregant.

Foods and substances that are excluded from the GM food definition

The updated definitions also specify several exemptions from the GM food definition:

• Substance intended for use as a food additive or processing aid
• Substance used to support the growth and viability of cells, or to process
• Food derived from part of a grafted plant that does not contain novel DNA or novel protein
• Food derived from null segregant

These exemptions are particularly significant for products developed using new breeding techniques. Developers should retain sufficient technical documentation to demonstrate that their products satisfy the relevant exemption criteria.

CIRS Summary

The updated guidance highlights an important regulatory principle: GM food classification is based primarily on the origin of the food and the production process, rather than solely on whether novel DNA is present in the final product. Accordingly, developers of foods produced using gene editing, synthetic biology, precision fermentation, or cell-culture technologies should carefully evaluate whether their products meet the definition of GM food by considering the source materials, production organisms or cells, and manufacturing process. Early regulatory assessment and compliance planning will be essential for successful market access in Australia and New Zealand.

What CIRS Can Do for You

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, and 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% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 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.

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