Part 1.   General Questions

How are genetically modified (GM) foods regulated in Australia and New Zealand?

Food Standards Australia New Zealand (FSANZ) has responsibility for regulating the sale and use of GM foods in Australia and New Zealand.  FSANZ is an independent statutory authority responsible for the development and maintenance of food standards and other food-related regulatory measures.  Food produced or imported for sale into Australia and New Zealand must comply with the food standards that are contained in the Australia New Zealand Food Standards Code (the Code).  GM foods are regulated under Standard 1.5.2 – Food Produced using Gene Technology of the Code. This Standard requires that before any GM food may enter the food supply FSANZ must conduct a pre-market assessment to evaluate the safety of the GM food. This process ensures that approved GM foods are as safe as conventional foods already in the food supply.

What is GM food?

In Standard 1.5.2, GM food is described as “food produced using gene technology” and is defined as “a food which has been derived or developed from an organism which has been modified by gene technology”, where gene technology is defined as “recombinant-DNA techniques that alter the heritable genetic material of living cells or organisms”. GM food is the common name by which we refer to such foods. Such foods may also be referred to as genetically engineered or GE foods, and sometimes biotechnology-derived foods.

What is the process for approving GM foods?

Companies or other bodies that have developed GM foods are required to make an application to FSANZ to have their GM food approved before it may be sold in Australia and New Zealand. As part of that application, companies are required to provide evidence that the GM food is safe for human consumption. Once an application has been received and accepted, FSANZ will then assess the application, which includes undertaking a full safety assessment of the GM food. GM foods that are approved are listed in a table contained in Standard 1.5.2.

How can the public participate in the GM food approval process?  

FSANZ has a transparent and consultative regulatory framework for developing food standards in Australia and New Zealand. Before making a change to the Code, comments are sought from interested members of the public (individuals, organisations) through a public consultation process. Public consultation is mandatory for all food standards matters including applications for GM foods. This system allows members of the public to raise relevant issues that can then be addressed by FSANZ during the assessment process.

As part of the open and transparent system operating at FSANZ, all information and data relating to a GM food is accessible via a public register file. An exception to this occurs only when certain information is given confidential commercial information status by FSANZ. Copies of all assessment reports are also available from the FSANZ website.

Who considers potential environmental risks associated with GM foods?

The potential environmental risks associated with the release of GM organisms (GMOs) into the environment are considered by the Office of the Gene Technology Regulator (OGTR) in Australia, and the Environmental Risk Management Authority (ERMA) in New Zealand. FSANZ does not have the legislative authority to assess matters relating to environmental risks resulting from the release of GMOs into the environment. However, information is shared between FSANZ and these other regulatory agencies in both Australia and New Zealand through Memoranda of Understanding.