Assessing the safety of GM foods

Producers of all future GM foods – both domestically produced and imported – must apply to FSANZ to seek approval for the food enter the food supply or be sold in Australia and New Zealand.

In applying, the producer provides information on what the genetic modification is, where the new genetic material came from, how the gene was inserted into the plant, nutritional values to ensure the nutritional value of the food has not changed and tests for toxicity.

As a result a large amount of scientific information is supplied with every application for food safety assessment by FSANZ. All scientific data obtained from the applicant must be generated according to international standards of Good Laboratory Practice in laboratories that are independently audited.

FSANZ supplements this data with information obtained from a variety of other sources, such as peer-reviewed scientific literature, general technical information, independent scientists, other regulator agencies, international bodies and the general community.

To make a safety assessment on GM foods FSANZ requires specific information on:

  1. The identity of host and donor organisms.
  2. Any known pathogenicity in host or donor organisms.
  3. The previous use of host and donor organisms in food production.
  4. The new genetic material that has been introduced through genetic modification:
    • origin, nature, purpose, function
    • method of introduction into the host organism.
  5. The new genetic material in the GM organism:
    • number of complete or incomplete copies present
    • stability.
  6. The new protein in the GM organism:
    • purpose, physical and biological characteristics
    • expression profile (which tissues the protein is found in and when the protein is present).
  7. Potential adverse effects of the new protein, such as allergenicity and toxicity:
    • similarity of new protein to known allergens or toxins
    • physical features that are characteristic of allergens
    • acute toxicity (animal studies).
  8. Composition compared to conventional counterpart - levels of nutrients, anti-nutrients, natural allergens and toxins.
  9. Impact on human health from potential transfer of new genetic material to cells in the human digestive tract.
  10. End uses of the food, including any requirement for processing prior to consumption.
  11. If required, ability of the food to promote typical growth and well being (animal feeding studies).
  12. Any other relevant information.