Basis for approval of GM foods

Basis for approval of GM foods (The safety assessment process)

FSANZ prepares a detailed report on the safety assessment of each new GM food, covering all the points outlined below. Ingeneral, a GM food is considered safe for human consumption if FSANZ is satisfied of the following:

All new genetic material has been examined in detail.

• Where did the new genetic material come from, what is its function, how was it put into the GM food and how is it arranged within the genetic material of the plant or animal?

The new genetic material stays the same and is passed on in a predictable way from generation to generation.

• Is the new genetic material stably intergrated within the DNA of the GM organism?
• Is the novel trait expressed consistently over a number of generation?

All new proteins have been examined in detail.

• Where and when re the new proteins found in the plant or animal?
• Do they have the expected size, structure and biological activity?

The new proteins are unlikely to be toxic or allergenic.

• Do the new proteins come from living organisms that contain no major toxins or allergens ?
• Are the new proteins dissimilar to known toxins and allergens?
• Do the new proteins lack other physical and biochemical characteristics typical of toxins and allergens?

The new proteins do not cause any detectable toxicity in animal studies.

• When the purified new proteins are given in large doses to rats or mice, are there any adverse effects?

The potential transfer of new genetic material to bacterial cells in the human digestive tract will not have a significant impact on human health.

• Are antbiotic resistance genes present? Is the corresponding anitbiotic used in human or veterinary medicine?
• What would be the health impact if the new genes were to be transferred to bacteria in the human gut?

The composition of the food, including naturally occuring toxins, allergens and antinutrients, is not significant altered compared to the non GM food.

• Is the composition of the food (for example, the proteins, fat, fibre, carbohydrate, amino acids, vitamins, minerals, moisture content, and other biologically acitve molecules) substainlly different from that of the conventional food?
• If so, does the difference found in the GM food affect the safety of the food, and will it make the food less nutritious or healthy?