All genetically modified (GM) foods intended for sale in Australia and New Zealand must undergo a safety evaluation by Food Standards Australia New Zealand (FSANZ). FSANZ will not approve a GM food unless it is safe to eat.
What are GM foods?
People have been manipulating the genetic make-up of plants and animals for countless generations using traditional cross breeding. This involves selecting plants and animals with the most desirable characteristics (e.g. disease resistance, high yield, good meat quality) for breeding the next generation. These desirable characteristics arose from naturally occurring variations in the genetic composition of individual plants or animals.
Today’s techniques of genetic modification – called gene technology – provide new ways of identifying particular characteristics and transferring them between living organisms. For example, it is now possible to make a copy of a particular gene from the cells of a plant, animal or microbe, and insert the copy into the cells of another organism to give a desired characteristic. Because the resulting plants, animals or microbes have had their genetic material altered in some way, they are commonly referred to as ‘genetically modified’ or ‘GM’ organisms. Foods derived from genetically modified organisms are called ‘GM foods’. Most of the GM foods produced so far have been obtained from GM plants. Some examples of GM foods are corn plants with a gene that makes them resistant to insect attack, or soybeans with a modified fatty acid content that makes the oil better suited for frying. Developments are also underway to produce plants that use less water to grow, and so make them more suitable for changing climatic conditions, that is, drought-tolerant crops.
How does the government regulate GM foods?
In Australia, the Office of the Gene Technology Regulator (OGTR) oversees the development and environmental release of GM organisms under the Gene Technology Act 2000. Most dealings with GM organisms must be licensed, and licences will not be issued unless the OGTR is satisfied that any risks posed can be managed in such a way as to protect the health and safety of people and to protect the environment.
In New Zealand, similar functions are undertaken by the Environmental Protection Authority, under the Hazardous Substances and New Organisms (HSNO) Act 1996. If the GM organism will be used to produce food, FSANZ will also determine if that food is safe for people to eat.
GM foods are regulated under Standard 1.5.2 – Food produced using Gene Technology, contained in the Australia New Zealand Food Standards Code (the Code). The standard (an enforceable regulation) has two provisions – mandatory pre-market approval (including a food safety assessment) and mandatory labelling requirements. This standard ensures that only assessed and approved GM foods enter the food supply. Anyone seeking to amend the Codeto include a new GM food under Standard 1.5.2 should refer to the Application Handbook .
Details on FSANZ' s assessments of GM foods and current approvals can be found here.
How does FSANZ assess the safety of GM foods?
Because GM foods are relatively new to the food supply, regulators take a cautious approach when assessing their safety for human consumption.
FSANZ carries out safety assessments on a case-by-case basis, which means each new genetic modification is assessed individually for its potential impact on the safety of the food. We compare the GM food with a similar, commonly eaten conventional food from a molecular, toxicological, nutritional and compositional point of view. The aim is to find out if there are any differences between the GM food and its conventional counterpart, which we already know to be safe to eat.
For example, a new GM corn variety will be compared to existing conventional (non-GM) corn varieties. Any differences that are detected are then examined to see if they will raise any safety concerns. If the genetic modification causes an unexpected effect in the food, such as increasing its allergenicity or toxicity, it will not be approved. To date, we have identified no safety concerns with any of the GM foods that we have assessed. Other national regulators who have independently assessed the same GM foods have reached the same conclusions.
For a detailed description of the process FSANZ uses to assess the safety of GM foods, please refer to the FSANZ Guidance Document: Safety Assessment of Genetically Modified Foods.
Does FSANZ require animal feeding studies?
Not routinely, although we acknowledge there may be future GM foods where the results of animal feeding studies may be useful and, in those cases, we may require such studies. FSANZ considers that a scientifically-informed comparative assessment of GM foods with their conventional counterparts can generally identify any potential adverse health effects or differences requiring further evaluation. For most GM foods, animal studies are unlikely to contribute any further useful information to the safety assessment and therefore are not warranted. FSANZ convened an expert panel in June 2007 to specifically consider the question of whether animal feeding studies are necessary to determine the safety of GM foods. The conclusions and recommendations from the expert panel are available here .
Does FSANZ commission its own scientific studies?
No. It is the responsibility of companies that have developed GM foods to demonstrate the safety of that food and to supply FSANZ with the raw data from scientific studies to prove this. The data must be obtained using sound scientific methods and be collected according to strict quality control criteria. This procedure is no different to that used for new chemicals and drugs and is standard practice for standards-setting agencies like FSANZ internationally. FSANZ experts review the scientific information and form their own conclusions from the results of the studies. We can, and do, request companies to undertake additional studies, where necessary.
Labelling of GM foods
FSANZ response to studies