Division 1.6.3 Nutritional studies of genetically modified food

The applicant shall determine the necessity and design of nutritional studies on the basis of the introduced trait(s), the outcome of the comparative analysis, and of the 90-day feeding study, where available. Supplementary information regarding the nutritional value may be obtained from comparative growth performance studies conducted with other animal species, such as broiler chickens, addressing the nutritional assessment of genetically modified feed. When nutritional studies are conducted, the control diet(s) shall include the conventional counterpart and where appropriate additional comparator(s). In the case of herbicide tolerant genetically modified plants, the tested material should come from the genetically modified plant exposed to the intended herbicide.

Genetically modified foods modified to provide additional health benefits to the consumer as compared to conventional foods, may benefit specific populations or subpopulations while others may be at risk from the same food. In cases where an altered bioavailability needs to be established and may raise concern for subpopulation(s), the level of the nutrient in the food shall be determined, taking into account all the different forms of the compound. The methods to test for bioavailability shall be selected on a case-by-case basis depending on the nutrient or other constituent, the food containing these constituents, as well as the health, nutritional status and dietary practices of the specific population(s) anticipated to consume the food.