Division 1.4.3 Information on altered levels of food and feed constituents

This Section shall apply only in the case where the intended or unintended effect of the genetic modification would result in an alteration of the levels of food and feed constituents beyond the natural variation.

To demonstrate the safety of the altered levels of food and feed constituents such as macro- and micro-nutrients, anti-nutrients, and natural toxins as well as other secondary plant metabolites, the applicant shall submit a detailed risk assessment based on the knowledge of the physiological function and/or toxic properties of these constituents.

The result of that risk assessment shall determine if, and to what extent, the applicant shall provide additional toxicological tests to the 90-day feeding study in rodents with whole genetically modified food/feed on selected food and feed constituents.