Previous expert Consultations convened by FAO/WHO and OECD have recommended that substantial equivalence be an important component in the safety assessment of foods and food ingredients derived from genetically modified plants intended for human consumption (OECD, 1993; FAO, 1996). This concept embodies a science-based approach in which a genetically modified food is compared to its existing, appropriate counterpart. The approach is not intended to establish absolute safety, which is an unattainable goal for any food. Rather, the goal of this approach is to ensure that the food, and any substances that have been introduced into the food as a result of genetic modification, is as safe as its traditional counterpart.
Several countries have used the concept of substantial equivalence as an important component of the safety evaluations of foods and food ingredients derived from genetically modified plants. They have found this approach to be scientifically sound and practical. Nevertheless, there has not been a universal consensus on the application of this concept. This has resulted in criticism that the approach does not provide a sufficient basis for safety and calls for national governments and international bodies to consider alternative approaches. As one example of the increased international focus on foods derived from biotechnology, the agenda of the G 8 meeting of Heads of State and Government scheduled to take place in Okinawa, Japan in July 2000, includes an item on the implications of biotechnology and other aspects of food safety.
FAO and WHO convened this Consultation to evaluate experience gained since the 1996 Joint FAO/WHO Consultation (FAO, 1996) and to assess whether any new scientific information would suggest a need for modifying current approaches for assessing the safety of foods and food ingredients derived from genetically modified plants. This Consultation also provided an opportunity, in the light of recent scientific reports, to review the scientific basis, application, and limitations of the concept of substantial equivalence.
