The concept of substantial equivalence in safety assessment of foods derived from genetically modified organisms

Foods derived from genetically modified organisms have been on the market in many countries, predominantly in the USA and in Canada, for more than five years now without any reports of adverse effects on human health. Safety assessment criteria have been the subject of early discussions among competent international and national organisations and institutions and have led to the development of guidelines. Common to all guidelines is the principle of substantial equivalence as a reasonable approach to identifying differences between novel foods and their traditional counterparts. In order to safeguard the food supply, differences are subject to further analyses with regards to their impact on human health. There has been a consensus among competent authorities and the scientific community, with respect to food safety, that the placing on the market of novel foods, regardless of whether they are a substantial equivalent or not, is only acceptable if they are as safe as the existing traditional products with which they can be compared. However, the concept of substantial equivalence itself has also been subject to criticism that calls for further discussion.