[en] In both the United States and the European Union the fundamental concept for the food and environmental safety assessment of products derived from modern biotechnology is the concept of substantial equivalence, where the novel product is compared to a closely related product that has an accepted standard of safety. The concept was initially introduced by the World Health Organization (WHO) and the United Nations Food and Agricultural Organization (FAO) (WHO, 1991). In 1992, the Organisation for Economic Cooperation and Development (OECD) elaborated the underlying concept and introduced the term “substantial equivalence” (OECD, 1993). The application of substantial equivalence has since been reinforced by international expert bodies (WHO, 1995; FAO, 1996) and has been adopted by regulatory authorities in most countries.
