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ernatives (nontargeted approach). This is of particular interest for plants with extensive modifications of the genome (second generation of geically modified foods) where chances of the occurrence of unintended effects may increase. Animal studies are deemed necessary to obtain information on the characteristics of newly expressed proteins, analogous to the conventional toxicity testing of food additives. Testing of whole foods may be considered if relevant changes in position may have taken place in addition to the expected ones。 key nutrients。 and the 5 role of the new food in the diet . In the third scenario, the novel crop or food would be not substantially equivalent with a traditional counterpart, and a casebycase assessment of the new food must be carried out according to the characteristics of the new product. FAO( short for Food and Agriculture Organization) and WHO(World Health Organization) have been anizing workshops and consultations on the safety of GMOs since 1990. At the Joint FAO/WHO Consultation in 1996 (FAO/WHO, 1996) it was remended that the safety evaluation should be based on the concept of substantial equivalence, which is ‘a(chǎn) dynamic, analytical exercise in the assessment of the safety of a new food relative to an existing food’. The following parameters should be considered to determine the substantial equivalence of a geically modified plant: molecular characterization。 potential for gene transfer from geically modified foods to human/animal gut flora。 or (iii) not equivalent at all. A positional analysis of key ponents, including key nutrients and natural toxicants, is the basis of assessment of substantial equivalence, in addition to phenotypic and agronomic characteristics of the geically modified plant. In the first scenario, no further specific testing is required as the product has been characterized as substantially equivalent to a traditional counterpart whose consumption is considered to be safe, for example, starch from potato. In the second scenario, substantial equivalence would apply except for the inserted trait, and so the focus of the safety testing is on this trait, for example, an insecticidal protein of geically modified tomato. Safety tests include specific toxicity testing according to the nature and function of the newly expressed protein。 Figure 1). The concept of substantial equivalence is part of a safety evaluation framework based on the idea that existing foods can serve as a basis for paring the properties of a geically modified food with the appropriate counterpart. The existing food supply is considered to be safe, as experienced by a long history of use, although it is recognized that foods may contain many antinutrients and toxicants which, at certain levels of consumption, may induce deleterious effects in humans and animals. Application of the concept is not a safety assessment per se, but helps to identify similarities and potential differ