SummaryInternational consensus has been reached on the principles regarding evaluation of the food safety of genetically modi®ed plants. The concept of substantial equivalence has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for comparing the properties of genetically modi®ed foods with the appropriate counterpart. Application of the concept is not a safety assessment per se, but helps to identify similarities and differences between the existing food and the new product, which are then subject to further toxicological investigation. Substantial equivalence is a starting point in the safety evaluation, rather than an endpoint of the assessment. Consensus on practical application of the principle should be further elaborated. Experiences with the safety testing of newly inserted proteins and of whole genetically modi®ed foods are reviewed, and limitations of current test methodologies are discussed. The development and validation of new pro®ling methods such as DNA microarray technology, proteomics, and metabolomics for the identi®cation and characterization of unintended effects, which may occur as a result of the genetic modi®cation, is recommended. The assessment of the allergenicity of newly inserted proteins and of marker genes is discussed. An issue that will gain importance in the near future is that of postmarketing surveillance of the foods derived from genetically modi®ed crops. It is concluded, among others that, that application of the principle of substantial equivalence has proven adequate, and that no alternative adequate safety assessment strategies are available.

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