The pre-market safety assessment of foods derived from genetically modified crops is carried out according to the consensus approach of "substantial equivalence", in other words: the comparative safety assessment. Currently, the safety assessment of genetically modified foods is harmonized at the international level. The starting point of the assessment is the comparison of a genetically modified product with an appropriate counterpart. Based upon the differences thus identified, it is decided what further information is needed. Recent developments pertaining to the issues that are commonly assessed are discussed, including compositional analysis, allergenicity, toxicity, gene transfer, and unintended effects. The International Life Sciences Institute, for example, has compiled a database with compositional background data from field-tested crops. Prediction of allergenicity by bioinformatic methods has been the subject of some studies, which sought to refine the current methodologies. Based on in vitro and in vivo studies, the UK Food Standards Agency concluded that there was an extremely low risk of gene transfer from biotech crops during digestion. With regard to toxicity testing, the applicability of biomarkers to animal models is currently investigated. To screen for unintended effects, holistic profiling techniques are developed that can supplement current targeted analytical methodologies. While it is recognized that the current approach has been sufficient to assess the current generation of biotech crops, the assessment of future crops with more complicated modifications may necessitate the use of additional tools. To this end, enabling methodologies are developed within EU research projects that are brought together in the ENTRANSFOOD thematic network.
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