Abstract
In the European Union (EU), genetically modified (GM) food and feed are subject to strict legal requirements. Thus, food and feed products derived from genetically modified organisms (GMO) may only be placed on the market if they have previously undergone a safety assessment. According to the concept of “substantial equivalence,” the safety assessment is centered on the comparison of the GM food and feed with non-GM food and feed that have a so-called history of safe use. The current approach usually comprises a molecular characterization of the genetic modification, agronomic and phenotypic analyses, as well as comparative analyses of nutritional, anti-nutritional, and toxic or allergenic constituents. Depending on identified changes in the composition, further investigations may be necessary to prove that a GMO-derived product is as safe as the non-GM comparator. Irrespective of this, feeding studies in rodents are usually required to account for the possibility of unforeseeable health effects. In the following, the general principles of the human health risk assessment as part of the market authorization process by the example of food and feed derived from GM plants are illustrated, and the current legislation framework on GM food and feed in the EU is summarized.
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Braeuning, A., Broll, H., Eisenreich, A., Menz, J., Niemann, B., Schäfer, B. (2021). Risk Assessment of Genetically Modified Food and Feed. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-36206-4_118-2
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DOI: https://doi.org/10.1007/978-3-642-36206-4_118-2
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