The safety evaluation of food flavoring substances: the role of genotoxicity studies
Nigel J. Gooderham, Samuel M. Cohen, Gerhard Eisenbrand, Shoji Fukushima, F. Peter Guengerich, Stephen S. Hecht, Ivonne M.C.M. Rietjens, Thomas J. Rosol, Maria Bastaki, Matthew J. Linman, Sean V. Taylor
Abstract
genotoxicity studies during the course of its ongoing safety evaluations of flavorings. The adherence of genotoxicity studies to standardized protocols and guidelines, the biological relevance of the results from those studies, and the human relevance of these studies are all important considerations in assessing whether the results raise specific concerns for genotoxic potential. The Panel evaluates genotoxicity studies not only for evidence of genotoxicity hazard, but also for the probability of risk to the consumer in the context of exposure from their use as flavoring substances. The majority of flavoring substances have given no indication of genotoxic potential in studies evaluated by the FEMA Expert Panel. Examples illustrating the assessment of genotoxicity data for flavoring substances and the consideration of the factors noted above are provided. The weight of evidence approach adopted by the FEMA Expert Panel leads to a rational assessment of risk associated with consumer intake of flavoring substances under the conditions of use.