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    This publication is the second in a series by the Expert Panel of the Flavor and Extract Manufacturers Association summarizing the conclusions of its third systematic re-evaluation of the safety of flavorings previously considered to be generally recognized as safe (GRAS) under conditions of intended use. Re-evaluation of GRAS status for flavorings is based on updated considerations of exposure, structural analogy, metabolism, pharmacokinetics and toxicology and includes a comprehensive review of the scientific information on the flavorings and structurally related substances. Of the 12 substituted thiophenes reviewed here, 11 were reaffirmed as GRAS based on their rapid absorption, metabolism and excretion in humans and animals; the low estimated dietary exposure from flavor use; the wide margins of safety between the conservative estimates of intake and the no-observed-adverse effect levels; and the lack of significant genotoxic and mutagenic potential. For one of the substituted thiophenes, 3-acetyl-2,5-dimethylthiophene, it was concluded that more detailed exposure information, comparative metabolism studies and comprehensive toxicity data, including an in-depth evaluation of the mechanism of action for any adverse effects observed, are required for continuation of its FEMA GRAS™ status. In the absence of these data, the compound was removed from the FEMA GRAS list. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

    Citation

    Samuel M Cohen, Shoji Fukushima, Nigel J Gooderham, F Peter Guengerich, Stephen S Hecht, Ivonne M C M Rietjens, Robert L Smith, Maria Bastaki, Christie L Harman, Margaret M McGowen, Luis G Valerio, Sean V Taylor. Safety evaluation of substituted thiophenes used as flavoring ingredients. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 2017 Jan;99:40-59

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    PMID: 27836750

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