Safety evaluation of substituted thiophenes used as flavoring ingredients

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

Research output: Contribution to journalReview articlepeer-review

12 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)40-59
Number of pages20
JournalFood and Chemical Toxicology
Volume99
DOIs
StatePublished - Jan 1 2017

Bibliographical note

Funding Information:
This work was supported by the Flavor and Extract Manufacturers Association and by the International Organization of Flavor Industries . The Expert Panel of the Flavor and Extract Manufacturers Association is independent but is financially supported by the Flavor and Extract Manufacturers Association. The authors declare that there are no conflicts of interest.

Publisher Copyright:
© 2016 The Authors

Keywords

  • FEMA GRAS
  • Flavoring ingredients
  • Thiophene

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