학술논문
FEMA GRAS assessment of derivatives of basil, nutmeg, parsley, tarragon and related allylalkoxybenzene-containing natural flavor complexes.
Document Type
Academic Journal
Author
Davidsen JM; Flavor and Extract Manufacturers Association, 1101 17th Street, N.W., Suite 700, Washington, D.C, 20036, USA.; Cohen SM; Havlik-Wall Professor of Oncology, Dept. of Pathology and Microbiology, University of Nebraska Medical Center, 983135 Nebraska Medical Center, Omaha, NE, 68198-3135, USA.; Eisenbrand G; University of Kaiserslautern, Germany (Retired), Kühler Grund 48/1, 69126, Heidelberg, Germany.; Fukushima S; Japan Bioassay Research Center, 2445 Hirasawa, Hadano, Kanagawa, 257-0015, Japan.; Gooderham NJ; Dept. of Metabolism, Digestion, Reproduction, Imperial College London, Sir Alexander Fleming Building, London, SW7 2AZ, United Kingdom.; Guengerich FP; Dept. of Biochemistry, Vanderbilt University School of Medicine, Nashville, TN, 37232-0146, USA.; Hecht SS; Masonic Cancer Center and Dept. of Laboratory Medicine and Pathology, Cancer and Cardiovascular Research Building, 2231 6th St, S.E, Minneapolis, MN, 55455, USA.; Rietjens IMCM; Division of Toxicology, Wageningen University, Stippeneng 6708 WE, Wageningen, the Netherlands.; Rosol TJ; Department of Biomedical Sciences, Heritage College of Osteopathic Medicine, Ohio University, 1 Ohio University, Athens, OH, 45701, USA.; Harman CL; Flavor and Extract Manufacturers Association, 1101 17th Street, N.W., Suite 700, Washington, D.C, 20036, USA.; Taylor SV; Scientific Secretary to the FEMA Expert Panel, 1101 17th Street, N.W., Suite 700, Washington, D.C, 20036, USA. Electronic address: staylor@vertosolutions.net.
Source
Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 8207483 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-6351 (Electronic) Linking ISSN: 02786915 NLM ISO Abbreviation: Food Chem Toxicol Subsets: MEDLINE
Subject
Language
English
Abstract
In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a program for the re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavoring ingredients in food. In this publication, tenth in the series, NFCs containing a high percentage of at least one naturally occurring allylalkoxybenzene constituent with a suspected concern for genotoxicity and/or carcinogenicity are evaluated. In a related paper, ninth in the series, NFCs containing anethole and/or eugenol and relatively low percentages of these allylalkoxybenzenes are evaluated. The Panel applies the threshold of toxicological concern (TTC) concept and evaluates relevant toxicology data on the NFCs and their respective constituent congeneric groups. For NFCs containing allylalkoxybenzene constituent(s), the estimated intake of the constituent is compared to the TTC for compounds with structural alerts for genotoxicity and when exceeded, a margin of exposure (MOE) is calculated. BMDL 10 values are derived from benchmark dose analyses using Bayesian model averaging for safrole, estragole and methyl eugenol using EPA's BMDS software version 3.2. BMDL 10 values for myristicin, elemicin and parsley apiole were estimated by read-across using relative potency factors. Margins of safety for each constituent congeneric group and MOEs for each allylalkoxybenzene constituent for each NFC were determined that indicate no safety concern. The scope of the safety evaluation contained herein does not include added use in dietary supplements or any products other than food. Ten NFCs, derived from basil, estragon (tarragon), mace, nutmeg, parsley and Canadian snakeroot were determined or affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients based on an evaluation of each NFC and the constituents and congeneric groups therein.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Drs. Cohen, Eisenbrand, Fukushima, Gooderham, Guengerich, Hecht, Rietjens and Rosol are members of the Expert Panel of the Flavor and Extract Manufacturers Association. Authors Davidsen, Harman and Taylor are employed by Verto Solutions which provides scientific and management support services to FEMA. A full description of the conflict of interest protections and procedures used to ensure that the FEMA Expert Panel decisions are fully objective and based solely on the merits of the available information have been published (Marnett et al., 2013) and are available on the FEMA website at https://www.femaflavor.org/gras#conflict.
(Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Drs. Cohen, Eisenbrand, Fukushima, Gooderham, Guengerich, Hecht, Rietjens and Rosol are members of the Expert Panel of the Flavor and Extract Manufacturers Association. Authors Davidsen, Harman and Taylor are employed by Verto Solutions which provides scientific and management support services to FEMA. A full description of the conflict of interest protections and procedures used to ensure that the FEMA Expert Panel decisions are fully objective and based solely on the merits of the available information have been published (Marnett et al., 2013) and are available on the FEMA website at https://www.femaflavor.org/gras#conflict.
(Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)