FEMA GRAS assessment of natural flavor complexes: Citrus-derived flavoring ingredients. (February 2019)

• Record Type: Journal Article
• Authors: Cohen, Samuel M.; Eisenbrand, Gerhard; Fukushima, Shoji; Gooderham, Nigel J.; Guengerich, F. Peter; Hecht, Stephen S.; Rietjens, Ivonne M.C.M.; Bastaki, Maria; Davidsen, Jeanne M.; Harman, Christie L.; McGowen, Margaret; Taylor, Sean V.
• Is Part Of: Food and chemical toxicology. Volume 124(2019)
• Page Start: 192
• Page End: 218
• Publication Date: 2019-02
• Subjects: Citrus -- Natural flavor complex -- Botanical -- GRAS -- Safety evaluation; CF Correction factor -- CFR Code of federal regulations -- CHO Chinese hamster ovary (cells) -- CYP Cytochrome P450 (enzymes) -- DFG Deutsche Forschungsgemeinschaft -- DTC Decision tree class -- EFFA European Flavour Association -- EFSA European Food Safety Authority -- EMEA European Medicines Agency -- ERS/USDA Economic Research Service/U.S. Department of Agriculture -- FAO Food and Agriculture Organization -- FDA Food and Drug Administration -- FEMA Flavor and Extract Manufacturers Association -- FID Flame ionization detector -- GC Gas chromatography -- GC-MS Gas chromatography-mass spectrometry -- GEF Global evaluation factor -- GLP Good laboratory practice -- GRAS Generally recognized as safe -- IARC International Agency for Research on Cancer -- IFEAT International Federation of Essential Oils and Aroma Trades -- IOFI International Organization of the Flavor Industry -- JECFA Joint FAO/WHO Expert Committee on Food Additives -- JFFMA Japan Fragrance and Flavor Materials Association -- LC-MS Liquid chromatography-mass spectrometry -- LD50 Median lethal dose -- MF Mutant frequency -- MLA Mouse lymphoma assay -- MoS Margin of safety -- MSD Mass spectrometric detector -- NAS National Academy of Sciences -- NFC Natural flavoring complex -- NOAEL No observed adverse effect level -- NTP National Toxicology Program -- OECD Organization for Economic Co-Operation and Development -- OSOM Outer stripe of the outer medulla -- PCI Per capita intake -- SCE Sister chromatid exchange -- SD Sprague-Dawley (rat) -- SKLM Senate Commission on Food Safety (Germany) -- TTC Threshold of toxicological concern -- UDS Unscheduled DNA synthesis (assay) -- USDA U.S. Department of Agriculture -- US-EPA U.S. Environmental Protection Agency -- WHO World Health Organization; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2018.11.052
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavoring ingredients. This publication is the first in a series and summarizes the evaluation of 54 Citrus -derived NFCs using the procedure outlined in Smith et al. (2005) and updated in Cohen et al. (2018) to evaluate the safety of naturally-occurring mixtures for their intended use as flavoring ingredients. The procedure relies on a complete chemical characterization of each NFC intended for commerce and organization of each NFC's chemical constituents into well-defined congeneric groups. The safety of the NFC is evaluated using the well-established and conservative threshold of toxicological concern (TTC) concept in addition to data on absorption, metabolism and toxicology of members of the congeneric groups and the NFC under evaluation. As a result of the application of the procedure, 54 natural flavor complexes derived from botanicals of the Citrus genus were affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavoring ingredients based on an evaluation of each NFC and the constituents and congeneric groups therein. Highlights: Safety evaluation of Citrus -derived flavoring ingredients. Evaluation used procedure for naturals developed by the FEMA Expert Panel. FEMA GRAS status determined/affirmed for 54 Citrus -derived natural flavor complexes.