Flavor and Extract Manufacturers Association, 1101 17th Street, N.W., Suite 700, Washington, D.C, 20036, USA.
Havlik-Wall Professor of Oncology, Dept. of Pathology and Microbiology, University of Nebraska Medical Center, 983135 Nebraska Medical Center, Omaha, NE, 68198-3135, USA.
Food Chem Toxicol. 2023 May;175:113646. doi: 10.1016/j.fct.2023.113646. Epub 2023 Feb 17.
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 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 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.
2015 年，香精和萃取物制造商协会（FEMA）的专家小组启动了一项计划，对 250 多种用作食品调味成分的天然风味复合物（NFC）的安全性进行重新评估。在本出版物中，是该系列的第十篇，评估了含有高比例至少一种天然存在的烯丙基烷氧基苯成分的 NFC，这些成分被怀疑具有遗传毒性和/或致癌性。在该系列的第九篇相关论文中，评估了含有茴香脑和/或丁子香酚且这些烯丙基烷氧基苯含量相对较低的 NFC。专家组应用毒理学关注阈值（TTC）概念，并评估了 NFC 及其各自的同系物组的相关毒理学数据。对于含有烯丙基烷氧基苯成分的 NFC，将成分的估计摄入量与具有遗传毒性结构警示的化合物的 TTC 进行比较，如果超过 TTC，则计算暴露量（MOE）。使用 EPA 的 BMDS 软件版本 3.2 进行贝叶斯模型平均的基准剂量分析，得出了黄樟素、欧芹酚和甲基丁香酚的 BMDL 值。通过使用相对效力因子进行外推，估算了肉豆蔻醚、白菖烯和欧芹脑的 BMDL 值。确定了每个 NFC 中每个烯丙基烷氧基苯成分的同系物组的安全边际和 MOE，表明不存在安全问题。本安全评估的范围不包括在膳食补充剂或除食品以外的任何产品中的添加使用。十种 NFC，源自罗勒、龙蒿（龙蒿）、肉豆蔻、肉豆蔻、欧芹和加拿大蛇根草，根据对每个 NFC 及其成分和同系物组的评估，被确定或确认为在其预期用作调味成分的条件下通常被认为是安全的（GRAS）。
