Department of Surgery and Cancer, Imperial College, London, UK.
Havlik-Wall Professor of Oncology, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, NE, USA.
Crit Rev Toxicol. 2020 Jan;50(1):1-27. doi: 10.1080/10408444.2020.1712589. Epub 2020 Mar 12.
The Flavor and Extract Manufacturers Association (FEMA) Expert Panel relies on the weight of evidence from all available data in the safety evaluation of flavoring substances. This process includes data from genotoxicity studies designed to assess the potential of a chemical agent to react with DNA or otherwise cause changes to DNA, either or . The Panel has reviewed a large number of and genotoxicity studies during the course of its ongoing safety evaluations of flavorings. The adherence of genotoxicity studies to standardized protocols and guidelines, the biological relevance of the results from those studies, and the human relevance of these studies are all important considerations in assessing whether the results raise specific concerns for genotoxic potential. The Panel evaluates genotoxicity studies not only for evidence of genotoxicity hazard, but also for the probability of risk to the consumer in the context of exposure from their use as flavoring substances. The majority of flavoring substances have given no indication of genotoxic potential in studies evaluated by the FEMA Expert Panel. Examples illustrating the assessment of genotoxicity data for flavoring substances and the consideration of the factors noted above are provided. The weight of evidence approach adopted by the FEMA Expert Panel leads to a rational assessment of risk associated with consumer intake of flavoring substances under the conditions of use.
风味和提取物制造商协会（FEMA）专家小组依靠所有可用数据的证据权重来评估调味物质的安全性。这一过程包括来自遗传毒性研究的数据，旨在评估化学物质与 DNA 反应的潜力或其他导致 DNA 变化的潜力。在对调味剂进行持续的安全性评估过程中，小组审查了大量的遗传毒性和非遗传毒性研究。遗传毒性研究遵循标准化方案和指南、这些研究结果的生物学相关性以及这些研究对人类的相关性，都是评估结果是否对遗传毒性潜力提出具体关注的重要考虑因素。小组不仅评估遗传毒性研究是否存在遗传毒性危害的证据，还评估在作为调味物质使用时接触对消费者的风险概率。在 FEMA 专家小组评估的研究中，大多数调味物质没有表现出遗传毒性的可能性。提供了一些例子来说明对调味物质遗传毒性数据的评估，并考虑了上述因素。FEMA 专家小组采用的证据权重方法导致了对在使用条件下消费者摄入调味物质相关风险的合理评估。
