对美国食品及药物管理局通报的 GRAS 决定中的致癌性评估进行回顾性分析。

Khatera Rahmani, Yen-Ching Wu, Neil R Buck, Alexandria Lau, Paul R Hanlon
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引用次数: 0

摘要

在数十年研究的基础上,为规范制药和农用化学品行业的致癌可能性评估,制定了相关框架。在对食品物质进行安全评估时,也会使用针对每种物质的独特综合方法来评估致癌性。为了更好地了解这些方法,我们对美国食品和药物管理局(US FDA)公开的公认安全物质(GRAS)数据库进行了回顾性评估。对这些 "公认安全 "通知(GRNs)中包含的数据进行了审查,以了解用于评估致癌可能性的方法(遗传毒性研究、2 年生物测定、其他临床前动物研究),从而找出可帮助了解不同类别食品物质如何进行评估的模式。虽然需要采用不同的安全评估方法来适应独特的食品物质,但所有通知中的数据都支持安全结论。对食品物质致癌性的评估必须考虑所有可用数据,包括确定何时需要生成更多数据以支持评估。由于食品中所用物质的复杂性,从确定的化学实体到微加工农产品再到活微生物,对食品物质进行安全性评估的方法必须能够适应最相关的、有科学依据的方法。本文阐述了支持不同类型食品物质安全性的常用数据,并提出了其他产品部门所熟悉的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Retrospective analysis of carcinogenicity assessments within FDA-notified GRAS determinations.

Frameworks have been developed to standardize the assessment of carcinogenic potential in the pharmaceutical and agrochemical industries, building upon decades of research. Carcinogenicity is also evaluated during the safety evaluation of food substances, using a comprehensive approach unique to each substance. To better understand these approaches, a retrospective assessment was conducted on the publicly available database of substances notified to the United States Food and Drug Administration (US FDA) as being Generally Recognized As Safe (GRAS). The data contained within these GRAS notifications (GRNs) were reviewed for the methods used to evaluate carcinogenic potential (genotoxicity studies, 2-year bioassays, other pre-clinical animal studies) to identify patterns that could provide an understanding of how this assessment has been conducted for different categories of food substances. While different approaches to the safety evaluation were required to adapt to the unique food substances, the data in all notifications supported the conclusion of safety. The evaluation of food substances for carcinogenic potential must consider all available data, including identifying the need for when more data must be generated to support an evaluation. Due to the complexity of substances used in food, ranging from defined chemical entities to minimally processed agricultural commodities to live microorganisms, the approach to conducting the safety evaluation of food substances must be able to adapt to the most relevant scientifically supported approach. This paper illustrates the data commonly used to support the safety of different types of food substances and proposes an approach familiar to other product sectors.

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