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在FDA通知的GRAS确定中对致癌性评估的回顾性分析

Khatera Rahmani¹, Yen-Ching Wu², Neil R Buck³

¹Mars Incorporated, McLean, VA, USA.

Human & experimental toxicology

|July 25, 2024

概括

评估食品物质的致癌潜力需要适应性安全评估. 这项研究回顾了美国食品和药物管理局 (US FDA) 一般公认的安全 (GRAS) 通知,以了解这些对各种食品成分的方法.

科学领域:

食品安全评估食品安全评估
毒理学毒理学毒理学
监管科学监管科学

背景情况:

现有标准化框架用于评估药品和农业化学品的致癌潜力.
食品物质安全评估采用全面的,特定物质的方法来评估致癌性.
美国食品和药物管理局 (US FDA) 维护一个总体公认安全 (GRAS) 通知的数据库.

研究的目的:

追溯评估用于评估GRAS通知中的食品物质致癌潜力的方法.
在不同类别的食品物质中识别致癌性评估方法的模式.
为食品物质提出一种可适应的安全评估方法,与其他产品部门进行并行.

主要方法:

对向美国FDA提交的公开可用的GRAS通知进行追溯审查.
分析用于致癌性评估的方法,包括基因毒性研究,两年生物测试和其他临床前动物研究.
食品物质的分类,以确定安全评估方法中的模式.

主要成果:

不同的安全评估方法是必要的,适应每个食品物质的独特性质.
所有审查的GRAS通知中的数据支持评估物质的安全性结论.
确定了用于支持各种食品物质安全性的共同数据类型.

结论:

评估食品中的致癌潜力需要考虑所有可用的数据,并在必要时生成进一步的数据.
食品物质的复杂性需要灵活,科学支持的安全评估方法.
这些发现表明,对食品物质安全性评估采取统一的方法,与其他行业的做法保持一致.

关键词:

食品毒理学食品毒理学一般被认为是安全的.化学致癌发生是化学致癌发生.监管毒理学监管毒理学

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