对三种烟雾调味原始产品的人类健康风险评估
G Brorby1, A Franzen2, C Thompson3
1ToxStrategies, San Rafael, CA, United States.
概括
安全性评估证实,三种烟雾调味原始产品 (SFPP) 是安全的. 广泛的测试显示没有基因毒性,生殖性或亚慢性毒性风险,支持它们作为食物吸烟替代品的使用.
科学领域:
- 食品科学与技术 食品科学与技术
- 毒理学 毒理学 毒理学
- 监管科学 监管科学
背景情况:
- 烟雾调味原始产品 (SFPPs) 需要每10年强制性安全重新授权.
- 欧洲食品安全局 (EFSA) 的指导方针规定了安全评估过程.
- 之前的评估确定了SFPP的食品应用安全性.
研究的目的:
- 根据EFSA的10年重新授权任务,重新评估三种SFPP的安全性.
- 评估基因毒性,生殖/发育毒性和次慢性毒性.
- 为了确定SFPP是否仍然安全继续使用作为传统食品吸烟的替代品.
主要方法:
- 对体内基因毒性,生殖/发育查和次慢性毒性进行了经合组织指南研究.
- 使用现有数据和in silico方法评估单个成分的基因毒性 (每 SFPP 约50),使用现有数据和in silico方法.
- 通过微核和转基因动物试验评估整个混合物的基因毒性.
- 对整个混合物进行生殖/发育查和90天的亚慢性毒性测试.
- 使用EFSA的DietEx模型估计的人类暴露,根据市场份额进行调整.
主要成果:
- 在预期使用条件下,对于单个成分没有发现基因毒性风险.
- 整个混合物的基因毒性测定在高剂量 (高达10,234 mg/kg体重/天) 时是负的.
- 生殖/发育查和亚慢性毒性研究产生了负面结果.
- 最低的观察到的不良影响水平 (NOAELs) 在785-1367 mg/kg体重/天之间.
- 安全边际 (2000-4700年) 显著超过了EFSA的300个目标.
结论:
- 安全评估支持继续授权三个SFPPs.
- 据估计,SFPPs具有良好的安全性,在估计的人类暴露水平下不构成重大健康风险.
- 这些SFPP被验证为传统食品吸烟方法的安全替代品.
关键词:
基于组件的组件.欧洲粮食安全局 (EFSA) 在基因毒性 基因毒性安全的边缘安全的边缘.风险评估 风险评估 风险评估安全的安全的安全的安全的安全.烟雾调味剂 烟雾调味剂有毒性 有毒性整体混合物 整体混合物更多相关视频
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