重新评估neotame (E 961) 作为食品添加剂的使用
EFSA journal. European Food Safety Authority
|July 8, 2025
概括
在对高强度甜味剂尼奥坦 (E 961) 的重新评估中,在允许水平下没有发现安全问题. 制定了新的每日可接受摄入量 (ADI) 10 mg/kg bw,取代了以前的每日 2 mg/kg bw.
科学领域:
- 食品添加剂安全 食品添加剂安全
- 毒理学 毒理学 毒理学
- 营养科学 营养科学
背景情况:
- 酸 (E 961) 是一种制造甜味剂,是N-[N-(3,3-二甲基乙) -l-α-阿斯巴尔提尔] -l-氨1-甲基.
- 它的主要杂质和代谢物是N-[N-(3,3-二甲基) -l-α-阿斯巴提尔] -l-氨 (NC-00751).
- 之前的安全评估是在2007年由EFSA进行的.
研究的目的:
- 重新评估neotame (E 961) 作为食品添加剂的安全性.
- 为了建立一个修订的可接受的每日摄入量 (ADI) 的neotame.
- 为了评估各种人口群体中饮食中对neotame的暴露.
主要方法:
- 来自EFSA (2007) 和文献的可用毒理学研究的综述.
- 对基因毒性,无遗传潜力和其他毒理学终点的评估.
- 基于老鼠慢性和致癌性研究的NOAEL计算ADI.
主要成果:
- 对于neotame (E 961) 没有发现任何基因毒性问题.
- 在现有毒理学研究中测试的最高剂量时没有观察到任何不良影响.
- 根据每天1000mg/kg体重的NOAEL,建立了每天10mg/kg体重的新ADI.
- 饮食暴露估计在所有人口群体和情景中均不超过新的ADI.
结论:
- 在当前允许的和报告的使用水平下,neotame (E 961) 被认为是安全的.
- 已确定的每天10毫克/公斤体重的ADI取代了2007年每天2毫克/公斤体重的ADI.
- 建议包括修订欧盟对新 (E 961) 的规范.
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