作为食品添加剂的阿塞苏尔法姆K (E 950) 的重新评估
EFSA journal. European Food Safety Authority
|May 1, 2025
概括
作为食品添加剂的阿塞苏尔法 (E 950) 的重新评估没有发现任何基因毒性问题. 确定了每日可接受摄入量 (ADI) 15 mg/kg的更新,取代了以前的9 mg/kg的ADI.
科学领域:
- 食品安全 食品安全
- 毒理学 毒理学 毒理学
- 化学分析 化学分析
背景情况:
- 硫酸 (E 950) 是欧盟广泛使用的人造甜味剂.
- 以前的安全评估和授权需要根据新的科学数据重新评估.
- 了解阿硫K的稳定性和潜在降解产物对于食品安全至关重要.
研究的目的:
- 重新评估阿塞苏尔法 (E 950) 作为食品添加剂的安全性.
- 审查现有的授权,科学评估,以及关于乙硫K.新数据.
- 为了建立一个修订的可接受的每日摄入量 (ADI) 乙硫K.
主要方法:
- 对现有的授权和科学评估进行全面审查.
- 对新科学数据的分析,包括基因毒性研究和in silico评估.
- 对人类和动物研究的系统评估,以确定有害影响的参考点.
主要成果:
- 阿硫K (E 950) 在大多数条件下稳定,但在低pH和高温下降解.
- 对于乙硫K或其降解产品,没有发现遗传毒性问题.
- 对杂质5-chloro-acesulfame确定了潜在的基因毒性问题,并推了限制值或进一步的数据.
- 修订了每天15毫克/体重 (bw) 千克的ADI,取代了以前每天9毫克/体重 (bw) 的ADI.
- 所有人口群体的估计暴露水平一般低于修订后的ADI.
结论:
- 硫酸 (E 950) 在确定的每日摄入量 (ADI) 时被认为是安全的,没有遗传毒性问题.
- 提出了关于杂质限值和对Acesulfame K.欧盟规格的潜在修订的建议.
- 修订后的ADI确保在欧盟内继续安全使用阿硫K作为食品添加剂.
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