为什么果提取物在欧盟只得到部分批准? 对食品创新的监管障碍和政策影响
Urszula Kaim1, Urszula Gawlik2, Katarzyna Lisiecka2
1Department of Bioprocess Engineering, Wrocław University of Economics & Business, St. Komandorska 118-120, 53-345 Wrocław, Poland.
Foods (Basel, Switzerland)
|August 28, 2025
概括
欧盟的监管障碍限制了天然甜味剂僧子果实提取物 (MFE) 的批准. 协调法规和促进行业参与是提高消费者获得MFE和其他天然甜味剂的关键.
科学领域:
- 食品科学与技术
- 监管事务
- 营养生物化学
背景情况:
- 修士水果提取物 (MFE) 是一种天然的无热量甜味剂,具有抗氧化和潜在的代谢益处.
- 虽然在某些地区被认可,但根据新食品法规 (EU) 2015/2283的欧盟法规对MFE的批准造成了重大障碍.
- 只有一个特定的水性MFE获得了欧盟的批准;由于数据缺口和缺乏应用,纯化mogrosides和非水性提取物仍未获得批准.
研究的目的:
- 系统地分析阻碍欧盟修士果提取物 (MFE) 获批的监管障碍.
- 将MFE的欧盟监管地位与其他非热量甜味剂和国际框架进行比较.
- 确定促进MFE授权和促进天然甜味剂创新的建议.
主要方法:
- 欧盟新食品法规 (EU) 2015/2283及相关许可的系统审查.
- 在欧盟范围内对MFE的监管状况进行比较分析.
- 审查美国,英国和中国的监管框架.
主要成果:
- 尽管欧盟批准了18种非热量甜味剂,但监管限制阻碍了MFE的广泛批准.
- 欧盟,英国,爱尔兰,美国和中国对MFE的监管地位存在显著差异.
- 毒理学数据的缺口和行业主导的应用是净化和非水性MFE的主要障碍.
结论:
- 欧盟的监管限制严重限制了果提取物的可用性和创新性.
- 协调法规,利用国际安全评估,鼓励行业合作对于MFE更广泛的欧盟授权至关重要.
- 应对这些监管挑战将使欧洲消费者和工业获得安全,创新和更健康的糖类替代品,符合公共卫生和可持续发展目标.
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