根据REACH的最后手段要求:从原则到实践
Donna S Macmillan1, Anders Bergqvist2, Eleanor Burgess-Allen3
1Humane Society International/Europe, Av. des Arts 50, 1000, Bruxelles, Belgium.
Regulatory toxicology and pharmacology : RTP
|December 24, 2023
概括
根据REACH规定,对化学品安全进行动物试验并不总是最后的手段. 本文确定了阻碍非动物方法的六个问题,并为欧盟委员会和注册人提出建议.
科学领域:
- 化学安全评估 化学安全评估
- 监管科学是一种监管科学.
- 毒理学和生态毒理学
背景情况:
- 欧盟的REACH法规要求保护人类健康和环境免受化学风险的影响.
- "REACH"第25条规定,动物试验只能作为最后的手段.
- 目前的做法通常依赖于动物研究来满足标准信息要求,尽管该法规的意图.
研究的目的:
- 为了说明REACH规定的动物试验不仅仅是最后的手段的情况.
- 确定阻碍采用非动物试验方法的系统性问题.
- 提出建议,以维护化学安全评估中的"最后手段"原则.
主要方法:
- 在REACH中分析现有数据和监管流程.
- 确定和分类六个关键问题,这些问题有助于不遵守"最后手段"原则.
- 为监管机构和化学品注册机构制定建议.
主要成果:
- 确定了六个总体问题:不接受现有数据 (动物和非动物),不接受交叉阅读,不灵活的行政流程,冗余测试,尽管存在动物福利问题,但仍进行测试,以及仅用于化品成分的测试.
- 实例表明,当有替代方案时,动物试验经常被进行.
- 无动物安全评估 (AFSA) 合作强调了这些障碍.
结论:
- 目前的REACH实施并不始终遵循动物试验的"最后手段"原则.
- 解决已识别的问题对于保护人类健康和环境而最大限度地减少动物使用至关重要.
- 建议建议方便采用非动物方法,并确保真正遵守REACH第25条.
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