Abstract：
Traditional animal models are increasingly being replaced by new approach methodologies (NAMs) which focus on predicting toxicity of chemicals based on mechanistic data rather than apical endpoint data usually obtained from animal models. Beyond in vitro genetic tests, however, only a handful of NAMs have been successfully implemented in regulatory decision-making processes, mostly in the cosmetics and chemicals sector. Regulatory guidance on food safety testing in many jurisdictions still relies on data obtained from animal studies. This is due to the lack of validated models to predict systemic toxicity, which is essential to develop health-based guidance values for food additives. Other factors limiting the adoption of NAMs into food safety assessment include sector legislation lagging behind scientific progress, and lack of training and expertise to use the new models. While regulatory and industry bodies are working to combat these challenges, more needs to be done before these models can be used as standalone tools for regulatory decision-making. This review summarizes the current state and challenges of regulatory acceptance of NAMs for decision-making, and the efforts by governing bodies and industry to transition from animal testing for food safety assessments.
摘要：
传统的动物模型越来越多地被新方法方法（NAM）所取代，新方法方法专注于基于机械数据而不是通常从动物模型获得的顶端终点数据来预测化学物质的毒性。除了体外基因测试，然而,只有少数NAM在监管决策过程中成功实施，主要是化妆品和化学品行业。许多司法管辖区对食品安全测试的监管指导仍然依赖于动物研究获得的数据。这是由于缺乏经过验证的模型来预测全身毒性，这对于开发基于健康的食品添加剂指导价值观至关重要。限制将NAM纳入食品安全评估的其他因素包括部门立法落后于科学进步，缺乏使用新模式的培训和专业知识。虽然监管和行业机构正在努力应对这些挑战，在这些模型可以用作监管决策的独立工具之前，还需要做更多的工作。这篇综述总结了监管机构接受NAM用于决策的现状和挑战，以及管理机构和行业从动物试验过渡到食品安全评估的努力。
