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Abstract：
Inclusion of alternative methods that replace, reduce, or refine (3R) animal testing within regulatory safety evaluations of chemicals generally faces many hurdles. The goal of the current work is to i) collect responses from key stakeholders involved in food safety evaluations on what they consider the most relevant factors that influence the acceptance and use of 3R methods and to ii) use these responses to formulate activities needed to increase the acceptance and use of 3R methods, particularly for kinetics. The stakeholders were contacted by e-mail for their opinions, asking the respondents to write down three barriers and/or drivers and scoring these by distributing 5 points over the three factors. The main barriers that obtained the highest aggregated scores were i) uncertain predictability 3R methods/lack of validation, ii) insufficient guidance regulators/industry and iii) insufficient harmonization of legislation. The major driver identified was the possibility of 3R methods to provide more mechanistic information. Based on the results, recommendations are given to enhance the acceptance and application of 3R toxicokinetic methods in food safety evaluations. These include steering of regulatory data requirements as well as creating (funding) opportunities for development and validation of alternative methods for kinetics and development of guidances.
摘要：
包括替代方法，reduce,在化学品的监管安全评估中，或完善（3R）动物测试通常面临许多障碍。当前工作的目标是i）收集参与食品安全评估的主要利益相关者对他们认为影响3R方法的接受和使用的最相关因素的回应，以及ii）使用这些回应来制定增加3R方法的接受和使用所需的活动。尤其是动力学。通过电子邮件与利益相关者联系，征求他们的意见，要求受访者写下三个障碍和/或驱动因素，并通过在这三个因素上分配5分来对这些障碍和/或驱动因素进行评分。获得最高综合分数的主要障碍是i)不确定的可预测性3R方法/缺乏验证，ii)监管机构/行业指导不足，iii)立法协调不足。确定的主要驱动因素是3R方法提供更多机械信息的可能性。根据结果,建议加强3R毒物动力学方法在食品安全评价中的接受度和应用。这些措施包括指导监管数据要求，以及为开发和验证动力学和指南开发的替代方法创造（资金）机会。
