食品添加剂新品种技术评审工作分析研究

Study on the work of new food additive safety evaluation in China

目的针对食品添加剂新品种申报中的常见问题进行汇总分析,对食品添加剂新品种申报和技术评审提出相关建议,有助于食品添加剂新品种技术评审工作更加科学合理、规范。方法通过"卫生行政许可管理系统"统计2010—2019年食品添加剂新品种的申报及评审情况,对常见问题进行分析,提出完善食品添加剂新品种技术评审的建议。结果分别对2010—2019年申报的769项食品添加剂新品种的申报情况和评审结论进行了分析,对受理阶段和技术评审阶段中的常见问题进行了汇总分析,从管理层面对进一步完善申报资料要求和安全性资料要求提出了建议。结论现有食品添加剂新品种管理规定基本能够满足食品添加剂新品种评审的需求,建议进一步细化申报要求、制定申报指南、完善食品添加剂新品种的安全性评估要求。

Objective Summarize and analyze the common issues on new food additive applications,and make suggestions on both processes of submission and evaluation of applications for new food additives,and facilitate scientific,reasonable and standardized evaluation.Methods Use the"health administrative authorization management system"to obtain the statistics of new food additives applied in the year of 2010-2019,analyze the common problems,and put forward suggestions from technical aspects for new food additives.Results By analyzing final decisions of 769 new food additives applied in 2010-2019,common problems in both reception and safety evaluation stage were pointed out.On this basis,suggestions were put forward to further improve dossier requirements and safety data requirements from the management perspective.Conclusion The existing new food additive regulations and requirements can basically meet the needs of the safety evaluation.It is suggested to further refine the application requirements,formulate the application guidelines,and reinforce the safety evaluation requirements of new food additives.