国内外政策工具视角下亚硫酸盐类药用辅料及添加剂风险控制措施

Risk Control Measures on Sulfite-based Pharmaceutical Excipients and Food Additives from the Perspective of Domestic and International Policy Tools

目的 分析国内外亚硫酸盐类药用辅料和食品添加剂风险控制政策的使用情况,为优化政策提供参考意见。方法 基于政策工具视角,构建政策工具-风险来源-国家/地区的三维政策分析框架,对纳入政策文件进行分析和编码。结果 共纳入政策文件101份,政策条目编码163条,政策发布年份为2000—2022年。强制性、混合性、自愿性政策工具分别占70.55%、16.56%、12.88%。结论 各类型政策工具内部使用频数差异大,使用结构不均衡。我国对亚硫酸盐类药用辅料缺少针对性管理政策,在食品药品标签无含量说明,有待调整。

Objective To analyze the use of risk control policies for sulfite-based pharmaceutical excipients and food additives in China and abroad,and to provide reference for optimizing policies.Methods Based on the perspective of policy tools,a three-dimensional policy analysis framework of policy tools was constructed,including risk sources,and countries/regions,and the included policy texts were analyzed and coded.Results A total of 101 policy documents with 163 policy item codes were included,which released from 2000 to 2022.In those,compulsory,mixed,and voluntary policy tools accounted for 70.55%,16.56%,and 12.88%,respectively.Conclusions The frequency of policy tools of each type varies greatly,and the structure of used policies is unbalanced.There lack of targeted management policies for sulfite-based pharmaceutical excipients in China.There is no content description of sulfite used in food and drug labels,which is awaited for adjustment.