部分国家和地区保健食品类似产品市场准入制度概况及对我国的启示

Overview of market access systems for health food products in other countries and regions and its enlightenment to China

上世纪末至本世纪初,基于不同的政策背景、监管能力、行业状况和文化传承,世界主要发达国家和地区相继建立或完善管理制度,对具功能声称的食品实行注册、备案或自主合规管理。我国于2015年修订《食品安全法》,将保健食品纳入特殊食品实行严格监管,同时明确保健食品由“注册审批制”转为“注册备案双轨制”管理,开启了保健食品市场准入制度的改革。本文通过对美国、加拿大、欧盟、澳大利亚、日本、韩国等国家和地区的保健食品类似产品管理制度进行介绍,以期对深化我国保健食品注册备案制度改革提供参考。

From the end of last century to the beginning of this century,based on different policy background,regulatory capacity,industry status and cultural heritage,major developed countries and regions in the world had successfully established and improved the management systems to implement registration,filing or independent compliance for food with functional claims.In China,the Food Safety Law was amended in 2015,where health foods were under the category of special foods with strict supervision.At the same time,it was clarified that the management of health food had changed from“Examination and approval system”to“Dual-track system of registration and filing”,which marked the evolution in China health food market access system.This article introduced health food management systems in US,Canada,the European Union,Australia,Japan and South Korea,in order to provide references for deepening the reform of health food registration system in China.