保健食品委托生产法规比较及建议

Strategies Analysis and Recommendations on Health Food Entrusting Production

委托生产是保健食品生产中一种常见的生产加工模式,根据保健食品全生命周期管理,保健食品批件持有人持有保健食品产品配方、生产技术要求,而将生产过程委托给受托企业,从而使管理链条延伸,给保健食品质量安全带来一定风险和隐患。通过梳理保健食品委托生产现行法规要求,并通过与“三品一械”委托生产监管比较,针对保健食品委托生产的法规现状和问题,提出相应的监管对策建议,对出台保健食品委托生产相关制度文件、加强保健食品委托生产提供参考依据。

Entrusting production is a common mode for health food.According to the whole life cycle management,the holder of health food license holds the formula and the technical requirements of health food,while entrusts the production process to the entrusted enterprise,thus extending the management chain,and bringing certain risks to the quality and safety of health food.By sorting out the requirements of current regulations on entrusting production of health food and comparing them with the regulation of entrusting production of medicine,medical equipment and cosmetics,this study puts forward corresponding regulatory authorities,and provides strategies and recommendations for entrusting production of health food products.