On Aug 20, 2019, China SAMR issued "Administrative Measures on Directory of Health Food Raw Materials and Directory of Health Functions" ("保健食品原料目录与保健功能目录管理办法"in Chinese), which will come into effect on Oct. 1, 2019. The measures outline the procedures involved in the expansion of the Directory of Health Food Raw Materials and The Directory of Health Functions, the authority petitioning process and requirements for the relevant dossiers, etc.
At present, the Directory of Health Food Raw Materials only consists of basic vitamins and minerals, and the Directory of Health Functions consists of 27 functions, such as enhancing immune function and increasing antioxidants etc. The two directories were both drafted and issued exclusively by the government with minimal practical input from the public and industry. At present, there are no official channels for companies or individuals to add other ingredients or functions to the directories.
Under the new measures, SAMR will encourage both public and private sector entities to apply for expansions to both The Directory of Health Food Raw Materials and The Directory of Health Functions. This process will be undertaken by 3rd party testing institutes who will gather relevant data and other materials to support applications made on behalf of their clients.
The new change will bring China's health food regulatory framework into alignment with global best practices and offer both domestic and international stakeholders a route to market for many products which were previously unviable.
This webinar will analyze and interpret the new measures and give instruction on how to submit an application to append either of the two directories.