SFDA issues Provisions for Health Food Registration (interim) and other relevant rules

The Provisions comprises 9 chapters with 105 articles and four appendixes. The nine chapters are General Provisions, Application and Approval, Raw Materials and Excipients, Labels and Package Inserts, Trails and Tests, Re-registration, Re-examination, Legal Liabilities and Supplementary Provisions. The four appendixes are Application Items for Product Registration, Application Items for Alteration, Application Items for Technical-Transfer Product Registration and Application Items for Re-registration.

In accordance with Provisions for Health Food Registration (interim), SFDA formulated and issued the following health food-related documents on May 20, 2005, which apply to the application and review of health food. They are:

Requirements for Nutritional Supplement Application and Reviewing (interim);

Requirements for Fungi Health Food Application and Reviewing (interim);

Requirements for Probiotic Microflora Health Food Application and Reviewing (interim);

Requirements for Nucleic Acid Health Food Application and Reviewing (interim);

Requirements for the Application and Reviewing of Health Food from Wild Plants or Animals Origin (interim);

Requirements for the Application and Reviewing of Amino Acid Chelate Health Food and others (interim);

Requirements for the Application and Reviewing of Health Food Produced by Applying Macro reticular Resin Separation and Purification Technique (interim);

Supplementary Requirements for Health Food Application and Reviewing (interim);

Requirements for Application Items of Health Food Registration (interim) ;

Format of Application Form for Registration of Health Food;

Format of Health Food License;

Format of Health Food Registration Related Notifications.