China Consults on New Dosage Forms for Health Food Filing

New dosage forms in this draft are applicable for vitamin and mineral products filing only. There may be new dosage forms for filing health food products other than vitamin and mineral supplements. The List of Auxiliary Materials for Health Food Filing and Terms of Use stipulates on permitted auxiliary materials for the two new dosage forms, 152 auxiliary materials are applicable for gelatinized confections and 172 auxiliary materials are applicable for powder. When the maximum limits listed in the List of Auxiliary Materials conflicts with that of GB 2760, the stricter one should be followed.

On Aug 28th, China SAMR consulted on two new dosage forms for health food filing, i.e., gelatinized confections and powder. Four supportive draft documents were released for public comments as written below:

1. List of Auxiliary Materials for Health Food Filing and Terms of Use (2020)

2. Dosage Forms and Manufacturing Techniques for Health Food Filing (2020)

3. Technical Requirements for Gelatinized Confections (2020)

4. Technical Requirements for Powder (2020).

Main contents of the supportive documents are:

1. Auxiliary materials for health food filing and terms of use

Auxiliary materials listed in the List of Auxiliary Materials for Health Food Filing and Terms of Use (2019) (now on referred to as the List) are permitted for health food filing of all dosage forms. Since gelatinized confection and powder are forms of ordinary food, according to the List, auxiliary materials for health food products of ordinary-food form should also comply with GB 2760 National Food Safety Standard for Uses of Food Additives.