China Health Food: CFDA Releases Detailed Guidance for Health Food Registration Approval

On Nov. 17, 2016, China CFDA released the “Detailed Guidance for Health Food Registration Approval”, which took effect on the day of announcement.

This guidance is applicable to the registration, registration renewal, technical transfer, change of registration, etc. of health food with raw materials not included in the approved health food raw material directory and also health foods imported for the first time (excluding vitamins and minerals).

This guidance stipulates the examination procedure of application dossiers for both domestic and imported health food, as well as health food registration technical review procedures:

• Safety examination

• Health function evaluation

• Production technique review

• Review of product technology requirements

• Field inspection and reexamination

Requirements for health food raw materials:

The sources of health food raw materials will be reviewed. Health food raw materials must be chosen from the following categories: conventional foods, new food raw materials, “substances used as both food and traditional Chinese medicine”, “raw materials to be included into health food raw material directory” (as the approved health food raw material directory has not been finalized yet), new raw materials for health food, etc.

Use of new raw materials in health foods will require a relevant safety evaluation report, toxicity test report, as well as reports on production techniques, quality requirements and inspections, all of which should be submitted according to “Review Procedures for Safety of New Food Raw Materials”.