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Q1What is the definition of health food in China

AFood that have certain health functions or aim at supplementing vitamins and minerals, namely, those foods which are used for certain groups of people with the aim to adjust organic function instead of curing diseases and will not cause any acute, sub-acute or chronic damages to human body.(《 Provisions for Health Food Registration 》)


Q2Is it record keeping system for health food in China

ANo, not yet. Health food need to be approved by State Food and Drug Administration, P. R .China.


Q3Can any health food (Functional food) get approval in China?

ANo, it needs to have been produced and sold in foreign territory for over one year.


Q4 What functions can be declared to the health food

AAccording to current regulations, there are 18 functions:help to strengthen the immune system, help to decrease blood lipid, help to reduce blood glucose, help to improve sleep, antioxidant, help to relieve physical fatigue, help to reduce body fat, help to increase bone density, help to improve the nutritional anemia, help to improve memory, clear throat, help to improve the anoxia tolerance, help to reduce alcoholic liver injury hazards, help to  excrete lead, help to lactate, help to ease eye fatigue, help to improve gastrointestinal function ,Contribute to the facial skin health.


Q5What to do if the applied health function is not included in the range above?

AIf the applied health function is not included in the range published, the applicant should conduct the animal test and pre-eating test on human body independently and provide the function research and development report to the inspection institution. If the animal test and pre-eating test on human body can not be done, the reason should be stated in the function research and development report and the relevant data should be submitted.


Q6What are the requirements of import health food applicant?

AThe foreign applicant should be a legal health food manufacturer in foreign countries. The imported heath food registration of foreign applicants should be conducted by its representative office in China or the agency in China who is entrusted by the foreign manufacturer.


Q7How long for the import health food approval certificate valid?

A Health Food License is valid for 5 years , If the valid period of health food license expires and needs to be extended, the applicant should apply for re-registration 3 months before the valid period expires.


Q8what is the procedure of import health food registration

Aregistration test—— pre-eat test on human body—— registration submission —— registration review Quality standard rechecking——registration approval Get approval certificate for import health food


Q9Which departments are needed for import health food registration approval?

ARegistration testing institutes approved by State Food and Drug Administration, P. R .China (commitment to pre-eat test on human body institutes)Health food evaluation center, State Food and Drug Administration health food and cosmetics Supervision Division


Q10How long will it take to registration import health food?

AIf no need for pre-eat test on human body, it takes 13~18months; If  pre-eat test on human body is needed, it takes 18~24months; For nutritional supplements , it takes 10~15months.


Q11How much do the registration test fee and pre-eat test on human body fee cost?

ARegistration tests include safety toxicology test, function test (including both animal testing and/or pre-eat test on human body), active ingredients or badge element test, hygiene test, stability test;  of the samples. The price is based on different testing institutes and declared functions.

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