One-stop service before approval involving Risk Evaluation, Document Organization, Register, Clinical Trial, Progress Tracking.
FAQs
Q1：What is the definition of health food in China？
A：Food 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 》）
Q2：Is it record keeping system for health food in China？
A：No, not yet. Health food need to be approved by State Food and Drug Administration, P. R .China.
Q3：Can any health food (Functional food) get approval in China?
A：No, 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？
A：According to current regulations, there are 18 functions:①help to strengthen the immune system, ②help to decrease blood lipid, ③help to reduce blood glucose, ④help to improve sleep, ⑤antioxidant, ⑥help to relieve physical fatigue, ⑦help to reduce body fat, ⑧help to increase bone density, ⑨help to improve the nutritional anemia, ⑩help to improve memory, ⑾clear throat, ⑿help to improve the anoxia tolerance, ⒀help to reduce alcoholic liver injury hazards, ⒁help to excrete lead, ⒂help to lactate, ⒃help to ease eye fatigue, ⒄help to improve gastrointestinal function ,⒅Contribute to the facial skin health.
Q5：What to do if the applied health function is not included in the range above?
A：If 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.
Q6：What are the requirements of import health food applicant?
A：The 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.
Q7：How 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.
Q8：what is the procedure of import health food registration？
A：①registration test——② pre-eat test on human body——③ registration submission ——④ registration review（ Quality standard rechecking）——⑤registration approval （Get approval certificate for import health food）
Q9：Which departments are needed for import health food registration approval?
A：Registration 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
Q10：How long will it take to registration import health food?
A：If 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.
Q11：How much do the registration test fee and pre-eat test on human body fee cost?
A：Registration 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.
