|1. Definition of Health Food
Health food is defined as food that has specified health functions, suitable to be taken by specified groups of people, and for the regulation of the functional states of the human body and is not used for the treatment of diseases.
The category includes vitamin and mineral supplements.
All health food sold within China must be approved and registered with the CFDA, which will assess and examine the security, effectiveness, quality control and labeling of products.
2. 27 Functions of Health Food approved by CFDA
1. Enhancing immune systems
2. Sleep improvement
3. Alleviating physical fatigue
4. Enhancing anoxia endurance
5. Irradiation hazard protection
6. Increasing bone density
7. Assisting liver protection against chemical injury
8. Alleviating eye fatigue
9. Eliminating skin pigmentation
10. Eliminating acne
11. Improving skin ability to retain moisture
12. Improving skin oil content function
13. Assisting blood lipids reduction
14. Assisting blood sugar reduction
15. Anti-oxidative function
16. Assisting memory improvement
17. Alleviating lead excretion
18. Improving throat-clearing function
19. Assisting blood pressure reduction
20. Facilitating milk secretion
21. Assisting weight control
22. Improving child growth
23. Improving nutritional anemia
24. Regulating gastrointestinal flora
25. Facilitating digestion (regularity)
26. Facilitating bowel movement
27. Protection of gastric mucosa
Notice: Both nutritional supplements and function health food are required to have toxicology, hygienic, stability, active ingredient tests. Among the 27 functions of health food, 1-7 need to have the animal study only, 8-12 need the human study only, and others need both animal and human studies.
3. The content change of the approval certificate
Tianjianhuacheng: If there are changes on the approval certificate, the applicant should apply the changes to the related departments, and the applicant must be the holder of the approval certificate.
The allowed changes include: the change of dairy intake, valid date, reduce the scope of suitable group, increase the scopes of unsuitable group, change the warnings, change the specifications and quality standards of the products (changes belong to these parts, the related products must be already on the market for distributing) , change the name of the products, change the name of applicant or address, overseas foreign manufacture company change its address, or change its Chinese responsible agent’s address.
The not allowed changes include: the name of the health food on the approval certificate, raw materials and their manufacture process, edible methods and the functional content.
CFDA will give opinions in 50-60 working days after they accept the application.
Tianjianhuacheng: CFDA will not allow changing the dairy intake in the future.
4. How to transfer the approval certificate?
Tianjianhuacheng: the transfer of the health food approval certificate means the holder of the certificate, totally transfer the rights of sell and manufacture and process technology to other health food company. And the domestic health food’s approval certificate can be transferred.
The acceptance part must have the hygiene license and conform with health food GMP’s related laws. Both parties must sign the contracts and the contract must be notarized.
The transfer part should guide the acceptance party to produce three continuous batch products.
The imported health food’s certificate transfer includes domestic transfer and overseas transfer, and changing of applying company in China is belonging to the filing change part, not transfer.
In addition, the formula, manufacture process, quality standards and other things related to products’ safety and functions cannot be changed.
CFDA will give opinions in 50-60 working days after they accept the application.
Tianjianhuacheng: the approval certificate of imported health food may not be allowed to be transferred in the future.
5. What tests need to be done during the health food registration?
Tianjianhuacheng: generally speaking, normal products need to have safety test (toxicology), functional test (including animals test/human tests), stability test, hygiene test, functional/key function identify test. According to the functions and the characteristics, it may need the hormones test, stimulant test, bacteria test and the raw materials identification test.
As for the nutrient supplement, there is no need to have function tests. If the raw materials belong to the Vitamins and Minerals Compound List, and the related manufacture process and quality standards confirm to Chinese related laws, generally it is no need to provide safety toxicology testing report.
Hygiene test is the test of the physical and chemical properties and microbiological index tests of the health food, such as heavy metal, pesticide residue, disintegration time, pH value, microbiological value and so on.
Stability test is the test of whether health food is stability on the valid date, and the tests are the same as the hygiene test. Generally, the test is accelerated stability test placed in 38℃ and 75 humidity in one, two and three months, then have tests of each required index.
Safety test is the test of the toxicology of the product. According to the different ingredients of the product, toxicology test subject can be different. Normal products need to have stage 1 and 2 tests, while others may need to have deeper test or 90 days eating test.
Function test means the test of the product’s announced functions according to CFDA qualified testing methods. According to the different functions of the products, it may need to have animal function test or human body test.
6. If the product already tested before, is the product still need to be tested?
Tianjianhuacheng: Some companies may have these ideas that the products have already tested before, is it still need to be tested in China? The result is that if the imported product only has the foreign testing report, and the imported testing report is only can be reference: the imported products must have testing in Chinese institution which qualified by CFDA.
7. Can a same series health food use a same approval certificate?
Tianiianhuacheng: Series health foods mean the health food which has same raw materials and auxiliary materials, but have different taste or colors. The brand name, common name and attribute name should be the same, and note the different tastes or colors after the attribute name. And one same series products can be applied as a group. The series products are no need to have toxicology test and functional test (but need to provide copies of original product’s testing report), and these testing methods, evaluation index and judgments standards should conform to related regulations.
In addition, if the health foods have the same function, same raw materials, but have different dosage forms, then these products must applied as different products.
8. How to accelerate the CFDA registration process?
Tianjianhuacheng: The time of health food’s CFDA registration is mainly depended on these factors: evaluation, testing, policies and documents preparation. The time of first two factors are hardly to be shorten, and because of the different policies in different time, so the mainly factor that we need to be focused is the documents preparation.
The documents preparation has big effects on the declaration period, and companies can control this part. If the documents are well-prepared, evaluation specialists will have fewer opinions, and then applicant only need bit modifications of the documents if necessary. But if there are many problems in the documents, the applicant may take a longer time to modify the documents, so the registration time will be longer. Besides, evaluation specialists may have questions and ask for some more testing reports and related literature reference of new technologies, and it may lengthen the registration period.
So if a company wants to shorten the registration time, it must arrange the time in each stage reasonable, and try to fully prepare the registration documents. But on the other hand, the policies may change all the time, and it may still influence the CFDA registration.
Tianjianhuacheng: The working principle of our agency is doing the basic jobs at the very beginning: review ingredients before the testing, check every document before submit the documents, correct the problems which may happen and avoid the problems modification during the registration.
9. What is the valid date of the CFDA certificate? What should the applicant do before the valid?
Tianjianhuacheng: The valid date of approval certificate is five years, and if the company needs to extend the certificate, the applicant should submit the re-register three months before the valid date.
10. Can we apply for multiple functions? Can we apply for the function other than the 27 allowed functions?
Tianjianhuacheng: YES. According to the related laws, when applicant applies for the new function, applicant should do the animal and human body tests by themselves, and provide the function research report to the testing institution. The product research report should include the research idea, function filter process and expecting effects; the function research report should include the function name, applying reasons, functional testing methods and evaluation results. If the company cannot proceed animal or human test, it must illustrate the reasons and provide related documents on the functional report.
Tianjianhuacheng: We recommend one product don’t have more than two functions, and different functions need to have some sorts of connections, otherwise it is hard to pass. Besides, apply for the new function is VERY hard to provide documents accepted by CFDA, so the risk is very high.
11. Requirements of the name of the health food
Tianjianhuacheng: Each product can only have one name, and the name should be consisted by trade name, generic name and attribute name, a series product must have the same trade name and generic name. Generally speaking, company should use the main raw material as the products’ name, and use scientific and standard name of raw material, but words numbers are no more than 10. The product cannot use the words like treatment, the exaggerate words like high efficiency, the words of human organs, people’s name and address, the special group and the letter, number, symbols and others.
12. The requirements of the manufacture company
Tianjianhuacheng: During the health food CFDA registration, applicant does not need to have his own manufacture factory, and the applicant can use the authorization kind of manufacture. And after applicant receive the approval certificate, the applicant can have their own manufacture or authorize other companies to manufacture. In any kind of manufacture, the manufacture companies must have the “health food hygiene license” and confirm to “health food GMP” (on the valid date), besides, the manufacture should have the manufacture facilities according with the type of the health food.
After CFDA accept the application, it will send staffs to production site to evaluate manufacture process and recorded documents, and check the reality, normative and integrity of the health food.
As for the imported products, the foreign manufacture company must conform to local GMP requirements. And CFDA will arrange production site investigate work.
13. The requirements of the auxiliary material of the health food
Tianjianhuacheng: The auxiliary material, usage amount should confirm to Chinese related laws. CFDA published or approved raw and auxiliary materials can be used in the health food.
In addition, the above materials and the usage amount should confirm to Chinese related health food laws. Many products cannot achieve CFDA approval certificate, one of the most important reasons is that the raw materials don’t confirm to Chinese laws: the materials of the health food must be allowed in China and confirm to hygiene standards, if not, the products may not pass the products tests and ingredients evaluation.
Tianjianhuacheng: The product should be evaluated before testing, and does the basis work at the beginning, then the product will have a high possibility to get CFDA certificate.
In conclusion, the laws of health food CFDA registration have been changed ALL the time, and CFDA still asks for opinions from the public of the related laws which may issued in 2014. So it is necessary for the applicant to know the health food registration process and requirements at the beginning and it may avoid detours and shorten the registration periods.