英文保健食物常见问题汇总.docx

1、英文保健食物常见问题汇总F & Qs of HEALTH FOOD CFDA REGISTRATION1. Definition of Health FoodHealth 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 o

2、f 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 CFDA1.Enh

3、ancing immune systems2.Sleep improvement3.Alleviating physical fatigue4.Enhancing anoxia endurance5.Irradiation hazard protection6.Increasing bone density 7.Assisting liver protection against chemical injury8.Alleviating eye fatigue9.Eliminating skin pigmentation10.Eliminating acne11.Improving skin

4、ability to retain moisture12.Improving skin oil content function13.Assisting blood lipids reduction14.Assisting blood sugar reduction15.Anti-oxidative function16.Assisting memory improvement17.Alleviating lead excretion18.Improving throat-clearing function19.Assisting blood pressure reduction20.Faci

5、litating milk secretion 21.Assisting weight control22.Improving child growth23.Improving nutritional anemia24.Regulating gastrointestinal flora25.Facilitating digestion (regularity)26.Facilitating bowel movement27.Protection of gastric mucosaNotice: Both nutritional supplements and function health f

6、ood 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 certificateTianjianhu

7、acheng: 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, incre

8、ase 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, ov

9、erseas foreign manufacture company change its address, or change its Chinese responsible agents 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 opi

10、nions 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

11、 transfer the rights of sell and manufacture and process technology to other health food company. And the domestic health foods approval certificate can be transferred.The acceptance part must have the hygiene license and conform with health food GMPs related laws. Both parties must sign the contrac

12、ts and the contract must be notarized.The transfer part should guide the acceptance party to produce three continuous batch products. The imported health foods certificate transfer includes domestic transfer and overseas transfer, and changing of applying company in China is belonging to the filing

13、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 import

14、ed 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, hygie

15、ne 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 bel

16、ong 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 t

17、ests 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 stabili

18、ty 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 an

19、d 2 tests, while others may need to have deeper test or 90 days eating test.Function test means the test of the products 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.

20、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,

21、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

22、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

23、 test and functional test (but need to provide copies of original products 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 dosag

24、e forms, then these products must applied as different products. 8. How to accelerate the CFDA registration process?Tianjianhuacheng: The time of health foods CFDA registration is mainly depended on these factors: evaluation, testing, policies and documents preparation. The time of first two factors

25、 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-prepare

26、d, 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, evaluatio

27、n 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

28、 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

29、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

30、 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 applic

31、ant 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

32、 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 dont 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 ris