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1、The Administration of Health Food Registration,The State Food and Drug Administration (SFDA)Director of Drugs RegistrationXie XiaoyuNov 2005,天马行空官方博客：http:/ ；QQ:1318241189；QQ群：175569632,The DefinitionThe LegislationThe organization for examination and approval The product range for registrationThe A
2、pplication & ApprovalRaw materials & supplementary materials,Labeling, instruction, namingTesting, inspectionRe-registrationRe-examinationDeclaration ItemsProduct Registration & The Situation of Product Manufacturing,Health Food,I. The Definition of Health Food,Health Food：refers to the foods claimi
3、ng to have specific healthcare functions or to be taken as vitamin or mineral supplements. That means it is suitable for a specific population with the actions to adjust body functions. It is not intended to be used to treat any diseases and it will not have any acute, sub-acute or chronic harm to h
4、uman body.,Two Major Features of Health Food1.“Food Safety”. It will not exert any acute, sub-acute or chronic harm to human body.2.“Food Function”. It can adjust human body for a specific population, but it cannot treat diseases, nor substitute for medicine as a medical regimen.,The Difference：,（1）
5、 The Likeness and Difference between Health Food and General FoodThe Likeness： Like general food, health food has its own specific color, smell, taste and shape to supply essential basic nutrients for the survival of human body.,Health FoodTo adjust body functions with specific health care actions (
6、as specified on label)To be consumed by a specific populationWith a particular daily dosage,General FoodNo emphasis on any specific functionsTo be consumed by general publicNo stipulation on the amount of consumption,天马行空官方博客：http:/ ；QQ:1318241189；QQ群：175569632,（2） The Difference between health food
7、 and Medicine,health foodNo medical treatment objective, but mainly used to adjust the running of human body (as specified on label)Have no acute, sub-acute or chronic harmSuitable for long-term useTo be taken orally,MedicineMust have an explicit treatment goal as well as corresponding indications a
8、nd major treatment area. May have adverse effectsWith exact expiry dateIn form of injection, topical medicine, oral drug, etc,II. The Legislation,The article 22, 23 and 45 of the “Food Hygiene Law of the Peoples Republic of China”(Adopted on October 30, 1995 by Order No. 59 of the President of the P
9、eoples Republic of China) has specified the rules and regulations for the approval and supervision of health food, and thus confirmed its legal status for the first time.,（1）The Law,（2）Rules and regulations,The Administrative Policy of Health Food Order No. 46 made by Ministry of Health on March 15,
10、 1996 has made a specific regulation on the health food definition, examination and approval, production administration, labeling, instruction and advertisements, administrative supervision and so on.The Administrative Policy of health food Registration （Trial Implementation）(Order No.19 made on Apr
11、il 30, 2005 by the Bureau Chief of SFDA to be implemented on July 1) has made specific regulation on health food registration regarding the application, examination and approval, raw material and supplementary material, labeling and instruction, testing and inspection, re-registration, re-examinatio
12、n, legal liability and so on.,（III）The Regulation Documents（1）,The 8 SFDA notices of the related regulations （ SFDA 2005 No. 202 ）about printing and distributing “The regulation on the declaration and assessment of Nutrient Supplements (Trial implementation)“, officially executed since July 1, 2005)
13、, including: Regulation of application and approval for nutrient supplements Regulation of application and approval for the health food of fungusRegulation of application and approval for the health food of probioticRegulation of application and approval for the health food of nucleic acidRegulation
14、 of application and approval for the health food of wild animals and plants Regulation of application and approval for the health food of amino acid chelate, etcRegulation of application and approval for the health food produced by the purification technique of resin separationSupplementary provisio
15、n of declaration and approval for health foodThe SFDA notice about printing and distributing the Requirements of Declaration Items for health food Registration （trial implementation）（SFDA 2005 No. 203), executed since July 1, 2005.,（III）The Regulation Documents（2）,The SFDA notice regarding the print
16、ing and distributing the 3 samples of Sample of Application Form for Health Food Registration（SFDA 2005No. 204）, executed since July 1, 2005. Specifically it includes:Sample of Application Form for Health Food RegistrationSample of Health Food Approval CertificateSample of Notification Letter on Hea
17、lth FoodThe SFDA notice regarding the implementation of printing and distributing the Regulation for the site examination of health food sample trial and testing （trial implementation）, executed since July 1, 2005. The SFDA notice （2005.5) for the concerned execution issues on The administrative policy of health food registration（trial implementation）,
