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1、The Administration of Health Food Registration,The State Food and Drug Administration(SFDA)Director of Drugs RegistrationXie XiaoyuNov 2005,The DefinitionThe LegislationThe organization for examination and approval The product range for registrationThe Application&ApprovalRaw materials&supplementary
2、 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 claiming to have specific healthcare functions or to be taken
3、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 human body.,Two Major Features of Health Food1.“Food Safety”
4、.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）The Likeness and Difference between Health Food and General Food
5、The 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(as specified on label)To be consumed by a specific populationWith a pa
6、rticular daily dosage,General FoodNo emphasis on any specific functionsTo be consumed by general publicNo stipulation on the amount of consumption,（2）The Difference between health food and Medicine,health foodNo medical treatment objective,but mainly used to adjust the running of human body(as speci
7、fied 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 and major treatment area.May have adverse effectsWith exact expiry dateIn form of injection,topical medicine,oral drug,e
8、tc,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 Peoples Republic of China)has specified the rules and regulations for the approval and supervision of health food,and thus confir
9、med 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 15,1996 has made a specific regulation on the health food definition,examination and approval,production administration,labeling,instr
10、uction and advertisements,administrative supervision and so on.The Administrative Policy of health food Registration（Trial Implementation）(Order No.19 made on April 30,2005 by the Bureau Chief of SFDA to be implemented on July 1)has made specific regulation on health food registration regarding the
11、application,examination and approval,raw material and supplementary material,labeling and instruction,testing and inspection,re-registration,re-examination,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 di
12、stributing“The regulation on the declaration and assessment of Nutrient Supplements(Trial implementation)“,officially executed since July 1,2005),including:Regulation of application and approval for nutrient supplements Regulation of application and approval for the health food of fungusRegulation o
13、f application and approval for the health food of probioticRegulation of application and approval for the health food of nucleic acidRegulation 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,
14、etcRegulation of application and approval for the health food produced by the purification technique of resin separationSupplementary provision of declaration and approval for health foodThe SFDA notice about printing and distributing the Requirements of Declaration Items for health food Registratio
15、n（trial implementation）（SFDA 2005 No.203),executed since July 1,2005.,（III）The Regulation Documents（2）,The SFDA notice regarding the printing 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
16、:Sample of Application Form for Health Food RegistrationSample of Health Food Approval CertificateSample of Notification Letter on Health FoodThe SFDA notice regarding the implementation of printing and distributing the Regulation for the site examination of health food sample trial and testing（tria
17、l 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）,The regulation from the ministry of health about naming healthcare related products(Ministry of Health 2001 No.109)The
18、 notice from the ministry of health about further regulating the administration of health food raw material(Ministry of Health 2002 No.51)The hygiene administrative policy on food additive for the Peoples Republic of China(released on March 15,1993 by Ministry of Health)The notice from the ministry
19、of health about restricting the use of licorice,Ma Huang Cao(ephedrine),Song Rong,saussurea involucrata(snow lotus)and its product as raw materials for the production of health food(Ministry of Health 2001 No.188),（III）The Regulation Documents（3）,The regulation of health food labeling（Ministry of He
20、alth 1996No.38）The notice from the ministry of health about printing and distributing the regulation of Good Manufacture Practice examination methods and assessment criteria.（Ministry of Health 2003No.77）The notice from the ministry of health about reorganizing the development of food specialization
21、.（Ministry of Health 2005No.128）,（III）The Regulation Documents（4）,The technical specification for health food inspection and assessment（2003 version）The specifications on the assessment procedures and inspection methods for the functionality of health foodThe specifications on assessment procedures
22、and inspection methods for the toxicology of health food safety The specifications on the inspection methods for the active ingredients and hygiene standards of health foodThe general hygiene requirements on health food（Ministry of Health 1996 No.38）The general standards of health food（functional）（G
23、B16740-1997）Standard of Good Manufacture Practice on health food（GB17405-1998）The hygiene standards for the use of food additives（GB2760）The recommended diet in-take amount of nutrients as reference for Chinese people（Released in Oct 2000 by The Chinese Nutrition Society）,（IV）Technical Specification
24、&Technical Standards,III.The Organization for Approval&the Concerning Departments,The Organization for Approval:The organization of State Food and Drug Administration(SFDA)is responsible for handling the registration,assessment and approval of health food for the whole country.,SFDADirector of Regis
25、tration,The Food and Drug Administration Departments in provinces,Health FoodAssessment Centre,The accredited health food examination agencies,State Food and Drug Administration(SFDA),Organization Relationship,The Concerned Departments：The Drug Registration Director of SFDA is completely responsible
26、 for the approval of health food.The drug&food administrative departments in provinces,autonomous regions and municipalities entrusted by SFDA are responsible for handling and formally inspecting the application for the Chinese locally made health food registration,product test inspection and sample
27、 production inspection,organizing sample test.Designated by SFDA,the SFDA Health Food Assessment Centre is responsible for organizing the technical assessment of health food.The examination agencies are responsible for the toxicology tests for safety,functionality tests(including in vivo tests and/o
28、r trials on human body),active ingredient tests or labeling ingredient tests,hygiene tests,stability tests,etc.They are also fully responsible for sample tests and reexamination tests.,IV、The Product Range for Registration,The food having specific health care functions Generally,the health food func
29、tions declared in the application should fall in the published range of 27 functions.If the health food functions are out of the published range,the application of registration still can also be submitted but the applicant should conduct its own animal test and human trial test and supply a research
30、 and development report on its function to the designated testing agency.After verifying the functionality test,evaluation methods and testing results by the testing agency,the application of registration can then be submitted to SFDA with the verification report.The food tends to be vitamin or mine
31、ral supplements（usually called“nutrient supplement”）.,health food,The published range of 27 functions,1.Enhance immunity 2.Sleep improvement 3.Relief physical fatigue 4.Enhance tolerability of oxygen deficiency 5.Help in the protection against the harms caused by radioactive matters 6.Increase bone
32、density 7.Help in the protection against liver damage caused by chemicals 8.Relief eye fatigue 9.Eliminate acne 10.Eliminate chloasma 11.Improve moisture of skin 12.Improve oil content of skin 13.Weight loss,14.Help in lowering blood glucose 15.Improve growth and development 16.Anti-oxidation 17.Imp
33、rove nutritional anemia 18.Help in memory improvement 19.Adjust enteric bacteria colony 20.Promote lead excretion 21.Promote digestion 22.Clear the throat 23.Help in the protection of gastric mucosa 24.Promote lactation 25.Catharsis 26.Help in lowering blood pressure 27.Help in lowering blood lipid,
34、V.Application&Approval,The application and approval of product registrationThe application and approval of technology transfer for product registrationThe application and approval of alteration Time limit of registration,Mainly include,Application of Product Registration refers to the application fo
35、r health food registration that the applicant intends to manufacture and/or sell in China.Including：Application of domestic health food registration Application of imported health food registration,（1）Application&Approval of Product Registration,Health Food Registration Applicant refers to the one w
36、ho files the health food registration application and bears the corresponding legal liabilities.It is also the one who holds the granted health food approval certificate after the approval of application.Domestic Applicant should be a legally registered citizen,legal person or other organization in
37、China.Overseas Applicant should be a legitimate foreign health food manufacturer.For overseas applicant to apply the imported health food registration,it should be done by its representative office or authorized agent in China.,The Applicant,Application&Approval Procedures of Domestic Health Food Re
38、gistration,Testing,Health Food Approval Certificate is granted,Accepted by provincial authority for examination,Inspection done by Testing Agencies,Stability Test Hygiene Test Ingredient Test Functionality test of active ingredients and indicating ingredientsToxicology Test for Safety,Provide examin
39、ation advice Collect samples for inspectionInspection of sample production siteInspection of test siteFormality examination of declared information,Sample Inspection Second Inspection,Technical Assessment done by Assessment Centers,For those fulfilled the requirements,Application,SFDAExamination,App
40、lication&Approval Procedures of Imported Health Food Registration,Testing,Health Food Approval Certificate is granted,Stability Test Hygiene Test Ingredient Test Active Ingredient Test or Indicating Ingredient Test Functionality TestToxicology Test for Safety,Sample Inspection Second Inspection,Tech
41、nical assessment by Assessment Centers,For those fulfilled the requirements,Inspected by Testing Agency,Formality examination,or site inspection if necessary,The product for application of imported health food registration should be available overseas for sale for more than one year,Samples for insp
42、ection,Accepted by SFDAfor examination,Application,The Difference between Imported and Domestic Health Food Registration,Domestic health foodAfter obtaining the Domestic Health Food Approval Certificate,applicant also has to apply for the production hygiene permit from the ministry of health.The min
43、istry of health has to inspect the production condition if it conforms to the requirement for the grant of production hygiene permit.After obtaining the production hygiene permit,the applicant can then carry on the production and sale of the product.In the course of examination and approval,all prod
44、uct testing site and sample production site must be inspected.,Imported health foodAfter the applicant obtained the“Imported Health Food Approval Certificate”and passed the inspection done by Import&Export Inspection and Quarantine Department,the Custom will then grant a permit for the product to be
45、 marketed directly in China.During the process of approval,the product testing site and sample production site will be inspected if necessary.The product for application of registration must be available in the producing country(area)for marketing for more than one year.,The validity of Health Food
46、Approval Certificate is 5 yearsFormat of domestic health food certificate No.：The State health food characters(国食健字)and letter“G”+4 numbers of year+4 serial numbersThe format for the certificate No.of imported health food：The State health food characters(国食健字)and letter”J”+4 numbers of year+4 serial
47、 numbers,（2）Application&Approval of Technology Transferred Product Registration,The application of technology transferred product registration refers to the act that a holder of the health food approval certificate transfers all the production and selling rights as well as the production technology
48、to another health food producer,and jointly apply for the issuance of a new health food approval certificate to the transferee.As a transferee,the domestic health food producer must be an enterprise that has obtained the health food hygiene license in accordance with the law and must be in complianc
49、e with the Good Manufacture Practice for Health Food;while the foreign health food producer must be in compliance with corresponding local standards of production quality control.,Application accepted by the authority in the transferees province for examination,Application and Approval Procedure of
50、Domestic/Foreign Transferred Product Registration,Joint application for the transferee,Sample inspection by examination agency,SFDA examination,The validity of the new approval certificate remains the same as the original one,For those fulfilled the requirements,Sample inspection,Transferor to colle
