英文保健食物常见问题汇总.docx

英文保健食物常见问题汇总.docx

《英文保健食物常见问题汇总.docx》由会员分享，可在线阅读，更多相关《英文保健食物常见问题汇总.docx（8页珍藏版）》请在冰豆网上搜索。

英文保健食物常见问题汇总

F&QsofHEALTHFOODCFDAREGISTRATION

1.DefinitionofHealthFood

Healthfoodisdefinedasfoodthathasspecifiedhealthfunctions,suitabletobetakenbyspecifiedgroupsofpeople,andfortheregulationofthefunctionalstatesofthehumanbodyandisnotusedforthetreatmentofdiseases.

Thecategoryincludesvitaminandmineralsupplements.

AllhealthfoodsoldwithinChinamustbeapprovedandregisteredwiththeCFDA,whichwillassessandexaminethesecurity,effectiveness,qualitycontrolandlabelingofproducts.

2.27FunctionsofHealthFoodapprovedbyCFDA

1.Enhancingimmunesystems

2.Sleepimprovement

3.Alleviatingphysicalfatigue

4.Enhancinganoxiaendurance

5.Irradiationhazardprotection

6.Increasingbonedensity

7.Assistingliverprotectionagainstchemicalinjury

8.Alleviatingeyefatigue

9.Eliminatingskinpigmentation

10.Eliminatingacne

11.Improvingskinabilitytoretainmoisture

12.Improvingskinoilcontentfunction

13.Assistingbloodlipidsreduction

14.Assistingbloodsugarreduction

15.Anti-oxidativefunction

16.Assistingmemoryimprovement

17.Alleviatingleadexcretion

18.Improvingthroat-clearingfunction

19.Assistingbloodpressurereduction

20.Facilitatingmilksecretion

21.Assistingweightcontrol

22.Improvingchildgrowth

23.Improvingnutritionalanemia

24.Regulatinggastrointestinalflora

25.Facilitatingdigestion（regularity）

26.Facilitatingbowelmovement

27.Protectionofgastricmucosa

Notice:

Bothnutritionalsupplementsandfunctionhealthfoodarerequiredtohavetoxicology,hygienic,stability,activeingredienttests.Amongthe27functionsofhealthfood,1-7needtohavetheanimalstudyonly,8-12needthehumanstudyonly,andothersneedbothanimalandhumanstudies.

3.Thecontentchangeoftheapprovalcertificate

Tianjianhuacheng:

Iftherearechangesontheapprovalcertificate,theapplicantshouldapplythechangestotherelateddepartments,andtheapplicantmustbetheholderoftheapprovalcertificate.

Theallowedchangesinclude:

thechangeofdairyintake,validdate,reducethescopeofsuitablegroup,increasethescopesofunsuitablegroup,changethewarnings,changethespecificationsandqualitystandardsoftheproducts（changesbelongtotheseparts,therelatedproductsmustbealreadyonthemarketfordistributing）,changethenameoftheproducts,changethenameofapplicantoraddress,overseasforeignmanufacturecompanychangeitsaddress,orchangeitsChineseresponsibleagent’saddress.

Thenotallowedchangesinclude:

thenameofthehealthfoodontheapprovalcertificate,rawmaterialsandtheirmanufactureprocess,ediblemethodsandthefunctionalcontent.

CFDAwillgiveopinionsin50-60workingdaysaftertheyaccepttheapplication.

Tianjianhuacheng:

CFDAwillnotallowchangingthedairyintakeinthefuture.

4.Howtotransfertheapprovalcertificate?

Tianjianhuacheng:

thetransferofthehealthfoodapprovalcertificatemeanstheholderofthecertificate,totallytransfertherightsofsellandmanufactureandprocesstechnologytootherhealthfoodcompany.Andthedomestichealthfood’sapprovalcertificatecanbetransferred.

TheacceptancepartmusthavethehygienelicenseandconformwithhealthfoodGMP’srelatedlaws.Bothpartiesmustsignthecontractsandthecontractmustbenotarized.

Thetransferpartshouldguidetheacceptancepartytoproducethreecontinuousbatchproducts.

Theimportedhealthfood’scertificatetransferincludesdomestictransferandoverseastransfer,andchangingofapplyingcompanyinChinaisbelongingtothefilingchangepart,nottransfer.

Inaddition,theformula,manufactureprocess,qualitystandardsandotherthingsrelatedtoproducts’safetyandfunctionscannotbechanged.

CFDAwillgiveopinionsin50-60workingdaysaftertheyaccepttheapplication.

Tianjianhuacheng:

theapprovalcertificateofimportedhealthfoodmaynotbeallowedtobetransferredinthefuture.

5.Whattestsneedtobedoneduringthehealthfoodregistration?

Tianjianhuacheng:

generallyspeaking,normalproductsneedtohavesafetytest（toxicology）,functionaltest（includinganimalstest/humantests）,stabilitytest,hygienetest,functional/keyfunctionidentifytest.Accordingtothefunctionsandthecharacteristics,itmayneedthehormonestest,stimulanttest,bacteriatestandtherawmaterialsidentificationtest.

Asforthenutrientsupplement,thereisnoneedtohavefunctiontests.IftherawmaterialsbelongtotheVitaminsandMineralsCompoundList,andtherelatedmanufactureprocessandqualitystandardsconfirmtoChineserelatedlaws,generallyitisnoneedtoprovidesafetytoxicologytestingreport.

Hygienetestisthetestofthephysicalandchemicalpropertiesandmicrobiologicalindextestsofthehealthfood,suchasheavymetal,pesticideresidue,disintegrationtime,pHvalue,microbiologicalvalueandsoon.

Stabilitytestisthetestofwhetherhealthfoodisstabilityonthevaliddate,andthetestsarethesameasthehygienetest.Generally,thetestisacceleratedstabilitytestplacedin38℃and75humidityinone,twoandthreemonths,thenhavetestsofeachrequiredindex.

Safetytestisthetestofthetoxicologyoftheproduct.Accordingtothedifferentingredientsoftheproduct,toxicologytestsubjectcanbedifferent.Normalproductsneedtohavestage1and2tests,whileothersmayneedtohavedeepertestor90dayseatingtest.

Functiontestmeansthetestoftheproduct’sannouncedfunctionsaccordingtoCFDAqualifiedtestingmethods.Accordingtothedifferentfunctionsoftheproducts,itmayneedtohaveanimalfunctiontestorhumanbodytest.

6.Iftheproductalreadytestedbefore,istheproductstillneedtobetested?

Tianjianhuacheng:

Somecompaniesmayhavetheseideasthattheproductshavealreadytestedbefore,isitstillneedtobetestedinChina?

Theresultisthatiftheimportedproductonlyhastheforeigntestingreport,andtheimportedtestingreportisonlycanbereference:

theimportedproductsmusthavetestinginChineseinstitutionwhichqualifiedbyCFDA.

7.Canasameserieshealthfooduseasameapprovalcertificate?

Tianiianhuacheng:

Serieshealthfoodsmeanthehealthfoodwhichhassamerawmaterialsandauxiliarymaterials,buthavedifferenttasteorcolors.Thebrandname,commonnameandattributenameshouldbethesame,andnotethedifferenttastesorcolorsaftertheattributename.Andonesameseriesproductscanbeappliedasagroup.Theseriesproductsarenoneedtohavetoxicologytestandfunctionaltest（butneedtoprovidecopiesoforiginalproduct’stestingreport）,andthesetestingmethods,evaluationindexandjudgmentsstandardsshouldconformtorelatedregulations.

Inaddition,ifthehealthfoodshavethesamefunction,samerawmaterials,buthavedifferentdosageforms,thentheseproductsmustappliedasdifferentproducts.

8.HowtoacceleratetheCFDAregistrationprocess?

Tianjianhuacheng:

Thetimeofhealthfood’sCFDAregistrationismainlydependedonthesefactors:

evaluation,testing,policiesanddocumentspreparation.Thetimeoffirsttwofactorsarehardlytobeshorten,andbecauseofthedifferentpoliciesindifferenttime,sothemainlyfactorthatweneedtobefocusedisthedocumentspreparation.

Thedocumentspreparationhasbigeffectsonthedeclarationperiod,andcompaniescancontrolthispart.Ifthedocumentsarewell-prepared,evaluationspecialistswillhavefeweropinions,andthenapplicantonlyneedbitmodificationsofthedocumentsifnecessary.Butiftherearemanyproblemsinthedocuments,theapplicantmaytakealongertimetomodifythedocuments,sotheregistrationtimewillbelonger.Besides,evaluationspecialistsmayhavequestionsandaskforsomemoretestingreportsandrelatedliteraturereferenceofnewtechnologies,anditmaylengthentheregistrationperiod.

Soifacompanywantstoshortentheregistrationtime,itmustarrangethetimeineachstagereasonable,andtrytofullypreparetheregistrationdocuments.Butontheotherhand,thepoliciesmaychangeallthetime,anditmaystillinfluencetheCFDAregistration.

Tianjianhuacheng:

Theworkingprincipleofouragencyisdoingthebasicjobsattheverybeginning:

reviewingredientsbeforethetesting,checkeverydocumentbeforesubmitthedocuments,correcttheproblemswhichmayhappenandavoidtheproblemsmodificationduringtheregistration.

9.WhatisthevaliddateoftheCFDAcertificate?

Whatshouldtheapplicantdobeforethevalid?

Tianjianhuacheng:

Thevaliddateofapprovalcertificateisfiveyears,andifthecompanyneedstoextendthecertificate,theapplicantshouldsubmitthere-registerthreemonthsbeforethevaliddate.

10.Canweapplyformultiplefunctions?

Canweapplyforthefunctionotherthanthe27allowedfunctions?

Tianjianhuacheng:

YES.Accordingtotherelatedlaws,whenapplicantappliesforthenewfunction,applicantshoulddotheanimalandhumanbodytestsbythemselves,andprovidethefunctionresearchreporttothetestinginstitution.Theproductresearchreportshouldincludetheresearchidea,functionfilterprocessandexpectingeffects;thefunctionresearchreportshouldincludethefunctionname,applyingreasons,functionaltestingmethodsandevaluationresults.Ifthecompanycannotproceedanimalorhumantest,itmustillustratethereasonsandproviderelateddocumentsonthefunctionalreport.

Tianjianhuacheng:

Werecommendoneproductdon’thavemorethantwofunctions,anddifferentfunctionsneedtohavesomesortsofconnections,otherwiseitishardtopass.Besides,applyforthenewfunctionisVERYhardtoprovidedocumentsacceptedbyCFDA,sotheris