英文保健食物常见问题汇总.docx
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英文保健食物常见问题汇总.docx
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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
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