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©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(GRAS)(SmithBusinessServices,LLC19WintergreenAvenueEastEdison,NewJersey08820)IntroductionforUSGRASRegulationSHIXiao2wei(SmithBusinessServices,LLC19WintergreenAvenueEastEdison,NewJersey08820)1GRASGenerallyRecognizedAsSafe()GRAS/,GRAS/GRAS,/(),,,;,,FDA,,GRASGRAS,//(WHO/FAO)(JECFA),,GRAS,()GRASGRAS,,,FDA,,,,FDAGRASGRAS,FDA;FDA,(Pre-market),FDAFDA(FDAhasnoquestion),FDA,GRASGRASGRAS;GRASGRAS,©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.:,(195811,,),212GRAS21211(tobesafe);21212(undertheconditionsofitsintendeduse);21213(amongexpertsqualifiedbyscientifictrainingandexperiencetoevaluateitssafety)(generallyrecog2nized);21214,,(scientificprocedures;experiencebasedoncommonuseinfood)3GRAS311GRAS(TechnicalStandard):31111(scientificprocedures),31112(experiencebasedoncommonuse)19581,,,FDA:,312GRAS(GenerallyRecognizedStandard),:31211,;312123121211(Generallyavailable)()3121212(Generallyacceptable)(consensus)313GRASGRAS:31311GRAS,GRAS,,313121958,GRASFDAFDA4FDAGRAS411GRAS(GRASList1958)19581972,GRAS1958,FDA1958,,,GRAS,GRAS(CodeofFederalRegula2©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.)21CFR182582GRAS,GRASGRAS,,412GRAS(GRASAffirmationProcess)19721997GRASFDAGRAS,FDAGRAS,FDA,413GRAS(GRASNotification)1997,GRAS1997FDAGRASGRAS,GRAS,FDAGRAS,GRASFDAFDAGRAS,GRAS,,GRAS,,FDAFDAGRAS;5GRAS(NotificationProcedure)GRAS,GRAS21CFR170130,GRAS,FDAGRAS511(GeneralRequirements)51111FDA,GRAS,FDA,FDA,GRAS51112GRAS,FDA,512(SpecificRequirements)FDA90,FDA,FDA51211GRAS(ExemptionClaim)GRASGRAS,GRAS,FDA,GRASGRAS,,,CAS,(EnzymeCommis2sionNumber),,,,,,GRASGRAS,GRASGRAS,,FDA,,GRAS:GRASFDA,FDA,FDA51212(IdentityandSpecifications)©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(),,CAS(CAS#),(EC),,,,(),,,//,,FDA(FoodChemicalsCodex,FCC),FCC90051213(Self-limitingLev2elsofUse),,,,,,GRAS,51214GRAS(ScientificProce2duresGRASDetermination),,GRAS,,,FDA,GRAS,,GRAS,GRASGRASGRAS,GRAS,,GRAS,,GRAS,,,(totali2ty),51215(CommonUseGRASDeter2mination)GRAS,FDA,,1958,,,GRAS,,195811,,(Polysorbates)195811,GRAS,GRAS,GRAS,GRASGRASGRASGRAS1958©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(AcknowledgmentofReceipt)FDA30,FDA5131290(90-DayResponseLet2ter)FDAGRAS,,FDAGRAS,GRASFDAGRAS,FDAGRAS:(1);(2);(3)FDA;(4)GRASFDA90(1)FDAGRAS(FDAhasnoquestion),FDAGRAS;(2)FDA,FDA51313FDAFDA,FDAGRAS(FDAGRASGRAS),FDA,FDA90,,FDA514(Appeals),FDAFDAFDAGRAS,,,FDA5141121CFR10175,FDAFDA(FDA)51412FDAFDA51413FDAFDA51414FDAGRAS,FDAFDA,515(PublicDisclosureandAccessibility)51511(PublicDisclosure)GRAS170136(f)(1)GRASGRAS,,,GRAS,(confidential)FDA,©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(PublicAccessibility)FDAFDA,:(1)FDAGRAS;(2)FDA;(3)FDA516(Inventory)170136(f)(2)FDA,FDAGRASFDA,FDA,,FDAGRASFDA:[1]GuidanceforIndustry:FrequentlyAskedQuestionsAboutGRAS,CFSAN/OfficeofFoodAdditiveSafetyDecember2004[2]REGULATORYREPORT:FDA’sGRASNotificationProgramWorks,REPRODUCEDFROMFOODSAFETYMAGAZINE,DECEMBER2005/JANUARY2006[3]FDAsApproachtotheGRASProvision:AHistoryofProces2ses,ExcerptedfromPosterPresentationattheFDAScienceFo2rum-April2006.[4]Title21CFR170,Section170.3:Definition[5]Title21CFR170,Section170.30:Eligibilityforclassificationasgenerallyrecognizedassafe(GRAS)[6]Title21CFR170,Section170.35:Affirmationofgenerallyrecognizedassafe(GRAS)status[7]SubstancesGenerallyRecognizedasSafe;ProposedRule.FoodandDrugAdministration,DepartmentofHealthandHumanServices,FederalRegister:April17,1997(Volume62,Number74)!2010323-25:(78)(77)(99)::010-59795833:010-59071335,59071336: