《21CFR170美国的食品添加剂允许使用限量》由会员分享，可在线阅读，更多相关《21CFR170美国的食品添加剂允许使用限量（4页珍藏版）》请在金锄头文库上搜索。
1、SUBCHAPTERBFOODFORHUMANCONSUMPTION#PART170FOODADDITIVESSubpartAGeneralProvisionsSec.170.3Definitions.170.6Opinionlettersonfoodadditivestatus.170.10Foodadditivesinstandardizedfoods.170.15AdoptionofregulationoninitiativeofCommissioner.170.17 xemptionforinvestigationaluseandprocedureforobtainingauthori
2、zationtomarketedibleproductsfromexperimentalanimals.170.18 Tolerancesforrelatedfoodadditives.170.19 Pesticidechemicalsinprocessedfoods.SubpartBFoodAdditiveSafety170.20 Generalprinciplesforevaluatingthesafetyoffoodadditives.170.22Safetyfactorstobeconsidered.170.30Eligibilityforclassificationasgeneral
3、lyrecognizedassafe(GRAS).170.35Affirmationofgenerallyrecognizedassafe(GRAS)status.170.38Determinationoffoodadditivestatus.170.39Thresholdofregulationforsubstancesusedinfood-contactarticles.SubpartCSpecificAdministrativeRulingsandDecisions170.45Fluorine-containingcompounds.170.50Glycine(aminoaceticac
4、id)infoodforhumanconsumption.170.60Nitritesand/ornitratesincuringpremixes.AUTHORITY:21U.S.C.321,341,342,346a,348,371.SOURCE:42FR14483,Mar.15,1977,unlessotherwisenoted.EDITORIALNOTE:Nomenclaturechangestopart170appearat66FR56035,Nov.6,2001.SubpartAGeneralProvisions170.3Definitions.Forthepurposesofthis
5、subchapter,thefollowingdefinitionsapply:(a) SecretarymeanstheSecretaryofHealthandHumanServices.(b) DepartmentmeanstheDepartmentofHealthandHumanServices.(c) CommissionermeanstheCommissionerofFoodandDrugs.(d) Asusedinthispart,thetermactmeanstheFederalFood,Drug,andCosmeticActapprovedJune25,1936,52Stat.
6、1040etseq.,asamended(21U.S.C.301-392).(e) (1)Foodadditivesincludesallsubstancesnotexemptedbysection201(s)oftheact,theintendeduseofwhichresultsormayreasonablybeexpectedtoresult,directlyorindirectly,eitherintheirbecomingacomponentoffoodorotherwiseaffectingthecharacteristicsoffood.Amaterialusedinthepro
7、ductionofcontainersandpackagesissubjecttothedefinitionifitmayreasonablybeexpectedtobecomeacomponent,ortoaffectthecharacteristics,directlyorindirectly,offoodpackedinthecontainer.Affectingthecharacteristicsoffooddoesnotincludesuchphysicaleffects,asprotectingcontentsofpackages,preservingshape,andpreven
8、tingmoistureloss.Ifthereisnomigrationofapackagingcomponentfromthepackagetothefood,itdoesnotbecomeacomponentofthefoodandthusisnotafoodadditive.Asubstancethatdoesnotbecomeacomponentoffood,butthatisused,forexample,inpreparinganingredientofthefoodtogiveadifferentflavor,texture,orothercharacteristicinthe
9、food,maybeafoodadditive.(2) Usesoffoodadditivesnotrequiringalistingregulation.Substancesusedinfood-contactarticles(e.g.,food-packagingandfood-processingequipment)thatmigrate,ormaybeexpectedtomigrate,intofoodatsuchnegligiblelevelsthattheyhavebeenexemptedfromregulationasfoodadditivesunder170.39.(f) Co
10、mmonuseinfoodmeansasubstantialhistoryofconsumptionofasubstanceforfoodusebyasignificantnumberofconsumers.(g) Thewordsubstanceinthedefinitionofthetermfoodadditiveincludesafoodorfoodcomponentconsistingofoneormoreingredients.(h) Scientificproceduresincludethosehuman,animal,analytical,andotherscientifics
11、tudies,whetherpublishedorunpublished,appropriatetoestablishthesafetyofasubstance.(i) Safeorsafetymeansthatthereisareasonablecertaintyinthemindsofcompetentscientiststhatthesubstanceisnotharmfulundertheintendedconditionsofuse.Itisimpossibleinthepresentstateofscientificknowledgetoestablishwithcompletec
12、ertaintytheabsoluteharmlessnessoftheuseofanysubstance.Safetymaybedeterminedbyscientificproceduresorbygeneralrecognitionofsafety.Indeterminingsafety,thefollowingfactorsshallbeconsidered:(1) Theprobableconsumptionofthesubstanceandofanysubstanceformedinoronfoodbecauseofitsuse.(2) Thecumulativeeffectoft
13、hesubstanceinthediet,takingintoaccountanychemicallyorpharmacologicallyrelatedsubstanceorsubstancesinsuchdiet.(3) Safetyfactorswhich,intheopinionofexpertsqualifiedbyscientifictrainingandexperiencetoevaluatethesafetyoffoodandfoodingredients,aregenerallyrecognizedasappropriate.(j) Thetermnonperishablep
14、rocessedfoodmeansanyprocessedfoodnotsubjecttorapiddecayordeteriorationthatwouldrenderitunfitforconsumption.Examplesareflour,sugar,cereals,packagedcookies,andcrackers.Notincludedarehermeticallysealedfoodsormanufactureddairyproductsandotherprocessedfoodsrequiringrefrigeration.(k) Generalrecognitionofs
15、afetyshallbedeterminedinaccordancewith170.30.(l) PriorsanctionmeansanexplicitapprovalgrantedwithrespecttouseofasubstanceinfoodpriortoSeptember6,1958,bytheFoodandDrugAdministrationortheUnitedStatesDepartmentofAgriculturepursuanttotheFederalFood,Drug,andCosmeticAct,thePoultryProductsInspectionAct,orth
16、eMeatInspectionAct.(m) Foodincludeshumanfood,substancesmigratingtofoodfromfoodcontactarticles,petfood,andanimalfeed.(n) Thefollowinggeneralfoodcategoriesareestablishedtogroupspecificrelatedfoodstogetherforthepurposeofestablishingtolerancesorlimitationsfortheuseofdirecthumanfoodingredients.Individualfoodproductswillbeincludedwithinthesecategoriesaccordingtothedetailedclassific
