21CFR170美国的食品添加剂允许使用限量

1、170.321CFRCh.I(4-1-02Edition) # # SUBCHAPTERBFOODFORHUMANCONSUMPTION170.321CFRCh.I(4-1-02Edition) # # #170.321CFRCh.I(4-1-02Edition) #PART170FOODADDITIVESSubpartAGeneralProvisionsSec.170.3Definitions.170.6Opinionlettersonfoodadditivestatus.170.10Foodadditivesinstandardizedfoods.170.15Adoptionofregul

2、ationoninitiativeofCommissioner.xemptionforinvestigationaluseandprocedureforobtainingauthorizationtomarketedibleproductsfromexperimentalanimals.Tolerancesforrelatedfoodadditives.Pesticidechemicalsinprocessedfoods.SubpartBFoodAdditiveSafetyGeneralprinciplesforevaluatingthesafetyoffoodadditives.170.22

3、Safetyfactorstobeconsidered.170.30Eligibilityforclassificationasgenerallyrecognizedassafe(GRAS).170.35Affirmationofgenerallyrecognizedassafe(GRAS)status.170.38Determinationoffoodadditivestatus.170.39Thresholdofregulationforsubstancesusedinfood-contactarticles.SubpartCSpecificAdministrativeRulingsand

4、Decisions170.45Fluorine-containingcompounds.170.50Glycine(aminoaceticacid)infoodforhumanconsumption.170.60Nitritesand/ornitratesincuringpremixes.AUTHORITY:21U.S.C.321,341,342,346a,348,371.SOURCE:42FR14483,Mar.15,1977,unlessotherwisenoted.EDITORIALNOTE:Nomenclaturechangestopart170appearat66FR56035,No

5、v.6,2001.SubpartAGeneralProvisions170.3Definitions.Forthepurposesofthissubchapter,thefollowingdefinitionsapply:SecretarymeanstheSecretaryofHealthandHumanServices.DepartmentmeanstheDepartmentofHealthandHumanServices.CommissionermeanstheCommissionerofFoodandDrugs.Asusedinthispart,thetermactmeanstheFed

6、eralFood,Drug,andCosmeticActapprovedJune25,1936,52Stat.1040etseq.,asamended(21U.S.C.301-392).(1)Foodadditivesincludesallsubstancesnotexemptedbysection201(s)oftheact,theintendeduseofwhichresultsormayreasonablybeexpectedtoresult,directlyorindirectly,eitherintheirbecomingacomponentoffoodorotherwiseaffe

7、ctingthecharacteristicsoffood.Amaterialusedintheproductionofcontainersandpackagesissubjecttothedefinitionifitmayreasonablybeexpectedtobecomeacomponent,ortoaffectthecharacteristics,directlyorindirectly,offoodpackedinthecontainer.Affectingthecharacteristicsoffooddoesnotincludesuchphysicaleffects,aspro

8、tectingcontentsofpackages,preservingshape,andpreventingmoistureloss.Ifthereisnomigrationofapackagingcomponentfromthepackagetothefood,itdoesnotbecomeacomponentofthefoodandthusisnotafoodadditive.Asubstancethatdoesnotbecomeacomponentoffood,butthatisused,forexample,inpreparinganingredientofthefoodtogive

9、adifferentflavor,texture,orothercharacteristicinthefood,maybeafoodadditive.Usesoffoodadditivesnotrequiringalistingregulation.Substancesusedinfood-contactarticles(e.g.,food-packagingandfood-processingequipment)thatmigrate,ormaybeexpectedtomigrate,intofoodatsuchnegligiblelevelsthattheyhavebeenexempted

10、fromregulationasfoodadditivesunder170.39.Commonuseinfoodmeansasubstantialhistoryofconsumptionofasubstanceforfoodusebyasignificantnumberofconsumers.Thewordsubstanceinthedefinitionofthetermfoodadditiveincludesafoodorfoodcomponentconsistingofoneormoreingredients.Scientificproceduresincludethosehuman,an

11、imal,analytical,andotherscientificstudies,whetherpublishedorunpublished,appropriatetoestablishthesafetyofasubstance.Safeorsafetymeansthatthereisareasonablecertaintyinthemindsofcompetentscientiststhatthesubstanceisnotharmfulundertheintendedconditionsofuse.Itisimpossibleinthepresentstateofscientifickn

12、owledgetoestablishwithcompletecertaintytheabsoluteharmlessnessoftheuseofanysubstance.Safetymaybedeterminedbyscientificproceduresorbygeneralrecognitionofsafety.Indeterminingsafety,thefollowingfactorsshallbeconsidered:Theprobableconsumptionofthesubstanceandofanysubstanceformedinoronfoodbecauseofitsuse

13、.Thecumulativeeffectofthesubstanceinthediet,takingintoaccountanychemicallyorpharmacologicallyrelatedsubstanceorsubstancesinsuchdiet.Safetyfactorswhich,intheopinionofexpertsqualifiedbyscientifictrainingandexperiencetoevaluatethesafetyoffoodandfoodingredients,aregenerallyrecognizedasappropriate.Theter

14、mnonperishableprocessedfoodmeansanyprocessedfoodnotsubjecttorapiddecayordeteriorationthatwouldrenderitunfitforconsumption.Examplesareflour,sugar,cereals,packagedcookies,andcrackers.Notincludedarehermeticallysealedfoodsormanufactureddairyproductsandotherprocessedfoodsrequiringrefrigeration.Generalrec

15、ognitionofsafetyshallbedeterminedinaccordancewith170.30.PriorsanctionmeansanexplicitapprovalgrantedwithrespecttouseofasubstanceinfoodpriortoSeptember6,1958,bytheFoodandDrugAdministrationortheUnitedStatesDepartmentofAgriculturepursuanttotheFederalFood,Drug,andCosmeticAct,thePoultryProductsInspectionA

16、ct,ortheMeatInspectionAct.Foodincludeshumanfood,substancesmigratingtofoodfromfoodcontactarticles,petfood,andanimalfeed.Thefollowinggeneralfoodcategoriesareestablishedtogroupspecificrelatedfoodstogetherforthepurposeofestablishingtolerancesorlimitationsfortheuseofdirecthumanfoodingredients.Individualf

17、oodproductswillbeincludedwithinthesecategoriesaccordingtothedetailedclassificationslistscontainedinExhibit33BofthereportoftheNationalAcademyofSciences/NationalResearchCouncilreport,AComprehensiveSurveyofIndustryontheUseofFoodChemicalsGenerallyRecognizedasSafe(September1972),whichisincorporatedbyrefe

18、rence.CopiesareavailablefromtheNationalTechnicalInformationService(NTIS),5285PortRoyalRd.,Springfield,VA22161,oravailableforinspectionattheOfficeoftheFederalRegister,800NorthCapitolStreet,NW.,suite700,Washington,DC20408:(1)Bakedgoodsandbakingmixes,includingallready-to-eatandready-to-bakeproducts,flo

19、urs,andmixesrequiringpreparationbeforeserving.Beverages,alcoholic,includingmaltbeverages,wines,distilledliquors,andcocktailmix.Beveragesandbeveragebases,nonalcoholic,includingonlyspecialorspicedteas,softdrinks,coffeesubstitutes,andfruitandvegetableflavoredgelatindrinks.Breakfastcereals,includingread

20、y-to-eatandinstantandregularhotcereals.Cheeses,includingcurdandwheycheeses,cream,natural,grating,processed,spread,dip,andmiscellaneouscheeses.Chewinggum,includingallforms.Coffeeandtea,includingregular,decaffeinated,andinstanttypes.Condimentsandrelishes,includingplainseasoningsaucesandspreads,olives,

21、pickles,andrelishes,butnotspicesorherbs.Confectionsandfrostings,includingcandyandflavoredfrostings,marshmallows,bakingchocolate,andbrown,lump,rock,maple,powdered,andrawsugars.Dairyproductanalogs,includingnondairymilk,frozenorliquidcreamers,coffeewhiteners,toppings,andothernondairyproducts.Eggproduct

22、s,includingliquid,frozen,ordriedeggs,andeggdishesmadetherefrom,i.e.,eggroll,eggfooyoung,eggsalad,andfrozenmulticourseeggmeals,butnotfresheggs.Fatsandoils,includingmargarine,dressingsforsalads,butter,saladoils,shorteningsandcookingoils.Fishproducts,includingallpreparedmaindishes,salads,appetizers,fro

23、zenmulticoursemeals,andspreadscontainingfish,shellfish,andotheraquaticanimals,butnotfreshfish.Fresheggs,includingcookedeggsandeggdishesmadeonlyfromfreshshelleggs.Freshfish,includingonlyfreshandfrozenfish,shellfish,andotheraquaticanimals.Freshfruitsandfruitjuices,includingonlyrawfruits,citrus,melons,

24、andberries,andhome-preparedadesandpunchesmadetherefrom.Freshmeats,includingonlyfreshorhome-frozenbeeforveal,pork,lambormuttonandhome-preparedfreshmeat-containingdishes,salads,appetizers,orsandwichspreadsmadetherefrom.Freshpoultry,includingonlyfreshorhome-frozenpoultryandgamebirdsandhome-preparedfres

25、hpoultrycontainingdishes,salads,appetizers,orsandwichspreadsmadetherefrom.Freshvegetables,tomatoes,andpotatoes,includingonlyfreshandhome-preparedvegetables.Frozendairydessertsandmixes,includingicecream,icemilks,sherbets,andotherfrozendairydessertsandspecialties.Fruitandwaterices,includingallfrozenfr

26、uitandwaterices.Gelatins,puddings,andfillings,includingflavoredgelatindesserts,puddings,custards,parfaits,piefillings,andgelatinbasesalads.Grainproductsandpastas,includingmacaroniandnoodleproducts,ricedishes,andfrozenmulticoursemeals,withoutmeatorvegetables.Graviesandsauces,includingallmeatsaucesand

27、gravies,andtomato,milk,buttery,andspecialtysauces.Hardcandyandcoughdrops,includingallhardtypecandies.Herbs,seeds,spices,seasonings,blends,extracts,andflavorings,includingallnaturalandartificialspices,blends,andflavors.Jamsandjellies,home-prepared,includingonlyhome-preparedjams,jellies,fruitbutters,p

28、reserves,andsweetspreads.Jamsandjellies,commercial,includingonlycommerciallyprocessedjams,jellies,fruitbutters,preserves,andsweetspreads.Meatproducts,includingallmeatsandmeatcontainingdishes,salads,appetizers,frozenmulticoursemeatmeals,andsandwichingredientspreparedbycommercialprocessingorusingcomme

29、rciallyprocessedmeatswithhomepreparation.Milk,wholeandskim,includingonlywhole,lowfat,andskimfluidmilks.Milkproducts,includingflavoredmilksandmilkdrinks,drymilks,toppings,snackdips,spreads,weightcontrolmilkbeverages,andothermilkoriginproducts.Nutsandnutproducts,includingwholeorshelledtreenuts,peanuts

30、,coconut,andnutandpeanutspreads.Plantproteinproducts,includingtheNationalAcademyofSciences/Na-tionalResearchCouncilreconstitutedvegetableproteincategory,andmeat,poultry,andfishsubstitutes,analogs,andextenderproductsmadefromplantproteins.Poultryproducts,includingallpoultryandpoultry-containingdishes,

31、salads,appetizers,frozenmulticoursepoultrymeals,andsandwichingredientspreparedbycommercialprocessingorusingcommerciallyprocessedpoultrywithhomepreparation.Processedfruitsandfruitjuices,includingallcommerciallyprocessedfruits,citrus,berries,andmixtures;salads,juicesandjuicepunches,concentrates,diluti

32、ons,ades,anddrinksubstitutesmadetherefrom.Processedvegetablesandvegetablejuices,includingallcommerciallyprocessedvegetables,vegetabledishes,frozenmulticoursevegetablemeals,andvegetablejuicesandblends.Snackfoods,includingchips,pretzels,andothernoveltysnacks.Softcandy,includingcandybars,chocolates,fud

33、ge,mints,andotherchewyornougatcandies.Soups,home-prepared,includingmeat,fish,poultry,vegetable,andcombinationhome-preparedsoups.Soupsandsoupmixes,includingcommerciallypreparedmeat,fish,poultry,vegetable,andcombinationsoupsandsoupmixes.Sugar,white,granulated,includingonlywhitegranulatedsugar.Sugarsub

34、stitutes,includinggranulated,liquid,andtabletsugarsubstitutes.Sweetsauces,toppings,andsyrups,includingchocolate,berry,fruit,cornsyrup,andmaplesweetsaucesandtoppings.Thefollowingtermsdescribethephysicalortechnicalfunctionaleffectsforwhichdirecthumanfoodingredientsmaybeaddedtofoods.Theyareadoptedfromt

35、heNationalAcademyofSciences/NationalResearchCouncilnationalsurveyoffoodindustries,reportedtotheFoodandDrugAdministrationunderthecontracttitleAComprehensiveSurveyofIndustryontheUseofFoodChemicalsGenerallyRecognizedasSafe(September1972),whichisincorporatedbyreference.CopiesareavailablefromtheNationalT

36、echnicalInformationService(NTIS),5285PortRoyalRd.,Springfield,VA22161,oravailableforinspectionattheOfficeoftheFederalRegister,800NorthCapitolStreet,NW.,suite700,Washington,DC20408:(1)Anticakingagentsandfree-flowagents:Substancesaddedtofinelypowderedorcrystallinefoodproductstopreventcaking,lumping,or

37、agglomeration.Antimicrobialagents:Substancesusedtopreservefoodbypreventinggrowthofmicroorganismsandsubsequentspoilage,includingfungistats,moldandropeinhibitors,andtheeffectslistedbytheNationalAcademyofSciences/NationalResearchCouncilunderpreservatives.Antioxidants:Substancesusedtopreservefoodbyretar

38、dingdeterioration,rancidity,ordiscolorationduetooxidation.Colorsandcoloringadjuncts:Substancesusedtoimpart,preserve,orenhancethecolororshadingofafood,includingcolorstabilizers,colorfixatives,color-retentionagents,etc.Curingandpicklingagents:Substancesimpartingauniqueflavorand/orcolortoafood,usuallyp

39、roducinganincreaseinshelflifestability.Doughstrengtheners:Substancesusedtomodifystarchandgluten,therebyproducingamorestabledough,includingtheapplicableeffectslistedbytheNationalAcademyofSciences/NationalResearchCouncilunderdoughconditioner.Dryingagents:Substanceswithmoisture-absorbingability,usedtom

40、aintainanenvironmentoflowmoisture.Emulsifiersandemulsifiersalts:Substanceswhichmodifysurfacetensioninthecomponentphaseofanemulsiontoestablishauniformdispersionoremulsion.Enzymes:Enzymesusedtoimprovefoodprocessingandthequalityofthefinishedfood.Firmingagents:Substancesaddedtoprecipitateresidualpectin,

41、thusstrengtheningthesupportingtissueandpreventingitscollapseduringprocessing.Flavorenhancers:Substancesaddedtosupplement,enhance,ormodifytheoriginaltasteand/oraromaofafood,withoutimpartingacharacteristictasteoraromaofitsown.Flavoringagentsandadjuvants:Substancesaddedtoimpartorhelpimpartatasteoraroma

42、infood.Flourtreatingagents:Substancesaddedtomilledflour,atthemill,toimproveitscolorand/orbakingqualities,includingbleachingandmaturingagents.Formulationaids:Substancesusedtopromoteorproduceadesiredphysicalstateortextureinfood,includingcarriers,binders,fillers,plasticizers,film-formers,andtabletingai

43、ds,etc.Fumigants:Volatilesubstancesusedforcontrollinginsectsorpests.Humectants:Hygroscopicsubstancesincorporatedinfoodtopromoteretentionofmoisture,includingmoisture-retentionagentsandantidustingagents.Leaveningagents:Substancesusedtoproduceorstimulateproductionofcarbondioxideinbakedgoodstoimpartalig

44、httexture,includingyeast,yeastfoods,andcalciumsaltslistedbytheNationalAcademyofSciences/NationalResearchCouncilunderdoughconditioners.Lubricantsandreleaseagents:Substancesaddedtofoodcontactsurfacestopreventingredientsandfinishedproductsfromstickingtothem.FoodandDrugAdministration,HHS170.6FoodandDrug

45、Administration,HHS170.6 # #Non-nutritivesweeteners:Substanceshavinglessthan2percentofthecaloricvalueofsucroseperequivalentunitofsweeteningcapacity.Nutrientsupplements:Substanceswhicharenecessaryforthebodysnutritionalandmetabolicprocesses.Nutritivesweeteners:Substanceshavinggreaterthan2percentoftheca

46、loricvalueofsucroseperequivalentunitofsweeteningcapacity.Oxidizingandreducingagents:Substanceswhichchemicallyoxidizeorreduceanotherfoodingredient,therebyproducingamorestableproduct,includingtheapplicableeffectlistedbytheNationalAcademyofSciences/NationalResearchCouncilunderdoughconditioners.pHcontro

47、lagents:Substancesaddedtochangeormaintainactiveacidityorbasicity,includingbuffers,acids,alkalies,andneutralizingagents.Processingaids:Substancesusedasmanufacturingaidstoenhancetheappealorutilityofafoodorfoodcomponent,includingclarifyingagents,cloudingagents,catalysts,flocculents,filteraids,andcrysta

48、llizationinhibitors,etc.Propellants,aeratingagents,andgases:Gasesusedtosupplyforcetoexpelaproductorusedtoreducetheamountofoxygenincontactwiththefoodinpackaging.Sequestrants:Substanceswhichcombinewithpolyvalentmetalionstoformasolublemetalcomplex,toimprovethequalityandstabilityofproducts.Solventsandve

49、hicles:Substancesusedtoextractordissolveanothersubstance.Stabilizersandthickeners:Substancesusedtoproduceviscoussolutionsordispersions,toimpartbody,improveconsistency,orstabilizeemulsions,includingsuspendingandbodyingagents,settingagents,jellyingagents,andbulkingagents,etc.Surface-activeagents:Substancesusedtomodifysurfacepropertiesofliquidfoodcomponentsforavarietyofeffects,otherthanemulsifiers,butincludingsolubilizingagents