21 CFR Part 170 食品添加剂标准

[CodeofFederalRegulations][Title21,Volume3]

[CITE:21CFR170]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION

DEPARTMENTOFHEALTHANDHUMANSERVICES

SUBCHAPTERB-FOODFORHUMANCONSUMPTION(CONTINUED)

PART170FOODADDITIVES

SubpartA-GeneralProvisions

Sec.170.3Definitions.

Forthepurposesofthissubchapter,thefollowingdefinitionsapply:

(a)SecretarymeanstheSecretaryofHealthandHumanServices.

(b)DepartmentmeanstheDepartmentofHealthandHumanServices.

(c)CommissionermeanstheCommissionerofFoodandDrugs.

(d)Asusedinthispart,thetermactmeanstheFederalFood,Drug,andCosmeticActapprovedJune25,1936,52Stat.1040etseq.,asamended(21U.S.C.301-392).

(e)(1)Foodadditivesincludesallsubstancesnotexemptedby

section201(s)oftheact,theintendeduseofwhichresultsormayreasonablybeexpectedtoresult,directlyorindirectly,

eitherintheirbecomingacomponentoffoodorotherwise

affectingthecharacteristicsoffood.Amaterialusedinthe

productionofcontainersandpackagesissubjecttothe

definitionifitmayreasonablybeexpectedtobecomea

component,ortoaffectthecharacteristics,directlyor

indirectly,offoodpackedinthecontainer."Affectingthe

characteristicsoffood"doesnotincludesuchphysicaleffects,asprotectingcontentsofpackages,preservingshape,and

preventingmoistureloss.Ifthereisnomigrationofapackagingcomponentfromthepackagetothefood,itdoesnotbecomea

componentofthefoodandthusisnotafoodadditive.A

substancethatdoesnotbecomeacomponentoffood,butthatis

used,forexample,inpreparinganingredientofthefoodtogive

adifferentflavor,texture,orothercharacteristicinthefood,maybeafoodadditive.

(2)Usesoffoodadditivesnotrequiringalisting

regulation.Useofasubstanceinafoodcontactarticle(e.g.,

food-packagingorfood-processingequipment)wherebythe

substancemigrates,ormayreasonablybeexpectedtomigrate,intofoodatsuchlevelsthattheusehasbeenexemptedfrom

regulationasafoodadditiveunder§170.39,andfoodcontact

substancesusedinaccordancewithanotificationsubmittedundersection409(h)oftheactthatiseffective.

(3)Afoodcontactsubstanceisanysubstancethatisintendedforuseasacomponentofmaterialsusedinmanufacturing,

packing,packaging,transporting,orholdingfoodifsuchuseisnotintendedtohaveanytechnicaleffectinsuchfood.

(f)Commonuseinfoodmeansasubstantialhistoryofconsumptionofasubstanceforfoodusebyasignificantnumberofconsumers.

(g)Thewordsubstanceinthedefinitionoftheterm"food

additive"includesafoodorfoodcomponentconsistingofoneormoreingredients.

(h)Scientificproceduresincludetheapplicationofscientific

data(including,asappropriate,datafromhuman,animal,analytical,orotherscientificstudies),information,andmethods,whetherpublishedorunpublished,aswellasthe

applicationofscientificprinciples,appropriatetoestablishthesafetyofasubstanceundertheconditionsofitsintendeduse.

(i)Safeorsafetymeansthatthereisareasonablecertaintyinthemindsofcompetentscientiststhatthesubstanceisnot

harmfulundertheconditionsofitsintendeduse.Itis

impossibleinthepresentstateofscientificknowledgeto

establishwithcompletecertaintytheabsoluteharmlessnessof

theuseofanysubstance.Safetymaybedeterminedbyscientificproceduresorbygeneralrecognitionofsafety.Indetermining

safety,thefollowingfactorsshallbeconsidered:

(1)Theprobableconsumptionofthesubstanceandofanysubstanceformedinoronfoodbecauseofitsuse.

(2)Thecumulativeeffectofthesubstanceinthediet,takingintoaccountanychemicallyorpharmacologicallyrelated

substanceorsubstancesinsuchdiet.

(3)Safetyfactorswhich,intheopinionofexpertsqualifiedbyscientifictrainingandexperiencetoevaluatethesafetyoffoodandfoodingredients,aregenerallyrecognizedasappropriate.

(j)Thetermnonperishableprocessedfoodmeansanyprocessedfoodnotsubjecttorapiddecayordeteriorationthatwould

renderitunfitforconsumption.Examplesareflour,sugar,cereals,packagedcookies,andcrackers.Notincludedare

hermeticallysealedfoodsormanufactureddairyproductsandotherprocessedfoodsrequiringrefrigeration.

(k)Generalrecognitionofsafetyshallbeinaccordancewith§170.30.

(l)Priorsanctionmeansanexplicitapprovalgrantedwith

respecttouseofasubstanceinfoodpriortoSeptember6,1958,bytheFoodandDrugAdministrationortheUnitedStates

DepartmentofAgriculturepursuanttotheFederalFood,Drug,andCosmeticAct,thePoultryProductsInspectionAct,ortheMeat

InspectionAct.

(m)Foodincludeshumanfood,substancesmigratingtofoodfromfood-contactarticles,petfood,andanimalfeed.

(n)Thefollowinggeneralfoodcategoriesareestablishedtogroupspecificrelatedfoodstogetherforthepurposeof

establishingtolerancesorlimitationsfortheuseofdirect

humanfoodingredients.IndividualfoodproductswillbeincludedwithinthesecategoriesaccordingtothedetailedclassificationslistscontainedinExhibit33BofthereportoftheNational

AcademyofSciences/NationalResearchCouncilreport,"A

ComprehensiveSurveyofIndustryontheUseofFoodChemicalsGenerallyRecognizedasSafe"(September1972),whichis

incorporatedbyreference.CopiesareavailablefromtheNational

TechnicalInformationService(NTIS),5285PortRoyalRd.,

Springfield,VA22161,orattheNationalArchivesandRecordsAdministration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call202-741-6030,orgo

to:/federal_register/code_of_federal_regulations/ibrlocations.html.

(1)Bakedgoodsandbakingmixes,includingallready-to-eatandready-to-bakeproducts,flours,andmixesrequiringpreparationbeforeserving.

(2)Beverages,alcoholic,includingmaltbeverages,wines,distilledliquors,andcocktailmix.

(3)Beveragesandbeveragebases,nonalcoholic,includingonlyspecialorspicedteas,softdrinks,coffeesubstitutes,and

fruitandvegetableflavoredgelatindrinks.

(4)Breakfastcereals,includingready-to-eatandinstantandregularhotcereals.

(5)Cheeses,includingcurdandwheycheeses,cream,natural,grating,processed,spread,dip,andmiscellaneouscheeses.

(6)Chewinggum,includingallforms.

(7)Coffeeandtea,includingregular,decaffeinated,andinstanttypes.

(8)Condimentsandrelishes,includingplainseasoningsaucesandspreads,olives,pickles,andrelishes,butnotspicesorherbs.

(9)Confectionsandfrostings,includingcandyandflavored

frostings,marshmallows,bakingchocolate,andbrown,lump,rock,maple,powdered,andrawsugars.

(10)Dairyproductanalogs,includingnondairymilk,frozenorliquidcreamers,coffeewhiteners,toppings,andothernondairyproducts.

(11)Eggproducts,includingliquid,frozen,ordriedeggs,andeggdishesmadetherefrom,i.e.,eggroll,eggfooyoung,egg

salad,andfrozenmulticourseeggmeals,butnotfresheggs.

(12)Fatsandoils,includingmargarine,dressingsforsalads,butter,saladoils,shorteningsandcookingoils.

(13)Fishproducts,includingallpreparedmaindishes,salads,appetizers,frozenmulticoursemeals,andspreadscontaining

fish,shellfish,andotheraquaticanimals,butnotfreshfish.

(14)Fresheggs,includingcookedeggsandeggdishesmadeonlyfromfreshshelleggs.

(15)Freshfish,includingonlyfreshandfrozenfish,shellfish,andotheraquaticanimals.

(16)Freshfruitsandfruitjuices,includingonlyrawfruits,

citrus,melons,andberries,andhome-prepared"ades"andpunchesmadetherefrom.

(17)Freshmeats,includingonlyfreshorhome-frozenbeefor

veal,pork,lambormuttonandhome-preparedfreshmeat-

containingdishes,salads,appetizers,orsandwichspreadsmadetherefrom.

(18)Freshpoultry,includingonlyfreshorhome-frozenpoultry

andgamebirdsandhome-preparedfreshpoultry-containingdishes,salads,appetizers,orsandwichspreadsmadetherefrom.

(19)Freshvegetables,tomatoes,andpotatoes,includingonlyfreshandhome-preparedvegetables.

(20)Frozendairydessertsandmixes,includingicecream,ice

milks,sherbets,andotherfrozendairydessertsandspecialties.

(21)Fruitandwaterices,includingallfrozenfruitandwaterices.

(22)Gelatins,puddings,andfillings,includingflavoredgelatindesserts,puddings,custards,parfaits,piefillings,andgelatinbasesalads.

(23)Grainproductsandpastas,includingmacaroniandnoodle

products,ricedishes,andfrozenmulticoursemeals,withoutmeatorvegetables.

(24)Graviesandsauces,includingallmeatsaucesandgravies,andtomato,milk,buttery,andspecialtysauces.

(25)Hardcandyandcoughdrops,includingallhardtypecandies.

(26)Herbs,seeds,spices,seasonings,blends,extracts,and

flavorings,includingallnaturalandartificialspices,blends,andflavors.

(27)Jamsandjellies,home-prepared,includingonlyhome-preparedjams,jellies,fruitbutters,preserves,andsweetspreads.

(28)Jamsandjellies,commercial,includingonlycommerciallyprocessedjams,jellies,fruitbutters,preserves,andsweet

spreads.

(29)Meatproducts,includingallmeatsandmeatcontaining

dishes,salads,appetizers,frozenmulticoursemeatmeals,andsandwichingredientspreparedbycommercialprocessingorusingcommerciallyprocessedmeatswithhomepreparation.

(30)Milk,wholeandskim,includingonlywhole,lowfat,andskimfluidmilks.

(31)Milkproducts,includingflavoredmilksandmilkdrinks,drymilks,toppings,snackdips,spreads,weightcontrolmilk

beverages,andothermilkoriginproducts.

(32)Nutsandnutproducts,includingwholeorshelledtreenuts,peanuts,coconut,andnutandpeanutspreads.

(33)Plantproteinproducts,includingtheNationalAcademyofSciences/NationalResearchCouncil"reconstitutedvegetable

protein"category,andmeat,poultry,andfishsubstitutes,analogs,andextenderproductsmadefromplantproteins.

(34)Poultryproducts,includingallpoultryandpoultry-

containingdishes,salads,appetizers,frozenmulticoursepoultrymeals,andsandwichingredientspreparedbycommercialprocessingorusingcommerciallyprocessedpoultrywithhomepreparation.

(35)Processedfruitsandfruitjuices,includingall

commerciallyprocessedfruits,citrus,berries,andmixtures;salads,juicesandjuicepunches,concentrates,dilutions,

"ades",anddrinksubstitutesmadetherefrom.

(36)Processedvegetablesandvegetablejuices,includingallcommerciallyprocessedvegetables,vegetabledishes,frozen

multicoursevegetablemeals,andvegetablejuicesandblends.

(37)Snackfoods,includingchips,pretzels,andothernoveltysnacks.

(38)Softcandy,includingcandybars,chocolates,fudge,mints,andotherchewyornougatcandies.

(39)Soups,home-prepared,includingmeat,fish,poultry,vegetable,andcombinationhome-preparedsoups.

(40)Soupsandsoupmixes,includingcommerciallypreparedmeat,fish,poultry,vegetable,andcombinationsoupsandsoupmixes.

(41)Sugar,white,granulated,includingonlywhitegranulatedsugar.

(42)Sugarsubstitutes,includinggranulated,liquid,andtabletsugarsubstitutes.

(43)Sweetsauces,toppings,andsyrups,includingchocolate,berry,fruit,cornsyrup,andmaplesweetsaucesandtoppings.

(o)Thefollowingtermsdescribethephysicalortechnical

functionaleffectsforwhichdirecthumanfoodingredientsmaybeaddedtofoods.TheyareadoptedfromtheNationalAcademyof

Sciences/NationalResearchCouncilnationalsurveyoffood

industries,reportedtotheFoodandDrugAdministrationunder

thecontracttitle"AComprehensiveSurveyofIndustryontheUseofFoodChemicalsGenerallyRecognizedasSafe"(September1972),whichisincorporatedbyreference.Copiesareavailablefromthe

NationalTechnicalInformationService(NTIS),5285PortRoyalRd.,Springfield,VA22161,orattheNationalArchivesand

RecordsAdministration(NARA).Forinformationonthe

availabilityofthismaterialatNARA,call202-741-6030,orgo

to:/federal_register/code_of_federal_regulations/ibrlocations.html.

(1)Anticakingagentsandfree-flowagents:Substancesaddedtofinelypowderedorcrystallinefoodproductstopreventcaking,lumping,oragglomeration.

(2)Antimicrobialagents:Substancesusedtopreservefoodbypreventinggrowthofmicroorganismsandsubsequentspoilage,

includingfungistats,moldandropeinhibitors,andtheeffectslistedbytheNationalAcademyofSciences/NationalResearch

Councilunder"preservatives."

(3)Antioxidants:Substancesusedtopreservefoodbyretardingdeterioration,rancidity,ordiscolorationduetooxidation.

(4)Colorsandcoloringadjuncts:Substancesusedtoimpart,

preserve,orenhancethecolororshadingofafood,including

colorstabilizers,colorfixatives,color-retentionagents,etc.

(5)Curingandpicklingagents:Substancesimpartingauniqueflavorand/orcolortoafood,usuallyproducinganincreaseinshelflifestability.

(6)Doughstrengtheners:Substancesusedtomodifystarchandgluten,therebyproducingamorestabledough,includingthe

applicableeffectslistedbytheNationalAcademyof

Sciences/NationalResearchCouncilunder"doughconditioner."

(7)Dryingagents:Substanceswithmoisture-absorbingability,usedtomaintainanenvironmentoflowmoisture.

(8)Emulsifiersandemulsifiersalts:Substanceswhichmodifysurfacetensioninthecomponentphaseofanemulsionto

establishauniformdispersionoremulsion.

(9)Enzymes:Enzymesusedtoimprovefoodprocessingandthequalityofthefinishedfood.

(10)Firmingagents:Substancesaddedtoprecipitateresidualpectin,thusstrengtheningthesupportingtissueandpreventingitscollapseduringprocessing.

(11)Flavorenhancers:Substancesaddedtosupplement,enhance,ormodifytheoriginaltasteand/oraromaofafood,without

impartingacharacteristictasteoraromaofitsown.

(12)Flavoringagentsandadjuvants:Substancesaddedtoimpartorhelpimpartatasteoraromainfood.

(13)Flourtreatingagents:Substancesaddedtomilledflour,atthemill,toimproveitscolorand/orbakingqualities,includingbleachingandmaturingagents.

(14)Formulationaids:Substancesusedtopromoteorproducea

desiredphysicalstateortextureinfood,includingcarriers,

binders,fillers,plasticizers,film-formers,andtabletingaids,etc.

(15)Fumigants:Volatilesubstancesusedforcontrollinginsectsorpests.

(16)Humectants:Hygroscopicsubstancesincorporatedinfoodtopromoteretentionofmoisture,includingmoisture-retention

agentsandantidustingagents.

(17)Leaveningagents:Substancesusedtoproduceorstimulateproductionofcarbondioxideinbakedgoodstoimpartalight

texture,includingyeast,yeastfoods,andcalciumsaltslistedbytheNationalAcademyofSciences/NationalResearchCouncil

under"doughconditioners."

(18)Lubricantsandreleaseagents:Substancesaddedtofoodcontactsurfacestopreventingredientsandfinishedproductsfromstickingtothem.

(19)Non-nutritivesweeteners:Substanceshavinglessthan2percentofthecaloricvalueofsucroseperequivalentunitofsweeteningcapacity.

(20)Nutrientsupplements:Substanceswhicharenecessaryforthebody'snutritionalandmetabolicprocesses.

(21)Nutritivesweeteners:Substanceshavinggreaterthan2

percentofthecaloricvalueofsucroseperequivalentunitofsweeteningcapacity.

(22)Oxidizingandreducingagents:Substanceswhichchemicallyoxidizeorreduceanotherfoodingredient,therebyproducinga

morestableproduct,includingtheapplicableeffectlistedby

theNationalAcademyofSciences/NationalResearchCouncilunder"doughconditioners."

(23)pHcontrolagents:Substancesaddedtochangeormaintainactiveacidityorbasicity,includingbuffers,acids,alkalies,andneutralizingagents.

(24)Processingaids:Substancesusedasmanufacturingaidstoenhancetheappealorutilityofafoodorfoodcomponent,

includingclarifyingagents,cloudingagents,catalysts,

flocculents,filteraids,andcrystallizationinhibitors,etc.

(25)Propellants,aeratingagents,andgases:Gasesusedto

supplyforcetoexpelaproductorusedtoreducetheamountofoxygenincontactwiththefoodinpackaging.

(26)Sequestrants:Substanceswhichcombinewithpolyvalentmetalionstoformasolublemetalcomplex,toimprovethe

qualityandstabilityofproducts.

(27)Solventsandvehicles:Substancesusedtoextractordissolveanothersubstance.

(28)Stabilizersandthickeners:Substancesusedtoproduceviscoussolutionsordispersions,toimpartbody,improve

consistency,orstabilizeemulsions,includingsuspendingandbodyingagents,settingagents,jellyingagents,andbulkingagents,etc.

(29)Surface-activeagents:Substancesusedtomodifysurfacepropertiesofliquidfoodcomponentsforavarietyofeffects,otherthanemulsifiers,butincludingsolubilizingagents,

dispersants,detergents,wettingagents,rehydrationenhancers,whippingagents,foamingagents,anddefoamingagents,etc.

(30)Surface-finishingagents:Substancesusedtoincrease

palatability,preservegloss,andinhibitdiscolorationoffoods,includingglazes,polishes,waxes,andprotectivecoatings.

(31)Synergists:Substancesusedtoactorreactwithanotherfoodingredienttoproduceatotaleffectdifferentorgreaterthanthesumoftheeffectsproducedbytheindividual

ingredients.

(32)Texturizers:Substanceswhichaffecttheappearanceorfeelofthefood.

[42FR14483,Mar.15,1977,asamendedat47FR11835,Mar.19,1982;53FR16546,May10,1988;54FR24896,June12,1989;60FR36595,July17,1995;67FR35729,May21,2002;81FR55047,Aug.17,2016]

Sec.170.6Opinionlettersonfoodadditivestatus.

(a)OvertheyearstheFoodandDrugAdministrationhasgiven

informalwrittenopinionstoinquiriesastothesafetyof

articlesintendedforuseascomponentsof,orincontactwith,food.PriortotheenactmentoftheFoodAdditivesAmendmentof1958(Pub.L.85-929;Sept.6,1958),theseopinionsweregivenpursuanttosection402(a)(1)oftheFederalFood,Drug,and

CosmeticAct,whichreadsinpart:"Afoodshallbedeemedtobeadulteratedifitbearsorcontainsanypoisonousordeleterioussubstancewhichmayrenderitinjurioustohealth".

(b)SinceenactmentoftheFoodAdditivesAmendment,theFoodandDrugAdministrationhasadvisedsuchinquirersthatanarticle:

(1)Isafoodadditivewithinthemeaningofsection201(s)oftheact;or

(2)Isgenerallyrecognizedassafe(GRAS);or

(3)Haspriorsanctionorapprovalunderthatamendment;or

(4)Isnotafoodadditiveundertheconditionsofintendeduse.

(c)Intheinterestofthepublichealth,sucharticleswhichhavebeenconsideredinthepastbytheFoodandDrug

Administrationtobesafeundertheprovisionsofsection402(a)(1),ortobegenerallyrecognizedassafefortheir

intendeduse,ortohavepriorsanctionorapproval,ornottobefoodadditivesundertheconditionsofintendeduse,mustbe

reexaminedinthelightofcurrentscientificinformationand

currentprinciplesforevaluatingthesafetyoffoodadditivesiftheiruseistobecontinued.

(d)Becauseofthetimespaninvolved,copiesofmanyofthe

lettersinwhichtheFoodandDrugAdministrationhasexpressed

aninformalopinionconcerningthestatusofsucharticlesmaynolongerbeinthefileoftheFoodandDrugAdministration.Intheabsenceofinformationconcerningthenamesandusesmadeofallthearticlesreferredtoinsuchletters,theirsafetyofuse

cannotbereexamined.Forthisreasonallfoodadditivestatusopinionsofthekinddescribedinparagraph(c)ofthissectiongivenbytheFoodandDrugAdministrationareherebyrevoked.

(e)Theprioropinionsofthekinddescribedinparagraph(c)ofthissectionwillbereplacedbyqualifiedandcurrentopinionsiftherecipientofeachsuchletterforwardsacopyofeachtotheDepartmentofHealthandHumanServices,FoodandDrug

Administration,CenterforFoodSafetyandAppliedNutrition,

5001CampusDr.,CollegePark,MD20740,alongwithacopyofhisletterofinquiry,onorbeforeJuly23,1970.

(f)ThissectiondoesnotapplytofoodadditivestatusopinionletterspertainingtoarticlesthatwereconsideredbytheFoodandDrugAdministrationtobefoodadditivesnortoarticles

includedinregulationsinparts170through189ofthischapterifthearticlesareusedinaccordancewiththerequirementsofsuchregulations.

[42FR14483,Mar.15,1977,asamendedat54FR24896,June12,1989;81FR49896,July29,2016]

Sec.170.10Foodadditivesinstandardizedfoods.

(a)Theinclusionoffoodingredientsinparts170through189ofthischapterdoesnotimplythattheseingredientsmaybeusedinstandardizedfoodsunlesstheyarerecognizedasoptional

ingredientsinapplicablefoodstandards.Whereapetitionis

receivedfortheissuanceoramendmentofaregulation

establishingadefinitionandstandardofidentityforafood

undersection401oftheAct,whichproposestheinclusionofafoodadditiveinsuchdefinitionandstandardofidentity,theprovisionsoftheregulationsinthispartshallapplywith

respecttotheinformationthatmustbesubmittedwithrespecttothefoodadditive.Sincesection409(b)(5)oftheActrequires

thattheSecretarypublishnoticeofapetitionforthe

establishmentofafood-additiveregulationwithin30daysafter

filing,noticeofapetitionrelatingtoadefinitionand

standardofidentityshallalsobepublishedwithinthattimelimitationifitincludesarequest,sodesignated,forthe

establishmentofaregulationpertainingtoafoodadditive.

(b)Ifapetitionforadefinitionandstandardofidentitycontainsaproposalforafood-additiveregulation,andthe

petitionerfailstodesignateitassuch,theCommissioner,upondeterminingthatthepetitionincludesaproposalforafood-

additiveregulation,shallsonotifythepetitionerandshallthereafterproceedinaccordancewiththeregulationsinthispart.

(c)Aregulationwillnotbeissuedallowingtheuseofafoodadditiveinafoodforwhichadefinitionandstandardof

identityisestablished,unlessitsissuanceisinconformity

withsection401oftheActorwiththetermsofatemporarypermitissuedunder§130.17ofthischapter.Whenthe

contemplateduseofsuchadditivecomplieswiththetermsofa

temporarypermit,thefoodadditiveregulationwillbeconditionedonsuchcomplianceandwillexpirewiththeexpirationofthetemporarypermit.

Sec.170.15AdoptionofregulationoninitiativeofCommissioner.

(a)TheCommissioneruponhisowninitiativemayproposetheissuanceofaregulationprescribing,withrespecttoany

particularuseofafoodadditive,theconditionsunderwhich

suchadditivemaybesafelyused.NoticeofsuchproposalshallbepublishedintheFederalRegisterandshallstatethereasonsfortheproposal.

(b)ActionuponaproposalmadebytheCommissionershallproceedasprovidedinpart10ofthischapter.

[42FR14486,Mar.15,1977,asamendedat42FR15673,Mar.22,1977]

Sec.170.17Exemptionforinvestigationaluseandprocedurefor

obtainingauthorizationtomarketedibleproductsfromexperimentalanimals.

Afoodadditiveorfoodcontainingafoodadditiveintendedfor

investigationalusebyqualifiedexpertsshallbeexemptfromthe

requirementsofsection409oftheActunderthefollowingconditions:

(a)Ifintendedforinvestigationaluseinvitroorinlaboratoryresearchanimals,itbearsalabelwhichstatesprominently,in

additiontotheotherinformationrequiredbytheact,thewarning:

Caution.Containsanewfoodadditiveforinvestigationaluseonlyinlaboratoryresearchanimalsorfortestsinvitro.Notforuseinhumans.

(b)Ifintendedforuseinanimalsotherthanlaboratoryresearch

animalsandiftheedibleproductsoftheanimalsaretobemarketedasfood,permissionforthemarketingoftheedibleproductsasfoodhasbeenrequestedbythesponsor,and

authorizationhasbeengrantedbytheFoodandDrug

Administrationinaccordancewith§511.1ofthischapterorby

theDepartmentofAgricultureinaccordancewith9CFR309.17,

anditbearsalabelwhichstatesprominently,inadditiontotheotherinformationrequiredbytheAct,thewarning:

Caution.Containsanewfoodadditiveforuseonlyininvestigationalanimals.Notforuseinhumans.

EdibleproductsofinvestigationalanimalsarenottobeusedforfoodunlessauthorizationhasbeengrantedbytheU.S.Foodand

DrugAdministrationorbytheU.S.DepartmentofAgriculture.

(c)Ifintendedfornonclinicallaboratorystudiesinfood-

producinganimals,thestudyisconductedincompliancewiththeregulationssetforthinpart58ofthischapter.

[42FR14483,Mar.15,1977,asamendedat43FR60021,Dec.22,1978]

Sec.170.18Tolerancesforrelatedfoodadditives.

(a)Foodadditivesthatcausesimilarorrelatedpharmacological

effectswillberegardedasaclass,andintheabsenceof

evidencetothecontrary,ashavingadditivetoxiceffectsandwillbeconsideredasrelatedfoodadditives.

(b)Tolerancesestablishedforsuchrelatedfoodadditivesmaylimittheamountofacommoncomponentthatmaybepresent,ormaylimittheamountofbiologicalactivity(suchas

cholinesteraseinhibition)thatmaybepresentormaylimitthetotalamountofrelatedfoodadditivesthatmaybepresent.

(c)Wherefoodadditivesfromtwoormorechemicalsinthesame

classarepresentinoronafood,thetoleranceforthetotalofsuchadditivesshallbethesameasthatfortheadditivehavingthelowestnumericaltoleranceinthisclass,unlessthereare

availablemethodsthatpermitquantitativedeterminationofthe

amountofeachfoodadditivepresentorunlessitisshownthatahighertoleranceisreasonablyrequiredforthecombined

additivestoaccomplishthephysicalortechnicaleffectfor

whichsuchcombinedadditivesareintendedandthatthehighertolerancewillbesafe.

(d)Whereresiduesfromtwoormoreadditivesinthesameclassarepresentinoronafoodandthereareavailablemethodsthat

permitquantitativedeterminationofeachresidue,thequantity

ofcombinedresiduesthatarewithinthetolerancemaybedeterminedasfollows:

(1)Determinethequantityofeachresiduepresent.

(2)Dividethequantityofeachresiduebythetolerancethatwouldapplyifitoccur