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CFR - Code of Federal Regulations Title 21

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[CodeofFederalRegulations]
[Title21,Volume2]
[RevisedasofApril1,2015]
[CITE:21CFR101.22]

TITLE21FOODANDDRUGS
CHAPTERIFOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERBFOODFORHUMANCONSUMPTION
PART101FOODLABELING
SubpartBSpecificFoodLabelingRequirements
Sec.101.22Foodslabelingofspices,flavorings,coloringsand
chemicalpreservatives.
(a)(1)Thetermartificialflavororartificialflavoringmeansany
substance,thefunctionofwhichistoimpartflavor,whichisnot
derivedfromaspice,fruitorfruitjuice,vegetableorvegetable
juice,edibleyeast,herb,bark,bud,root,leaforsimilarplant
material,meat,fish,poultry,eggs,dairyproducts,orfermentation
productsthereof.Artificialflavorincludesthesubstanceslistedin
172.515(b)and182.60ofthischapterexceptwherethesearederived
fromnaturalsources.
(2)Thetermspicemeansanyaromaticvegetablesubstanceinthewhole,
broken,orgroundform,exceptforthosesubstanceswhichhavebeen
traditionallyregardedasfoods,suchasonions,garlicandcelery
whosesignificantfunctioninfoodisseasoningratherthan
nutritionalthatistruetonameandfromwhichnoportionofany
volatileoilorotherflavoringprinciplehasbeenremoved.Spices
includethespiceslistedin182.10andpart184ofthischapter,such
asthefollowing:
Allspice,Anise,Basil,Bayleaves,Carawayseed,Cardamon,Celery
seed,Chervil,Cinnamon,Cloves,Coriander,Cuminseed,Dillseed,
Fennelseed,Fenugreek,Ginger,Horseradish,Mace,Marjoram,Mustard
flour,Nutmeg,Oregano,Paprika,Parsley,Pepper,blackPepper,white
Pepper,redRosemary,Saffron,Sage,Savory,Staraniseed,Tarragon,
Thyme,Turmeric.
Paprika,turmeric,andsaffronorotherspiceswhicharealsocolors,
shallbedeclaredas"spiceandcoloring"unlessdeclaredbytheir
commonorusualname.
(3)Thetermnaturalflavorornaturalflavoringmeanstheessential
oil,oleoresin,essenceorextractive,proteinhydrolysate,distillate,
oranyproductofroasting,heatingorenzymolysis,whichcontainsthe
flavoringconstituentsderivedfromaspice,fruitorfruitjuice,
vegetableorvegetablejuice,edibleyeast,herb,bark,bud,root,leaf
orsimilarplantmaterial,meat,seafood,poultry,eggs,dairy
products,orfermentationproductsthereof,whosesignificantfunction
infoodisflavoringratherthannutritional.Naturalflavorsinclude
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thenaturalessenceorextractivesobtainedfromplantslistedin
182.10,182.20,182.40,and182.50andpart184ofthischapter,and
thesubstanceslistedin172.510ofthischapter.
(4)Thetermartificialcolororartificialcoloringmeansany"color
additive"asdefinedin70.3(f)ofthischapter.
(5)Thetermchemicalpreservativemeansanychemicalthat,whenadded
tofood,tendstopreventorretarddeteriorationthereof,butdoesnot
includecommonsalt,sugars,vinegars,spices,oroilsextractedfrom
spices,substancesaddedtofoodbydirectexposurethereoftowood
smoke,orchemicalsappliedfortheirinsecticidalorherbicidal
properties.
(b)Afoodwhichissubjecttotherequirementsofsection403(k)of
theactshallbearlabeling,eventhoughsuchfoodisnotinpackage
form.
(c)Astatementofartificialflavoring,artificialcoloring,or
chemicalpreservativeshallbeplacedonthefoodoronitscontainer
orwrapper,oronanytwoorallthreeofthese,asmaybenecessaryto
rendersuchstatementlikelytobereadbytheordinarypersonunder
customaryconditionsofpurchaseanduseofsuchfood.Thespecific
artificialcolorusedinafoodshallbeidentifiedonthelabeling
whensorequiredbyregulationinpart74ofthischaptertoassure
safeconditionsofuseforthecoloradditive.
(d)Afoodshallbeexemptfromcompliancewiththerequirementsof
section403(k)oftheactifitisnotinpackageformandtheunits
thereofaresosmallthatastatementofartificialflavoring,
artificialcoloring,orchemicalpreservative,asthecasemaybe,
cannotbeplacedonsuchunitswithsuchconspicuousnessastorender
itlikelytobereadbytheordinaryindividualundercustomary
conditionsofpurchaseanduse.
(e)Afoodshallbeexemptwhileheldforsalefromtherequirementsof
section403(k)oftheact(requiringlabelstatementofanyartificial
flavoring,artificialcoloring,orchemicalpreservatives)ifsaid
food,havingbeenreceivedinbulkcontainersataretail
establishment,isdisplayedtothepurchaserwitheither(1)the
labelingofthebulkcontainerplainlyinviewor(2)acountercard,
sign,orotherappropriatedevicebearingprominentlyandconspicuously
theinformationrequiredtobestatedonthelabelpursuanttosection
403(k).
(f)Afruitorvegetableshallbeexemptfromcompliancewiththe
requirementsofsection403(k)oftheactwithrespecttoachemical
preservativeappliedtothefruitorvegetableasapesticidechemical
priortoharvest.
(g)Aflavorshallbelabeledinthefollowingwaywhenshippedtoa
foodmanufacturerorprocessor(butnotaconsumer)foruseinthe
manufactureofafabricatedfood,unlessitisaflavorforwhicha
standardofidentityhasbeenpromulgated,inwhichcaseitshallbe
labeledasprovidedinthestandard:
(1)Iftheflavorconsistsofoneingredient,itshallbedeclaredby
itscommonorusualname.
(2)Iftheflavorconsistsoftwoormoreingredients,thelabeleither
maydeclareeachingredientbyitscommonorusualnameormaystate
"Allflavoringredientscontainedinthisproductareapprovedforuse
inaregulationoftheFoodandDrugAdministration."Anyflavor
ingredientnotcontainedinoneoftheseregulations,andanynonflavor
ingredient,shallbeseparatelylistedonthelabel.
(3)Incaseswheretheflavorcontainsasolelynaturalflavor(s),the
flavorshallbesolabeled,e.g.,"strawberryflavor","bananaflavor",
or"naturalstrawberryflavor".Incaseswheretheflavorcontainsboth
anaturalflavorandanartificialflavor,theflavorshallbeso
labeled,e.g.,"naturalandartificialstrawberryflavor".Incases
wheretheflavorcontainsasolelyartificialflavor(s),theflavor
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shallbesolabeled,e.g.,"artificialstrawberryflavor".
(h)Thelabelofafoodtowhichflavorisaddedshalldeclarethe
flavorinthestatementofingredientsinthefollowingway:
(1)Spice,naturalflavor,andartificialflavormaybedeclaredas
"spice","naturalflavor",or"artificialflavor",oranycombination
thereof,asthecasemaybe.
(2)Anincidentaladditiveinafood,originatinginaspiceorflavor
usedinthemanufactureofthefood,neednotbedeclaredinthe
statementofingredientsifitmeetstherequirementsof101.100(a)(3).
(3)Substancesobtainedbycutting,grinding,drying,pulping,or
similarprocessingoftissuesderivedfromfruit,vegetable,meat,
fish,orpoultry,e.g.,powderedorgranulatedonions,garlicpowder,
andcelerypowder,arecommonlyunderstoodbyconsumerstobefood
ratherthanflavorandshallbedeclaredbytheircommonorusualname.
(4)Anysalt(sodiumchloride)usedasaningredientinfoodshallbe
declaredbyitscommonorusualname"salt."
(5)Anymonosodiumglutamateusedasaningredientinfoodshallbe
declaredbyitscommonorusualname"monosodiumglutamate."
(6)Anypyroligneousacidorotherartificialsmokeflavorsusedasan
ingredientinafoodmaybedeclaredasartificialflavororartificial
smokeflavor.Norepresentationmaybemade,eitherdirectlyor
implied,thatafoodflavoredwithpyroligneousacidorother
artificialsmokeflavorhasbeensmokedorhasatruesmokedflavor,or
thataseasoningsauceorsimilarproductcontainingpyroligneousacid
orotherartificialsmokeflavorandusedtoseasonorflavorother
foodswillresultinasmokedproductoronehavingatruesmoked
flavor.
(7)Becauseproteinhydrolysatesfunctioninfoodsasbothflavorings
andflavorenhancers,noproteinhydrolysateusedinfoodforits
effectsonflavormaybedeclaredsimplyas"flavor,""naturalflavor,"
or"flavoring."Theingredientshallbedeclaredbyitsspecificcommon
orusualnameasprovidedin102.22ofthischapter.
(i)Ifthelabel,labeling,oradvertisingofafoodmakesanydirect
orindirectrepresentationswithrespecttotheprimaryrecognizable
flavor(s),byword,vignette,e.g.,depictionofafruit,orother
means,orifforanyotherreasonthemanufacturerordistributorofa
foodwishestodesignatethetypeofflavorinthefoodotherthan
throughthestatementofingredients,suchflavorshallbeconsidered
thecharacterizingflavorandshallbedeclaredinthefollowingway:
(1)Ifthefoodcontainsnoartificialflavorwhichsimulates,
resemblesorreinforcesthecharacterizingflavor,thenameofthefood
ontheprincipaldisplaypanelorpanelsofthelabelshallbe
accompaniedbythecommonorusualnameofthecharacterizingflavor,
e.g.,"vanilla",inlettersnotlessthanonehalftheheightofthe
lettersusedinthenameofthefood,exceptthat:
(i)Ifthefoodisonethatiscommonlyexpectedtocontaina
characterizingfoodingredient,e.g.,strawberriesin"strawberry
shortcake",andthefoodcontainsnaturalflavorderivedfromsuch
ingredientandanamountofcharacterizingingredientinsufficientto
independentlycharacterizethefood,orthefoodcontainsnosuch
ingredient,thenameofthecharacterizingflavormaybeimmediately
precededbytheword"natural"andshallbeimmediatelyfollowedbythe
word"flavored"inlettersnotlessthanonehalftheheightofthe
lettersinthenameofthecharacterizingflavor,e.g.,"natural
strawberryflavoredshortcake,"or"strawberryflavoredshortcake".
(ii)Ifnoneofthenaturalflavorusedinthefoodisderivedfromthe
productwhoseflavorissimulated,thefoodinwhichtheflavorisused
shallbelabeledeitherwiththeflavoroftheproductfromwhichthe
flavorisderivedoras"artificiallyflavored."
(iii)Ifthefoodcontainsbothacharacterizingflavorfromthe
productwhoseflavorissimulatedandothernaturalflavorwhich
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simulates,resemblesorreinforcesthecharacterizingflavor,thefood
shallbelabeledinaccordancewiththeintroductorytextandparagraph
(i)(1)(i)ofthissectionandthenameofthefoodshallbeimmediately
followedbythewords"withothernaturalflavor"inlettersnotless
thanonehalftheheightofthelettersusedinthenameofthe
characterizingflavor.
(2)Ifthefoodcontainsanyartificialflavorwhichsimulates,
resemblesorreinforcesthecharacterizingflavor,thenameofthefood
ontheprincipaldisplaypanelorpanelsofthelabelshallbe
accompaniedbythecommonorusualname(s)ofthecharacterizing
flavor,inlettersnotlessthanonehalftheheightoftheletters
usedinthenameofthefoodandthenameofthecharacterizingflavor
shallbeaccompaniedbytheword(s)"artificial"or"artificially
flavored",inlettersnotlessthanonehalftheheightoftheletters
inthenameofthecharacterizingflavor,e.g.,"artificialvanilla",
"artificiallyflavoredstrawberry",or"grapeartificiallyflavored".
(3)Whereverthenameofthecharacterizingflavorappearsonthelabel
(otherthaninthestatementofingredients)soconspicuouslyastobe
easilyseenundercustomaryconditionsofpurchase,thewords
prescribedbythisparagraphshallimmediatelyandconspicuously
precedeorfollowsuchname,withoutanyinterveningwritten,printed,
orgraphicmatter,except:
(i)Wherethecharacterizingflavorandatrademarkorbrandare
presentedtogether,otherwritten,printed,orgraphicmatterthatisa
partoforisassociatedwiththetrademarkorbrandmayinterveneif
therequiredwordsareinsuchrelationshipwiththetrademarkorbrand
astobeclearlyrelatedtothecharacterizingflavorand
(ii)Ifthefinishedproductcontainsmorethanoneflavorsubjectto
therequirementsofthisparagraph,thestatementsrequiredbythis
paragraphneedappearonlyonceineachstatementofcharacterizing
flavorspresentinsuchfood,e.g.,"artificiallyflavoredvanillaand
strawberry".
(iii)Ifthefinishedproductcontainsthreeormoredistinguishable
characterizingflavors,orablendofflavorswithnoprimary
recognizableflavor,theflavormaybedeclaredbyanappropriately
descriptivegenericterminlieuofnamingeachflavor,e.g.,
"artificiallyflavoredfruitpunch".
(4)Aflavorsuppliershallcertify,inwriting,thatanyflavorhe
supplieswhichisdesignatedascontainingnoartificialflavordoes
not,tothebestofhisknowledgeandbelief,containanyartificial
flavor,andthathehasaddednoartificialflavortoit.The
requirementforsuchcertificationmaybesatisfiedbyaguarantee
undersection303(c)(2)oftheactwhichcontainssuchaspecific
statement.Aflavorusershallberequiredtomakesuchawritten
certificationonlywhereheaddstoorcombinesanotherflavorwitha
flavorwhichhasbeencertifiedbyaflavorsupplierascontainingno
artificialflavor,butotherwisesuchusermayrelyuponthesupplier's
certificationandneedmakenoseparatecertification.Allsuch
certificationsshallberetainedbythecertifyingpartythroughoutthe
periodinwhichtheflavorissuppliedandforaminimumofthreeyears
thereafter,andshallbesubjecttothefollowingconditions:
(i)Thecertifyingpartyshallmakesuchcertificationsavailableupon
requestatallreasonablehourstoanydulyauthorizedofficeor
employeeoftheFoodandDrugAdministrationoranyotheremployee
actingonbehalfoftheSecretaryofHealthandHumanServices.Such
certificationsareregardedbytheFoodandDrugAdministrationas
reportstothegovernmentandasguaranteesorotherundertakings
withinthemeaningofsection301(h)oftheactandsubjectthe
certifyingpartytothepenaltiesformakinganyfalsereporttothe
governmentunder18U.S.C.1001andanyfalseguaranteeorundertaking
undersection303(a)oftheact.Thedefensesprovidedundersection
303(c)(2)oftheactshallbeapplicabletothecertificationsprovided
forinthissection.
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(ii)Whereverpossible,theFoodandDrugAdministrationshallverify
theaccuracyofareasonablenumberofcertificationsmadepursuantto
thissection,constitutingarepresentativesampleofsuch
certifications,andshallnotrequestallsuchcertifications.
(iii)Wherenopersonauthorizedtoprovidesuchinformationis
reasonablyavailableatthetimeofinspection,thecertifyingparty
shallarrangetohavesuchpersonandtherelevantmaterialsand
recordsreadyforverificationassoonaspracticable:Provided,That,
whenevertheFoodandDrugAdministrationhasreasontobelievethat
thesupplierorusermayutilizethisperiodtoalterinventoriesor
records,suchadditionaltimeshallnotbepermitted.Wheresuch
additionaltimeisprovided,theFoodandDrugAdministrationmay
requirethecertifyingpartytocertifythatrelevantinventorieshave
notbeenmateriallydisturbedandrelevantrecordshavenotbeen
alteredorconcealedduringsuchperiod.
(iv)Thecertifyingpartyshallprovide,toanofficeror
representativedulydesignatedbytheSecretary,suchqualitative
statementofthecompositionoftheflavororproductcoveredbythe
certificationasmaybereasonablyexpectedtoenabletheSecretary's
representativestodeterminewhichrelevantrawandfinishedmaterials
andflavoringredientrecordsarereasonablynecessarytoverifythe
certifications.TheexaminationconductedbytheSecretary's
representativeshallbelimitedtoinspectionandreviewofinventories
andingredientrecordsforthosecertificationswhicharetobe
verified.
(v)Reviewofflavoringredientrecordsshallbelimitedtothe
qualitativeformulaandshallnotincludethequantitativeformula.The
personverifyingthecertificationsmaymakeonlysuchnotesasare
necessarytoenablehimtoverifysuchcertification.Onlysuchnotes
orsuchflavoringredientrecordsasarenecessarytoverifysuch
certificationortoshowapotentialoractualviolationmayberemoved
ortransmittedfromthecertifyingparty'splaceofbusiness:Provided,
That,wheresuchremovalortransmittalisnecessaryforsuchpurposes
therelevantrecordsandnotesshallberetainedasseparatedocuments
inFoodandDrugAdministrationfiles,shallnotbecopiedinother
reports,andshallnotbedisclosedpubliclyotherthaninajudicial
proceedingbroughtpursuanttotheactor18U.S.C.1001.
(j)Afoodtowhichachemicalpreservative(s)isaddedshall,except
whenexemptpursuantto101.100bearalabeldeclarationstatingboth
thecommonorusualnameoftheingredient(s)andaseparate
descriptionofitsfunction,e.g.,"preservative","toretard
spoilage","amoldinhibitor","tohelpprotectflavor"or"topromote
colorretention".
(k)Thelabelofafoodtowhichanycoloringhasbeenaddedshall
declarethecoloringinthestatementofingredientsinthemanner
specifiedinparagraphs(k)(1)and(k)(2)ofthissection,exceptthat
coloringsaddedtobutter,cheese,andicecream,ifdeclared,maybe
declaredinthemannerspecifiedinparagraph(k)(3)ofthissection,
andcoloringsaddedtofoodssubjectto105.62and105.65ofthis
chaptershallbedeclaredinaccordancewiththerequirementsofthose
sections.
(1)Acoloradditiveorthelakeofacoloradditivesubjectto
certificationunder721(c)oftheactshallbedeclaredbythenameof
thecoloradditivelistedintheapplicableregulationinpart74or
part82ofthischapter,exceptthatitisnotnecessarytoincludethe
"FD&C"prefixortheterm"No."inthedeclaration,buttheterm"Lake"
shallbeincludedinthedeclarationofthelakeofthecertifiedcolor
additive(e.g.,Blue1Lake).Manufacturersmayparentheticallydeclare
anappropriatealternativenameofthecertifiedcoloradditive
followingitscommonorusualnameasspecifiedinpart74orpart82
ofthischapter.
(2)Coloradditivesnotsubjecttocertificationandnototherwise
requiredbyapplicableregulationsinpart73ofthischaptertobe
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declaredbytheirrespectivecommonorusualnamesmaybedeclaredas
"ArtificialColor,""ArtificialColorAdded,"or"ColorAdded"(orby
anequallyinformativetermthatmakesclearthatacoloradditivehas
beenusedinthefood).Alternatively,suchcoloradditivesmaybe
declaredas"Coloredwith________"or"________color,"theblankto
befilledinwiththenameofthecoloradditivelistedinthe
applicableregulationinpart73ofthischapter.
(3)Whenacoloringhasbeenaddedtobutter,cheese,oricecream,it
neednotbedeclaredintheingredientlistunlesssuchdeclarationis
requiredbyaregulationinpart73orpart74ofthischapterto
ensuresafeconditionsofuseforthecoloradditive.Voluntary
declarationofallcoloringsaddedtobutter,cheese,andicecream,
however,isrecommended.
[42FR14308,Mar.15,1977,asamendedat44FR3963,Jan.19,1979
44FR37220,June26,197954FR24891,June12,198958FR2875,
Jan.6,199363FR14818,Mar.27,199874FR216,Jan.5,2009]
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