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ThiselectronicdocumentwasdownloadedfromtheGPOwebsite,October2002,andisprovidedforinformationpurposesonly.TheCodeofFederalRegulations,Title21,isupdatedeachyearinearlysummer.ThemostcurrentversionoftheregulationsmaybefoundattheGPOwebsiteorfromthecurrentprintedversion.

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR701.1]

[Page132-133]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART701--COSMETICLABELING--TableofContents

SubpartA--GeneralProvisions

Sec.701.1Misbranding.

（a）Amongrepresentationsinlabelingofacosmeticwhichrender

suchcosmeticmisbrandedisafalseormisleadingrepresentationwith

respecttoanothercosmeticorafood,drug,ordevice.

（b）Thelabelingofacosmeticwhichcontainstwoormore

ingredientsmaybemisleadingbyreason（amongotherreasons）ofthe

designationofsuchcosmeticinsuchlabelingbyanamewhichincludes

orsuggeststhenameofoneor

[[Page133]]

morebutnotallsuchingredients,eventhoughthenamesofallsuch

ingredientsarestatedelsewhereinthelabeling.

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR701.2]

[Page133]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART701--COSMETICLABELING--TableofContents

SubpartA--GeneralProvisions

Sec.701.2Formofstatinglabelingrequirements.

（a）Aword,statement,orotherinformationrequiredbyorunder

authorityoftheActtoappearonthelabelmaylackthatprominenceand

conspicuousnessrequiredbysection602（c）oftheActbyreason（among

otherreasons）of:

（1）Thefailureofsuchword,statement,orinformationtoappearon

thepartorpanelofthelabelwhichispresentedordisplayedunder

customaryconditionsofpurchase;

（2）Thefailureofsuchword,statement,orinformationtoappearon

twoormorepartsorpanelsofthelabel,eachofwhichhassufficient

spacetherefor,andeachofwhichissodesignedastorenderitlikely

tobe,undercustomaryconditionsofpurchase,thepartorpanel

displayed;

（3）Thefailureofthelabeltoextendovertheareaofthe

containerorpackageavailableforsuchextension,soastoprovide

sufficientlabelspacefortheprominentplacingofsuchword,

statement,orinformation;

（4）Insufficiencyoflabelspace（fortheprominentplacingofsuch

word,statement,orinformation）resultingfromtheuseoflabelspace

foranyword,statement,design,ordevicewhichisnotrequiredbyor

underauthorityoftheActtoappearonthelabel;

（5）Insufficiencyoflabelspace（fortheprominentplacingofsuch

word,statement,orinformation）resultingfromtheuseoflabelspace

togivemateriallygreaterconspicuousnesstoanyotherword,statement,

orinformation,ortoanydesignordevice;

（6）Smallnessorstyleoftypeinwhichsuchword,statement,or

informationappears,insufficientbackgroundcontrast,obscuringdesigns

orvignettes,orcrowdingwithotherwritten,printed,orgraphic

matter.

（b）

（1）Allwords,statements,andotherinformationrequiredbyor

underauthorityoftheActtoappearonthelabelorlabelingshall

appearthereonintheEnglishlanguage:

Provided,however,Thatinthe

caseofarticlesdistributedsolelyintheCommonwealthofPuertoRico

orinaTerritorywherethepredominantlanguageisoneotherthan

English,thepredominantlanguagemaybesubstitutedforEnglish.

（2）Ifthelabelcontainsanyrepresentationinaforeignlanguage,

allwords,statements,andotherinformationrequiredbyorunder

authorityoftheActtoappearonthelabelshallappearthereoninthe

foreignlanguage.

（3）Ifthelabelingcontainsanyrepresentationinaforeign

language,allwords,statements,andotherinformationrequiredbyor

underauthorityoftheActtoappearonthelabelorlabelingshall

appearonthelabelingintheforeignlanguage.

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR701.3]

[Page133-139]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART701--COSMETICLABELING--TableofContents

SubpartA--GeneralProvisions

Sec.701.3Designationofingredients.

（a）Thelabeloneachpackageofacosmeticshallbearadeclaration

ofthenameofeachingredientindescendingorderofpredominance,

exceptthatfragranceorflavormaybelistedasfragranceorflavor.An

ingredientwhichisbothfragranceandflavorshallbedesignatedby

eachofthefunctionsitperformsunlesssuchingredientisidentified

byname.Noingredientmaybedesignatedasfragranceorflavorunless

itiswithinthemeaningofsuchtermascommonlyunderstoodby

consumers.WhereoneormoreingredientsisacceptedbytheFoodand

DrugAdministrationasexemptfrompublicdisclosurepursuanttothe

procedureestablishedinSec.720.8（a）ofthischapter,inlieuoflabel

declarationofidentitythephrase``andotheringredients''maybeused

attheendoftheingredientdeclaration.

（b）Thedeclarationofingredientsshallappearwithsuchprominence

andconspicuousnessastorenderitlikelytobereadandunderstoodby

ordinaryindividualsundernormalconditionsofpurchase.The

declarationshallappearonanyappropriateinformationpanelinletters

notlessthan\1/16\ofaninchinheightandwithoutobscuringdesign,

vignettes,orcrowding.Intheabsenceofsufficientspaceforsuch

declarationonthepackage,orwherethemanufacturerordistributor

wishestouseadecorativecontainer,thedeclarationmayappearona

firmlyaffixedtag,tape,orcard.Inthosecaseswhere

[[Page134]]

thereisinsufficientspaceforsuchdeclarationonthepackage,andit

isnotpracticaltofirmlyaffixatag,tape,orcard,theCommissioner

mayestablishbyregulationanacceptablealternate,e.g.,asmaller

typesize.Apetitionrequestingsucharegulationasanamendmentto

thisparagraphshallbesubmittedpursuanttopart10ofthischapter.

（c）Acosmeticingredientshallbeidentifiedinthedeclarationof

ingredientsby:

（1）ThenamespecifiedinSec.701.30asestablishedbythe

Commissionerforthatingredientforthepurposeofcosmeticingredient

labelingpursuanttoparagraph（e）ofthissection;

（2）IntheabsenceofthenamespecifiedinSec.701.30,thename

adoptedforthatingredientinthefollowingeditionsandsupplementsof

thefollowingcompendia,listedinorderasthesourcetobeutilized:

（i）CTFA（Cosmetic,ToiletryandFragranceAssociation,Inc.）

CosmeticIngredientDictionary,SecondEd.,1977（availablefromthe

Cosmetic,ToiletryandFragranceAssociation,Inc.1110VermontAve.

NW.,Suite800,Washington,DC20005,oravailableforinspectionatthe

OfficeoftheFederalRegister,800NorthCapitolStreet,NW.,suite

700,Washington,DC20408）,whichisincorporatedbyreference,except

forthefollowingdeletionsandrevisions:

（a）Thefollowingnamesarenotadoptedforthepurposeofcosmetic

ingredientlabeling:

AcidBlack58

AcidBlack107

AcidBlack139

AcidBlue168

AcidBlue170

AcidBlue188

AcidBlue209

AcidBrown19

AcidBrown30

AcidBrown44

AcidBrown45

AcidBrown46

AcidBrown48

AcidBrown224

AcidOrange80

AcidOrange85

AcidOrange86

AcidOrange88

AcidOrange89

AcidOrange116

AcidRed131

AcidRed213

AcidRed252

AcidRed259

AcidViolet73

AcidViolet76

AcidViolet99

AcidYellow114

AcidYellow127

DirectYellow81

SolventBlack5

SolventBrown43

SolventYellow63

SolventYellow90

（b）Thefollowingnamesareadoptedforthepurposeofcosmetic

ingredientlabeling,providedtherespectivemonographsarerevisedto

describetheirotherwisedisclosedchemicalcompositions,ordescribe

theirchemicalcompositionsmoreprecisely,andsuchrevisedmonographs

arepublishedinsupplementstothisdictionaryeditionbyJuly18,

1980.

AcidBlack2

Benzophenone-11

Carbomer934

Carbomer934P

Carbomer940

Carbomer941

Carbomer960

Carbomer961

Chlorofluorocarbon11S

DimethiconeCopolyol

DisperseRed17

PigmentGreen7

PolyaminoSugarCondensate

SDAlcohol（all27alphanumericdesignations）

SodiumChondroitinSulfate

SyntheticBeeswax

（c）Thefollowingnamesareadoptedforthepurposeofcosmetic

ingredientlabelinguntilJanuary19,1981.

Amphoteric（all20numericdesignations）

Quaternium（all49numericdesignations）

（ii）UnitedStatesPharmacopeia,19thEd.,1975,andSecond

SupplementtotheUSPXIXandNFXIV,1976.（Copiesareavailablefrom

theU.S.PharmacopeialConvention,Inc.,12601TwinbrookParkway,

Rockville,MD20852,oravailableforinspectionattheOfficeofthe

FederalRegister,800NorthCapitolStreet,NW.,suite700,Washington,

DC20408.）

（iii）NationalFormulary,14thEd.,1975,andSecondSupplementto

theUSPXIXandNFXIV,1976.（CopiesareavailablefromtheU.S.

PharmacopeialConvention,Inc.,12601Twinbrook

[[Page135]]

Parkway,Rockville,MD20852,oravailableforinspectionattheOffice

oftheFederalRegister,800NorthCapitolStreet,NW.,suite700,

Washington,DC20408）.

（iv）FoodChemicalsCodex,2dEd.,1972;FirstSupplement,1974,and

SecondSupplement,1975,whichareincorporatedbyrefer