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

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR720.1]

[Page146]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART720--VOLUNTARYFILINGOFCOSMETICPRODUCTINGREDIENTCOMPOSITIONSTATEMENTS--TableofContents

Sec.720.1Whoshouldfile.

Eitherthemanufacturer,packer,ordistributorofacosmetic

productisrequestedtofileFormFDA2512（``CosmeticProduct

IngredientStatement''）,whetherornotthecosmeticproductenters

interstatecommerce.Thisrequestextendstoanyforeignmanufacturer,

packer,ordistributorofacosmeticproductexportedforsaleinany

Stateasdefinedinsection201（a）

（1）oftheFederalFood,Drug,and

CosmeticAct.Nofilingfeeisrequired.

[57FR3129,Jan.28,1992]

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR720.2]

[Page146]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART720--VOLUNTARYFILINGOFCOSMETICPRODUCTINGREDIENTCOMPOSITIONSTATEMENTS--TableofContents

Sec.720.2Timesforfiling.

Within180daysafterformsaremadeavailabletotheindustry,Form

FDA2512shouldbefiledforeachcosmeticproductbeingcommercially

distributedasoftheeffectivedateofthispart.FormFDA2512should

befiledwithin60daysafterthebeginningofcommercialdistribution

ofanyproductnotcoveredwithinthe180-dayperiod.

[57FR3129,Jan.28,1992]

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR720.3]

[Page146]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART720--VOLUNTARYFILINGOFCOSMETICPRODUCTINGREDIENTCOMPOSITIONSTATEMENTS--TableofContents

Sec.720.3Howandwheretofile.

FormsFDA2512andFDA2514（``DiscontinuanceofCommercial

DistributionofCosmeticProductFormulation''）areobtainableon

requestfromtheFoodandDrugAdministration,DepartmentofHealthand

HumanServices,Washington,DC20204,oratanyFoodandDrug

Administrationdistrictoffice.Thecompletedformshouldbemailedor

deliveredto:

CosmeticProductStatement,FoodandDrugAdministration,

DepartmentofHealthandHumanServices,Washington,DC20204,according

totheinstructionsprovidedwiththeforms.

[57FR3129,Jan.28,1992]

[CodeofFederalRegulations]

[Title21,Volume7]

[RevisedasofApril1,2002]

FromtheU.S.GovernmentPrintingOfficeviaGPOAccess

[CITE:

21CFR720.4]

[Page146-148]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN

SERVICES（CONTINUED）

PART720--VOLUNTARYFILINGOFCOSMETICPRODUCTINGREDIENTCOMPOSITIONSTATEMENTS--TableofContents

Sec.720.4Informationrequestedaboutcosmeticproducts.

（a）FormFDA-2512requestsinformationon:

（1）Thenameandaddress,includingpostofficeZIPcodeofthe

person（manufacturer,packer,ordistributor）designatedonthelabelof

theproduct.

（2）Thenameandaddress,includingpostofficeZIPcode,ofthe

manufacturerorpackeroftheproductifdifferentfromtheperson

designatedonthelabeloftheproduct,whenthemanufacturerorpacker

submitstheinformationrequestedunderthisparagraph.

（3）Thebrandnameornamesofthecosmeticproduct.

（4）Thecosmeticproductcategoryorcategories.

（5）Theingredientsintheproduct.

[[Page147]]

（b）ThepersonfilingFormFDA-2512should:

（1）Providetheinformationrequestedinparagraph（a）ofthis

section.

（2）Havetheformsignedbyanauthorizedindividual.

（3）Providepoisoncontrolcenterswithingredientinformationand/

oradequatediagnosticandtherapeuticprocedurestopermitrapid

evaluationandtreatmentofaccidentalingestionorotheraccidentaluse

ofthecosmeticproduct.

（4）Provideingredientinformation（and,whenrequested,ingredient

samples）toalicensedphysicianwho,inconnectionwiththetreatment

ofapatient,requestsassistanceindeterminingwhetheraningredient

inthecosmeticproductisthecauseoftheproblemforwhichthe

patientisbeingtreated.

（c）Oneormoreofthefollowingcosmeticproductcategoriesshould

becitedtoindicatetheproduct'sintendeduse.

（1）Babyproducts.（i）Babyshampoos.

（ii）Lotions,oils,powders,andcreams.

（iii）Otherbabyproducts.

（2）Bathpreparations.（i）Bathoils,tablets,andsalts.

（ii）Bubblebaths.

（iii）Bathcapsules.

（iv）Otherbathpreparations.

（3）Eyemakeuppreparations.（i）Eyebrowpencil.

（ii）Eyeliner.

（iii）Eyeshadow.

（iv）Eyelotion.

（v）Eyemakeupremover.

（vi）Mascara.

（vii）Othereyemakeuppreparations.

（4）Fragrancepreparations.（i）Colognesandtoiletwaters.

（ii）Perfumes.

（iii）Powders（dustingandtalcum）（excludingaftershavetalc）.

（iv）Sachets.

（v）Otherfragrancepreparations.

（5）Hairpreparations（noncoloring）.

（i）Hairconditioners.

（ii）Hairsprays（aerosolfixatives）.

（iii）Hairstraighteners.

（iv）Permanentwaves.

（v）Rinses（noncoloring）.

（vi）Shampoos（noncoloring）.

（vii）Tonics,dressings,andotherhairgroomingaids.

（viii）Wavesets.

（ix）Otherhairpreparations.

（6）Haircoloringpreparations.（i）Hairdyesandcolors（alltypes

requiringcautionstatementandpatchtest）.

（ii）Hairtints.

（iii）Hairrinses（coloring）.

（iv）Hairshampoos（coloring）.

（v）Haircolorsprays（aerosol）.

（vi）Hairlightenerswithcolor.

（vii）Hairbleaches.

（viii）Otherhaircoloringpreparations.

（7）Makeuppreparations（noteye）.（i）Blushers（alltypes）.

（ii）Facepowders.

（iii）Foundations.

（iv）Legandbodypaints.

（v）Lipstick.

（vi）Makeupbases.

（vii）Rouges.

（viii）Makeupfixatives.

（ix）Othermakeuppreparations.

（8）Manicuringpreparations.（i）Basecoatsandundercoats.

（ii）Cuticlesofteners.

（iii）Nailcreamsandlotions.

（iv）Nailextenders.

（v）Nailpolishandenamel.

（vi）Nailpolishandenamelremovers.

（vii）Othermanicuringpreparations.

（9）Oralhygieneproducts.（i）Dentifrices（aerosol,liquid,pastes,

andpowders）.

（ii）Mouthwashesandbreathfresheners（liquidsandsprays）.

（iii）Otheroralhygieneproducts.

（10）Personalcleanliness.（i）Bathsoapsanddetergents.

（ii）Deodorants（underarm）.

（iii）Douches.

（iv）Femininehygienedeodorants.

（v）Otherpersonalcleanlinessproducts.

（11）Shavingpreparations.（i）Aftershavelotions.

（ii）Beardsofteners.

（iii）Men'stalcum.

（iv）Preshavelotions（alltypes）.

（v）Shavingcream（aerosol,brushless,andlather）.

（vi）Shavingsoap（cakes,sticks,etc.）.

（vii）Othershavingpreparationproducts.

（12）Skincarepreparations,（creams,lotions,powder,andsprays）.

（i）Cleansing（coldcreams,cleansinglotions,liquids,andpads）.

[[Page148]]

（ii）Depilatories.

（iii）Faceandneck（excludingshavingpreparations）.

（iv）Bodyandhand（excludingshavingpreparations）.

（v）Footpowdersandsprays.

（vi）Moisturizing.

（vii）Night.

（viii）Pastemasks（mudpacks）.

（ix）Skinfresheners.

（x）Otherskincarepreparations.

（13）Suntanpreparations.（i）Suntangels,creams,andliquids.

（ii）Indoortanningpreparations.

（iii）Othersuntanpreparations.

（d）Ingredientsintheproductshouldbelistedasfollows:

（1）Alistofeachingredientofthecosmeticproductindescending

orderofpredominancebyweight（exceptthatthefragranceand/orflavor

maybedesignatedassuchwithoutnamingeachindividualingredientwhen

themanufacturerorsupplierofthefragranceand/orflavorrefusesto

discloseingredientdata）.

（2）AningredientshouldbelistedbythenameadoptedbytheFood

andDrugAdministration（FDA）fortheingredientpursuantto

Sec.701.3（c）ofthischapter.

（3）IntheabsenceofanameadoptedbyFDApursuantto

Sec.701.3（c）ofthischapter,itscommonorusualname,ifithasone,

oritschemicalortechnicalnameshouldbelisted.

（4）Ifaningredientisamixture,eachingredientofthemixture

shouldbelistedinaccordancewithparagraphs（d）

（2）and（d）（3）ofthis

section,unlesssuchmixtureisaformulationvoluntarilyregisteredon

FormFDA2512,inwhichcasesuchmixtureshouldbeidentifiedas

``fragrance,''``flavor,''``fragranceandflavor''or``base

formulation,''asappropriate,andbystatingitsFDA-assignedcosmetic

productingredientstatementnumber.

（5）Whenthemanufacturerorsupplierofafragranceand/orflavor

refusestodiscloseingredientdata,thefragranceand/orflavorshould

belistedassuch.Thenonconfidentiallistingoftheproductnameand/

ortradenameornameofthemanufacturerorsupplierofeach

proprietaryfragranceand/orflavormixtureisoptional.

（e）AseparateFormFDA-2512shouldbefiledforeachdifferent

formulationofacosmeticproduct.However,exceptforthehaircoloring

preparationslistedinparagraph（c）（6）ofthissectionforwhicha

statementforeachshadeofsuchproductisrequired,asingleFormFDA-

2512maybefiledfortwoormoreshadesofacosmetic