16030302KJ01颜色添加剂目录.pptVIP

ColorAdditiveCategories

CONTENT1[FullText全文阅读]ColoradditivesaresubjecttoastrictsystemofapprovalunderU.S.law[FederalFood,Drug,andCosmeticAct(FDCAct)].Allcoloradditivesusedincosmetics(oranyotherFDA-regulatedproduct)mustbeapprovedbyFDA.Inadditiontoapproval,anumberofcoloradditivesmustbebatchcertifiedbyFDAiftheyaretobeusedincosmetics(oranyotherFDA-regulatedproduct)marketedintheU.S.AllcoloradditivesmustmeettherequirementsforidentityandspecificationsstatedintheCodeofFederalRegulations(CFR).Coloradditivesmaybeusedonlyfortheintendedusesstatedintheregulationsthatpertaintothem.TheFDCActSection721(c)[21U.S.C.379e(c)]andcoloradditiveregulations[21CFRParts70and80]separateapprovedcoloradditivesintotwomaincategories:thosesubjecttocertification(sometimescalledcertifiable)andthoseexemptfromcertification.Inaddition,theregulationsrefertootherclassifications,suchasstraightcolorsandlakes.

CONTENT1[FullText全文阅读]Colorssubjecttocertification.Thesecoloradditivesarederivedprimarilyfrompetroleumandaresometimesknownascoal-tardyesorsynthetic-organiccolors.(NOTE:Coal-tarcolorsarematerialsconsistingofoneormoresubstancesthateitheraremadefromcoal-tarorcanbederivedfromintermediatesofthesameidentityascoal-tarintermediates.)Thesecertifiedcolorsgenerallyhavethree-partnames.ThenamesincludeaprefixFDC,DC,orExternalDC;acolor;andanumber.AnexampleisFDCYellowNo.5.Certifiedcolorsalsomaybeidentifiedincosmeticingredientdeclarationsbycolorandnumberalone,withoutaprefix(suchasYellow5).Colorsexemptfromcertification.Thesecoloradditivesareobtainedprimarilyfrommineral,plant,oranimalsources.Theyarenotsubjecttobatchcertificationrequirements.However,theystillareconsideredartificialcolors,andwhenusedincosmeticsorotherFD