ColoradditivesaresubjecttoastrictsystemofapprovalunderU.S.law[FederalFood,Drug,andCosmeticAct(FD&CAct),sec.721;21U.S.C.379e].Exceptinthecaseofcoal-tarhairdyes,failuretomeetU.S.coloradditiverequirementscausesacosmetictobeadulterated[FD&CAct,sec.601(e);21U.S.Code361(e)].Coloradditiveviolationsareacommonreasonfordetainingimportedcosmeticproductsofferedforentryintothiscountry.
如果您的产品（煤焦油染发剂除外）含有着色剂，则根据法律[FD&C法案第721条；《美国法典》第21篇，第379条(e)款；《联邦法规汇编》第21篇第70和第80部分]，您必须遵守以下规定：
Ifyourproduct(exceptcoal-tarhairdyes)containsacoloradditive,bylaw[FD&CAct,Sec.721;21U.S.C.379e;21CFRParts70and80]youmustadheretorequirementsfor:
FD&C法案第721条(c)款[《美国法典》第21篇第379条e款(c)项]和着色剂法规[《联邦法规汇编》第21篇第70和第80部分]将着色剂分为两大类：需要认证的着色剂（有时被称为“可认证的”着色剂）和免于认证的着色剂。此外，该法规还涉及其他分类，如纯品色和色淀。
TheFD&CActSection721(c)[21U.S.C.379e(c)]andcoloradditiveregulations[21CFRParts70and80]separateapprovedcoloradditivesintotwomaincategories:thosesubjecttocertification(sometimescalled"certifiable")andthoseexemptfromcertification.Inaddition,theregulationsrefertootherclassifications,suchasstraightcolorsandlakes.
以下预防措施能够帮助您避免您的化妆品因使用被掺假的着色剂而违规。
Severalprecautionscanhelpyouavoidcoloradditiveviolationsthatwillcauseyourcosmetictobeadulterated:
是的。不论特定的染料是否需要认证或免于认证，美国法律禁止其在化妆品（或任何其他FDA监管的产品）中使用，除非其已获得预期用途的特别批准[FD&C法案第721条(a)款(1)项(A)目；《美国法典》第21篇第379e条(a)款(1)项(A)目]。
Yes.Nomatterwhetheraparticularcolorissubjecttocertificationorexemptfromcertification,U.S.lawprohibitsitsuseincosmetics(oranyotherFDA-regulatedproduct)unlessitisapprovedspecificallyfortheintendeduse[FD&CAct,sec.721(a)(1)(A);21U.S.C.379e(a)(1)(A)].
Theregulationsalsorestrictintendeduseasfollows:
Nomatterhowexoticornovelthecoloradditiveoritsintendeduse,itissubjecttothesameregulationsasthemoreeverydaycolorsandproducts.Thefollowingitemsareasamplingofsomeout-of-the-ordinarycoloradditives.Thislistisnotexhaustive.Rather,itisintendedtoshowhowtheregulationsapplytosuchcolors: