§70.3 着色剂的定义(Definitions of Color additives)

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　　   § 70.3   Definitions.

        （a） Secretary means the Secretary of Health and Human Services.

　　（b） Department means the Department of Health and Human Services.

　　（c） Commissioner means the Commissioner of Food and Drugs.

　　（d） Act means the Federal Food, Drug, and Cosmetic Act as amended.

　　（e） Color Certification Branch means the unit established within the Food and Drug Administration located in the Center for Food Safety and Applied Nutrition, charged with the responsibility for the mechanics of the certification procedure hereinafter described, and including the examination of samples of color additives subject to certification.

　　（f） A color additive is any material, not exempted under section 201（t） of the act, that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable （alone or through reaction with another substance） of imparting a color thereto. Substances capable of imparting a color to a container for foods, drugs, or cosmetics are not color additives unless the customary or reasonably foreseeable handling or use of the container may reasonably be expected to result in the transmittal of the color to the contents of the package or any part thereof. Food ingredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural color when mixed with other foods are not regarded as color additives ; but where a food substance such as beet juice is deliberately used as a color, as in pink lemonade, it is a color additive. Food ingredients as authorized by a definitions and standard of identity prescribed by regulations pursuant to section 401 of the act are color additives, where the ingredients are specifically designated in the definitions and standards of identity as permitted for use for coloring purposes. An ingredient of an animal feed whose intended function is to impart, through the biological processes of the animal, a color to the meat, milk, or eggs of the animal is a color additive and is not exempt from the requirements of the statute. This definition shall apply whether or not such ingredient has nutritive or other functions in addition to the property of imparting color. An ingested drug the intended function of which is to impart color to the human body is a color additive. For the purposes of this part, the term color includes black, white, and intermediate grays, but substances including migrants from packaging materials which do not contribute any color apparent to the naked eye are not color additives.

　　（g） For a material otherwise meeting the definition of color additive to be exempt from section 721 of the act, on the basis that it is used （or intended to be used） solely for a purpose or purposes other than coloring, the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. （It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color.）

　　（h） The exemption that applies to a pesticide chemical, soil or plant nutrient, or other agricultural chemical, where its coloring effect results solely from its aiding, retarding, or otherwise affecting directly or indirectly, the growth or other natural physiological processes of produce of the soil, applies only to color developed in such product through natural physiological processes such as enzymatic action. If the pesticide chemical, soil or plant nutrient, or other agricultural chemical itself acts as a color or carries as an ingredient a color, and because of this property colors the produce of the soil, it is a color additive and is not exempt.

　　（i） Safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.

　　（j） The term straight color means a color additive listed in parts 73, 74, and 81 of this chapter, and includes lakes and such substances as are permitted by the specifications for such color.

　　（k） The term mixture means a color additive made by mixing two or more straight colors, or one or more straight colors and one or more diluents.

　　（l） The term lake means a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by simple mixing process.

　　（m） The term diluent means any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed therein to facilitate the use of the mixture in coloring foods, drugs, or cosmetics or in coloring the human body. The diluent may serve another functional purpose in the foods, drugs, or cosmetics, as for example sweetening, flavoring, emulsifying, or stabilizing, or may be a functional component of an article intended for coloring the human body.

　　（n） The term substratum means the substance on which the pure color in a lake is extended.

　　（o） The term pure color means the color contained in a color additive, exclusive of any intermediate or other component, or of any diluent or substratum contained therein.

　　（p） The term batch means a homogeneous lot of color additive or color additive mixture produced by an identified production operation, which is set apart and held as a unit for the purpose of obtaining certification of such quantity.

　　（q） The term batch number means the number assigned to a batch by the person who requests certification thereof.

　　（r） The term lot number means an identifying number or symbol assigned to a batch by the Food and Drug Administration.

　　（s） The term area of the eye means the area enclosed with in the circumference of the supra-orbital ridge and the infra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge.

　　（t） The term package means the immediate container in which a color additive or color additive mixture has been packed for shipment or delivery. If the package is then packed in a shipping carton or other protective container, such container shall not be considered to be the immediate container. In the case of color additive mixtures for household use containing less than 15 percent pure color, when two or more containers of 3 ounces each or less, each containing a different color, are distributed as a unit, the immediate container for such unit shall be considered to be the package as defined in this section.

　　（u） The hair dye exemption in section 601（a） of the act applies to coal tar hair dyes intended for use in altering the color of the hair and which are, or which bear or contain, color additives derived from coal tar with the sensitization potential of causing skin irritation in certain individuals and possible blindness when used for dyeing the eyelashes or eyebrows. The exemption is permitted with the condition that the label of any such article bear conspicuously the statutory caution and adequate directions for preliminary patch-testing. The exemption does not apply to coloring ingredients in hair dyes not derived from coal tar, and it does not extend to poisonous or deleterious diluents that may be introduced as wetting agents, hair conditions, emulsifiers, or other components in a color shampoo, rinse, tint, or similar dual-purpose cosmetic that alter the color of the hair.

　　（v） The terms externally applied drugs and externally applied cosmetics mean drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane.

　　[42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996]

　　§70.3　定义

　　（a）部长，是指卫生部部长（the Secretary of Health and Human Services）。

　　（b）部，是指卫生部（the Department of Health and Human Services）。

　　（c）专员，是指食品与药物专员（the Commissioner of Food and Drugs）。

　　（d）法规，是指被修订的联邦食品、药品和化妆品法（the Federal Food, Drug and Cosmetic Act）。

　　（e）着色剂认证科（Color Certification Branch），是在食品与药物管理局内部，设置在食品安全与应用营养中心的一个单位，负责下文中介绍的认证和发证的例行手续，包括为签发产品证书所进行的着色样品的检验工作。

　　（f）着色剂（color additive），是未被本法规201（t）节排除在外的任何物料，它是用合成的或其它类似的方法，或萃取，或单离或其它分离方法加工出来的染料或色素；有或者没有经历中间的或最终的特性变化；它们可能来源自蔬菜、动物、矿物或其它来源。在施加于食品、药品、化妆品或人体或任何地方，能够（单独或同其它物质一道）赋予色彩效果。如果在容器的搬运和使用中，一般情况下或有理由预见到其着色物质不会转移到包装的内容物或其任何部位上，则赋予食品、药品和化妆品容器的这种着色物质不属于着色剂。食品添加剂，例如樱桃、红辣椒或青辣椒、巧克力，以及橙汁，这些产品在同其它食品混合后会以其自身天然的颜色影响其它成分，不能看做是着色剂；但是有一种食品可慎用为着色剂--甜菜汁，用在粉红色柠檬汁中，它是作为着色剂使用的。由本法规401节中的规定所给出的定义和特性标准的食品配料是着色剂，这些配料被专门设计成符合用做着色作用的定义和特性标准。拟定功能是通过动物的生理过程赋予动物的肉、奶或蛋以颜色的动物饲料的配料是着色剂，这并不排除其法规性质的要求。这一定义的应用不考虑该配料除了赋予色彩之外是否还具有营养或其它功能。拟定功能是赋予人体颜色的内服药是着色剂。就本节的内容而言，颜色这个术语还包括黑、白和两者之间的灰色，但是从包装材料迁移出的、未能被人类的视觉所感受到颜色的物质不属于着色剂。

　　（g）对于一种被本法规721节内容免除，在其它方面满足着色剂定义的物料，依据其单独使用（或拟使用）的目的并非是着色，该物料必须以这样的方式使用，即其所形成的颜色对（该产品的）外观、价值、市场能力和消费者的接受性显然是不重要的。［如果有条件说明这种物料最主要的作用不是赋予（产品）以颜色，则不值得证明需要免除］。

　　（h）如果杀虫剂、土壤、植物营养素或其它农业化学物质仅仅是由于帮助或阻止作物的生长或其它自然生理过程，换言之，仅仅是通过直接或间接的作用而产生着色作用，作物的颜色形成仅仅是通过像酶促反应这样的自然生理过程而着色的，则属于免除之列。如果杀虫剂、土壤和植物营养剂或其它农用化学品本身用做为色素，或色素的载体，并且由于这种性质使土壤的产物染上颜色，则它是一种着色剂，不能被免除。

　　（i）安全，是指有令人信服的证据，它确保着色剂的使用将不会导致有害结果。

　　（j）术语直接使用着色剂，是指列于本章73、74和81部分的着色剂，包括色淀及其质量规格允许其作为着色剂使用的这类物质。

　　（k）术语混合物，是指把两种以上的直接使用的着色剂或一种以上的直接使用的着色剂和一种以上的稀释剂混合后所得到的物料。

　　（l）术语色淀，是指直接通过吸附、共同沉淀或化学结合的方法扩散到基料中，但不包括任何简单混合的方法制得的配料。

　　（m）术语稀释剂，是指着色剂混合物中的，本身不是着色剂，但是有意识地将其同色料混合，以方便着色食品、药品和化妆品以及人体的物质。稀释剂在食品、药品或化妆品中可具有其它功能作用，例如作为甜味剂、香味剂、乳化剂或稳定剂，或者在着色人体的物料中起其它功能作用。

　　（n）术语基料，是指纯色料在其中扩散的物质。

　　（o）术语纯色料，是指着色剂中所含色料，其中不含任何中间体或其它成分，或任何稀释剂或基料。

　　（p）术语生产批料，是指通过特定的生产操作生产出的一批均匀的着色剂或着色剂混合料，出于申请产品证书的目的，将这个数量的产品作为一个计量单位。

　　（q）术语生产批号，是指申请许可证的人为区分的目的为所生产的一定量的物料编制的号码。

　　（r）术语产品批号，是指由FDA为一批生产批料指定的专门编号或标记。

　　（s）术语眼部，是指人体上眼眶脊骨和下眼眶脊骨之间的部位，包括眉毛、眉毛下方的皮肤、眼睑和睫毛以及泪囊、眼球和眼眶内的软组织。

　　（t）术语包装，是指直接与着色剂或者着色剂混合物接触的容器，为便于着色剂发货和运输而置于其中。如果包装物在盛放着色剂后再包装于转动纸板箱中或其它保护性容器中，则后一类容器不能认为是直接容器。对于家用着色剂，在纯色料低于15%，两瓶以上每瓶容量3oz以下，且其中每瓶装有不同的着色剂作为一个发售单位时，按本节定义的包装，这种包装单位的容器也被认定为直接容器。

　　（u）本法规601（a）中的染发剂免除条件适用于拟用来改变头发颜色的煤焦油染发剂，它们是带有或含有以煤焦油中提取的着色剂，对某些个体可能会造成皮肤刺激的过敏反应，以及在用于睫毛或眉毛染色时存在造成失明的可能性。免除条件在这种条件下适用：即在任何一种这类物品的标签的显著位置上以警告语声明，并且辅以基本的皮肤试验法指导语。免除条件不适用于不是自煤焦油中提取的染发剂的着色成分，也不能被延伸到有毒或有害的稀释剂，它们可能会作为润湿剂、头发调理剂、乳化剂或其它成分引入洗发香波、染发液、染色剂或类似的用来改变头发颜色的双功能化妆品中。

　　（v）术语外用药和外用化妆品，是指仅仅施用于人体外部的，并且不得用于唇部或皮肤黏膜上的药品和化妆品。