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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 定義
（a）部長，是指衛生部部長（the Secretary of Health and Human Services）。
（b）部，是指衛生部（the Department of Health and Human Services）。
（c）專員，是指食品與藥物專員（the Commissioner of Food and Drugs）。
（d）法規，是指被修訂的聯邦食品、藥品和化妝品法（the Federal Food, Drug and Cosmetic Act）。
（e）著色劑認證科（Color Certification Branch），是在食品與藥物管理局內部，設置在食品安全與應用營養中心的一個單位，負責下文中介紹的認證和發證的例行手續，包括為簽發產品證書所進行的著色樣品的檢驗工作。
（f）著色劑（color additive），是未被本法規201（t）節排除在外的任何物料，它是用合成的或其它類似的方法，或萃取，或單離或其它分離方法加工出來的染料或色素；有或者沒有經歷中間的或最終的特性變化；它們可能來源自蔬菜、動物、礦物或其它來源。在施加于食品、藥品、化妝品或人體或任何地方，能夠（單獨或同其它物質一道）賦予色彩效果。如果在容器的搬運和使用中，一般情況下或有理由預見到其著色物質不會轉移到包裝的內容物或其任何部位上，則賦予食品、藥品和化妝品容器的這種著色物質不屬于著色劑。食品添加劑，例如櫻桃、紅辣椒或青辣椒、巧克力，以及橙汁，這些產品在同其它食品混合后會以其自身天然的顏色影響其它成分，不能看做是著色劑；但是有一種食品可慎用為著色劑--甜菜汁，用在粉紅色檸檬汁中，它是作為著色劑使用的。由本法規401節中的規定所給出的定義和特性標準的食品配料是著色劑，這些配料被專門設計成符合用做著色作用的定義和特性標準。擬定功能是通過動物的生理過程賦予動物的肉、奶或蛋以顏色的動物飼料的配料是著色劑，這并不排除其法規性質的要求。這一定義的應用不考慮該配料除了賦予色彩之外是否還具有營養或其它功能。擬定功能是賦予人體顏色的內服藥是著色劑。就本節的內容而言，顏色這個術語還包括黑、白和兩者之間的灰色，但是從包裝材料遷移出的、未能被人類的視覺所感受到顏色的物質不屬于著色劑。
（g）對于一種被本法規721節內容免除，在其它方面滿足著色劑定義的物料，依據其單獨使用（或擬使用）的目的并非是著色，該物料必須以這樣的方式使用，即其所形成的顏色對（該產品的）外觀、價值、市場能力和消費者的接受性顯然是不重要的。［如果有條件說明這種物料最主要的作用不是賦予（產品）以顏色，則不值得證明需要免除］。
（h）如果殺蟲劑、土壤、植物營養素或其它農業化學物質僅僅是由于幫助或阻止作物的生長或其它自然生理過程，換言之，僅僅是通過直接或間接的作用而產生著色作用，作物的顏色形成僅僅是通過像酶促反應這樣的自然生理過程而著色的，則屬于免除之列。如果殺蟲劑、土壤和植物營養劑或其它農用化學品本身用做為色素，或色素的載體，并且由于這種性質使土壤的產物染上顏色，則它是一種著色劑，不能被免除。
（i）安全，是指有令人信服的證據，它確保著色劑的使用將不會導致有害結果。
（j）術語直接使用著色劑，是指列于本章73、74和81部分的著色劑，包括色淀及其質量規格允許其作為著色劑使用的這類物質。
（k）術語混合物，是指把兩種以上的直接使用的著色劑或一種以上的直接使用的著色劑和一種以上的稀釋劑混合后所得到的物料。
（l）術語色淀，是指直接通過吸附、共同沉淀或化學結合的方法擴散到基料中，但不包括任何簡單混合的方法制得的配料。
（m）術語稀釋劑，是指著色劑混合物中的，本身不是著色劑，但是有意識地將其同色料混合，以方便著色食品、藥品和化妝品以及人體的物質。稀釋劑在食品、藥品或化妝品中可具有其它功能作用，例如作為甜味劑、香味劑、乳化劑或穩定劑，或者在著色人體的物料中起其它功能作用。
（n）術語基料，是指純色料在其中擴散的物質。
（o）術語純色料，是指著色劑中所含色料，其中不含任何中間體或其它成分，或任何稀釋劑或基料。
（p）術語生產批料，是指通過特定的生產操作生產出的一批均勻的著色劑或著色劑混合料，出于申請產品證書的目的，將這個數量的產品作為一個計量單位。
（q）術語生產批號，是指申請許可證的人為區分的目的為所生產的一定量的物料編制的號碼。
（r）術語產品批號，是指由FDA為一批生產批料指定的專門編號或標記。
（s）術語眼部，是指人體上眼眶脊骨和下眼眶脊骨之間的部位，包括眉毛、眉毛下方的皮膚、眼瞼和睫毛以及淚囊、眼球和眼眶內的軟組織。
（t）術語包裝，是指直接與著色劑或者著色劑混合物接觸的容器，為便于著色劑發貨和運輸而置于其中。如果包裝物在盛放著色劑后再包裝于轉動紙板箱中或其它保護性容器中，則后一類容器不能認為是直接容器。對于家用著色劑，在純色料低于15%，兩瓶以上每瓶容量3oz以下，且其中每瓶裝有不同的著色劑作為一個發售單位時，按本節定義的包裝，這種包裝單位的容器也被認定為直接容器。
（u）本法規601（a）中的染發劑免除條件適用于擬用來改變頭發顏色的煤焦油染發劑，它們是帶有或含有以煤焦油中提取的著色劑，對某些個體可能會造成皮膚刺激的過敏反應，以及在用于睫毛或眉毛染色時存在造成失明的可能性。免除條件在這種條件下適用：即在任何一種這類物品的標簽的顯著位置上以警告語聲明，并且輔以基本的皮膚試驗法指導語。免除條件不適用于不是自煤焦油中提取的染發劑的著色成分，也不能被延伸到有毒或有害的稀釋劑，它們可能會作為潤濕劑、頭發調理劑、乳化劑或其它成分引入洗發香波、染發液、染色劑或類似的用來改變頭發顏色的雙功能化妝品中。
（v）術語外用藥和外用化妝品，是指僅僅施用于人體外部的，并且不得用于唇部或皮膚黏膜上的藥品和化妝品。
