§70.25 对着色剂的标签要求(染发剂除外)(Labeling requirements for color additives (other than hair dyes))

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   　　§ 70.25   Labeling requirements for color additives （other than hair dyes）.

　　（a） General labeling requirements. All color additives shall be labeled with sufficient information to assure their safe use and to allow a determination of compliance with any limitations imposed by this part and parts 71, 73, 74, 80, and 81 of this chapter. In addition to all other information required by the act, labels for color additives, except those in a form suitable for coloring the human body, shall state:

　　（1） The name of the straight color or the name of each ingredient comprising the color additive, if it is a mixture.

　　（2） A statement indicating general limitations for the use of the color additive, such as “for food use only”； “for food, drug, and cosmetic use”； “for use in drugs for external application only.”

　　（3） Where regulations issued impose quantitative limitations for a general or specific use of a straight color, the amount of each such straight color in terms of weight per unit/volume or percent by weight.

　　（4） An expiration date if stability data require it.

　　（b） Special labeling for color additives with tolerances. Where tolerances are imposed for a general or specific use of a color additive, the label shall in addition provide directions for use of the color additive which if followed will preclude the food, drug, or cosmetic to which it is added from containing an amount of the color additive in excess of the tolerance.

　　（c） Special labeling for color additives with other limitations. If use of the color additive is subject to other limitations prescribed in this part, such limitations shall be stated on the label of the color additive by a plain and conspicuous statement. Examples of such limitation statements are: “Do not use in products used in the area of the eye”； “Do not use for coloring drugs for injection.”

　　（d） Special labeling for color additives not exempt from certification. Color additives not exempt from the certification procedures shall in addition include in the labeling the lot number assigned by the Color Certification Branch, except that in the case of any mixture for household use which contains not more than 15 percent of pure color and which is in packages containing not more than 3 ounces there appears on the label, a code number which the manufacturer has identified with the lot number by giving to the Food and Drug Administration written notice that such code number will be used in lieu of the lot number.

　　§70.25　对着色剂的标签要求（染发剂除外）

　　（a）标签要求通则：所有的着色剂均应标注上充分的资料数据，以确保它们的安全使用，并且能确定是否符合本部分以及本章71、73、74、80和81部分中强制规定的限度。除了本法规要求的所有其它资料之外，着色剂（不包括以适当方式用于着色人体的着色剂）的标签应当表述为：

　　（1）直接色素的名称，如果它是混合物的话，应标注着色剂中包含的每一种成分的名称。

　　（2）表明该着色剂使用的一般限制条件的表述，例如，"仅用于食品"，"适用于食品、药品和化妆品"，或"仅用于外用药"等等。

　　（3）在公布的规定中对某种直接色素的一般或特殊用量有硬性限定的场合，每一种这类直接色素的量按单位质量/体积或质量分数表示。

　　（4）有效期，如果对它的稳定期限有要求的话。

　　（b）关于带有允许用量的着色剂的特殊标签：对某种着色剂的一般或特殊用途的容许使用量有强制要求时，该着色剂的标签还要注明它的使用指南，以防该着色剂在食品、药品或化妆品中的含量超出容许使用量。

　　（c）关于具有其它使用限制的着色剂的特殊标签：如果着色剂的使用要经受本部分介绍的其它限制条件，则这些限制条件应当在该着色剂的标签上用简单明了的语言表述清楚。这类限制条件表述的例子如："不得在用于眼部的产品中使用"；"不得用于着色注射用药物"。

　　（d）需要证书的着色剂的特殊标签：需要证书的着色剂在其标签上应包含由"色素证书科"签发核准的批号，家用的纯色素含量不超过15%的着色剂混合物以及每个包装不足3oz的着色剂除外，在标签上的显著地方加印制造商自己的与报送给FDA的批号相一致的产品编号，以取代批号。