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

　?。╝） 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:

　?。?） 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.”

　?。?） 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.

　?。╞） 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.”

　?。╠） 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　對著色劑的標(biāo)簽要求（染發(fā)劑除外）

　?。╝）標(biāo)簽要求通則：所有的著色劑均應(yīng)標(biāo)注上充分的資料數(shù)據(jù)，以確保它們的安全使用，并且能確定是否符合本部分以及本章71、73、74、80和81部分中強(qiáng)制規(guī)定的限度。除了本法規(guī)要求的所有其它資料之外，著色劑（不包括以適當(dāng)方式用于著色人體的著色劑）的標(biāo)簽應(yīng)當(dāng)表述為：

　?。?）直接色素的名稱，如果它是混合物的話，應(yīng)標(biāo)注著色劑中包含的每一種成分的名稱。

　?。?）表明該著色劑使用的一般限制條件的表述，例如，"僅用于食品"，"適用于食品、藥品和化妝品"，或"僅用于外用藥"等等。

　　（3）在公布的規(guī)定中對某種直接色素的一般或特殊用量有硬性限定的場合，每一種這類直接色素的量按單位質(zhì)量/體積或質(zhì)量分?jǐn)?shù)表示。

　?。?）有效期，如果對它的穩(wěn)定期限有要求的話。

　　（b）關(guān)于帶有允許用量的著色劑的特殊標(biāo)簽：對某種著色劑的一般或特殊用途的容許使用量有強(qiáng)制要求時，該著色劑的標(biāo)簽還要注明它的使用指南，以防該著色劑在食品、藥品或化妝品中的含量超出容許使用量。

　?。╟）關(guān)于具有其它使用限制的著色劑的特殊標(biāo)簽：如果著色劑的使用要經(jīng)受本部分介紹的其它限制條件，則這些限制條件應(yīng)當(dāng)在該著色劑的標(biāo)簽上用簡單明了的語言表述清楚。這類限制條件表述的例子如："不得在用于眼部的產(chǎn)品中使用"；"不得用于著色注射用藥物"。

　　（d）需要證書的著色劑的特殊標(biāo)簽：需要證書的著色劑在其標(biāo)簽上應(yīng)包含由"色素證書科"簽發(fā)核準(zhǔn)的批號，家用的純色素含量不超過15%的著色劑混合物以及每個包裝不足3oz的著色劑除外，在標(biāo)簽上的顯著地方加印制造商自己的與報送給FDA的批號相一致的產(chǎn)品編號，以取代批號。

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編輯：foodfagui