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(Definitions) |
Blue 1 Lake is the salt of Blue 1 extended on an appropriate substrate in compliance with 21CFR82.1051. See Regulatory and Ingredient Use Information, for Colorants in Volume 1, Introduction, Part A. To identify the certified colorant for labeling purposes in the US, the INCI Name Blue 1 Lake must be used. The INCI Name for batches of this colorant that have not been certified is Acid Blue 9 Aluminum Lake. To identify the colorant allowed for use in the European Union (EU), the INCI Name CI 42090 must be used, except for hair dye products. To identify the colorant allowed for use in Japan, the INCI name Ao1 must be used. |
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■ U.S. Colorants
The term color additive is defined, in part, by U.S. law as a material which:
(A) 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;
(B) 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 other substances) of imparting color thereto. Federal Food, Drug, and Cosmetic Act, Section 201(t)(1).
In the United States, a cosmetic containing a colorant (except a coal-tar hair dye) that is not approved by the FDA is regarded as adulterated and subject to regulatory action by FDA. Federal Food, Drug, and Cosmetic Act, Section 601(e).
NOTE: An exception to this requirement exists for coal-tar (synthetic organic) colorants used in hair dyes, provided other regulatory requirements are met (see information in this section under U.S. Hair Colorants and the U.S. Hair Dye Exemption).
Colorants approved for use in the United States are listed in Title 21 of the U.S. Code of Federal Regulations, 21 CFR, Parts 73, 74, and 82.
A listing of the INCI names of U.S. approved colorants may be found in Section 3, Chemical Classes, under the following headings:
. Color Additives - Batch Certified by the U.S. Food and Drug Administration
. Color Additive Lakes - Batch Certified by the U.S. Food and Drug Administration
. Color Additives - Exempt from Batch Certification by the U.S. Food and Drug Administration
Color Additives Subject to Batch Certification
With the exception of coal-tar hair dyes, all synthetic organic color additives are subject to batch certification by the FDA. Each batch of an approved synthetic organic colorant must be tested and certified by the FDA as meeting standards and specifications found in 21 CFR 74.
Color Additives Exempt from Batch Certification
Some U.S. approved colorants are exempt from batch certification by the FDA. In order to be legally used in the U.S., however, these colorants must meet specification and use restrictions stipulated in 21 CFR 73.
Abbreviated Labeling Names for U.S. Colorants
Official names for colorants subject to batch certification may be found in 21 CFR Parts 73, 74, and 82. These names must be used by the colorant manufacturer to identify the product that has been batch certified by the FDA. Industry proposed an alternative labeling scheme for cosmetic product labeling, and the FDA agreed to accept abbreviated names.
FDA originally proposed the use of abbreviated names for U.S. colorants in the Federal Register on June 6, 1985 (50 FR 23815). At that time, the FDA stated that firms may use the abbreviated names on product labels. In correspondence with CTFA, dated June 7, 1999, the FDA reaffirmed its intention to permit cosmetic firms to use the abbreviated names on product labels while a final rule on the matter is pending.
The abbreviated labeling names apply only to U.S. color additives that are subject to batch certification. Under this scheme, the cosmetic product manufacturer does not have to include FD&C or D&C, EXT, or the type of lake Aluminum, Zirconium, etc., on their product labels. Examples of the abbreviated and the original names associated with U.S. colorants are:
Abbreviated Labeling Name --/-- U.S. FDA Batch Certification Name
Blue 1 --/-- FD&C Blue No. 1
Red 6 --/-- D&C Red No. 6
Ext. Violet 2 --/-- Ext. D&C Violet No. 2
Red 40 Lake --/-- FD&C Red No. 40 Aluminum Lake
Other Restrictions for U.S. Colorants
There may be specific use restrictions for some U.S. approved colorants, such as: nor external use except eye area. Restrictions for U.S. approved colorants may be found in 21 CFR 73, 74, and 83.
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