Colors in Cosmetics: Regulation and Nomenclature in the United States

In the United States, with the exception of one class of hair dyes, all color additives for cosmetics must be specifically pre-approved for use by the Food and Drug Administration. A law that governs cosmetics, the Federal Food, Drug, and Cosmetic Act, requires that FDA issue a specific regulation for each color additive which prescribes its conditions of use and the specifications for its safe use (www.cfsan.fda.gov/~dms/col-cfr.html). In addition, batch certification (testing by FDA) is required for most color additives to assure that they meet the specifications of the regulations. Use of an unapproved color additive in a cosmetic product, or of an approved color additive, but in an unapproved manner, makes the product illegal, adulterated and subject to seizure by FDA (www.cfsan.fda.gov/~dms/col-enf.html).

The official names for color additives in the U.S. are designated by FDA. Colors subject to batch certification are designated as FD&C (food, drug, and cosmetics), D&C (drug and cosmetics), or Ext. D&C (external drugs and cosmetics). This is followed by a color designation, such as blue or red, and by No. (for number), and by a numeral. An example of such a name is FD&C Red No. 40. Colors made by combining these "straight" colors with "substrates" (sodium, potassium, aluminum, barium, calcium strontium, or zirconium) are known as "lakes" and are named using the same convention, but with the addition of the word lake and the substrate, for example: FD&C Red No. 40 Aluminum Lake.

Cosmetic colors that are not subject to batch certification are known by more common names, for example: Caramel or Henna. The important thing to note is that all of these colors, both those that are subject to batch certification and those that are not, must be pre-approved, and have specifications set, before being used in cosmetic products in the U.S.

Identification of the color additives on cosmetic product labels has been a discussion item between FDA and industry for many years. Manufacturers would like to have a simpler system of identifying these color additives, one that could be used world-wide so that all products would use the same terminology for the same basic ingredients. FDA has been cautious in considering industry’s proposals in this area.

The FDA has granted permission for the cosmetic industry to use abbreviated names on the labels of products containing the certifiable colors or lakes. For example, FD&C Blue No. 1 now may be listed as Blue 1, and FD&C Red No. 40 Aluminum Lake may now be listed as Red 40 Lake (www.cfsan.fda.gov/~dms/col-ltr.html). The original color names also may still be used.

FDA also allows companies marketing their products internationally to use dual labeling for colors, listing names acceptable to the FDA as well as Colour Index (CI) numbers that are required for labeling colors in the European Union and other countries in the world. Thus, for example, a cosmetic product in the U.S. may bear ingredient labeling for colors such as Yellow 5/CI 19140 or FD&C Yellow No. 5/CI 19140.

The Council has asked FDA to allow listing of color additives on cosmetic products using only the CI numbers, as is currently being done in the rest of the world. If this approach is accepted by FDA, the following cross reference will enable consumers to find the FDA designation for the corresponding CI Number. NOTE: Although there may be differing names allowed for color additives in the United States and elsewhere, those used in products must still meet the regulatory requirements of the relevant jurisdiction, regardless of the labeling name applied.

Color Additive Labeling Guide for Colorants Approved in the U.S.

July 13, 2005