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 (http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.htm). 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 (http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.htm).

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 (http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.htm). 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.

EU Labeling Name

FDA Color Additive Name

Abbreviated Name

CI 10316

Ext. D&C Yellow No. 7

Ext. Yellow 7

CI 12085

D&C Red No. 36

Red 36

CI 14700

FD&C Red No. 4

Red 4

CI 15510

D&C Orange No. 4

Orange 4

CI 15800

D&C Red No. 31

Red 31

CI 15850

D&C Red No. 6

Red 6

CI 15850

D&C Red No. 7

Red 7

CI 15880

D&C Red No. 34

Red 34

CI 15985

FD&C Yellow No. 6

Yellow 6

CI 16035

FD&C Red No. 40

Red 40

CI 17200

D&C Red No. 33

Red 33

CI 19140

FD&C Yellow No. 5

Yellow 5

CI 20170

D&C Brown No. 1

Brown 1

CI 26100

D&C Red No. 17

Red 17

CI 42053

FD&C Green No. 3

Green 3

CI 42090

FD&C Blue No. 1

Blue 1

CI 42090

D&C Blue No. 4

Blue 4

CI 45350

D&C Yellow No. 7

Yellow 7

CI 45350

D&C Yellow No. 8

Yellow 8

CI 45370

D&C Orange No. 5

Orange 5

CI 45380

D&C Red No. 21

Red 21

CI 45380

D&C Red No. 22

Red 22

CI 45410

D&C Red No. 27

Red 27

CI 45410

D&C Red No. 28

Red 28

Banned  (CI 45425)

D&C Orange No. 10

Orange 10

Banned  (CI 45425)

D&C Orange No. 11

Orange 11

CI 47000

D&C Yellow No. 11

Yellow 11

CI 47005

D&C Yellow No. 10

Yellow 10

CI 59040

D&C Green No. 8

Green 8

CI 60725

D&C Violet No. 2

Violet 2

CI 60730

Ext. D&C Violet No. 2

Ext. Violet 2

CI 61565

D&C Green No. 6

Green 6

CI 61570

D&C Green No. 5

Green 5

CI 73360

D&C Red No. 30

Red 30

CI 77266

D&C Black No. 2

Black 2

CI 77267 D&C Black No. 3 Black 3

CI 75120

Annatto

Annatto

CI 40800

CI 75130

Beta-Carotene

Beta-Carotene

CI 75170

Guanine

Guanine

CI 75470

Carmine

Carmine

CI 75810

Chlorophyllin-Copper Complex

Chlorophyllin-Copper Complex

CI 77000

Aluminum Powder

Aluminum Powder

CI 77007

Ultramarines

Ultramarines

CI 77163

Bismuth Oxycholoride

Bismuth Oxycholoride

CI 77288

Chromium Oxide Greens

Chromium Oxide Greens

CI 77289

Chromium Hydroxide Green

Chromium Hydroxide Green

CI 77400

Bronze Powder

Bronze Powder

CI 77400

Copper Powder

Copper Powder

CI 77489

CI 77491

CI 77492

CI 77499

Iron Oxides

Iron Oxides

CI 77510

Ferric Ferrocyanide or Ferric Ammonium Ferrocyanide

Ferric Ferrocyanide or Ferric Ammonium Ferrocyanide

CI 77742

Manganese Violet

Manganese Violet

CI 77820

Silver

Silver

CI 77891

Titanium Dioxide

Titanium Dioxide

CI 77947

Zinc Oxide

Zinc Oxide

Not Listed as a Color Additive

Bismuth Citrate (Hair Color Only)

Bismuth Citrate

Caramel

Caramel

Caramel

Not Listed as a Color Additive

Dihydroxyacetone

Dihydroxyacetone

Not Listed as a Color Additive

Disodium EDTA-Copper

Disodium EDTA-Copper

Not Listed as a Color Additive

Guaiazulene

Guaiazulene

Not Listed as a Color Additive

Henna (Hair Color Only)

Henna

Banned

Lead Acetate (Hair Color Only)

Lead Acetate

Not Listed as a Color Additive

Mica

Mica

Not Listed as a Color Additive

Pyrophyllite

Pyrophyllite

Not Listed as a Color Additive

Luminescent Zinc Sulfide

Luminescent Zinc Sulfide

July 13, 2005