Cosmetic Color Additives
Only approved color additives may be used in cosmetic products.
This article applies to the United States, but most other countries have similar laws
When it comes to cosmetics, the term color additive is defined in the law.1 It is:
- A material that is a dye, pigment, or other substance made by synthesis or a similar process; OR
- A substance that is capable of imparting color to a cosmetic or to any part of the human body.
It is important to note that the additive could be a natural or synthetic substance; could be derived from any animal, vegetable, mineral, or other source; or could be the result of a reaction between two or more compounds. Needless to say, it is a very broad definition — the key is that the substance is a dye or pigment OR it is capable of changing the color of a PRODUCT or the HUMAN BODY.
Examples of color additives:
- A dye, such as an FD&C or D&C color.
- A pigment, such as an iron oxide or an ultramarine.
- Activated charcoal as an ingredient in soap can change the soap's color – therefore activated charcoal is a color additive.2
When a substance is added to a product for some reason other than changing the color but it also changes the color as a side effect, is it still a color additive unless the resulting color is not at all important to the appearance, value, marketability, or consumer acceptability of the product.3
Example: Cocoa powder is added to a soap for the chocolate aroma (although chocolate fragrance oil provides the primary scent), but the cocoa powder also turns the soap a chocolate brown color. The soap is sold as "chocolate soap.” The brown color is important to the appearance, value, marketability, and consumer acceptance of the chocolate soap (would they buy it if the soap was white?). Therefore, the cocoa powder IS a color additive4.
Example: Pomace olive oil is used in a soap for the feel and lather, but it also turns the soap a pale green. Whether the soap is white or greenish is unimportant to the appearance, value, marketability, or consumer acceptance of the soap, so the pomace olive oil IS NOT a color additive.
Example: A sugar scrub named Herbal Green & Natural contains various herbs, including powdered sage and rosemary. The rosemary and sage provide benefits, but they also give the product its green "herbal green” color. If the product were not green, it would be less marketable under the name "Herbal Green & Natural.” Therefore sage and rosemary ARE color additives.
Example: A sugar scrub named Herbal Green & Natural contains various green herbs which provide scent and texture and are green. The product ALSO contains chromium oxide greens. Whether or not the herbs make the product green is unimportant because it is already green from the chromium oxide greens. In this case, the herbs are likely NOT color additives.
FDA Responsibility for Color Additives
The FDA has a specific mandate to verify the safety of any color additive before it may be used in food, drugs, cosmetics, or medical devices. Once the FDA has determined a color additive is safe, regulations are issued that specify the technical description of the color additive and any limitations or restrictions on how or where it can be used. Once approved and regulations are issued, the color is sometimes referred to as a "listed color.”
There are separate color additive lists for foods, drugs, cosmetics, and medical devices. For example, a color additive may be approved for drugs but not cosmetics, or for cosmetics but not foods.
Certified Colors
Some color additives must have each batch tested and certified by the FDA before they can be sold for use in cosmetic products. These are often called "certified colors” but were originally called "coal-tar dyes” because they were produced as a byproduct of coal processing. Now they are considered "synthetic-organic colors” (but are still synthesized from coal or petroleum products). You can normally recognize them by their names, which are prefaced by "FD&C” (Food Drug & Cosmetic) or D&C (Drug & Cosmetic) followed by the color number.
Examples:
- D&C Yellow No. 8
- FD&C Red No. 40
Exempt Colors
Other color additives are exempt from batch certification by FDA but may still have specific specifications that must be met in order to be legally used in cosmetics. These are mostly plant, animal, or mineral derived (but may also be synthetic). Regardless of their source, they are still considered artificial colors because they are used to artificially and intentionally change the color of the product.
Examples:
- Mica (mineral)
- Ultramarines (synthetic)
- Iron Oxides (mineral)
- Annatto (plant)
- Carmine (animal)
For both certified and exempt-from-certification color additives, the manufacturer is responsible for ensuring that they are appropriately certified (if applicable) and that any required specifications are met.
Only Approved Color Additives
The law prohibits selling an adulterated cosmetic.7
Several of the ways the that a cosmetic can be adulterated (and therefore prohibited from being sold) pertain to color additives:8
- You can only use approved color additives in cosmetic products.
A cosmetic is adulterated if it contains an unapproved color additive.
Example: An herb, plant, or spice that was added to a cosmetic product to change the color, but which is not an approved color additive, such as paprika used to make a cosmetic soap orange or powdered sage to make a soap green. - You can only use an approved color additive in the way it is authorized for use.
A cosmetic is adulterated if it contains an approved color additive that is used in a way for which it wasn't authorized.
Example: A lipstick that is colored with a color additive that is not approved for use on the lips, such as Red 31 or purple ultramarines. - You can only use an approved color additive that meets the required standards and specifications.
A cosmetic is adulterated if it contains a color additive that does not meet the required standards and specifications.
Example: Using mica that is larger than 149 microns (the maximum size allowed per the specifications for mica) as a cosmetic color additive. - You can only use a certified color when it has been batch certified by the FDA.
A cosmetic is adulterated when it contains a color additive that should have batch certification by the FDA but does not.
Example: Pigment Red 57 (also known as CI 15850 and Red No 201) is the same chemical compound as D&C Red 6. Once a batch of Pigment Red 57 has been tested and certified by the FDA it is called D&C Red 6 and may be used in cosmetics.
Uses, Limitations & Restrictions
When initially approving a color additive for use in cosmetics, limitations or restrictions may be set on its use. There are three main usage designations:
- General use
- External use only
- Eye area use
General Use
Color additives approved for general use may be used in cosmetics that are generally used, including lip products. They may not be used in the eye area unless they have been specifically approved for eye area use.10
External Use Only
Color additives for external use may be used in cosmetics that are only applied to external parts of the body, but not to any body surface covered by mucous membrane, which includes lips, inside of the eyelids, inside ears, nose, and mouth, or the genitals.9
External use cosmetics may not be used in the eye area unless specifically approved for eye area use.10
In-Bath Products: When a color additive is used in an in-bath product, the color may infuse into the water and could come in contact with mucous membranes or the genital area. The FDA has determined that color additives that are approved for external application may be used in in-bath products because there is limited potential for exposure.
Eye Area Use
Color additives must be specifically approved for use in the eye area. Even if the color additive is approved for general or external use, it cannot be used around the eye area unless the FDA has specifically approved it as safe for use near the eyes. 10
The eye area is defined as the whole area between the top and bottom bones around the eye, including the eyebrow, skin below the eyebrow, eyelids and eyelashes, the eyeball and the sac holding it, and the soft tissue that is around and under the eye. 11
Eye Area: the whole area between the top and bottom bones around the eye
If a product is intended to be used around the eyes and contains a color additive that is not approved for eye area use, the product is adulterated and prohibited from being sold or introduced for sale.
Blended Colors
Color additives are frequently blended together by suppliers to create a variety of different colors. Occasionally the blends will include ingredients that are not color additives but are used for a different purpose. These are most commonly synthetic mica (correct name "synthetic fluorphlogopite”12) and tin oxide.
Colored Mica
Mica is a mineral which is whitish or translucent. It has no real color itself but may have a small amount of sparkle. Colored micas are sold as colorants for soap and cosmetics. These are actually blends of mica and some other color additives.
Glitter and Pearlescent Colors
Most glitter and pearlescent (shimmer) colors, when not made with mica, are made with a plastic which is colored and cut into fine pieces. When it is very important that you know the actual color additives used to make the glitter. See Color Additives: Glitter. [link to upcoming article]
Restrictions and Limitations
Your supplier should provide you with a list of the ingredients in the blended color and tell you how the color additives in it may be used. All the rules that apply to how a color additive may be used apply to the components in a blended color.
Example: A blend of mica and Red 30 could be used in lipstick, because Red 30 and mica are approved for general use, including lips.
Example: A blend of mica and Red 31 may not be used in lipstick, because Red 31 is only approved for external use (not lips).
Example: Any blended color containing ultramarines would be for external use only and could not be used in lipstick or lip balm.
Special Situations
Hair Dye may contain unapproved coal-tar dyes under very specific circumstances. See Color Additives: Hair Dye [link to upcoming article].
Tattoo ink and permanent makeup are considered cosmetics, but there aren't any color additives that are approved for injection into the skin.13 It's one of those FDA anomalies.
Theatrical & Halloween soap and cosmetics (including face makeup) are still subject to the same regulations as normal, everyday cosmetic products when it comes to color additives. There is only one glow-in-the-dark color additive approved for use in cosmetics (luminescent zinc sulfide). There are limited fluorescent colors approved for use in cosmetics (Orange 5, 10, and 11; and Red 21, 22, 27, and 28). There are also limitations on how these may be used.
Ingredient Declaration
Color additives may be placed at the end of the ingredient declaration regardless of the amount of the color additive.14
Certified color additives should be identified by just the color and the number (i.e. "Red 31” or "Yellow 8”).
Non-certified colors should be identified by their official name (i.e. "ultramarines” or "annatto”). For ultramarines and iron oxides don't use the color associated with it (for example, use "ultramarines” not "purple ultramarine”).
When a blended color additive is used, all of the approved color additives may be placed at the end of the ingredient declaration. However, any non-color additives that are in the blend should be placed in the correct order with the non-color ingredients in the ingredient declaration.
1 21 CFR 70.3(f)
2 Note that activated charcoal is not approved as a color additive in cosmetics.
3 21 CFR 70.3(g)
4 Note that cocoa powder is NOT an approved color additive for cosmetics.
5 Note that rosemary and sage are NOT approved color additives for cosmetics.
6 Chromium oxide green IS an approved color additives for cosmetics (although it is not approved for use on lips or genitals.
7 21 USC 331(a)
8 21 USC 379e(a) and 21 USC 361(e)
9 21 CRF 70.3(v)
10 21 CFR 70.5(a)
11 21 C FR 70.3(s)
12 International Cosmetic Ingredient Dictionary and Handbook. 16thed. See “synthetic fluorphlogopite”.
13 FDA. Color Additives and Cosmetics: Fact Sheet
14 21 CFR 701.3(f)
