Color Additives

Safety Information

How are color additives in cosmetics regulated?

Color additives are subject to a strict system of approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Except in the case of coal-tar hair dyes, all color additives used in cosmetics must be approved by FDA.  Color additive violations are a common reason for detaining imported cosmetic products offered for entry into the United States.

According to FDA regulations, if your product (except coal-tar hair dyes) contains a color additive, you must adhere to requirements for:

  • Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, its specifications, and restrictions.
  • Certification. In addition to approval, for a number of color additives, every batch made must be certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
  • Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
  • Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

According to Linda Katz, M.D., M.P.H., Director of the Office of Cosmetics and Colors in FDA’s Center for Food Safety and Applied Nutrition, “Color additives are very safe when used properly.”

The FDA conducts detailed safety reviews for colors used in cosmetics and the approval process may involve numerous studies to establish safety. FDA lists the approved colors in the Code of Federal Regulations (Title 21). These regulations describe the identity of the color, the allowed composition, the uses and restrictions and any other requirement necessary to ensure safe use.

Find out more about FDA regulation of Color Additives in Cosmetics

How are color additives regulated around the world?

Colors are also regulated in other countries. For instance, in the European Union, colors are identified on a list of allowed ingredients for coloring purposes. The colors are identified by a Colour Index number rather than a descriptive name such as Yellow 5 or Red 7. Many other countries follow the European Union model for color regulation.


Color Additives

What Is It?

Color additives provide consumers with everything from the red tint in their blush to the green hue of their mint-flavored toothpaste. They are dyes, pigments, or other substances that can impart color when added or applied to a food, drug or cosmetic.They can be found in a wide range of consumer products—from cough syrup and breakfast cereal to contact lenses and eyeliner.

Why Is It Used?

Modern day color additives have been safely used for more than 150 years to make cosmetic and personal care products decorative, attractive and appealing. Color additives may be used to create a product image or recognition, the “mood” of the product, or other visual impressions. Prior to the development of the wide color palette currently available, products tended to appear drab and colors were very unstable and faded quickly. Mixing colors to achieve the exact desired effect requires great skill and knowledge of the properties of the ingredients and products – it is truly an art form.

Scientific Facts

The visual perception of color occurs primarily by the absorption and/or reflection of visible light by the product and corresponds to humans seeing red, yellow, blue, green, black, etc. Such color derives from the different wavelengths of light interacting with the light receptor cells in the eye and sending a message to the brain.

Color additives have long been a part of human culture. Archaeologists date cosmetic colors as far back as 5000 B.C., and ancient Egyptian writings tell of drug colorants. Many of us are familiar with and recognize drawings of Cleopatra with her wonderful eye makeup. Historians say food colors likely emerged around 1500 B.C.

Before the development of modern technology, colors primarily came from substances found in nature, such as indigo, turmeric, paprika and saffron. But as the 19th century approached, new kinds of colors appeared that offered marketers wider coloring possibilities. These colors, made in the laboratory, were found to be much more stable with greater coloring intensity, meaning that less colorant could be used in the product to accomplish the same effect. They also could be produced without using plants harvested in the wild.