How are cosmetic color additives regulated in the U.S.?

July 26, 2021

What is a color additive?

A color additive, as defined by the FDA (Food and Drugs Administration), is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body.

Color additives are essential in the cosmetic industry, as they make creams and shampoos seem more appealing, or make-up to actually stain the skin. They also often play a key role in brand image, as some brands can be associated with certains colors and shades.

Cosmetic color additives can be divided into two broad categories:

  • Organic additives: The term “organic” does not bear the same meaning we associate with our groceries, it indicates in this case that the chemical structure of the colorant includes carbon atoms. Synthetic dyes, lakes and botanicals are the three different types of organic color additives.
  • Inorganic color additives: They are made up of mineral compounds, such as iron oxide and zinc oxide. While many of the colors found in the inorganic group can be found in nature today, all of these color additives are synthetic and made in a lab to ensure consumer safety.

How are color additives regulated in the U.S.?

Cosmetic products are regulated by the FDA, but they don’t need to be registered before marketing. However, the FDA does have a strict system of approval when it comes to color additives.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), color additives, except for coal tar hair dyes, have to be approved by the FDA before they may be used in food, drugs, or cosmetics, or in medical devices.

Approved cosmetic colors additives are part of 2 lists:

  • Listing of Color Additives Exempt from Certification (21 CFR Part 73 Subpart C—Cosmetics)
  • Listing of Color Additives Subject to Certification (21 CFR Part 74 Subpart C—Cosmetics)

There are two different processes for the regulation of color additives:

  • Color additives from Petroleum and coal sources: A sample per batch has to be sent to the FDA for assessment of its purity and safety for an intended purpose. If the color additive complies with the requirements, the FDA issues a certification for the batch. Certified color additives get a special name, which consists of a prefix, such as FD&C, D&C or Ext. D&C, a color, and a number.
  • Color additives from mineral, botanical or animal sources: They don't require FDA’s control before use, but they still have to comply with the regulatory requirements and safety standards for color additives.

In case there is a restriction for the use of the approved color additive, its usage has to be strictly limited to the restrictions for the intended use. For example, if a manufacturer wants to make a lipstick, they have to use only color additives that have been approved for use on lips.

The regulations specifically restrict the use of color additives in eye contour area, in externally applied cosmetics and for the injection (for tattooing or permanent makeup).

Here is a list of all the color Additives permitted for use in cosmetics by the FDA:

It is important to make sure that the color additives you use in your cosmetics are approved by the FDA, otherwise, the product will be considered adulterated and you can face FDA's penalties.

EcoMundo guides you through the whole process

EcoMundo's experts are by your side to make sure the color additives used on your products are compliant with FDA's regulation.

Check color additives compliance with EcoMundo's experts

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