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  • Writer's pictureDaniel Jiménez

Color Additives in Cosmetics, an Introduction

Understanding the requirements for coloring agents in cosmetics in the US is crucial for compliance. This article provides a comprehensive overview of the additives permitted for use in cosmetics based on FDA guidelines.

Color Additives in Cosmetics, an Introduction
Color Additives in Cosmetics, an Introduction

The Significance of Color Additives in Cosmetics

According to the FDA, a color additive is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body. They are essential for creating appealing products such as lipsticks, eyeshadows, blushes, and nail polishes, making them more attractive to consumers.

The United States Food and Drug Administration (FDA) is the primary body responsible for overseeing the safety and approval of color additives in cosmetics. They are required to be pre-approved by the FDA and listed in the specific regulations before they may be used and intended for sale in the United States.

Types of Color Additives

Color additives approved for use in cosmetics are classified into two main categories: certified colors and colors exempt from certification.

  • Certified Colors: also known as color additives from Petroleum and coal sources. These are synthetic additives that undergo a batch certification process by the FDA to ensure they meet strict safety standards. Each batch is tested for purity and safety before it can be used in products.

  • 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.

  • Some examples are: FD&C Blue No. 1 and D&C Red No. 7. Certified colors are known for their vibrant and consistent coloring capabilities.

  • Colors exempt from certification: these coloring agents are generally derived from mineral, botanical, or animal sources. Despite this, they must still meet FDA safety requirements. Some examples are caramel color and mica.


If you have a new colorant that is not identified and listed by the FDA you must submit a petition to the FDA.

FDA: Color Additives in Cosmetics
FDA: Color Additives in Cosmetics

The data typically cover toxicological studies, manufacturing processes, and proposed usage levels. The FDA reviews the submitted data to assess the safety of the coloring additive. This includes evaluating potential health risks such as toxicity, carcinogenicity, and allergic reactions.

If the FDA determines that the color additive is safe for its intended use, it publishes a regulation listing the approved uses and restrictions of the additive in the Federal Register.



In conclusion, the regulation of color additives permitted for use in cosmetics by the FDA is essential for ensuring the safety and quality of cosmetic products. They specifically restrict the use of color additives in eye contour areas and externally applied cosmetics.


If you’re looking to ensure the safety of your products, we’re here to provide you with answers and specialized guidance. Email us at

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