FDA Classifications

What is a Color Additive?

  • 21 CFR 70.3: A color additive is any dye, pigment or other substance synthesized, extracted, isolated or otherwise derived from a vegetable, animal, mineral or other source and that, when added to a food, drug, or cosmetic or any part of the human body, is capable of imparting color.

Exempt from Certification

  • Regulated by the FDA; 21CFR Part 73

  • Color additives that are referred to as “natural colors” in the industry

  • These colors are obtained from fruit, vegetable, animal and mineral sources or, are the synthetic duplicates of the naturally existing colorants.

Exempt Colors

  • While the Exempt Colors are mostly derived from natural sources, the term “natural” is not allowed for finished product ingredient labeling.

  • Below is a list of permitted terms as stated by the FDA:

    • Artificial Color

    • Artificial Color Added

    • Color Added

    • Colored with (name of color)

    • Name of color (color)

    • Equally Informative Term

  • Cochineal Extract and Carmine must be declared on the ingredient label.

Certified Colorants

  • Regulated by the FDA; 21CFR Parts 74 and 82

  • Color additives that are compounds produced by chemical synthesis and must conform to the high purity specifications established by the Food and Drug Administration.

  • Available as soluble dyes or insoluble lake pigments.

Certified Colors

  • The Certified Dyes and Lakes must be declared individually by name on the finished product ingredient label. The use of “FD&C” or “No.” is not required.

  • The use of the term “Lake” when the lakes are used must be declared as part of the color name on the ingredient label.