The Regulation of Colors in the US

The US FDA has established regulations for color additives in Title 21 of the CFR, parts 70-82. These regulations identify each listed color additive, provide chemical specifications and identify uses and restrictions, labeling requirements and the requirement for certification. The regulations in 21 CFR part 71 describe the premarket approval process for new color additives or new uses for listed color additives. Color manufacturers routinely carry out quality assurance testing on the products they sell to ensure that they meet the specifications laid out in the Code of Federal Regulations.

FDA defines a color additive in FD&C Act Section 201(t) as a material which is a dye, pigment, or other substance …  and when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto. FDA excludes substances determined by the Secretary to be used solely for a purpose other than coloring. A color additive is unsafe if not used in accord with a regulation/exemption and there is no generally recognized as safe (GRAS) exemption.

 

There are two categories of FDA approved colors: certified (FD&C) colors and exempt from certification colors. FDA does not consider any color additive to be “natural” and food ingredients such as strawberries and chocolate that contribute their own natural colors are not color additives.

Certified Colors (FD&C Colors)

Color additives subject to batch certification (21 CFR 74) are synthetic organic dyes, lakes, or pigments.  A sample of each and every batch of a certified color is submitted to the FDA for testing to ensure that the color meets the standards set by the FDA.

Exempt Colors

Color additives exempt from certification (21 CFR 73) generally include those derived from plant or mineral sources. Certification exempt colors must comply with the identity and purity specifications and use limitations described in their listing regulation. Exempt from certification colors do not require additional batch by batch testing, but have also been thoroughly evaluated by the FDA.

More public information on the safety and regulation of food colors can be found via the International Food Information Council.