Color Additives

While some believe that the Food and Drug Administration (FDA) of the United States has a more lenient approach to regulation than agencies in other regions, notably the European Union, when it comes to color additives the FDA is pretty specific. If the chief purpose of an additive is to change the color of food, then the additive is considered a color. If the purpose of the ingredient is something else, like flavor, then any color imparted must be clearly unimportant to appearance.

Any color additive must be approved for use in food by the FDA. There are two categories of color additives permitted in the US. These are listed in 21 Code of Federal Regulations (21CFR) Parts 73-82. Certified color additives and exempt-from-certification color additives. The latter are commonly referred to as “natural” colors and the former are the synthetic or FD&C colors. Note that technically, the FDA considers all color additives “artificial” whether they originate from natural sources or are synthetic.

For certified colors, all manufacturers submit a sample of each batch for certification testing to the FDA. The testing process determines whether the batch meets the color’s requirement for composition and purity. Once the batch is approved, the FDA issues a certified lot number and the manufacture is permitted to sell the product. Colors subject to certification include:

• FD&C Red #40 and its lake
• FD&C Red #3
• FD&C Yellow #5 and its lake
• FD&C Yellow #6 and its lake
• FD&C Green #3 and its lake
• FD&C Blue #1 and its lake
• FD&C Blue #2 and its lake

Exempt from certification colors are primarily natural colors derived from plant, animal, or mineral sources. Natural Colors are not subject to batch certification. However, they must meet the FDA requirements for identity, composition and purity. In addition, some of these additives are limited to certain classifications of food products or certain usage levels. But importantly, food color manufacturers, rather than the FDA, bear the responsibility for self-certifying these colors.

In the U.S., the FDA mandates that all color additives be labeled in the ingredient statement. Certified colors are declared by their name, such as “Yellow 5 (color)” or “Color (Blue 1 Lake.)”

Exempt from certification colors can be listed as “Colored with Vegetable/Fruit Juice, Vegetable/Fruit Juice for Color, or Color (Vegetable/Fruit Juice).”

Note that cochineal extract and carmine are the two exempt colors that require declaration by name. Please refer to 21 CFR 101.22(k) for additional labeling details.

Use of the term natural color is prohibited on an ingredient statement because, regardless of the source of the color, FDA regulations do not consider any added color to be natural unless the color is “natural to” the food product itself, such as coloring strawberry ice cream with strawberry juice. These are the regulations, at least for now! As most of you know, FDA regulations can sometimes change very quickly.