A food color additive is any dye, pigment, or other substance that can impart color to a food product. The U.S. Food and Drug Administration (FDA) regulates food color additives, including both synthetic substances and substances derived from natural sources.

Color additives must undergo FDA’s approval process before being used in food. FDA may take enforcement action against a firm distributing products containing an unapproved color or one used in a manner not described in regulation. These actions may include Warning Letters, placement of the company on Import Alert, or detention and refusal of the product in port.

Companies should assure that the color additives they are using in their food products are compliant with FDA’s regulations. Keep reading to learn more about food color additive requirements.

Color Additive Approval Process

Many food ingredients in the U.S. fall into one of three categories: GRAS (generally recognized as safe), food additives, or color additives.

GRAS substances are generally recognized among qualified experts to have been demonstrated to be adequately safe under the conditions of their intended uses. Experts may recognize a substance to be GRAS if the substance has a widespread history of consumption for food use by a significant number of consumers or if scientific procedures confirm the ingredient’s safety.

Food additives are not considered GRAS and must be approved by FDA through the food additive petition process.

By law, color additives are not considered GRAS, and they are also considered distinct from food additives. Instead, color additives must be approved through a petition process that is unique to color additives. Under the Federal Food, Drug, and Cosmetic Act, FDA must approve color additives for their intended use before they are used in food, even if the color is achieved through a natural substance, such as fruit or vegetable juice.

When FDA evaluates the safety of a new color additive or a new use for a listed additive, the agency considers the following:

• Composition and properties
• Likely amount of consumption/exposure
• Manufacturing process
• Short and long-term effects of consumption
• Stability
• Availability of analytical methods for determining its purity and the amount in food

For some synthetic color additives, approval for use is contingent upon “batch certification”. Color batch certification must be obtained for every individual batch of color by sending sample to FDA. FDA will then test the sample to ensure that it meets the specifications described in regulation, including whether any contaminants contained in the batch, such as lead or arsenic, exceed the amount allowed. The name of the color additive is changed to reflect the certified status. For example, allura red must be certified and then referenced as FD&C Red No. 40.

Using a Certified Color Additive in Food

If you are manufacturing a food product that includes a color additive requiring batch certification, you should request proof of certification from the manufacturer before purchasing the additive. Because names of color additives can vary by country, you must use the U.S. name of a color additive to determine its requirements for batch certification.

FDA includes a lot number on the certificate for a color additive. FDA may contact the manufacturer or the U.S. Agent to confirm the lot number of a color additive included in a food product being shipped to the U.S.  If the contact cannot provide a valid lot number, FDA may deem the product adulterated and may refuse the shipment’s entry into the United States.