Color Additives Fact Sheet

Updated June 11, 2025

Background

There’s been growing scrutiny over the use of color additives in foods. This is due to, in part, to increased attention and concerns about the potential health effects of color additives. While many of these concerns have not been substantiated, many states have moved to limit or ban certain color additives, creating a patchwork of regulations. Inconsistent regulations across states create major compliance challenges for the food industry prompting manufacturers to seek alternatives. Adjusting formulations on a state-by-state basis is impractical so many manufacturers may be forced to change formulations nationwide or otherwise leave certain markets. While in many cases, reformulation is possible, it is not a matter of switching out one ingredient for another, rather it is a well-defined iterative process that is complex, takes time, in some cases years, and requires coordination across the supply chain.

What are color additives?

A color additive as defined in the Federal Food, Drug and Cosmetic Act (FDCA) (21 CFR 70.3(f)), provides that any substance that imparts color to a food, drug, cosmetic, or to the human body is a color additive. Color additives are used in foods for variety of reasons, including to enhance natural color or correct natural variations in color.

How are color additives classified?

Color additives are often classified as either “natural” or “synthetic.” Generally, color additives considered to be natural are extracted from natural sources in the environment, such as plant or mineral sources (e.g., paprika, turmeric, iron oxide, and lead oxides, etc.). Synthetic color additives are manmade and are synthetically produced. While “natural” color additives are found naturally in the environment, production still requires chemical synthesis. Regardless, the use of any color additive in food is strictly regulated and both natural and synthetic color additives must meet the same standard for safety.

Color additives are classified under three categories: Straight colors, lakes, and mixtures.

Straight colors are colors that have not been mixed or chemically reacted with any other substance (e.g., FD&C Red No. 40).
Lakes are made from reacting straight colors with aluminum cations as precipitants and aluminum hydroxide as substratum (ex. Blue 1 Lake). Lakes for food must be made from certified batches of straight colors. (An exception is carmine, which is a lake made from cochineal extract.)
Mixtures are colors additives formed by mixing one color additive with one or more other color additives or non-colors diluents. For mixtures, no chemical reaction occurs.

What are “coal-tar” and “petroleum-based” color additives?

Certified color additives have been called “coal-tar” colors or “petroleum-based” colors, but these colors do not contain coal or petroleum. Rather these colors are synthesized from raw materials that are extracted from petroleum or coal. For example, FD&C Red No. 40 is made from p-cresidine, which is derived from petroleum, also known as a petrochemical.

Who regulates color additives in the U.S.?

FDA regulates color additives used in the U.S. and is responsible for approving color additives before they can be used in foods. As part of this approval process, the safety of a color additive is evaluated for the intended use as well as at the intended level of use. After a thorough evaluation by the Agency, only color additives determined to be safe at the intended level of use can be used in food. Approval of a color additive for one intended use does not mean approval for other uses. Furthermore, approval of color additives specifies the foods in which it can be used, the maximum amount allowed to be used, how the color additive is declared on the food label and whether batch certification is required. When a color additive is approved, it is placed on an FDA list of approved colors found at 21 CFR Parts 73 and 74.

How does FDA evaluate the safety of color additives?

As part of the approval process, FDA’s evaluates the safety of color additives—whether a new color additive or a new use for a listed color additive—FDA considers factors such as probable consumption or exposure from its use, cumulative effect in the diet, safety and stability data, and purity levels. FDA continues to thoroughly review the safety of color additives through both pre and post market review processes. This includes a detailed analysis of chemical properties, the manufacturing process, stability data, analytical methods used for determining purity, and other factors that might otherwise affect the safety of these color additives.

This approval process has a margin of safety built into the process, and the levels of use that are approved are much lower than what is needed to have any adverse effect. FDA’s color additive approval does not provide an absolute certainty of no risk, rather provides a determination, based on the available science, that there is reasonable certainty of no harm to consumers under the color additive’s conditions of use.

What are certified color additives and exempt color additives?

All permitted food colors that are listed fall into one of two categories—color additives subject to certification or color additives exempt certification—both of which are required to meet the same safety standard before being approved for use in foods.

Certified color additives are synthetically produced and are widely used in foods due to their color intensity, color uniformity, cost effectiveness and ability to blend with other colors. These additives are classified as certified because that are required to undergo certification anytime a batch is produced. Certified color additives approved for use in foods are called “FD&C” color additives because they also may be used in drugs and cosmetics. Color additives subject to batch certification are listed in 21 CFR part 74.

Exempt color additives are color additives are typically color additives derived from natural sources such as plant or minerals. Although exempt from batch certification, users of these color additives are responsible for ensuring the color additives comply with the listing regulations, including the purity specifications and use limitations. Color additives exempt from batch certification are listed in 21 CFR part 73.

What is color additive certification?

Synthetic color additives are required to undergo batch certification before they can be used in food. Batch certification is a process in which FDA analyzes a representative sample of each batch of the color additive manufactured to ensure it meets the required identity and specifications described in the listing regulation for the color additive.

The need for batch certification is determined during the approval process for listing a color additive. Some color additives may contain impurities that can be toxic and harmful to human health; therefore, the composition of these color additives needs to be controlled. Batch certification is necessary and required to verify the composition of certain color additives to protect public health.

Until a batch is certified, the batch cannot be used in food and must be stored separately from batches already certified. If a batch meets the specifications and is certified, FDA assigns a lot number for the batch and the name of the batch changes. For example,

"tartrazine" becomes "FD&C Yellow No. 5." Quarterly reports on the certification of color additives color are published on FDA’s website.

Can FDA revoke the use of a color additive that has been approved?

FDA continually monitors the safety of color additives after they are approved as part of the post market assessment process to assure the use of a color additive remains safe. If new data or information suggests that a color additive already in use may be unsafe, or if consumption levels changed that requires further evaluation, FDA has the authority to revoke use or conduct additional studies to determine if the use is still considered safe.

What is the use of color additives in other countries such as Canada and the European Union?

Below is a chart of commonly used synthetic dyes in the US and their names used in other countries. Synthetic color additives have different names in other countries, which has led to some confusion regarding their global regulatory status. Except for FD&C Green No. 3 (banned in the EU) and FD&C Blue No. 2 (no approved uses in the EU), the listed synthetic color additives are not prohibited in Canada or the EU, though they may be more heavily regulated for specific uses.

United States	Canada	European Union
FD&C Yellow No. 5	Tartrazine	E 102
FD&C Yellow No. 6	Sunset Yellow FCF	E 110
FD&C Red No. 3**	Erythrosine	E 127
FD&C Red No. 40	Allura Red AC	E 129
FD&C Blue No. 1	Brilliant Blue FCF	E 133
FD&C Blue No. 2	Indigotine, indigo carmine	E 132*
FD&C Green No. 3	Fast Green FCF	E 143*

**As of January 15, 2025, FDA has revoked authorization of FD&C Red No. 3 for use in food and ingested drugs by January 15, 2027, and January 18, 2028, respectively. In March 2025, FDA announced phasing out additional color additives and encouraging the use of natural colors.