SAFETY
CARAMEL COLOR: REGULATORY

How Is Caramel Color Regulated Around The World?    

Caramel color is regulated as a color additive. Prominent public health agencies, including the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), Codex Alimentarius, the European Food Safety Authority (EFSA) and Health Canada (HC), all provide oversight for caramel color in their respective countries, regions, or globally.    

Under the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), all color additives must be approved by FDA before they may be used in foods, drugs, cosmetics, or certain medical devices, or on the human body. FDA classifies approved color additives as either subject to certification or exempt from certification. Both types of additives must meet the same safety standard prior to their approval for use in foods.    

Certified color additives (i.e., color additives subject to certification) are synthetically produced (or human made) and used widely, because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues. There are seven certified color additives approved for use in foods called “FD&C” color additives, because they also may be used in drugs and cosmetics. For example, FD&C Yellow No. 6. A complete list of FDA-certified color additives is available on FDA’s website.    

Color additives that are exempt from certification generally include dyes and pigments derived from natural sources such as vegetables, minerals, or animals. Examples of certification exempt color additives include annatto extract (yellow), dehydrated beets (bluish-red to brown), caramel (yellow to tan), beta-carotene (yellow to orange), and grape skin extract (red or purple).   Caramel colors fall into the latter category and are exempt from certification.    

Should You Worry About Caramel Color As A Health Risk?     

Some consumer advocacy groups have raised concerns about a chemical compound called 4-MEI, that is present in very low levels in class III and IV caramel colors. This compound forms naturally during normal cooking processes — such as roasting coffee beans, baking bread, and caramelizing sugar during caramel color manufacturing.

The U.S. Food and Drug Administration (FDA) states that it “has no reason to believe that there are any immediate or short-term health risks presented by 4-MEI at the levels expected in food.” The European Food Safety Authority (EFSA) states that, in its assessment, “the highest exposure level to 4-MEI that could result from the consumption of foods containing E150c [caramel color class III] and E150d [caramel color class IV] did not give rise to concern.” In other words, the everyday consumption of caramel color is not expected to present a health concern.    

Regulators, as well as commercial food and color manufacturers, continue their efforts to understand and control 4-MEI. In the interim, the FDA is not recommending that consumers change their diets because of concerns about 4-MEI. To learn more, visit www.foodinsight.org and search for “caramel color.”    

How Can You Tell What Food Products Contain Caramel Color?

You can find out if caramel color is used in a food or beverage by simply looking at the ingredients list on the package. Every food that contains added color is required to list it on the label either by name, such as “caramel color,” or by a phrase, such as “artificial color” or “color added.” (The terms “artificial color” and “color added” don’t necessarily mean that caramel coloring is present in a food. A variety of other color ingredients are also commonly used in food, and may have been incorporated.)  

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