How are color additives regulated?

In 1900, there were about 80 man-made color additives available for use in foods. At that time there were no regulations regarding the purity and uses of these dyes.

Legislation enacted since the turn of the century, however, has greatly improved food color additive safety and stimulated improvements in food color technology.

The Food and Drug Act of 1906 permitted or "listed" seven man-made color additives for use in foods. The Act also established a voluntary certification program, which was administered by the U.S. Department of Agriculture (USDA); hence man-made color additives became known as "certifiable color additives.

The Federal Food, Drug & Cosmetic (FD&C) Act of 1938 made food color additive certification mandatory and transferred the authority for its testing from USDA to FDA. To avoid confusing color additives used in food with those manufactured for other uses, three categories of certifiable color additives were created.

Food, Drug and Cosmetic (FD&C)- Color additives with application in foods, drugs or cosmetics; Drug and Cosmetic (D&C)- Color additives with applications in drugs or cosmetics; and External Drug and Cosmetic (External D&C)- Color additives with applications in externally applied drugs (e.g. ointments) and in externally applied cosmetics.

In 1960, the Color Additive Amendments to the FD&C Act placed color additives on a "provisional" list and required further testing using up-to -date procedures. One section of the amendment known as the Delaney Clause, prohibits adding to any food substance that has been shown to cause cancer in animals or man regardless of the dose. Under the amendments, color additives exempt from certification also are required to meet rigorous safety standards prior to being permitted for use in foods.

According to the Nutrition Labeling and Education Act of 1990, an certifiable color additive used in food must be listed in the ingredient statement by its common or usual name. All label printed after July 1, 1991 must comply with this requirement.