On Jul. 12, 1960, the Color Additive Amendments of 1960 defined “color additive” and required that only color additives (except coal-tar hair dyes) listed as “suitable and safe” for a given use could be used in foods, drugs, cosmetics, and medical devices. The 1960 Amendments also contained a “Delaney Clause” that prohibited the listing of a color additive shown to be a carcinogen.

In the fall of 1950, many children became ill from eating an orange Halloween candy containing 1-2% FD&C Orange No. 1, a color additive approved for use in food. That same year, U.S. House Representative James Delaney began holding hearings on the possible carcinogenicity of pesticide residues and food additives. These events prompted FDA to reevaluate all of the listed color additives. In the next few years, FDA found that several caused serious adverse effects and proceeded to terminate their listings. During that time, it also became clear that coal was no longer the primary raw material source for the manufacture of color additives.

The Color Additive Amendments of 1960 defined “color additive” and required that only color additives (except coal-tar hair dyes) listed as “suitable and safe” for a given use could be used in foods, drugs, cosmetics, and medical devices. The 1960 Amendments prescribed the factors that FDA must consider in determining whether a proposed use of a color additive is safe, as well as the specific conditions for safe use that must be included in the listing regulation. FDA updated the procedural regulations for the petition process in response to these amendments. Under these amendments, the approximately 200 color additives that were in commercial use at the time were provisionally listed and could be used on an interim basis until they were either permanently listed or terminated due to safety concerns or lack of commercial interest. Permanently listing a color additive for a proposed use was prohibited unless scientific data established its safety.

The 1960 Amendments also contained a “Delaney Clause” that prohibited the listing of a color additive shown to be a carcinogen. The clause states that “A color additive shall be deemed unsafe. . . if the additive is found. . . to induce cancer when ingested by man or animal, or . . . after other relevant exposure of man or animal to such additive.”

After 1960, FDA gradually removed color additives from the provisional list either by permanent listing or by termination of listing. Today about half of the “1960” color additives remain listed; only color additive lakes remain provisionally listed and initiatives are underway to permanently list them.