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” named after U.S. House Representative James Delaney, that prohibited the listing of a color additive shown to be a carcinogen.

The “Delaney Clause” 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.