This article includes a brief history of the use of colorants in foods, drugs, cosmetics, and medical devices, and the development of legislation in the United States to control them. It describes where and why colorants are used, lists all those currently in use, identifies each as either needing certification or not, and describes the chemical and physical properties, method of manufacture, chemical structure, chemical classification, and uses of each. Individual and general restrictions relating to the use of colorants are described, and sample specifications are shown. The weight of each colorant certified in the United States each year from 1983 to 1990 is given. Includes references and sources for more information regarding colorants including their analysis as is and in product matrices.
This article includes a brief history of the use of colorants in foods and the development of legislation in the United States to control them. It describes where and why colorants are used, lists all those currently in use, identifies each as either needing certification or not, and describes the chemical and physical properties, method of manufacture, chemical structure, chemical classification, and uses of each. Individual and general restrictions relating to the use of colorants are described, and sample specifications are shown. Includes references and sources for more information regarding colorants including their analysis as is and in product matrices.
Colorants have been added to foods, drugs, and cosmetics for centuries. Natural sources were used as dyes until the discovery of the first synthetic organic dyestuff by Perkin in 1856. A host of new and different colorants became available. The use of these new dyes in food, drugs, and cosmetics increased rapidly. The proliferation of color additives was soon recognized as a public health concern and it was soon made clear that some sort of government control was necessary.
In 1938 the Federal Food, and Drug, and Cosmetic Act was instituted and several new and important practices were enacted. Among other restrictions the law stated that colorants that could be used were limited, certification became mandatory, and governmental control was extended to the coloring of drugs and cosmetics. Most colorants used today have specifications that must be met before sold. Typical specifications are given. Colorants can be divided into two groups: those listed for use and those provisionally listed. Azo colors comprise the largest group of certified colorants. Colorants are exempt from certification when it is believed that certification is not necessary to protect the public health. In general, exempt colorants have less coloring power than the certified colors and have to be used at higher concentrations. Certified and exempt colors for food, drugs, and cosmetics are listed. Opportunities for natural colorants are discussed.
Fourteen analysts from 9 laboratories evaluated a high pressure liquid chromatographic procedure for the determination of 4,4′-(diazoamino)-dibenzenesulfonic acid (DAADBSA) in FD&C Yellow No. 6. Each collaborator analyzed 5 samples nominally containing 0—0.050% DAADBSA. The repeatability and reproducibility of the method are estimated to be 0.003% and 0.020%, respectively. The method has been adopted as official first action.
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