FD&C Lakes

The U.S. Food and Drug Administration defines "Lakes" as the aluminum salts of FD&C water-soluble dyes extended on a substratum of alumina. Lakes prepared by extending the calcium salts of the FD&C dyes are also permitted but, to date, none have been made to our knowledge.

Lake pigments are primarily used for foods, drugs, cosmetics, personal care products and food packaging materials. In the U.S., they must be certified by the FDA's Division of Color Technology. The FDA is part of the U.S. Department of Health and Human Services. The specifications they must meet are listed in the Code of Federal Regulations Title 21, Part 82, Subpart B-Section 82.51, published April 1,1991. FD&C Red No. 40 Lake is permanently listed according to CFR Title 21, Part 74, Subpart A-Section 74.340.

To fully explain Lakes and their properties and purposes, it is necessary to understand the difference between dyes and pigments. Dyes are chemical compounds which exhibit their coloring power or tinctorial strength when dissolved in a solvent. Pigments are insoluble colored materials which color by dispersion. Because dyes have been used for over 75 years most people are familiar with them, but many do not realize the challenge of coloring with pigments.

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