FD&C Green No. 3 Aluminum Lake

Excipient (pharmacologically inactive substance)

What is FD&C Green No. 3 Aluminum Lake?

FD&C Green No. 3, also known as Fast Green FCF is a food, drug and cosmetic synthetic dye with an aquamarine color. The FDA lists it as a safe additive. However, the European Union does not allow the use of Fast Green. This substance has been found to have tumorigenic effects in experimental animals, as well as mutagenic effects in both experimental animals and humans.[1]

According to the FDA, lakes are formed by reacting straight dyes (such as FD&C Green No. 3) with precipitants and salts. Aluminum is often a component. Lakes may be used as color additives for tablet coatings due to their stability, and may also be used for cosmetics such as eye shadows.[1][2] Its use in coloring foods, pharmaceuticals and cosmetics may be of quantities allowable by the U.S. FDA.

[1] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.1.31.6

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