The U.S. Food and Drug Administration (FDA) has revised its requirements for cochineal extract and carmine, two common colour additives derived from cochineals (Coccoidea), an insect that was already used by the Aztec and Maya peoples to produce dye.

When contained in food or cosmetic products, cochineal extract or carmine will have to be prominently and conspicuously declared in the statement of ingredients listing their respective common or usual name. An example would be: ‘‘Contains carmine as a color additive.’’

The additive, which has been approved by the FDA since 1977 for cosmetics in general including eye area use, is currently labelled as Carmine in the ingredients list of cosmetics placed on the U.S. market. [1] The ingredient will have to be indicated more prominently and conspicuously.

The FDA said this ruling “responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carmine-containing food and cosmetics”. The new labelling “will allow consumers who are allergic to these colour additives to identify and thus avoid products where they’re contained”, the FDA added.

The new labelling requirement will be effective on January 5, 2011.

The new rule was published in the Federal Register / Vol. 74, No. 2 / Monday, January 5, 2009 :

Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration