WASHINGTON—The safety of certain caramel colors is under fire again after the Center for Science in the Public Interest (CSPI) released results of new lab tests that found "unsafe levels" of 4-methylimidazole (4-MI), a suspected carcinogenic formed when it mixes in the ammonia compound to make caramel color, in cans of Coca-Cola, Pepsi-Cola, Dr Pepper Snapple Group Inc's Dr. Pepper and Whole Foods' 365 Cola.
CSPI on March 5, reiterated its 2011 request for the U.S. Food and Drug Administration (FDA) to revoke its authorization for caramel colorings that contain 4-MI, and in the interim to change the name of the additive to “ammonia-sulfite process caramel coloring" or “chemically modified caramel coloring" for labeling purposes.
FDA considers caramel color a GRAS ingredient and it is exempt from certification for use as a coloring agent. Four distinct classes of caramel are officially recognized by the Joint FAO/WHO Expert Committee on Food Additives (Compendium for Caramel Color): Class 1 (plain caramel, or caustic caramel); Class 2 (caustic sulfite caramel); Class 3 (ammonia caramel); and Class 4 (sulfite ammonia caramel).
“Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer," said CSPI Executive Director Michael F. Jacobson. “The coloring is completely cosmetic, adding nothing to the flavor of the product. If companies can make brown food coloring that is carcinogen-free, the industry should use that. And industry seems to be moving in that direction. Otherwise, the FDA needs to protect consumers from this risk by banning the coloring."
The American Beverage Association responded to the CSPI news regarding the safety of 4-MEI, which forms in foods such as caramel (which adds color and flavor to many foods and beverages) during the heating, roasting or cooking process, with the following statement: "This is nothing more than CSPI scare tactics, and their claims are outrageous. The science simply does not show that 4-MEI in foods or beverages is a threat to human health. In fact, findings of regulatory agencies worldwide, including the U.S. Food and Drug Administration, European Food Safety Authority and Health Canada, consider caramel coloring safe for use in foods and beverages. CSPI fraudulently claims to be operating in the interest of the public's health when it is clear its only motivation is to scare the American people."
Last year, the European Food Safety Authority (EFSA) completed a safety review of caramel colors and concluded they are not carcinogenic or genotoxic and there is no evidence to show that they have any adverse effects on human reproduction or for the developing child.