There are four classes of caramel coloring recognized by JECFA, the Joint FAO/WHO Expert Committee on Food Additives, of which two classes (III and IV) are produced using ammonium compounds, resulting in the formation of small amounts of 2-methylimidazole (2-MEI) and/or 4-methylimidazole (4-MEI). Class III caramel coloring is often used in soy sauce and brewing, while class IV is common in cola drinks.
The CSPI’s regulatory petition, filed with the FDA on Wednesday, cites government research that linked giving laboratory rats extremely high doses of 2-MEI and 4-MEI with increased risk of developing lung, liver, or thyroid cancer or leukemia.
CSPI executive director Michael Jacobson said: “Carcinogenic colorings have no place in the food supply, especially considering that their only function is a cosmetic one. The FDA should act quickly to revoke its approval of caramel colorings made with ammonia.”
In particular, the organization noted that the state of California is considering listing 4-MEI under Proposition 65, which would require products that could expose people to more than 16 micrograms of 4-MEI per day to carry a carcinogen warning label. It said that a 12-oz can of cola contains about 130 micrograms.
However, the CSPI also said that the sugar content of cola beverages “presents a greater health risk than the ammonia sulfite process caramel”.
In response to the CSPI petition, the Grocery Manufacturers Association said: “4-MEI is found in trace amounts in a wide variety of foods and beverages. There is no evidence that 4-MEI causes cancer or poses any other health risks to humans. In addition, no health regulatory agency around the globe, including the FDA, has said that 4-MEI is a known human carcinogen.”
Whether or not the colorings are banned, CSPI said that the FDA should at least change the name of caramel colorings because, at present, the name conjures images of “the caramel one might make at home by melting sugar in a saucepan”.
The American Beverage Association also issued a statement in response to the FDA’s petition, in which it said: “4-MEI is virtually ubiquitous, found in trace amounts in a wide variety of foods and beverages. It forms during the heating, roasting or cooking process…This petition is nothing more than another attempt to scare consumers by an advocacy group long-dedicated to attacking the food and beverage industry.”