Last January, significant worldwide media attention was generated when the state of California's Office of Environmental Health Hazard Assessment (OEHHA), a specialized department within its Environmental Protection Agency responsible for evaluating health risks, listed 4-MEI among substances that can cause negative health effects.
The move of the OEHHA was made under the state's Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, which requires the governor of California to publish, at least annually, a list of chemicals known to the state to cause cancer or reproductive toxicity.
A number of industry groups representing a wide variety of food and beverage companies and manufacturers have already filed a lawsuit asserting that the Proposition 65 listing of 4-MEI should be rescinded.
The EFSA published its opinion last March 8 and reaffirmed the safety of the caramel used in beverages.
According to the group, caramel colorings are neither genotoxic, nor carcinogenic, and that there is no evidence to show that caramel colors have adverse effects on human reproduction or for the developing child. Caramel colors are widely used in a large variety of foods, contributing to achieving optimal organoleptic properties to meet consumer expectations.
Scientists have demonstrated that 4-MEI can be formed when foods undergo browning reactions as in baking, roasting, and frying. Thus all foods that are baked, roasted, or fried have the potential to contain detectable amounts of 4-MEI, including coffee. In addition, because 4-MEI can be formed when caramel coloring is made, caramel-containing foods such as cereals, beverages, baked goods, confectionary products, dairy products and condiments like soy sauce could contain detectable amounts of the compound.
Current regulatory specifications for certain types of caramel color (USFDA, the European Commission, and Codex) allow for those colors to contain up to 250 ppm 4-MEI based upon safety studies conducted in animals.
From the April 4, 2011, Prepared Foods E-dition