Caramel color concerns prompt change

by Jeff Gelski
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Caramel color suppliers are promoting the safety of their ingredients while simultaneously striving to meet customer requests for certain classes of caramel color that contain less of a byproduct, 4-methylimidazole (4-MeI). As a result, color suppliers are developing alternatives to address customer concerns.

The customers may face labeling concerns in California since the Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency added 4-MeI to its list of chemicals known to the state to cause cancer and fall under the auspices of the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

The California determination comes even though last year Health Canada determined low levels of 4-MeI that may be found in food, including certain caramel colors, do not represent a risk to consumers. The European Food Safety Authority established a group acceptable daily intake (A.D.I.) of 300 mg per kilogram (2.2 lbs) of body weight per day for caramel colors while one caramel color (E150c) had an A.D.I. of 100 mg per kilogram of body weight per day.

The Food and Drug Administration lists caramel color as Generally Recognized As Safe (GRAS), said Brian Sethness of Sethness Products Co., Lincolnwood, Ill.

“For generations caramel colors have been safely manufactured and used throughout the world, and it is the most widely used food colorant,” he said. “GRAS status would not be available for caramel color without sound evidence. There have been numerous studies showing the safety of its use in food and beverages.”

D.D. Williamson, Louisville, Ky., reaffirms the safety of caramel color on the company web site, through customer contacts, traditional media, trade media, social media, trade associations and government agencies, said Margaret Lawson, chief science officer.

The California ruling is based on research associated with the National Toxicology Program that involved feeding diets containing 4-MeI to 50 male rats, 50 female rats, 50 male mice and 50 female mice over two years. Research found equivocal evidence of carcinogenic activity of 4-MeI in female rats based on increased evidence of mononuclear cell leukemia. It also found clear evidence of carcinogenic activity of 4-MeI in male and female mice based on increased evidence of alveolar/bronchiolar neoplasms.

In California, warning labels now need to be placed on products sold in the state that contain levels of 4-MeI above the “safe harbor” amount, Ms. Lawson said. The OEHHA has decided a daily intake of 4-MeI up to 29 micrograms a day over a lifetime is safe, she said.

The chemical 4-MeI is a byproduct formed — and not an ingredient added — during the heating and maillard browning process, Mr. Sethness said. Foods containing 4-MeI as a result of heating include coffee, some carbonated beverages, beer and wine, soy sauce, molasses and meats. He stressed 4-MeI is not banned in California.

Mr. Sethness said 4-MeI may appear in Class III (E150c) and Class IV (E150d) caramel colors. In Class IV colors, the reactants used help contribute to provide the brown color in colas and other dark foods and beverages. It requires a nitrogen (ammonia) source and sugar to make the chemical byproduct 4-MeI.
“Some of our customers have decided to switch to low 4-MeI caramel colors to meet specific California requirements,” Mr. Sethness said.

The company also manufactures Class I and Class II caramel colors that do not have 4-MeI, he said.
Last year the Center for Science in the Public Interest, Washington, petitioned the F.D.A. to prohibit Class III and Class IV caramel colors.

D.D. Williamson also is striving to meet customer requests.

“Even though we know that caramel colors are safe, we are working with our customers that wish to reduce the level of 4-MeI in their products,” Ms. Lawson said. “DDW offers multiple options: low 4-MeI versions of our Class III and Class IV caramel colors in both liquid and powder forms, as well as Class I options.”

She added, “Although DDW believes strongly that the developments in California are wholly unsupported by any scientific evidence or reasonableness, DDW scientists have formulated exclusive Class IV caramel colors with substantially reduced levels of 4-MeI for those food manufacturers struggling to avoid Prop-65 labels in California.”

The Coca-Cola Co., Atlanta, on March 9 said it was looking to reduce 4-MeI in its beverages.

“The caramel color in all of our products has been, is and always will be safe, and The Coca-Cola Co. is not changing the world famous formula for our Coca-Cola beverages,” the company said. “We have asked our caramel manufacturers to modify their production process to reduce the amount of 4-MeI in the caramel, but that will have no effect on the formula or on the great-tasting, high-quality products that consumers expect from us.”

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