Studies confirm safety of synthetic colors

by Jeff Gelski
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Colorful macarons
The I.A.C.M. has three studies as tools to prove the safety of synthetic colors in foods and beverages.

WASHINGTON — The International Association of Color Manufacturers has three freshly published studies as tools to prove the safety of synthetic colors in foods and beverages.

While activists and other studies have associated synthetic colors with such adverse effects as hyperactivity among children, the I.A.C.M. has notified three regulatory agencies — the Food and Drug Administration, the European Food Safety Authority and the JECFA (the joint F.A.O./WHO Expert Committee on Food Additives) — about the results of its studies.

Maria Bastaki, Ph.D.
Maria Bastaki, Ph.D., scientific director for the I.A.C.M.

“That was the primary purpose of the studies, to inform regulatory agencies with the best data possible,” said Maria Bastaki, Ph.D., scientific director for the Washington-based I.A.C.M. “From that perspective we accomplished the primary purpose of the studies.”

A study appearing on-line April 19 in Food Additives & Contaminants examined the estimated daily intake (E.D.I.) of the seven FD&C straight-color additives and five FD&C color lakes approved in the United States. Besides Dr. Bastaki, other researchers were from Colorcon, Inc., Harleysville, Pa.; Coca-Cola Co., Atlanta; and the Center for Chemical Regulation and Food Safety, Washington.

The researchers collected data from an industry survey of companies that use color additives and input from food color manufacturers. Food-consumption data came from the National Health and Nutrition Examination Survey (NHANES).

“Regardless of whether it was an average or the higher end of the spectrum, in all cases the estimated intake was way lower, many folds lower, than what the acceptable daily intake was for each color,” said Dr. Bastaki, who has a Ph.D. in pharmacology from the University of Patras in Greece. “Each color has its own E.D.I.”

The researchers compared the estimated daily exposures determined in the study to the A.D.I.s set by the JECFA as a measure of magnitude of the exposure.

The other two studies tested colors for genotoxicity and appeared on-line in Food and Chemical Toxicology. A study with yellow No. 5 (tartrazine) was published April 25. A study with red No. 40 (allura red AC) was published April 27. Besides Dr. Bastaki, other researchers were from the Coca-Cola Co. and BioReliance/Sigma-Aldrich Corp., Rockville, Md.

A 2013 opinion from the E.F.S.A. had questioned the possible genotoxicity of the two colors. The researchers communicated with the E.F.S.A. to make certain the studies’ procedures aligned with what the E.F.S.A. sought, such as using mice in the tests with yellow No. 5 and red No. 40. Doses as high as 2 grams per kilogram (2.2 lbs) of body weight were given to the mice. No genotoxic effects were found at any dose level.

Dr. Bastaki will present findings of the three studies June 28 at the Institute of Food Technologists’ annual meeting in Las Vegas. The I.A.C.M. plans to publish three more color studies, Dr. Bastaki said.

Those questioning the safety of synthetic colors often point to a study from the University of Southampton in the United Kingdom that appeared Sept. 6, 2007, in The Lancet. The randomized, double-blinded, placebo-controlled, crossover trial tested 153 3-year-olds and 144 8- or 9-year-olds to see if artificial food colors and additives affected behavior. The children drank a placebo or one of two mixes with artificial colors. The researchers found artificial colors or a sodium benzoate preservative, or both, resulted in increased hyperactivity.

Dr. Bastaki said the doses of the colors in the drinks were high, or not reached under conditions of routine consumption.

“In addition, they also were given four colors together and a preservative, all at once,” she said. “Altogether it was not realistic.”

When reviewing scientific literature in general, finding studies that show effects is more likely than finding studies that show no effects, she said in describing a trend known as “publication bias” in the scientific community.

“It’s partly the result of the researchers,” she said. “When they run a study, and they don’t find anything, they don’t think it’s worth publishing. So they don’t submit it. Sometimes it’s the journals that reject publication. They don’t think (a test with no effects) is interesting.” 
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