EFSA Finds Food-Color Research Lackluster

To ban or not to ban? That was the question for the European Food Safety Authority (EFSA) regarding various food colors and the preservative, sodium benzoate. After reviewing results from a study out of the University of Southampton, Hampshire, England, EFSA decided not to recommend banning the colors and preservative in question.

The study, funded by the Food Standards Agency and published in the Nov. 2007 issue of The Lancet, tested the hypothesis that mixtures of certain artificial food colors with the preservative sodium benzoate (E211), compared with a placebo, increase the mean level of hyperactive behavior of children drawn from the general population. Study participants included 153 3-year-old children and 144 children ages 8 to 9 from the general population, including children with normal to high level activity, but not children on medication for Attention Deficit Hyperactivity Disorder (ADHD). The colors featured in the study were sunset yellow (E110), quinoline yellow (E104), carmoisine (E122), allura red (E129), tartrazine (E102) and ponceau 4R (E124).

After assessing the results, EFSA’s Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food released an opinion, noting: “Since mixtures and not individual additives were tested in the study … it is not possible to ascribe the observed effects to any of the individual compounds. The clinical significance of the observed effects also remains unclear. In the context of the overall weight of evidence and in view of the considerable uncertainties, such as the lack of consistency and relative weakness of the effect and the absence of information on the clinical significance of the behavioural changes observed, the Panel concludes that the findings of the study cannot be used as a basis for altering the ADI (Acceptable Daily Intake) of the respective food colours or sodium benzoate.”

Nevertheless, FSA “advises parents of children showing signs of hyperactivity or ADHD that cutting certain artificial colours used in the study from their diets might have beneficial effects.”

In the United States, the following colors are approved for food use subject to batch certification (Title 21 of the Code of Federal Regulations (CFR), Part 74): FD&C Yellow No. 6: sunset yellow (E110); FD&C Red No. 40: allura red (E129); and FD&C Yellow No. 5: tartrazine (E102). Sodium benzoate is GRAS for use at a level not exceeding 0.1% (21 CFR 582.3733).