There is no evidence of carcinogenicity, genotoxicity, neurotoxicity, or reproductive and developmental toxicity at the permitted dietary exposures; the European acceptable daily intake is 0.7 mg/kg and the WHO/FAO ADI is 4 mg/kg. The production process may result in unsulfonated aromatic amines present in concentrations of up to 100 mg/kg which may be linked to cancer. The lake pigment form of the colour additive can also increase the intake of aluminium beyond the tolerable weekly intake of 1 mg/kg/week. Therefore, the limit for aluminium may be adjusted to accommodate for this.
Possible cause of hyperactivity
Since the 1970s and the well-publicized advocacy of Benjamin Feingold, there has been public concern that food colourings may cause ADHD-like behavior in children. These concerns have led the FDA and other food safety authorities to regularly review the scientific literature, and led the UK FSA to commission a study by researchers at Southampton University of the effect of a mixture of six food dyes and sodium benzoate on children in the general population, who consumed them in beverages; the study published in 2007. The study found "a possible link between the consumption of these artificial colours and a sodium benzoate preservative and increased hyperactivity" in the children; the advisory committee to the FSA that evaluated the study also determined that because of study limitations, the results could not be extrapolated to the general population, and further testing was recommended". The European regulatory community, with a stronger emphasis on the precautionary principle, required labelling and temporarily reduced the acceptable daily intake for the food colourings; the UK FSA called for voluntary withdrawal of the colourings by food manufacturers. However, in 2009 the EFSA re-evaluated the data at hand and determined that "the available scientific evidence does not substantiate a link between the colour additives and behavioural effects". There is no evidence to support broad claims that food colouring causes food intolerance and ADHD-like behaviour in children. It is possible that certain food colouring may act as a trigger in those who are genetically predisposed, but the evidence is weak.
