Panel members at the time of adoption
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on the appropriateness of the food azo-colours Tartrazine (E 102), Sunset Yellow (E 110), Carmoisine (E 122), Amaranth (E 123), Ponceau 4R (E 124), Allura Red AC (E 129), Brilliant Black BN (E 151), Brown FK (E 154), Brown HT (E 155) and Litholrubine BK (E 180) for inclusion in the list of food ingredients set up in Annex IIIa of Directive 2000/13/EC. This opinion addresses the potential of food azo-colours to cause intolerance and/or allergic reactions in humans after oral exposure. There is a shortage of large, well-controlled intervention studies with defined criteria following double-blind placebo-controlled food challenge principles. In addition, most of the studies have been conducted on selected patients. The frequency of Tartrazine intolerance has been estimated to be <1 % in subjects with food-induced urticaria and angioedema. Only few cases of intolerance reactions to Tartrazine and Ponceau 4R, and to a lesser extent to Sunset Yellow FCF and Amaranth, in sensitive individuals have been reported. These reactions include urticaria, angioedema, wheezing, and leukoclastic vasculitis. No data on sensitivity to Brown FK, Brown HT, Litholrubine BK, Brilliant Black BN, Carmoisine, and Allura Red AC are available, and no well-documented cases of intolerance reactions after oral exposure have been reported. Only few cases of intolerance reactions to colour mixtures including azo-dyes have been reported. Intolerance reactions include urticaria, periorbital oedema, facial flushing, as well as higher hyperactivity scores in children. The Panel concludes that it is unlikely that oral consumption of the food colours under consideration, either individually or in combination, would trigger severe adverse reactions in human subjects at the current levels of use.