Scientific Opinion on the re-evaluation of carnauba wax (E 903) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion re-evaluating the safety of carnauba wax (E 903). Carnauba wax (E 903) is authorised in the EU as food additive as glazing agent. It has been evaluated by the Scientific Committee on Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) who allocated an Acceptable Daily Intake (ADI) of 7 mg/kg bw/day. The SCF did not establish an ADI but considered the use of carnauba wax as a glazing agent acceptable. Carnauba wax is a complex mixture of compounds consisting mainly of aliphatic esters (wax esters), α-hydroxyl esters and cinnamic aliphatic diesters obtained from the Brazilian Mart wax palm, Copernicia cerifera. The Panel considered that carnauba wax would be predicted to not be significantly absorbed from the diet and that if hydrolysed its main constituents could be absorbed and incorporated into normal cellular metabolic pathways. Based on the available data and the lack of structural alerts on carnauba wax it was concluded that there is no concern for genotoxicity for carnauba wax. Subchronic and reproductive and developmental toxicity studies did not showed adverse effects related to carnauba wax intake. No chronic toxicity or carcinogenicity studies were available on carnauba wax. Overall, the Panel considered that long-term toxicity data on carnauba wax were lacking and therefore did not establish an ADI.. However, the Panel considered that the exposure estimates to carnauba wax from the proposed uses resulted in sufficient margins of safety compared to the identified No Observed Adverse Effect Levels (NOAELs) for carnauba wax, allowing the Panel to conclude that the use of carnauba wax as a food additive with the currently authorised uses would not be of safety concern.