Scientific Opinion on the reconsideration of the ADI and a refined exposure assessment of β-apo-8′-carotenal (E 160e): EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)

The Panel on Food Additives and Nutrient Sources added to Food (ANS) has previously provided a scientific opinion re-evaluating the safety of β-apo-8′-carotenal (E 160e) as a food additive in the EU and establishing an acceptable daily intake (ADI) of 0.05 mg/kg body weight (bw)/day (EFSA ANS Panel, 2012). Following a request by the European Commission, the ANS Panel was asked to consider newly submitted information on the interpretation of the 13-week study in rats used as a basis to establish the ADI, to clarify its impact on that ADI and to carry out the refined exposure assessment of β-apo-8′-carotenal. The new information comprised an evaluation of all of the original kidney section slides from the 13-week toxicological study under improved visualisation conditions. The ANS Panel has considered that the supplementary information provided by the Commission and the present toxicological database on β-apo-8′-carotenal provides a basis to revise the established ADI and concluded that, based on the NOAEL of 30 mg/kg bw/day from the 13-week study in rats and an uncertainty factor of 100, a new ADI for β-apo-8′-carotenal of 0.3 mg/kg bw/day can be established. The Panel concluded that using data provided by the food industry, which are based only on a limited number of regulated categories, the reported uses and use levels of β-apo-8’-carotenal (E 160e) would not be of safety concern.