Scientific Opinion on the re-evaluation of β-apo-8’-carotenal (E 160e) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of β-apo-8’-carotenal (E 160e) as a food additive in the EU. β-Apo-8’-carotenal was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974 and the EU Scientific Committee for Food (SCF) in 1975 and 2000. Both committees established an Acceptable Daily Intake (ADI) of 0-5 mg/kg bw/day, which was withdrawn by the SCF in 2000. The Panel concluded that the available in vitro and in vivo genotoxicity studies do not give reason for concern with respect to genotoxicity. Upon a public call for data two subchronic toxicity studies in rats performed according to OECD guidelines and under GLP became available for evaluation. Based on the 13-week study the Panel established that based on increased incidence of eosinophilic droplets in the kidneys the LOAEL was 10 mg β-apo-8’-carotenal active ingredient/kg bw/day. Upon a public call for data two additional studies on reproductive and developmental toxicity became available revealing a NOAEL of 500 mg/kg bw/day, the highest dose level tested. Overall, the Panel concluded that the present database on β-apo-8'-carotenal provides a basis to revise the ADI. The Panel concluded that based on the LOAEL of 10 mg/kg bw/day from the 13 week study in rats and an uncertainty factor of 200, an ADI for β-apo-8’-carotenal of 0.05 mg/kg bw/day can be established. Exposure estimates at Tier 3 indicate that the newly set ADI is reached for adults on average and exceeded by adults at the 95^th percentile and by children on average and at the 95^th/97.5th percentile.