Scientific Opinion on the food additive E 160e

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 by 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 Both committees established an Acceptable Daily Intake (ADI) of 0–5 mg/kg bw/day, which was later withdrawn by the SCF in 2000.

The Panel concluded that the available in vitro and in vivo genotoxicity studies do not raise concerns with respect to genotoxicity. Following a public call for data, two subchronic toxicity studies in rats, performed according to OECD guidelines and under Good Laboratory Practice (GLP), became available for evaluation.

Based on the 13-week study, the Panel identified a Lowest Observed Adverse Effect Level (LOAEL) of 10 mg β-apo-8’-carotenal active ingredient/kg bw/day, due to an increased incidence of eosinophilic droplets in the kidneys.

After an additional public call for data, two studies on reproductive and developmental toxicity were submitted, revealing a No Observed Adverse Effect Level (NOAEL) of 500 mg/kg bw/day, which was the highest dose tested.

Overall, the Panel concluded that the available database on β-apo-8′-carotenal provides a sufficient basis to revise the ADI. Using the LOAEL of 10 mg/kg bw/day from the 13-week rat study and applying an uncertainty factor of 200, the Panel established a new ADI of 0.05 mg/kg bw/day.

Exposure estimates at Tier 3 indicate that the newly established ADI is reached on average by adults and exceeded by adults at the 95th percentile, as well as by children both on average and at the 95th and 97.5th percentiles.