Scientific Opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of mixed carotenes [E 160a (i)] and β-carotene [E 160a (ii)] when used as food colouring substances. Mixed carotenes [E 160a (i)] and β-carotene [E 160a (ii)] are authorised as food additives in the EU and have been evaluated previously by the JECFA the latest in 2001 and by the SCF in 1997 and 2000. Both Committees established an Acceptable Daily Intake (ADI) of 0-5 mg/kg bw/day. In this opinion the mixed carotenes are defined according to the Commission Directive 2008/128/EC and consist of two groups of substances: plant carotenes and algal carotenes. β-Carotene comprises (synthetic) β-carotene and β-carotene obtained by fermentation of the fungus Blakeslea trispora. The Panel noted (i) that the specifications of mixed carotenes are inadequate and need to be updated, (ii) that most toxicological studies have been performed with rodents, although rodents, in contrast to humans, very efficiently convert β-carotene to vitamin A. The Panel concluded that based on the presently available dataset, no ADIs for mixed carotenes and β-carotene can be established and that the use of (synthetic) β-carotene and mixed β-carotenes obtained from palm fruit oil, carrots and algae as food colour is not of safety concern, provided the intake from this use as a food additive and as food supplement, is not more than the amount likely to be ingested from the regular consumption of the foods in which they occur naturally (5-10 mg/day). This would ascertain that the exposure to β-carotene from these uses would remain below 15 mg/day, the level of supplemental intake of β-carotene for which epidemiological studies did not reveal any increased cancer risk. Furthermore, the Panel could not conclude on the safety in use of mixed carotenes [E 160a (i)]