Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

annatto extracts, E 160b, bixin, norbixin, comet assay, exposure assessment
First published in the EFSA Journal
13 mars 2019
31 janvier 2019
Scientific Opinion


The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. The Panel was not able to conclude on the safety of annatto E. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, the use levels provided by food industry as well as the proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the 2017 EFSA statement related to the exposure assessment of colouring principles bixin and norbixin considering new proposed uses and use levels, the dietary exposure for bixin did not exceed the ADI. For norbixin, dietary exposure exceeded the ADI at the high level (95th percentile) for toddlers and children. In the current opinion, the Panel concluded that food colour annatto E does not raise concern for genotoxicity. Accordingly, the ADIs established in 2016 for the two colouring principles bixin and norbixin can be applied also to the annatto E. For bixin, none of the exposure estimates exceeded the ADI of 6 mg/kg bw per day. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country. Considering the uncertainties and the very likely overestimation of the exposure, the Panel concluded that the level of exposure does not raise a health concern.

Panel members at the time of adoption

Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle and Maged Younes.
Panel on Food Additives and Flavourings
fip [at]
EFSA Journal 2019;17(3):5626
Question Number
On request from
European Commission