Positive Safety evaluation of Annatto E
EFSA Positive Safety evaluation of Annatto E and New exposure assessment for annatto extracts
The European Food Safety Authority (EFSA) carried out a safety evaluation of Annatto E and an exposure assessment of the annatto coloring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels.
Safety of Annatto E
EFSA evaluated positively and recognised Annatto E (aqueous-processed bixin) as safe. With this latest scientific opinion, EFSA has now confirmed that all five Annatto extracts currently on the market are safe.
On the basis of data submitted by NATCOL which included a mutagenicity study, EFSA concluded that food color Annatto E does not raise concern for genotoxicity. Accordingly, the acceptable daily intakes (ADIs) established in 2016 for the two coloring principles bixin and norbixin can also be applied to the Annatto E.
New exposure assessment for Annatto extracts
EFSA also carried out an exposure assessment of the annatto coloring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new NATCOL proposed uses and use levels.
NATCOL revised its 2017 levels and proposed new uses and use levels for bixin-based and norbixin-based annatto extracts, in the form of three alternative scenarios. EFSA concluded that the level of exposure does not raise a health concern.
NATCOL is very pleased with this EFSA new scientific opinion which confirms the safety of all Annatto extracts for which we submitted data. It also reaffirms Annatto use and use levels.