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The Annatto Interest Group (AIG), formed in 1995 from the NATCOL membership with Annatto interests, IACM Annatto Committee and the Japanese Annatto Interest Group (J-AIG) coordinates the re-testing of commercial Annatto preparations in the wake of the EU Colours Directive (94/36/EC) and the JECFA call for additional information on Annatto Extracts. Annatto was evaluated at the 61st JECFA 2003; however the meeting proposed temporary ADI values and tentative specifications which were different from those previously used. These were difficult to enforce and impossible to provide Intake Data for.

Consequently, Annatto was re-evaluated at the 67th JECFA 2006 and following on from the submission of information on the safety and composition of Annatto Extracts, as requested by JECFA in its call for data for the 67th meeting, two permanent ADIs were established; one for Bixin and a Group ADI for Norbixin.

In response to the request from EFSA for a dossier on Annatto Extracts (Bixin & Norbixin), NATCOL AIG submitted a dossier for the evaluation by DG SANCO / EFSA in April 2008. DG SANCO subsequently requested EFSA to provide a scientific opinion on the safety of Annatto Extracts (Bixin & Norbixin) when used as food colour in the food categories specified in the dossier submitted. Since November 2010, EFSA have subsequently reverted with a series of additional information requests (including another public call for data 23 March 2014) on Characterisation/Chemistry Issues; Toxicological Issues and Intake/Exposure Issues, necessitating further genotoxicity studies on specific Annatto Extracts to be funded by the AIG. Data on Intake/Exposure issues were submitted to EFSA by end December 2014 and NATCOL AIG would expect to submit the requested genotoxicity studies and outstanding Characterisation/Chemistry data before end 2015

Secretary – Dr Mary O’Callaghan
Dossier Consultant – Manfred Luetzow
Intake Consultant – David Tennant