The Parma, Italy-based agency was asked by the European Commission to re-evaluate the safety of different extracts derived from the seeds of Bixa orellana, a tropical tree native to central and south America, following a request from industry group, the Natural Food Colours Association (NATCOL) to extend its use into other applications.
The colouring pigments present in annatto come from the carotenoids bixin and norbixin.
EFSA looked at five annatto extracts that are processed in different ways: aqueous-processed bixin (Annatto E); solvent-extracted bixin (Annatto B); alkali-processed norbixin, acid-precipitated (Annatto F); alkali-processed norbixin, not acid-precipitated (Annatto G) and solvent-extracted norbixin (Annatto C).
"No reliable conclusion on the genotoxic potential of annatto extracts (E 160b) can be drawn from the available published studies, which use non-validated test methods or suffer from methodological shortcomings and inadequate reporting," the panel's opinion concluded.
Annatto extract is a natural food colouring, listed in Europe under the E number E160b, which provides yellow, orange and orange-red colour shades. It has been used in Europe for over 200 years, and gives English Red Leicester cheese and French Mimolette their typical orange colour.
According to Mintel data, E 160b was listed on the label of more than 4,500 food, drink and supplement products between 2011 and 2015 in Europe.
Its panel of experts concluded that the safety of the (currently EU authorised) solvent-extracted bixin and norbixin (E 160b (i)), alkali-extracted annatto (E 160b (ii)) and oil-extracted annatto (E 160b (iii)) could not be determined due to a lack of data " both in terms of identification and toxicological studies".
It therefore recommended they be replaced by other annatto extractions: solvent-extracted bixin (Annatto B), solvent-extracted norbixin (Annatto C), alkali-processed, acid-precipitated norbixin (Annatto F) and alkali-processed, not acid-precipitated norbixin (Annatto G).
However it added that the toxicological data is sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin per kilo body weight per day and an ADI of 0.3 mg norbixin per kilo body weight per day.
In Europe E 160b is an authorised food colour in the EU with maximum permitted levels ranging from 10 to 50 mg per kilo depending on the food application.
Bixin-based annatto extracts are used to colour foods such as margarine and shortenings, and are widely used
in bakery products, biscuit fillings, sauces, dressings and cream desserts, while norbixin-based extracts are used for cheese, smoked fish and breakfast cereals.
Main producer countries are Brazil, Guatemala, India, Peru and the Philippines. In Latin America annatto is often blended with other spices and used as a seasoning in home cooking, much like paprika in Europe.
To read EFSA's full opinion click here.