Precautions
Annatto is safe for most people when used in food amounts; however, it can cause rare allergic reactions for those who are sensitive. Annatto has been linked to few cases of food-related allergies, but it is not one of the "Big Eight" allergens (cow's milk, egg, peanut, tree nuts, fish, shellfish, soy, and wheat) which are responsible for more than 90% of allergic food reactions. The Food and Drug Administration and experts at the Food Allergy Research and Resource Program (FARRP) at the University of Nebraska do not, at present, consider annatto to be a major food allergen.
Natural food colors such as annatto extract have not been extensively investigated with respect to potential allergenic properties. In one 1978 study among 61 consecutive patients suffering from chronic hives and/or angioedema, 56 patients were orally provoked by annatto extract during an elimination diet. A challenge was performed with a dose equivalent to the amount used in 25 grams (0.88 oz) of butter. Twenty six per cent of the patients reacted to this color four hours after intake, worse than amaranth (9%) or synthetic dyes such as tartrazine (11%), Sunset Yellow FCF (17%), Food Red 17 (16%), Ponceau 4R (15%), erythrosine (12%) and Brilliant Blue FCF (14%).
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