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Annatto is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Generally considered safe. However, annatto has been associated with allergic reactions, including hives (urticaria), in sensitive individuals — more frequently than most other natural food colorants. A 2008 review in the Annals of Allergy, Asthma & Immunology documented cases of annatto-induced reactions. There is also ongoing debate among consumer advocates (including CSPI) about whether annatto is truly risk-free due to these allergic properties, though EFSA and FDA maintain it is safe at approved use levels.
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