What Is Annatto?
FDA rules at 21 CFR 73.30 define annatto extract as a color additive prepared from annatto seed, Bixa orellana L., using food-grade extractants. The FDA says color additives exempt from certification generally come from natural sources such as vegetables, minerals or animals, and lists annatto extract, which gives a yellow color, among its examples. A 2009 letter in the World Allergy Organization Journal says that in processed foods annatto is most often used to color butter, cheeses and other snack foods.
Under the rule, annatto extract may be safely used to color foods generally in amounts consistent with good manufacturing practice, except in foods with standards of identity unless those standards authorize added color. The rule says certification of the color additive is not necessary for the protection of the public health, so its batches are exempt from certification requirements.
Allergic reactions are uncommon. A 2020 review in the Journal of Food Allergy says hypersensitivity to food additives is rare overall and that natural substances are the principal offenders among additives that cause allergic reactions, and it reports that cases of anaphylaxis have been reported after eating carmine, saffron and annatto.
Sources checked September 15, 2026. Every point below links the page it came from.
The sources behind this answer
- Regulatory filingFDA rules at 21 CFR 73.30 define the color additive annatto extract as an extract prepared from annatto seed, Bixa orellana L., using food-grade extractants. US FDA, 21 CFR 73.30 (eCFR) ↗
- Regulatory filingUnder 21 CFR 73.30, annatto extract may be safely used to color foods generally in amounts consistent with good manufacturing practice, with limits for standardized foods. US FDA, 21 CFR 73.30 (eCFR) ↗
- Regulatory filing21 CFR 73.30 says certification of annatto extract is not necessary to protect public health, so its batches are exempt from certification. US FDA, 21 CFR 73.30 (eCFR) ↗
- Government sourceThe FDA says certification-exempt color additives generally come from natural sources, and lists annatto extract, which is yellow, among its examples. US FDA ↗
- StudyA 2009 World Allergy Organization Journal letter says annatto is most often used in processed foods to color butter, cheeses and other snack foods. Myles and Beakes, World Allergy Organization Journal, via PubMed Central ↗
- StudyA 2020 review in the Journal of Food Allergy says cases of anaphylaxis have been reported after eating carmine, saffron and annatto. Journal of Food Allergy, via PubMed Central ↗
- StudyThe 2020 review says hypersensitivity to food additives is rare overall, with natural substances the principal offenders among additives that cause allergic reactions. Journal of Food Allergy, via PubMed Central ↗
Sources checked September 15, 2026. A brand statement is the company’s own claim, which we report but have not verified. Our grades are model-based estimates, not lab tests.