Annatto
Annatto is regulated as a color additive rather than a flavoring or preservative. In the U.S., FDA lists annatto extract as permanently listed and exempt from batch certification for foods, with good-manufacturing-practice use and heavy-metal and residual-solvent specifications. In 2026, FDA filed a color-additive petition that would remove methylene chloride, trichloroethylene, and ethylene dichloride as permitted extraction solvents for annatto extract and two other natural-color oleoresins; that is a manufacturing-specification issue, not a finding that annatto pigments are unsafe. In the EU, the older broad E 160b entry was replaced by Annatto bixin E 160b(i) and Annatto norbixin E 160b(ii), with food-category limits and specifications; Codex, Canada, and Australia/New Zealand also use category limits or good-manufacturing-practice permissions. Toxicology reviews do not point to a strong cancer or DNA-damage concern at permitted food uses. The main exposure caveat is norbixin: EFSA found the acceptable daily intake could be reached or exceeded for high-consuming toddlers and children in some modeled scenarios, although it judged the refined estimates likely conservative and not a health concern. A separate, uncommon issue is allergy-like hypersensitivity, including hives, swelling, and rare anaphylaxis.
- Concern
- Limited
- Function
- Coloring Agents
- Updated
- May 25, 2026
What this is
Annatto is regulated as a color additive rather than a flavoring or preservative. In the U.S., FDA lists annatto extract as permanently listed and exempt from batch certification for foods, with good-manufacturing-practice use and heavy-metal and residual-solvent specifications. In 2026, FDA filed a color-additive petition that would remove methylene chloride, trichloroethylene, and ethylene dichloride as permitted extraction solvents for annatto extract and two other natural-color oleoresins; that is a manufacturing-specification issue, not a finding that annatto pigments are unsafe. In the EU, the older broad E 160b entry was replaced by Annatto bixin E 160b(i) and Annatto norbixin E 160b(ii), with food-category limits and specifications; Codex, Canada, and Australia/New Zealand also use category limits or good-manufacturing-practice permissions. Toxicology reviews do not point to a strong cancer or DNA-damage concern at permitted food uses. The main exposure caveat is norbixin: EFSA found the acceptable daily intake could be reached or exceeded for high-consuming toddlers and children in some modeled scenarios, although it judged the refined estimates likely conservative and not a health concern. A separate, uncommon issue is allergy-like hypersensitivity, including hives, swelling, and rare anaphylaxis.
Safety Review
The critical endpoints experts review in safety assessments. This is not a prediction of harm.
EFSA and JECFA evaluations support acceptable daily intakes for the main pigments bixin and norbixin, and EFSA’s later review found no genotoxicity concern for annatto E. The most concrete food-use issue is exposure-related: norbixin intake reached or exceeded the acceptable daily intake in some high-percentile toddler and child scenarios, though EFSA considered those estimates conservative and not a health concern. Separately, annatto has rare case reports of allergy-like reactions, including urticaria, angioedema, and anaphylaxis, which are important for sensitive individuals but do not establish population-wide toxicity. A current U.S. petition targets removal of older chlorinated extraction solvents from the rule, which is a manufacturing-specification issue rather than evidence of broad toxicity from annatto pigments.
No safety review endpoints are listed for this ingredient yet.
Restaurant Usage
4 linked ingredient reports
State Policies
0 linked policies
No current state policy is listed for this ingredient in the policy tracker.
Federal Policies
0 linked policies
No direct federal policy is linked to this ingredient right now.
Sources
0 visible sources
Source population is still pending for this dossier. The page stays visible because the restaurant and policy context is still useful.