FDA Status
Approved
Color Additive · CAS 1393-63-1 · EU E160b
Annatto (Bixin)
FDA status: Approved. EU: Approved. No U.S. state has enacted a specific ban yet.
4.0 / 5
Composite safety Low Risk
Score 4 of 5
Annatto (Bixin): 4/5 (Low Risk)
According to the U.S. Food and Drug Administration, Annatto (Bixin) is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 4 out of 5 (Low Risk), and the European Union separately classifies it as approved.
The verdict
Annatto (Bixin) is FDA-approved, and no U.S. state has moved to restrict it.
- 4/5
- Low Risk
- Approved
- FDA status
- Approved
- EU status
- 0
- state regulations
Annatto (Bixin) (E160b), CAS 1393-63-1, is a color additive additive holding a composite safety score of 4 out of 5 (Low Risk). According to the U.S. Food and Drug Administration's Substances Added to Food inventory, it is currently classified as Approved, while the European Union lists it as Approved. It is most commonly used as Cheese, butter, margarine, custard.
No U.S. state has enacted specific legislation targeting Annatto (Bixin) to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
Peer-reviewed research has flagged 1 distinct area of health concern for Annatto (Bixin), which factors directly into the assigned safety score. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| FDA Status | Approved | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | E160b | EU additive register |
| CAS Number | 1393-63-1 | CAS Registry |
| Category | Color Additive | FDA functional class |
| Composite Safety Score | 4 / 5 (Low Risk) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | Not yet tracked | Open Food Facts (US) |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
EU Status
Approved
E160b
U.S. State Regulations
0 states
None enacted
Safety Assessment
Annatto (Bixin)'s 4/5 (Low Risk) score reflects where this specific ingredient lands on that scale. The FDA has approved Annatto (Bixin) for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Annatto (Bixin). Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
How Annatto (Bixin) compares
Where a safety score of 4/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Annatto (Bixin) highlighted)
4,369 of 4,509 scored ingredients (96.9%) share a safety score of 4/5.
What is Annatto (Bixin)?
Natural orange-yellow from annatto seeds.
Health Concerns
- Generally safe. Rare allergic reactions.
Common Uses
Cheese, butter, margarine, custard
Frequently Asked Questions
Is Annatto (Bixin) safe to consume?
Annatto (Bixin) has a safety score of 4/5 (Low Risk). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Annatto (Bixin) used for in food?
Annatto (Bixin) is commonly used as: Cheese, butter, margarine, custard. It belongs to the Color Additive category of food additives.
Is Annatto (Bixin) banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Annatto (Bixin). However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Annatto (Bixin)?
The FDA classifies Annatto (Bixin) as "Approved", while the EU status is "Approved" (E160b). The FDA and EU use separate evaluation frameworks, the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
What health concerns are associated with Annatto (Bixin)?
Research has identified the following health concerns for Annatto (Bixin): Generally safe. Rare allergic reactions.. These findings inform its safety score of 4/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Annatto (Bixin) calculated?
The safety score of 4/5 for Annatto (Bixin) is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Related Color Additive Ingredients
What to do about Annatto (Bixin)
Use the regulatory picture, not a single score, to decide.
- Check the FDA status (Approved) and EU status (Approved) before assuming it is risk-free. How we score
- Compare it against the most-restricted additives in the U.S. supply. View rankings
- Scan a whole ingredient label at once to flag the concerning entries. Label checker
Safety scores summarise regulatory status and published concerns; they are not medical or dietary advice.
Every figure on PlainIngredients is rendered directly from FDA, EU, EFSA and U.S. state regulatory records, no number is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.