FDA Status
Approved
Color Additive · CAS 3844-45-9 · EU E133
FDA status: Approved. EU: Approved. No U.S. state has enacted a specific ban yet.
According to the U.S. Food and Drug Administration, Blue 1 (Brilliant Blue) is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 2 out of 5 (Caution), and the European Union separately classifies it as approved.
The verdict
Blue 1 (Brilliant Blue) is FDA-approved, and no U.S. state has moved to restrict it.
Blue 1 (Brilliant Blue) (E133), CAS 3844-45-9, is a color additive additive holding a composite safety score of 2 out of 5 (Caution). 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 Candy, beverages, ice cream, canned peas.
No U.S. state has enacted specific legislation targeting Blue 1 (Brilliant Blue) 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. Our regulatory timeline records 1 distinct regulatory event spanning multiple jurisdictions, illustrating how oversight has evolved over time.
Peer-reviewed research has flagged 1 distinct area of health concern for Blue 1 (Brilliant Blue), which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2010/11/22. EFSA has noted an overexposure risk classification of "moderate" for typical consumption patterns. 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.
| Property | Value | Source |
|---|---|---|
| FDA Status | Approved | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | E133 | EU additive register |
| CAS Number | 3844-45-9 | CAS Registry |
| Category | Color Additive | FDA functional class |
| Composite Safety Score | 2 / 5 (Caution) | 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.
FDA Status
Approved
EU Status
Approved
E133
U.S. State Regulations
0 states
None enacted
Blue 1 (Brilliant Blue)'s 2/5 (Caution) score reflects where this specific ingredient lands on that scale. The FDA has approved Blue 1 (Brilliant Blue) for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Blue 1 (Brilliant Blue). Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
Where a safety score of 2/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
43 of 4,509 scored ingredients (1%) share a safety score of 2/5.
Synthetic blue dye. Petroleum-based.
Included in FDA food dye phaseout.
Blue 1 (Brilliant Blue) has a safety score of 2/5 (Caution). Scientific studies have raised health concerns. Check with a healthcare provider for personalized advice.
Blue 1 (Brilliant Blue) is commonly used as: Candy, beverages, ice cream, canned peas. It belongs to the Color Additive category of food additives.
Currently, no US states have enacted specific bans or regulations targeting Blue 1 (Brilliant Blue). However, state food safety legislation is evolving rapidly.
The FDA classifies Blue 1 (Brilliant Blue) as "Approved", while the EU status is "Approved" (E133). 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.
Research has identified the following health concerns for Blue 1 (Brilliant Blue): Generally considered lower risk than red/yellow dyes, but FDA phaseout announced by 2027.. These findings inform its safety score of 2/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
The safety score of 2/5 for Blue 1 (Brilliant Blue) 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.
What to do about Blue 1 (Brilliant Blue)
This additive is flagged, worth checking labels for.
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.