FDA Status
Approved
Food Additive · EU 131
FDA status: Approved. EU: Approved. No U.S. state has enacted a specific ban yet.
According to the U.S. Food and Drug Administration, Patent Blue V is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 3 out of 5 (Mixed Evidence), and the European Union separately classifies it as approved.
The verdict
Patent Blue V is FDA-approved, and no U.S. state has moved to restrict it.
Patent Blue V (131) is a food additive additive holding a composite safety score of 3 out of 5 (Mixed Evidence). 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 Various processed foods.
No U.S. state has enacted specific legislation targeting Patent Blue V 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 Patent Blue V, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2013/03/01, with an Acceptable Daily Intake (ADI) of 5. 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 | 131 | EU additive register |
| CAS Number | - | CAS Registry |
| Category | Food Additive | FDA functional class |
| Composite Safety Score | 3 / 5 (Mixed Evidence) | PlainIngredients methodology |
| EFSA ADI | 5 | 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
131
U.S. State Regulations
0 states
None enacted
Patent Blue V's 3/5 (Mixed Evidence) score reflects where this specific ingredient lands on that scale. The FDA has approved Patent Blue V for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Patent Blue V. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
Where a safety score of 3/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
25 of 4,509 scored ingredients (0.6%) share a safety score of 3/5.
PATENT BLUE V is a dark bluish synthetic triphenylmethane dye used as a food coloring. It is not widely used, but in Europe it can be found in Scotch eggs, certain jelly sweets, blue Curaçao, certain jello varieties -though not in actual Jell-O brand products-, among others.
Patent Blue V has a safety score of 3/5 (Mixed Evidence). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
Patent Blue V is commonly used as: Various processed foods. It belongs to the Food Additive category of food additives.
Currently, no US states have enacted specific bans or regulations targeting Patent Blue V. However, state food safety legislation is evolving rapidly.
The FDA classifies Patent Blue V as "Approved", while the EU status is "Approved" (131). 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 Patent Blue V: EFSA evaluation: Scientific Opinion on the re‐evaluation of Patent Blue V -E 131- as a food additive. EFSA overexposure risk: moderate. These findings inform its safety score of 3/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
The safety score of 3/5 for Patent Blue V 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 Patent Blue V
Use the regulatory picture, not a single score, to decide.
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.