FDA Status
Approved
Patent Blue V (131) is a food additive additive holding a composite safety score of 3 out of 5 (Mixed Evidence). The U.S. Food and Drug Administration currently classifies it 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.
Regulatory Snapshot
| 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.
3.0 / 5
Composite Safety Mixed Evidence
Safety Score: 3 out of 5
Safety Rating 60.0%
EU Status
Approved
131
U.S. State Regulations
0 states
None enacted
Safety Assessment
Patent Blue V receives a safety score of 3/5 (Mixed Evidence) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. 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.
What is Patent Blue V?
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.
Health Concerns
- EFSA evaluation: Scientific Opinion on the re‐evaluation of Patent Blue V -E 131- as a food additive. EFSA overexposure risk: moderate
Common Uses
Various processed foods
Frequently Asked Questions
Is Patent Blue V safe to consume?
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.
What is Patent Blue V used for in food?
Patent Blue V is commonly used as: Various processed foods. It belongs to the Food Additive category of food additives.
Is Patent Blue V banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Patent Blue V. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Patent Blue V?
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.
What health concerns are associated with Patent Blue V?
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.
How is the safety score for Patent Blue V calculated?
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.
Explore PlainIngredients
Related Data Sources
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 Resources
Related Food Additive Ingredients
- 4 1-(2-FURYL)-1,3-BUTANEDIONE": - cell "25790-35-6" - cell "1-(2-FURYL)-1,3-BUTANEDIONE": - link "1-(2-FURYL)-1,3
- 4 1-hydroxyethylidene-1,1-diphosphonic Acid
- 4 1-octenyl Succinic Anhydride
- 4 1‚4-Heptonolactone
- 4 2,2-dibromo-3-nitrilopropionamide Antimicrobial Agent
- 4 2-TERT-PENTYLCYCLOHEXYL ACETATE": - cell "67874-72-0" - cell "2-TERT-PENTYLCYCLOHEXYL ACETATE": - link "2-TERT-
Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial