FDA Status
Approved
Red 40 (Allura Red) (E129), CAS 25956-17-6, is a color additive additive holding a composite safety score of 2 out of 5 (Caution). 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 Beverages, candy, cereal, snacks, condiments.
Regulatory pressure is notable: 1 U.S. state has enacted legislation targeting Red 40 (Allura Red), including California. State actions frequently diverge from federal FDA policy, with legislative trends tending toward stricter controls than the federal baseline. 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 Red 40 (Allura Red), which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2015/02/13. EFSA has noted an overexposure risk classification of "no" 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 | E129 | EU additive register |
| CAS Number | 25956-17-6 | 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 | 1 state | 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.
2.0 / 5
Composite Safety Caution
Safety Score: 2 out of 5
Safety Rating 40.0%
EU Status
Approved
E129
U.S. State Regulations
1 state
California
Safety Assessment
Red 40 (Allura Red) receives a safety score of 2/5 (Caution) 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 Red 40 (Allura Red) for use in food products under specified conditions.
Notably, 1 US state has enacted regulations targeting Red 40 (Allura Red), reflecting growing legislative attention to food additive safety at the state level. These state actions may differ from federal FDA policy and can range from outright bans to usage restrictions in certain product categories.
Research has identified 1 area of health concern associated with Red 40 (Allura Red). Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Red 40 (Allura Red)?
Most widely used food dye in the US. Petroleum-derived synthetic color.
Health Concerns
- Studies link to hyperactivity in children. FDA phaseout announced by end of 2027.
Common Uses
Beverages, candy, cereal, snacks, condiments
Regulatory Timeline
2025-04-15 FDA
Phaseout Announced
FDA announced phaseout of all 6 petroleum-based food dyes by end of 2027.
State Regulations
| State | Status | Effective Date | Bill |
|---|---|---|---|
| California | Warning Required | 2028-01-01 | AB 2316 |
Frequently Asked Questions
Is Red 40 (Allura Red) safe to consume?
Red 40 (Allura Red) has a safety score of 2/5 (Caution). Scientific studies have raised health concerns. It is regulated in 1 US state. Check with a healthcare provider for personalized advice.
What is Red 40 (Allura Red) used for in food?
Red 40 (Allura Red) is commonly used as: Beverages, candy, cereal, snacks, condiments. It belongs to the Color Additive category of food additives.
Is Red 40 (Allura Red) banned in any US states?
Yes, Red 40 (Allura Red) is regulated in 1 US state: California. Regulations vary from full bans to restrictions on specific uses.
What is the difference between FDA and EU regulation of Red 40 (Allura Red)?
The FDA classifies Red 40 (Allura Red) as "Approved", while the EU status is "Approved" (E129). 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 Red 40 (Allura Red)?
Research has identified the following health concerns for Red 40 (Allura Red): Studies link to hyperactivity in children. FDA phaseout announced by end of 2027.. These findings inform its safety score of 2/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Red 40 (Allura Red) calculated?
The safety score of 2/5 for Red 40 (Allura Red) 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.
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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 Color Additive Ingredients
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