FDA Status
Approved
Color Additive · CAS 25956-17-6 · EU E129
Red 40 (Allura Red)
FDA status: Approved. EU: Approved. 1 U.S. state regulates it.
2.0 / 5
Composite safety Caution
Score 2 of 5
Red 40 (Allura Red): 2/5 (Caution)
According to the U.S. Food and Drug Administration, Red 40 (Allura Red) is FDA-approved, though 1 U.S. state has enacted independent regulation on it, a sign federal and state views on this additive diverge. Its composite safety score is 2 out of 5 (Caution), and the European Union separately classifies it as approved. It is a comparatively niche additive by product count.
- 20th percentile by tracked product prevalence
- Regulated by 1 U.S. state, independent of federal FDA status
The verdict
Red 40 (Allura Red) is FDA-approved, but 1 state has acted independently, a sign federal and state views on this additive diverge. It is a comparatively niche additive by product count (20th percentile by tracked product count).
- 2/5
- Caution
- Approved
- FDA status
- 20th pctile
- by product prevalence
- 1
- state regulation
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). 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. This ingredient appears in approximately 3 tracked food products across our database. 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 | 3 | 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
E129
U.S. State Regulations
1 state
California
Safety Assessment
Red 40 (Allura Red)'s 2/5 (Caution) score reflects where this specific ingredient lands on that scale. 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.
How Red 40 (Allura Red) compares
Where a safety score of 2/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Red 40 (Allura Red) highlighted)
43 of 4,509 scored ingredients (1%) share a safety score of 2/5.
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.
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 Red 40 (Allura Red)
This additive is flagged, worth checking labels for.
- Check the FDA status (Approved) and EU status (Approved) before assuming it is risk-free. How we score
- 1 state has acted on this additive, see which and why. State actions
- 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.