FDA Status
GRAS
Lycopene (E160d), CAS 502-65-8, is a color additive additive holding a composite safety score of 5 out of 5 (Generally Safe). The U.S. Food and Drug Administration currently classifies it as GRAS, while the European Union lists it as Approved. This ingredient appears in approximately 11 tracked food products across our database. It is most commonly used as Sauces, ketchup, beverages.
No U.S. state has enacted specific legislation targeting Lycopene 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 Lycopene, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2014-01-22. 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 | GRAS | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | E160d | EU additive register |
| CAS Number | 502-65-8 | CAS Registry |
| Category | Color Additive | FDA functional class |
| Composite Safety Score | 5 / 5 (Generally Safe) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 11 | 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.
5.0 / 5
Composite Safety Generally Safe
Safety Score: 5 out of 5
Safety Rating 100.0%
EU Status
Approved
E160d
U.S. State Regulations
0 states
None enacted
Safety Assessment
Lycopene receives a safety score of 5/5 (Generally Safe) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA classifies Lycopene as "Generally Recognized As Safe" (GRAS), meaning qualified experts consider it safe under intended conditions of use.
Research has identified 1 area of health concern associated with Lycopene. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Lycopene?
Natural red pigment from tomatoes.
Health Concerns
- Safe. Powerful antioxidant.
Common Uses
Sauces, ketchup, beverages
Frequently Asked Questions
Is Lycopene safe to consume?
Lycopene has a safety score of 5/5 (Generally Safe). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Lycopene used for in food?
Lycopene is commonly used as: Sauces, ketchup, beverages. It belongs to the Color Additive category of food additives.
Is Lycopene banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Lycopene. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Lycopene?
The FDA classifies Lycopene as "GRAS", while the EU status is "Approved" (E160d). 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 Lycopene?
Research has identified the following health concerns for Lycopene: Safe. Powerful antioxidant.. These findings inform its safety score of 5/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Lycopene calculated?
The safety score of 5/5 for Lycopene 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