FDA Status
Approved
Lutein (161b) is a color additive additive holding a composite safety score of 4 out of 5 (Low Risk). The U.S. Food and Drug Administration currently classifies it as Approved, while the European Union lists it as Approved. This ingredient appears in approximately 12 tracked food products across our database. It is most commonly used as Processed foods, beverages, confectionery.
No U.S. state has enacted specific legislation targeting Lutein 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 Lutein, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2010-07-28. 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 | 161b | EU additive register |
| CAS Number | — | CAS Registry |
| Category | Color Additive | FDA functional class |
| Composite Safety Score | 4 / 5 (Low Risk) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 12 | 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.
4.0 / 5
Composite Safety Low Risk
Safety Score: 4 out of 5
Safety Rating 80.0%
EU Status
Approved
161b
U.S. State Regulations
0 states
None enacted
Safety Assessment
Lutein receives a safety score of 4/5 (Low Risk) 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 Lutein for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Lutein. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Lutein?
LUTEIN is a xanthophyll and one of 600 known naturally occurring carotenoids. Lutein is extracted from the petals of African marigold -Tagetes erecta-. It is approved for use in the EU and Australia and New Zealand. In the United States lutein may not be used as a food coloring for foods intended for human consumption, but can be added to animal feed.
Health Concerns
- EFSA evaluation: Scientific Opinion on the re-evaluation of lutein -E 161b- as a food additive. Flagged by ANSES (French food safety agency) as additive of interest
Common Uses
Processed foods, beverages, confectionery
Frequently Asked Questions
Is Lutein safe to consume?
Lutein has a safety score of 4/5 (Low Risk). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Lutein used for in food?
Lutein is commonly used as: Processed foods, beverages, confectionery. It belongs to the Color Additive category of food additives.
Is Lutein banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Lutein. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Lutein?
The FDA classifies Lutein as "Approved", while the EU status is "Approved" (161b). 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 Lutein?
Research has identified the following health concerns for Lutein: EFSA evaluation: Scientific Opinion on the re-evaluation of lutein -E 161b- as a food additive. Flagged by ANSES (French food safety agency) as additive of interest. These findings inform its safety score of 4/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Lutein calculated?
The safety score of 4/5 for Lutein 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