Color Additive · EU 161b
Lutein
FDA status: Approved. EU: Approved. No U.S. state has enacted a specific ban yet.
According to the U.S. Food and Drug Administration, Lutein is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 4 out of 5 (Low Risk), and the European Union separately classifies it as approved. By tracked product count it ranks #228 of 417.
- #228 of 417 by tracked product prevalence
The verdict
Lutein is FDA-approved, and no U.S. state has moved to restrict it. By Open Food Facts product count it sits #228 of 417 among additives with tracked product presence (45th percentile).
- 4/5
- Low Risk
- Approved
- FDA status
- #228 of 417
- product-prevalence rank
- 0
- state regulations
Product-footprint and regulatory snapshot
Lutein: 12 tracked U.S. products (moderate band, #228 of 417) frame how often this additive appears on shelves.
| Property | Value | Source |
|---|---|---|
| Tracked Products | 12 · #228 of 417 | Open Food Facts (US) |
| 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 |
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.
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
Shelf-footprint peer axes
Nationwide peers for a moderate OFF footprint
Nearest OFF product-count peers (12 tracked here); safety-score column omitted on prevalence-led pages.
Frequently Asked Questions
Is Lutein safe to consume?
Lutein scores 4/5 (Low Risk). FDA status is Approved. On the Open Food Facts U.S. sample it is a moderate additive (12 tracked products, #228 of 417), so product footprint, not just the score label, frames how widely a shopper will meet it.
What is Lutein used for in food?
Lutein shows up as Processed foods, beverages, confectionery in the Color Additive class, and the OFF sample puts it in the moderate footprint band (12 products).
Where does Lutein sit among food additives PlainIngredients tracks?
Among additives with at least one tracked product, it ranks #228 of 417 by Open Food Facts product count. See /methodology#corpus-placement for the ranking bases.
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.