E161b / Colours
Lutein
Safety in brief
Safe
Recorded EatMatrix rating, not a new clinical review. The amount, your sensitivities and country rules still matter.
- Watch for
- Recorded sensitivities: ragweed/marigold family sensitivity (rare, since lutein is often marigold-derived).
- Our advice
- Read the whole food label and consider how often you eat the product. A name or E number does not tell you the amount, and an ingredient rating cannot assess the entire food.
What it is
Lutein is a naturally occurring carotenoid found in leafy green vegetables, corn, and egg yolks, commonly extracted from marigold flowers for commercial use. It is used both as a food colorant (E161b) and a dietary supplement, valued for its role in eye health — it accumulates in the retina, where it helps filter blue light. Some evidence suggests regular dietary intake may support reduced risk of age-related macular degeneration (AMD), though this is best supported for dietary lutein rather than the additive specifically. It is considered safe by regulatory agencies at typical use levels.
Also appears on labels as: Lutein, E161b, E 161b, E-161b, Lutein Extract, Lutein Carotenoid, Natural Lutein, Marigold Extract, Liuteinas, Luteīns, Luteiin, Luteina.
Dietary information
- Vegan
- Yes
- Halal
- Yes
- Gluten-free
- Yes
- Allergens
- Caution
Recorded ingredient information. Check the product label or certification: sources, other ingredients and cross-contact can vary.
Research & body effects
Health notes from our ingredient record
- No significant safety concerns identified at typical food-use or supplemental levels.
- Generally recognized as safe at typical food-use levels.
Other references from our ingredient record
These links come from the original ingredient record. They are separate from the source reviews above and have not all been checked for the exact ingredient, amount consumed or claim. Dates are shown newest first.
- Scientific Opinion on the re‐evaluation of lutein (E 161b) as a food additive — EFSA Panel on Food Additives, EFSA Journal (2010). Official EFSA scientific opinion (bibliographic reference, imported 2026-10-13). It covers the additive as a group assessment and is not an individual human study; read the opinion for its findings.
- Lutein (E161b) – Recent Findings — EFSA Panel on Food Additives, EFSA Journal (2010). Xanthophyll carotenoid; EFSA ADI 1 mg/kg bw/day; safe; used in fortified foods and supplements.[safe_in_moderation]
Country rules
Country checks for E161B
Permission depends on the market, type of food, amount and conditions. A scientific opinion or an E-number alone does not establish a legal use. These checks are separate from the stored EatMatrix rating.
Compare all eight markets and their sources
| Market | What is checked |
|---|---|
| European Union | Regulation (EC) 1333/2008, Annex II Part B, version , contains the exact code E161B: Lutein. Listing alone does not allow every food use. Part E food categories, limits, specifications and applicable later acts still need a product-specific check. Source read: . |
| Great Britain | The FSA register record for E161B (Lutein) lists “Authorised” in England, Scotland and Wales. Register updated: 01 April 2025; record checked: . Food-specific conditions and specifications still need a separate legal check. |
| United States | Complete current-use review pending. Any scoped provision in the label guide above applies only to the stated use. FDA explains the applicable food-additive and GRAS framework. |
| Northern Ireland | Review pending. Check the applicable EU rules and territory arrangements; the GB register alone does not establish this status. FSA guidance is a starting source, not a verified permission for this entry. |
| Canada | Named preparation located; broader identity needs matching CFIA links E161b to xanthophyll. A particular lutein preparation must still match that Canadian colour specification; the broad name is not sufficient. EatMatrix reading: Match the named preparation, specifications, food, purpose and every limit below before using these rows for a product decision. Name and category review: . This describes the legal source check, not a finding that the ingredient is safe, unsafe or untested. Sources and names checkedNames checked: Lutein; Xanthophyll. All 15 Health Canada permitted-additive lists were checked by exact name, with the reviewed alternatives above. E-numbers alone are not Canadian ingredient names. The Justice Canada consolidation read was current to 21 September 2026. A complete product decision also requires its composition, specifications, intended food and use, quantities, applicable separate provisions and any later changes. Named food-use records located. Health Canada lists the preparations below for specified foods and purposes. This is conditional permission for those uses, not approval of every product or a personal safety verdict. CFIA links E161b to xanthophyll. A particular lutein preparation must still match that Canadian colour specification; the broad name is not sufficient. Source tables captured . List publication dates are shown separately. Good Manufacturing Practice (GMP) is a condition of use, not an unlimited amount or a recommended intake. Food and Drug Regulations B.16.003 requires the listed source, purpose, amount and other conditions to match. The official consolidation read was current to 21 September 2026; product specifications and applicable later changes still need checking. Read 3 listed food-use conditionsXanthophyllHealth Canada: List of Permitted Food Colours. List published ; item X.1.
EatMatrix reading: match the exact preparation and food first. A manufacturing limit is not an acceptable daily intake (ADI). A label without the amount cannot establish exposure, and an unlisted name here does not establish a ban. |
| Australia | Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry. |
| New Zealand | Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry. |
| Japan | Review pending. The relevant list, identity and use standards need an additive-specific check. CAA food-additive lists is a starting source, not a verified permission for this entry. |
Sources & review status
Check what each source covers: an authority’s conclusion, a research finding and a country’s legal permission answer different questions.
What this guide covers
- Official assessment sources
- Commission-listed EFSA references for E161B. Bibliographic identity checked; latest findings and current use rules need separate review.
- Original ingredient record
- 2 research links; newest recorded date: . Sources added separately to this guide are not included in this count.
This guide brings together our ingredient record and the dated sources shown here. Missing information describes a gap in this guide; it does not mean an ingredient is untested, safe or harmful. This is not a complete review of every study, preparation or current country rule. The amount in a product and how it is used still matter.
How to read the ratings, research and country checksAgency labels recorded by EatMatrix
These are imported database classifications, not verified current statements from each authority. Use the dated official sources below for their actual scope and conclusions.
| Authority | Database label |
|---|---|
| FDA | Safe |
| WHO | Safe |
| EFSA | Safe |
| FSANZ | Safe |
| Japan | Safe |
| UK FSA | Safe |
| Health Canada | Safe |
Official assessment sources for E161B
The European Commission’s re-evaluation table lists official EFSA documents for this additive. Their identifiers and subjects were checked against publisher bibliographic records. A missing research link in the EatMatrix database does not mean the additive has never been assessed.
Name in the Commission table: Lutein.
- Scientific Opinion on the re‐evaluation of lutein (E 161b) as a food additive
EFSA scientific opinion. Published: .
These are assessment references, including historical or group assessments. They do not establish the latest scientific conclusion, a human health benefit or risk, or current permission to use the additive in a particular food. Later assessments, corrections and food-use conditions need separate review. The recorded EatMatrix rating above is unchanged.
European Commission re-evaluation table, status as of . EatMatrix checked this bibliography on .
Database updated: . What does an E number mean on a food label?
Common questions
Frequently asked questions
What is EatMatrix's recorded rating for E161B?
The recorded EatMatrix rating for E161B (Lutein) is “Safe”. It is calculated from labels stored in our ingredient database. These labels are not verified current regulator decisions or country permissions. A database update date is not a scientific review date.
Is E161B vegan, halal or gluten-free?
According to our ingredient data for Lutein — vegan: yes, vegetarian: yes, halal: yes, kosher: yes, gluten-free: yes, dairy-free: yes. Manufacturing sources can vary between products; check the label if it matters to you.
What is E161B and why is it used?
Lutein is a naturally occurring carotenoid found in leafy green vegetables, corn, and egg yolks, commonly extracted from marigold flowers for commercial use. It is used both as a food colorant (E161b) and a dietary supplement, valued for its role in eye health — it accumulates in the retina, where it helps filter blue light. Some evidence suggests regular dietary intake may support reduced risk of age-related macular degeneration (AMD), though this is best supported for dietary lutein rather than the additive specifically. It is considered safe by regulatory agencies at typical use levels.
Does E161B contain allergens?
No known allergens are recorded for Lutein, with a caution: ragweed/marigold family sensitivity (rare, since lutein is often marigold-derived).
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This page shows information and classifications recorded in our ingredient database. Current scientific and market-specific verification remains pending as described above. It is general information, not medical advice.