Lutein (E161b) β€” What You Need to Know

Safe(9/10)Natural

The score is an eNumbers.org editorial summary, not an official agency rating or medical advice. Start with the regulatory status and primary sources below.

What Is Lutein?

Lutein is a naturally occurring carotenoid pigment primarily extracted from marigold flowers (Tagetes erecta). It is found naturally in dark green leafy vegetables, egg yolks, and corn. Lutein is extensively studied for its benefits to eye health, particularly in reducing the risk of age-related macular degeneration and cataracts.

What Is It Used For?

Provides yellow to orange coloring in baked goods, confectionery, and processed foods. Also widely sold as a dietary supplement for eye health.

Function: Yellow-orange natural carotenoid food coloring extracted from marigold flowers

Regulatory & Editorial Context

πŸ“Š
Acceptable Daily Intake (ADI)
1 mg/kg bw/day
πŸ›οΈ
Regulatory Status
πŸ‡ΊπŸ‡Έ USA (FDA): GRAS (no objection for use as food ingredient)
πŸ‡ͺπŸ‡Ί EU (EFSA): Authorized; ADI of 1 mg/kg bw/day (set in 2010)
⚠️ Key Concerns

A naturally occurring carotenoid found in dark green leafy vegetables, egg yolks, and marigold flowers. Extensively studied for eye health benefits β€” associated with reduced risk of age-related macular degeneration (AMD) and cataracts. EFSA set ADI of 1 mg/kg bw/day in 2010 for lutein as a food additive. Widely sold as a dietary supplement for eye health. No significant safety concerns at normal dietary or supplemental levels.

Editorial context score

eNumbers.org currently assigns Lutein an editorial context label of Safe with a score of 9/10. This is 3.2 points above the database average for colorings (5.8/10). Dataset reference year: 2010.

This score is not issued by EFSA, FDA, WHO or another regulator.

Commonly Found In

Baked goodsConfectioneryDietary supplementsBaby foodBreakfast cereals
Example brands:
CentrumVarious baby food brands

Always check the label for E161b or 'Lutein'

β–ΆChemical Information
Formula: C40H56O2
Molecular Weight: 568.87 g/mol
CAS Number: 127-40-2
INS Number: 161b
Also known as: E161b, Xanthophyll, INS 161b, Lutein esters

Primary Sources

Source review: 2026-08-08

Official references relevant to this page. Check the agency record for current permitted uses, limits and jurisdiction-specific wording.

How eNumbers.org uses sources β†’

Frequently Asked Questions about Lutein

Current dataset status: FDA β€” GRAS (no objection for use as food ingredient); EFSA/EU β€” Authorized; ADI of 1 mg/kg bw/day (set in 2010). Reported concerns: A naturally occurring carotenoid found in dark green leafy vegetables, egg yolks, and marigold flowers. Extensively studied for eye health benefits β€” associated with reduced risk of age-related macular degeneration (AMD) and cataracts. EFSA set ADI of 1 mg/kg bw/day in 2010 for lutein as a food additive. Widely sold as a dietary supplement for eye health. No significant safety concerns at normal dietary or supplemental levels. Regulatory status and individual risk are not the same; check the primary sources and permitted conditions of use.

Quick Facts

E-Number
E161b
INS Number
161b
Category
Colorings
Origin
Natural
FDA Status
GRAS (no objection for use as food ingredient)
EFSA Status
Authorized; ADI of 1 mg/kg bw/day (set in 2010)
ADI
1 mg/kg bw/day
Dataset Review
2010
Ingredient-level Dietary Notes
Vegan: βœ… YesHalal: βœ… YesKosher: βœ… YesGluten-Free: βœ… Yes

Carriers, processing aids and product certification can change suitability. Verify the final label and certifier.

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult a healthcare professional for health-related decisions.

Related Additives

Other colorings in the same family