Lutein | whatsinit

About

What it is and where it shows up.

Lutein is a naturally occurring xanthophyll carotenoid pigment found in green leafy vegetables, egg yolks, and marigold (Tagetes erecta) flowers, used as a yellow food colourant. It is also added to foods and supplements for its role in supporting eye health, particularly macular pigment density.

Safety summary

The regulatory and scientific consensus.

Lutein is not genotoxic and is of low acute toxicity; EFSA established an ADI of 1 mg/kg body weight/day based on a NOAEL of 200 mg/kg bw/day in a 90-day rat study applying an uncertainty factor of 200. JECFA previously set a group ADI of 0–2 mg/kg bw for lutein from Tagetes erecta and zeaxanthin. At typical dietary exposure levels, intake is well below the ADI and no significant safety concerns have been identified for the general adult population.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	ADI of 1 mg/kg bw/day established by EFSA ANS Panel (2010) re-evaluation of E161b as a food additive; authorised as a food colour under Regulation (EC) No 1333/2008. Also listed in EU Register of Feed Additives under Regulation (EC) No 1831/2003.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Lutein is approved by FSSAI as an ingredient in specific infant formula and food products (e.g., Similac Plus with added Lutein) under the FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. INS 161b recognised under FSSAI food additive framework.source
FDA (Food and Drug Administration) (United States)	Approved	Crystalline lutein affirmed as GRAS (GRN 000140 and multiple subsequent notices) for use in baked goods, beverages, breakfast cereals, dairy analogues, and other food categories. FDA has issued 'no questions' letters for seven lutein GRAS notifications. No RDI established for lutein.source

Who should approach with care

Whose guidance would steer them away.

Infants — Lutein is used in some specialised infant formulas only under specific FSSAI and FDA-approved conditions; unsupervised supplementation in infants should not occur without medical guidance, as the toxicological database for high-purity lutein preparations in this age group is limited per EFSA.

Pregnancy — EFSA noted the absence of multigeneration reproductive toxicity studies when establishing the ADI, so high-dose supplemental lutein during pregnancy should be taken only under medical supervision.

Research citations

The sources behind this verdict.

1FSSAI. List of product(s)/ingredient(s) applications Approved under Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, 2024. fssai.gov.in
2EFSA. Safety and efficacy of lutein and lutein/zeaxanthin extracts from Tagetes erecta for poultry for fattening and laying (except turkeys), 2019. ncbi.nlm.nih.gov
3FDA. Agency Response Letter GRAS Notice No. GRN 000140 — Crystalline Lutein (Kemin Foods), 2016. fda.gov
4EFSA. Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive, 2010. efsa.europa.eu
5EFSA. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on Lutein for use in particular nutritional uses, 2007. efsa.europa.eu

Independently researched5 citations