Zeaxanthin | whatsinit

About

What it is and where it shows up.

Zeaxanthin is a yellow-orange xanthophyll carotenoid pigment found naturally in corn, egg yolks, green leafy vegetables, and paprika; it is used as a natural food colourant and nutritional supplement. It is also one of the two primary pigments concentrated in the human macular region of the retina, where it plays a role in protecting against oxidative damage.

Safety summary

The regulatory and scientific consensus.

Zeaxanthin has a well-established safety profile with no evidence of genotoxicity and broad GRAS acceptance at typical dietary and supplemental intake levels. EFSA derived an ADI of 0.75 mg/kg bw/day (approximately 53 mg/day for a 70 kg adult) for synthetic zeaxanthin based on a 200-fold uncertainty factor applied to a NOAEL of 150 mg/kg bw/day from a two-generation reproduction toxicity study. JECFA established a combined group ADI of 0–2 mg/kg bw/day for lutein and zeaxanthin together; no significant safety concerns have been identified for the general adult population at normal food and supplement use levels.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Lutein/zeaxanthin extracts from Tagetes erecta approved as sensory colourant additives in animal feed for poultry (fattening and laying, except turkeys) under Regulation (EC) No 1831/2003.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Zeaxanthin is permitted as a natural colour under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, consistent with INS 161h. Specific maximum use limits are product-category dependent under Appendix A of the FSS Regulations.source
FDA (Food and Drug Administration) (United States)	Approved	Zeaxanthin (from marigold and paprika sources) is GRAS under 21 CFR 170.30 for use in multiple food categories including baked goods, beverages, cereals, dairy products, and more. Does not include infant formula. Multiple GRAS notices accepted (GRN 481, 550, 588, 639).source

Who should approach with care

Whose guidance would steer them away.

Infants — FDA GRAS notices for zeaxanthin from marigold and paprika explicitly exclude infant formula, and safety data in very young infants at supplemental doses have not been fully established.

Pregnancy — While zeaxanthin is found naturally in foods, high-dose supplemental zeaxanthin has not been evaluated for safety in pregnancy in clinical trials; EFSA's two-generation reproductive toxicity NOAEL provides indirect reassurance but supplemental use should be discussed with a physician.

Research citations

The sources behind this verdict.

1FDA. Agency Response Letter GRAS Notice No. GRN 000639 — Zeaxanthin from Marigold. fda.gov
2EFSA. Safety and efficacy of lutein and lutein/zeaxanthin extracts from Tagetes erecta for poultry for fattening and laying (except turkeys), 2019. efsa.europa.eu
3FDA. Agency Response Letter GRAS Notice No. GRN 000588 — Zeaxanthin from Capsicum annuum (paprika), 2018. fda.gov
4PubMed. Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake, 2016. pmc.ncbi.nlm.nih.gov
5EFSA. Safety of Synthetic Zeaxanthin as a Novel Food Ingredient in Food Supplements, 2012. efsa.europa.eu

Independently researched5 citations