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E161bColorantLow concern

Lutein

In plain words

The short version

A natural xanthophyll carotenoid from marigold petals — clean-label yellow and the dominant macular-pigment supplement.

Why it's green

It's widely considered safe at the amounts used in food, so we mark it green. The Safety section below has the details.

Safety

Safety profile

ADI of 1 mg/kg body weight per day (EFSA 2010 re-evaluation, for lutein from Tagetes erecta); EFSA noted that high-end intake estimates at the use levels of the time were above this ADI. JECFA's group ADI of 0–2 mg/kg body weight (2004) was changed in 2018 to 'not specified' for lutein and lutein esters from Tagetes erecta and synthetic zeaxanthin. Supplemental use has a longer safety history with no documented adverse effects at typical intake. Unlike canthaxanthin, no retinopathy concerns at any realistic dose.

The detail

Sources

  1. EFSA — Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive (2010) — European Food Safety Authority (ANS Panel), 2010. EFSA ADI 1 mg/kg bw/day (not 0–2)
  2. WHO JECFA database — Lutein from Tagetes erecta (INS 161b(i)) — Joint FAO/WHO Expert Committee on Food Additives, 2018. JECFA group ADI 0–2 (2004) changed to 'not specified' (2018)
  3. EU — Regulation (EC) No 1333/2008 on food additives, Annex II (consolidated text of 18.08.2026) — Publications Office of the European Union, 2026. EU: lutein is in Group III, colours with combined maximum limits
  4. US eCFR — 21 CFR 73.295 Tagetes (Aztec marigold) meal and extract (version of 2026-10-13) — Office of the Federal Register / US FDA, 2026. Marigold (Tagetes erecta) colour in chicken feed for skin and egg yolk colour

Checked against these sources on .

Educational information only. Not medical, dietary or veterinary advice. Spotted an error? Tell us.