Lutein
A yellow-orange pigment extracted from marigold flowers, used to colour foods from beverages to confectionery.
EFSA set an Acceptable Daily Intake of 1 mg per kg body weight per day for lutein from Tagetes erecta containing at least 80% carotenoids, finding it not genotoxic.
What is it?
Lutein is a xanthophyll carotenoid, a fat-soluble plant pigment from the same family as beta-carotene. For food use it is extracted by solvent from dried petals of marigold flowers (Tagetes erecta), then purified to yield an orange-red powder. It also occurs naturally in kale, spinach, egg yolks and many other foods.
What does it do?
It imparts a yellow to orange colour to food and drink. As a fat-soluble pigment it disperses in oil-based ingredients, making it well suited to margarine, sauces, baked goods and flavoured drinks. It does not dissolve readily in water. In the body, lutein accumulates in the macula of the eye, where it acts as an antioxidant and blue-light filter.
Where you will see it
Non-alcoholic flavoured drinks, edible ices and ice cream, fine bakery products and pastry glazes, confectionery, desserts and flavoured dairy products, sauces and seasonings. It is most commonly listed on packaging as 'Lutein' or 'E161b' within the ingredients list.
What the science says
EFSA re-evaluation and data gaps
The European Food Safety Authority re-evaluated lutein as a food additive in 2010. It set an acceptable daily intake of 1 mg per kg of body weight per day, but applied an uncertainty factor of 200 rather than the standard 100 because the available toxicology database lacked a multigenerational reproductive toxicity study and a long-term carcinogenicity study. Lutein was found to be non-genotoxic, and no effects on reproductive organs were seen in 90-day animal studies. A 2012 EFSA follow-up found that at typical use levels adults were unlikely to exceed the ADI, but children in the UK and the Netherlands at the 95th percentile of intake could exceed it when lutein from food colours was added to background dietary exposure.
EFSA set an ADI of 1 mg/kg body weight per day, applying an uncertainty factor of 200 to account for the absence of multigenerational reproductive toxicity and chronic carcinogenicity data.
Lutein was not genotoxic in the available in vitro and in vivo tests; no effects on reproductive organs were observed in 90-day rat studies.
Based on corrected industry use-level data, EFSA estimated adult exposure to lutein from food colour was 0.1 mg/kg body weight per day at the mean and 0.3 mg/kg per day at the 97.5th percentile, below the ADI. For children, the ADI was not exceeded at the mean, but was exceeded at the 95th to 97.5th percentile in the UK and Netherlands when background dietary lutein was included.
International evaluation and revised ADI
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) previously set a group ADI of 0 to 2 mg/kg body weight per day for lutein from Tagetes erecta and synthetic zeaxanthin in 2004. At its 86th meeting in 2018, JECFA reassigned lutein from Tagetes erecta an ADI of 'not specified', reflecting the conclusion that, in the context of the full safety dataset including absence of toxicity across a wide range of studies, no numerical ceiling was necessary.
JECFA established a group ADI of 0-2 mg/kg body weight per day for lutein from Tagetes erecta and synthetic zeaxanthin at its 63rd meeting.
At its 86th meeting JECFA revised the ADI for lutein from Tagetes erecta to 'not specified', based on the absence of toxicity in a wide range of studies and the substance's status as a normal component of the human body.
Lutein and eye health
Observational studies consistently find that people with higher dietary intakes of lutein and zeaxanthin have a lower risk of developing late age-related macular degeneration (AMD). Lutein and zeaxanthin concentrate in the macula, where they absorb blue light and act as antioxidants. However, EFSA has, on multiple occasions up to 2014, declined to approve a health claim linking lutein intake to maintenance of normal vision, finding the evidence insufficient to establish a cause-and-effect relationship at the dietary intake levels in question. The observational associations are consistent but remain associations, not proof of direct prevention.
A meta-analysis of observational studies found that people with the highest dietary intakes of lutein and zeaxanthin had a significantly reduced risk of developing late AMD compared to those with the lowest intakes.
EFSA's NDA Panel concluded that a cause-and-effect relationship between dietary lutein and maintenance of normal vision had not been established at the levels that could be achieved through normal diet.
Where it stands with the regulators
Who should be careful
No specific population is required to avoid lutein used as a food colour at permitted levels. People with known hypersensitivity to marigold or other plants in the Asteraceae family may wish to note that E161b is derived from Tagetes erecta, though reported allergic reactions to food-grade lutein are not documented in the regulatory literature. Look for 'Lutein' or 'E161b' in the ingredients list.
The honest read
Lutein is a pigment the human body already knows. It sits in your eyes and circulates in your blood from everyday foods such as kale and eggs. As a food colour it adds yellow-orange tones to products and is used at levels that, for most adults, represent a very small fraction of what EFSA considers the threshold of concern. The picture is slightly less settled for children eating heavily coloured diets at the top of the intake range, where EFSA's modelling found the daily intake ceiling could be nudged. The most authoritative current international verdict, from JECFA in 2018, removed the numerical ADI entirely, reflecting confidence across a broad set of studies. The eye-health story is a live area of nutrition science: the link between lutein intake and macular protection is consistent in observational data, but regulators have not accepted the evidence as strong enough for a formal health claim. Science here is ongoing, not closed.
Related additives
Common questions
Is E161b banned in the UK?
No. Lutein (E161b) is authorised for use in food in Great Britain under the UK FSA approved-additives list, which retains the pre-Brexit EU permissions. It is also approved across the EU under Regulation (EC) No 1333/2008.
Why did EFSA use a higher uncertainty factor when setting the ADI for lutein?
When EFSA re-evaluated lutein in 2010 it applied an uncertainty factor of 200 rather than the standard 100 because the toxicology database at the time was missing a multigenerational reproductive toxicity study and a long-term carcinogenicity study. JECFA's later 2018 review, with a larger dataset, concluded no numerical ADI was needed at all.
What foods contain E161b?
E161b is used in flavoured soft drinks, sweets and confectionery, ice cream, fine bakery products and their glazes, desserts, sauces and seasonings. It can appear on the label as 'Lutein' or 'E161b'.
Is E161b vegan?
Yes. Lutein used as food colour E161b is extracted from the petals of marigold flowers (Tagetes erecta), a plant source. It contains no animal-derived ingredients and is acceptable to vegans and vegetarians.
Sources
- EFSA ANS Panel: Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive, EFSA Journal 2010;8(7):1678
- EFSA ANS Panel: Statement on the safety assessment of the exposure to lutein preparations based on new data on the use levels of lutein, EFSA Journal 2012;10(3):2589
- EFSA NDA Panel: Lutein and maintenance of normal vision (further assessment), EFSA Journal 2012;10(7):2716
- EFSA ANS Panel: Scientific Opinion on the re-evaluation of lutein preparations other than lutein with high concentrations of total saponified carotenoids, EFSA Journal 2011;9(5):2144
- UK FSA: Approved additives and E numbers - E161b entry
- JECFA: WHO Food Additives and Contaminants Database, lutein from Tagetes erecta (Chemical ID 4904)
- Ma L et al., Lutein and zeaxanthin intake and the risk of age-related macular degeneration: a systematic review and meta-analysis, British Journal of Nutrition, 2012
- International Association of Colour Manufacturers: Lutein colour profile
- Food Standards Agency: Approved additives and E numbers
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