The European limit and the missing studies
European reviewers looked at lutein in 2010 and set a daily limit of 1mg per kg of body weight. They divided by 200 instead of the usual 100, because there was no multi-generation reproduction study and no long-term cancer study. Lutein did not damage DNA in the tests available, and 90-day animal studies showed no effect on reproductive organs. A 2012 follow-up found adults were unlikely to go over the limit, but children in the UK and the Netherlands at high intake could, once lutein already in food was counted.
Reviewers set a daily limit of 1mg per kg of body weight, using a safety factor of 200 because multi-generation reproduction and long-term cancer data were missing.
2010Regulator reviewEFSA ANS Panel, Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive, EFSA Journal 2010, volume 8, 1678
Lutein did not damage DNA in the lab and animal tests available, and 90-day rat studies found no effect on reproductive organs.
2010Regulator reviewEFSA ANS Panel, Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive, EFSA Journal 2010, volume 8, 1678
Using corrected use data, adult intake from the colour was 0.1mg per kg of body weight on average and 0.3mg per kg at the top end, below the limit. Children went over the limit at the highest intakes in the UK and the Netherlands when lutein already in the diet was included.
2012Regulator reviewEFSA 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, volume 10, 2589
The international committee dropped its limit
The international committee set a shared limit of up to 2mg per kg of body weight for lutein and zeaxanthin in 2004. In 2018 it changed lutein from marigold to no numerical limit, based on a wider set of studies showing no toxicity.
The international committee set a shared daily limit of up to 2mg per kg of body weight for lutein from marigold and synthetic zeaxanthin.
2004Regulator reviewJECFA, WHO Food Additives Series / Chemical and Technical Assessment, 63rd JECFA
The international committee changed the limit for lutein from marigold to not specified, because a wide range of studies found no toxicity and lutein is a normal part of the human body.
2018Regulator reviewJECFA, WHO Food Additives and Contaminants Database, Chemical ID 4904
Lutein and the eyes
Studies of large groups consistently find that people who eat more lutein and zeaxanthin have less late age-related macular degeneration, a common cause of sight loss in older people. But European reviewers have repeatedly turned down a health claim linking lutein to normal vision, finding the evidence did not show cause and effect at dietary amounts. The link is consistent, but it is a link.
Pooling observational studies, people with the highest intake of lutein and zeaxanthin had clearly less late macular degeneration than those with the lowest.
2012Review of many studiesMa et al., Lutein and zeaxanthin intake and the risk of age-related macular degeneration, British Journal of Nutrition
Reviewers concluded a cause-and-effect link between dietary lutein and normal vision had not been shown at amounts reachable through normal diet.
2012Regulator reviewEFSA NDA Panel, Lutein and maintenance of normal vision (further assessment), EFSA Journal 2012, volume 10, 2716