EFSA established an ADI and flagged that young children can exceed it
EFSA set an acceptable daily intake of 0.5mg per kilogram of body weight per day, derived from a one-year rat study in which higher doses caused raised liver enzyme levels (ALT and AST). EFSA considered those liver-enzyme changes toxicologically significant; JECFA, reviewing the same study, did not, and assigned lycopene an ADI of 'not specified'. Neither agency identified harm to humans at dietary levels. Separately, EFSA's exposure modelling has consistently found that toddlers and pre-school children are the groups most likely to reach or exceed the ADI when lycopene is present at its maximum permitted level across multiple food categories simultaneously. A 2026 EFSA dietary exposure assessment reconfirmed this, with toddlers reaching up to 2.52mg/kg body weight per day at the 95th percentile in the regulatory maximum level scenario, around five times the ADI, though naturally occurring lycopene from food dominated that estimate rather than the additive alone.
EFSA derived an ADI of 0.5mg/kg body weight/day for lycopene from all sources, based on a NOAEL of 50mg/kg/day from a one-year rat study showing raised liver enzyme levels; the effect was partly reversible.
2008RegulatoryEFSA AFC Panel, Scientific Opinion on lycopene as a food colour, EFSA Journal
EFSA found that pre-school and school children were the groups most likely to exceed the ADI when lycopene from all permitted uses was combined, with high-level toddler exposure reaching 2.8 times the ADI in worst-case modelling.
2008Regulatory reviewEFSA AFC Panel, EFSA Journal, pub/674
JECFA assigned lycopene an ADI of 'not specified', considering the elevated liver enzymes seen in the same rat study not to be adverse, because there were no accompanying signs of liver damage such as increased organ weight or histopathological changes.
2009RegulatoryJECFA 71st meeting
EFSA reaffirmed its 0.5mg/kg ADI after reviewing the divergence with JECFA, concluding the disagreement reflected different interpretations of the toxicological significance of the rat liver enzyme findings, not new data.
2010Regulatory reviewEFSA, Statement on the divergence between EFSA and JECFA risk assessment of lycopene, EFSA Journal
A 2026 EFSA dietary exposure assessment found that in the regulatory maximum level scenario, toddlers reached a mean of 1.2mg/kg bw/day and a 95th percentile of 2.52mg/kg bw/day, both exceeding the ADI; naturally occurring lycopene was the main contributor in the more realistic refined scenario.
2026Regulatory reviewEFSA, Dietary exposure to lycopene from background diet, novel foods and food additive use in the European population, EFSA Journal 24(4):e9994
Prostate cancer: observational associations, not established cause
A sizeable body of observational research has found that men with higher dietary intake or higher blood levels of lycopene tend to have a lower rate of prostate cancer diagnosis. A 2015 meta-analysis of 26 studies covering over 563,000 participants found a statistically significant association between higher circulating lycopene and reduced prostate cancer risk. However, the evidence comes almost entirely from observational studies, and the few intervention trials that have tested lycopene supplementation directly have largely not demonstrated a protective effect. No regulatory body currently recommends lycopene supplementation to prevent prostate cancer.
A meta-analysis of 26 observational studies (563,299 participants, 17,517 prostate cancer cases) found higher lycopene consumption and circulating concentration were associated with lower prostate cancer risk; a linear dose-response was observed between intakes of approximately 9-21mg/day.
2015Meta-analysisGuo et al., Lycopene and Risk of Prostate Cancer: A Systematic Review and Meta-Analysis, Medicine (Baltimore), PMC4616444
A dose-response meta-analysis of observational studies estimated prostate cancer risk was reduced by approximately 3% per 1mg/day increment of dietary lycopene intake, with relative risk of 0.86 (95% CI: 0.75-0.98) for dietary intake and 0.81 (95% CI: 0.69-0.96) for blood lycopene levels.
2017Meta-analysisRowles et al., Increased dietary and circulating lycopene are associated with reduced prostate cancer risk: a systematic review and meta-analysis, Prostate Cancer and Prostatic Diseases
Most intervention trials testing lycopene supplementation have not demonstrated a cancer-preventive effect, in contrast to the positive signals from observational data, suggesting confounding may partly explain the epidemiological associations.
2022ObservationalSaini et al., The Anti-Cancer Activity of Lycopene, PMC9741066
Cardiovascular effects: mechanistic and observational evidence, mixed trial data
Laboratory and animal studies show lycopene has antioxidant and anti-inflammatory properties that could in principle protect blood vessels. Epidemiological studies associate higher lycopene intake with lower rates of cardiovascular disease and ischaemic stroke. One randomised controlled trial found that lycopene supplementation improved endothelial function in patients with existing cardiovascular disease. However, 11 out of 43 studies reviewed in a 2022 analysis found no reduction in cardiovascular risk factors, and most human evidence remains observational, making it difficult to separate lycopene's effect from that of a generally tomato-rich diet.
A randomised controlled trial found endothelium-dependent vasodilatation improved by 53% in cardiovascular disease patients taking lycopene supplementation compared to placebo.
2014RCTGajendragadkar et al., Effects of Oral Lycopene Supplementation on Vascular Function, PLOS One, PMC4049604
A 2022 narrative review of 43 studies found evidence supporting lycopene's role in reducing oxidative stress, inflammation, and atherosclerosis, but 11 of those studies found no reduction in cardiovascular risk factors; the authors noted that most human evidence remained observational.
2022ObservationalMozos et al., Lycopene in the Prevention of Cardiovascular Diseases, PMC8880080