Lycopene
A natural red pigment found in tomatoes and watermelon, used to give foods a pink or red colour.
What is it?
Lycopene is a carotenoid pigment responsible for the red and pink colour in tomatoes, watermelon, pink grapefruit, papaya, and guava. As a food additive it can come from three sources: extracted from tomatoes (the most common), produced synthetically, or derived from a fermentation process using the fungus Blakeslea trispora. It is fat-soluble and belongs to the same chemical family as beta-carotene, but unlike beta-carotene it does not convert to vitamin A in the body.
What does it do?
Lycopene absorbs light in the blue-green part of the visible spectrum, giving foods a pink-to-red hue. Because it is fat-soluble, it blends into oily or fatty food matrices more readily than water-based ones. Bioavailability is higher from cooked or processed tomato products than from raw tomatoes, because heat converts the straight-chain (trans) form into bent (cis) forms that are more readily absorbed alongside dietary fat.
Where you will see it
Used to colour processed meat products (such as vegetarian sausages), flavoured dairy products, soups, sauces, bakery icings and decorations, edible ices, confectionery, non-alcoholic flavoured drinks, and certain seafood preparations. On a UK label it appears as 'colour: lycopene', 'colour: E160d', or simply 'lycopene' in the ingredients list.
What the science says
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Where it stands with the regulators
Who should be careful
No specific group must avoid lycopene-coloured foods; it is not a known allergen and is not contraindicated in pregnancy or infancy. Parents of young children who eat a diet already rich in tomato-based products (pasta sauces, soups, ketchup) alongside other lycopene-coloured products may wish to note that combined intakes in that age group can, at the upper end, exceed the level EFSA considers acceptable. Look for 'colour: lycopene', 'colour: E160d', or 'lycopene' in the ingredients list.
The honest read
Lycopene is one of the most studied carotenoids and is a normal constituent of a tomato-containing diet. As an additive, it has a well-established regulatory history in the UK and EU. The main unresolved question is the liver-enzyme finding in rats: EFSA considers it meaningful enough to set a numerical ADI, while JECFA does not, leading to two different international conclusions from the same data. The practical consequence is that EFSA's exposure modelling consistently shows toddlers and young children can exceed EFSA's ADI when multiple lycopene-coloured products are combined, though this reflects the stricter of two legitimate expert interpretations, and naturally occurring lycopene from food contributes more to that total than the additive itself. On the potential health benefits, the observational evidence linking dietary lycopene to lower prostate cancer risk and cardiovascular protection is consistent and substantial, but intervention trials have not clearly confirmed a causal effect. The science here is live and continues to be updated, most recently by EFSA's 2026 dietary exposure assessment.
Related additives
Common questions
Is E160d banned in the UK?
No. E160d lycopene is approved for use as a food colour in the UK under the assimilated EU Regulation 1333/2008, and it appears on the UK FSA's approved-additives list.
Can young children eat a lot of lycopene-coloured foods?
EFSA has flagged that toddlers and pre-school children are the age group most likely to exceed the acceptable daily intake it set for lycopene when multiple lycopene-coloured products are consumed alongside a tomato-rich diet. This concern is specific to cumulative intake across many products, not to any single food. JECFA, using the same underlying data, did not set a numerical limit at all, so there is genuine scientific disagreement about where the threshold lies.
What foods contain E160d?
Lycopene (E160d) is permitted in non-alcoholic flavoured drinks, flavoured dairy products, soups, sauces, confectionery, bakery coatings and fillings, edible ices, certain meat preparations, and food supplements. It appears on labels as 'colour: lycopene', 'colour: E160d', or 'lycopene' in the ingredients list.
Is E160d vegan?
It depends on the source. Tomato-derived lycopene (E160d ii) is vegan. Lycopene from the fungus Blakeslea trispora (E160d iii) is vegan. Synthetic lycopene (E160d i) is also vegan. None of the three authorised sources involves animal products. However, UK labels are not required to state which source was used, so you cannot determine this from the label alone.
Sources
- UK FSA: Approved additives and E numbers
- EFSA AFC Panel: Use of lycopene as a food colour, EFSA Journal 2008
- EFSA: Statement on the divergence between EFSA and JECFA risk assessment of lycopene, EFSA Journal 2010
- EFSA: Statement on the post-marketing monitoring of the use of lycopene, EFSA Journal 2015
- EFSA: Extension of use of lycopene (E 160d) to certain meat preparations and meat products, EFSA Journal 2017
- EFSA: Dietary exposure to lycopene from background diet, novel foods and food additive use in the European population, EFSA Journal 24(4):e9994, 2026
- Guo et al., Lycopene and Risk of Prostate Cancer: A Systematic Review and Meta-Analysis, Medicine (Baltimore) 2015
- Rowles et al., Increased dietary and circulating lycopene are associated with reduced prostate cancer risk, Prostate Cancer and Prostatic Diseases 2017
- Gajendragadkar et al., Effects of Oral Lycopene Supplementation on Vascular Function, PLOS One 2014
- Mozos et al., Lycopene in the Prevention of Cardiovascular Diseases, International Journal of Molecular Sciences 2022
- Saini et al., The Anti-Cancer Activity of Lycopene: A Systematic Review of Human and Animal Studies, Antioxidants 2022
- Commission Regulation (EU) No 1129/2011 establishing Annex II to Regulation 1333/2008
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