Beta-carotene
A yellow-orange plant pigment used to colour foods. The body can convert it to vitamin A.
High-dose beta-carotene supplements are linked to increased lung cancer risk in people who smoke. Regulators advise smokers to avoid supplements containing it. The amounts used as a food colour are far lower than the doses studied, but label-readers who smoke should know the connection exists.
What is it?
Beta-carotene is a carotenoid pigment that gives carrots, sweet potatoes and many orange or yellow plants their colour. As a food additive it comes either extracted from plant material such as carrots, palm fruit oil or algae, or produced synthetically. Both forms carry the same E160a code, with sub-codes E160a(i) for synthetic and E160a(ii) for plant-derived. It is also a provitamin A: the body converts it to vitamin A as needed.
What does it do?
It absorbs blue and green light and reflects yellow-orange wavelengths, giving products a golden to deep orange colour. As a provitamin A it is cleaved by gut enzymes into retinol (vitamin A), though conversion is relatively inefficient compared to preformed vitamin A. Because the body only converts what it needs, dietary beta-carotene does not itself cause vitamin A toxicity.
Where you will see it
Margarines and butter blends, soft drinks and fruit-flavoured beverages, cheese, yogurt, custard, cake mixes, confectionery, processed snacks and some ready meals. On a UK ingredient list it appears as colour (E160a), colour (beta-carotene), or colour (carotenes).
What the science says
High-dose supplements and lung cancer in smokers
Two large randomised trials, the ATBC study and the CARET study, were halted early when participants who smoked and took high-dose beta-carotene supplements (20 to 30mg per day) showed higher rates of lung cancer and death than those on placebo. The CARET trial recorded a 28% increase in lung cancer incidence and 17% increase in mortality. No such signal has been found for beta-carotene consumed through ordinary food.
Male smokers given 20mg of beta-carotene daily for a median of six years had an 18% higher rate of lung cancer than those on placebo.
Smokers and asbestos workers given 30mg of beta-carotene plus retinyl palmitate daily had a 28% increase in lung cancer incidence and 17% increase in total mortality; the trial was stopped 21 months early.
A meta-analysis of trials found that among current smokers, beta-carotene supplementation was associated with a 24% increased risk of lung cancer.
Dietary beta-carotene versus supplement doses
EFSA concluded in 2012 that beta-carotene exposure below 15mg per day, from food colour use and food supplements combined, does not raise concerns for the general population including heavy smokers. Typical exposure from the food colouring alone is well below this. The 2024 EFSA NDA Panel noted that there is no evidence that dietary beta-carotene is linked to adverse health effects, and it explicitly advised that smokers should avoid food supplements containing beta-carotene.
EFSA ANS Panel concluded that beta-carotene use as food colour is not of safety concern provided combined intake from food colour and supplements stays within the amount found naturally in the diet (around 5 to 10mg per day).
EFSA NDA Panel stated: smokers should avoid consuming food supplements containing beta-carotene, and dietary beta-carotene shows no indication of adverse health effects.
JECFA and no group ADI
JECFA (the UN joint expert committee) withdrew the previous acceptable daily intake for synthetic beta-carotene in 2019. The committee could not set a group ADI that would cover the entire general population because the general population includes heavy smokers, and the risk data from smokers made it impossible to set a universal safe level. JECFA noted it will likely never be possible to gather the data needed to resolve this, for ethical reasons.
JECFA withdrew the previous group ADI for synthetic beta-carotene (0 to 5mg/kg body weight) because a group ADI covering the whole population must include heavy smokers, for whom the risk is elevated.
Carotenodermia: skin yellowing at high dietary intakes
Very high regular intake of beta-carotene from food can cause carotenodermia, a harmless yellowing or orange tinting of the skin, particularly on the palms, soles and folds around the nose. It reverses on reducing intake and is not associated with organ damage. It is distinct from jaundice, as the whites of the eyes remain white.
Carotenodermia occurs with prolonged high beta-carotene intake (roughly 20 to 50mg per day from food) and is reversible; it does not involve the eyes and is not toxic.
Where it stands with the regulators
Who should be careful
People who smoke are advised by EFSA not to take food supplements containing beta-carotene. As a food colour, the amounts present in everyday foods are much smaller than the doses studied in clinical trials. Anyone seeking to avoid it should look for colour (E160a), colour (beta-carotene), or colour (carotenes) in the ingredients list.
The honest read
The science on beta-carotene divides sharply by dose and by whether someone smokes. From food alone there is no demonstrated harm: dietary carotenoids at everyday levels have been studied extensively and no regulator links them to cancer or organ damage. The picture changes with high-dose supplements. Two large trials in the 1990s gave smokers 20 to 30mg a day and found increased lung cancer and mortality, not a protective effect as originally hypothesised. The dose gap between food colour exposure and supplement trials is real and large, but regulators including EFSA, JECFA and the EFSA NDA Panel have all chosen to flag the signal explicitly rather than dismiss it, refusing to set a universal safe intake for the whole population. The signal is for supplements at pharmacological doses in smokers. The science on whether any signal exists at food-level doses in non-smokers does not currently point to a concern.
Related additives
Common questions
Is E160a banned in the UK?
No. E160a is approved for use in the UK under the UK FSA approved-additives list and the retained EU Regulation 1333/2008. It is permitted in a wide range of food categories.
Does beta-carotene increase lung cancer risk?
High-dose supplements (20 to 30mg per day) were linked to increased lung cancer in people who smoke in two large randomised trials, the ATBC study (1994) and the CARET study (1996). EFSA and other international bodies explicitly advise smokers not to take supplements containing beta-carotene. No equivalent signal has been found for beta-carotene from everyday foods, where amounts are much lower.
What foods contain E160a?
Margarines, butter blends, soft drinks, fruit juices, hard and soft cheese, yogurt, custard, cake mixes, confectionery, snack foods and some ready meals. On the label look for colour (E160a), colour (beta-carotene), or colour (carotenes).
Is E160a vegan?
It depends on the source and formulation. Plant-derived E160a(ii), extracted from carrots, palm oil or algae, is vegan. Synthetic E160a(i) is also vegan. However, the additive is sometimes dissolved in a carrier oil that may be of animal origin, and finished products containing E160a may contain other non-vegan ingredients. Products certified vegan by a recognised scheme will carry that assurance.
Sources
- UK FSA Approved Additives and E Numbers
- EFSA ANS Panel: Re-evaluation of mixed carotenes (E160a(i)) and beta-carotene (E160a(ii)) as food additives, EFSA Journal 10(3):2593
- EFSA ANS Panel: Statement on the safety of beta-carotene use in heavy smokers, EFSA Journal 10(10):2953
- EFSA NDA Panel: Scientific opinion on the tolerable upper intake level for preformed vitamin A and beta-carotene, EFSA Journal 22(6):8814
- ATBC Cancer Prevention Study Group: The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers, NEJM 330:1029-1035
- Omenn et al. (CARET): Effects of a Combination of Beta Carotene and Vitamin A on Lung Cancer and Cardiovascular Disease, NEJM 334:1150-1155
- Tanvetyanon & Bepler: Beta-carotene in multivitamins and possible risk of lung cancer among smokers vs former smokers, Cancer 113(1):150-157
- JECFA 87th Meeting Summary and Conclusions (2019) - withdrawal of beta-carotene ADI
- JECFA food additive database: beta-carotene (synthetic)
- DermNet NZ: Carotenoderma
This is a guide, not medical advice. If an additive affects you, speak to your GP or a dietitian.
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