• Open Access

Statement on the safety of β-carotene use in heavy smokers


  • EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)

  • Panel members: Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright
  • Correspondence: ans@efsa.europa.eu
  • Adoption date: 6 November 2012
  • Published date: 6 December 2012
  • Question number: EFSA-Q-2012-00880
  • On request from: European Commission


Following a request by the European Commission the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to conclude on the possible link between the ingestion of β-carotene and cancer enhancement in heavy smokers. The safety of (synthetic) β-carotene [E 160a (ii)] has been evaluated previously by JECFA (1975) and by the SCF (2000a). In 2000, the SCF concluded that there were insufficient data to set a precise figure for a Tolerable Upper Intake Level (UL) of β-carotene (SCF, 2000b). Unexpectedly, two independent trials revealed that heavy smokers (at least 1 package/day for 36 years on average) receiving long-term β-carotene (20 mg/day) supplementation or β-carotene (30 mg/day) + retinol (25 000 International Unit (IU) vitamin A) supplementation, showed increased rather than decreased incidences of lung cancer. A meta-analysis of randomized controlled trials (RCT) demonstrated absence of any protective effect associated with β-carotene supplementation with regard to cancer risk. Epidemiological studies reported no increased lung cancer incidence in heavy smokers at supplemental dose levels of β-carotene varying from 6 – 15 mg/day for about 5 up to 7 years. The Panel concluded that exposure to β-carotene from its use as food additive and as food supplement at a level below 15 mg/day do not give rise to concerns about adverse health effects in the general population, including heavy smokers.