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

Safety, β-carotene, heavy smokers
First published in the EFSA Journal
6 dicembre 2012
6 novembre 2012


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.

Panel members at the time of adoption

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
Panel on Food Additives and Nutrient Sources Added to Food
ans [at]
EFSA Journal 2012;10(12):2953
Question Number
On request from
European Commission