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

Food, EFSA Panel on Food Additives and Nutrient Sources added to

doi:10.2903/j.efsa.2012.2953

Cited by 11 publications

(3 citation statements)

References 7 publications

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“…In 2012, the ANS Panel of EFSA concluded that exposure to beta‐carotene from its use as food additive and as food supplement at a level below 15 mg/day does not give rise to concerns about adverse health effects in the general population, including heavy smokers (EFSA ANS Panel, 2012 ). The maximum intake of beta‐carotene from the NF when consumed as a food supplement at 100 mg per day would be 0.6 mg per day.…”

Section: Assessmentmentioning

confidence: 99%

Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bohn²,

Castenmiller³

et al. 2023

EFS2

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Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on yellow/orange tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid-rich extract from the yellow/orange tomato containing predominantly phytoene and phytofluene, as well as a lesser amount of beta-carotene, zeta-carotene and lycopene. The NF is produced from the tomato pulp using supercritical CO 2 extraction. The applicant proposes the use of the NF in cereal bars, functional drinks and as a food supplement in individuals above 15 years of age. For the use of the NF in cereal bars and functional drinks, the Panel considers, the target population is the general population. According to EFSA's latest exposure assessment for lycopene as a food additive (EFSA ANS Panel, 2017), the highest P95 intakes for children (< 10 and 10-17 years) and adults when combined to the use of lycopene as a food colour from natural occurrence would exceed the established acceptable daily intake (ADI) for lycopene (0.5 mg/kg body weight (bw) day). The estimated intakes of the NF would lead to an exceedance of the ADI when considering natural occurrence and exposure to lycopene when used as a food additive. Due to the absence of safety data regarding phytoene and phytofluene intake from the NF, and the contribution of the NF to the estimated high daily intakes of lycopene, the Panel considers that it cannot be established whether or not the consumption of the NF is nutritionally disadvantageous. The Panel concludes that the safety of the NF has not been established under the proposed conditions of use.

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Section: Assessmentmentioning

confidence: 99%

Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bohn²,

Castenmiller³

et al. 2023

EFS2

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“…In 2012, EFSA's ANS Panel reassessed the safety of β‐carotene for use as food additive and in food supplements. Based on human data, the Panel concluded that exposure to β‐carotene from these sources at levels < 15 mg/day is not associated with adverse health effects in the general population, including heavy smokers (EFSA ANS Panel, 2012b ).…”

Section: Introductionmentioning

confidence: 99%

“…When developing the protocol to update the ULs for vitamin A and β‐carotene ( Annex A ), the NDA Panel noticed that no new supplementation trials have been conducted/published with high doses of β‐carotene (≥ 15–20 mg/day) after the evaluations of the SCF ( 2000b ) and the EFSA ANS Panel ( 2012b , 2012a ), and that the available evidence for adverse health effects of supplemental β‐carotene (other than lung cancer risk in smokers) was limited and conflicting. Thus, in the context of deriving a UL, the Panel considered that supplemental β‐carotene should be primarily assessed as a source of vitamin A, and therefore for its potential to increase preformed vitamin A toxicity.…”

Section: Introductionmentioning

confidence: 99%

Scientific opinion on the tolerable upper intake level for preformed vitamin A and β‐carotene

Turck,

Bohn,

Castenmiller

et al. 2024

EFS2

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Following two requests from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for preformed vitamin A and β‐carotene. Systematic reviews of the literature were conducted for priority adverse health effects of excess vitamin A intake, namely teratogenicity, hepatotoxicity and endpoints related to bone health. Available data did not allow to address whether β‐carotene could potentiate preformed vitamin A toxicity. Teratogenicity was selected as the critical effect on which to base the UL for preformed vitamin A. The Panel proposes to retain the UL for preformed vitamin A of 3000 μg RE/day for adults. This UL applies to men and women, including women of child‐bearing age, pregnant and lactating women and post‐menopausal women. This value was scaled down to other population groups using allometric scaling (body weight0.75), leading to ULs between 600 μg RE/day (infants 4–11 months) and 2600 μg RE/day (adolescents 15–17 years). Based on available intake data, European populations are unlikely to exceed the UL for preformed vitamin A if consumption of liver, offal and products thereof is limited to once per month or less. Women who are planning to become pregnant or who are pregnant are advised not to consume liver products. Lung cancer risk was selected as the critical effect of excess supplemental β‐carotene. The available data were not sufficient and suitable to characterise a dose–response relationship and identify a reference point; therefore, no UL could be established. There is no indication that β‐carotene intake from the background diet is associated with adverse health effects. Smokers should avoid consuming food supplements containing β‐carotene. The use of supplemental β‐carotene by the general population should be limited to the purpose of meeting vitamin A requirements.

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Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Nagao

Warnakulasuriya

Nakamura

et al. 2014

Intl Journal of Cancer

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Management of oral leukoplakia-a potentially malignant disorder-is currently not evidence-based. Of the few randomized trials that have been reported, most have negative data. Therefore, a multi-centre, randomized, double-blind controlled trial (RCT) was undertaken to evaluate the use of low-dose beta-carotene combined with vitamin C supplements for the treatment and to prevent malignant transformation of oral leukoplakia. 46 Japanese participants with oral leukoplakia were allocated randomly either to an experimental arm (10 mg day 21 of beta-carotene and 500 mg day 21 of vitamin C) or placebo arm (50 mg day 21 of vitamin C). Current or ex-smokers within 3 months of cessation were excluded. The supplements were continued over a period of 1 year. The primary endpoint was clinical remission at 1-year and the likelihood of malignant transformation during a 5-year follow-up period as a secondary endpoint. The overall clinical response rate in the experimental arm was 17.4% (4/23) and 4.3% (1/23) in the placebo arm (p 5 0.346). During the median 60-month follow-up period, two subjects in the experimental arm and three in the control arm developed oral cancer. Under the intention-to-treat principle, relative risk by supplementing with beta-carotene and vitamin C was 0.77 (95%CI: 0.28-1.89) (p 5 0.580) by the Cox proportional hazards model. No unfavorable side-effects were noted. Beta-carotene (10 mg day 21 ) and vitamin C were neither effective for clinical remission, nor for protection against the development of cancer. Data from this RCT does not support the hypothesis that chemoprevention with this treatment is effective for oral leukoplakia.Oral leukoplakia-a potentially malignant disorder of the oral cavity-is associated with an increased risk of oral cancer. 1 Although a number of options for treatment of oral leukoplakia are available, 2 there is a lack of consensus on the most appropriate method of management and ways to minimize malignant transformation. 3 Tobacco and alcohol misuse are significant risk factors for the development of oral leukoplakia. 4 While it is possible to treat tobacco dependence, 5 the compliance of users and resources offered by healthcare delivery systems have been disappointing. Surgical and laser treatment of oral leukoplakia, although reducing the risk of malignant transformation, is at times associated with recurrences. 6 In this context, a medical treatment for leukoplakia is attractive, particularly if a chemopreventive agent that is effective and safe, and produces lasting benefit, can be found. 7,8 In 1981, Peto et al. hypothesized that high dietary intake of carotenoids may reduce cancer among humans. 9 Observational studies on diet suggest that its role in cancer prevention is mainly related to antioxidants in foods and/or beverages. 10,11 The incidence of a number of cancer types (i.e. lung, oral, pharyngeal and stomach) are inversely related to beta-carotene intake or blood concentrations. 12,13 A Japanese population study reported that high serum beta-carotene levels wer...

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

Cited by 11 publications

References 7 publications

Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283

Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283

Scientific opinion on the tolerable upper intake level for preformed vitamin A and β‐carotene

Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

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