EFSA's Review of Tolerable Upper Intake Levels

The European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens (NDA) has released a revised scientific opinion on the tolerable upper intake level (UL) for preformed vitamin A and β‐carotene. This follows requests from the European Commission.

Systematic Literature Reviews

The panel conducted systematic reviews of the literature, focusing on the priority adverse health effects of excess vitamin A intake: teratogenicity, hepatotoxicity, and bone health endpoints. Despite these efforts, the available data did not provide sufficient evidence to address whether β‐carotene could exacerbate preformed vitamin A toxicity.

Critical Effects and Proposed UL

The EFSA Panel identified teratogenicity as the critical effect for setting the UL for preformed vitamin A. The panel proposes retaining the current UL of 3000 μg RE/day for adults. This UL applies universally to men, women (including those of child-bearing age), pregnant and lactating women, and post-menopausal women. The panel scaled this value down for other population groups using allometric scaling (body weight^0.75), resulting in ULs ranging from 600 μg RE/day for infants aged 4–11 months to 2600 μg RE/day for adolescents aged 15–17 years.

Population Intake and Recommendations

Based on available intake data, it is unlikely that European populations will exceed the UL for preformed vitamin A if the consumption of liver, offal, and related products is limited to once per month or less. Women planning to become pregnant or who are pregnant are advised to avoid liver products altogether.

β-Carotene Intake and Lung Cancer Risk

Lung cancer risk was identified as the critical effect of excess supplemental β‐carotene. However, the panel concluded that the data were insufficient to characterize a dose–response relationship and establish a UL for β‐carotene. They found no indication that β‐carotene intake from the background diet is associated with adverse health effects. Nonetheless, smokers are advised to avoid food supplements containing β‐carotene, and the use of such supplements by the general population should be limited to meeting vitamin A requirements.

Highlights

• The EFSA Panel retains the UL for preformed vitamin A at 3000 μg RE/day for adults.
• ULs for other groups range from 600 μg RE/day for infants to 2600 μg RE/day for adolescents.
• Women who are or plan to become pregnant should avoid liver products.
• No UL could be established for β‐carotene due to insufficient data on lung cancer risk.
• Smokers should avoid β‐carotene supplements; general population use should be limited to meeting vitamin A needs.

Data Source: https://doi.org/10.2903/j.efsa.2024.8814