Scientific opinion on the tolerable upper intake level for selenium

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for selenium. Systematic reviews of the literature were conducted to identify evidence regarding excess selenium intake and clinical effects and potential biomarkers of effect, risk of chronic diseases and impaired neuropsychological development in humans. Alopecia, as an early observable feature and a well‐established adverse effect of excess selenium exposure, is selected as the critical endpoint on which to base a UL for selenium. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 330 μg/day is identified from a large randomised controlled trial in humans (the Selenium and Vitamin E Cancer Prevention Trial (SELECT)), to which an uncertainty factor of 1.3 is applied. A UL of 255 μg/day is established for adult men and women (including pregnant and lactating women). ULs for children are derived from the UL for adults using allometric scaling (body weight 0.75 ). Based on available intake data, adult consumers are unlikely to exceed the UL, except for regular users of food supplements containing high daily doses of selenium or regular consumers of Brazil nuts. No risk has been reported with the current levels of selenium intake in European countries from food (excluding food supplements) in toddlers and children, and selenium intake arising from the natural content of foods does not raise reasons for concern. Selenium‐containing supplements in toddlers and children should be used with caution, based on individual needs.

Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food

“…Food supplements other than calcidiol are excluded. To that end, the following data from the newly available EFSA scientific opinion on the UL for vitamin D (EFSA NDA Panel, 2023) have been used: a factor of 2.5 for the conversion of the intake of calcidiol monohydrate into VDE; the most recent, harmonised vitamin D intake data from the background diet that is currently available. Intake estimates across population groups and European countries were calculated using the EFSA Comprehensive food consumption and the EFSA food composition databases; combined intakes of vitamin D from the background diet and fortified foods based on published data from national food consumption surveys. …”

“…Sources of uncertainty in the intake estimates for vitamin D from the background diet and fortified foods are discussed in the scientific opinion (EFSA NDA Panel, 2023).…”

“…The UL for adults including pregnant and lactating women, and for children aged 11–17 years, was set at 100 μg VDE/day (EFSA NDA Panel, 2023). The UL covers dietary intake of vitamin D from all sources, including fortified foods and food supplements.…”

The imprecision of micronutrient requirement values: the example of vitamin D

“…Risk characterization is a continuous process as it can be seen by recent reappraisal of several tolerable upper intake levels for vitamins (vitamin B9 and B6, vitamin A and β‐carotene, vitamin D, and vitamin E) and minerals (iron, selenium, and manganese) (de Sesmaisons Lecarré et al., 2022; Turck et al., 2023).…”

Natural Sources of Selenium as Functional Food Products for Chemoprevention

“…Regarding cancer prevention, some researchers suggest a daily dose of 100–200 µg of Se to inhibit genetic damage and cancer development [ 19 ]. The Scientific Committee for Food (SCF) adopts the tolerable upper level (UL) of Se for adults as 255 µg/day [ 20 ]. Consequently, functional food rich in Se is of interest due to difficulties in meeting the daily Se requirements and its beneficial anti-cancer properties.…”