Update of the tolerable upper intake level for vitamin D for infants

Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to revise the tolerable upper intake level (UL) for vitamin D for infants (≤ 1 year) set in 2012. From its literature review, the Panel concluded that the available evidence on daily vitamin D intake and the risk of adverse health outcomes (hypercalciuria, hypercalcaemia, nephrocalcinosis and abnormal growth patterns) cannot be used alone for deriving the UL for infants. The Panel conducted a meta‐regression analysis of collected data, to derive a dose–response relationship between daily supplemental intake of vitamin D and mean achieved serum 25(OH)D concentrations. Considering that a serum 25(OH)D concentration of 200 nmol/L or below is unlikely to pose a risk of adverse health outcomes in infants, the Panel estimated the percentage of infants reaching a concentration above this value at different intakes of vitamin D. Based on the overall evidence, the Panel kept the UL of 25 μg/day for infants aged up to 6 months and set a UL of 35 μg/day for infants 6–12 months. The Panel was also asked to advise on the safety of the consumption of infant formulae with an increased maximum vitamin D content of 3 μg/100 kcal (Commission Delegated Regulation (EU) 2016/127 repealing Directive 2006/141/EC in 2020). For infants aged up to 4 months, the intake assessment showed that the use of infant formulae containing vitamin D at 3 μg/100 kcal may lead some infants to receive an intake above the UL of 25 μg/day from formulae alone without considering vitamin D supplemental intake. For infants aged 4–12 months, the 95th percentile of vitamin D intake (high consumers) estimated from formulae and foods fortified or not with vitamin D does not exceed the ULs, without considering vitamin D supplemental intake.

Vitamin D testing and treatment: a narrative review of current evidence

“…(80) under the terms of the CC Attribution 4.0 International (CC BY 4.0) licence).Country (health authority)United States and Canada (IOM)Europe (EFSA) Age group Vitamin D in µg (international units, IU) per day (1 µg = 40 IU) 0–6 months25 (1000)25 (1000)6–12 months37.5 (1500)35 (1400)*1–3 years62.5 (2500)50 (2000)4–8 years75 (3000)50 (2000)9–10 years100 (4000)50 (2000)11–17 years100 (4000)100 (4000)18 years and older100 (4000)100 (4000)Pregnancy100 (4000)100 (4000)Lactation100 (4000)100 (4000)EFSA, European Food Safety Authority; IOM, Institute of Medicine. *recently updated (180)…”

Safety of Vitamin D2 mushroom powder (Agaricus bisporus) as a Novel food pursuant to Regulation (EU) 2015/2283

“…For this age group, P95 intakes for vitamin D ranged across the surveys from 13.2 to 16.9 lg/day in formula consumers not consuming (voluntarily) fortified foods. For non-formula consumers who were also not consuming (voluntarily) fortified foods, the P95 vitamin D intake from the diet ranged between 0.7 and 2.8 lg/day (EFSA NDA Panel, 2018Panel, , 2020.…”

“…The Panel notes that the combined estimated intake of 29.6 lg/day is below the UL of 35 lg/day for infants aged 6-11 months established by EFSA (EFSA NDA Panel, 2018). However, following the EU supplementation recommendations of 10 lg vitamin D per day in infants (ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition) Committee on Nutrition, Braegger et al, 2013cited in EFSA NDA Panel, 2016a, there is a potential risk of approaching or exceeding the UL for vitamin D in infants (EFSA NDA Panel, 2018. This is a general issue related to the combined consumption of vitamin D via fortified foods and supplements and does not specifically relate to this NF application.…”

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the update of the tolerable upper intake level for vitamin D for infants

“…The updated Scientific Opinion was discussed and adopted at the NDA Plenary meeting on 28 June 2018, and is published in the EFSA Journal (EFSA NDA Panel, 2018). The NDA Panel prepared an updated version of the Scientific Opinion, taking into account the comments received.…”

“…The NDA Panel prepared an updated version of the Scientific Opinion, taking into account the comments received. The updated Scientific Opinion was discussed and adopted at the NDA Plenary meeting on 28 June 2018, and is published in the EFSA Journal (EFSA NDA Panel, 2018). EFSA is committed to publishing the comments received during the public consultation, as well as a short report on the outcome of the consultation.…”