TY - JOUR
T1 - Update of the tolerable upper intake level for vitamin D for infants
AU - Pentieva, K.
AU - Turck, Dominique
AU - Bresson, Jean‐Louis
AU - Burlingame, Barbara
AU - Dean, Tara
AU - Fairweather‐Tait, Susan
AU - Heinonen, Marina
AU - Ildico Hirsch‐Ernst, Karen
AU - Mangelsdorf, Inge
AU - McArdle, Harry J
AU - Naska, Androniki
AU - Nowicka, Grazyna
AU - Sanz, Yolanda
AU - Siani, Alfonso
AU - Sjodin, Anders
AU - Stern, Martin
AU - Tome, Daniel
AU - Van Loveren, Henk
AU - Vinceti, Marco
AU - Willatts, Peter
AU - Fewtrell, Mary
AU - Lamberg-Allardt, Christel
AU - Przyrembel, Hildegard
AU - Arcella, Davide
AU - Dumas, Celine
AU - Fabiani, Lucia
AU - Martino, Laura
AU - Tomcikova, Daniela
AU - Neuhauser-Berthold, Monika
PY - 2018/8/7
Y1 - 2018/8/7
N2 - 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.
AB - 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.
KW - vitamin D
KW - infants
KW - adverse health outcome
KW - 25(OH)D
KW - UL
KW - Intake
U2 - 10.2903/j.efsa.2018.5365
DO - 10.2903/j.efsa.2018.5365
M3 - Article
SN - 1831-4732
VL - 16
JO - EFSA Journal
JF - EFSA Journal
IS - 8
ER -