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.

Update of the tolerable upper intake level for vitamin D for infants / Turck, Dominique; Bresson, Jean-Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; Mcardle, Harry J; Naska, Androniki; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Siani, Alfonso; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Loveren, Henk Van; Vinceti, Marco; Willatts, Peter; Fewtrell, Mary; Lamberg-Allardt, Christel; Przyrembel, Hildegard; Arcella, Davide; Dumas, Céline; Fabiani, Lucia; Martino, Laura; Tomcikova, Daniela; Neuhäuser-Berthold, Monika. - In: EFSA JOURNAL. - ISSN 1831-4732. - 16:8(2018), pp. 5365-5365. [10.2903/j.efsa.2018.5365]

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

Burlingame, Barbara;Vinceti, Marco;
2018

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.
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Update of the tolerable upper intake level for vitamin D for infants / Turck, Dominique; Bresson, Jean-Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; Mcardle, Harry J; Naska, Androniki; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Siani, Alfonso; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Loveren, Henk Van; Vinceti, Marco; Willatts, Peter; Fewtrell, Mary; Lamberg-Allardt, Christel; Przyrembel, Hildegard; Arcella, Davide; Dumas, Céline; Fabiani, Lucia; Martino, Laura; Tomcikova, Daniela; Neuhäuser-Berthold, Monika. - In: EFSA JOURNAL. - ISSN 1831-4732. - 16:8(2018), pp. 5365-5365. [10.2903/j.efsa.2018.5365]
Turck, Dominique; Bresson, Jean-Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; Mcardle, Harry J; Naska, Androniki; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Siani, Alfonso; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Loveren, Henk Van; Vinceti, Marco; Willatts, Peter; Fewtrell, Mary; Lamberg-Allardt, Christel; Przyrembel, Hildegard; Arcella, Davide; Dumas, Céline; Fabiani, Lucia; Martino, Laura; Tomcikova, Daniela; Neuhäuser-Berthold, Monika
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