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

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel); Dominique Turck; Jean Louis Bresson; Barbara Burlingame; Tara Dean; Susan Fairweather-Tait; Marina Heinonen; Karen Ildico Hirsch-Ernst; Inge Mangelsdorf; Harry J. McArdle; Androniki Naska; Grażyna Nowicka; Kristina Pentieva; Yolanda Sanz; Alfonso Siani; Anders Sjödin; Martin Stern; Daniel Tomé; Henk Van Loveren; Marco Vinceti; Peter Willatts; Mary Fewtrell; Christel Lamberg-Allardt; Hildegard Przyrembel; Davide Arcella; Céline Dumas; Lucia Fabiani; Laura Martino; Daniela Tomcikova; Monika Neuhäuser-Berthold

doi:10.2903/j.efsa.2018.5365

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

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel)
, Dominique Turck
, Jean Louis Bresson
, Barbara Burlingame
, Tara Dean
, Susan Fairweather-Tait
, Marina Heinonen
, Karen Ildico Hirsch-Ernst
, Inge Mangelsdorf
, Harry J. McArdle
, Androniki Naska
, Grażyna Nowicka
, Kristina Pentieva
, Yolanda Sanz
, Alfonso Siani
, Anders Sjödin
, Martin Stern
, Daniel Tomé
, Henk Van Loveren
, Marco Vinceti

Peter Willatts, Mary Fewtrell, Christel Lamberg-Allardt, Hildegard Przyrembel, Davide Arcella, Céline Dumas, Lucia Fabiani, Laura Martino, Daniela Tomcikova, Monika Neuhäuser-Berthold

Psychology

Research output: Contribution to journal › Article › peer-review

45 Citations (Scopus)

504 Downloads (Pure)

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.

Original language	English
Article number	e05365
Pages (from-to)	1-118
Number of pages	118
Journal	EFSA Journal
Volume	16
Issue number	8
Early online date	7 Aug 2018
DOIs	https://doi.org/10.2903/j.efsa.2018.5365
Publication status	Published - Aug 2018

Keywords

25(OH)D
adverse health outcomes
infants
intake
UL
vitamin D

ASJC Scopus subject areas

Food Science
veterinary (miscalleneous)
Animal Science and Zoology
Microbiology
Parasitology
Plant Science

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10.2903/j.efsa.2018.5365Licence: CC BY-ND

Final Published VersionFinal published version, 12.1 MBLicence: CC BY-ND

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EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., Heinonen, M., Hirsch-Ernst, K. I., Mangelsdorf, I., McArdle, H. J., Naska, A., Nowicka, G., Pentieva, K., Sanz, Y., Siani, A., Sjödin, A., Stern, M., Tomé, D., Loveren, H. V., ... Neuhäuser-Berthold, M. (2018). Update of the tolerable upper intake level for vitamin D for infants. EFSA Journal, 16(8), 1-118. Article e05365. https://doi.org/10.2903/j.efsa.2018.5365

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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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year = "2018",

month = aug,

doi = "10.2903/j.efsa.2018.5365",

language = "English",

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EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather-Tait, S, Heinonen, M, Hirsch-Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Nowicka, G, Pentieva, K, Sanz, Y, Siani, A, Sjödin, A, Stern, M, Tomé, D, Loveren, HV, Vinceti, M, Willatts, P, Fewtrell, M, Lamberg-Allardt, C, Przyrembel, H, Arcella, D, Dumas, C, Fabiani, L, Martino, L, Tomcikova, D & Neuhäuser-Berthold, M 2018, 'Update of the tolerable upper intake level for vitamin D for infants', EFSA Journal, vol. 16, no. 8, e05365, pp. 1-118. https://doi.org/10.2903/j.efsa.2018.5365

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AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel)

AU - Turck, Dominique

AU - Bresson, Jean Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather-Tait, Susan

AU - Heinonen, Marina

AU - Hirsch-Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Nowicka, Grażyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Siani, Alfonso

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Loveren, Henk Van

AU - Vinceti, Marco

AU - Willatts, Peter

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AU - Tomcikova, Daniela

AU - Neuhäuser-Berthold, Monika

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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 - 25(OH)D

KW - adverse health outcomes

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KW - intake

KW - UL

KW - vitamin D

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JO - EFSA Journal

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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