Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate
Abstract Following two requests from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for vitamin D and to propose a conversion factor (CF) for calcidiol...
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| Format: | Article |
| Language: | English |
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Wiley
2023-08-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.8145 |
| _version_ | 1827811955786645504 |
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| author | EFSA Panel on Nutrition, Novel Foods and FoodAllergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan deHenauw Karen‐Ildico Hirsch‐Ernst Helle Katrine Knutsen Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Susan Lanham‐New Giovanni Passeri Ionut Craciun Lucia Fabiani Rita Ferreira De Sousa Laura Martino Silvia Valtueña Martínez Androniki Naska |
| author_facet | EFSA Panel on Nutrition, Novel Foods and FoodAllergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan deHenauw Karen‐Ildico Hirsch‐Ernst Helle Katrine Knutsen Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Susan Lanham‐New Giovanni Passeri Ionut Craciun Lucia Fabiani Rita Ferreira De Sousa Laura Martino Silvia Valtueña Martínez Androniki Naska |
| author_sort | EFSA Panel on Nutrition, Novel Foods and FoodAllergens (NDA) |
| collection | DOAJ |
| description | Abstract Following two requests from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for vitamin D and to propose a conversion factor (CF) for calcidiol monohydrate into vitamin D3 for labelling purposes. Vitamin D refers to ergocalciferol (vitamin D2), cholecalciferol (vitamin D3), and calcidiol monohydrate. Systematic reviews of the literature were conducted to assess the relative bioavailability of calcidiol monohydrate versus vitamin D3 on serum 25(OH)D concentrations, and for priority adverse health effects of excess vitamin D intake, namely persistent hypercalcaemia/hypercalciuria and endpoints related to musculoskeletal health (i.e. falls, bone fractures, bone mass/density and indices thereof). Based on the available evidence, the Panel proposes a CF for calcidiol monohydrates of 2.5 for labelling purposes. Persistent hypercalciuria, which may be an earlier sign of excess vitamin D than persistent hypercalcaemia, is selected as the critical endpoint on which to base the UL for vitamin D. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 250 μg/day is identified from two randomised controlled trials in humans, to which an uncertainty factor of 2.5 is applied to account for the absence of a no‐observed‐adverse‐effect‐level (NOAEL). A UL of 100 μg vitamin D equivalents (VDE)/day is established for adults (including pregnant and lactating women) and for adolescents aged 11–17 years, as there is no reason to believe that adolescents in the phase of rapid bone formation and growth have a lower tolerance for vitamin D compared to adults. For children aged 1–10 years, a UL of 50 μg VDE/day is established by considering their smaller body size. Based on available intake data, European populations are unlikely to exceed the UL, except for regular users of food supplements containing high doses of vitamin D. |
| first_indexed | 2024-03-11T23:12:35Z |
| format | Article |
| id | doaj.art-89e387e407ab418fb297d94eb355e85b |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-11T23:12:35Z |
| publishDate | 2023-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-89e387e407ab418fb297d94eb355e85b2023-09-21T06:30:43ZengWileyEFSA Journal1831-47322023-08-01218n/an/a10.2903/j.efsa.2023.8145Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrateEFSA Panel on Nutrition, Novel Foods and FoodAllergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan deHenauwKaren‐Ildico Hirsch‐ErnstHelle Katrine KnutsenAlexandre MaciukInge MangelsdorfHarry J McArdleKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiSusan Lanham‐NewGiovanni PasseriIonut CraciunLucia FabianiRita Ferreira De SousaLaura MartinoSilvia Valtueña MartínezAndroniki NaskaAbstract Following two requests from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for vitamin D and to propose a conversion factor (CF) for calcidiol monohydrate into vitamin D3 for labelling purposes. Vitamin D refers to ergocalciferol (vitamin D2), cholecalciferol (vitamin D3), and calcidiol monohydrate. Systematic reviews of the literature were conducted to assess the relative bioavailability of calcidiol monohydrate versus vitamin D3 on serum 25(OH)D concentrations, and for priority adverse health effects of excess vitamin D intake, namely persistent hypercalcaemia/hypercalciuria and endpoints related to musculoskeletal health (i.e. falls, bone fractures, bone mass/density and indices thereof). Based on the available evidence, the Panel proposes a CF for calcidiol monohydrates of 2.5 for labelling purposes. Persistent hypercalciuria, which may be an earlier sign of excess vitamin D than persistent hypercalcaemia, is selected as the critical endpoint on which to base the UL for vitamin D. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 250 μg/day is identified from two randomised controlled trials in humans, to which an uncertainty factor of 2.5 is applied to account for the absence of a no‐observed‐adverse‐effect‐level (NOAEL). A UL of 100 μg vitamin D equivalents (VDE)/day is established for adults (including pregnant and lactating women) and for adolescents aged 11–17 years, as there is no reason to believe that adolescents in the phase of rapid bone formation and growth have a lower tolerance for vitamin D compared to adults. For children aged 1–10 years, a UL of 50 μg VDE/day is established by considering their smaller body size. Based on available intake data, European populations are unlikely to exceed the UL, except for regular users of food supplements containing high doses of vitamin D.https://doi.org/10.2903/j.efsa.2023.8145Ergocalciferolcholecalciferolcalcidiol monohydrateconversion factortolerable upper intake level |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and FoodAllergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan deHenauw Karen‐Ildico Hirsch‐Ernst Helle Katrine Knutsen Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Susan Lanham‐New Giovanni Passeri Ionut Craciun Lucia Fabiani Rita Ferreira De Sousa Laura Martino Silvia Valtueña Martínez Androniki Naska Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate EFSA Journal Ergocalciferol cholecalciferol calcidiol monohydrate conversion factor tolerable upper intake level |
| title | Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate |
| title_full | Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate |
| title_fullStr | Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate |
| title_full_unstemmed | Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate |
| title_short | Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate |
| title_sort | scientific opinion on the tolerable upper intake level for vitamin d including the derivation of a conversion factor for calcidiol monohydrate |
| topic | Ergocalciferol cholecalciferol calcidiol monohydrate conversion factor tolerable upper intake level |
| url | https://doi.org/10.2903/j.efsa.2023.8145 |
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