Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food
Abstract EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA adopted scientific opinion on ‘Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283’, including its bioavailability as a metabo...
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| Format: | Article |
| Language: | English |
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Wiley
2024-01-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8520 |
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| author | European Food Safety Authority (EFSA) Dominique Turck Harry J. McArdle Androniki Naska Monika Neuhäuser‐Berthold Giovanni Passeri Ionut Craciun Ruth Roldán‐Torres Silvia Valtueña Martínez |
| author_facet | European Food Safety Authority (EFSA) Dominique Turck Harry J. McArdle Androniki Naska Monika Neuhäuser‐Berthold Giovanni Passeri Ionut Craciun Ruth Roldán‐Torres Silvia Valtueña Martínez |
| author_sort | European Food Safety Authority (EFSA) |
| collection | DOAJ |
| description | Abstract EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA adopted scientific opinion on ‘Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283’, including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. On 5 July 2023, EFSA adopted the ‘Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate’. This opinion concerns an updated exposure assessment for vitamin D and proposes a conversion factor for calcidiol monohydrate into vitamin D3 of 2.5 for labelling purposes. In addition, in reference to the EFSA opinion on the safety of calcidiol monohydrate, the Commission had received a letter from the pharmaceutical company EirGen Pharma Ltd requesting a revision of this opinion based on new data concerning calcidiol. Based on the information and data considered in this scientific technical report, EFSA concludes that the novel food calcidiol monohydrate proposed for use in food supplements is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25‐dihydroxyvitamin D, that a conversion factor of 2.5 reflects the relative bioavailability of calcidiol vs vitamin D3 under the proposed conditions of use and use levels, and that it is safe under the proposed conditions of use and use levels, i.e. up to 10 μg/day for children ≥ 11 years old and adults, including pregnant and lactating women, and up to 5 μg/day for children 3–10 years of age. |
| format | Article |
| id | doaj-art-63ee5e76edfc4d8d8a1b845933d6d2e3 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-63ee5e76edfc4d8d8a1b845933d6d2e32024-11-13T07:31:25ZengWileyEFSA Journal1831-47322024-01-01221n/an/a10.2903/j.efsa.2024.8520Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel foodEuropean Food Safety Authority (EFSA)Dominique TurckHarry J. McArdleAndroniki NaskaMonika Neuhäuser‐BertholdGiovanni PasseriIonut CraciunRuth Roldán‐TorresSilvia Valtueña MartínezAbstract EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA adopted scientific opinion on ‘Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283’, including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. On 5 July 2023, EFSA adopted the ‘Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate’. This opinion concerns an updated exposure assessment for vitamin D and proposes a conversion factor for calcidiol monohydrate into vitamin D3 of 2.5 for labelling purposes. In addition, in reference to the EFSA opinion on the safety of calcidiol monohydrate, the Commission had received a letter from the pharmaceutical company EirGen Pharma Ltd requesting a revision of this opinion based on new data concerning calcidiol. Based on the information and data considered in this scientific technical report, EFSA concludes that the novel food calcidiol monohydrate proposed for use in food supplements is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25‐dihydroxyvitamin D, that a conversion factor of 2.5 reflects the relative bioavailability of calcidiol vs vitamin D3 under the proposed conditions of use and use levels, and that it is safe under the proposed conditions of use and use levels, i.e. up to 10 μg/day for children ≥ 11 years old and adults, including pregnant and lactating women, and up to 5 μg/day for children 3–10 years of age.https://doi.org/10.2903/j.efsa.2024.852025‐hydroxycholecalciferol monohydratecalcidiol monohydrateconversion factorfood supplementnovel foodtolerable upper intake level |
| spellingShingle | European Food Safety Authority (EFSA) Dominique Turck Harry J. McArdle Androniki Naska Monika Neuhäuser‐Berthold Giovanni Passeri Ionut Craciun Ruth Roldán‐Torres Silvia Valtueña Martínez Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food EFSA Journal 25‐hydroxycholecalciferol monohydrate calcidiol monohydrate conversion factor food supplement novel food tolerable upper intake level |
| title | Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food |
| title_full | Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food |
| title_fullStr | Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food |
| title_full_unstemmed | Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food |
| title_short | Scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food |
| title_sort | scientific and technical assistance to the evaluation of the safety of calcidiol monohydrate as a novel food |
| topic | 25‐hydroxycholecalciferol monohydrate calcidiol monohydrate conversion factor food supplement novel food tolerable upper intake level |
| url | https://doi.org/10.2903/j.efsa.2024.8520 |
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