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Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources.

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Title: Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources.
Authors: Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, de Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Knutsen, Helle Katrine, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Kass, George, Heng, Leng, Sofroniou, Angeliki, Ververis, Ermolaos, Valtueña Martínez, Silvia, Naska, Androniki
Source: EFSA Journal; Sep2024, Vol. 22 Issue 9, p1-29, 29p
Subject Terms: FOOD labeling, DIETARY supplements, CONSUMER education, REFERENCE sources, BIOAVAILABILITY
Company/Entity: EUROPEAN Commission, EUROPEAN Food Safety Authority
Abstract: Following the adoption of Regulation (EU) No 1169/2011 on food information to consumers, the European Commission requested EFSA to update its 'Guidance on safety evaluation of sources of nutrients and bioavailability of the nutrient from the sources' regarding the scientific principles and data requirements for the scientific assessment of all new forms of micronutrients and to derive a conversion factor for new micronutrient sources or forms of micronutrients to be authorised for addition to foods, including food supplements. This guidance outlines the scientific principles that the NDA Panel will consider for the assessment of the safety and the quantification of the relative bioavailability of new sources of micronutrients, which applicants are requested to consider when preparing their applications. It also outlines the data requirements for dossiers. Applicants should integrate the data presented in different sections to provide their overall considerations on how the information provided supports the safety of the new micronutrient source and the quantification of its relative bioavailability compared to a reference source under the proposed conditions of use. As preparatory work for the development of this guidance, EFSA launched an Expert Survey and held an online workshop on 9th March 2023 inviting scientific input from stakeholders and scientific experts, the report of which is now available online in the EFSA's webpage. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Complementary Index
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  Data: Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources.
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  Data: <searchLink fieldCode="AR" term="%22Turck%2C+Dominique%22">Turck, Dominique</searchLink><br /><searchLink fieldCode="AR" term="%22Bohn%2C+Torsten%22">Bohn, Torsten</searchLink><br /><searchLink fieldCode="AR" term="%22Castenmiller%2C+Jacqueline%22">Castenmiller, Jacqueline</searchLink><br /><searchLink fieldCode="AR" term="%22de+Henauw%2C+Stefaan%22">de Henauw, Stefaan</searchLink><br /><searchLink fieldCode="AR" term="%22Hirsch‐Ernst%2C+Karen+Ildico%22">Hirsch‐Ernst, Karen Ildico</searchLink><br /><searchLink fieldCode="AR" term="%22Knutsen%2C+Helle+Katrine%22">Knutsen, Helle Katrine</searchLink><br /><searchLink fieldCode="AR" term="%22Maciuk%2C+Alexandre%22">Maciuk, Alexandre</searchLink><br /><searchLink fieldCode="AR" term="%22Mangelsdorf%2C+Inge%22">Mangelsdorf, Inge</searchLink><br /><searchLink fieldCode="AR" term="%22McArdle%2C+Harry+J%2E%22">McArdle, Harry J.</searchLink><br /><searchLink fieldCode="AR" term="%22Pentieva%2C+Kristina%22">Pentieva, Kristina</searchLink><br /><searchLink fieldCode="AR" term="%22Siani%2C+Alfonso%22">Siani, Alfonso</searchLink><br /><searchLink fieldCode="AR" term="%22Thies%2C+Frank%22">Thies, Frank</searchLink><br /><searchLink fieldCode="AR" term="%22Tsabouri%2C+Sophia%22">Tsabouri, Sophia</searchLink><br /><searchLink fieldCode="AR" term="%22Vinceti%2C+Marco%22">Vinceti, Marco</searchLink><br /><searchLink fieldCode="AR" term="%22Kass%2C+George%22">Kass, George</searchLink><br /><searchLink fieldCode="AR" term="%22Heng%2C+Leng%22">Heng, Leng</searchLink><br /><searchLink fieldCode="AR" term="%22Sofroniou%2C+Angeliki%22">Sofroniou, Angeliki</searchLink><br /><searchLink fieldCode="AR" term="%22Ververis%2C+Ermolaos%22">Ververis, Ermolaos</searchLink><br /><searchLink fieldCode="AR" term="%22Valtueña+Martínez%2C+Silvia%22">Valtueña Martínez, Silvia</searchLink><br /><searchLink fieldCode="AR" term="%22Naska%2C+Androniki%22">Naska, Androniki</searchLink>
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  Data: EFSA Journal; Sep2024, Vol. 22 Issue 9, p1-29, 29p
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  Data: <searchLink fieldCode="DE" term="%22FOOD+labeling%22">FOOD labeling</searchLink><br /><searchLink fieldCode="DE" term="%22DIETARY+supplements%22">DIETARY supplements</searchLink><br /><searchLink fieldCode="DE" term="%22CONSUMER+education%22">CONSUMER education</searchLink><br /><searchLink fieldCode="DE" term="%22REFERENCE+sources%22">REFERENCE sources</searchLink><br /><searchLink fieldCode="DE" term="%22BIOAVAILABILITY%22">BIOAVAILABILITY</searchLink>
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– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Following the adoption of Regulation (EU) No 1169/2011 on food information to consumers, the European Commission requested EFSA to update its 'Guidance on safety evaluation of sources of nutrients and bioavailability of the nutrient from the sources' regarding the scientific principles and data requirements for the scientific assessment of all new forms of micronutrients and to derive a conversion factor for new micronutrient sources or forms of micronutrients to be authorised for addition to foods, including food supplements. This guidance outlines the scientific principles that the NDA Panel will consider for the assessment of the safety and the quantification of the relative bioavailability of new sources of micronutrients, which applicants are requested to consider when preparing their applications. It also outlines the data requirements for dossiers. Applicants should integrate the data presented in different sections to provide their overall considerations on how the information provided supports the safety of the new micronutrient source and the quantification of its relative bioavailability compared to a reference source under the proposed conditions of use. As preparatory work for the development of this guidance, EFSA launched an Expert Survey and held an online workshop on 9th March 2023 inviting scientific input from stakeholders and scientific experts, the report of which is now available online in the EFSA's webpage. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.2903/j.efsa.2024.8946
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        Text: English
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