Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals: Draft for internal testing

K. Pentieva, Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Carmen Pel ́aez, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti Vinceti, Peter Aggett, Marta Crous Bou, Francesco Cubadda, Agn`es de Sesmaisons Lecarre, Laura MartinoAndroniki Naska

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Abstract

Vitamins and essential minerals are micronutrients that are essential for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. The concept of a tolerable upper intake level (UL) is a science-based reference value, which was introduced to support policy-makers and other relevant actors in managing the risks of excess nutrient intake. EFSA’s principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. Since then, experience has been gained and the scientific field developed. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework to support EFSA’s UL assessments. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied (hazard identification, hazard characterisation, intake assessment, risk characterisation). Peculiar to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homoeostasis and body burden of the nutrient. These must be considered when conducting a risk assessment of nutrients. This document constitutes a draft guidance that will be applied in EFSA’s assessments during a 1-year pilot phase and be revised and complemented as necessary. Before finalisation of the guidance, a public consultation will be launched.
Original languageEnglish
Article numbere200102
Pages (from-to)1-27
Number of pages27
JournalEFSA Journal
Volume20
Issue number1
DOIs
Publication statusPublished - 24 Jan 2022

Bibliographical note

Funding Information:
The NDA Panel?wishes to thank for the support provided to this scientific output: the hearing expert Josef Schlatter; the EFSA staff Laura Ciccollalo, Ionut Craciun, Ariane Titz and Silvia Valtuena Martinez.

Publisher Copyright:
© 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

Keywords

  • tolerable upper level of intake
  • vitamins
  • minerals
  • tolerable upper intake level
  • UL
  • mineral
  • dietary reference value
  • vitamin

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