Risk assessment of nutrients: There must be a threshold for their effects

Michiel Löwik*, Arne Astrup, Alan Boobis, Philip Calder, Hannelore Daniel, Ivonne Rietjens, John Sievenpiper, Hans Verhagen

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Nutrients serve physiological functions in a dose-dependent manner and that needs to be recognized in risk assessment. An example of the consequences of not properly considering this can be seen in a recent assessment by the European Food Safety Authority (EFSA). EFSA concluded in 2022 that the intake of added and free sugars should be “as low as possible in the context of a nutritionally adequate diet”. That conclusion of EFSA is based on the effects on two surrogate endpoints for an adverse effect found in randomized controlled trials with high sugars intake levels: fasting glucose and fasting triglycerides. The lowest intake levels in these trials were around 10 energy% and at this intake level there were no adverse effects on the two outcomes. This indicates that the adverse effects of sugars have an observable threshold value for these two endpoints. The most appropriate interpretation from the vast amount of data is that currently no definitive conclusion can be drawn on the tolerable upper intake level for dietary sugars. Therefore, EFSA's own guidance would lead to the conclusion that the available data do not allow the setting of an upper limit for added sugars and hence, that more robust data are required to identify the threshold value for intake of sugars.

Original languageEnglish
Article number105539
JournalRegulatory Toxicology and Pharmacology
Publication statusPublished - Jan 2024


  • Dose-response
  • EFSA opinion
  • Risk assessment
  • Sugars
  • Threshold
  • Upper limit


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