Annex A to TOX/2025/32

Uncertainties

Annex A to TOX/2025/32

Last updated: 28 August 2025

This is a paper for discussion. This does not represent the views of the Committee and should not be cited.

58.           The following uncertainties and limitations in the assessment were identified:

  • The current assessment was based on consumption data from the NDNS for women of maternal/childbearing age (16-49) and therefore may not be representative of maternal diet. In addition, the NHS recommends that those who are pregnant or planning to become pregnant should not drink alcohol. The inclusion of the UB values for  wine, beer, alcopops and cocktails in the assessment may therefore lead to an over estimation of exposure when considering pregnant women.
  • Whilst there was an indication that CIT can cross the placenta (Singh, 2012), there was limited evidence to support this, and hence there remains uncertainty whether CIT can affect the foetus and to what extent.
  • RYR as a food additive and/or as a supplement was not considered in this assessment as consumption data was not available and an exposure assessment could not be carried out. However, the majority of packaging of RYR supplements in the UK state that the product was either not suitable for women who are pregnant or breast feeding, or, it was recommended these groups should consult a general practitioner (GP) prior to consumption. In cultures which use RYR as an additive a higher exposure to citrinin may be possible, which may lead to an underestimation in the exposure assessment for certain population groups.
  • Different ethnic groups and their specific dietary behaviours have not been characterized, hence there could be an over-or underestimation of exposure.
  • Possible additive/synergistic effects with other mycotoxins have not been considered in this assessment. This could lead to an underestimation of the toxicological effects where multiple mycotoxin exposures occur.
  • Due to the limitations in the database a risk of genotoxicity and carcinogenicity cannot be excluded. A well-designed toxicological study would be required to further explore the genotoxic and carcinogenic potential of CIT.
  • The transfer of CIT from feed to animal products was not considered further in this assessment as CIT was not detected in animal products in the TDS. However, data suggested that transfer can occur, and this  could lead to a potential underestimation of exposure, if the occurrence data has changed since the TDS was undertaken.
  • It should be noted that the TDS data used to calculate exposure are from 2014 and changes in the prevalence of citrinin may have occurred since then. Dietary patterns may also have changed, for example the increased consumption of plant-based drinks, and vegan/vegetarian diets, which may not be fully represented in the data.