Uncertainties

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

• The current assessment is based on consumption data from the National Diet and Nutrition Survey for women of maternal/childbearing age (16-49) and therefore may not be representative of maternal diet. In addition, the inclusion of the upper bound values for wine, beer, alcopops and cocktails in the assessment may lead to an overestimation of exposure when considering pregnant women because the NHS recommends that those who are pregnant or planning to become pregnant should not drink alcohol.
• Whilst there are suggestions that citrinin can cross the placenta (Singh, 2012), there is limited evidence to support this, and hence there remains uncertainty whether, and to what extent, citrinin can affect the foetus.
• RYR as a food additive and/or as a supplement was not considered in this assessment because 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. Higher exposure to citrinin may occur in communities which use RYR as an additive. This may lead to underestimation of exposure 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 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 citrinin.
•  The transfer of citrinin from feed to animal products was not considered further in this assessment because citrinin was not detected in animal products in the TDS. This could lead to an underestimation of exposure, should newer TDS data report transfer of citrinin into animal products.
• It should be noted that the TDS data used to calculate exposure were from 2014. Changes in population exposure to citrinin may have occurred since then. Dietary patterns may also have changed; for example, widespread adoption of vegan/vegetarian diets and increased consumption of plant-based drinks may not be fully represented in the data.