The Draft is available for comments. The previous risk assessment was published in 2006. A series of studies on biomarkers of exposure of humans to OTA published since then have been evaluated. The new information suggested that OTA may be genotoxic and carcinogenic. In such cases, EFSA experts calculate a margin of exposure (MOE) for consumers. In general, the higher the MOE, the lower the level of concern for consumers. The estimated MOE for OTA is below 10,000 across most consumer groups, suggesting a possible health concern.
The dietary OTA exposure assessment included a total of 72,350 data. About 44% of the data came from Germany and the Netherlands. The proportion of left-censored data (results below the limit of detection/quantification (LOD/LOQ)) was 75.5%. The highest mean concentrations of OTA were recorded in the categories ‘Plant extract formula’, ‘Flavorings or essences’ (both containing liquorice extracts) and ‘Chili pepper’. The most important contributors to the chronic dietary exposure to OTA were ‘Preserved meat’, ‘Cheese’ and ‘Grains and grain-based products’. Dried and fresh fruit such as grapes, figs, and dates were particularly important contributors in some of the ‘Toddlers’ and ‘Other children’ groups.
EFSA recognizes that the overall uncertainty associated is high and the assessment is more likely to overestimate than to underestimate the risk. In addition, EFSA highlights the necessity of more scientific data on toxicity as well as more data on occurrence.
The deadline for comments is January 24, 2019.
More information
The dietary OTA exposure assessment included a total of 72,350 data. About 44% of the data came from Germany and the Netherlands. The proportion of left-censored data (results below the limit of detection/quantification (LOD/LOQ)) was 75.5%. The highest mean concentrations of OTA were recorded in the categories ‘Plant extract formula’, ‘Flavorings or essences’ (both containing liquorice extracts) and ‘Chili pepper’. The most important contributors to the chronic dietary exposure to OTA were ‘Preserved meat’, ‘Cheese’ and ‘Grains and grain-based products’. Dried and fresh fruit such as grapes, figs, and dates were particularly important contributors in some of the ‘Toddlers’ and ‘Other children’ groups.
EFSA recognizes that the overall uncertainty associated is high and the assessment is more likely to overestimate than to underestimate the risk. In addition, EFSA highlights the necessity of more scientific data on toxicity as well as more data on occurrence.
The deadline for comments is January 24, 2019.
More information