Table 19.
Summary of qualitative evaluation of the impact of uncertainties on the risk assessment of opium alkaloids in poppy seeds
| Sources of uncertainty | Directiona |
|---|---|
| Extrapolation of occurrence data to the whole of Europe | +/− |
| Effect of food processing not taken into account in the exposure assessment | + |
| Overestimation of P95 dietary exposure for the ‘low‐morphine’ scenario due to the presence of poppy seed samples from varieties grown for pharmaceutical use | + |
| Underestimation of dietary exposure for the ‘high‐morphine’ scenario due to the possible presence of poppy seed samples from varieties grown for use as food | − |
| Imputation of codeine content in a number of samples for the calculation of morphine equivalents | +/− |
| Use of mean disaggregation factors to convert eating occasions of poppy seed‐containing foods into amounts of consumed poppy seeds | +/− |
| Consumption of foods containing small amounts of poppy seeds not always captured in dietary surveys (e.g. bread roll) | +/− |
| Dietary surveys not capturing possible high consumption of poppy seeds during festivities (e.g. Easter) | − |
| Uncertainty in the LOAEL for establishing the ARfD | − |
| Possible interactions of morphine and codeine with other opium alkaloids contaminating poppy seeds | +/− |
| Additive adverse effects of morphine and codeine with concomitant intake of alcohol, or central depressant drugs are not taken into account | − |
| Intrinsic toxicity of thebaine could not be taken into account in the risk assessment | − |
LOAEL: lowest‐observed‐adverse‐effect level.
a
+ = uncertainty with potential to cause over‐estimation of exposure/risk; − = uncertainty with potential to cause under‐estimation of exposure/risk.