Retrospective cumulative dietary risk assessment of craniofacial alterations by residues of pesticides

EFSA established cumulative assessment groups and conducted retrospective cumulative risk
assessments for two types of craniofacial alterations (alterations due to abnormal skeletal
development, head soft tissue alterations and brain neural tube defects) for 14 European populations
of women in childbearing age. Cumulative acute exposure calculations were performed by probabilistic
modelling using monitoring data collected by Member States in 2017, 2018 and 2019. A rigorous
uncertainty analysis was performed using expert knowledge elicitation. Considering all sources of
uncertainty, their dependencies and differences between populations, it was concluded with varying
degrees of certainty that the MOET resulting from cumulative exposure is above 100 for the two types
of craniofacial alterations. The threshold for regulatory consideration established by risk managers is
therefore not exceeded. Considering the severity of the effects under consideration, it was also
assessed whether the MOET is above 500. This was the case with varying levels of certainty for the
head soft tissue alterations and brain neural tube defects. However, for the alterations due to
abnormal skeletal development, it was found about as likely as not that the MOET is above 500 in
most populations. For two populations, it was even found more likely that the MOET is below 500.
These results were discussed in the light of the conservatism of the methodological approach.

The indicators of craniofacial alterations, input and output data for the exposure assessment are reported in the following annexes:

• Annex A – Indicators of craniofacial alterations collected for 85 selected active substances;
• Annex B1 – Input data for the exposure assessment of CAG-DACL;
• Annex B2 – Input data for the exposure assessment of CAG-DAH;
• Annex C1 – Output data for the Tier I exposure assessment of CAG-DAC;
• Annex C2 – Output data for the Tier I exposure assessment of CAG-DAH;
• Annex D1 – Output data for the Tier II exposure assessment of CAG-DAC;
• Annex D2 – Output data for the Tier II exposure assessment of CAG-DAH.