Underreporting of toxicity data in EU pesticide regulation – occurrence, mechanisms and consequences

This project aims at evaluating and improving the integrity of the EU approval system for pesticides with respect to protection on the developing human brain.Pesticide approval relies strongly on toxicity studies commissioned and funded by the producer.

We have identified nine industry-funded studies of developmental neurotoxicity (DNT) that have been withheld from EU authorities entirely.

We have further identified multiple omissions and misleading analyses and statements in two such studies that, once identified, contributed to a rapid ban of those substances in the EU.In this project, we will systematically and in detail investigate the reporting of results in 40 DNT studies.

We will perform uniform statistical analyses and evaluate the scientific basis for any dismissal of observed effects for risk assessment.

We will develop statistical, graphical, and text screening tools to identify effects that have not been transparently reported. This work is enabled by recent transparency regulations in the EU.

Our detailed analysis will go beyond what is normally done by regulatory authorities.Disturbance of brain developmental processes has high societal costs.

Prevention through identification of DNT hazards will contribute to achieving the EU’s goals of reducing chemical health risks including those from pesticides.