One in four industry-funded studies examining the potential harm from pesticides on the developing brain were not shared with EU authorities by the manufacturers. This finding raises concern about the reliability of EU safety evaluations of pesticides and undermines trust in the system designed to protect European consumers.
Several cases with potential consequences for regulatory action
In seven of the nine cases, the DNT studies, when made available to the regulatory authority, have already had or may potentially have future regulatory consequences such as lowering of the toxicological reference values, changes in hazard classification, or even contribute to decisions to remove products from the market.
“We do not know how the producers have reasoned in these cases, but we do know that if a pesticide is known to damage brain development, it may not be allowed on the EU market,” says Axel Mie.
In the European Union, pesticide producers are responsible for performing tests that enables a safety assessment of their products. The law requires that test results be submitted to EU authorities when seeking market approval.
Non-disclosure of studies is a recurring phenomenon
The new study highlights significant issues. Firstly, non-disclosure of studies seems to be a recurring phenomenon despite clear legal requirements to submit all relevant information. Secondly, the non-disclosure could introduce a bias into regulatory risk assessments, that in the worst case can lead to unsafe products being allowed on the market, thereby putting human health at an unacceptable risk.
“When we, as consumers and EU citizens, decide to allow products on our market, that decision is based on the condition that the producers follow the law, and not intentionally jeopardize our safety,” says Christina Rudén.
Need to revise the regulatory system
To improve this situation, the regulatory system needs to be revised so that all previously performed studies are made available to the authorities. Future studies should be commissioned by regulatory bodies rather than companies. This would ensure that authorities have complete knowledge of all performed studies and prevent the influence of economic interests on the process. Additionally, the law should be revised to impose significant legal consequences on pesticide companies for non-disclosure of toxicity studies.
“In situations where companies decide themselves which studies they submit to authorities and which ones they withhold, the authorities’ conclusions are not reliable,” concludes Axel Mie.