Companies withhold DNT-studies from EU authorities

Companies withhold DNT studies from EU authorities

One in four industry-funded study examining developmental neurotoxicity of pesticides were not shared with EU authorities by the producing companies, in spite of clear legal obligations, according to a recent PARC publication. The authors conclude that full access of regulatory agencies to industry-funded toxicity studies is a prerequisite for a reliable safety assessment. 

"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, researcher at the Department of Environmental Science at Stockholm University and co-author of the study.  

9 out of 35 reports missing 

In the European Union, pesticide producers are responsible for the safety of their products, which includes performing tests on their products’ toxicity. The law requires that such test results be submitted to EU authorities when seeking market approval.  

Some pesticide compounds are evaluated for their potential to interfere with normal brain development, with a so-called developmental neurotoxicity (DNT) study. The researchers found that 9 out of 35 such DNT study reports were missing in the companies’ documentation that was submitted to authorities within the EU. 

Suggestion for a way forward 

Accordingly, the researchers concluded that the non-disclosure of DNT studies to EU authorities seems to be a recurring phenomenon although clear legal requirements exist. Also, the non-disclosure may introduce a bias in the agencies’ assessment. Furthermore, the safety evaluation of pesticides by EU authorities cannot be reliable without full access to all performed toxicity studies.  

We suggest that applications for pesticide approval should be cross-checked against lists of studies performed at test facilities operating under Good Laboratory Practice (GLP), to ensure that all studies have been submitted to authorities. Furthermore, non-disclosure of toxicity studies should carry a significant legal risk for pesticide companies,” says Christina Rudén, professor in regulatory toxicology at the Department of Environmental Science at Stockholm University and co-author of the study.