Pesticides, ineffective testing and side effects hidden from the EU

Research published in the journal Environmental health: data on the toxicity of some molecules transmitted to US regulatory authorities only

Several agrochemical companies have hidden from the European regulatory authorities the inappropriate results of toxicological tests of some drug molecules that can cause neurodevelopmental problems in people. Although the same studies were submitted years earlier to the regulatory authorities of the United States that did not raise any objections. When Community authorities were notified of inappropriate studies, between 14 and 21 years after implementation, new security restrictions were put in place in some cases and in other cases the evaluation is still ongoing.

This is the evidence of a study published by the journal Environmental healththe results of research conducted by chemist Axel Mie (Stockholm University, Karolinska Institute) and toxicologist Christina Rudén (Stockholm University), and relaunched by a pool of journalists formed by German-Swiss public radio and television. SRF extension in conjunction with Bayerischer Rundfunk, spiegel (all in Germany), Guardian (UK) and Le Monde (France).

The harmful effects of pesticides would concern neurodevelopmental problems in people, so they have direct effects on the brain, such as “autism, attention deficit and other mental disabilities”, which are reported to be increasing in many countries.

The two researchers did a very careful job of comparing “the data sent by the producers to the American authorities on the one hand, and the European authorities on the other”, and thus they were able to “identify nine pesticides that different producers submitted tests carried out in the laboratory. animals on the growth of neurotoxins (Dnt) – joint pesticide studies – to the US Environmental Protection Agency (EPA), but not to the European Food Safety Authority (EFSA).” Among the undisclosed findings of the study were changes in brain size, delayed sexual maturation and weight loss in the offspring of lab rats exposed to the drug during pregnancy.

These tests, carried out between 2001 and 2007, “were not considered by the European Authority during the first approval of nine substances (abamectin, etoprofos, buprofezin, fenamidone, fenamiphos, fluazinam, glyphosate-trimesio, pymetrozine, pyrigranted inchini), at the end of the years of 2000.” Read on Le Monde the opinion of neurobiologist Yehezkel Ben-Ari, of the National Institute of Health and Medical Research (Inserm): the work of the two researchers “must be taken more seriously as the effects of pesticides on neurodevelopmental disorders have been demonstrated beyond doubt, not only in laboratory animals, but also in humans”.

The Swiss broadcaster noted that one of the drugs is “Vertimec Gold”, a pesticide used on plants and containing the pesticide abamectin. In the spring of this year, the EU renewed the approval of abamectin, but further restricted its use, based on Syngenta’s studies from 2005 and 2007 – which have recently emerged – which showed adverse effects of the chemical on mice.

According to a group of Swedish journalists and researchers, EU law has mandated the reporting of all adverse data found on products since the early 1990s. Internal EU documents seen by journalists show that Brussels officials have ” great concern” about the lack of lessons.

Syngenta said a SRF extension that he has not violated any obligation and that the relevant studies were carried out to meet the requests of the US regulatory authorities, before being requested later by the European authorities. The company added that the studies did not lead to any negative results. Among the pesticide producers involved are Germany’s Bayer and Japan’s IKS and Nissan Chemical Corporation.

“We reviewed 35 neurotoxicity tests submitted by companies to the EPA. Of these tests, nine were not sent to the same European standards”, explained Rudén, who according to him is not known why the American authorities are yes and the European ones are not. However “if it is confirmed at the European level that what is being tested promotes a neurological problem, it can be banned immediately on the European market. So it is easy to imagine the financial risk that these types of companies run if they present the tests to the relevant authorities”.

Of the nine accused molecules, three were released as soon as the tests were sent, but after years, because these cases started in the early 2000s. An example is the insecticide Etoprofo. “The Americans – reported Rudén – have tests in hand that show the effects of abnormal behavior at every level of measurement. Bayer claims that this is not the case, and passes its conclusions to the Europeans without indicating the opinion of the United States. We had to wait until 2017 to see the product blocked by The EU, at the suggestion of two Swedish researchers “, reads the press survey.

For Sarah Wiener, Austrian MEP of the Greens and author of the European Parliament for new proposals for the regulation of European Union pesticides, “the analysis shows that the pesticide industry is lying to the EU authorities. The health of European citizens is endangered when the relevant studies are rejected. So the EU must ensure that there are negative consequences for withholding data. This could mean that companies will have to pay huge fines.”

Strict EU rules on the notification of safety studies came into force from March 2021, meaning that companies now have to notify the authorities of all approved studies and cannot refuse to submit them even if they are deemed to have no negative results. The power to fine companies if they fail to disclose illegal European toxicity studies rests with national regulators. But so far, no known fine has been levied against the pesticide company. Currently, pesticide safety studies are commissioned and paid for by companies. Mie and Rudén suggested that such studies should be carried out by regulators, to avoid conflicts of interest, while costs are recovered from companies.

Chemical companies, notably Bayer and Syngenta, are on the defensive. They say, among other things, that European legislation, at the time of the material, did not impose studies on neurotoxicity. And so that they were not legally obliged to submit studies.

A spokesman for Syngenta, which commissioned two DNT studies on abamectin in 2005 and 2007, as well as studies on two other pesticides, said “Syngenta complied with all EU data requests and provided relevant research data in accordance with regulatory requirements”. And he added that the studies on abamectin were not submitted to the EU authorities in the authorization application, which was successfully completed in 2008, because the studies were carried out for its regulatory application in the United States and at that time it was not a requirement in the EU.

However, an EFSA spokesperson said “DNT studies have been used to find safe health levels for consumers and operator exposure”.

A Bayer spokesman said that “we always submitted the studies required by the regulations at the time. For all three ingredients mentioned in the new study, the studies would not change the authorities’ risk assessment.”

For its part, Nissan Chemical Corporation said it submitted a Dnt study for its drug pyridaben, completed in 2007, to EU regulators in February 2023. Japan’s ISK said it submitted a 2005 Dnt study on its drug fluazinam to EU authorities in 2020 but that he was not supposed to do that earlier. EFSA said that the study is now being evaluated as part of its assessment of whether to renew the drug’s approval.

Mie and Rudén’s proposed amendments to ensure all toxicology studies submitted to EU regulators include cross-checking data sets with counterparts in other countries, such as the US EPA. “Laws should also be reviewed to ensure that non-disclosure of toxicology studies poses significant legal risk to pesticide companies,” they said.