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Agrochemical companies have withheld important studies when approving their products. This is shown by a study by Stockholm University, which BR present. The studies examine potential health risks for fetuses and children.
“I shook my head when I saw the first study,” recalls Swedish chemist Axel Mie. Then he searched further, found the second and finally the third. We are talking about studies on the extent to which pesticide active ingredients can damage brain development. When Axel Mie had the first indications that chemical companies had not submitted these studies to the European authorities, it was clear to the scientist: “We have to investigate this systematically.”
Relevant studies systematically withheld?
Together with the toxicologist Christina Rudén from Stockholm University, the chemist combed through the databases of the American Environmental Protection Agency. They compiled lists of studies on developmental neurotoxicity that manufacturers had submitted as part of the approval process there. Then the two checked whether these studies were also submitted to the approval authorities in the European Union.
“We found a total of 35 such studies in the USA,” says Mie, “nine of them, about a quarter, were missing in the EU.” In view of the highly formalized approval process, Mie thinks it is unlikely that they simply “fell behind the desk”.
consequences on developmental disabilities proven
Studies on developmental neurotoxicity should be taken seriously, and there is scientific consensus on this. The developing brain is very sensitive to pesticides, says French neurology professor Yehezkel Ben-Ari. “We know that when the mother is exposed to drugs, it affects the unborn child.” The developmental disorders have not only been proven in laboratory animals, but also in humans in numerous studies. Autism could be a result.
Agrochemical giant Syngenta did not submit studies
Syngenta is one of the companies that has withheld studies – for example in the case of the active ingredient abamectin, which primarily controls pests on fruit and vegetables. The active ingredient was approved throughout Europe in 2009. For this, Syngenta had to submit a comprehensive dossier with studies to the authorities to prove that the substance is harmless.
However, Syngenta had not even submitted two studies on developmental neurotoxicity from 2005 and 2007, as the company did BR concedes to. According to the written statement, these studies were not “proactively” submitted to the European authorities as part of the approval process. They were carried out as part of the approval process in the USA and were not requested in the European process at the time. Syngenta classified the studies in such a way that they did not result in any new findings regarding the toxicity of the active substance.
“Acute risk” for humans not excluded
When the European Food Safety Authority EFSA found out about the two studies about ten years later, they classified them differently. The health experts lowered the reference values due to the findings on the neurotoxic effects of abamectin – for example, the permitted residue levels of the substance on cucumbers, tomatoes or zucchini were lowered.
In its risk report from 2021, the authorities concluded that an “acute risk” for humans could not be ruled out for twelve types of fruit and vegetables that were allowed to be treated with abamectin. The substance should no longer be used for pest control on apples and pears.
EUcommission staff sees a “serious problem”
“Had Syngenta duly submitted these studies to the authorities in 2005 and 2007, the applications in different cultures would probably have been banned or restricted at that time,” believes the Swedish scientist.
Studies on developmental neurotoxicity are not generally required in the EU approval process. In the case of the active substance abamectin, however, Syngenta carried out the studies. And according to the Swedish researchers, these should then have been submitted to the European authorities, as the results indicated possible harmful effects. The European Food Safety Authority EFSA confirms at the request of BRthat the studies were not available.
Have the corporations violated EU law? The EU Commission does not comment on the Abamectin case, but writes in general that manufacturers are obliged “to submit all information about potentially harmful effects of the active substance.” An email from Commission circles shows that there was alarm in September last year when Information about the missing studies was received.
If manufacturers don’t submit studies with “unfavorable results,” it poses “a serious problem,” said a representative of the Food Safety Commission in an email BR present.
Syngenta not an isolated case
In addition to Syngenta, the German chemical company Bayer has not submitted studies on developmental neurotoxicity to the European authorities. Bayer writes down BR-Request that the studies required by the regulations at the time had been submitted. The risk assessment was carried out reliably. In the case of an active substance, for example, the submission was not required by law at the time. In the end, the substance “was no longer approved for other reasons”.
How the regulatory authorities found out about the studies afterwards differs from case to case: sometimes they researched them themselves, sometimes the Swedish scientists drew their attention to them. In three of the nine cases examined, studies that were not submitted subsequently led to a reassessment of the substances, as the study by Stockholm University shows. In four other cases, the authorities are still examining a possible reassessment.
A incomplete Picture
“The study by Stockholm University reveals a security gap,” says Innsbruck toxicologist Martin Paparella. “It cannot be that the industry carries out studies that they then do not submit.” This creates an incomplete picture, says the scientist from the Medical University of Innsbruck. For many years he was jointly responsible for the approval process for chemicals in an Austrian authority.
The outcome of an approval procedure for pesticides in the EU depends heavily on the studies by agrochemical companies. The industry must prove that the respective agent is compatible with humans, animals and the environment. “If the industry withholds this evidence,” says toxicology professor Christina Rudén from the University of Stockholm, “then to me it means that they are not living up to their responsibilities.” Then authorities would not be able to judge whether the products are safe or not, according to Rudén, and consumers could be endangered.
#PesticideSecrets is a research cooperation – involved: BR Recherche, “Der Spiegel”, SRF Investigativ, “Le Monde” and “The Guardian”.