The failure of agrochemical giants Bayer and Syngenta to disclose studies on the brain toxicity of their products  is “unethical” and requires financial penalties, according to European officials.

European regulators insist Bayer and Syngenta are in breach of legal obligations by withholding information on the brain toxicity risk of pesticides. MEPs questioned executives from the companies and said their actions had been “outrageous” and represented a “scandal”.

The European Food Safety Authority (EFSA’s) Executive Director Bernard Url said: “It’s not only unethical, it is also a breach of the regulation. The ones who do not play by the rules should have a big risk of financial disadvantages.”

In the European Union (EU), the safety assessment of plant protection products relies to a large extent on toxicity studies commissioned by the companies producing them. By law, all performed studies must be included in the dossier submitted to authorities when applying for approval or renewal of the active substance.

The products’ producers are obliged to pass on all results to EU agencies, notably the EFSA and the European Chemicals Agency (ECHA).

However, a study in the Environmental Health journal, found Bayer and Syngenta did not disclose several studies on the brain toxicity of some of their pesticides to competent EU authorities. The study stated: “Withholding data can distort the knowledge base, leading to biased assessments, wrong decisions and in the worst case, insufficient risk management.”

Researchers found that out of 35 studies the companies had submitted to US authorities, nine were not disclosed to the EU, even though most of them would have had “an actual or potential regulatory impact,” the study found.

Claire Bury, deputy director-general at the European Commission’s DG SANTE said :“This is a matter of very serious concern, and we consider a breach of the legal obligations of those companies. What was done was not correct. It was not in compliance with the obligations.”

However, the two companies maintain they have fulfilled all of the requirements asked of them. “We did not submit them at that time to EU regulators because they were not mandatory [and] we determined they did not provide any new information,” said Alexandra Brand, Syngenta’s executive director for Europe, Africa and the Middle East.

She added the European crop protection regulation at the time encouraged the applicants “to only submit necessary data”.

While it is the responsibility of the EU countries to put forward sanctions and penalties in a case of a breach of legal obligation such as a non-submission of relevant documents, no member state has informed the EU executive of their intentions to do so. “We have reminded the member states of the path that they need to foresee sanctions and penalties for misbehaviour and apply them consistently:” added Bury.

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