EU says pesticide giants breached law over withheld brain toxicity studies

Agrochemical giants Bayer and Syngenta are in breach of legal obligations for withholding information on the brain toxicity risk of pesticides, the European Commission said on Tuesday (18 July).

“This is a matter of very serious concern, and we consider a breach of the legal obligations of those companies,” Claire Bury, deputy director-general at the Commission’s DG SANTE said during a meeting with environment lawmakers at the European Parliament.

The comments come on the back of a study published in June in the Environmental Health journal, where researchers found that the companies in question – agrochemical giants Bayer and Syngenta – did not disclose several studies on the brain toxicity of some of their pesticides to competent EU authorities.

Safety assessments of pesticides and other plant protection products (PPP) in the EU rely heavily on studies commissioned by the products’ producers, which are obliged to pass on all results to EU agencies, notably the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA).

But the 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.

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,” Alexandra Brand, Syngenta’s executive director for Europe, Africa and the Middle East, said during the hearing.

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

But the Commission was unequivocal.

“What was done was not correct. It was not in compliance with the obligations,” Bury said, adding that the EU executive thinks “the studies should have been submitted”. 

Meanwhile, EFSA’s Executive Director Bernard Url added that from an “ethical, scientific view” he can not concur with the companies. “It’s not only unethical, it’s also a breach of the regulation,” he said, adding that from his perspective, the behaviour was “not okay”.

Leading MEP wants to quiz pesticide firms on withheld toxicity studies

Head of the European Parliament Committee on Environment, Public Health and Food Safety (ENVI), Pascal Canfin,  wants to hold a hearing with agrochemical giants Bayer and Syngenta after researchers accused them of withholding information on the brain toxicity risk of pesticides. 

What would it have changed?

The Commission’s Bury stressed that the studies in question were not the “decisive element” for the decision on the pesticides’ non-renewal or the imposition of restricted conditions, but not everyone concurred.

For Axel Mie, a researcher at Stockholm University who co-wrote the original study, it is “possible, but not certain” that the disclosure of the studies may have blocked their approval in the EU.

“If that actual reference dose had been decreased at that time by a factor of 30, my best guess is that they would have not been allowed,” he said.

Possible sanctions? 

According to the Commission, it is the responsibility of the EU countries to put forward sanctions and penalties on the applicants in case of a breach of legal obligation such as a non-submission of relevant documents.

However, for the moment, no member state has informed the EU executive of their intentions to do so, although the Commission has “explicitly reminded them of these cases”.

“We have reminded the member states […] of the path that they need to foresee sanctions and penalties for misbehaviour and apply them consistently,” Bury said. 

For his part, EFSA’s Url urged EU countries to consider financial sanctions.

“The ones who do not play by the rules should have a big risk of financial disadvantages,” he said, stressing that the question of penalties “deserves consideration” by the risk managers.

[Edited by Gerardo Fortuna/Zoran Radosavljevic]

Read more with Euractiv

EU-Morocco fisheries deal stuck pending court decision on self-determination claim

A millions-worth fisheries deal between the European Union and the Kingdom of Morocco expired due to a dispute over its legality and the inclusion of Western Sahara's representatives in the negotiations pending a decision from the EU’s highest court.