The fungicide fluazinam can harm brain development, but this evidence was effectively hidden from regulators for more than a decade- new research from scientists at Stockholm University has revealed.
It is not the first case of regulatory fraud involving pesticides. It should lead to immediate withdrawal of fluazinam pesticide products from the market, legal sanctions for those responsible, and a comprehensive review of how regulatory studies are conducted, reported and assessed.
A developmental neurotoxicity study conducted in 2003–2004 by the industry-contracted laboratory Huntingdon Life Sciences found major adverse effects on brain development in offspring exposed to the pesticide before birth. Yet the study was never submitted by the manufacturer (ISK Biosciences Europe), who had commissioned it, during fluazinam's 2009 EU renewal process. As a result, fluazinam remains approved and in use across Europe today.
When the study was re-examined, researchers identified multiple instances of false reporting and incorrect statistics that masked harmful effects on brain development. The scientists had already notified the authorities about the study, who in turn requested it from the industry and reviewed it. However, the authorities failed to apply more appropriate analyses and even accepted a threshold that is not sufficiently protective, allowing brain effects in up to 10% of the population to be considered acceptable.
This is more than a regulatory failure: it is a breach of the core requirements of EU pesticide law, which aims to ensure a high level of protection for human health against pesticides used in intensive agriculture, and ultimately to promote safer food production methods.
The implications go far beyond a single pesticide regulatory fraud. It is not the first time such a fraud has come to light: a similar case was published in 2018 [1], and regulators have not taken any measures against the accountable industry, nor to strengthen the system.
This case raises -once again- fundamental questions about a regulatory system that relies heavily on industry-funded studies and their own conclusions. Meanwhile, regulatory authorities lack the resources and capacity to independently scrutinise the underlying data in depth. If a developmental neurotoxicity study could remain hidden for years and critical findings could be overlooked, how many other false reportings have been undetected?
Better pesticide reviews instead of weakening the regulations
At a time when the EU is considering reforms through the Food and Feed Safety Omnibus proposal that could further reduce regulatory scrutiny, this case points in the opposite direction. We need stronger oversight, greater transparency, independent scientific review, and better-resourced authorities.
Angeliki Lysimachou, Head of Science and Policy at PAN Europe, stated: "When credible evidence points to risks for children's neurological development, public health must come before commercial interests."
The findings deserve urgent investigation of all pesticides marketed by ISK and all regulatory studies carried out for EU pesticides by contract laboratory Huntingdon Life Sciences, full accountability, and a broader discussion about how Europe evaluates chemical safety.
"The EU pesticide regulation foresees that when industry does not respect the law regarding a pesticide, Member States are obliged to suspend the pesticide's national authorisations. This must be the case when important information is withheld. We thus expect Member States to react and take their responsibilities," added Martin Dermine, Executive Director at PAN Europe.
Fluazinam is also a PFAS pesticide and emitter of trifluoroacetic acid (TFA)- a common breakdown product of PFAS pesticides, which is widely detected in drinking water, groundwater and plant-based food. TFA will soon be classified as ‘toxic to reproduction’ category 1B [2], which means all PFAS pesticides must be banned. Another reason for fluazinam to be taken immediately off the market.
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Notes:
[2] ECHA classifies TFA as highly hazardous to early-life development
