Revealed: EU Glyphosate assessment was based on flawed science
A new scientific analysis (1) concludes that the European Food Safety Authority's (EFSA) claim that glyphosate is not genotoxic cannot be justified on the basis of manufacturers’ studies. Of the 53 industry-funded studies used for the EU’s current authorization of glyphosate, 34 were identified as "not reliable", 17 as "partly reliable" and only 2 studies as "reliable" from a methodological point of view.
Several civil society organizations from the successful European Citizen Initiative (ECI) "Stop Glyphosate" (2) are calling on the European Food Safety Authority (EFSA) to take into account these new findings in the new authorization procedure of glyphosate, which are very worrying from an environmental and health point of view (3).
Genotoxicity studies indicate the risk of cancer and reproductive damage posed by a chemical. Public authorities that were involved in the previous European authorization procedure – namely the German Health Authority BfR and EFSA – wrongfully accepted these industry studies as key evidence of the absence of glyphosate genotoxicity. EFSA used this flawed science as a basis to contradict the International Agency for Research on Cancer (IARC)'s 2015 conclusion that glyphosate does in fact "probably cause cancer".
The current approval of glyphosate on the EU market is expiring on 15 December 2022. A first screening of industry's 2020 new glyphosate application dossier shows that 38 of the 53 genotoxicity studies (on both pure glyphosate and glyphosate-based products) used in the previous assessment have been submitted once more to the EU authorities by Bayer Agriculture BV, on behalf of the Glyphosate Renewal Group. .
Angeliki Lyssimachou, Environmental Scientist at the Health and Environment Alliance (HEAL) said: "This new scientific analysis shows yet again that the European Union's claim to having the most rigorous pesticide authorization procedure in the world has to be taken with a heavy grain of salt. The authorization procedure in place is evidently not rigorous enough to detect errors in the execution of the regulatory studies that are blindly considered the gold standard. Yet these were at the heart of the 2017 EU-market approval of glyphosate, and they have now been submitted again in an effort to water down scientific evidence that glyphosate may cause cancer and is a danger to human health."
Helmut Burtscher, Biochemist at GLOBAL 2000 said: "If you subtract from the 53 genotoxicity studies, those studies that are not reliable and those studies that are of minor importance for the assessment of genotoxicity in humans, then nothing remains. Nothing, except the question on what basis the EU authorities have claimed that glyphosate is 'not genotoxic'. Did they have a crystal ball?"
Peter Clausing, Toxicologist at Pesticide Action Network Germany (PAN Germany) said: "A rigorous authorization procedure is a necessary, but not a sufficient condition to protect the health of the people and the environment. In 2017 the authorities of the European Union violated their own rules to ensure an outcome that pleased the chemical industry. Not much is achieved, if rules and recommendations are on paper, but not applied."
Nina Holland, Researcher at Corporate Europe Observatory said: "The last re-approval process of glyphosate caused huge controversies, as Monsanto was shown to be undermining the science regarding the harmful effects of glyphosate. This new scientific review puts once more a finger on a sore spot: that national regulators and EU authorities alike do not seem to pay close scrutiny when looking at the quality of industry's own studies. This is shocking as it is their job to protect people's health and the environment, not serve the interests of the pesticide industry."
Eoin Dubsky, Campaigner at SumOfUs said: "People are sick of glyphosate, and we're sick of being lied to. That's why SumOfUs members funded this important analysis, and why we'll keep campaigning until this herbicide is banned. How could EFSA give glyphosate a thumbs-up based on such shoddy scientific studies, when IARC warned that it's genotoxic, and probably cancer-causing too?"
You can find the scientific study here
You can find a Q&A on the study here
You can find a short backgrounder on what happened so far in the glyphosate dossier here
Notes to the editor
1. The scientific analysis was conducted by Armen Nersesyan and Prof. Siegfried Knasmueller, two renowned experts on genotoxicity testing, from the Institute of Cancer Research at the Department of Medicine I, Medical University of Vienna. No less than 34 out of 53 industry-funded genotoxicity studies used for the EU's current authorization of glyphosate were identified by the scientists as "not reliable", because of substantial deviations from OECD Test Guidelines, which can be expected to impair the sensitivity and accuracy of the test system. As for the rest of the 53 studies, 17 were "partly reliable" and only 2 studies "reliable".
● 3. The European Commission and member states are gearing up to review the current authorisation of glyphosate, which expires on 15 December 2022. The industry has started the process to renew it. The assessment of the application for EU renewal of glyphosate was performed by the AGG, consisting of the authorities for the assessment of active ingredients of France, Hungary, the Netherlands and Sweden (the last assessment procedure was handled by Germany alone). The assessment was sent to EFSA on 15 June and was based on a dossier submitted last summer by the applicants, the Glyphosate Renewal Group (GRG). See: pesticides_aas_agg_report_202106.pdf (europa.eu)
● Glyphosate is the most widely-used pesticide in the world. Exposure to glyphosate-based herbicides has been linked to certain types of cancer, as well as to adverse effects on the development and hormonal system.
● In 2015, the International Agency for Research on Cancer (IARC) concluded that glyphosate "probably causes cancer". Yet in 2017, glyphosate was reauthorised on the European market until December 2022 by representatives of European governments. This decision was criticised heavily by civil society groups and scientists alike for lacking transparency and scientific objectivity, being predominantly based on industry-sponsored studies and overlooking findings from academic independent literature.
● Back in 2015-2017 civil society and members of the European Parliament managed to reduce the glyphosate authorization in the European Union from 15 years to 5 years. More importantly, the campaign raised awareness on the toxicity of glyphosate-based products, the major problems underlying the pesticide authorization system and how there are alternatives to glyphosate in agriculture.
●In March 2019 four Green Members of the European Parliament got a positive ruling from the ECJ stating EFSA should publish all (secret) studies around the cancer risks of glyphosate. NGO SumOfUs requested 54 genotoxicity studies from EFSA and started a crowd funding action to be able to pay independent scientists to screen these studies.