Scientists show how two EU regulatory agencies failed to fulfil their role as foreseen in EU pesticide law. A new scientific study reveals that ECHA dismissed important carcinogenicity findings and neglected evidence that glyphosate induces oxidative stress, a recognised mechanism that can lead to cancer. EFSA in its conclusion wrongfully relied on ECHA's classification of glyphosate as 'noncarcinogenic'. This is a critical failure, since accepting this scientific evidence would inevitably lead to the conclusion that the glyphosate authorisation cannot be prolonged under EU law.
The new scientific study (1), shows the deep flaws in the EU health assessment on glyphosate, highlighting that ECHA did not appropriately assess glyphosate’s carcinogenicity and underestimated its potential to cause cancer. Not only did it disregard the observed tumour incidences in cancer studies as irrelevant but it also dismissed evidence from independent literature that glyphosate causes oxidative stress, a recognised mechanism that can lead to cancer. When the evidence from cancer studies and oxidative stress is combined, the cancer potential of glyphosate cannot be denied. EFSA in its conclusion wrongfully relied on ECHA's classification of glyphosate as 'noncarcinogenic'.
The scientists show how the two EU regulatory agencies failed to fulfil their role as foreseen in EU pesticide law (EC Regulation 1107/2009), aiming to ensure a higher level of human health and environmental protection. This raises serious concerns, especially as the Commission is about to present its proposal Regulation for the renewal of glyphosate’s approval to member state representatives during the upcoming SCoPAFF ad-hoc meeting later this week.
Poll in six EU countries: citizens do not support glyphosate renewal
The study comes out together with the results of a poll across 6 EU countries (Denmark, France, Germany, Poland, Romania and Spain), where only a mere 14% is in favour of prolonged use of glyphosate. Two thirds (62%) of EU citizens in these countries responded that the use of glyphosate should be banned in Europe. Among the 6 countries, France had the highest percentage of citizens (70.5%) in favour of a ban. (2)
Open letter to EU Health Commissioner Kyriakides
In an open letter to Health Commissioner Kyriakides (3), sent on the 7th September, members of the European coalition Stop Glyphosate informed the Commission of the new study and highlighted that solely based on the cancer evidence glyphosate, the world’s most used herbicide, does not fulfil the criteria to be approved.
On top of the evidence that glyphosate can cause oxidative stress, NGOs highlighted the following shortcomings in ECHA’s and EFSA’s assessment on carcinogenicity leading to its misclassification as a non-carcinogen:
- There were statistically significant tumour incidences observed in animal cancer studies provided by the applicants (for the glyphosate EU re-authorization)
- Two genotoxicity OECD protocol studies are absent from the applicants’ dossier;
- EFSA is being deceitful by claiming a non existing “limit dose” in carcinogenicity assessment
- Malignant lymphomas in animal studies complement the evidence on non-Hodgkin's lymphoma in epidemiology studies.
On behalf of the StopGlyphosate Coalition (4), PAN Europe urges Kyriakides to stop the fast-track reapproval of glyphosate, based on the above quoted evidence and to apply the precautionary principle, which is at the heart of EU pesticide law.
Angeliki Lysimachou, Head of Science and Policy at PAN Europe, said: “ECHA and EFSA’s disregard of the evidence of glyphosate's cancer-causing potential, is a direct violation of EU law that clearly demands harmful pesticides to be banned. The carcinogenicity potential of glyphosate is only the tip of the iceberg when it comes to its wide range of impacts on human health and biodiversity. By proposing to renew its market licence, the European Commission and Member States prioritise agribusiness over the citizens’ health, environment, and independent science.”
Peter Clausing, toxicologist and co-author of the study said: “In our study we show that oxidative stress was not adequately taken into account during the assessment prior to ECHA’s RAC Opinion. This leads to very serious deficiencies with regard to the evaluation of the potential hazards of glyphosate and their underlying mechanisms. Because oxidative stress is not covered by OECD test guidelines, it is crucial to properly integrate the results of studies on oxidative stress published in the peer-reviewed scientific literature into the hazard assessment. ECHA failed to do so in its Opinion on glyphosate released in May 2022 and EFSA failed to correct this deficiency.”
João Camargo, researcher at Corporate Europe Observatory said: “The haste of the European Commission to grant the agrochemical industry several more years of glyphosate-cash making is really remarkable. This example shows once more that the EU system to allow toxic pesticides on the market serves the pesticide industry's interests only too well."
For more information or interview requests, please contact: Tjerk Dalhuisen (PAN Europe), tjerk [at] pan-europe.info +31 614699126
Notes to the Editor:
[i]1 Clausing et al, 2023: Glyphosate and Oxidative Stress: ECHA's superficial approach neglects existing hazards & Summary of the study
[iv]4 Stop Glyphosate website