Only two out of 38 glyphosate genotoxicity studies submitted by industry were found reliable

Forty-one civil society organisations, including GMWatch and several of the organisers of the successful European Citizens’ Initiative #StopGlyphosate, are urging EU Health Commissioner Stella Kyriakides to guarantee that the ongoing assessment of glyphosate is based on updated independent scientific evidence and remains free from vested interests.[1][2]

In an open letter published today, the groups express their concerns about the current renewal assessment procedure of glyphosate following the preliminary conclusions by four EU member states that the substance has no harmful effects on human and animal health, or any unacceptable effects on the environment.[3]

The organisations express specific concerns about the credibility of the studies that have been provided by industry applicants to support the renewal of the European authorization of the pesticide, the current approval of which expires on 15 December 2022.

A recent independent scientific analysis showed that only two out of the 38 glyphosate genotoxicity studies (the mechanism that underlines cancer development) that were submitted by the industry for the assessment of the active substance can be considered reliable from a methodological point of view.[4] This could also be true for other industry studies that have not yet been independently reviewed.  

“Independent scientific evidence has associated exposure to glyphosate and glyphosate-based products with certain types of cancer in humans, adverse effects on early life development and hormone disruption," said Genon K. Jensen, Executive Director at the Health and Environment Alliance (HEAL). “By giving priority to industry studies, the EU Commission fails to fulfil its commitment for an objective and transparent assessment and ultimately to ensure that pesticides that cause harm to human health or the environment are removed from the EU market.”

The 41 organisations ask the EU Commission to guarantee that the current assessment procedure is based on updated independent scientific evidence, and takes into consideration the toxicity of the active substance glyphosate as well as of glyphosate-based products. In this respect they are bringing attention to the Ramazzini Institute’s Global Glyphosate Study, which is the most comprehensive toxicity study ever done on a pesticide substance by an independent and non-profit institution.[5]

The provisions of the recently introduced Transparency Regulation grants the EU Commission the power to request the European Food Safety Authority (EFSA) to commission scientific studies “in circumstances of serious controversies or conflicting results”.[6] The glyphosate evaluation is illustrative of such circumstances and the Ramazzini Glyphosate Study is an independent study that could be supported to cater for this need.

“The independently conducted Global Glyphosate Study may just be the key to resolve any remaining doubts regulators have on the toxicity of real-life exposures of glyphosate and glyphosate-based products, in relation to their cancer potential and other health impacts," said Angeliki Lyssimachou, senior science policy officer at HEAL. “The Commission should ensure that all available results are duly reported and taken into account in the EU evaluation in response to growing public concerns on the toxicity of glyphosate.”

Notes

1. https://www.env-health.org/wp-content/uploads/2021/10/13-October-2021-Letter-to-EU-Commissioner-Kyriakides-concerning-assessment-of-glyphosate_final.pdf

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.

Back in 2015, the International Agency of Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans”. According to EU law (EC 1107/2009), this class of chemicals are not permitted to be used as active substances in pesticide products.

In the meantime, however, the German Health Authority (BfR), followed by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA), concluded that the substance did not pose any other health hazard or risk to humans, be it for carcinogenicity, mutagenicity, reproductive toxicity, or endocrine disruption. The contradiction in the carcinogenicity assessment between EU authorities and IARC, together with the demand of over one million citizens to ban glyphosate because of health concerns, resulted in Member States agreeing to renew the glyphosate license only for five years instead of the initially proposed 15-years period.

Ahead of the expiry of the current license (expected on 15th December 2022), the re-assessment of glyphosate is underway. To our great concern, the four Member States leading the assessment (France, the Netherlands, Sweden, Hungary) and forming the Assessment Group on Glyphosate released similar preliminary conclusions, according to which glyphosate meets the approval criteria set in the EU pesticide Regulation (EC 1107/2009). The draft assessment reports have now been delivered to ECHA and EFSA in order to complete the hazard and risk assessments, respectively.

2. Stop Glyphosate – European Citizens’ Initiative to Ban Glyphosate http://www.banglyphosate.eu/

3. In June 2021, four EU member states (France, Hungary, the Netherlands and Sweden) released a statement which concluded that glyphosate does not pose risks for human health. https://www.env-health.org/ominous-first-step-in-eu-renewal-process-of-glyphosate-4-member-states-suggest-no-risk-for-human-health-heal-comment/

4. A scientific analysis published in July 2021 revealed that the previous EU glyphosate assessment was based on flawed science, and concluded that the European Food Safety Authority’s claim that glyphosate is not genotoxic cannot be justified on the basis of the manufacturers’ studies. https://www.env-health.org/revealed-eu-glyphosate-assessment-was-based-on-flawed-science/

5. The Global Glyphosate Study of the Ramazzini Institute is the first of a kind long-term animal toxicity study, which is currently being performed in one of the most world-renowned animal facilities. https://glyphosatestudy.org/

A special webinar was organised in June 2021 by HEAL in collaboration with the Ramazzini Institute, where lead scientists presented the Global Glyphosate Study. https://www.env-health.org/webinar-the-global-glyphosate-study-the-most-comprehensive-study-on-worlds-most-used-pesticide-ever/

6. https://ec.europa.eu/food/horizontal-topics/general-food-law/implementation-transparency-regulation_en


Source: HEAL https://www.env-health.org/glyphosate-41-health-and-environment-groups-urge-eu-commission-to-put-an-end-to-use-of-unreliable-industry-studies/