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Part 4: Is glyphosate genotoxic?

We sometimes read that ” Glyphosate does not present a carcinogenic risk”; “It is not genotoxic “” It is the safest herbicide on the market ” etc

These claims are based on the opinion of the regulatory agencies which classified it as irritant onlyT for Eye and which gave their favorable opinion on the renewal of its marketing authorization. However, the International Agency for Research on Cancer (IARC), in 2018, classified glyphosate as a “probable human carcinogen”. Insurm, the French medical research, said during the public consultation of the renewal file that “glyphosate may present endocrine disrupting properties that affect reproductive function”.

Why are these different opinions? ? This is what future generations want to understand With a particular focus on suspected glyphosate genotoxicity and how this issue is addressed in the Glyphosate Reinstatement Report (RAR).

According to this report from 4 rapporteur member states (France, Netherlands, Sweden and Hungary) ‘glyphosate is not genotoxic’. How to explain this review ? Synthetic explanation (see GF’s full report for more details):

  1. Authorities rely exclusively on studies from manufacturers. The number of studies available on the genotoxicity of glyphosate is very large. Thus, RAR cites a total of 21 university studies performed in vitro, of which 18 show effects. In addition to these data in the literature, 5 in vitro studies from industry report the absence of effects. These industrial studies are considered acceptable or acceptable with reservations and therefore have a significant weight in the final decision, in contrast to the 21 university studies considered only “complementary” by the RAR and therefore no weight in the face of the study. The same applies to industrial in vivo data: 15 industrial studies show no effect for the conclusion, while 5 studies from the scientific literature show an effect but are ignored in the conclusion! For organizations, university studies are ignored due to a perceived lack of reliability. Authorities omit several points, including methodological weaknesses of the industry study.
  2. The authority ignored the flaws in the studies provided by the manufacturers: Industrial Studies is not so damned as the OECD and BPL claim. Exceptionally, the NGO SumOfUs succeeded in gaining access to these data and communicated them to two genotoxicity experts. They considered that most of these studies were factually unreliable and did not comply with the requirements issued by the OECD.[1].
  3. In vivo data are available for only one experiment and cell type : Assessment of in vivo genotoxicity of glyphosate relies exclusively on the micronucleus test, which is not very reliable. Consequently, genotoxic effects have only been studied in vivo on a single cell type. However, it is important to get results on different types of cells, which the comet test allows. In vitro, comet tests have shown the effect of glyphosate on blood cells, but also liver, epithelial (etc.). But the manufacturers have not provided any in vivo comet test! This vulnerability was reported by experts commissioned by ANSES in 2016[2]
  4. Data from “non-standard” organisms were not taken into account. Although IARC and Inserm analyzed research from academic studies on other, so-called “non-standard” models (especially fish), authorities simply rejected them. However, this approach is not in question due to numerous existing publications showing the relevance of fish-like models for the assessment of genotoxic effects for humans. ANSES itself supports this position[3] . By excluding such tests from evaluation, numerous studies found in the literature and showing genotoxic effects are in fact immediately rejected. Negative studies provided by manufacturers are given more weight.
  5. Overly restrictive regulatory classification criteria According to CLP, only mutagenic character at the germ cell level is retained to classify a substance and consider it as genotoxic. According to these criteria, the data obtained on somatic cells (other than germ cells) do not allow for their own classification of any substance in category 1, which is synonymous with pesticides with exclusion and non-marketing authorization. Also, genotoxicity tests, such as the comet test, are only considered “indicative tests” for mutagenicity and allow a maximum classification of 2 classes if positive effects are shown in vivo. On the other hand, in vitro genotoxicity tests carry almost no weight. The comet test, although it appears to be the most sensitive and relevant for evaluating the genotoxicity of glyphosate and is widely used by academic researchers, therefore has only very limited weight for classification. By comparing these classification criteria with the available data on glyphosate considered acceptable by the authorities, we see that the type of tests that have been carried out due to the lack of cell microbiological data cannot be classified in category 1 (they are not necessary. The authorities!) as evidence of these classification criteria. Problematic, ANSES asked[4] Amendment of the CLP Regulations during the public consultation held on the occasion of the amendment. The intention is to allow classification in category 1B even if no germ cell data are available.

Conclusion :

Although many studies show that glyphosate causes genotoxic and mutagenic effects, these have been ignored by the authorities.. The same is true of mechanistic studies demonstrating the oxidative stress effects of glyphosate. However, the repetition of these positive studies and the conclusions of internationally recognized research organizations should have prompted authorities to reassess the reliability of the studies provided by the manufacturers. and ask for additional studies, especially tests that allow the cells being studied to be modified or tests on germ cells, required for classification in Category 1. Renewed files in 2016, arguments are mainly taken from files submitted by manufacturers themselves. This biased assessment of genotoxicity greatly affects the assessment of carcinogenicity of glyphosate.

For more information, read the full file:

[1] Armen Narsesian and Siegfried Nasmueller, Assessment of the Scientific Quality of Research on the Genotoxic Properties of Glyphosate – 2021

[2] National Agency for Food, Environmental, and Occupational Health and Safety Opinion Regarding Referral for Glyphosate No. 2015-SA-0093, 09/02/2016

[3] Initial Impact Assessment on Amendments to the CLP Regulation-ANSES Commentary

[4] Initial Impact Assessment on Amendments to the CLP Regulation-ANSES Commentary

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