The present paper scrutinises the European authorities’ assessment of the carcinogenic hazard posed by glyphosate based on Regulation (EC) 1272/2008. We use the authorities’ own criteria as a benchmark to analyse their weight of evidence (WoE) approach. Therefore, our analysis goes beyond the comparison of the assessments made by the European Food Safety Authority and the International Agency for Research on Cancer published by others. We show that not classifying glyphosate as a carcinogen by the European authorities, including the European Chemicals Agency, appears to be not consistent with, and in some instances, a direct violation of the applicable guidance and guideline documents. In particular, we criticise an arbitrary attenuation by the authorities of the power of statistical analyses; their disregard of existing dose–response relationships; their unjustified claim that the doses used in the mouse carcinogenicity studies were too high and their contention that the carcinogenic effects were not reproducible by focusing on quantitative and neglecting qualitative reproducibility. Further aspects incorrectly used were historical control data, multisite responses and progression of lesions to malignancy. Contrary to the authorities’ evaluations, proper application of statistical methods and WoE criteria inevitably leads to the conclusion that glyphosate is ‘probably carcinogenic’ (corresponding to category 1B in the European Union).
- weight of evidence
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Contributors PC wrote the draft text which was commented and supplemented by CR and HB-S.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests PC is member of the executive board of Pesticide Action Network (PAN Germany, without remuneration). For writing a report related to the topic of this manuscript he received funding from Global 2000 (Friends of the Earth Austria). CR receives a salary from GMWatch and HB-S receives a salary from Global 2000. Their work on the manuscript of this paper was, however, unpaid. The organisations the authors are affiliated with had no role in the analysis and interpretation of the data or in the preparation and review of the manuscript, though open access is funded jointly by PAN Germany and Global 2000.
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Provenance and peer review Commissioned; externally peer reviewed.
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