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).
There is much debate about whether the (mostly synthetic) pesticide active substances (AS) in conventional agriculture have different non-target effects than the natural AS in organic agriculture. We evaluated the official EU pesticide database to compare 256 AS that may only be used on conventional farmland with 134 AS that are permitted on organic farmland. As a benchmark, we used (i) the hazard classifications of the Globally Harmonized System (GHS), and (ii) the dietary and occupational health-based guidance values, which were established in the authorization procedure. Our comparison showed that 55% of the AS used only in conventional agriculture contained health or environmental hazard statements, but only 3% did of the AS authorized for organic agriculture. Warnings about possible harm to the unborn child, suspected carcinogenicity, or acute lethal effects were found in 16% of the AS used in conventional agriculture, but none were found in organic agriculture. Furthermore, the establishment of health-based guidance values for dietary and non-dietary exposures were relevant by the European authorities for 93% of conventional AS, but only for 7% of organic AS. We, therefore, encourage policies and strategies to reduce the use and risk of pesticides, and to strengthen organic farming in order to protect biodiversity and maintain food security.
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