Re-registration Challenges of Glyphosate in the European Union

András Székács,Béla Darvas

doi:10.3389/fenvs.2018.00078

Abstract

One of the most controversial societal issues today, regarding pesticide registration in the European Union (EU) may be the case surrounding re-registration of the active herbicide ingredient glyphosate. Shortly before the announcement of the conflicting views regarding the carcinogenicity status of this regulated agrochemical by EU Agencies, the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) on the one hand, and the International Agency for Research on Cancer (IARC) on the other hand, the Cancer Assessment Review Committee of the US Environmental Protection Agency (US EPA) also published re-evaluations. The US EPA assessment classified glyphosate into Group E, “not likely to be carcinogenic to humans”. Similar positions were reached by EFSA and ECHA, assessing glyphosate as “unlikely to pose a carcinogenic hazard to humans” and “not classified as a carcinogen”, respectively. A strongly opposing evaluation has previously been reached by IARC by classifying glyphosate into Group 2A, “probably carcinogenic to humans”. IARC identified potential cancer hazards in this case, but did not estimate the level of risk it may present, which was taken into consideration by opposing agencies. Multiple effects of glyphosate have been reported, of which carcinogenic effects are only one component. Formulated glyphosate products – especially with polyethoxylated tallowamine and related compounds – have been shown to cause stronger cytotoxic or endocrine disrupting effects than the active ingredient glyphosate alone. Questions related to hazards and corresponding risks identified in relation to this active ingredient and its formulated herbicide preparations divide scientific circles and official health and environmental authorities and organizations, and touch upon fundamental aspects of risk assessment and product regulation. The decision has to consider both hazard-based (IARC) and risk-based analysis (EFSA); the former may not be suitable to calculate practical significances, and the latter being challenged if exposure estimations are uncertain in light of new data on residue levels. The results of current analytical surveys on surface water are particularly worrisome. In turn, the precautionary principle appears to be the optimal approach in this case for regulation in the EU.

Highlights

Since its introduction as an herbicide active ingredient in 1971 (Baird et al, 1971), glyphosate [N-(phosphonomethyl)glycine] became and remains the market leading herbicide active ingredient worldwide (Dill et al, 2010; Székács and Darvas, 2012; Benbrook, 2016)
The legal case has not been finalized to date, it has led to a decision by the Court of Justice of the European Union (EU) that the European Commission (EC) has to make information on the release of plant protection product (PPP) into the environment accessible to any applicant requesting it, including the “identity” and the quantity of all of the impurities contained in the active substance, as well as the composition of the PPPs (InfoCuria, 2017). This is of particular importance, as in the previous policy the manufacturer had only to account for the technical purity of the active ingredient, and the exact chemical identity of the formulating agents could be handled as proprietary information
Considering acute toxicity, legislatory decision-makers focus on risks as a product of hazard and exposure, and weigh the subsequently identified hazards based on their likelihood of occurrence through real exposures

Summary

Introduction

Since its introduction as an herbicide active ingredient in 1971 (Baird et al, 1971), glyphosate [N-(phosphonomethyl)glycine] became and remains the market leading herbicide active ingredient worldwide (Dill et al, 2010; Székács and Darvas, 2012; Benbrook, 2016). Its initial patent protection commenced in 1971 (Franz, 1974), and was renewed in the eighties on the basis of novel composition—through a process that involved property acquisitions among major pesticide companies. Even this extended patent protection eventually expired, and glyphosate became a generic compound in 1991 in many parts of the world outside the United States (US), and even the US patent expired in 2000. The introduction of glyphosate-tolerant (GT), genetically modified (GM) crops, began in the US in 1996 and gave a further protected status and market boost to glyphosate, securing its market leading position ever since. Re-registration of the compound received prominent attention, due to significant commercial interests and environmental and health concerns

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