Abstract

The recent Regulation (EU) 2019/1381, published on the 6th September 2019, aims to improve the transparency and sustainability of the EU risk assessment in the food chain by amending the General Food Law Regulation (EC 178/2002) and a number of other regulations related to the food sector. This Regulation is introduced as a response to the Fitness Check of the General Food Law Regulation as well as a response to public concerns expressed by a European Citizens’ Initiative on glyphosate and pesticides. This article evaluates the amendments introduced by Regulation 2019/1381with respect to the institutional and regulatory environment in the food chain and more specifically concerning the risk assessment procedure. For this purpose, we perform a comparison of the institutional and organizational characteristics of the European Food Safety Authority (EFSA) and European Medicines Agency (EMA) in relation to the processes of risk assessment and risk evaluation, especially the processes surrounding genetically modified foods and pesticides, and how these characteristics affect the politicization of these processes. We conclude that the risk assessment process followed by EFSA would have benefitted and become more effective and less politicized, if the recent Regulation 2019/1381 had introduced some of EMA’s institutional structures and methods on risk evaluation.

Highlights

  • In the past, food policy was within the competence of the Member States in the European Union (EU)

  • Taking stock on the existing literature on risk governance, this paper addresses the overall question: to what extent will the recent Regulation, on the transparency and sustainability of the EU risk assessment in the food chain, improve the risk assessment process in European Food Safety Authority (EFSA) and increase trust among the European people?

  • Regulation 2019/1381 focuses significantly on risk communication through: (1) Automatic publication of all studies and supporting information submitted to EFSA for risk assessment, in an electronic format that would be publicly available and accessible; (2) Stakeholders would be consulted on submitted studies, and confidentiality would be protected in justified circumstances; (3) A specific procedure would be implemented for renewals of substances already authorized; and (4) The Commission would, via delegated act, adopt a general plan for risk communications in the agrifood chain (Comitology Newsletter #52, 2018)

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Summary

INTRODUCTION

Food policy was within the competence of the Member States in the European Union (EU). The EU introduced an optout mechanism (Directive EU 2015/412) in 2015 which allowed member states to restrict or prohibit cultivation of authorized GM crops in their territory, this did not resolve these issues (Eriksson et al, 2019) Such incidents reflect a broader uncertainty with respect to the risk management at the Commission level (following EFSA’s risk assessment), which the existing decision-making and governance processes have not been able to address adequately. These incidents demonstrate the importance of the national views and interests in the decision-making, which seem not to be based on EFSA’s scientific risk assessment on safety for health and the environment Such changes can potentially contribute to elimination of delays and promote innovation in food biotechnology in a responsible manner

THE INSTITUTIONAL STRUCTURES AND RISK ASSESSMENT IN EFSA AND EMA
CHRONOLOGY OF EVENTS
Findings
DISCUSSION
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