Introduction

The European Union (EU) has a thorough and comprehensive system for the assessment and authorisation of Genetically Modified Organisms (GMOs) for import and processing, consumption as food or feed, and cultivation. The European Food Safety Authority (EFSA) issues a GM product specific safety assessment, focusing on impacts on human and animal health and the environment. Based on this EFSA assessment, the European Commission, together with the EU Member States, decides whether or not to authorise a GM product. Although the regulatory framework, as well as the scope of the assessment, is broadly similar to other parts of the world, there are significant differences in the functioning and results of GM authorisation regimes worldwide.

The objective of this report is to raise awareness of the need for the system to work better. The report identifies specific challenges to applicants due to the way the regulatory framework is implemented in the EU and proposes clear constructive solutions geared at addressing those problems. All solutions offered maintain the strict, thorough and independent EU authorisation system. This report was drafted on own initiative for the benefit of all parties involved in the EU authorisation process: EU Member States, the European Commission and the European Food Safety Authority (EFSA), and stakeholders who rely on an efficient and workable authorisation system for GM products: trait developers, seed companies, grain traders, food and feed industry and farmers...