The report at hand addresses the application of the precautionary principle in GMO policy at EU level. Wherever possible, relevant experience in related regulatory fields in the EU is considered. Further actions are recommended to implement a comprehensive precautionary approach in EU GMO regulation. A review of the current risk assessment and risk management processes, by way of case studies, is suggested and specific guidance for applying the precautionary principle in GMO policy should be elaborated to complement the relevant Communication of the European Commission, published in 2000. Based on a critical analysis of the current system, measures for implementing a broader precautionary approach are suggested, including regulatory changes to strengthen the Member States’ responsibilities for the protection of regional environments.