Guidance on the environmental risk assessment of genetically modified plants

This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with problem formulation including hazard identification; hazard characterisation; exposure characterisation; risk characterisation; risk management strategies; and an overall risk evaluation.