Abstract

The pre‐market environmental risk assessment ( ERA ) of regulated products such as genetically modified organisms, plant protection products and feed additives is an important process to safeguard the desired level of protection of the environment and biodiversity. ERA evaluates the potential adverse effects on the environment of certain actions, and is an important analytical scientific tool to support regulatory decision‐making. Significant advances have been made in the field in recent years. Potential avenues to the further advancement of ERA of regulated products under EFSA 's remit were discussed during the breakout session ‘Advancing environmental risk assessment’ held at the EFSA 2nd Scientific Conference ‘Shaping the Future of Food Safety, Together’ (Milan, Italy, 14–16 October 2015). The value of ERA and its relevance to decision‐making can be increased by: (1) using the ecosystem services approach to make protection goals operational; (2) relying on problem formulation to enhance the relevance of ERA studies; (3) complying with quality standards to warrant the reliability of ERA studies; (4) making ERA more contextual by accounting for multiple stressors and environmental benefits; and (5) acknowledging the strengths and limitations of post‐market environmental monitoring as a tool to resolve scientific uncertainties.