The Responsiveness of the European Commission in Risk-related Decisions: External Pressure and Internal Dynamics

The authorization of risk-related products in the EU such as pharmaceuticals, food and feed and chemical substances is widely based on (scientific) risk assessment. The assessment is conducted by EU agencies and expert committees whereas the Commission formally remains in charge of risk management, thus drafting risk-related decisions based on such assessment. The scholarly literature presents a puzzle here as there is evidence that the Commission responds differently to risk assessments. As regards pharmaceuticals, for instance, the Commission drafts decisions always in line with the outcome of the assessment. However, as regards chemicals it often deviates from the assessment. Why does the Commission in some cases go along with the risk assessment whereas in others it deviates from the assessment and thus takes a more active role as risk manager? What factors influence the Commission’s behaviour on potential risks and the way to manage them? To what extent is the Commission responsive to various demands from either societal actors or Member States when shaping its position? In order to open the black box of the internal dynamics of the Commission, we conduct empirical analysis of Commission’s draft decisions between 2006 and 2012. The empirical evidence is based on documentary analysis as well as semi-structured interviews with policy makers, experts and stakeholders. Based on a comparative analysis of selected policy areas we aim to address the aforementioned puzzle by investigating the factors which determine the responsiveness of the Commission when drafting risk-related decisions.