The European Commission introduced impact assessment (IA) in 2002 following recommendations from the Mandelkern group on Better Regulation. The basic rationale of IA is that proposals must be prepared on the basis of an analysis of whether regulatory intervention is needed and whether it is appropriate to intervene at the EU level. An IA report, published together with the proposal, summarises the results and highlights the trade-offs between the potential economic, social and environmental impacts associated with various policy options. Nowadays, IA is required for all major proposals. It is also increasingly being used throughout the whole legislative process as the European Parliament and the Council of Ministers are implementing their respective commitments to IA. The thesis starts out by developing a typology of possible uses of impact assessment in EU lawmaking, which serves as a framework of reference for the subsequent analysis of the development of EU IA. The idea is explored that the three âco-legislatorsâ are not the only relevant actors in IA processes; national institutions, advisory bodies, review institutions, regulatory bodies, private co-actors and third-country actors all play their part. Case-studies on the new chemicals regulation (REACH), the thematic strategy on air quality (CAFE), the pre-packaging directive and the data retention directive lend empirical backing to the theoretical claims. The thesis arrives at the conclusion that IA is becoming a self-standing normative force in EU lawmaking by contrasting EU IA as 'soft constitutional law' and EU IA as 'meta-regulation'.The Legitimacy and Effectiveness of Law & Governance in a World of Multilevel Jurisdiction