Abstract
In response to serious deficiencies in current risk assessment and management practices, the EU has adopted a regulation for the Registration, Evaluation and Authorisation of Chemicals (REACH). As the most ambitious and complex single piece of chemical legislation ever devised, REACH aims to regulate approximately 30,000 chemical substances. Although efficient and effective implementation will depend on the interaction of Member State regulators during EU decision-making, political debates surrounding the new legislation have only focused on mechanisms for conducting hazard assessments. To facilitate EU decision-making, this PhD thesis proposes a framework for risk management under REACH. As a first step, the regulatory approaches of four prominent countries in EU decision-making are analysed and compared: France, Germany, Sweden and the UK. On the basis of 36 interviews conducted with regulators and stakeholder representatives, the study examines how these Member States influence EU chemical regulation, and vice versa. From these findings, the research concludes that a framework for EU decision-making must incorporate hazard, technical and risk-henefit approaches to risk management. As a final step, the potential operability of the proposed framework is tested using risk assessment data for 33 chemicals subject to regulatory review.