Coping with uncertainty : the regulation of chemicals in the European Union

Abstract

Defence date: 28 June 1999 ; Examining Board: Prof. Karl-Heinz Ladeur, European University Institute (Supervisor); Prof. Christian Joerges, European University Institute (Co-supervisor); Prof. Jan H. Jans, University of Amsterdam; Prof. Marc Pallemaerts, Vrije Universiteit Brussels ; First made available online on 23 February 2018 ; The project of this thesis is to investigate how law operates in politically precarious, scientifically complex and uncertain areas. It examines whether the legal framework for the regulation of health and environmental threats adequately takes into account problems of risk and uncertainty. Furthermore, it proposes structural legal reforms to optimise the conditions under which decisions for risk control are taken. Chapter I of the thesis lays down a theoretical framework for analysis of the tensions between law, risk and uncertainty. It explains why traditional modes of legal reasoning are ill-suited to deal with contemporary health and environmental threats, and proposes the adoption of a risk-oriented approach to law and regulation as a more productive alternative. The remainder of the thesis examines the practical utility of a riskoriented approach for health and environmental protection. The substantive area selected for analysis, is the European Community regulatory framework for the control of chemicals. The structure of the thesis mimics the "regulatory life cycle" of chemical substances. Chapter II focuses on the first major prerequisite for chemical control: the availability of sufficient information on chemical hazards and risks. It provides an overview and critique of existing arrangements to stimulate the production of chemical data. Chapter III addresses the question how this data is processed into a format that is relevant for the purposes of risk regulation. The prevalent technique is risk assessment. Chapter III analyses risk assessment practices prescribed in EC law, and discusses the controversies that surround the use of risk assessment in regulatory decision-making. Chapter IV discusses the stage of risk decision-making. It reviews a range of regulatory techniques that aim to secure health and environmental protection, and examines chemical risk reduction mechanisms in EC law. It furthermore investigates whether and how information on chemical risks is put to use to inform decision-making processes. Each Chapter concludes with an evaluation of the incumbent legal framework, focusing in particular on its compatibility with the risk-oriented approach developed in Chapter I. Finally, Chapter V draws the strands of the preceding analyses together, and offers an overview of the main leitmotifs, strengths and weaknesses of European chemical legislation. Chapter V concludes with a number of reform proposals that, hopefully, will contribute to the ongoing discussion and elaboration of a legal framework that does not shy away from uncertainty.