With the increasing "agencification" of policy making in the European Union (EU), normative questions regarding the legitimacy of EU agencies have become ever more important. This article analyses the role of expertise and legitimacy with regard to the European Chemicals Agency ECHA. Based on the REACH regulation, so-called Substances of Very High Concern (SVHCs) are subject to authorisation. The authorisation procedure aims to ensure the good functioning of the internal market, while assuring that risks of SVHCs are properly controlled. Since ECHA has become operational in 2008, recurring decisions on SVHCs have been made. The question posed in this article is: to what extent can decision making in the REACH authorisation procedure be assessed as legitimate? By drawing on the notion of throughput legitimacy, this article argues that decision making processes in the authorisation procedure are characterized by insufficient legitimacy.
The adoption of the REACH regulation, setting out to reformchemicals policy of the European Union (EU), was accompanied by intense controversy over the role of the precautionary principle. Analysing decision making on so called Substances of Very High Concern (SVHCs), this article demonstrates that despite legal underpinning, precaution plays a limited role in the implementation of the REACH authorisation procedure. Due to ambiguous legislative provisions, the controversiesof the legislativeprocessare carriedover tothe implementationprocess.
With the increasing "agencification" of policy making in the European Union (EU), normative questions regarding the legitimacy of EU agencies have become ever more important. This article analyses the role of expertise and legitimacy with regard to the European Chemicals Agency ECHA. Based on the REACH regulation, so-called Substances of Very High Concern (SVHCs) are subject to authorisation. The authorisation procedure aims to ensure the good functioning of the internal market, while assuring that risks of SVHCs are properly controlled. Since ECHA has become operational in 2008, recurring decisions on SVHCs have been made. The question posed in this article is: to what extent can decision making in the REACH authorisation procedure be assessed as legitimate? By drawing on the notion of throughput legitimacy, this article argues that decision making processes in the authorisation procedure are characterized by insufficient legitimacy.
This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level. Content Introduction: Background and Methodology • Pharmacovigilance • The EU Pharmacovigilance System • Timely and Correct Transposition of Pharmacovigilance across Member States • Practical Implementation in Six Member States • Challenges and Best Practices in Perspective • Conclusions and Recommendations The authors Dr. Michael Kaeding is Professor for European Integration and European Union Politics at the Department of Political Science of the University of Duisburg-Essen, Germany and holds an ad personam Jean Monnet Chair in "Understanding EU Decision Making and Member States´ Compliance with EU Policies". Julia Schmälter is a research assistant at the Jean Monnet Chair for European Integration and European Union Politics at the Department of Political Science at the University of Duisburg-Essen. Christoph Klika is a lecturer at the Department of Political Science at the University of Duisburg-Essen
The centralised authorisation of GMOs in the European Union (EU) has received considerable academic attention in recent years, partly due to the fact thatMember States have not been able to agree on authorisation decisions in the comitology committee. As a consequence, these authorisations are given by the European Commission. These decisions are invariably in favour of authorisation despite the fact that Member States had been divided on this issue. Apart from the on-going discussions on a possible reform of the GMO authorisation (allowing for national restrictions or prohibitions), the new comitology rules brought about by the Lisbon Treaty are of equal importance as they might affect the authorisation of GMOs. In this article we discuss some of the changes to comitology and present empirical material on the first authorisation decisions after the entering into force of the new comitology rules. By drawing on delegation theory we will argue that, for the time being, the level of politicisation ofGMOauthorisation is unlikely to change.