European agencies and the implementation of global standards in the EU

This presentation analyzes the role of EU agencies in the implementation of global standards, focusing on the regulatory areas of pharmaceuticals, foods, chemicals. In these fields, EMA, EFSA and ECHA participate in the setting of standards on the global level (e.g. in the ICH, the Codex and the OECD) and are an important gateway for global standards into the EU legal framework, often due to the adoption of administrative soft law. This presentation will examine the role of EU agencies in global standard-setting in-between the global and EU level. It will compare their role in the setting of pharmaceutical, chemical and food standards as well as the role these bodies play in the implementation of global standards on the EU level, revealing sector specific differences in the practices of the agencies. Finally, it will question the legitimacy of EU agencies as key actor in the implementation of global standards, by examining its compliance with basics principles of good administration.