Issue 02/2010
- Defining Nanomaterials for the Purpose of Regulation within the European Union
- Putting Risk Management to the Test
- ...
| The European Regulatory Response to the Volcanic Ash Crisis between Fragmentation and Integration Prof. Dr. Alberto Alemanno More than twenty years after the EU eliminated its internal land borders, the Union still lacks an integrated airspace. This seems to be the most immediate regulatory lesson of the recent volcanic ash crisis. Yet more research is needed before establishing its net effects. |
| Alice’s Adventures in Volcano Land: The Use and Abuse of Expert Knowledge
in Safety Regulation Prof. Emeritus Dr. Jur. Vincent M. Brannigan As a volcano refugee in Frankfurt, it was rather interesting to see a slow motion regulatory science disaster taking place. On April 14 2010 the Icelandic volcano Eyjafjallajökull erupted sending millions of tons of ash into the upper atmosphere. The ash cloud, blown by the prevailing winds, moved down over northern Europe. European air traffic authorities, following well established and widely published safety protocols, began shutting down the air transport system due to the well known hazard of volcano ash. |
| Defining Nanomaterials for the Purpose of Regulation within the European Union Dr. Diana Bowman, Joel D’Silva, Geert van Calster Consumer desire for superior and new products has provided industry with the opportunity and market demand to incorporate and experiment with new technologies, including nanotechnologies. While these products and processes have fallen under the scope of existing regulatory frameworks, potential health and safety concerns has prompted some stakeholders to call for new, nano-specific regulations. |
| Putting Risk Management to the Test or Why it is Ineffectual to Separate Risk Assessment from Risk Management: The Story of Maximum Levels for Aflatoxins Liana Giorgi, Annuradha Tandon This article reviews the policy process of setting maximum levels for aflatoxins by the European Union and the Codex Alimentarius Commission. The differences between the two regulatory organizations and the difficulties entailed in the alignment of the two standards are illustrative of the problems inherent in risk analysis in the food sector. This case is also instructive with respect to the way in which scientific evidence is used when deciding on appropriate food safety standards. |
| An Assessment of the EU Approach to Medical Device Regulation against the Backdrop of the US System Bernhard Lobmayr A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. |
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