Italy—GMOs and Synthetic Biology Rules/Regulations and Biodiversity: The Legal Perspective of Italy

Abstract

The Italian regulatory framework on genetically modified organisms (GMOs) follows the cardinal principles of the European Union legal order. The incomplete implementation of the Italian legislation has led to a de facto moratorium of the deliberate releases of GMOs into the environment, also for experimental purposes, thus slowing down the Italian research in this field. The most recent technological developments opened new perspectives for research and applications, posing new challenges for the regulatory system. Synthetic biology is one of these new challenges: even if in Italy there is still a growing debate on whether the application of the existing legislation on GMOs to some of the organisms resulting from the applications of synthetic biology is possible, training and research activities are already under way. We would like to emphasize that, although the present GMOs regulatory framework is effective to preserve biodiversity, further improvements could be needed and should be focused on simplifying the authorization procedure for certain products. It is also necessary to promote and guarantee research and experimentation, in order to provide policy makers with science-based decision support system, and not to keep Italy out of the opportunities offered by technological advances.