L'art. 62 dopo le ultime decisioni

Italian exports of the food products to the US Market, as it is clear from the data collected during the planning of the negotiation of the EU-US Free Trade Agreement (Transatlantic Trade and Investment Partnership - TTIP), are particularly affected by costs due to regulatory divergences. The process of validation and registration of importers and Italian facilities (and European ones) requested by U.S. Administrative Authorities may be included in this “regulatory asymmetry”. At the same time it is now evident - in the light of recent changes in U.S. Food Law - a clear new centrality of the role of law that would seem to invert the traditional reading of the U.S. system as a purely market-oriented, in which the consumers have the total control of health risks. Indeed, the Food Safety Modernization Act of 2011 (FSMA), replacing and supplementing in many parts the Public Health Security and Bioterrorism Preparedness Response Act of June 2, 2002 (known as “Bioterrorism Act”), has changed the Federal Food, Drug and Cosmetic Act of 1938 (FDCA), setting a new approach to food safety, also in relation to imports, on a “preventative approach “ (and, perhaps, until to an “ moderate precautionary principle”), based on the criterion of “reasonable probability”, in place of the one of “credible evidence”, in the detection and control of health risks. In this new context, the role of the “Food Facility Registration” for importers and foreign facilities is key.