Coexistence - The Missing Link in the EU Legislative Framework: Subsidiarity vs. Harmonization on the Final Frontier of the EU Regulatory Regime for Agricultural Biotechnology

Abstract

In contrast to the whirlwind pace and the efficiency with which the science and commercialization of modern biotechnology have developed in the past few decades, the creation of an adequate and comprehensive regulatory regime for agricultural biotechnology has proven to be a lengthy and arduous affair.The EU’s troubled experience with the regulation of ‘green’ biotechnology in the agricultural and food production sectors is, in many respects, the quintessential example of these difficulties. Complexities of, inter alia, persistent political deadlock among Member States as well as EU institutions, fierce public opposition, and a struggling global competitiveness position, have frustrated the EU regulatory efforts since their inception.Following the disintegration of the initial EU legal framework, in the 1990s, a major revision has been undertaken in recent years. By 2004, the European Commission declared the overhaul of the regulatory regime complete, and effectively lifted the longstanding de facto moratorium on authorization of imports of GMOs. Moreover, it has resumed the authorization process for the EU-wide cultivation of GM crops, in the face of unrelenting deep political divide between the Member States. With this re-opening of the floodgates to Europe’s internal market to GMO imports, and with the imminent commercial-scale cultivation of GM-crops on EU soil, the regulatory regime will be put to the test once again. The pressing question which emerges is thus whether, this time around, the revised regime will indeed prove complete and adequate, and whether a repeat of events leading to the political stalemate of the 1990s can be avoided.However, this paper argues that, contrary to the Commission’s conviction, the EU regulatory regime is not yet complete, and that the lack of a consistent, coherent, and integral regulatory approach threatens to undermine the effectiveness of, or even make redundant, the legislation that has so far been put into place. Serious omissions can be identified in the arsenal of regulatory instruments and the definition of pivotal legal concepts, with the ultimate potential to paralyze the entire framework, once again..