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Progress in the field of recombinant nucleic acid techniques and cross-species gene delivery in the 1970s and 1980s prompted legislators in the European Union (EU) to develop biosafety regulations encompassing these techniques and their resulting products. The ensuing procedure for risk assessment and risk management of genetically modified organisms (GMOs), as these were denominated, in the EU has thus been established with the purpose of ensuring a high level of protection of human health and the environment. The early draft legislative texts on GMOs in the EU (Commission of the European Communities, 1988) resulted in the first Council Directive on the deliberate release into the environment of GMOs (Dir 90/220/EEC) in 1990 (Official Journal of the European Communities, 1990). From these early drafts, it is clear that the intentions were to have an evolving and increasingly trait-oriented regulatory framework taking into account technical developments, potential safe history of use as well as potential benefits resulting from the application of these techniques and their resulting products. However, despite nearly three decades of research, product development, demonstrated benefits and a lack of demonstrated risks associated with recombinant nucleic acids per se, the GMO regulatory framework in the EU has neither evolved nor been implemented as intended. I here list four details for which policy makers in the EU need to consider the original intentions of the GMO regulatory framework in order to correctly interpret the current legislative texts as well as allow for necessary updates following technical progress.

Recovering the Original Intentions of Risk Assessment and Management of Genetically Modified Organisms in the European Union