Public and political views on the regulation of genetically modified organisms (GMOs) and on the role of biotechnology continue to be extremely polarised in Europe. The EU started legislating on the authorisation and use of GMOs in the early 1990s. Despite the early regulation of this complex field, agricultural applications of biotechnology continue to be very controversial. In order to address public concerns and strengthen its regulatory framework, the EU reviewed its legislation on GMOs between 1997 and 2003. The cornerstone of the regulatory framework is Directive 2001/18/EC on the deliberate release into the environment of GMOS, whose provisions for placing on the market are the main focus of this article. The implementation of the Directive to date and the difficulties encountered will be briefly analysed.