Since the beginning of the mandate of the present European Commission in September 1999, genetically modified organisms (GMOs) have been high up on the political agenda and presented an important political and legal challenge. Considerable work has been invested in tackling the present situation of public concern for GMOs and the current standstill in the authorization process of GM products. The challenge is to find ways and means to meet the current consumer concerns, and to restore public and market confidence in the authorization procedure for GMOs. In order to upgrade the legislative framework, a new Directive has been adopted in 2001, establishing that GMOs cannot be released into the environment without a prior assessment of any potential risks to human health or the environment and without explicit approval from the authorities. The Directive has been complemented by draft legislation on traceability and labelling of GM products, which are currently debated in the Council and in the Parliament. However, a new, more stringent, regulatory framework might not be sufficient to restore public confidence in terms of the purchase and consumption of genetically modified food products. It will be necessary for all stakeholders, Member States, the European institutions, industry and research as well as NGOs and the media, to reflect upon their responsibilities and provide a balanced response to public concerns.