In 2000, the European Union and every Member State signed the Cartagena Protocol, which regulates the safe transport, handling and use of living modified organisms. The Protocol was ratified by the EU on 25 June 2002.

According to Directive 2001/18/EC, the legal conditions for the implementation of the Protocol must to be established. Gene technology activities are regulated in detail by community regulation, but the export of GMOs to third countries is not. The above Regulation was adopted to facilitate the realisation of the requirements laid down in the Protocol.

Accordingly, the Regulation covers the export of GMOs to third countries, and its prescriptions are adequate to the provisions of the Cartagena Protocol.

The Protocol permits Member States to apply their own regulations with regard to the cross-border transport of living modified organisms, if such regulations comply with the provisions of the Protocol. In this Regulation, the EU declares that its own regulations will be applied with regard to transport within the territory of the EU.