Advice on the decision by the European Commission on the GMO status of viral replicon particles

The European Commission (EC) has made a decision on the status of viral replicon particles (VRPs). The EC states that VRPs are not genetically modified organisms (GMOs). However, VRPs are derived from viruses that are genetically modified to express a foreign gene in animal or human cells. They can be used for various applications, including vaccines. The EC’s decision means that applications for placing on the market of products containing, consisting of or produced from VRPs do not have to be accompanied by an environmental risk assessment. COGEM observes that in the absence of an environmental risk assessment for all possible VRPs, adverse consequences for humans and the environment cannot be ruled out.

In this letter COGEM points out that this decision raises ambiguities, lacks a sound scientific and legal basis and may have adverse consequences for environmental risk prevention and public acceptance. Furthermore, COGEM highlights the need for consultation and coordination between the EC and the EU member states on the status of VRPs.