PARMA, Italy - The European Food Safety Authority (EFSA) has published the first European guidelines for growing genetically modified plants in the non-food sector. The guidance describes how developers of GM plants grown for purposes other than human or animal consumption, such as producing pharmaceuticals or industrial enzymes, will need to assess the potential risks to humans, animals and the environment.
According to the guideline, EFSA risk assessment will be required when developers seek commercial approval to grow the plant. The evaluation will be passed on to the European Commission and Member States, which then decide whether to grant permission. In contrast, scientists that wish to grow GM crops for research purposes need only apply for a licence in the individual Member State in which they wish to grow the crop. This correlates to the procedures already in place for GMO crops.
Under the EFSA guidance, developers must detail the biological differences between the GM plant and the conventional crop it is derived from and how these affect the plant's function and growth. They also have to assess the risk of engineered genes being passed on to other plants and any danger posed to humans or animals who accidentally eat the transgenic crops.
According to the guideline, the EFSA and the European Medicines Agency (EMEA) will both have a say in future GMO plants which produce drugs. The EFSA will only consider the risks of growing the GM plant. The safety of the plant's product will be considered by the European Medicines Agency (EMEA), which has guidelines on the safety and quality requirements of plant-derived drugs that came into effect in February.
At the moment drugs out of genetically modified plants still remain dreams of the future. The EFSA has not yet received any applications for such a plant.
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