2. Identification of safety issues to be resolved

Now that the scene has been set, it is possible to identify the issues that could potentially give rise to health concerns. These are essentially linked to the substances that will be newly produced and that are foreign to the unprocessed plant.

The first concern, however, is the presence of foreign genes or DNA sequences. Can these genes or certain DNA fractions be transmitted to other organisms, in particular to humans or animals that will consume the GMPs, and if so, with what consequences?

A second concern relates to proteins newly synthesized by the plant, resulting from the action of genes of interest and marker genes. As we have just seen, only these genes will determine protein synthesis, the other genes or DNA sequences having the sole purpose of enabling transformation and regulating the expression of the genes of interest and...