The European Commission’s Regulatory Proposal on New Genomic Techniques in Plants: A Spotlight on Equivalence, Complexity, and Artificial Intelligence

The European Commission (COM) has proposed to exempt certain genetically modified plants generated with new genomic techniques (NGTs) from the current European regulatory framework for genetically modified organisms (GMOs). In the suggested lex specialis so-called “category 1 NGT plants” (NGT1) are delineated from all other GMOs, as their genetic modifications are supposed to be equivalent to modifications found in nature or conventionally bred plants. Assuming a proportional risk potential, these NGT1 plants shall be marketed without any risk assessment. Here, we analyze the biological foundations of the proposal. We focus on the suggested equivalence criteria for NGT1 plants, which include thresholds for the size and number of genetic modifications per NGT1 plant. Our analysis shows that the constraints imposed by fundamental genetic principles are not adequately considered in the argumentation of the proposal. In this context, we discuss how genetic modifications in NGT1 plants can go beyond what can be achieved by conventional breeding techniques. Accordingly, the proposal would allow not only ”simple” NGT knockout mutants, but also complex genetic modifications, including de novo protein design and the use of artificial intelligence. We conclude that the approach of equating NGT applications with conventional breeding in such a general manner is invalid. The proposal does not consider the risk related intended and unintended effects on the phenotype. It is therefore neither scientifically justified nor suitable to adequately address potential risks of NGT plants.