The European Commission’s regulatory proposal on new genomic techniques in plants: a focus on equivalence, complexity, and artificial intelligence

The European Commission has proposed to amend the EU GMO regulation, exempting certain genetically modified plants generated with new genomic techniques (NGTs) from risk assessment. In the suggested lex specialis so-called “category 1 NGT plants” would be treated as equivalent to conventionally bred plants, if they meet threshold-based criteria, which limit the number and size of induced genetic changes. Here, we critically analyze the scientific validity of these thresholds and show that the proposal oversimplifies genetic complexity—disregarding the biological context, mutational bias, and functional consequences. The proposal’s central claim of equivalence between NGT1 plants and conventionally bred plants is thus scientifically unfounded. Many conceivable genetic modifications produced with NGTs—including those created with CRISPR prime editing and AI-assisted design—could be highly complex and exceed the capabilities of conventional breeding. Nevertheless, the regulatory proposal treats all possible genetic changes as equally likely and overlooks the purpose and function of genetic edits. By eliminating case-by-case risk assessment, the proposal creates a regulatory gap that allows complex and novel traits to bypass scrutiny—undermining the EU’s legally binding precautionary principle. In contrast, a risk-based regulatory approach is needed to ensure safe and future-proof oversight of NGT plants.