Statement by the ZKBS on the ECJ ruling

The ZKBS views the ECJ ruling (see AGCT-Gentechnik. report from...) critically in light of the numerous problems it raises with regard to genome editing. In particular, the ruling fails to take into account the current state of scientific knowledge, ignoring previous assessments by recognized institutions (European Academics Science Advisory Council (EASAC); High Level Group of Scientific Advisors (part of SAM); German Academy of Sciences Leopoldina; German Research Foundation (DFG); German Academy of Science and Engineering acatech). From the ZKBS's perspective, it is not in line with the current state of scientific knowledge to classify newer mutagenesis techniques entirely as GMOs. The ECJ ruling concerns two new techniques: so-called oligonucleotide-directed mutagenesis and so-called gene scissors, which also allow the targeted insertion of foreign genes. Such modifications are already subject to genetic engineering law. Genome editing techniques, known as oligonucleotide-directed mutagenesis, on the other hand, only involve minimal changes to the target organism. While the end result can be detected in the target organism, the developmental process corresponds to that of a natural mutation and is undetectable. In this context, for example, the plant produced in this way is no different from one produced by conventional mutagenesis or naturally. According to the ECJ, however, the target organism of this type of mutagenesis is obtained in an unnatural way. The ZKBS considers subjecting such minimal genome changes to the strict regulations and procedures of genetic engineering law to be questionable for the following reasons: Firstly, these new methods represent a significant advance in scientific research and are being used particularly promisingly in plant breeding and agriculture. They are characterized in particular by a targeted modification of the genome of the target organism, thus achieving more efficient and faster breeding progress. These new procedures are also already subject to complex, multi-year approval procedures, so there is no need for regulation under genetic engineering law. Secondly, human-induced conventional mutagenesis and so-called oligonucleotide-directed mutagenesis are based on the same mechanisms as the development of natural, environmentally caused mutations. Unlike conventional mutagenesis, the latter new procedure is equated with so-called gene scissors and classified as a GMO, which is why the latter procedures, unlike conventional procedures, are subject to the regulations of genetic engineering law. Furthermore, it is pointed out that mutagenesis procedures outside Europe are assessed according to their products – so-called product-based risk assessment – ​​which does not classify them as GMOs. The ECJ ruling, in contrast, leads to a process-based risk assessment. In this case, the risk assessment is carried out according to the underlying procedure. This could result in two genetically identical organisms being subject to different regulations. Because of the similar mechanisms applied, the ZKBS considers a separate risk assessment under genetic engineering law to be unnecessary and scientifically unjustifiable. This would mean that organisms obtained in Europe would be subject to stricter regulatory and approval requirements under the Genetic Engineering Directive than those of other major agricultural countries. This could lead to major problems with international trade and controls by the relevant European customs authorities. Finally, the ZKBS demands that European genetic engineering law—which is essentially based on the state of knowledge from 1990—be urgently adapted to the current state of scientific knowledge.