Mutation and genetic engineering: when lawyers decide on scientific issues

For a long time it was taken for granted. The same regulations apply to plants from mutation breeding as to those from conventional breeding: none except for plant variety rights.

In July 2018, however, the European Court of Justice (ECJ) ruled that mutagenesis with radiation or chemicals also leads to a "genetically modified organism" (GMO), as "a change to the genetic material of an organism that is not possible in the natural way is carried out". At the same time, plants (and animals) produced in this way are exempt from the provisions applicable under genetic engineering law, such as authorisation and labelling requirements. The ECJ judges justify this with the long experience that has been gained with mutation breeding. It is therefore justified to regard the resulting plants as "safe" without further testing.

This experience is lacking in the new genome editing methods. Therefore, according to the ECJ judgement, they must be regulated in exactly the same way as a GMO. A genome-edited plant is subject to the same authorisation and labelling regulations as a genetically modified plant. Mutation breeding with random, individually unknown genetic changes is generally considered safe because the process has been used for a long time.

Genome editing, which is based on a precise mutation at a precisely known location in the genome, is categorised by the ECJ as "novel" and the plants bred with it as unsafe - as long as the contrary is not proven. However, the ECJ judgement is not scientific expertise, but a legal interpretation of laws that were passed 25 years ago and reflect the state of science at the time, which is now long outdated. Today's scientists rightly claim that there is over 30 years of experience in the safe application of classical genetic engineering and that this can be used for even more precise genome editing.