The Court of Justice of the European Union decides in favour of clear regulation

New genetic engineering techniques will be subject to EU GMO regulation

25 July 2018 / The European Court of Justice today ruled on the regulation of new methods of genetic engineering. According to the ruling, plants that are changed in their genetic condition through application of new genetic engineering methods cannot be exempted from existing EU GMO regulation. Testbiotech welcomes this decision. The Court follows a similar legal interpretation as provided in legal dossier that was published by Testbiotech already some weeks ago.

Testbiotech emphasises that in most cases there are significant differences between conventional methods and methods used in genome editing. The application of techniques, such as CRISPR& Co, leave a unique fingerprint in the genome, a kind of signature that would not happen with conventional breeding. This is also the case if no additional gene sequences are inserted.

The reason: The application of nucleases, such as CRISPR-Cas, is not subject to natural control mechanisms of gene regulation and heredity to the same extent as conventional breeding. The DNA scissors can also change genetic conditions in ways that would not be expected under natural conditions. Furthermore, unlike conventional breeding, genome editing always changes all the copies of a gene at the same time. Whereas conventional breeding usually means that there are still some backup copies present in the genome that can compensate the effects of random mutations.

In addition, it has in many cases been observed that errors in CRISPR mechanisms leave numerous unintended changes in the genome. The pattern of these unintended changes can be very different to those as caused by ‘random’ mutations.

This means that plants and other organisms can be created with changes not only in their genetic structure, but with unintended biological effects and risks that are clearly different to plants derived from conventional breeding.

Therefore, Testbiotech is assuming that on the basis of the EUCJ ruling, plants derived from the new methods of genetic engineering will in each case have to undergo mandatory risk assessment before a decision is made on agricultural usage or release into the environment. It is now up to the legislator to implement the decision of the court in a way that protects consumer choice and the precautionary principle.

Christoph Then, Phone 0049 151 54638040,