64 GERMINATION.CA NOVEMBER 2018 TheimpactofEurope’srecentcourtrulingonplantbreedinginnovation.MarcelBruins/SeedWorld.com AGREATLOSSFOREUROPE MANY MEMBERS OF the plant breeding sector in Europe are voicing their opposition against the European Court of Justice’s (ECJ) July 25 ruling, which states that crops obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive. The ruling, which subjects some of the most promising plant breeding innovations to the EU’s rules and regula- tions for GMOs, is the talk of the town amongst plant breeders and the wider agricultural community. Seed World sat down with Garlich von Essen, secretary general of the European Seed Association (ESA), to discuss its consequences and impact. Seed World (SW): Looking at the international media reactions and published statements, it seems the ECJ’s ruling has come as a big surprise to most observers. Garlich von Essen (GvE): That is true. It’s fair to say that many expected the Court to follow the opinion of its Advocate General Bobeck who had taken a very different approach in his interpretation of the relevant EU Directive. In most cases, that is what the Court does: follow the Advocate General and add further details. And of course, the intervening Member States like the United Kingdom or Sweden, as well as three EU institutions, foremost the EU Commission, basically all argued that a differentiated view should be taken. In the end, the Court opted for a very static interpretation of the letter of the law rather than a forward-looking, more dynamic one as suggested by the Advocate General and others. It took an extremely conservative, legalistic approach. SW: What direction of regulatory clarification was the indus- try hoping for? GvE: The seed sector in Europe had hoped for a clarifica- tion that finally acknowledged that these technologies can be applied in different ways, leading to different results that may be treated differently by the regulator. While some lead to a regulated GMO, others do not. This differ- entiation can only be made when we do not solely look at technologies but also consider the final outcome of the process, i.e. the final plant product. It is the approach most other countries all over the world are now following as they realize that the rather simplistic approaches of the old GM rules are not fit for the purposes of the next era of plant breeding innovation. Unfortunately, the judges overturned the opinion of the Advocate General who had proposed exactly such a more differentiated, more end result-oriented interpretation of the EU legislation. SW: Will the Court’s ruling stifle plant breeding innovation in Europe? GvE: The commercial release of any new variety obtained by advanced mutagenesis breeding methods now requires the regular EU GMO risk assessment clearance, which constructs an immense financial hurdle that effec- tively rules out applications for any smaller market or species. Today, no applications for cultivation of GMOs are pending in the EU. Not only is the authorization procedure notoriously cumbersome and slow, it’s also completely politicized with Member States now having the right to ban the cultivation of GMOs on their own territory even following an EU-level approval. Before this background, a wider introduction of new varieties developed with the latest breeding methods is financially and practically impossible. We should not forget the impact on further research. Field trials with plants classified as GMOs have basi- cally ceased to exist in Europe. We must now expect that the same will happen to research projects involving advanced mutagenesis breeding. SW: Bayer, BASF and probably some others, have already announced that they will not pursue advanced genetic plant breeding anymore in the EU. Are you seeing more companies and inventors saying this too? GvE: I would expect that this position will become the rule, not be an exception. It also needs to be said that such relocation of plant breeding-related research and innovation activities (and consequent product develop- ment and marketing) will be easier for those entities that already possess respective facilities outside the EU. The smaller and more regionally or even locally focused European companies are the ones that will suffer most. It is sad to see that history seems to repeat itself. We already observed this effect with the classical GM tech- nology and products. Those now applauding the ruling as preserving a diverse European plant breeding sector will in the end see that quite the contrary will become true. Only larger companies would be capable of cross- ing the high regulatory and financial bars of the EU’s GM authorization system.