32 / SEEDWORLD.COM OCTOBER 2018 the old GM rules are not fit for purpose for the next era of plant breeding innovation. Unfortunately, the judges overturned the opinion of Advocate General who had proposed exactly such a more differentiated, more end result-oriented interpretation of the EU legislation. SW: Is this it, or are there other possibilities to appeal the ruling and get a different outcome? GvE: There is no appeal procedure to an ECJ preliminary ruling; the ruling’s interpretation of the Directive on those four questions submitted by the French Court stands. And any similar or related potential cases would be interpreted on the base of the interpretation given in this one. The problem is that science, unfortunately, has been pretty much absent and widely disregarded in this case. That has led to a ruling that may make sense from a purely legal point of view but that doesn’t make sense if we look at the biological facts as well as the technological developments. Why would we consider it necessary to regulate the same product by two different sets of rules? And how do we practically enforce rules that will consistently be challenged; not by man but by nature itself. It seems that more and more people start to see that it is probably not the ruling itself that is the problem but what it is based on: scientifically outdated concepts determining legal rules that today prove to be too narrow to keep pace with a changing reality. 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 effectively 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 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 basically ceased to exist in Europe. We must now expect that the same will happen to research projects involving advanced mutagenesis breed- ing. With that, also public research into plant breeding innova- tion applications will largely come to an end as crucial industry co-funding will dry out and public-private partnerships lack the necessary economic basis. This will have dramatic consequences for product development for Europe. SW: Do you expect Europe to lag behind other regions? GvE: Yes. Europe will start to lag behind. The only question is at what point in time this will become fully evident. Companies will quickly concentrate plant breeding related research and innovation activities outside of Europe. It is likely that this will go hand-in-hand with a refocusing of overall elite germplasm and variety development to those regions that are already embracing the new breeding methods and are gearing their respective regulatory frameworks to support this. But what is worse is the fundamental message the ruling sends to anybody considering a career in plant sciences in Europe: you’re not welcome here! That may prove the most devastating effect in the long run. SW: What impact do you think the decision will have on importers of GMO food and feed? Do you think the decision will impact future trade negotiations? GvE: It is probably a bit too early to fully understand and predict the consequences. The EU approval system for GM food and feed imports is already largely dysfunctional. Member States disregard the opinion of the EU’s competent scientific authority, the European Food Safety Authority (EFSA), and generally fail to approve any new product according to the applicable rules and procedure. Similarly, the European Parliament passes (non-binding) resolution after resolution asking the Commission not to apply the legislation, and in the absence of a decision by Member States, approve the import authorization based on the safety confirmation of EFSA. All of this tit-for-tat has resulted in a continuous backlog and undue delays — with the known negative consequences for the international trade. With the new methods, things will be very different. First, most countries other than the EU do not consider them to result in regulated GMOs. This means we have a fundamental differ- ence at the starting point. And if the new breeding methods are taken-up worldwide, and at the pace and breadth we predict, this will quickly result in dozens and probably soon hundreds of new varieties in many, many different species. All of these will be considered conventional in the countries they will be grown in. Even if these countries would acknowledge the EU’s different interpretation: such a massive influx of import applications can Garlich von Essen serves as secretary general of the European Seed Association.