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EUROPEAN-SEED.COM I EUROPEAN SEED I 19 a list of eight newer plant breeding methods in the context of the current EU GMO legislation Directive 200118. The outcome of the evaluation has never been published officially by the EU Commission. However the majority of the experts came to the conclusion that six of these newer breeding methods do not result in a GM plant. Other expert groups and plant breeders associations came to similar results see Table 1 Although these experts are aligned with regard to the outcomes of their evaluations the EU Commission has still not come to a conclusion. The publication of guidelines by the Commission has been delayed several times. Non-governmental organisations some organic farming organisations and a German environmental authority published legal expert reports which had come to the conclusion that all newer breeding methods have to be regulated under current GM law because the GM definition of the EU legislation is according to their interpretation a pure process-based definition excluding the characteristics of the product created by those processes. These entities blame industry for trying to introduce GM through the backdoor. Their legal expert statements were questioned by other official statements such as the Opinion on the Legal Classification of New Plant Breeding Techniques in particular ODM and CRISPR-Cas9 which was published by the German competent authority in December 2015.5 This statement came to the conclusion that plants which exhibit point mutations induced by means of ODM and CRISPR-Cas9 techniques do not constitute GMOs within the meaning of the Directive. It is not only the use of a genetic engineering method that is decisive for classification as GMO but also the resulting product. This must differ from plants which could also arise through conventional breeding methods. For the point mutations in question here this is not the case. Those genetic modifications could also arise through other mutagenesis techniques. A well-known expert from the organic sector raised his voice on the potential of newer plant breeding methods saying CRISPRCAS has great potential and You can turn off genes for susceptibility to disease or insert from the related wild plant resistance genes back into modern varieties.6 SIMILAR NEEDS SCIENTIFIC COMMUNITY AND SEED SECTOR The scientific community in Europe is alarmed by the ongoing debate and legal uncertainty which impede scientific progress. According to a statement issued by the European Plant Science Organisation it welcomes the outcome of the majority opinion of the Member States expert working group report and asks the European Commission as a matter of urgency . to provide legal certainty for science and industry concerning the application and exploration of New Plant Breeding Techniques. 7 In addition the scientific community asks for a more detailed and comprehensive discussion on a new approach for the regulation of new plants that might be exclusively based on the new characteristics of a producttrait. They also address the requirement that such a concept needs a clear and reliable definition based on scientific evidence of what constitutes a novel plant trait and thus needs to be assessed by an appropriate body legal certainty to avoid overregulation whereby an unwarranted number of processes and products will have to undergo expensive and lengthy authorisation procedures creating a disadvantage for small- and medium-sized enterprises and scientists. LEGAL CERTAINTY IS ESSENTIAL Governmental policy must be firmly based on sound scientific principles to avoid the risk of impeding innovation in plant breeding otherwise farmers access to better varietiesand consequently the availability of improved and sufficient products for consumersis in danger. Regulatory policy will determine utilisation of methods across companies and across crops. An overly high regulatory burden will limit utilisation to the largest companies and cash crops e.g. corn soybeans as well as to a limited number of traits e.g. herbicide tolerance. While products from newer breeding methods are in the RD pipeline of several if not the majority of public institutes and companies only one company has asked for regulatory assessment in some EU Member States. In 2015 the US-based company Cibus developed a herbicide-tolerant rapeseed variety using ODM a breeding method which results in a non-GM product according to the expert reports listed in Table 1. Regulatory bodies in Germany Sweden the United Kingdom and Finland took the position that the Cibus rapeseed is non-GM and could be released without approval. The EU Commission intervened asking Member States to forbid the growing of rapeseed plants until the Commission came to a conclusion regarding the legal interpretation of Directive 200118. In addition several NGOs objected to the decision of the competent authority in Germany but the Federal Office of Consumer Protection and Food Safety rejected the objection against its decision. All these activities have triggered a public debate about the future regulation of new plant breeding techniques. Breeding Method MS Expert Working Group Report German Commission on Biological Safety ZKBS2 European Seed Association ESA3 EFSA4 Current GM procedures for environmental safety assess- ment applicable and sufficient Detectability of Genetic Modification1 Oligonucleotide-directed mutagenesis ODM non-GM non-GM non-GM similar to natural or induced mutagenesis no Zinc-Finger Nuclease 12 non-GM non-GM non-GM similar to natural or induced mutagenesis no Zinc-Finger Nuclease 3 GM GM GM yesless off-target effects compared to transgenic plants yes Cisgenesis GM GM GM yescomparable to conventional breeding yes Grafting of non-GM scion onto GM rootstock non-GM non-GM non-GM no Agroinfiltration non-GM non-GM non-GM no RNA-dependent DNA methylation RdDM non-GM non-GM non-GM no alteration of genetic material no Reverse Breeding non-GM non-GM non-GM no Table 1. Comparison of the outcomes of the different expert groups on the analysis of the applicability of EU GM law Directive 200118 on newer plant breeding methods. Evaluation of the fruits