Regulation of plant varieties obtained using new plant breeding technologies in the European Union
Keywords:genome editing, genetically modified organisms, mutagenesis, substantial equivalence, determination methods, regulation
Purpose. Analyze the legal regulation of plants obtained using new plant breeding technologies in the European Union.
Results. General information on New Plant Breeding Technologies (genome editing) is given. In contrast to the traditional mutagenesis NPBTs provide an opportunity to obtain the precise and target genome modification such as replacement, insertion or deletion of the single nucleotide at the specific loci or even site-specific insertion of the whole gene. Thanks to new breeding technologies plants resistant to pathogens, herbicides and abiotic stress factors with increased yields and improved nutritional properties have already been developed. In many countries, plants developed with genome editing are not subject to special regulation and equated to those obtained by traditional mutagenesis. At the same time, according to the decision of the European Court of 25 July 2018, organisms obtained as a result of targeted mutagenesis are subject to streamlining acts which regulate work with genetically modified organisms (GMOs). In this regard, the regulatory framework of the European Union concerning traditional GMOs was analyzed in terms of risk assessment and obtaining a permit for commercial use. It was shown that some provisions of the EU legislation, for example, the assignment of mutagenesis under the influence of ionizing radiation to safe methods of selection and analysis of substantial equivalence via simple comparison of GMOs and their non-GM counterparts do not fully reflect recent scientific advances. The problem of the lack of adequate methods for detecting new organisms obtained using genome editing tools is also discussed.
Conclusions. The current regulatory framework formed in the European Union in relation to the handling of GMOs, and which, according to a court decision, should also be applied in case of regulation of genome edited plants does not meet the requirements of the present and needs changes.
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