Roads forward for European GMO policy-uncertainties in wake of ECJ judgment have to be mitigated by regulatory reform

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dc.identifier.uri http://dx.doi.org/10.15488/5229
dc.identifier.uri https://www.repo.uni-hannover.de/handle/123456789/5276
dc.contributor.author Wasmer, Martin
dc.date.accessioned 2019-08-26T07:56:08Z
dc.date.available 2019-08-26T07:56:08Z
dc.date.issued 2019
dc.identifier.citation Wasmer, M.: Roads forward for European GMO policy-uncertainties in wake of ECJ judgment have to be mitigated by regulatory reform. In: Frontiers in Bioengineering and Biotechnology 7 (2019), 132. DOI: https://doi.org/10.3389/fbioe.2019.00132
dc.description.abstract This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer. eng
dc.language.iso eng
dc.publisher Lausanne : Frontiers Media S.A.
dc.relation.ispartofseries Frontiers in Bioengineering and Biotechnology 7 (2019)
dc.rights CC BY 4.0 Unported
dc.rights.uri https://creativecommons.org/licenses/by/4.0/
dc.subject CJEU C-528/16 eng
dc.subject CRISPR/Cas eng
dc.subject Directed mutagenesis eng
dc.subject Directive 2001/18/EC eng
dc.subject Future policy eng
dc.subject Genome editing eng
dc.subject GMO regulation eng
dc.subject New genetic modification techniques (nGM) eng
dc.subject Genes eng
dc.subject Genetic engineering eng
dc.subject Mutagenesis eng
dc.subject CJEU C-528/16 eng
dc.subject CRISPR/Cas eng
dc.subject Directed mutagenesis eng
dc.subject Directive 2001/18/EC eng
dc.subject Genetic modifications eng
dc.subject GMO regulation eng
dc.subject Laws and legislation eng
dc.subject.ddc 570 | Biowissenschaften, Biologie ger
dc.title Roads forward for European GMO policy-uncertainties in wake of ECJ judgment have to be mitigated by regulatory reform
dc.type article
dc.type Text
dc.relation.issn 2296-4185
dc.relation.doi https://doi.org/10.3389/fbioe.2019.00132
dc.bibliographicCitation.volume 7
dc.bibliographicCitation.firstPage 132
dc.description.version publishedVersion
tib.accessRights frei zug�nglich


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