Commentary: Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?

¹ Scientific Institute of Public Health, Division of Biosafety and Biotechnology, Rue J. Wytsmanstraat 14, 1050 Brussels, Belgium
² Université Libre de Bruxelles, IBMM-IRIBHM, Rue des professeurs Jeener et Brachet 12, 6041 Gosselies, Belgium
³ Ghent University, Department Molecular Biotechnology, Coupure Links 653, 9000 Ghent, Belgium
⁴ VIB, Department for Molecular Biomedical Research, Technologiepark 927, 9052 Ghent, Belgium
⁵ Ghent University, Department of Biomedical Molecular Biology, Technologiepark 927, 9052 Ghent, Belgium
⁶ Université Catholique de Louvain, Laboratoire d'ingénierie des protéines et des peptides, Institut des Sciences de la Vie, Place Croix du Sud 4-5, bte 3, 1348 Louvain-la-Neuve, Belgium
⁷ KATHO, Departement verpleegkunde en biotechnologie, HIVB – Campus Roeselare, Wilgenstraat 32, 8800 Roeselare, Belgium
⁸ VIB, Rijvisschestraat 120, 9052 Zwijnaarde, Belgium
⁹ Ghent University, Department of Plant Production, Faculty of Bioscience Engineering, Coupure Links 653, 9000 Ghent, Belgium

Corresponding author: didier.breyer@iph.fgov.be

Abstract

In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.