The evolving EU regulatory framework for precision breeding

Dennis Eriksson

doi:10.1007/s00122-018-3200-9

Abstract

Plant breeding has always relied on progress in various scientific disciplines to generate and enable access to genetic variation. Until the 1970s, available techniques generated mostly random genetic alterations that were subject to a selection procedure in the plant material. Recombinant nucleic acid technology, however, started a new era of targeted genetic alterations, or precision breeding, enabling a much more targeted approach to trait management. More recently, developments in genome editing are now providing yet more control by enabling alterations at exact locations in the genome. The potential of recombinant nucleic acid technology fueled discussions about potentially new associated risks and, starting in the late 1980s, biosafety legislation for genetically modified organisms (GMOs) has developed in the European Union. However, the last decade has witnessed a lot of discussions as to whether or not genome editing and other precision breeding techniques should be encompassed by the EU GMO legislation. A recent ruling from the Court of Justice of the European Union indicated that directed mutagenesis techniques should be subject to the provisions of the GMO Directive, essentially putting many precision breeding techniques in the same regulatory basket. This review outlines the evolving EU regulatory framework for GMOs and discusses some potential routes that the EU may take for the regulation of precision breeding.

Highlights

Ever since humans started to actively cultivate plants for near-settlement access to harvest 12–14,000 years ago, the genetic make-up of plants has been altered to better suit human needs in terms of cultivation properties and nutritional quality
When the first transgenic plants were produced in the early 1980s (Barton et al 1983; Herrera-Estrella et al 1983), further discussions were triggered about biosafety assessments and regulation of the commercial activities within the field of plant genetic engineering, and the first biosafety legislation on genetically modified organisms (GMOs) was drafted in the European Union (EU) in the late 1980s
A recent ruling from the Court of Justice of the European Union (CJEU) on the legal status of mutagenesis gives an indication regarding how the EU GMO legal framework may be applied. This Court ruling stated that the risks linked to the use of new mutagenesis techniques might prove to be similar to those that result from the production and release of a transgenic GMO. Excluding these organisms from the scope of the GMO Directive would compromise the objective, which is to avoid adverse effects on human health and the environment, and the exemption that applies to the products of conventional mutagenesis should not apply to the products of directed and other new mutagenesis techniques (CJEU 2018)

Summary

Introduction

Ever since humans started to actively cultivate plants for near-settlement access to harvest 12–14,000 years ago, the genetic make-up of plants has been altered to better suit human needs in terms of cultivation properties and nutritional quality. When the first transgenic plants were produced in the early 1980s (Barton et al 1983; Herrera-Estrella et al 1983), further discussions were triggered about biosafety assessments and regulation of the commercial activities within the field of plant genetic engineering, and the first biosafety legislation on genetically modified organisms (GMOs) was drafted in the European Union (EU) in the late 1980s.

Results

Conclusion