Home About Browse Search
Svenska


A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward

Eriksson, Dennis and Kershen, Drew and Nepomuceno, Alexandre and Pogson, Barry J. and Prieto, Humberto and Purnhagen, Kai and Smyth, Stuart and Wesseler, Justus and Whelan, Agustina (2019). A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. 222 :4 , 1673-1684
[Journal article]

[img] PDF - Accepted Version
511kB

Abstract

A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome-edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case-by-case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process-based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.

Authors/Creators:Eriksson, Dennis and Kershen, Drew and Nepomuceno, Alexandre and Pogson, Barry J. and Prieto, Humberto and Purnhagen, Kai and Smyth, Stuart and Wesseler, Justus and Whelan, Agustina
Title:A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward
Year of publishing :2019
Volume:222
Number:4
Page range:1673-1684
Number of Pages:12
Publisher:Wiley
ISSN:0028-646X
Language:English
Publication Type:Journal article
Refereed:Yes
Article category:Scientific peer reviewed
Version:Accepted version
Full Text Status:Public
Subjects:(A) Swedish standard research categories 2011 > 4 Agricultural Sciences > 401 Agricultural, Forestry and Fisheries > Agricultural Science
(A) Swedish standard research categories 2011 > 5 Social Sciences > 506 Political Science > Public Administration Studies
Keywords:CJEU, directed mutagenesis, genetically modified organism (GMO), genome editing, precision breeding
URN:NBN:urn:nbn:se:slu:epsilon-p-98842
Permanent URL:
http://urn.kb.se/resolve?urn=urn:nbn:se:slu:epsilon-p-98842
Additional ID:
Type of IDID
DOI10.1111/nph.15627
Web of Science (WoS)000467301100003
ID Code:16181
Faculty:LTV - Fakulteten för landskapsarkitektur, trädgårds- och växtproduktionsvetenskap
Department:(LTJ, LTV) > Department of Plant Breeding (from 130101)
Deposited By: SLUpub Connector
Deposited On:01 Oct 2019 07:02
Metadata Last Modified:14 Dec 2019 00:15

Repository Staff Only: item control page

Downloads

Downloads per year (since September 2012)

View more statistics

Downloads
Hits