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

Title data

Eriksson, Dennis ; Kershen, Drew ; Nepomuceno, Alexandre ; Pogson, Barry J. ; Prieto, Humberto ; Purnhagen, Kai ; Smyth, Stuart ; Wesseler, Justus ; Whelan, Agustina:
A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward.
In: New Phytologist. Vol. 222 (2019) Issue 4 . - pp. 1673-1684.
ISSN 1469-8137
DOI: https://doi.org/10.1111/nph.15627

Abstract in another language

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.

Further data

Item Type: Article in a journal
Refereed: Yes
Institutions of the University: Faculties > Faculty of Life Sciences: Food, Nutrition and Health
Faculties > Faculty of Life Sciences: Food, Nutrition and Health > Chair Food Law > Chair Food Law - Univ.-Prof. Dr. Kai Purnhagen
Profile Fields > Emerging Fields > Food and Health Sciences
Research Institutions > Research Units > Forschungsstelle für Deutsches und Europäisches Lebensmittelrecht
Result of work at the UBT: No
DDC Subjects: 300 Social sciences > 340 Law
500 Science > 500 Natural sciences
500 Science > 570 Life sciences, biology
500 Science > 580 Plants (Botany)
600 Technology, medicine, applied sciences > 630 Agriculture
Date Deposited: 24 Jul 2020 07:33
Last Modified: 24 Jul 2020 07:33
URI: https://eref.uni-bayreuth.de/id/eprint/56111