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Abstract

According to a predominant interpretation of the C-528/16 judgment of the Court of Justice of the European Union, mutants resulting from gene editing, even those featuring only single nucleotide variants, should be subject to the authorization procedures designed for organisms developed through genetic modification (i.e. insertion of large DNA fragments). In this article, we illustrate practical problems with the authorization of products of gene editing in the EU. On the basis of these problems, we analyze the influence of the current interpretation of EU legislation and judgment on the practical ability to authorize and detect such products on the EU market. We show that the predominant interpretation of the judgment leads to legally unacceptable consequences, in particular to the violation of the principle of proportionality with regard to individuals who wish to develop and market products of gene editing. As a result of our considerations, we show that the C-528/16 judgment did not need to be interpreted in the dominant way.

Keywords

GMO; Gene editing; Detection; Policy making; Legislation; Principle of proportionality

Published in

New Biotechnology
2021, volume: 60, pages: 183-188
Publisher: ELSEVIER

SLU Authors

Global goals (SDG)

SDG16 Peace, justice and strong institutions

UKÄ Subject classification

Plant Biotechnology
Law

Publication identifier

  • DOI: https://doi.org/10.1016/j.nbt.2020.10.008

Permanent link to this page (URI)

https://res.slu.se/id/publ/109378