Biotech Updates

Regulatory Status of Gene-edited Agricultural Products in the EU

October 11, 2017

Governments all over the world are struggling with the regulatory status of gene-edited organisms. Should they be regulated? A paper authored by René Custers from VIB in Flanders, Belgium focuses on the regulatory status of gene-edited organisms within the European regulatory framework.

A stepwise analysis is performed that comes to the conclusion that gene-edited agricultural products that carry edits that can also occur naturally by mating and/or natural recombination are not genetically modified organisms. They are not subject to the provisions of EU legislation, and they are outside the scope of the EU GMO definition.

On the question of whether they should be regulated, it is argued that it is difficult to require regulatory oversight that would go beyond what we now require for conventional products that can carry the same types of alterations. A regulatory approach is pleaded for that abides to fundamental principles of law making, and which allows for gene editing to be developed responsibly.

For more information, read the full paper in Emerging Topics in Life Sciences.