Regulatory aspects of gene editing in Argentina.

Argentina is a world leader in regards to regulation and adoption of genetically modified (GM) crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively by the Argentinian regulators, who implemented simple but solid pioneering regulatory criteria for gene edited crops. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of "novel combination of genetic material" derived from the Cartagena Protocol on Biosafety is of decisive importance. After some pilot cases that have been managed under this criteria, now applicants appreciate the ease, speed and predictability of the regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.