Regulatory requirements for the identification, detection and quantification of gene-edited products in light of the (r)evolution of new genomic techniques : State of the Art and Prospects for Changes

The key requirement for GMO authorization is the submission of analytical methods for the detection, identification, and quantification (DIQ), which has proven challenging in case of New Genomic Techniques (NGTs) due to the minimal genomic alterations induced by the latter. Currently available non-analytical approaches, such as blockchain traceability and probabilistic analysis, while potentially useful for monitoring, are insufficient for authorization purposes. The lack of reliable DIQ methods hinders the authorization of NGT products and raises concerns for both organic and conventional agriculture, where the presence of NGT products go undetected. Therefore, the existing GMO regulatory framework requires reevaluation to address the challenges posed by NGTs while ensuring compliance with the broader EU food law framework.