Detection, identification and quantification of NGTs in EU authorization procedures – No solution without legislative change

<ns3:p>For the purposes of GMO authorisation, applicants are required to submit validated methods for the detection, identification and quantification (DIQ). For classical transgenic organisms, this requirement has proven workable. For products derived from New Genomic Techniques (NGTs), specifically those introducing small insertions and deletions (InDels) without foreign genetic material, it has not. NGT-induced genomic changes are frequently indistinguishable from naturally occurring mutations, making identification legally required but technically unachievable with currently available analytical tools. This open letter examines whether recently proposed DIQ methodologies, including genomic fingerprinting approaches based on single nucleotide variant (SNV) profiling, can bridge this gap. We find that while such approaches advance detection capabilities, they fall short of the identification and quantification standards demanded by EU law, for reasons such as the absence of universal pangenome datasets, the complexity of polyploid crop genomes, the loss of fingerprint integrity through elite line crossing, and the dependence of recombination rates on multiple species-specific factors. The mismatch between legal requirements and scientific feasibility has consequences for authorisation procedures, supply chain compliance, organic farming integrity, and international trade. We conclude that no purely technical solution is forthcoming and that legislative change is necessary. Aligning the EU’s evidentiary standards with technical reality is a precondition for a functional and enforceable GMO authorisation system.</ns3:p>