at Google ScholarTitle data
Purnhagen, Kai ; Bartsch, Detlef ; Eckermann, Kolja ; Hubar-Kolodziejczyk, Aleksandra ; Lämke, Jörn ; Pallarz, Steffen ; Wesseler, Justus:
Detection, identification and quantification of NGTs in EU authorization procedures – No solution without legislative change.
In: Open Research Europe.
(2026)
.
Abstract in another language
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 including 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.
Further data
| Item Type: | Article in a journal |
|---|---|
| Refereed: | Yes |
| Institutions of the University: | Faculties > Faculty of Law, Business and Economics Faculties > Faculty of Law, Business and Economics > Department of Law Faculties > Faculty of Life Sciences: Food, Nutrition and Health > Chair Food Law > Chair Food Law - Univ.-Prof. Dr. Kai Purnhagen Profile Fields > Emerging Fields > Innovation and Consumer Protection Profile Fields > Emerging Fields > Food and Health Sciences Research Institutions > Research Units > Forschungsstelle für Deutsches und Europäisches Lebensmittelrecht |
| Result of work at the UBT: | Yes |
| DDC Subjects: | 300 Social sciences > 340 Law |
| Date Deposited: | 05 May 2026 05:17 |
| Last Modified: | 05 May 2026 05:17 |
| URI: | https://eref.uni-bayreuth.de/id/eprint/96973 |