Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing part 2

The document "Definition of Minimum Performance Requirements for analytical methods of GMO testing" (ENGL 2015) is a guidance developed by the ENGL and the EU Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF). It supports the development and validation of methods for GMO analysis submitted in the frame of applications for EU market authorisation of GMO products, as well as those to be used in the official control of food and feed. The guidance document provides definitions and requirements to assess the performance of the methods developed for the detection and quantification of GMOs based on real-time PCR. More recently, technologies like digital PCR were successfully applied in various fields for the quantification of nucleic acid molecules, including GMOs. Moreover, GM animals and products developed by means of so-called new genomic techniques (Broothaerts et al. 2021) are being released on the market and present additional challenges from the analytical viewpoint. Therefore, ENGL experts have extended the original method performance parameters for guiding users in the development and validation of digital PCR methods for GMO analysis. While the developments in the fields of GM animals and new genomic techniques are still evolving, in addition to the Minimum Performance Requirements guidelines also specific recommendations for methods for the detection and quantification of organisms with short genomic alterations and of GM animals are provided. Given that developments in the fields of GM animals and new genomic techniques are ongoing, these recommendations may be further elaborated in the future.