Event-specific method for the quantification of maize line T25 using real-time PCR v. 1.01 : validation report and validated method

The JRC as European Union Reference Laboratory (EURL) for the GM Food and Feed (see Regulation EC 1829/2003), in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a collaborative study to assess the performance of a quantitative event-specific method to detect and quantify the T25 transformation event in maize flour (unique identifier ACS-ZMØØ3-2). The collaborative trial was conducted according to internationally accepted guidelines. Bayer CropScience provided the method-specific samples (genomic DNA extracted from the 0% and 100% event T25 maize), whereas the JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage). The trial involved thirteen laboratories from eleven Countries of the European Union. The results of the collaborative trial fully met ENGLs performance requirements and the scientific understanding about satisfactory method performance. Therefore, the JRC as European Union Reference Laboratory considers the method validated as fit for the purpose of regulatory compliance. The results of the collaborative study are publicly available under http://gmo-crl.jrc.it/. The method will also be submitted to CEN, the European Standardisation body, to be considered as international standard. This document replaces "Event-specific Method for the Quantification of Maize line T25 Using Real-time PCR - Validation Report and Protocol" with ISBN number 92-79-00107-8 and PUBSY request number JRC32123.