Event-specific method for the quantitation of rice line LLRICE62 using real-time PCR : validation report

The JRC as Community Reference Laboratory (CRL) 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 LLRICE62 transformation event in rice DNA (unique identifier ACS-OS002-5). 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 LLRICE62 rice ), whereas the JRC prepared the validation samples ( calibration samples and blind samples at unknown GM percentage ). The trial involved eleven laboratories from eight Countries of the European Union. The results of the collaborative trial met the ENGL performance requirements and the scientific understanding about satisfactory method performance. Therefore, the JRC as Community Reference Laboratory considers the method validated as fit for the purpose of regulatory compliance. The results of the collaborative study are made publicly available under http://gmo-crl.jrc.it/. The method will also be submitted to ISO for consideration as international standard.