Event-specific method for the quantification of oilseed rape line RT73 using real-time PCR, Validation report
The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF) (see Regulation EC 1829/2003), in collaboration with the European Network of GMO Laboratories (ENGL), has carried out an international collaborative study to assess the performance of a quantitative event-specific method to detect and quantify the RT73 transformation event in oilseed rape DNA (unique identifier MON-00073-7). The collaborative trial was conducted according to internationally accepted guidelines (1.2). In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Monsanto provided the detection method and the samples (whole oilseed rape seed containing the transformation event and whole conventional oilseed rape seeds), whereas the JRC extracted the DNA and prepared the validation samples (calibration samples and blind samples at unknown GM percentage DNA/DNA). The collaborative trial involved fourteen laboratories from twelve European Countries. The results of the international collaborative trial met the ENGL performance requirements and the scientific understanding about satisfactory method performance. Therefore, the CRL-GMFF considers the method validated as fit for the purpose of regulatory compliance.
Bibliographic Reference: EUR 22918 EN (2007), 44 pp. Free of charge
Availability: Katalogue Number: LB-NA-22918-EN-C The PDF version can be downloaded from: http://bookshop.europa.eu
ISBN: ISBN 978-92-79-06935-2
Record Number: 200819759 / Last updated on: 2008-05-05
Original language: en
Available languages: en