Report on the verification of the performance of a MON 810 event-specific method on maize line MON 810 using real-time PCR : validation report and protocol

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF) (see Regulation EC No 1829/2003), has carried out an in-house verification study to assess the performance of the MON810 method to detect and quantify the MON810 transformation event in maize DNA (unique identifier MON-ØØ810-6). The method has previously undergone a full validation on samples represented by certified reference material. The present verification was conducted in order to verify the performance of the validated method on the control samples provided by the applicant as requested by Annex I.2.C.2 to Regulation (EC) No 641/2004 stating that "The method shall be applicable to samples of the food or feed, to the control samples and to the reference material, which is referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003." The study was conducted according to internationally accepted guidelines (1,2). In accordance with 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, the CRL-GMFF carried out a verification of the event-specific detection method previously validated by the Federal Institute for Risk Assessment (BfR) in collaboration with the American Association of Cereal Chemists (AACC), Joint Research Centre (JRC) of the European Commission (EC), Institute for Reference Material and Measurement (IRMM), the Institute for Health and Consumer Protection (IHCP) and GeneScan, Berlin; Monsanto Company provided the control samples (MON810 maize seeds and conventional maize seeds) used in the verification. The JRC prepared the in-house verification samples (calibration samples and blind samples at different GM percentages). The results of the in-house verification study were evaluated with reference to ENGL method performance requirements (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and to the results of the full validation (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of CRL-GMFF in-house verification study are made publicly available at http://gmocrl. jrc.ec.europa.eu/statusofdoss.htm).