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In-house validation of an Event-specific Method for the Quantification of Oliseed Rape RF2 using Real-time PCR

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The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house validation study to assess the performance of a quantitative event-specific method on the oilseed rape event RF2 (unique identifier ACS-BN002-5). 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, Bayer CropScience provided the detection method and the control samples. The EU-RL GMFF prepared the validation samples [calibration samples and blind samples at different GM percentages (DNA/DNA)]. The results of the in-house validation were evaluated with respect to method acceptance criteria and method performance requirements recommended by the European Network of GMO Laboratories (ENGL) (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm) and to its applicability in different real-time PCR instruments. The results obtained indicate that the method complies with the ENGL criteria. The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I – 2.C.2 to Regulation (EC) No 641/2004.
2012-05-07
Publications Office of the European Union
JRC68067
978-92-79-22476-8,   
1831-9424,   
EUR 25135 EN,    OP LB-NA-25135-EN-N,   
https://publications.jrc.ec.europa.eu/repository/handle/JRC68067,   
10.2788/37967,   
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