Brussels, Belgium
April 26, 2005
European Commission
Directorate General JRC
Joint Research Center
Institute for Health and Consumer Protection
Community Reference Laboratory for GM Food and Feed
Report on the In-House Validation of a Detection
Method for Event Bt10 Maize using a Qualitative PCR Assay
EXECUTIVE
SUMMARY
Following the
Commission Decision of 18 April 2005 (2005/317/EC) 'on emergency
measures regarding the non-authorized genetically modified
organism Bt10 in maize products", the JRC as Community Reference
Laboratory (CRL) for the GM Food and Feed, Regulation EC
1829/2003), has carried out an in-house validation of the
event-specific detection method proposed by GeneScan on Bt10
maize developed by Syngenta Crop Protection AG. The validation
was conducted according to internationally accepted guidelines.
Syngenta Crop
Protection AG provided the DNA samples (genomic DNA extracted
from the Bt10 maize line and from a control wild type maize
line). GeneScan provided the event-specific detection method
based on a qualitative PCR assay.
The rest of
the JRC validation demonstrated that the method reliably detects
an amplification product specific for Bt10 maize, and therefore
allows discriminating event Bt10 from other GM-events in maize
lines. The sensitivity of the method is below 0.1%.
The absolute LOD of the method is below 20 copies. This
corresponds to less than 0.1% in relative terms when 50 ng are
analyzed in PCR.
Bt10 can be selectively detected also when present in low
concentration in mixture with Bt11.
The method is
therefore considered by the CRL as fit for the purpose of Bt10
detection and is the only accepted to certify the presence of
Bt10 in maize commodities in accordance with the Commission
Decision 2005/317/EC.
Validation report in PDF format:
http://gmo-crl.jrc.it/detectionmethods/Bt10%20validation%20report.pdf
Method:
http://gmo-crl.jrc.it/detectionmethods/Bt10%20validation%20report.pdf
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