Verification of the Performance of Bt11 and MIR604 Maize Event-specific Methods on the Maize Event Bt11 x MIR604 Using Real-time PCR. Validation Report and Protocols

The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established by Regulation (EC) No 1829/2003, has carried out a verification study to assess the performance of two quantitative event-specific methods on the maize event Bt11 x MIR604 (unique identifier SYN-BTØ11-1 x SYN-IR6Ø4-5) which combines the Bt11 and MIR604 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in maize samples. This study 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, Syngenta Seeds S.A.S. provided the detection methods and the control samples: genomic DNA extracted from homogenised seeds of Bt11 x MIR604 maize (NP2276Bt11/NP2391MIR604), genomic DNA extracted from homogenised seeds of non-GM maize (NP2276/NP2391) and flour ground from seeds of NP2276Bt11/NP2391MIR604 and from seed of NP2276/NP2391. The EURL-GMFF prepared the verification samples (calibration samples and blind samples at different GM percentages). The results of the in-house verification study were evaluated with reference to the European Network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl. jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this EURL-GMFF verification study are made publicly available at http://gmocrl. jrc.ec.europa.eu/.JRC.DG.I.4-Molecular biology and genomic

Verification of the Performance of MIR604 and GA21 Maize Event-specific Methods on the Maize Event MIR604 x GA21 Using Real-time PCR. Validation Report and Protocols

The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on maize event MIR604 x GA21 (unique identifier SYN-IR6Ø4-5 x MON-ØØØ21-9) which combines the MIR604 and GA21 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in maize samples. This study 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, Syngenta Seeds S.A.S. provided the detection methods and the control samples: genomic DNA extracted from homogenised seeds of MIR604 x GA21 maize (NP2171MIR604/NP2673GA21), genomic DNA extracted from homogenised seeds of non-GM maize (NP2171/NP2673) and flour ground from seed of NP2171MIR604/NP2673GA21 and from seed of NP2171/NP2673. The EURL-GMFF 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 the European network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl. jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this EURL-GMFF in-house verification studt are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.JRC.DG.I.4-Molecular biology and genomic

Report on the Verification of the Performance of MON 88017 and MON 810 Event-specific Methods on the Maize Event MON 88017 x MON 810 Using Real-Time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on the maize event MON 88017 x MON 810 (unique identifier MON-88Ø17-3 x MON-ØØ810-6) which combines the MON 88017 and MON 810 transformation events. The two methods have been previously validated individually on single-trait event, to detect and quantify each event in maize samples; a validation report for each method is available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm. This study 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 Europe S.A. provided the detection methods and the control samples: whole seeds of MON 88017 x MON 810 maize (TPX151-DT, GLP-0409-15526-S) and whole conventional maize seeds of EXP258 (GLP-0409-15528-S). 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 validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.JRC.DDG.I.4-Molecular biology and genomic

Event-specific Method for the Quantification of Soybean Line A5547-127 Using Real-time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 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 A5547-127 transformation event in soybean DNA (unique identifier ACS-GMØØ6-4). The collaborative trial 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 with 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 samples (genomic DNA from leaves of plants harbouring the A5547-127 event and from leaves of conventional A5547 soybean plants). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved twelve laboratories from eight European countries. The results of the international collaborative trial met the ENGL performance requirements. The method is, therefore, considered applicable to the control samples provided, in accordance with the requirements of Annex I-2.C.2 to Commission Regulation (EC) No 641/2004. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.it/.JRC.DDG.I.4-Molecular biology and genomic

Report on the Verification of the Performance of MON89034 and MON88017 Event-specific Methods on the Maize Event MON89034 x MON88017 Using Real-Time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on the maize event MON89034 x MON88017 (unique identifier MON-89Ø34-3 x MON-88Ø17-3) which combines the MON89034 and MON88017 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in maize samples. This study 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 Company provided the detection methods and the control samples: genomic DNA extracted from seeds of MON89034 x MON88017 maize, genomic DNA extracted from seeds of non-GM maize, seeds of MON89034 x MON88017 and seed of conventional maize. 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 validation results on the parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.ec.europa.eu/JRC.DDG.I.4-Molecular biology and genomic

Report on the Verification of the Performance of 59122 and NK603 Event-specific Methods on the Hybrid Maize Line 59122xNK603 Using Real-Time PCR. Validation Report and Protocol

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on the hybrid maize line 59122xNK603 (unique identifier DAS-59122-7xMON-ØØ6Ø3-6) which combines the 59122 and NK603 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in maize samples. This study 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, Pioneer Hi-Bred Intl. Inc. provided the detection methods and the control samples (59122xNK603 ground maize flour, conventional ground maize flour and non genetically modified control DNA). 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.it/doc/Method%20requirements.pdf) and to the validation results on the individual parental events (http://gmo-crl.jrc.it/statusofdoss.htm). The results of this CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.it/. CRL-JRC.I.6-Biotechnology and GMO

Report on the Verification of the Performance of 59122, 1507 and NK603 Event-specific Methods on the Hybrid Maize Line 59122x1507xNK603 Using Real-Time PCR - Validation Report and Protocol

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of three quantitative event-specific methods on the hybrid maize line 59122x1507xNK603 (unique identifier DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6) which combines the 59122, 1507 and NK603 transformation events. The three methods have been validated individually on single-trait events, to detect and quantify each event in maize samples. This study 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, Pioneer Hi-Bred Intl. Inc. provided the detection methods and the control samples (59122x1507xNK603 ground maize flour and conventional ground maize flour). 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.it/doc/Method%20requirements.pdf) and to the validation results on the individual parental events (http://gmo-crl.jrc.it/statusofdoss.htm). The results of this CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.it/.JRC.I.6-Biotechnology and GMO

Event-specific Method for the Quantification of Soybean Line 40-3-2 Using Real-time PCR - Validation Report and Protocol - Report on the Validation of a DNA Extraction Method for Soybean Seeds

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 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 40-3-2 transformation event in soybean DNA (unique identifier MON-¿4¿32-6). The collaborative trial 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 with 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 (soybean seeds containing the transformation event and conventional soybean seeds). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved fourteen laboratories from nine 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. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.it/.JRC.I.6-Biotechnology and GMO

Event-specific Method for the Quantification of Cotton MON 88913 Using Real-time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 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 MON 88913 transformation event in cotton DNA (unique identifier MON-88913-8). The collaborative trial 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 with 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: genomic DNA from cotton seeds harbouring the MON 88913 event (line ST 4664) and from conventional cotton seeds (line ST 474). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved twelve laboratories from nine European countries. The results of the international collaborative trial met the ENGL performance requirements. 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. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/JRC.DDG.I.4-Molecular biology and genomic

Event-specific Method for the Quantification of Soybean Line 40-3-2 Using Real-time PCR - Validation Report and Protocol - Report on the Validation of a DNA Extraction Method for Soybean Seeds

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 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 40-3-2 transformation event in soybean DNA (unique identifier MON-¿4¿32-6). The collaborative trial 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 with 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 (soybean seeds containing the transformation event and conventional soybean seeds). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved fourteen laboratories from nine 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. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.it/.JRC.I.6-Biotechnology and GMO