GMO molecular characterization details

GMO detailed information

GMO:
Bt11 x NK603
Alias:
UID:
SYN-BTØ11-1 x MON-ØØ6Ø3-6
Tradename:

Agrisure CB/LL, Roundup Ready 2
Companies/Institutions:
Syngenta
Species:
Zea mays
(maize, corn)
Traits:
EU authorisation:

no Reference materials could be found

Detection Methods

49 results

Name	Type	Target	Description	Validation	Standardisation	Verification
QL-CON-00-003	construct-specific	Bt10 maize, Bt11	Qualitative conventional PCR method for detection of maize event Bt11 (ISO 21569)	ring trial validation	ISO standard	1
QL-CON-00-008	construct-specific	2904/1 kgs, ASR368, DBN9004, DBN9936, GT200, GT73, GTSB77, H7-1, J101, J163, KWS20-1, MON1445, MON1698, MON71200, MON71700, MON71800, MON80100, MON802, MON809, MON832, MON87411, MON87427, MON87429, MON87705, MON88017, MON88302, MON88913, MON89788, NK603, RBMT22-082, RBMT22-186, RBMT22-238, RBMT22-262, ZSR500, ZSR502, ZSR503	Qualitative real-time PCR (TaqMan) method for detection of the junction between the chloroplast transit peptide 2 and the CP4 epsps gene (ISO 21569 AMD1).	ring trial validation	ISO standard	1
QL-CON-00-011	construct-specific	40416, 4114, 43A47, 676, 678, 680, A2704-12, A2704-21, A5547-127, A5547-35, B0050-027, Bt10 maize, Bt11, DAS1507, DAS59122, DAS59132, DBN9004, DP32316, Falcon GS 40/90, GU262, HCN10, HCR-1, Liberator, MZHG0JG, MZIR098, SYHT0H2, T120-7, T14, T25, T45, Topas 19/2	Qualitative real-time PCR (TaqMan) method for detection of the junction between the 35S promoter and the phosphinothricin N-acetyltransferase (pat) gene (ISO 21569-3).	ring trial validation	ISO standard	1
QL-ELE-00-001	element-specific	P-Cauliflower mosaic virus	Qualitative conventional PCR method for detection of Cauliflower mosaic virus 35S promoter (Official Collection of Methods according to § 64 LFGB, L 00.00-31)	ring trial validation	national standard	1
QL-ELE-00-004	element-specific	P-Cauliflower mosaic virus	Qualitative conventional PCR method for detection of Cauliflower mosaic virus 35S promoter (Lipp et al., 2001)	ring trial validation	ISO standard	1
QL-ELE-00-005	element-specific	P-Cauliflower mosaic virus	Qualitative conventional PCR method for detection of Cauliflower mosaic virus 35S promoter (ISO/FDIS 21569)	ring trial validation	ISO standard	1
QL-ELE-00-006	element-specific	T-nos-RHIRD	Qualitative conventional PCR method for detection of nopaline synthase terminator (Official Collection of Methods according to § 64 LFGB, L 00.00-31)	ring trial validation	national standard	1
QL-ELE-00-007	element-specific	T-nos-RHIRD	Qualitative conventional PCR method for detection of nopaline synthase terminator (EU-Project SMT4-CT96-2072:1998)	ring trial validation	national standard	1
QL-ELE-00-009	element-specific	T-nos-RHIRD	Qualitative conventional PCR method for detection of nopaline synthase terminator (Lipp et al.,2001)	ring trial validation	ISO standard	1
QL-ELE-00-011	element-specific	T-nos-RHIRD	Qualitative real-time PCR (TaqMan) method for detection of nopaline synthase terminator (ISO 21569 AMD1).	ring trial validation	ISO standard	1
QL-ELE-00-012	element-specific	E-35S-CaMV, P-Cauliflower mosaic virus, P-scp1-SYNTH	Qualitative real-time PCR (TaqMan) method for detection of Cauliflower mosaic virus 35S promoter (partim P-35S). Part of the qualitative duplex real-time PCR (TaqMan) method for detection of Cauliflower mosaic virus 35S promoter and nopaline synthase terminator (ISO 21569 AMD1)	ring trial validation	ISO standard	1
QL-ELE-00-013	element-specific	T-nos-RHIRD	Qualitative real-time PCR (TaqMan) method for detection of nopaline synthase terminator (partim T-nos). Part of the qualitative duplex real-time PCR (TaqMan) method for detection of Cauliflower mosaic virus 35S promoter and nopaline synthase terminator (partim T-nos) (ISO 21569 AMD1)	ring trial validation	ISO standard	1
QL-ELE-00-016	element-specific	CS-cry1Ab-BACTU, CS-cry1Ab_1Ac_tr-SYNTH, CS-cry1Ac-BACTU	Qualitative real-time PCR (TaqMan) method for detection of the element coding for synthetic cry1Ab/Ac genes (ISO/TS 21569-6).	ring trial validation	ISO standard	1
QL-ELE-00-017	element-specific	P-Cauliflower mosaic virus	Qualitative real-time PCR (SYBRGreen) method for detection of P-35S CaMV (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-ELE-00-018	element-specific	T-nos-RHIRD	Qualitative real-time PCR (SYBRGreen) method for detection of T-nos-RHIRD (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-ELE-00-019	element-specific	CS-CP4epsps-RHIRD	Qualitative real-time PCR (SYBRGreen) method for detection of CS-CP4epsps-RHIRD (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-ELE-00-020	element-specific	CS-cry1Ab-BACTU	Qualitative real-time PCR (SYBRGreen) method for detection of CS-cry1Ab-BACTU (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-ELE-00-021	element-specific	CS-pat-STRVR	Qualitative real-time PCR (SYBRGreen) method for detection of CS-pat-STRVR (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-ELE-00-023	element-specific	T-Cauliflower mosaic virus	Qualitative real-time PCR (SYBRGreen) method for detection of T-35S pCAMBIA sequences (EU-RL GMFF GMOMETHODS database as of January 20, 2017).	ring trial validation	EU reference method	1
QL-ELE-00-025	element-specific	CS-pat-STRVR	Qualitative real-time PCR (TaqMan) method for detection of the synthetic phosphinothricin acetyltransferase (pat) gene (BVL L00.00-154). EU-RL GMFF GMOMETHODS database as of December 23, 2016.	ring trial validation	EU reference method	1
QL-ELE-AINT 2-5'/AINT 2-3'	element-specific	I-actin	Qualitative real-time PCR (TaqMan) method for detection of rice actin 1 intron (I-ractI) (Mano et al. 2009).	in-house validation	none	1
QL-ELE-P-Rice actin-F/P-Rice actin-R	element-specific	P-act1-ORYSA	Qualitative real-time PCR (TaqMan) method for detection of rice actin 1 promoter (P-ractI) (Debode et al. 2013).	in-house validation	none	1
QL-ELE-Patf-n2/Patr-n2	element-specific	CS-pat-STRVR	Qualitative real-time PCR (TaqMan) method for detection of the pat gene (Xu et al., 2006)	in-house validation	none	1
QL-ELE-T-35S-F/T-35S-R	element-specific	T-Cauliflower mosaic virus	Qualitative real-time PCR (TaqMan) method for detection of the 35S terminator from Cauliflower mosaic virus (Debode et al., 2013)	in-house validation	none	1
QL-ELE-cry1A 4-5'/cry1A 4-3'	element-specific	CS-cry1Ab-BACTU	Qualitative real-time PCR (TaqMan) method for detection of the cry1Ab gene (Scholtens et al. 2013).	in-house validation	none	1
QL-ELE-epsps 1-5'/epsps 3-3'	element-specific	CS-CP4epsps-RHIRD	Qualitative real-time PCR (TaqMan) method for detection of the CP4-epsps gene (Scholtens et al. 2013).	in-house validation	none	1
QL-ELE-epsps2 1-5'/epsps2 1-3'	element-specific	CS-CP4epsps-RHIRD	Qualitative real-time PCR (TaqMan) method for detection of the CP4 epsps gene (Mano et al., 2009)	in-house validation	none	1
QL-TAX-ZM-002	taxon-specific	Zea mays	Qualitative real-time PCR (SYBRGreen) method for detection of maize alcoholdeydrogenase 1 gene (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-TAX-ZM-003	taxon-specific	Zea mays	Qualitative conventional PCR method for detection of the maize invertase gene (ISO 21569)	ring trial validation	ISO standard	1
QT-CON-00-006	construct-specific	Bt10 maize, Bt11	Quantitative real-time PCR (TaqMan) method for detection of maize event Bt11 (Shindo et al., 2002)	ring trial validation	ISO standard	1
QT-ELE-00-001	element-specific	P-Cauliflower mosaic virus	Quantitative real-time PCR (TaqMan) method for detection of Cauliflower mosaic virus 35S promoter (Feinberg et al., 2005)	ring trial validation	unknown	1
QT-ELE-00-002	element-specific	CS-pat-STRVR	Quantitative real-time PCR (TaqMan) method for detection of phosphinothricin N-acetyltransferase gene (Weighardt et al., 2004) (EURL GMFF GMOMETHODS database as of February 5, 2020)	ring trial validation	unknown	1
QT-ELE-00-003	element-specific	CS-cry1Ab-BACTU	Quantitative real-time PCR (TaqMan) method for detection of synthetic cryIA(b) gene (ISO/FDIS 21570)	ring trial validation	ISO standard	1
QT-ELE-00-004	element-specific	E-35S-CaMV, P-Cauliflower mosaic virus, P-scp1-SYNTH	Quantitative real-time PCR (TaqMan) method for detection of Cauliflower mosaic virus 35S promoter (ISO 21570 Annex B.1)	ring trial validation	ISO standard	1
QT-ELE-NOS ter 2-5' /NOS ter 2-3'	element-specific	T-nos-RHIRD	Quantitative real-time PCR (TaqMan) method for detection of T-nos (Kodama et al., 2009)	ring trial validation	none	1
QT-ELE-P35S 1-5'/P35S 1-3'	element-specific	P-Cauliflower mosaic virus	Quantitative real-time PCR (TaqMan) method for detection of the Cauliflower mosaic virus 35S promoter (Kodama et al., 2009)	ring trial validation	national standard	1
QT-EVE-ZM-006	event-specific	Bt11	Quantitative real-time PCR (TaqMan) method for detection of maize event Bt11 (ISO 21570)	ring trial validation	ISO standard	1
QT-EVE-ZM-008	event-specific	NK603	Quantitative real-time PCR (TaqMan) method for detection of maize event NK603 (EU-RL GMFF GMOMETHODS database as of October 01, 2014)	ring trial validation	EU reference method	1
QT-EVE-ZM-015	event-specific	Bt11	Quantitative real-time PCR (TaqMan) method for detection of maize event Bt11 (EU-RL GMFF GMOMETHODS database as of October 01, 2014)	ring trial validation	EU reference method	1
QT-TAX-ZM-001	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of maize alcohol dehydrogenase 1 (adh1) gene. Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	ISO standard	1
QT-TAX-ZM-002	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of the maize high-mobility-group A (hmgA) gene (ISO 21570). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	ISO standard	1
QT-TAX-ZM-003	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of maize alcohol dehydrogenase 1 (adh1) gene (EU-RL GMFF GMOMETHODS database as of October 01, 2014)	ring trial validation	EU reference method	1
QT-TAX-ZM-004	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) for detection of maize aldolase 1 (ald1) gene (EU-RL GMFF GMOMETHODS database as of July 14, 2016). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 2	ring trial validation	EU reference method	1
QT-TAX-ZM-005	taxon-specific	Zea mays	Quantitative PCR method for detection of maize high-mobility-group (hmg) gene (EU-RL GMFF GMOMETHODS database as of May 28, 2018).	ring trial validation	EU reference method	1
QT-TAX-ZM-006	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of maize starch synthase IIb gene (ISO 21570)	ring trial validation	ISO standard	1
QT-TAX-ZM-008	taxon-specific	Zea mays	Quantitative real-time PCR method for detection of maize high-mobility-group (hmg) gene (EU-RL GMFF GMOMETHODS database as of July 20, 2023). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	1
QT-TAX-ZM-011	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of the maize alcohol dehydrogenase 1 gene (EU-RL GMFF GMOMETHODS database as of March 06, 2014)	ring trial validation	EU reference method	1
QT-TAX-ZM-014	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of maize alcohol dehydrogenase 1 gene (EU-RL GMFF GMOMETHODS database as of March 06, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	1
QT-TAX-zSSIIb-3F/zSSIIb-4R	taxon-specific	Zea mays	Quantitative real-time PCR (TaqMan) method for detection of maize starch synthase IIb gene (Yang et al., 2005)	unknown	unknown	1

Description:	For Reference Materials, please consult the materials mentioned under the separate GMO events.
Links regarding to this GMO:
Transformation / Modification technique:	conventional crossing

	Application reference number	Species	GMO	Intended use and EU authorisation status	Applicant	Commission decision number	Expiry date
1	GMFF-2024-22152 AP194	Zea mays (maize, corn)	Bt11 x NK603	food feed cultivation other	Syngenta Crop Protection
2	GMFF-2024-22091 AP191	Zea mays (maize, corn)	Bt11 x NK603	food feed cultivation other	Syngenta Crop Protection

Citation	Publication year	Publishing authority	Publication type	Content types
Application for renewal of the authorisation to place on the market NK603 maize under Regulation (EC) No 1829/2003 on genetically modified food and feed, GMFF-2023-21250 RX040, Summary of Application	2024	EFSA	application summary	application summary
Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-016)	2021	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Commission implementing decision (EU) 2021/1392 of 17 August 2021 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021)5999)	2021	EU	EU Commission Decision	decision document
Application (EFSA-GMO-RX-016) for renewal of the authorisation of Bt11 maize import in the European Union under Articles 11 and 23 of Regulation (EC) No 1829/2003, Summary	2018	EFSA	application summary	application summary
Commission implementing decision (EU) 2015/684 of 24 April 2015 authorising the placing on the market of genetically modified maize NK603 (MON-ØØ6Ø3-6) and renewing the existing maize NK603 (MON-ØØ6Ø3-6) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2753)	2015	EU	EU Commission Decision	decision document
Huber, I. et al. (2013). Development and Validation of Duplex, Triplex, and Pentaplex Real-Time PCR Screening Assays for the Detection of Genetically Modified Organisms in Food and Feed. J. Agric. Food Chem. 61, 10293–10301	2013	Research group	peer-reviewed article	detection
Scientific Opinion - Statement supplementing the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize Bt11 for cultivation (C/F/96/05-10 second submission)	2011	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Commission Decision of 28 July 2010 renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council and repealing Decision 2004/657/EC (notified under document C(2010) 5129) (2010/419/EU)	2010	EU	EU Commission Decision	decision document
Opinion on application reference EFSA-GMO-RX-Bt11 for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No 1829/2003 from Syngenta Scientific Opinion of the Panel on Genetically Modified Organisms (Question No EFSA-Q-2007-146)	2009	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Overall opinion of the European Food Safety Authority in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 on applications (references EFSA-GMO-NL-2005-22, EFSA-GMO-RX-NK603) for the placing on the market of the genetically modified glyphosate tolerant maize NK603 for cultivation, food and feed uses, import and processing and for renewal of the authorisation of maize NK603 as existing products, both under Regulation (EC) No 1829/2003 from Monsanto Report of the GMO Unit (Questions No EFSA-Q-2005-249 and EFSA-Q-2008-075)	2009	EFSA	EFSA overall opinion	risk assessment document
Applications (references EFSA-GMO-NL-2005-22, EFSA-GMO-RX-NK603) for the placing on the market of the genetically modified glyphosate tolerant maize NK603 for cultivation, food and feed uses, import and processing and for renewal of the authorisation of maize NK603 as existing products, both under Regulation (EC) No 1829/2003 from Monsanto Scientific Opinion of the Panel on Genetically Modified Organisms (Questions No EFSA-Q-2005-249, No EFSA-Q-2008-075)	2009	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Opinion of the European Food Safety Authority in accordance with Articles 6 and 18 of Regulation (EC) No. 1829/2003 on application EFSA-GMO-RX-Bt11 Application for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No. 1829/2003 from Syngenta (Question No. EFSA-Q-2007-146)	2009	EFSA	EFSA overall opinion	risk assessment document
SCIENTIFIC OPINION Opinion on application reference EFSA-GMO-RX-Bt11 for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No 1829/2003 from Syngenta	2009	EFSA	Scientific opinion EFSA GMO Panel	risk assessment document
Grisolia, C. K., Oliveira, R., Domingues, I., Oliveira-Filho, E. C., Monerat, R. G., & Soares, A. M. V. M. (2009). Genotoxic evaluation of different delta-endotoxins from Bacillus thuringiensis on zebrafish adults and development in early life stages. Mutation Research-Genetic Toxicology and Environmental Mutagenesis, 672(2), 119-123.	2009	Research group	peer-reviewed article	safety
Opinion on application reference EFSA-GMO-RX-Bt11 for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No 1829/2003 from Syngenta. Scientific Opinion of the Panel on Genetically Modified Organisms (Question No EFSA-Q-2007-146).	2009	EFSA	Scientific opinion EFSA GMO Panel	risk assessment document
Application for renewal of authorization of Bt11 maize and derived products notified according to Articles 11 and 23 of Regulation (EC) No 1829/2003 on genetically modified food and feed. Part II - Summary	2008	EFSA	application summary	application summary
Application for authorization to use NK603 maize in the European Union, according to Regulation (EC) No 1829/2003 on genetically modified food and feed, including the use for cultivation of varieties Part II Summary	2008	EFSA	application summary	application summary
Application for authorization to use NK603 maize in the European Union, according to Regulation (EC) No 1829/2003 on genetically modified food and feed, including the use for cultivation of varieties Part II - Summary	2008	EFSA	application summary	application summary
Scientific Opinion - Request from the European Commission to review scientific studies related to the impact on the environment of the cultivation of maize Bt11 and 1507 (C/F/96/05-10 second submission)	2008	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/F/96/05.10) for the placing on the market of insect resistant genetically modified maize Bt11, for cultivation, feed and industrial processing, under Part C of Directive 2001/18/EC from Syngenta Seeds (Question No EFSA-Q-2004-012)	2005	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Commission Decision of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 1865) (2004/657/EC)	2004	EU	EU Commission Decision	decision document
Commission Decision of 19 July 2004 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance (notified under document number C(2004) 2761) (2004/643/EC)	2004	EU	EU Commission Decision	decision document
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference CE/ES/00/01) for the placing on the market of herbicide-tolerant genetically modified maize NK603, for import and processing, under Part C of Directive 2001/18/EC from Monsanto (Question No EFSA-Q-2003-003)	2003	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Kuribara, H., Shindo, Y., Matsuoka, T., Takubo, K., Futo, S., Aoki, N., et al. (2002). Novel reference molecules for quantitation of genetically modified maize and soybean. Journal of the AOAC International, 85, 1077–1089.	2002	AOAC	peer-reviewed article	detection
Shindo, Y., Kuribara, H., Matsuoka, T., Futo, S., Sawada, C., Shono, J., Akiyama, H., Goda, Y., Toyoda, M., Hino, A. (2002). Validation of real-time PCR analyses for line-specific quantitation of genetically modified maize and soybean using new reference molecules. Journal of the AOAC International, 85, 1119-1126	2002	AOAC	peer-reviewed article	detection
Scientific Committee on Plants - Opinion of the Scientific Committee on Plants on the submission for placing on the market of genetically modified insect resistant and glufosinate ammonium tolerant (Bt-11) maize for cultivation. Notified by Novartis Seeds SA Company (notification C/F/96/05-10 - first submission)	2000	Scientific Committee on Plants (EU)	scientific opinion	risk assessment document
Commission decision 98/292/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line Bt-11), pursuant to Council Directive 90/220/EEC	1998	EU	EU Commission Decision	decision document
Opinion of the Scientific Committee on Plants - Application for consent to place on the market genetically-modified maize with Btk resistance to Lepidoptera and herbicide tolerance to glufosinate ammonium (Bt11). Notification C/GB/96/M4/1.	1998	Scientific Committee on Plants (EU)	scientific opinion	risk assessment document

European GMO Initiative for a Unified Database System

GMO detailed information

GMO:

Alias:

UID:

Tradename:

Companies/Institutions:

Species:

Traits:

EU authorisation:

General Information

Links regarding to this GMO:

Inserts / Modification

Transformation Vectors

Detection Methods

Reference Materials

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Literature reference