GMO molecular characterization details

GMO detailed information

GMO:
DP305423 x GTS 40-3-2
Alias:

DP305423 x 40-3-2, 305423 x GTS 40-3-2, 305423 x 40-3-2
UID:
DP-3Ø5423-1 x MON-Ø4Ø32-6
Tradename:

Plenish, Roundup Ready
Companies/Institutions:
DuPont, Pioneer Hi-Bred International
Species:
Glycine max
(soybean)
Traits:
EU authorisation:

no Reference materials could be found

Detection Methods

36 results

Name	Type	Target	Description	Validation	Standardisation	Verification
QL-CON-00-001	construct-specific	GTS 40-3-2	Qualitative conventional PCR method for detection of soybean event GTS 40-3-2 (ISO 21569)	ring trial validation	ISO standard	1
QL-CON-00-006	construct-specific	GTS 40-3-2	Qualitative conventional PCR method for detection of soybean event GTS 40-3-2 (ISO 21569)	ring trial validation	ISO standard	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-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-00-017	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-TAX-GM-001	taxon-specific	Glycine max	Qualitative real-time PCR (SYBRGreen) method for detection of soybean lectin gene (Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-TAX-GM-002	taxon-specific	Glycine max	Qualitative conventional PCR method for detection of soybean lectin gene (ISO/FDIS 21569).	ring trial validation	ISO standard	1
QL-TAX-GM-008	taxon-specific	Glycine max	Qualitative conventional PCR method for detection of soybean lectin gene (ISO 21569)	ring trial validation	ISO standard	1
QT-CON-00-001	construct-specific	GTS 40-3-2	Quantitative real-time PCR (TaqMan) method for detection of soybean event GTS 40-3-2 (ISO 21570)	ring trial validation	ISO standard	1
QT-CON-00-002	construct-specific	GTS 40-3-2	Quantitative real-time PCR (TaqMan) method for detection of soybean event GTS 40-3-2 (Hird et al., 2003).	ring trial validation	national standard	1
QT-CON-00-003	construct-specific	GTS 40-3-2	Quantitative real-time PCR (TaqMan) method for detection of soybean event GTS 40-3-2 (ISO/FDIS 21570).	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-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-00-004	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-EVE-GM-005	event-specific	GTS 40-3-2	Quantitative real-time PCR (TaqMan) method for detection of soybean event GTS 40-3-2 (EU-RL GMFF GMOMETHODS database as of October 01, 2014)	ring trial validation	EU reference method	1
QT-EVE-GM-008	event-specific	DP305423	Quantitative real-time PCR (TaqMan) method for detection of soybean event DP305423 (EU-RL GMFF GMOMETHODS database as of January 23, 2014)	ring trial validation	EU reference method	1
QT-TAX-GM-001	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin gene	ring trial validation	ISO standard	1
QT-TAX-GM-002	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin gene (ISO 21570). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	ISO standard	1
QT-TAX-GM-003	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin (Le1) gene (EU-RL GMFF GMOMETHODS database as of July 2020). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	1
QT-TAX-GM-004	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin gene (Hird et al., 2003).	ring trial validation	unknown	1
QT-TAX-GM-005	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) for detection of soybean lectin gene (EU-RL GMFF GMOMETHODS database as of November 8, 2023).	ring trial validation	EU reference method	1
QT-TAX-GM-007	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin gene	ring trial validation	ISO standard	1
QT-TAX-GM-009	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin (Le1) gene (EU-RL GMFF GMOMETHODS database as of January 22, 2014)	ring trial validation	EU reference method	1
QT-TAX-GM-020	taxon-specific	Glycine max	Quantitative real-time PCR (TaqMan) method for detection of soybean lectin (Le1) gene (EU-RL GMFF GMOMETHODS database as of January 22, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	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

Citation	Publication year	Publishing authority	Publication type	Content types
Commission Implementing Decision (EU) 2023/1213 of 21 June 2023 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean 40-3-2 (MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council	2023	EU	EU Commission Decision	decision document
Assessment of genetically modified soybean 40-3-2 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-023)	2022	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Application for renewal of the authorisation for continued marketing of products containing, consisting of, or produced from 40-3-2 soybean under Regulation (EC) No 1829/2003 on genetically modified food and feed (Commission Implementing Decision 2012/82/EU of 10 February 2012), EFSA-GMO-RX-023 / EFSA-Q-2021-00077, Part III - Summary	2021	EFSA	application summary	application summary
COMMISSION IMPLEMENTING DECISION (EU) 2017/2448 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (notified under document C(2017) 9040)	2017	EU	EU Commission Decision	decision document
Scientific Opinion on an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 3 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003	2016	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 an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 × 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003	2016	EFSA	EFSA overall opinion	risk assessment document
COMMISSION IMPLEMENTING DECISION (EU) 2015/698 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2773)	2015	EU	EU Commission Decision	decision document
SCIENTIFIC OPINION Scientific Opinion on application EFSA-GMO-NL-2007-45 for the placing on the market of herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer	2013	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
TECHNICAL REPORT Overall opinion of the European Food Safety Authority in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 on application (reference EFSA-GMO-NL-2007-45) for the placing on the market of herbicide tolerant, high oleic acid genetically modified soybean 305423 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer	2013	EFSA	EFSA overall opinion	risk assessment document
Scientific Opinion on an application (EFSA-GMO-NL-2005-24) for the placing on the market of the herbicide tolerant genetically modified soybean 40-3-2 for cultivation under Regulation (EC) No 1829/2003 from Monsanto EFSA Panel on Genetically Modified Organisms (GMO)	2012	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 application (reference EFSA-GMO-NL-2005-24) for the placing on the market of the genetically modified herbicide tolerant soybean 40-3-2 for cultivation under Regulation (EC) No 1829/2003 from Monsanto European Food Safety Authority	2012	EFSA	EFSA overall opinion	risk assessment document
Commission implementing decision of 10 February 2012 as regards the renewal of the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified soybean 40-3-2 (MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2012) 700) (2012/82/EU)	2012	EU	EU Commission Decision	decision document
PCR reactions set up and amplification conditions Online Publication (2010); QT-CON-00-002	2010		EU reference method protocol	detection
Overall opinion of the European Food Safety Authority in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 on the application (reference EFSA-GMO-RX-40-3-2[8-1a/20-1a]) for renewal of the authorisation of existing products produced from glyphosate tolerant genetically modified soybean 40-3-2 for food and feed uses from Monsanto	2010	EFSA	EFSA overall opinion	risk assessment document
Scientific Opinion on applications (EFSA-GMO-RX-40-3-2[8-1a/20-1a], EFSA-GMO-RX-40-3-2[8-1b/20-1b]) for renewal of authorisation for the continued marketing of (1) food containing, consisting of, or produced from genetically modified soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; (3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto EFSA Panel on Genetically Modified Organisms (GMO)	2010	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 the application (reference EFSA-GMO-RX-40-3-2[8-1b/20-1b]) for renewal of the authorisation of existing products produced from glyphosate tolerant genetically modified soybean 40-3-2 for food and feed uses from Monsanto	2010	EFSA	EFSA overall opinion	risk assessment document
Mathesius, C. A., Barnett, J. F., Jr., Cressman, R. F., Ding, J., Carpenter, C., Ladics, G. S., . . . Delaney, B. (2009). Safety assessment of a modified acetolactate synthase protein (GM-HRA) used as a selectable marker in genetically modified soybeans. Regulatory Toxicology and Pharmacology, 55(3), 309-320.	2009	Research group	peer-reviewed article	safety
SUMMARY OF THE APPLICATION FOR THE AUTHORISATION OF GENETICALLY MODIFIED 305423x40-3-2 SOYBEAN AND DERIVED FOOD AND FEED IN ACCORDANCE WITH REGULATION (EC) 1829/2003	2008	EFSA	application summary	application summary
PART II SUMMARY SUMMARY OF THE APPLICATION FOR AUTHORISATION OF GENETICALLY MODIFIED 305423 SOYBEAN AND DERIVED FOOD AND FEED IN ACCORDANCE WITH REGULATION (EC) 1829/2003	2008	EFSA	application summary	application summary
Application for renewal of the authorisation for continued marketing of existing food additives, feed materials and feed additives produced from 40-3-2 soybean that were notified according to Articles 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 on genetically modified food and feed	2008	EFSA	application summary	application summary
Application for renewal of the authorisation for continued marketing of existing 40-3-2 soybean products that were authorised under Directive 90/220/EEC (Decision 96/281/EC) and subsequently notified according to Articles 8(1)(a) and 20(1)(a) of Regulation (EC) No 1829/2003 on genetically modified food and feed	2008	EFSA	application summary	application summary
Application under Regulation (EC) No 1829/2003 on genetically modified food and feed for authorization of 40-3-2 soybean for cultivation in the European Union Part II Summary	2008	EFSA	application summary	application summary
Mazzara M., Munaro B., Larcher S., Grazioli E., Charles Delobel C., Savini C., Van Den Eede G.; 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. Online Publication (2007)	2007	JRC	website	detection
Hird H., Powell J., Johnson M.L., Oehlschlager S.; Determination of percentage of RoundUp Ready soya in soya flour using real-time polymerase chain reaction: interlaboratory study J AOAC Int 86:66-71 (2003)	2003		peer-reviewed article	detection

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

Authorisation

Literature reference