GMO molecular characterization details

GMO detailed information

GMO:
GTS 40-3-2
Alias:

40-3-2, MON 40-3-2, RRS
UID:
MON-Ø4Ø32-6
Tradename:

Roundup Ready
Companies/Institutions:
Bayer Crop Science (formerly Monsanto Company)
Species:
Glycine max
(soybean)
Traits:
EU authorisation:

Inserts / Modification

Name:	insert_GTS 40-3-2
Comment:
Map:

Genetic Elements:

Reference: application documents

Elements:

Order	Name	Donor	Position	Definition	Trait
1	P-e35S-CaMV	Cauliflower mosaic virus	-	Cauliflower mosaic virus (CaMV) 35S promoter with duplicated enhancer region; inserted element length can vary between e.g. 307bp/322bp/296bp/551bp/615bp. Kay R, et al. (1987) Science 236, 1299-1302.
2	TP-ctp4-PETHY	Petunia hybrida	-
3	CS-CP4epsps-RHIRD	Agrobacterium tumefaciens ssp. CP4	-	5-enolpyruvylshikimate- 3-phosphate synthase gene. Steinruecken et al. (1980) Biochem Biophys Res Com. 94:1207-1212.	Glyphosate tolerance
4	T-nos-RHIRD	Agrobacterium tumefaciens	-	3' untranslated region (3' UTR) of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA. Bevan et al. (1983) Nucleic Acids Res. 11: 369-385; Fraley et al. (1983) Proc Nat L Acad Sci. 80:4803-4807.

Related DNA Sequences:

Acc.No.	Reference	Sequence	Size (bp)	Annotation
	application documents	No
RIKILT_CP4epsps_element_GTS_40-3-2	Wageningen Food Safety Research (WFSR)	Yes	118	Amplicon sequence of CP4epsps for element-specific method QL-ELE-epsps 1-5'/epsps 3-3' without probe
RIKILT_GTS_40-3-2_event	Wageningen Food Safety Research (WFSR)	Yes	85	Amplicon sequence of GTS 40-3-2 for event-specific method without probe
RIKILT_ctp4-CP4epsps_construct_GTS_40-3-2	Wageningen Food Safety Research (WFSR)	Yes	121	Amplicon sequence of ctp4-CP4epsps for construct-specific method QT-CON-00-001 without probe

Detection Methods

35 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	3
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	3
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	2
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	2
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	2
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	2
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	2
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	2
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	3
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	2
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	2
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	2
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-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	3
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-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	3
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	3
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	3
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	2
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	3
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	3
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	3
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	3
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

Reference Materials

Catalogue number	Source	Value	Type	Certified	Available
5211500601	Eurofins GeneScan	100 cp/µl	genomic DNA	no	no
5211514202	Eurofins GeneScan	20 cp/μl	genomic DNA	no	no
5211514220	Eurofins GeneScan	20 cp/µl	genomic DNA	no	no
5211521801	Eurofins GeneScan	10,000 cp/µl	genomic DNA	no	no
ERM-BF410a	JRC - CRM (ERM)	<0.03 % (m/m)	dried powder	yes	no
ERM-BF410ak	JRC - CRM (ERM)	<0.07 % (m/m)	dried powder	yes	no
ERM-BF410ap	JRC - CRM (ERM)	<0.009 %	dried powder	yes	yes
ERM-BF410b	JRC - CRM (ERM)	0.1 % (m/m)	dried powder	yes	no
ERM-BF410bk	JRC - CRM (ERM)	0.1 % (m/m)	dried powder	yes	no
ERM-BF410bp	JRC - CRM (ERM)	>98.5 %	dried powder	yes	yes
ERM-BF410c	JRC - CRM (ERM)	0.5 % (m/m)	dried powder	yes	no
ERM-BF410cp	JRC - CRM (ERM)	0.1 % (m/m)	dried powder	yes	yes
ERM-BF410dk	JRC - CRM (ERM)	1 % (m/m)	dried powder	yes	no
ERM-BF410dp	JRC - CRM (ERM)	1 % (m/m)	dried powder	yes	yes
ERM-BF410e	JRC - CRM (ERM)	2 % (m/m)	dried powder	yes	no
ERM-BF410ep	JRC - CRM (ERM)	10 % (m/m)	dried powder	yes	yes
ERM-BF410gk	JRC - CRM (ERM)	10 % (m/m)	dried powder	yes	no

Authorisation

UID

Decision Date

Legislation

Traits

Genetic Elements

Tradenames

Companies/Institutions

Your Search criteria is: ( GMO: GTS 40-3-2 ) AND ( country: EU ) Refine Search

	Application reference number	Species	GMO	Intended use and EU authorisation status	Applicant	Commission decision number	Expiry date
1	EFSA-GMO-RX-023	Glycine max (soybean)	GTS 40-3-2	food feed cultivation other	Bayer CropScience	(EU) 2023/1213	20.06.2033
2	EFSA-GMO-RX-40-3-2-(8.1a/20.1a)	Glycine max (soybean)	GTS 40-3-2	food feed cultivation other	Monsanto Europe	2012/82/EU	09.02.2022
3	EFSA-GMO-RX-40-3-2-(8.1b/20.1b)	Glycine max (soybean)	GTS 40-3-2	food feed cultivation other	Monsanto Europe	2012/82/EU	09.02.2022
4	EFSA-GMO-NL-2005-24	Glycine max (soybean)	GTS 40-3-2	food feed cultivation other	Monsanto Europe

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
European Union Reference Laboratory for Genetically Modified Food and Feed, 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 – corrected version 1. Online Publication (2017)	2017	JRC	EU reference method protocol	detection
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
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
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
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
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
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
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
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 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
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
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

European GMO Initiative for a Unified Database System

GMO detailed information

GMO:

Alias:

UID:

Tradename:

Companies/Institutions:

Species:

Traits:

EU authorisation:

General Information

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Inserts / Modification

Transformation Vectors

Detection Methods

Reference Materials

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Literature reference