GMO molecular characterization details

GMO detailed information

GMO:
MON1445
Alias:
UID:
MON-Ø1445-2
Tradename:

Roundup Ready
Company:
Bayer Crop Science (formerly Monsanto Company)
Developer:

Bayer Crop Science (formerly Monsanto Company)
Species:
Gossypium hirsutum
(cotton)
Traits:
EU authorisation:

General Information

Inserts / Modification

Name:	insert_MON1445
Comment:	Insert order indicates order of genetic elements as described in the T-DNA. Sequencing of the pre-insertion locus demonstrated that 67 bp of cotton genomic DNA were deleted upon insertion. Cotton MON1445 was shown to contain one additional base pair at the 3' junction next to the T-DNA border that was not present in the parental line.
Map:

Genetic Elements:

Reference: ANZFA

Elements:

Order	Name	Donor	Position	Definition	Trait
1	V-RB-RHIRD	Agrobacterium tumefaciens	-
2	T-rbcS_E9-PEA	Pisum sativum	-	3' untranslated region (3' UTR) f the rinulose-1,5-bisphosphate carboxylase, small subunit (rbcS E9) gene. Coruzzi et al. (1984) EMBO J. 3:1671-1679
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	TP-ctp2-ARATH	Arabidopsis thaliana	-
5	P-34S FMV	Figwort mosaic virus	-	34S promoter derived from Figwort mosaic virus (FMV). Shepard et al. (1987) Phytopathology 77:1668-1673; Richins et al. (1987) Nucl Acids Res. 15:8451-8466; Gowda et al. (1989) J Cell Biochem. 13D (supplement):301
6	CS-aadA-ECOLX	Escherichia coli	-	3''(9)-O-aminoglycoside adenyltransferase (aadA). Fling et al. (1985) Nucleic Acid Res. 13(19):7095-7106	Streptomycin/spectromycin resistance
7	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
8	CS-nptII-ECOLX	Escherichia coli	-	Neomycin phosphotransferase II gene from the Eschrichia coli Tn5 transposon. Beck et al (1982). Gene, 19, 327-336	Kanamycin/neomycin resistance
9	P-35S-CaMV	Cauliflower mosaic virus	-

Related DNA Sequences:

Acc.No.	Reference	Sequence	Size (bp)	Annotation
	ANZFA	No
GX660824	NCBI - GenBank	Yes	320	Sequence 7 from patent US 7820392, sequence of event MON1445 (including amplicon for method QT-EVE-GH-003)
RIKILT_MON1445_event	Wageningen Food Safety Research (WFSR)	Yes	87	Amplicon sequence of MON1445 for event-specific method QT-EVE-GH-003 without probe

Detection Methods

35 results

Name	Type	Target	Description	Validation	Standardisation	Verification
QL-CON-CP1/pFMV2	construct-specific	GT200, GT73, GTSB77, H7-1, J101, J163, MON1445, MON1698, MON87705, MON88302, MON88913, MON89788, RBMT22-082, RBMT22-186, RBMT22-238, RBMT22-262, ZSR500, ZSR502, ZSR503	Qualitative conventional PCR method for detection of the junction between the FMV promoter and the cp4-epsps gene (BVL G30.40-11).	ring trial validation	national standard	1
QL-CON-00-008	construct-specific	2904/1 kgs, ASR368, DBN9004, DBN9936, GT200, GT73, GTSB77, H7-1, J101, J163, 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	3
QL-CON-35S-F/nptII-R	construct-specific	23-18-17, 23-198, 31807, 31808, 5345, 8338, ATBT04-06, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, BT10 potato, BT12 potato, BT16 potato, BT17 potato, BT18 potato, BT23 potato, BT6 potato, BXN10211, CZW-3, EE-1, Event 1, FLAVR SAVR, MON1076, MON1445, MON15985, MON1698, MON531, MON757, MON80100, MON863, MON87460, SP951, SPBT02-7, pap1 GM Gypsophila	Qualitative real-time PCR (TaqMan) method for detection of the junction between the CaMV 35S promoter and the nptII gene (Reiting, 2010).	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	3
QL-ELE-npt 1-5'/npt 1-3'	element-specific	CS-nptII-ECOLX, V-nptII-ECOLX	Qualitative real-time PCR (TaqMan) method for detection of the nptII gene (Scholtens et al., 2013).	in-house validation	none	3
QL-ELE-PFMV 1-5'/PFMV 1-3'	element-specific	P-34S FMV	Qualitative real-time PCR (TaqMan) method for detection of P-FMV (Mano et al., 2009)	in-house validation	none	3
QL-ELE-P-FMV-F/P-FMV-R	element-specific	P-34S FMV	Qualitative real-time PCR (TaqMan) method for detection of the P-FMV promoter (Debode et al., 2013)	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-00-002	element-specific	CS-nptII-ECOLX, V-nptII-ECOLX	Qualitative conventional PCR method for detection of neomycin phosphotransferase II gene (ISO 21569)	ring trial validation	ISO standard	2
QL-ELE-00-003	element-specific	CS-nptII-ECOLX, V-nptII-ECOLX	Qualitative conventional PCR method for detection of the neomycin phosphotransferase II gene (nptII) (BVL L 00.00-31, 2001)	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	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	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-00-010	element-specific	E-FMV, P-34S FMV	Qualitative conventional PCR method for detection of Figwort mosaic virus 34S promoter (Pan et al., 2007)	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-00-015	element-specific	E-FMV, P-34S FMV	Qualitative real-time PCR (TaqMan) method for detection of Figwort mosaic virus 34S promoter (ISO/TS 21569-5).	ring trial validation	ISO standard	3
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-00-024	element-specific	T-rbcS_E9-PEA	Qualitative real-time PCR (TaqMan) method for detection of the terminator of the pea ribulose-1,5-bisphosphate carboxylase small subunit (rbcS) E9 gene (EU-RL GMFF GMOMETHODS database as of January 20, 2017).	ring trial validation	EU reference method	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-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	3
QT-EVE-GH-003	event-specific	MON1445	Quantitative real-time PCR (TaqMan) method for detection of cotton event MON1445 (EU-RL GMFF GMOMETHODS database as of January 13, 2014)	ring trial validation	EU reference method	3
QT-TAX-GH-015	taxon-specific	Gossypium hirsutum	Quantitative real-time PCR (TaqMan) method for detection of cotton fiber-specific acyl carrier protein (ACP1) gene (EU-RL GMFF GMOMETHODS database as of January 07, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 2	ring trial validation	EU reference method	1
QT-TAX-GH-016	taxon-specific	Gossypium hirsutum	Quantitative PCR method for detection of putative cotton SAH7 protein gene (123 bp) (Mazzara et al., 2006). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 2	ring trial validation	EU reference method	1
QT-TAX-GH-018	taxon-specific	Gossypium hirsutum	Quantitative real-time PCR (TaqMan) method for detection of cotton alcohol dehydrogenase C (adhC) gene (EU-RL GMFF GMOMETHODS database as of January 17, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	1
QT-TAX-GH-019	taxon-specific	Gossypium hirsutum	Quantitative real-time PCR (Taqman) method for detection of cotton alcohol dehydrogenase C gene (EU-RL GMFF GMOMETHODS database as of November 1, 2018). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	1
QT-TAX-GH-020	taxon-specific	Gossypium hirsutum	Quantitative real-time PCR (TaqMan) method for detection of cotton alcohol dehydrogenase C (adhC) 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-GH-021	taxon-specific	Gossypium hirsutum	Quantitative real-time PCR (TaqMan) method for detection of putative cotton SAH7 protein gene (115bp) (EU-RL GMFF GMOMETHODS database as January 22, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 2	ring trial validation	EU reference method	1

Catalogue number	Source	Value	Type	Certified
AOCS 0804-A	AOCS	<0.4 % (m/m)	dried powder	yes
AOCS 0804-A2	AOCS	<0.08 % (m/m)	dried powder	yes
AOCS 0804-B	AOCS	>99.40 % (m/m)	dried powder	yes
AOCS 0804-B2		≥99.10 % (m/m)		yes
5211511301	Eurofins GeneScan	100 cp/µl	genomic DNA	no

Continent	Country	File Reference	Intendend Use Details	Legal Status Details	Legislation	Decision Date
Europe	EU	EFSA-GMO-RX-MON1445 (8.1.a-8.1.b-20.1.b)	feed - feed produced from GMO	approved - approved	Regulation (EC) No 1829/2003	April 24, 2015
Europe	EU	EFSA-GMO-RX-MON1445 (8.1.a-8.1.b-20.1.b)	other uses - products other than food and feed containing or consisting of GMO for the same uses as any other of this species with the exception of cultivation	not approved - not submitted	Regulation (EC) No 1829/2003	April 24, 2015
Europe	EU	EFSA-GMO-RX-MON1445 (8.1.a-8.1.b-20.1.b)	cultivation - cultivation	not approved - not submitted	Regulation (EC) No 1829/2003	April 24, 2015
Europe	EU	EFSA-GMO-RX-MON1445 (8.1.a-8.1.b-20.1.b)	food - food produced from GMO	approved - approved	Regulation (EC) No 1829/2003	April 24, 2015

Citation	Publication year	Publishing authority	Publication type	Content types
Commission implementing decision (EU) 2015/693 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON1445 (MON-Ø1445-2) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2766)	2015	EU	EU Commission Decision	decision document
Scientific Opinion on application EFSA-GMO-RX-MON1445 for renewal of the authorisation for continued marketing of cottonseed oil, food additives, feed materials and feed additives produced from cotton MON1445 that were notified as existing products under Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 from Monsanto	2011	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-MON1445) for renewal of the authorisation for continued marketing of existing food produced from cotton MON1445 (cottonseed oil), food additives produced from cotton MON1445 and feed produced from cotton MON1445 (feed materials and feed additives) from Monsanto	2011	EFSA	EFSA overall opinion	risk assessment document
Application for renewal of the authorization for continued marketing of existing foods and food ingredients produced from MON1445 cotton, as well as food additives, feed materials and feed additives produced from MON1445 cotton that were notified according to Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 on genetically modified food and feed. Part II - Summary	2011	EFSA	application summary	application summary

European GMO Initiative for a Unified Database System

GMO detailed information

GMO:

Alias:

UID:

Tradename:

Company:

Developer:

Species:

Traits:

EU authorisation:

General Information

Links regarding to this GMO:

Inserts / Modification

Transformation Vectors

Detection Methods

Reference Materials

Authorisation

Literature reference