GMO molecular characterization details

GMO detailed information

GMO:
MIR604
Alias:
UID:
SYN-IR6Ø4-5
Tradename:

Agrisure RW
Companies/Institutions:
Syngenta
Species:
Zea mays
(maize, corn)
Traits:
EU authorisation:

General Information

Inserts / Modification

Name:	insert_MIR604
Comment:	The nucleotide sequence of the insert in maize event MIR604 has been determined. The intact T-DNA copy has been inserted with the exception of 43 bp and 44 bp deletions at the left and right borders respectively. In addition, three base pair changes have occurred in the insert, two of which result in amino acid substitutions in the PMI protein.
Map:

Genetic Elements:

Reference: patent documents

Elements:

Order	Name	Donor	Position	Definition	Trait
1	V-Flanking Ti-nos-RHIRD	Agrobacterium tumefaciens	-	Flanking sequence from Agrobacterium tumefaciens Ti plasmids of the nopaline type; sequence located in the promoter of nopaline synthase.
2	P-mtl-MAIZE	Zea mays	-	Promoter of the metallothionein-like gene. de Framond, A. (1991). FEBS 290, 103-106
3	CS-mcry3A-SYNTH	Synthetic	-	version of the native cry3A gene (maize optimised) modified to incorporate a cathepsin-G serine protease recognition site within the expressed protein; first 47 aa were removed (N-terminal region).	Coleoptera resistance
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
5	P-ubi1-MAIZE	Zea mays	-	Promoter region of the polyubiquitin gene. Christensen et al. (1992). Plant Mol Biol, 18, 675-689
6	I-1_ubi1-MAIZE	Zea mays	-
7	CS-pmi-ECOLX	Escherichia coli	-	Phosphomannose isomerase. Reed et al (2001). In Vitro Cell Dev Biol Plant, 37, 127-132	Mannose metabolism
8	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
LQ579566.1	patent documents	Yes	11632	Sequence 135 from Patent WO2016106121
RIKILT_MIR604_event	Wageningen Food Safety Research (WFSR)	Yes	76	Amplicon sequence of MIR604 for event-specific method QT-EVE-ZM-013 without probe
RIKILT_mcry3A_element_MIR604	Wageningen Food Safety Research (WFSR)	Yes	117	Amplicon sequence of mcry3A for element-specific method QL-ELE-cry3A-F/cry3A-R without probe

Detection Methods

23 results

Name	Type	Target	Description	Validation	Standardisation	Verification
QL-ELE-AgroBS1 F/AgroBS1 R	element-specific	V-Flanking Ti-nos-RHIRD	Qualitative real-time PCR (TaqMan) method for detection of the Agrobacterium tumefaciens Ti plasmids of the nopaline type aka Agroborder I. Part of the qualitative triplex real-time PCR (TaqMan) method for detection of Ti plasmid (AgroBorder) sequences and a sequence of the Cassava vein mosaic virus promoter pat construct (P-CsVMV-pat) for screening for components of genetically modified organisms in food (Official Collection of Methods according to § 64 LFGB, L 00.00-176)	ring trial validation	national standard	3
QL-ELE-cry3A-F/cry3A-R	element-specific	CS-cry3A-BACTT, CS-mcry3A-SYNTH	Qualitative real-time PCR (TaqMan) method for detection of the cry3A, the modified mcry3A, the cry3A083, the cry3A085 and the chimaera cry3A/cry1Ab gene (Prins et al., 2016)	in-house validation	national standard	3
QL-ELE-P-Ubi-F/P-Ubi-R	element-specific	P-ubi1-MAIZE	Qualitative real-time PCR (TaqMan) method for detection of ubiquitin promoter of Zea mays (Debode et al., 2013)	in-house validation	none	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-00-011	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-00-013	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-00-018	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-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-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-EVE-ZM-013	event-specific	MIR604	Quantitative real-time PCR (TaqMan) method for detection of maize event MIR604 (EU-RL GMFF GMOMETHODS database as of October 01, 2014)	ring trial validation	EU reference method	3
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

Catalogue number	Source	Value	Type	Certified	Available
AOCS 0407-A	AOCS	<0.1 % (m/m)	dried powder	yes	yes
AOCS 0607-A	AOCS	>99.98 % (m/m)	dried powder	yes	no
AOCS 0607-A2	AOCS	presence of event MIR604	dried powder	yes	yes
AOCS 0917-A	AOCS	<0.1 % (m/m)	dried powder	yes	yes
ERM-BF423a	JRC - CRM (ERM)	<0.09 % (m/m)	dried powder	yes	yes
ERM-BF423b	JRC - CRM (ERM)	0.1 % (m/m)	dried powder	yes	yes
ERM-BF423c	JRC - CRM (ERM)	0.98 % (m/m)	dried powder	yes	yes
ERM-BF423d	JRC - CRM (ERM)	9.85 % (m/m)	dried powder	yes	yes
5211506401	Eurofins GeneScan	100 cp/µl	genomic DNA	no	no

	Application reference number	Species	GMO	Intended use and EU authorisation status	Applicant	Expiry date
1	EFSA-GMO-RX-013	Zea mays (maize, corn)	MIR604	food feed cultivation other	Syngenta Crop Protection	21.01.2031
2	EFSA-GMO-UK-2005-11	Zea mays (maize, corn)	MIR604	food feed cultivation other	Syngenta Seeds SAS, France	29.11.2019
3	EFSA-GMO-UK-2010-83	Zea mays (maize, corn)	MIR604	food feed cultivation other	Syngenta Crop Protection

Citation	Publication year	Publishing authority	Publication type	Content types
Commission Implementing Decision (EU) 2021/62 of 22 January 2021 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2021) 260)	2021	EU	EU Commission Decision	decision document
Assessment of genetically modified maize MIR604 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-013)	2019	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Application for renewal of the authorisation of MIR604 maize import in the European Union under Articles 11 and 23 of Regulation (EC) No 1829/2003 - Summary	2018	EFSA	application summary	application summary
Prins, T.W., van Hoof, R.A., Scholtens, I.M.J., Kok, E.J. (2016). Novel TaqMan PCR screening methods for element cry3A and construct gat/T‑pinII to support detection of both known and unknown GMOs. Eur Food Res Technol, 243, 481–488.	2016	Research group	peer-reviewed article	detection
Application for authorization of Event MIR604 maize cultivation in the European Union under Regulation (EC) No 1829/2003 PART II: SUMMARY	2011	EFSA	application summary	application summary
COMMISSION DECISION of 30 November 2009 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (2009/866/EC)	2009	EU	EU Commission Decision	decision document
SCIENTIFIC OPINION Application (Reference EFSA-GMO-UK-2005-11) for the placing on the market of insect-resistant genetically modified maize MIR604 event, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds S.A.S on behalf of Syngenta Crop Protection AG1 Scientific Opinion of the Panel on Genetically Modified Organisms (Question No EFSA-Q-2005-046)	2009	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
TECHNICAL REPORT OF EFSA 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-UK-2005-11) for the placing on the market of the genetically modified insect resistant maize MIR604 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta seeds S.A.S. on behalf of Syngenta Crop Protection AG1 Report of the GMO Unit (Question No EFSA-Q-2005-046)	2009	EFSA	EFSA overall opinion	risk assessment document
EU register of genetically modified food and feed; pr_id=37	2009	EU	website	application summary
Application for import and use of Event MIR604 maize derived products PART II: SUMMARY	2008	EFSA	application summary	application summary

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