GMO molecular characterization details

GMO detailed information

GMO:
T45
Alias:

HCN28
UID:
ACS-BNØØ8-2
Tradename:

LibertyLink
Companies/Institutions:
Bayer CropScience, AgrEvo
Species:
Brassica napus
(canola, oilseed rape, rapeseed)
Traits:
EU authorisation:

Inserts / Modification

Name:	insert_T45
Comment:	Insert order indicates order of genetic elements as described for cassettes present in the construct. Upon integration 48 bp of genomic sequence from the host genome were deleted.
Map:

Genetic Elements:

Reference: application documents

Elements:

Order	Name	Donor	Position	Definition	Trait	Comment
1	V-LB-RHIRD	Agrobacterium tumefaciens	-
2	P-35S-CaMV	Cauliflower mosaic virus	-			element length: approx. 530 bp
3	V-MCS-SYNTH	Synthetic	-			element length: approx. 30 bp
4	CS-pat-STRVR	Streptomyces viridochromogenes	-	Phosphinothricin acetyltransferase gene derived from Streptomyces viridochromogenes a.k.a. pat gene; shares 85 per cent homology at the amino acid level with the bar gene. Wohlleben et al. (1988) Gene 70:25-37	Glufosinate tolerance	element length: approx. 550 bp
5	V-MCS-SYNTH	Synthetic	-			element length: approx. 20 bp
6	T-35S-CaMV	Cauliflower mosaic virus	-	3' untranslated region (3' UTR) of the 35S gene from Cauliflower mosaic virus. Gardner et al. (1981). Nucleic Acids Res, 9:2871-2888		element length: approx. 200 bp
7	V-MCS-SYNTH	Synthetic	-			element length: approx. 10 bp
8	V-RB-RHIRD	Agrobacterium tumefaciens	-

Related DNA Sequences:

Acc.No.	Reference	Sequence	Size (bp)	Annotation
	application documents	No
RIKILT_T45_event	Wageningen Food Safety Research (WFSR)	Yes	123	Amplicon sequence of T45 for event-specific method QT-EVE-BN-001 without probe

Detection Methods

24 results

Name	Type	Target	Description	Validation	Standardisation	Verification
QL-CON-00-005	construct-specific	32316, 40416, 4114, 43A47, 676, 678, 680, A2704-12, A2704-21, A5547-127, A5547-35, DAS1507, DAS59122, DAS59132, DBN9004, DP62151, Falcon GS 40/90, GU262, HCN10, HCR-1, Liberator, T120-7, T14, T25, T45, Topas 19/2	Qualitative conventional PCR method for detection of maize event T25 (ISO 21569)	ring trial validation	ISO standard	2
QL-CON-00-011	construct-specific	32316, 40416, 4114, 43A47, 676, 678, 680, A2704-12, A2704-21, A5547-127, A5547-35, Bt10 maize, Bt11, DAS1507, DAS59122, DAS59132, DBN9004, DHA, 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	3
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	3
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-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-00-012	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-00-017	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-00-021	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	2
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	2
QL-TAX-BN-003	taxon-specific	Brassica napus	Qualitative real-time PCR (SYBRGreen) method for detection of oilseed rape cruciferin A gene(Barbau-Piednoir et al., 2014)	ring trial validation	unknown	1
QL-TAX-BN-004	taxon-specific	Brassica napus	Qualitative conventional PCR method for detection of oilseed rape high mobility group protein I/Y gene (Pan et al., 2007).	ring trial validation	unknown	1
QT-CON-00-005	construct-specific	32316, 40416, 4114, 43A47, 676, 678, 680, A2704-12, A2704-21, A5547-127, A5547-35, DAS1507, DAS59122, DAS59132, DBN9004, DP62151, Falcon GS 40/90, GU262, HCN10, HCR-1, Liberator, T120-7, T14, T25, T45, Topas 19/2	Quantitative real-time PCR (TaqMan) method for detection of maize event T25 (Shindo et al., 2002)	ring trial validation	ISO standard	2
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	2
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	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-EVE-BN-001	event-specific	T45	Quantitative real-time PCR (TaqMan) method for detection of oilseed rape event T45 (EU-RL GMFF GMOMETHODS database as of October 01, 2014)	ring trial validation	EU reference method	3
QT-TAX-BN-001	taxon-specific	Brassica napus	Quantitative real-time PCR (TaqMan) method for detection of oilseed rape acyl-ACP thioesterase (FatA) gene (EU-RL GMFF GMOMETHODS database as of January 23, 2014) Estimated number of target copies per haploid genome (Jacchia et al. 2018): 1	ring trial validation	EU reference method	1
QT-TAX-BN-002	taxon-specific	Brassica napus	Quantitative real-time PCR (TaqMan) method for detection of oilseed rape cruciferin storage protein (EU-RL GMFF GMOMETHODS database as of January 27, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 4	ring trial validation	EU reference method	1
QT-TAX-BN-003	taxon-specific	Brassica napus	Quantitative real-time PCR (TaqMan) method for detection of oilseed rape cruciferin A gene (Jacchia et al. 2019) (EU-RL GMFF GMOMETHODS database as of January 15, 2020)	ring trial validation	EU reference method	1
QT-TAX-BN-012	taxon-specific	Brassica napus	Quantitative real-time PCR (TaqMan) method for detection of oilseed rape cruciferin A (CruA) gene (EU-RL GMFF GMOMETHODS database as of March 06, 2014). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 2	ring trial validation	EU reference method	1
QT-TAX-FatA primer1/FatA primer2	taxon-specific	Brassica napus	Quantitative real-time PCR (TaqMan) method for the detection of oilseed rape (Monsanto, 2004, A recommended procedure for real-time quantitative TaqMan PCR for Roundup Ready canola RT73). Estimated number of target copies per haploid genome (Jacchia et al. 2018): 2	in-house validation	none	1

Description:	Southern blot, PCR and sequence analysis indicated the integration of one copy of the pat gene (CS-pat-STRVR) at a single genomic locus. In addition, data suggested a 48 bp deletion at the insertion site and the absence of vector backbone.
Links regarding to this GMO:	BCH http://bch.cbd.int/database/record.shtml?documentid=14762
Transformation / Modification technique:	Agrobacterium-induced

Catalogue number	Source	Value	Type	Certified	Available
AOCS 0208-A	AOCS	100 % (m/m)	genomic DNA	yes	no
AOCS 0208-A3	AOCS	>99.99 % (m/m)	genomic DNA	yes	no
AOCS 0208-A4	AOCS	>99.99 % (m/m)	genomic DNA	yes	no
AOCS 0208-A5	AOCS	>99.99 % (m/m)	genomic DNA	yes	no
AOCS 0208-A6	AOCS	>99.99 % (m/m)	genomic DNA	yes	no
AOCS 0208-A7	AOCS	>99.99 % (m/m)	genomic DNA	yes	yes
AOCS 0306-B	AOCS	<0.01 % (m/m)	genomic DNA	yes	no
AOCS 0306-B3	AOCS	<0.01 % (m/m)	genomic DNA	yes	no
AOCS 0306-B4	AOCS	<0.01 % (m/m)	genomic DNA	yes	no
AOCS 0306-B5	AOCS	<0.005 % (m/m)	genomic DNA	yes	yes
5211512501	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-012	Brassica napus (canola, oilseed rape, rapeseed)	T45	food feed cultivation other	BASF Agricultural Solutions Seed US	27.11.2029
2	EFSA-GMO-RX-T45	Brassica napus (canola, oilseed rape, rapeseed)	T45	food feed cultivation other	Bayer CropScience	09.03.2019
3	EFSA-GMO-UK-2005-25	Brassica napus (canola, oilseed rape, rapeseed)	T45	food feed cultivation other	BASF Agricultural Solutions Seed US	09.03.2019

Citation	Publication year	Publishing authority	Publication type	Content types
Horizontal methods for molecular biomarker analysis — Methods of analysis for the detection of genetically modified organisms and derived products — Part 3: Construct-specific real-time PCR method for detection of P35S-pat-sequence for screening for genetically modified organisms (ISO/TS 21569-3)	2020	ISO	other document	detection
Overall opinion of the European Food Safety Authority on genetically oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-012) European Food Safety Authority	2019	EFSA	EFSA overall opinion	risk assessment document
Commission Implementing Decision (EU) 2019/2081 of 28 November 2019 renewing the authorisation for the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2), resulting from the commercialisation of this oilseed rape in third countries until 2005, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 7480)	2019	EU	EU Commission Decision	decision document
Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-012)	2019	EFSA GMO Panel	Scientific opinion EFSA GMO Panel	risk assessment document
Request for Renewal of the Authorization for placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialization of this oilseed rape in third countries until 2005, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 - Summary	2018	EFSA	application summary	application summary
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
COMMISSION DECISION of 10 March 2009 authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2009) 1541) (2009/184/EC)	2009	EU	EU Commission Decision	decision document
Request for authorisation of gm food and gm feed in accordance with Articles 5 and 17 of Regulation (EC) No. 1829/2003 - glufosinate ammonium-tolerant oilseed rape transformation event T45 - Part II - Summary	2008	EFSA	application summary	application summary
PART II SUMMARY OF THE REQUEST FOR AUTHORIZATION OF GM FOOD AND GM FEED IN ACCORDANCE WITH ATICLES 5 AND 17 OF REGULATION (EC) NO. 1829/2003 GLUFOSINATE AMMONIUM-TOLERANT OILSEED RAPE TRANSFORMATION EVENT T45	2008	EFSA	application summary	application summary
Opinion of the Scientific Panel on Genetically Modified Organisms on applications (references EFSA-GMO-UK-2005-25 and EFSA-GMO-RX-T45) for the placing on the market of the glufosinate-tolerant genetically modified oilseed rape T45, for food and feed uses, import and processing and for renewal of the authorisation of oilseed rape T45 as existing product, both under Regulation (EC) No 1829/2003 from Bayer CropScience (Questions No EFSA-Q-2005-278 and EFSA-Q-2007-154)	2008	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-UK- 2005-25 for the placing on the market of glufosinate-ammonium tolerant genetically modified oilseed rape T45 for food and feed uses, import and processing and application EFSA-GMO-RX-T45 for renewal of the authorisation of oilseed rape T45 as existing products in the sense of Articles 8 and 20 of that Regulation (food additives, feed materials produced from genetically modified T45 oilseed rape) submitted by Bayer CropScience. (Questions No. EFSA-Q-2005-278 and EFSA-Q-2007-154)	2008	EFSA	EFSA overall 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

Authorisation

Literature reference