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Genetically Modified Organisms
GMO - Update on Approval, Planting
and Detection
Ulf Rathjens
16.02.2018
Commercial Planting of GMOs
2
Increase of GM Crops in Countries
with Highest Production 1996-2016
• ˃ 90% of global planting area in USA, Brazil, Argentina, India, Canada, China
• EU:
• Only MON810 corn approved for commercial planting
• Most EU member states prohibited GMO planting
• Planting in Spain, Portugal, (Czech Republik, Slovakia, Romania)
0
20
40
60
80
100
120
140
160
180
96 98 00 02 04 06 08 10 12 14 16
M ha
year
USA Brazil Argentina India Canada China
GMO - Update on Approval, Planting and Detection
Commercial Planting of GMOs
3
Global Adoption Rates (%) for
Principal Biotech Crops, 2016:
by Crop (Million Hectares)
• >99% of the global GM planting
area is shared by four crops:
Maize, Soybean, Cotton, Canola
• In addition, regional commercial
planting of GMOs from other
plants • Sugarbeet, Alfalfa, Papaya,
Zucchini (Squash), Tomato,
Carnation, Sweet Pepper,
Poplar, Eggplant, Potato etc.
• Accidental release of GMO,
contamination of seeds in the
past years: • Maize, Rice, Linseed, Papaya,
Petunia
Figures based on ISAAA Brief 52: Global Status of Commercialized of Biotech/Crops 2016
0
50
100
150
200
250
Maize Soybean Canola Cotton
M ha
Crop Type
non-GM
GM
GMO - Update on Approval, Planting and Detection
Facts & Figures – GM Soybean
4
• Planted in more than
10 countries
• Global planting area
91.4 M ha
• 14 approved events in the EU
• 1 with 0.1% tolerance (feed)
• 3 pending EU approvals
• Customer information GM-soy
• www.eurofins.de/gmo-soy
GMO - Update on Approval, Planting and Detection
Commercial Planting of GMOs
5
Please do not hesitate to contact us for our actual customer information on GM-Soy,
GM-Corn, GM-Canola, GM-Cotton, which are updated in regular intervals
GMO - Update on Approval, Planting and Detection
Facts & Figures – GM Soybean
6
Planting of GM soybean – GM and non-GM planting area
(Countries with more than 1 M ha GM soybean planting, 2016)
0
5
10
15
20
25
30
35
USABrazil
ArgentinaParaguay
CanadaUruguay
Bolivia
M ha
Country
non-GM
GM
GMO - Update on Approval, Planting and Detection
7
Russia
• Commercial production: “Russia does not cultivate any GE crops,
including GE seed production”
• Export: “ Some soybean meal exports from Russia may have GE lines. […] is
the major exporter of soybean meal in Russia, and its soybean meal is
primarily a result of crushing of imported soybeans. Therefore, Russia’s
soybean meal exports may contain GE lines” http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Agricultural%20Biotechnology%20Annual_Moscow_Russia
n%20Federation_7-9-2015.pdf
Ukraine
• Zhanna Pastovenska (Ministry of Economy of Ukraine), 2007: “So far, no GMO
is registered for commercial planting in Serbia and the Ukraine BUT Results of
several laboratories in Ukraine, […] clearly showed that in Ukrainian fields it is
possible to find out GM soybean with resistance to RoundUp […]”
• “Rumours” on illegal planting: GM-soy 40 – 70% of soy planting area
Romania
• Commercial planting of GM soy before EU membership (2006: ~ 100.000 ha)
• Still positive findings
Facts & Figures – GM Soybean
GMO - Update on Approval, Planting and Detection
Facts & Figures – GM Soybean
8
New GM soy events are entering the market
Not detectable with common screening methods
Commercial planting in different
stacked events
New screening-strategies
needed to cover all new events
GMO - Update on Approval, Planting and Detection
GM Soy – Commercialization
9
GMO EU approval
status
planting
GTS 40-3-2 app. +
MON89788 app. +
MON87701 app. +
MON87708 app. +
MON87705 app. +
A2704-12 app. +
A5547-127 app. +
CV127 app. +
FG72 app. +
305423 app. +
356043 app.
MON87769 app.
DAS-68416-4 app.
DAS-44406-6 app.
DAS-81419-2 pend., 0,1% feed
SYHT0H2 pend.
MON87751 pend.
The table lists all GMOs with EU authorization
and pending approvals
app.: approved for food and feed in the EU
pend.: pending approval in the EU
0,1% feed: tolerated in feed in a proportion
no higher than 0,1% according to
Regulation (EC) No. 619/2011
planting: commercial or closed loop planting in
one or more countries according to
CropLife International and other
sources
GMO - Update on Approval, Planting and Detection
Detection of GM Soybean
10
GMO EU approval status 35S NOS FMV ABII SAMs/als CV127 CsVMV
GTS 40-3-2 app. + +
MON89788 app. + +
MON87701 app. +
MON87708 app. +
MON87705 app. + +
A2704-12 app. +
A5547-127 app. +
CV127 app. +
FG72 app. +
MON87769 app. +
305423 app. +
356043 app. +
DAS-68416-4 app. +
DAS-44406-6 app. +
DAS-81419-2 pend., 0,1% feed +
SYHT0H2 pend. + + +
MON87751 pend. +
GMO - Update on Approval, Planting and Detection
Detection of GM Soybean
Recommended Detection Package
11
• CaMV 35S Promoter
Detection of important GMOs such as Roundup Ready™ soybean and relevant
LibertyLink™ events. The optimized Eurofins GeneScan 35S promoter method also
detects related promoter elements, e.g. present in Optimum GAT™ (event 356043)
• NOS
Detection of Roundup Ready™ (GTS-40-32) and Balance™ (event FG72) soybean
• AgroBorder II
Covers more approved soybean events than the FMV promoter detection method
• Event 305423
Specific detection of Enlist™ (event 305423) soybean
• Event CV127
Specific detection of Cultivance™ soybean (event CV127)
• CsVMV modification
Detection of the following three soybean events:
DAS-68416-4, DAS-44406-6, DAS-81419-2
GMO - Update on Approval, Planting and Detection
Detection of GM Soybean
Recommended Detection Package
12
• CaMV 35S Promoter Quantification
Detection of important GMOs such as Roundup Ready™ soybean and relevant
LibertyLink™ events. The optimized Eurofins GeneScan 35S promoter method also
detects related promoter elements, e.g. present in Optimum GAT™ (event 356043)
• NOS
Detection of Roundup Ready™ (GTS-40-32) and Balance™ (event FG72) soybean
• AgroBorder II Quantification
Covers more approved soybean events than the FMV promoter detection method
• Event 305423
Specific detection of Enlist™ (event 305423) soybean
• Event CV127
Specific detection of Cultivance™ soybean (event CV127)
• CsVMV modification
Detection of the following three soybean events:
DAS-68416-4, DAS-44406-6, DAS-81419-2
Recommendation for products known to contain traces of GM-soy
Combination of
• direct quantification of most dominant GM-Soy
• qualitative detection of less dominant GM-Soy
GMO - Update on Approval, Planting and Detection
Facts & Figures – GM Corn
13
• Planted in over 15 countries
• Global planting area 60.6 M ha
• 14 approved events in the EU
• 5 with 0.1% tolerance (feed)
• 10 pending EU approvals
• EU Commercial planting of MON810 (Spain, Portugal, Czech Republic, Slovakia)
• Customer Information GM Corn
• www.eurofins.de/gmo-corn
GMO - Update on Approval, Planting and Detection
Facts & Figures – GM Corn
14
Planting of GM corn – GM and non-GM planting area
(Countries with more than 1 M ha GM corn planting, 2016)
0
5
10
15
20
25
30
35
40
USABrazil
ArgentinaSouth Africa
Canada
M ha
Country
non_GM
GM
GMO - Update on Approval, Planting and Detection
GM Corn – Commercialization
15
GMO EU approval
status
planting
Bt11 app. +
GA21 app. +
TC1507 app. +
DAS-59122-7 app. +
T25 app. +
MIR604 app. +
MON810 app. +
MON88017 app. +
MON89034 app. +
NK603 app. +
MIR162 app. +
DAS-40278-9 app. +
MON87460 app.
MON87427 app.
Genetically modified corn
with valid EU approval
planting: commercial or closed loop planting
in one or more countries according
to CropLife International and other
sources
GMO - Update on Approval, Planting and Detection
GM Corn – Commercialization
16
GMO EU approval
status
planting
3272 pend. , 0,1% feed
event 5307 pend. , 0,1% feed
VCO-01981-5 pend. , 0,1% feed
DP-098140-6 pend.
MON87411 pend.
MON87403 pend.
DP-004114-3 pend.
MZHG0JG pend.
MON87419 pend.
MZIR098 pend.
Bt 176 exp., 0,1% feed disc.
MON863 exp., 0,1% feed disc.
LY038 withdr.
Genetically modified corn with pending or
expired EU approval
pend.: pending approval in the EU
exp.: approval expired
withdr.: application for authorization
withdrawn
0,1% feed: tolerated in feed in a proportion
no higher than 0,1% according to
Regulation (EC) No. 619/2011
disc.: discontinued commercial planting
according to CropLife International
and other sources, contaminations
with this GMO can not be
excluded
GMO - Update on Approval, Planting and Detection
Detection GM Corn
17
GMO EU approval
status Planting
35
S
NO
S
AB
II
Eve
nt
VC
O-0
19
81-5
Eve
nt
DA
S-4
02
78
-9
LY
03
8
Bt11 appr. + + +
GA21 appr. + +
TC1507 appr. + +
DAS-59122-7 appr. + +
T25 appr. + +
MIR604 appr. + +
MON810 appr. + +
MON88017 appr. + + + +
MON89034 appr. + + + +
NK603 appr. + + +
MIR162 appr. + +
DAS-40278-9 appr. + +
MON87460 appr. + + +
MON87427 appr. + + +
GMO - Update on Approval, Planting and Detection
Detection GM Corn
18
GMO EU approval status
35
S
NO
S
AB
II
Eve
nt
VC
O-0
19
81-5
Eve
nt
DA
S-4
02
78
-9
LY
03
8
3272 pend. , 0,1% feed +
event 5307 pend. , 0,1% feed +
VCO-01981-5 pend. , 0,1% feed +
Event 98140 pend. , 0,1% feed +
MON87411 pend. + +
MON87403 pend. + +
DP-004114-3 pend. +
MZHG0JG pend. + +
MON87419 pend. +
MZIR098 pend. + +
Bt 176 exp., 0,1% feed +
MON863 exp., 0,1% feed + +
LY038 withdr. +
GMO - Update on Approval, Planting and Detection
Detection of GM Corn
Recommended Detection Package
19
• CaMV 35S / NOS / (ABII) - Screening
• Optimized 35S promoter method detects also related promoter elements,
as present e.g. in Optimum GAT™ corn (event DP-098140-6)
• NOS terminator detection for important corn events with no 35S promoter
element such as GA21, MIR162, MIR604 and others
• AgroBorder II screening provides additional information about GMOs and
covers upcoming corn events such as MON87419 corn
• Plus Specific detection of GM corn events not covered by screening
elements
• VCO-01981-5
• DAS-40278-9
• LY038
GMO - Update on Approval, Planting and Detection
Next Generation GMOs
20
„ArcticTM“ first Commercialized GM Apple
Developed by Okanagan Specialty Fruits
Reduced browning
Approval in the US and in Canada
Available in the US since 2017
as Golden Delicious, Granny Smith
and Fuji Apples
Genetically Modified Apple
GMO - Update on Approval, Planting and Detection
Next Generation GMOs
21
AquAdvantage®-Salmon – the First GM Animal Approved for Food
developed by AquaBounty Technologies
Approved for food in Canada and the US
Sold for human consumption
in Canada in 2017
Assay for the detection of genetically modified salmon available
Genetically Modified Salmon
GMO - Update on Approval, Planting and Detection
Broad and Cost Efficient Testing
22
Combination of
PCR targets should
cover relevant
GMOs
Commercial Planting
in Country of Origin
Formulation /
Raw Materials
Special
Requirements
Legal
Framework in
Country of Destination
Customer Demand
GMO - Update on Approval, Planting and Detection
Broad and Cost Efficient Testing
23
Combination of
PCR targets should
cover relevant
GMOs
Commercial Planting
in Country of Origin
Formulation /
Raw Materials
Special
Requirements
Legal
Framework in
Country of Destination
Customer Demand
Potential Botanical
Impurities
Accidential
Release of GMO
GMO - Update on Approval, Planting and Detection
Eurofins GeneScan
24
> 100 different PCR methods for GMO detection
GMO Screening – GMO Identification – GMO Quantification
Identification of plant species:
Corn Soy Canola Cotton many other
Quantification of admixture / Botanical impurities
Result: E.g. mass % soy flour in flour-sample (maize)
Very short TAT lead time - (same day service available)
Competent consultation & tailored customer agreements
Molecular Biology is our Core Business
International Competence Centre for GMO testing of Eurofins
GMO - Update on Approval, Planting and Detection
25
Contact
T: +49 40 49294 3403
If you have questions,
please contact
The information included in this publication is based on our current knowledge and was thoroughly verified. Nevertheless there is no guarantee for it to be up-to-date, complete and correct. Eurofins is not to be held liable for damages or injury, which are connected to the use of this information.
Especially the confirmation of legal details is up to the user. All offers are non-binding and without obligation.
