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Country's Decision or any other Communication
Record information and status
Record ID
112254
Status
Published
Date of creation
2017-07-14 10:25 UTC (Joachim.Kreysa@ec.europa.eu)
Date of publication
2017-07-14 10:25 UTC (Joachim.Kreysa@ec.europa.eu)

General information
Country submitting the decision or communication
  • European Union
Competent National Authority(ies) responsible for the decision or communication
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Brussels
Belgium, 1040
Phone:+32 2 2962362
Fax:+32 2 2964736
Email:chantal.bruetschy@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Title / Reference number of the decision or communication
COMMISSION IMPLEMENTING DECISION (EU) 2017/1209 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maize combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council on genetically modified food and feed
Date of the decision
2017-07-04
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • European Union
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
Uses of the LMO(s)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Importer’s or Applicant’s contact details
Esteban ALCALDE
Syngenta Crop Protection NV/SA
Avenue Louise, 489
Brussels
Belgium, B-1050
Phone:+32 2 642 2727
Email:esteban.alcalde@syngenta.com
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Article 5: Specific conditions for the placing on the market
1.The authorisation holder shall ensure that the specific conditions, referred to in point (g) of the Annex, are implemented.
2.The authorisation holder shall submit annual reports on the results of the activities set out in the specific conditions of this authorisation to the Commission for the duration of the authorisation.
Annex I
(g) Conditions or restrictions on the placing on the market, use or handling of the products: Specific conditions in accordance with Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003:
(1) The authorisation holder shall inform the Commission if any of the sub-combinations were to be created via targeted breeding approaches and commercialised.
(2) If it is the case, the authorisation holder shall collate information on the expression levels of the newly expressed proteins.
Reasons
EFSA recommended the collection of relevant information on expression levels of the newly expressed proteins, if any of the 20 sub-combinations were to be created via targeted breeding approaches and commercialised.
LMO identification
SYN-BTØ11-1 x DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
DAS-59122-7 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
SYN-BTØ11-1 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
DAS-59122-7 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
DAS-59122-7 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Agrisure® 3122
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
SYN-BTØ11-1 x DAS-59122-7 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
Risk assessment
Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2011-99) for the placing on the market of maize Bt11 x 59122 x MIR604 x 1507 x GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Agrisure® 3122
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
Selectable marker genes and reporter genes
SYN-BTØ11-1 x DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
Selectable marker genes and reporter genes
SYN-BTØ11-1 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
SYN-BTØ11-1 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Maize modified for insect resistance and herbicide tolerance
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
DAS-59122-7 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera)
Resistance to herbicides - Glufosinate, Glyphosate
Selectable marker genes and reporter genes
DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
SYN-BTØ11-1 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DAS-59122-7 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera)
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
DAS-59122-7 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Resistance to herbicides - Glufosinate, Glyphosate
SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
SYN-BTØ11-1 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
SYN-BTØ11-1 x DAS-59122-7 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes
SYN-BTØ11-1 x DAS-59122-7 x DAS-Ø15Ø7-1 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
Selectable marker genes and reporter genes
SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Insect resistant, herbicide tolerant maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
Selectable marker genes and reporter genes
SYN-BTØ11-1 x DAS-59122-7 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Decision document
Additional Information
Additional Information
Detection methods for the single events maize Bt11, 59122, MIR604, 1507 and GA21 and methods for the maize stack event (Bt11 x 59122 x MIR604 x 1507 x GA21) respectively validated and verified by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF) are available at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx