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Country's Decision or any other Communication
Record information and status
Record ID
114236
Status
Published
Date of creation
2019-01-29 14:13 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2019-01-29 14:13 UTC (chantal.bruetschy@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) 2018/1110 of 3 August 2018 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU (notified under document C(2018) 4937)
Date of the decision
2018-08-03
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?
Yes
BCH decision amended
Commission Decision 2009/815/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122xNK603
DAS-59122-7 x MON-ØØ6Ø3-6 - Herculex™ RW Rootworm Protection Roundup Ready™ 2 maize
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Resistance to herbicides - Glufosinate, Glyphosate
European Commission Decision 2010/428/EU authorising the placing on the market for food and feed uses of genetically modified maize 59122x1507xNK603 (DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6))
DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 - Herculex XTRA™ Roundup Ready™ 2 maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
European Commission Decision 2010/432/EU authorising the placing on the market for food and feed uses of genetically modified maize 1507x59122 (DAS-Ø15Ø7-1xDAS-59122-7)
DAS-Ø15Ø7-1 x DAS-59122-7 - Herculex XTRA™ maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
Reasons for the amendment
The authorisation holder(s) asked the Commission to repeal those three Decisions when authorising maize 1507 × 59122 × MON 810 × NK603 and sub-combinations, including maize 1507 x 59122, maize 59122 x 1507 x NK603, and maize 59122 x NK603.
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
Pioneer Overseas Corporation
Avenue des Arts 44
Brussels
Belgium, B-1040
Result of the decision
  • Approval of the import/use of the LMO(s) without conditions
LMO identification
DAS-Ø15Ø7-1 x DAS-59122-7 x MON-ØØ81Ø-6 x MON-ØØ6Ø3-6 - Optimum™ Intrasect XTRA maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
DAS-Ø15Ø7-1 x DAS-59122-7 x MON-ØØ81Ø-6 - 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)
DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 - Herculex XTRA™ Roundup Ready™ 2 maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x MON-ØØ6Ø3-6 - Maize resistant to Lepidoptera and tolerant to glufosinate and glyphosate herbicides
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
DAS-59122-7 x MON-ØØ81Ø-6 x MON-ØØ6Ø3-6 - 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)
DAS-Ø15Ø7-1 x DAS-59122-7 - Herculex XTRA™ maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 - Maize modified for insect resistance and herbicide tolerance
Msc Goran Kuhar Jezovsek Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate
Show detection method(s)
DAS-59122-7 x MON-ØØ81Ø-6 - 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)
DAS-59122-7 x MON-ØØ6Ø3-6 - Herculex™ RW Rootworm Protection Roundup Ready™ 2 maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
Risk assessment
Assessment of genetically modified maize 1507 × 59122 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2011-92)
DAS-Ø15Ø7-1 x DAS-59122-7 x MON-ØØ81Ø-6 x MON-ØØ6Ø3-6 - Optimum™ Intrasect XTRA maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
DAS-Ø15Ø7-1 x DAS-59122-7 x MON-ØØ81Ø-6 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DAS-59122-7 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 - Herculex XTRA™ Roundup Ready™ 2 maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 x MON-ØØ6Ø3-6 - Maize resistant to Lepidoptera and tolerant to glufosinate and glyphosate herbicides
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
DAS-59122-7 x MON-ØØ81Ø-6 x MON-ØØ6Ø3-6 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
DAS-Ø15Ø7-1 x DAS-59122-7 - Herculex XTRA™ maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DAS-Ø15Ø7-1 x MON-ØØ81Ø-6 - Maize modified for insect resistance and herbicide tolerance
Msc Goran Kuhar Jezovsek

Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DAS-59122-7 x MON-ØØ81Ø-6 - Insect resistant, herbicide tolerant maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
DAS-59122-7 x MON-ØØ6Ø3-6 - Herculex™ RW Rootworm Protection Roundup Ready™ 2 maize
Resistance to diseases and pests - Insects - Coleoptera (beetles)
Resistance to herbicides - Glufosinate, Glyphosate
Additional Information
Additional Information
Detection methods for the single events maize 1507,59122,MON810 and NK603 and methods for the stack (1507x9122xON810xNK603)
respectively validated and verified by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF) available at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx)