European Union | BCH-DEC-EU-265658 | Country's Decision or any other Communication

Amendment

Is this an amendment to a decision or communication already published on the BCH?

No

Country

Competent National Authority(ies) responsible for the decision or communication

- Competent National Authority: | BCH-CNA-EU-49387-11

Competent National Authority:

European Commission - Health and Food Safety Directorate General SANTE ()

Rue Belliard, B232
Brussels,
1040, Belgium
Phone: +32 2 29 57616,

Fax:

Email: thomas.weber@ec.europa.eu,

Website: http://ec.europa.eu/dgs/health_food-safety/index_en.htm,

BCH-CNA-EU-49387-11

Title / Reference number of the decision or communication

Commission Implementing Decision (EU) 2023/1209 of 21 June 2023 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP4114 x MON89034 x MON87411 x DAS-40278-9 and its sub-combinations DAS-40278-9 x DP4114 x MON 87411, MON 89034 x DP4114 x MON 87411, MON 89034 x DAS-40278-9 x MON 87411, MON 89034 x DAS-40278-9 x DP4114, DP4114 x MON 87411, DAS-40278-9 x MON 87411, DAS-40278-9 x DP4114, MON 89034 x DP4114, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

EN

Date of the decision

21 Jun 2023

Is the decision taken prior to entry into force of the Protocol?

No

Jurisdiction

European Union

EN

Subject of the decision, notification, communication or declaration

Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
Decision on domestic use of an LMO, including its placing on the market (Article 11.1)

LMOs for direct use as food or feed, or for processing (LMOs-FFP)

Use(s) of LMO

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

Applicant’s contact details

- Person: Filip Cnudde | BCH-CON-EU-116279-3

Person:

Filip Cnudde

Phone: +3226635952,

Fax:

Email: Filip.Cnudde@corteva.com,

Website:

Related Organization

Corteva Agriscience Belgium B.V. ()

Rue Montoyer 25
Brussels,
1000, Belgium
Phone: +3226635952,

Fax:

Email: Filip.Cnudde@corteva.com,

Website:

Result of the decision

Approval of the import and/or use of the LMO(s) without conditions

LMO identification & risk assessment

LMO identification

BCH-LMO-SCBD-265634-1 Living Modified Organism DP-ØØ4114-3 × MON-89Ø34-3 × MON-87411-9 - Insect-resistant, herbicide-tolerant maize

Pioneer Hi-Bred International Inc., Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate, Glyphosate)
BCH-LMO-SCBD-265635-1 Living Modified Organism MON-89Ø34-3 × MON-87411-9 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize

Dow AgroSciences, Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi)), Resistance to herbicides (Glyphosate)
BCH-LMO-SCBD-116232-1 Living Modified Organism DP-ØØ4114-3 × MON-89Ø34-3 × MON-87411-9 × DAS-4Ø278-9 - Insect resistant, herbicide tolerant maize

Pioneer Hi-Bred International Inc. | Resistance to Diabrotica virgifera virgifera, Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Tolerance to 2,4-Dichlorophenoxyacetic acid, Tolerance to aryloxyphenoxypropionate
BCH-LMO-SCBD-265633-2 Living Modified Organism DP-ØØ4114-3 × MON-87411-9 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize

Pioneer Hi-Bred International Inc., Dow AgroSciences, Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate, Glyphosate)
BCH-LMO-SCBD-265641-1 Living Modified Organism DP-ØØ4114-3 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize

Pioneer Hi-Bred International Inc., Dow AgroSciences | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate)
BCH-LMO-SCBD-265640-1 Living Modified Organism MON-87411-9 × DAS-4Ø278-9 - Insect-resistance, herbicide-tolerant maize

Dow AgroSciences, Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi)), Resistance to herbicides (Glyphosate)
BCH-LMO-SCBD-265638-1 Living Modified Organism DP-ØØ4114-3 × MON-89Ø34-3 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize

Dow AgroSciences, Pioneer Hi-Bred International Inc., Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate)
BCH-LMO-SCBD-265639-1 Living Modified Organism DP-ØØ4114-3 × MON-87411-9 - Insect-resistant, herbicide-tolerant maize

Pioneer Hi-Bred International Inc., Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate, Glyphosate)
BCH-LMO-SCBD-265642-1 Living Modified Organism DP-ØØ4114-3 × MON-89Ø34-3 - Insect-resistant, herbicide-tolerant maize

Pioneer Hi-Bred International Inc., Bayer CropScience | Resistance to diseases and pests (Insects, Coleoptera (beetles), Colorado potato beetle (Leptinotarsa decemlineata), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths), Cotton bollworm (Helicoverpa spp.), European corn borer (Ostrinia nubilalis), Fall armyworm (Spodoptera frugiperda)), Resistance to herbicides (Glufosinate)

Risk assessment

BCH-RA-EU-265657-1 Risk Assessment generated by a regulatory process Assessment of genetically modified maize DP4114 × MON 89034 × MON 87411 × DAS-40278-9 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA GMO-NL-2020-171)

DP-ØØ4114-3 × MON-89Ø34-3 × MON-87411-9 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | MON-89Ø34-3 × MON-87411-9 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | DP-ØØ4114-3 × MON-89Ø34-3 × MON-87411-9 × DAS-4Ø278-9 - Insect resistant, herbicide tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | DP-ØØ4114-3 × MON-87411-9 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | DP-ØØ4114-3 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | MON-87411-9 × DAS-4Ø278-9 - Insect-resistance, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | DP-ØØ4114-3 × MON-89Ø34-3 × DAS-4Ø278-9 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | DP-ØØ4114-3 × MON-87411-9 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides | DP-ØØ4114-3 × MON-89Ø34-3 - Insect-resistant, herbicide-tolerant maize | Maize, Corn, MAIZE, Resistance to diseases and pests, Resistance to herbicides

Document on the decision, communication, notification or declaration

EU Decision 2023/1209.pdf [ English ]
EUR-Lex [ English ]
EU register of GM Food and Feed [ English ]

Additional Information

Detection methods for the Maize DP4114 x MON 89034 x MON 87411 x DAS-40278-9 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.

EN

Other relevant website addresses and/or attached documents

EU Detection Method Maize DP4114.pdf [ English ]
EU Detection Method Maize MON 89034.pdf [ English ]
EU Detection Method Maize MON 87411.pdf [ English ]
EU Detection Method Maize DAS40278.pdf [ English ]
EURL GMFF [ English ]
GMO METHODS: European Union database of reference methods for GMO analysis [ English ]

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