Record details

General information

Country submitting the decision or communication

European Union

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

Record #49387

European Commission - Health and Food Safety Directorate General SANTE

Rue Belliard, B232

Brussels

Belgium, 1040

Phone:	+32 2 2963814
Email:	hans.moons@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) 2019/1302 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × LLCotton25 × MON 15985 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

Date of the decision

2019-07-26

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

Jurisdiction

European Union

Is this an amendment to a previous decision / communication?

Decision or communication details

Subject(s) of the decision

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

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?

Importer’s or Applicant’s contact details

Record #115399

Ms Wenderoth

BASF SE

Carl-Bosch-Str. 38

Ludwigshafen

Germany, 67063

Phone:	+49 621 60-28341
Email:	irina.wenderoth@basf.com

Result of the decision

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

LMO identification

Record #101802

BCS-GHØØ2-5 x ACS-GHØØ1-3 x MON-15985-7 - Herbicide-tolerant, insect-resistant cotton

Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes

Show detection method(s)

Risk assessment

Record #115393

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

BCS-GHØØ2-5 x ACS-GHØØ1-3 x MON-15985-7 - Herbicide-tolerant, insect-resistant cotton
Resistance to antibiotics - Kanamycin, Streptomycin
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate, Glyphosate
Selectable marker genes and reporter genes

Decision document

EUR-Lex

EU Decision 2019/1302.pdf

EU register of GM Food and Feed

Additional Information

The quantitative event-specific PCR detection methods for cotton GHB614 × LLCotton25 × MON 15985 are those validated for genetically modified cotton events BCS-GHØØ2-5, ACS-GHØØ1-3 and MON-15985-7. The detection methods have been validated on genomic DNA extracted from leaves BCS-GHØØ2-5, ACS-GHØØ1-3 and MON-15985-7 cotton. Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx

Other relevant website address or attached documents

EURL GMFF

GMOMETHODS

EU Detection Method Cotton GHB614.pdf

EU Detection Method LLCotton25.pdf

EU Detection Method MON15985.pdf