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Country's Decision or any other Communication
Record information and status
Record ID
113271
Status
Published
Date of creation
2018-03-08 17:22 UTC (Joachim.Kreysa@ec.europa.eu)
Date of publication
2018-03-08 17:22 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) 2017/2448 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) 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
2017-12-21
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
Pioneer Overseas Corporation
Avenue des Arts 44
Brussels
Belgium, B-1040
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Conditions or restrictions on the placing on the market, use or handling of the products
(1) The authorisation holder shall collect the following information:
(i) Quantities of DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean oil and DP-3Ø5423-1 × MON-Ø4Ø32-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food.
(ii) In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(2) The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.
Labelling
the words 'with increased monounsaturated fat and reduced polyunsaturated fat' shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products
Reasons
The genetically modified DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean, as described in the application, has a reduced expression of the soybean enzyme omega-6 desaturase, which results in a high oleic acid and reduced linoleic acid profile
LMO identification
DP-3Ø5423-1 x MON-Ø4Ø32-6 - Modified fatty acid, herbicide-tolerant soybean
Pioneer Hi-Bred Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to herbicides - Glyphosate, Sulfonylurea
Show detection method(s)
Risk assessment
Scientific Opinion on an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 x 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
DP-3Ø5423-1 x MON-Ø4Ø32-6 - Modified fatty acid, herbicide-tolerant soybean
Pioneer Hi-Bred

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to herbicides - Glyphosate, Sulfonylurea
Additional Information
Additional Information
Detection methods for the single soybean events 3Ø5423 and GTS-40-3-2 and the stack event (3Ø5423 x GTS-40-3-2) 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