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Country's Decision or any other Communication
(DEC)
last updated: 08 Mar 2018
No
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
EN
21 Dec 2017
No
- Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
- LMOs for direct use as food
- LMOs for direct use as feed
- LMOs for processing
No
Approval of the import and/or use of the LMO(s) with 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
EN
(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
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
EN
-
BCH-LMO-SCBD-101262-8 Living Modified Organism DP-3Ø5423-1 × MON-Ø4Ø32-6 - Modified fatty acid, herbicide-tolerant soybeanPioneer Hi-Bred | Resistance to herbicides (Glyphosate, Sulfonylurea)
-
BCH-RA-EU-113270-2 Risk Assessment generated by a regulatory process 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 1829/2003DP-3Ø5423-1 x MON-Ø4Ø32-6 - Modified fatty acid, herbicide-tolerant soybean | Soybean, Soya bean, Soya, SOYBN, Resistance to herbicides
- EUR-Lex [ English ]
- EU Decision 2017/2448.pdf [ English ]
- EU Register of GM Food and Feed [ English ]
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
EN
- EURL GMFF [ English ]
- EU Detection Method Soybean 305423.pdf [ English ]
- EU Detection Method Soybean GTS-40-3-2.pdf [ English ]
- EU Detection Method Soybean (3Ø5423 × GTS-4Ø-3-2) Verification.pdf [ English ]
- GMOMETHODS: European Union database of reference methods for GMO analysis [ English ]
