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Country's Decision or any other Communication (DEC)
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BCH-DEC-EU-110989-2   |   PDF   |   Print   |  
published: 12 Oct 2016 last updated: 17 Feb 2025
Amendment
No
General Information
COMMISSION IMPLEMENTING DECISION (EU) 2016/1217 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (MON-877Ø5-6 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
EN
22 Jul 2016
No
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)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
Article 3
For the purposes of the labelling requirements laid down in Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003, 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.
Article 5
Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003
1.The authorisation holder shall ensure that the post-market monitoring plan of the MON 87705 x MON 89788 soybean oil, as set out in point (g) of the Annex, is put in place and implemented.
2.The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the post-market monitoring plan for the duration of the authorisation.
Annex
(g) Conditions or restrictions on the placing on the market, use or handling of the products
Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003
(1) The authorisation holder shall collect the following information:
(i) Quantities of MON-877Ø5-6 × MON-89788-1 soybean oil and MON-877Ø5-6 × MON-89788-1 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.
EN
The genetically modified MON-877Ø5-6 × MON-89788-1 soybean, as described in the application, has a reduced expression of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, which results in increased oleic acid and reduced linoleic acid profile. On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87705 × MON 89788 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.
In addition, and for the same reason a post-market monitoring plan needs to be implemented, focusing on the collection of consumption data for the European population.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-104776-4 Living Modified Organism MON-877Ø5-6 × MON-89788-1 - Soybeans with modified fatty acid profile and glyphosate tolerance
    Monsanto | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to herbicides (Glyphosate)
  • BCH-RA-EU-110981-2 Risk Assessment generated by a regulatory process Scientific Opinion on an application (Reference EFSA-GMO-NL-2011-100) for the placing on the market of the herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
    MON-877Ø5-6 x MON-89788-1 - Soybeans with modified fatty acid profile and glyphosate tolerance | Soybean, Soya bean, Soya, SOYBN, Resistance to herbicides, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
Additional Information
Detection methods for the single events MON87705 and MON89788 and methods for the stack (MON87705xMON89788) 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