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National Node of the BCH
Country's Decision or any other Communication
Record information and status
Record ID
108081
Status
Published
Date of creation
2015-06-03 15:47 UTC (Joachim.Kreysa@ec.europa.eu)
Date of publication
2015-06-03 15:47 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) 2015/686 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87769 (MON-87769-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date of the decision
2015-04-24
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
Monsanto Europe S.A.
Avenue de Tervuren 270-272
Brussels
Belgium, B-1150
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Article 3
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words 'with stearidonic acid' 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-87769-7 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-87769-7 soybean oil and MON-87769-7 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 referred to in point (i), results of 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;
(iii) in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU.
2. The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.
Reasons
The genetically modified MON-87769-7 soybean, as described in the application, expresses Δ15 desaturase which results in conversion of linoleic acid to α-linolenic acid and Δ6 desaturase which results in conversion of α-linolenic acid to stearidonic acid (SDA). SDA is a normal intermediate in the formation of the long-chain omega-3 polyunsaturated fatty acids.
On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87769 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c). This specific labelling should ensure informed choice without misleading the consumers.
In addition, for the same reason, EFSA has recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
LMO identification
MON-87769-7 - Soybean with modified fatty acid composition
Changes in quality and/or metabolite content - Lipid and fatty acids
Show detection method(s)
Risk assessment
Scientific Opinion on application (EFSA-GMO-UK-2009-76) for the placing on the market of soybean MON 87769 genetically modified to contain stearidonic acid, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto1
MON-87769-7 - Soybean with modified fatty acid composition
Changes in quality and/or metabolite content - Lipid and fatty acids
Decision document
Additional Information
Additional Information
EU detection method for soybean MON87769 validated by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF)