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Décision de pays ou tout autre communication (DEC)
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last updated: 04 juin 2015
Amendement
Non
Informations générales
COMMISSION IMPLEMENTING DECISION (EU) 2015/698 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
EN
24 avr. 2015
Non
Sujet de la décision, notification, communication ou déclaration :
  • Décisions sur les OVM destinés à être utilisés directement pour l'alimentation humaine ou animale ou à être transformés (article 11, OVM-AHAT)
Les OMV destinés à être utilisés directement pour l'alimentation humaine ou animale ou à être transformés (OMV-FFP).
  • OVM destinés à être utilisés directement pour l'alimentation humaine
  • OVM destinés à être utilisés directement pour l'alimentation animale
  • OVM destinés à être transformés
Non
Résultat de la décision
Approbation de l'importation/utilisation de l'OVM avec 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 DP-3Ø5423-1 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 DP-3Ø5423-1 soybean oil and 305423 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 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 DP-3Ø5423-1 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.
On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of soybean 305423 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 EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
EN
Évaluation des OVM et des risques
  • BCH-LMO-SCBD-49073-10 Organisme vivant modifié DP-3Ø5423-1 - TREUS™, Plenish™ Soybean
    Pioneer Hi-Bred Production Inc. | Changemetns dans la qualité et/ou la teneur en métabolites (Lipides et acides gras), Résistance aux herbicides (Sulfonyluréa)
  • BCH-RA-EU-108090-1 Évaluation des risques générée par un processus de réglementation Scientific Opinion on application EFSA-GMO-NL-2007-45 for the placing on the market of herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer1
    DP-3Ø5423-1 - TREUS™Plenish™ Soybean | Soybean, Soya bean, Soya, SOYBN, Résistance aux herbicides, Changemetns dans la qualité et/ou la teneur en métabolites
Document sur la décision, la communication, la notification ou la déclaration
Informations supplémentaires
Detection method for soybean 305423 validated by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF)
EN