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Country's Decision or any other Communication
(DEC)
last updated: 03 Jun 2015
No
COMMISSION IMPLEMENTING DECISION (EU) 2015/696 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87705 (MON-877Ø5-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
EN
24 Apr 2015
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
Article 3
2.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 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-877Ø5-6 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 soybean oil and MON-877Ø5-6 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.
EN
2.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 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-877Ø5-6 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 soybean oil and MON-877Ø5-6 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.
The genetically modified MON-877Ø5-6 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 MON87705 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, EFSA recommended in the complementing statement a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
EN
On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON87705 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, EFSA recommended in the complementing statement a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
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BCH-LMO-SCBD-104683-5 Living Modified Organism MON-877Ø5-6 - Vistive Gold™ SoybeanMonsanto | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to herbicides (Glyphosate)
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BCH-RA-EU-108076-2 Risk Assessment generated by a regulatory process Scientific Opinion on application (EFSA-GMO-NL-2010-78) for the placing on the market of herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto1MON-877Ø5-6 - Vistive Gold™ Soybean | Soybean, Soya bean, Soya, SOYBN, Resistance to herbicides, Changes in quality and/or metabolite content
- EUR-Lex [ English ]
- Decision 2015/696.pdf [ English ]
- EU Register of GM Food and Feed [ English ]
EU detection method for soybean MON87705 validated by the European Union Reference Laboratory for GM Food and Feed (EURL GMFF)
EN
- EURL GMFF [ English ]
- EU Detection Method Soybean MON87705.pdf [ English ]
- GMOMETHODS: European Union database of reference methods for GMO analysis [ English ]
