Commission Implementing Decision (EU) 2016/1216 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788 (MON-877Ø8-9 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2016) 4580) (Text with EEA relevance)

Genetically modified organism and unique identifier

Article 1

Genetically modified soybean ( Glycine max (L.) Merr.) MON 87708 × MON 89788, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø8-9 × MON-89788-1, as provided for in Regulation (EC) No 65/2004.

Authorisation

Article 2

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision: (a) foods and food ingredients containing, consisting of, or produced from MON-877Ø8-9 × MON-89788-1 soybean; (b) feed containing, consisting of, or produced from MON-877Ø8-9 × MON-89788-1 soybean; (c) MON-877Ø8-9 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.

Labelling

Article 3

1.   For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’. 2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø8-9 × MON-89788-1 soybean, with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects

Article 4

1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) 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 monitoring plan in accordance with Decision 2009/770/EC.

Community register

Article 5

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

Article 6

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity

Article 7

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

Article 8

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels, Belgium.

ANNEXSupplementary provisions

ANNEX (a)    Applicant and Authorisation holder: Name : Monsanto Europe S.A. Address : Avenue de Tervuren 270-272, B-1150 Brussels — Belgium On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America. (b)    Designation and specification of the products: (1) foods and food ingredients containing, consisting of, or produced from MON-877Ø8-9 × MON-89788-1 soybean; (2) feed containing, consisting of, or produced from MON-877Ø8-9 × MON-89788-1 soybean; (3) MON-877Ø8-9 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation. The genetically modified MON-877Ø8-9 × MON-89788-1 soybean, as described in the application, expresses the DMO proteins which confer tolerance to dicamba-based herbicides and the CP4 EPSPS protein which confers tolerance to glyphosate-based herbicides. (c)    Labelling: (1) For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’; (2) The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø8-9 × MON-89788-1 soybean, with the exception of products referred to in point (a) of Article 2. (d)    Method for detection: (1) Event specific real-time quantitative PCR based methods for MON-877Ø8-9 and MON-89788-1 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-877Ø8-9 × MON-89788-1 soybean. (2) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx; (3) Reference Material: AOCS 0311-A and AOCS 0906-A (for MON-877Ø8-9), and AOCS 0906-B and AOCS 0906-A (for MON-89788-1) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248 (e)    Unique identifier: MON-877Ø8-9 × MON-89788-1 (f)    Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity: [Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified ]. (g)    Conditions or restrictions on the placing on the market, use or handling of the products: Not required. (h)    Monitoring plan for environmental effects: Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. [Link: plan published in the Community register of genetically modified food and feed ] (i)    Post-market monitoring requirements for the use of the food for human consumption: Not required. Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.