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Document 02015D0700-20210216

    Consolidated text: Commission Implementing Decision (EU) 2015/700 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87708 (MON-877Ø8-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2785) (Only the French and Dutch texts are authentic) (Text with EEA relevance)Text with EEA relevance

    Access initial legal act

    ELI: http://data.europa.eu/eli/dec_impl/2015/700/2021-02-16

    02015D0700 — EN — 16.02.2021 — 002.001

    This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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    COMMISSION IMPLEMENTING DECISION (EU) 2015/700

    of 24 April 2015

    authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87708 (MON-877Ø8-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

    (notified under document C(2015) 2785)

    (Only the French and Dutch texts are authentic)

    (Text with EEA relevance)

    (OJ L 112 30.4.2015, p. 81)

    Amended by:

     

     

    Official Journal

      No

    page

    date

     M1

    COMMISSION IMPLEMENTING DECISION (EU) 2019/1579 of 18 September 2019

      L 244

    8

    24.9.2019

    ►M2

    COMMISSION IMPLEMENTING DECISION (EU) 2021/184 of 12 February 2021

      L 55

    4

    16.2.2021



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    COMMISSION IMPLEMENTING DECISION (EU) 2015/700

    of 24 April 2015

    authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87708 (MON-877Ø8-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

    (notified under document C(2015) 2785)

    (Only the French and Dutch texts are authentic)

    (Text with EEA relevance)



    Article 1

    Genetically modified organism and unique identifier

    Genetically modified soybean (Glycine max (L.) Merr.) MON87708, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø8-9, as provided for in Regulation (EC) No 65/2004.

    Article 2

    Authorisation

    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 soybean MON-877Ø8-9;

    (b) 

    feed containing, consisting of, or produced from soybean MON-877Ø8-9;

    (c) 

    soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

    Article 3

    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 documents accompanying products containing or consisting of soybean MON-877Ø8-9 with the exception of products referred to in point (a) of Article 2.

    Article 4

    Monitoring for environmental effects

    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.

    Article 5

    Community register

    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.

    ▼M2

    Article 6

    Authorisation holder

    The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.

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    Article 7

    Validity

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

    ▼M2

    Article 8

    Addressee

    This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.

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    ANNEX

    ▼M2

    (a)    Applicant and Authorisation holder

    Name

    :

    Bayer Agriculture BV

    Address

    :

    Scheldelaan 460, 2040 Antwerp, Belgium

    On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States.

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    (b)    Designation and specification of the products

    (1) 

    foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;

    (2) 

    feed containing, consisting of, or produced from soybean MON-877Ø8-9;

    (3) 

    soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.

    The genetically modified soybean MON-877Ø8-9, as described in the application, expresses the DMO (dicamba mono-oxygenase) proteins which confer tolerance to dicamba-based herbicides.

    (c)    Labelling

    (1) 

    for the purposes of the specific 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 documents accompanying products containing or consisting of soybean MON-877Ø8-9 with the exception of products referred to in point (a) of Article 2.

    (d)    Method for detection

    — 
    event-specific real-time PCR based method for the quantification of soybean MON-877Ø8-9,
    — 
    validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
    — 
    Reference Material: AOCS 0311-A and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

    (e)    Unique identifier

    MON-877Ø8-9

    (f)    Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity

    Biosafety Clearing-House, Record ID: see [to be completed when notified].

    (g)    Conditions or restrictions on the placing on the market, use or handling of the products

    Not required.

    (h)    Monitoring plan

    Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

    [Link: plan published on the internet]

    (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.

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