02010D0429 — EN — 24.09.2019 — 001.001

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►B COMMISSION DECISION of 28 July 2010 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 x MON 810 (MON-88Ø17-3 x MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2010) 5139) (Only the Dutch and French texts are authentic) (Text with EEA relevance) (2010/429/EU) (OJ L 201 3.8.2010, p. 46)

Amended by:









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COMMISSION DECISION

of 28 July 2010

authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 x MON 810 (MON-88Ø17-3 x MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2010) 5139)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)

(2010/429/EU)







Article 1

Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.), MON 88017 x MON 810 as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-88Ø17-3 x MON-ØØ81Ø-6, as provided for in Regulation (EC) No 65/2004.

Article 2

Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 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-88Ø17-3 x MON-ØØ81Ø-6 maize;

(b) feed containing, consisting of, or produced from MON-88Ø17-3 x MON-ØØ81Ø-6 maize;

(c) products other than food and feed containing or consisting of MON-88Ø17-3 x MON-ØØ81Ø-6 maize for the same uses as any other maize with the exception of cultivation.

Article 3

Labelling

1. For the purposes of the labelling requirements laid down in Article 13(1) and Article 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 ‘maize’.

2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-88Ø17-3 x MON-ØØ81Ø-6 maize referred to in Article 2(b) and (c).

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.

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Article 6

Authorisation holder

The authorisation holder shall be Bayer Agriculture BVBA, Belgium, representing Monsanto Company, United States of America.

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Article 7

Validity

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

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Article 8

Addressee

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

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ANNEX

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(a) Applicant and authorisation holder:

Name : Bayer Agriculture BVBA

Address : Scheldelaan 460, 2040 Antwerp, Belgium

On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.

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(b) Designation and specification of the products:

1. foods and food ingredients containing, consisting of, or produced from MON-88Ø17-3 x MON-ØØ81Ø-6 maize;

2. feed containing, consisting of, or produced from MON-88Ø17-3 x MON-ØØ81Ø-6 maize;

3. products other than food and feed containing or consisting of MON-88Ø17-3 x MON-ØØ81Ø-6 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified MON-88Ø17-3 x MON-ØØ81Ø-6 maize, as described in the application, is produced by crosses between maize containing MON-88Ø17-3 and MON-ØØ81Ø-6 events and expresses the Cry3Bb1 and Cry1Ab proteins which respectively confer protection against certain coleopteran and lepidopteran pests and the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.

(c) Labelling:

1. for the purposes of the specific labelling requirements laid down in Article 13(1) and Article 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 ‘maize’;

2. the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-88Ø17-3 x MON-ØØ81Ø-6 maize referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection:

— event specific real-time quantitative PCR based method for genetically modified maize MON-88Ø17-3 and MON-ØØ81Ø-6 validated on MON-88Ø17-3 x MON-ØØ81Ø-6 maize,

— validated on seeds by the Community Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

— reference material: AOCS 0406-D (for MON-88Ø17-3) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/ and ERM®-BF413 (for MON-ØØ81Ø-6) accessible via the Joint Research Centre JRC) of the European Commission, Institute for reference Materials and Measurements (IRMM) accessible at https://irmm.jrc.ec.europa.eu/rmcatalogue

(e) Unique identifier:

MON-88Ø17-3 x MON-ØØ81Ø-6.

(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 time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.