02015D0684 — EN — 24.09.2019 — 001.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2015/684 of 24 April 2015 authorising the placing on the market of genetically modified maize NK603 (MON-ØØ6Ø3-6) and renewing the existing maize NK603 (MON-ØØ6Ø3-6) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2753) (Only the Dutch and the French texts are authentic) (Text with EEA relevance) (OJ L 112 30.4.2015, p. 6)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2015/684

of 24 April 2015

authorising the placing on the market of genetically modified maize NK603 (MON-ØØ6Ø3-6) and renewing the existing maize NK603 (MON-ØØ6Ø3-6) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2015) 2753)

(Only the Dutch and the French texts are authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.) NK603, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ6Ø3-6, 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 MON-ØØ6Ø3-6 maize;

(b) feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize;

(c) MON-ØØ6Ø3-6 maize 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 ‘maize’.

2. The words ‘not for cultivation’ shall appear on the label and in the documents accompanying the products containing or consisting of MON-ØØ6Ø3-6 maize 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

EU register

The information set out in the Annex to this Decision shall be entered in the EU 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.

Article 8

Repeal

Decisions 2004/643/EC and 2005/448/EC are repealed.

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Article 9

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-ØØ6Ø3-6 maize.

2. Feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize.

3. MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.

The genetically modified MON-ØØ6Ø3-6 maize, as described in the applications, expresses the CP4 EPSPS protein which confers tolerance to the glyphosate 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 ‘maize’.

2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-ØØ6Ø3-6 maize 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 MON-ØØ6Ø3-6 maize.

— Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, on genomic DNA extracted from Certified Reference Material, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

— Reference Material: ERM®-BF415 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue

(e) Unique identifier

MON-ØØ6Ø3-6

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

Biosafety Clearing-House [to be entered in the EU 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

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC [to be entered in the EU register of genetically modified food and feed when notified].

(i) Post market monitoring requirements for the use of the food for human consumption

Not required.