Commission Implementing Decision (EU) 2018/2045 of 19 December 2018 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize NK603 × MON 810 (MON-ØØ6Ø3-6 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2018) 8239) (Text with EEA relevance.)
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Article 1 Genetically modified organism and unique identifier
Genetically modified maize (Zea mays L.) NK603 × MON 810 produced by crosses between maize containing MONØØ6Ø3-6 and MON-ØØ81Ø-6 events, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ6Ø3-6 × MON-ØØ81Ø-6, in accordance with Regulation (EC) No 65/2004.
Article 2 Renewal of the authorisation
The authorisation for the placing on the market of the following products is renewed in accordance with the conditions set out in this Decision: (a) foods and food ingredients containing, consisting of, or produced from maize NK603 × MON 810; (b) feed containing, consisting of, or produced from maize NK603 × MON 810; (c) products, other than food and feed, containing or consisting of maize NK603 × MON 810 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 the documents accompanying the products containing or consisting of maize NK603 × MON 810, with the exception of food and food ingredients.
Article 4 Method for detection
The method set out in point (d) of the Annex shall apply for the detection of maize NK603 × MON 810.
Article 5 Monitoring plan 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 the format set out in Decision 2009/770/EC.
Article 6 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 referred to in Article 28 of Regulation (EC) No 1829/2003.
Article 7 Authorisation holder
The authorisation holder shall be Monsanto Company, United States of America, represented by Monsanto Europe S.A./N.V., Belgium.
Article 8 Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Article 9 Addressee
This Decision is addressed to Monsanto Europe S.A./N.V., Scheldelaan 460, 2040 Antwerp, Belgium.
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