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Commission Implementing Decision (EU) 2016/1685 of 16 September 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of the events Bt11, MIR162, MIR604 and GA21, and repealing Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU (notified under document C(2016) 5746) (Text with EEA relevance)

CELEX
32016D1685
Document type
DEC_IMPL
Sector
Legislation
Date of document
2016-09-16
In force since
2016-09-20
Status
In force

Text

Article-level text, parsed from the formex manifestation.

Article 1 Genetically modified organism and unique identifier

1 The following unique identifiers for genetically modified organisms (GMOs) are assigned in accordance with Regulation (EC) No 65/2004: (a) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × MIR604 × GA21; (b) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × MIR604; (c) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × GA21; (d) the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR604 × GA21; (e) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × MIR604 × GA21; (f) the unique identifier SYN-BTØ11-1 × SYN-IR162-4 for genetically modified maize (Zea mays L.) Bt11 × MIR162; (g) the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × MIR604; (h) the unique identifier SYN-BTØ11-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × GA21; (i) the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) MIR162 × MIR604; (j) the unique identifier SYN-IR162-4 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × GA21; (k) the unique identifier SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR604 × GA21.

2 The genetically modified maizes referred to in paragraph 1 are specified in point (b) of the Annex.

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 the GMOs referred to in Article 1; (b) feed containing, consisting of, or produced from the GMOs referred to in Article 1; (c) GMOs referred to in Article 1 in products containing them or consisting of them for any other use than those provided in points (a) and (b), 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 products containing or consisting of the GMOs referred to in Article 1, 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 Specific conditions for the placing on the market

1 The authorisation holder shall ensure that the specific conditions, referred to in point (g) of the Annex, are implemented.

2 The authorisation holder shall submit to the Commission annual reports on the results of the activities set out in the specific conditions of this authorisation for the duration of the authorisation.

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 provided for in Article 28 of Regulation (EC) No 1829/2003.

Article 7 Authorisation holder

The authorisation holder shall be Syngenta France SAS, representing Syngenta Crop Protection AG, Switzerland.

Article 8 Repeal

Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU are repealed.

Article 9 Validity

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

Article 10 Addressee

This Decision is addressed to Syngenta France SAS, 12, Chemin de l`Hobit, 31790 Saint-Sauveur, France.

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