02016D1215 — EN — 17.11.2021 — 002.001

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►B COMMISSION IMPLEMENTING DECISION (EU) 2016/1215 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2016) 4576) (Only the German text is authentic) (Text with EEA relevance) (OJ L 199 26.7.2016, p. 16)

Amended by:









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COMMISSION IMPLEMENTING DECISION (EU) 2016/1215

of 22 July 2016

authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2016) 4576)

(Only the German text is authentic)

(Text with EEA relevance)







Article 1

Genetically modified organism and unique identifier

Genetically modified soybean (Glycine max (L.) Merr.) FG72, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MST-FGØ72-2, 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 MST-FGØ72-2 soybean;

(b) feed containing, consisting of, or produced from MST-FGØ72-2 soybean;

(c) MST-FGØ72-2 soybean in products containing it or consisting of it 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 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 the documents accompanying products containing or consisting of MST-FGØ72-2 soybean, 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.

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Article 6

Authorisation holder

The authorisation holder shall be Syngenta Crop Protection AG, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, Belgium.

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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 Syngenta Crop Protection AG, Rosentalstrasse 67, CH 4058 Basel, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.

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ANNEX

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(a) Applicant and authorisation holder:

Name: Syngenta Crop Protection AG

Address: Rosentalstrasse 67, CH 4058 Basel, Switzerland,

Represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.

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(b) Designation and specification of the products:

(1) foods and food ingredients containing, consisting of, or produced from MST-FGØ72-2 soybean;

(2) feed containing, consisting of, or produced from MST-FGØ72-2 soybean;

(3) MST-FGØ72-2 soybean in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.

The genetically modified MST-FGØ72-2 soybean, as described in the application, expresses the 2mEPSPS protein which confers tolerance to glyphosate herbicides and HPPD W336 protein which confers tolerance to isoxaflutole herbicides.

(c) 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 the accompanying documents of the products containing or consisting of MST-FGØ72-2 soybean, with the exception of products referred to in point (a) of Article 2.

(d) Method for detection:

(1) Event specific real-time PCR based method for the quantification of MST-FGØ72-2 soybean;

(2) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from seeds of MST-FGØ72-2 soybean, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;

(3) Reference Material: AOCS 0610-A3 and AOCS 0707-A6 accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248.

(e) Unique identifier:

MST-FGØ72-2

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

[Biosafety Clearing-House, Record ID number: published in the Community 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 for environmental effects:

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

[Link: plan published in the Community register of genetically modified food and feed]

(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.