Legal provisions of COM(2008)47 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation 1829/2003 (Only the French text is authentic)

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dossier COM(2008)47 - Authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize ...
document COM(2008)47 EN
date March 28, 2008

Contents

Article 1 - Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.) GA21, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØØ21-9, 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-ØØØ21-9 maize;

(b)feed containing, consisting of, or produced from MON-ØØØ21-9 maize;

(c)products, other than food and feed, containing or consisting of MON-ØØØ21-9 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 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-ØØØ21-9 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 the 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.

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.

Article 6 - Authorisation holder

The authorisation holder shall be Syngenta Seeds S.A.S., France, representing Syngenta Crop Protection AG, Switzerland.

Article 7 - Validity

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

Article 8 - Addressee

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France.

Done in Brussels, 28 March 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission


(1) OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

(2) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(3) http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785956.htm

(4) OJ L 10, 16.1.2004, p. 5.

(5) OJ L 268, 18.10.2003, p. 24.

(6) OJ L 287, 5.11.2003, p. 1.


ANNEX

(a)   Applicant and Authorisation holder:

Name:Syngenta Seeds S.A.S.
Address:Chemin de l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France

On behalf of Syngenta Crop Protection AG, Schwarzwaldallee 215, CH 4058 Basle, Switzerland

(b)   Designation and specification of the products:

(1)Foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize;

(2)Feed containing, consisting of, or produced from MON-ØØØ21-9 maize;

(3)Products other than food and feed containing or consisting of MON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified maize MON-ØØØ21-9, as described in the application, expresses the mEPSPS protein which confers tolerance to herbicide glyphosate

(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 ‘maize’.

(2)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-ØØØ21-9 maize referred to in Article 2(b) and (c).

(d)   Method for detection:

—Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØØ21-9,

—Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm

—Reference Material: AOCS 0407-A and AOCS 0407-B accessible via the American Oil Chemists Society (AOCS) at http://www.aocs.org

(e)   Unique identifier:

MON-ØØØ21-9

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