2009/813/EC: Commission Decision of 30 October 2009 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2009) 8383) (Text with EEA relevance)
Genetically modified organism and unique identifier
Genetically modified maize ( Zea mays L.) MON 89034, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-89Ø34-3, as provided for in Regulation (EC) No 65/2004.
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-89Ø34-3 maize;
(b)
feed containing, consisting of, or produced from MON-89Ø34-3 maize;
(c)
products other than food and feed containing or consisting of MON-89Ø34-3 maize for the same uses as any other maize with the exception of cultivation.
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-89Ø34-3 maize referred to in Article 2(b) and (c).
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.
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.
Authorisation holder
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Addressee
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
(a) Applicant and Authorisation holder:
Name
:
Monsanto Europe SA
Address
:
Avenue de Tervuren 270-272, 1150 Brussels, Belgium
On behalf of Monsanto Company – 800 N. Lindbergh Boulevard – St. Louis, Missouri 63167 – United States of America.
(b) Designation and specification of the products:
1.
Foods and food ingredients containing, consisting of, or produced from MON-89Ø34-3 maize;
2.
feed containing, consisting of, or produced from MON-89Ø34-3 maize;
3.
products other than food and feed containing or consisting of MON-89Ø34-3 maize for the same uses as any other maize with the exception of cultivation.
The genetically modified MON-89Ø34-3 maize, as described in the application, expresses the Cry1A.105 and Cry2Ab2 proteins which confer protection to certain lepidopteran pests.
(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-89Ø34-3 maize referred to in Article 2(b) and (c) of this Decision.
(d) Method for detection:
—
Event specific real-time PCR based method for the quantification of MON-89Ø34-3 maize,
—
validated on seeds by the Community Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
—
reference material: AOCS 0906-E accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/corn.cfm
(e) Unique identifier:
MON-89Ø34-3
(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.
NB: 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.