Scientific Opinion on a request from the European Commission related to the emergency measure notified by France on genetically modified maize MON 810 according to Article 34 of Regulation (EC) No 1829/2003

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Article
EFSA Journal 2012;10(5):2705 [21 pp.].
doi
10.2903/j.efsa.2012.2705
EFSA Panel on Genetically Modified Organisms (GMO)
Panel Members
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright and Jean-Michel Wal
Acknowledgement

The Panel wishes to thank the members of the Standing Environmental Working Group on Applications for the preparation of this Scientific Opinion; and EFSA staff: Yann Devos and Sylvie Mestdagh for the support provided to this Scientific Opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2012-00345
Adopted
7 Mai 2012
Published
21 Mai 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (208.87 KB)208.87 KB
Abstract

Following a request of the European Commission, the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) evaluated the documentation submitted by France in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 34 of Regulation (EC) No 1829/2003. The EFSA GMO Panel notes that some publications referred to by France were already part of the submission package by France for its safeguard clause and emergency measure on maize MON 810 in 2008. Those publications were addressed previously by the EFSA GMO Panel in its 2008 Scientific Opinion on the safeguard clause and emergency measure notified by France on maize MON 810. In the remaining documentation provided by France in support of the current emergency measure on maize MON 810, the EFSA GMO Panel could not identify any new science-based evidence indicating that maize MON 810 cultivation in the EU poses a significant and imminent risk to the human and animal health or the environment. With regard to issues related to management and monitoring of maize MON 810, the EFSA GMO Panel refers to its recent recommendations for management and monitoring measures of maize MON 810. In conclusion, the EFSA GMO Panel considers that, based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 34 of Regulation (EC) No 1829/2003 and that would invalidate its previous risk assessments of maize MON 810.

Summary

On 20 February 2012, France provided to the European Commission a scientific argumentation in support of its request for the prohibition of the placing on the market of the genetically modified (GM) maize MON 810 according to Article 34 of Regulation (EC) No 1829/2003.

On 16 April 2012, the European Commission requested the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) to assess the supporting documentation submitted by France.

The EFSA GMO Panel considered the relevance of concerns raised by France in the light of the most recent and relevant scientific data published in the scientific literature. During its evaluation of the supporting documentation, the EFSA GMO Panel has noted that some publications referred to by France were already part of the submission package by France for its safeguard clause and emergency measure on maize MON 810 in 2008. Those publications were addressed previously by the EFSA GMO Panel in its 2008 Scientific Opinion on the safeguard clause and emergency measure notified by France on maize MON 810, which concluded that no specific scientific evidence, in terms of risk to human and animal health or the environment, was provided that would justify the invocation of a safeguard clause under Article 23 of Directive 2001/18/EC and an emergency measure under Article 34 under Regulation (EC) No 1829/2003.

In the remaining documentation provided by France in support of the current emergency measure on maize MON 810, the EFSA GMO Panel could not identify any new science-based evidence indicating that maize MON 810 cultivation in the EU poses a significant and imminent risk to the human and animal health or the environment.

In relation to the management and monitoring of maize MON 810, the EFSA GMO Panel has previously assessed the Post-Market Environmental Monitoring (PMEM) plan and PMEM reports of maize MON 810 for the 2009 and 2010 growing seasons. Hence, the EFSA GMO Panel refers to its recent recommendations to improve the management and monitoring measures of maize MON 810 and other Bt-maize transformation events. The EFSA GMO Panel confirms from its evaluation of the PMEM results on maize MON 810 that no adverse effects on the environment, human and animal health due to maize MON 810 cultivation were identified during the 2009 and 2010 growing seasons.

In conclusion, the EFSA GMO Panel is of the opinion that, based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 34 of Regulation (EC) No 1829/2003 and that would invalidate its previous risk assessments of maize MON 810.

Keywords
GMO, maize (Zea mays), MON 810, France, emergency measure, environment, Regulation (EC) No 1829/2003
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Number of Pages
21