Scientific Opinion on a request from the European Commission related to the safeguard clause notified by Greece on genetically modified maize MON 810 according to Article 23 of Directive 2001/18/EC

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Article
EFSA Journal 2012;10(9):2877 [20 pp.].
doi
10.2903/j.efsa.2012.2877
EFSA Panel on Genetically Modified Organisms (GMO)
Panel Members
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Pagona Lagiou, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe.
Acknowledgement

The Panel wishes to thank the members of the Standing Working Group on Applications - Environment for the preparation of this Scientific Opinion; Hans Christer Andersson and EFSA staff: Yann Devos, Yi Liu 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-2012-00612
Adopted
6 September 2012
Published
11 September 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (200.42 KB)200.42 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 Greece in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 23 of Directive 2001/18/EC. The EFSA GMO Panel notes that the majority of the publications referred to by Greece were already addressed by the EFSA GMO Panel in previous scientific outputs on maize MON 810 or other related insect-resistant genetically modified maize transformation events. In the remaining evidence provided by Greece, the EFSA GMO Panel could not identify any new data subject to scientific scrutiny or scientific information that would invalidate its previous risk assessments of maize MON 810. 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 Greece, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of a safeguard clause under Article 23 of Directive 2001/18/EC and that would invalidate the GMO Panel’s previous risk assessments of maize MON 810.

Summary

In November 2011, Greece 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 23 of Directive 2001/18/EC.

On 22 May 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 Greece.

The EFSA GMO Panel has scrutinized the documentation provided by Greece in support of its safeguard clause on GM maize MON 810. The EFSA GMO Panel considered the relevance of concerns raised by Greece in the light of the most recent and relevant scientific data published in the scientific literature. This also includes the conclusions of the EFSA GMO Panel assessments of the PMEM results on maize MON 810 during the 2009 and 2010 growing seasons.

During its evaluation of the supporting documentation, the EFSA GMO Panel has noted that the majority of the publications referred to by Greece were already addressed in its past scientific outputs on maize MON 810 or other related insect-resistant GM maize transformation events and therefore refers to them.

In the four remaining evidence related to the environmental risk assessment provided by Greece, the EFSA GMO Panel could not identify any new data subject to scientific scrutiny or scientific information that would invalidate its previous risk assessments of maize MON 810. Against this background and in order to facilitate a thorough assessment of potential risks, the EFSA GMO Panel strongly recommends Member States who invoke safeguard clauses under Directive 2001/18/EC or emergency measures under Regulation (EC) No 1829/2003 to supply scientific data of a quality which can be subjected to detailed scientific scrutiny.

In addition, Greece did not supply scientific evidence to show that the conclusions of the previous risk assessments of the EFSA GMO Panel of maize MON 810 were not applicable to Greece.

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 finds that the scientific evidence currently available does not sustain the arguments provided by Greece and that cultivation of maize MON 810 in Greece is unlikely to have an adverse effect on human and animal health and the environment.

Keywords
GMO, maize (Zea mays), MON 810, Greece, safeguard clause, environment, Directive 2001/18/EC
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Number of Pages
20