EFSA Statement, 17 November 2006

GM FOOD - Opinion of the GMO Panel related to the safeguard clause invoked by Greece according to Article 23 of Directive 2001/18/EC and to Article 18 of Directive 2002/53/EC

Adopted on 7 November 2006. (Question No EFSA-Q-2006-048)

Following a review of scientific information provided by EU Member State Greece and a meeting with Greek experts in July 2006, EFSA has found no new evidence that would change the risk assessment of MON810 maize which currently has marketing consent in the EU. The EFSA GMO Panel also found that there was insufficient scientific evidence that the environment or ecology of Greece was different from other regions in the EU to merit separate risk assessments in addition to those already conducted in other EU regions.

In conclusion:

• there is no new data that would invalidate the initial risk assessment conducted on MON810 maize established under Directive 90/220/EEC or Directive 2001/18/EC,
• there is no specific scientific evidence, in terms of risk to human health and the environment, that would justify a prohibition of cultivation of the MON810 maize authorised under Directive 90/220/EEC or Directive 2001/18/EC in Greece.
• EFSA's GMO Panel reviewed the available data on molecular characterisation, food and feed safety together with available data on environmental impact. The GMO Panel also reviewed new literature on CRY1Ab-expressing maize.

SCP, 1998. Opinion of the Scientific Committee on Plants regarding the genetically modified, insect resistant maize lines notified by the Monsanto Company (Notification C/F/95/12/02). http://ec.europa.eu/food/fs/sc/scp/out02_en.html

EFSA MON810 Assessments to date

• Opinion adopted on 6 July 2005 (Question No EFSA-Q-2004-086) - Opinion of the GMO Panel on an application (Reference EFSA GMO BE 2004 07) for the placing on the market of insect-protected glyphosate-tolerant genetically modified maize MON863 x MON810 x NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Monsanto
• Opinion adopted on 13 October 2006 (Question No EFSA-Q-2004-086) - Opinion of the Scientific Panel GMO on an application (Reference EFSA-GMO-UK-2004-01) for the placing on the market of glyphosate-tolerant and insect-resistant genetically modified maize NK603 x MON810, for food and feed uses under Regulation (EC) No 1829/2003 from Monsanto
• Opinion adopted on 6 July 2005 (Question No EFSA-Q-2004-154) - Opinion of the GMO Panel on an application (Reference EFSA GMO UK 2004 06) for the placing on the market of insect-protected glyphosate-tolerant genetically modified maize MON863 x NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Monsanto
• Opinion adopted on 13 October 2005 (Question No EFSA-Q-2005-056) - Opinion of the Scientific Panel GMO related to genetically modified crops (Bt176 maize, MON810 maize, T25 maize, Topas 19/2 oilseed rape and Ms1xRf1 oilseed rape) subject to safeguard clauses invoked according to Article 16 of Directive 90/220/EEC

Summary

On 29 March 2006, Greece invoked Article 23 of Directive 2001/18/EC and Article 18 of Directive 2002/53/EC (safeguard clause) to provisionally prohibit the cultivation of the authorised genetically modified maize MON810 on its territory. The European Commission received from Greece a written submission, composed of a scientific report, listing detailed reasons for supporting measures taken by Greece , and of 71 publications and statements.

As a consequence, the European Commission requested in a letter dated 4 May, 2006 a scientific opinion as to whether the scientific report and publications submitted by the Greek authorities show that there is an imminent danger for human health and the environment due to the cultivation of the maize varieties with the genetic modification MON810 expressing CRY1Ab protein.

Following investigation of the evidences presented in the Greek submission, EFSA's Scientific Panel on Genetically Modified Organisms (GMO Panel) concludes that, in terms of risk to human health and the environment, no new scientific evidence was presented that would invalidate the risk assessment of genetically modified maize MON810 established under Directive 90/220/EEC (repealed by Directive 2001/18/EC from 17 October 2002). The GMO Panel concluded that MON810 maize is unlikely to have adverse effects on human and animal health or on the environment due to the cultivation of the maize varieties with the genetic modification MON810 in Greece .