Renewal application cultivation of genetically modified maize MON810

This notification concerns the renewal of the authorization for continued cultivation of genetically modified maize line MON810. Maize line MON810 contains the cry1Ab gene causing the plant to be resistant to certain lepidopteran insects such as the European corn borer (Ostrinia nubilalis).
Previously, COGEM advised positively on the import as well as the cultivation of maize line MON810. In 1996 COGEM gave a positive recommendation on the market authorisation of this line. MON810 was authorised by the United States in 1996 and has been approved for import and cultivation in Europe since 1998. MON810 was first commercially cultivated in Europe in 2003. In 2006 this maize line was cultivated in six European countries (Spain, France, Czech Republic, Germany, Portugal and Slovakia). COGEM also advised positively on the import of hybrid maize lines with MON810 such as NK603 x MON810 and MON88017 x MON810.

Recently, COGEM was requested to advice on the report ‘Projet d’avis sur la dissemination du MON810 sur le territoire français’ by the French Comité de préfiguration d’une haute autorité sur les organismes génétiquement modifiés. This report concludes that new facts about the genetically modified maize line MON810 raise questions about the consequences of MON810 for human health and the environment. In reaction to the French report, COGEM analysed the data and concluded that risks associated with the cultivation of MON810 are negligible. Consequently, COGEM assessed there is no reason to rescind the authorisation of MON810.

In this renewal application, the MON810 dossier has been updated to comply with the current European guidelines. The applicant provided amongst others a more up-to-date molecular characterisation and series of monitoring reports which have been composed over the years MON810 has been cultivated in Europe.
In general, no wild relatives of maize are present in the Netherlands and establishment of maize plants in the wild has never been observed. There are no reasons to assume that the inserted traits will increase the potential of the maize line to establish feral populations. In addition, the appearance of volunteers is very rare under Dutch conditions.

COGEM is of the opinion that the molecular characterization of MON810 was adequate and that that the risk for human health or the environment with the modification of maize MON810 is negligible. Furthermore, based on the available scientific literature, COGEM is of the opinion that cultivation of maize MON810 poses negligible risks to non-target organisms.
Based on the history of safe use of maize line MON810 and the considerations put forward in this advice, COGEM is of the opinion that the cultivation of maize line MON810 poses a negligible risk the environment. Therefore, COGEM is of the opinion that the authorization for cultivation of MON810 can be renewed.