Additional advice on the import and processing of MON89034xNK603

Advisory reports | 20.10.2009 | 091020-01

In October 2007, COGEM advised negatively on the import and processing for use in feed and food of genetically modified maize line MON89034xNK603. The hybrid maize line MON89034xNK603 contains the genes cry1A.105 and cry2Ab2, conferring resistance to certain lepidopteran insects. In addition, this maize line contains the genes cp4 epsps and cp4 epsps L214P, resulting in tolerance to glyphosate containing herbicides.

In her previous advice, COGEM concluded that incidental spillage of MON89034xNK603 most likely poses negligible risks to man and the environment. However, the molecular characterization of parental maize line MON89034 was incomplete. Therefore, she could not issue a positive advice on the import and processing of MON89034xNK603. COGEM also had comments on the general surveillance plan that was provided. In response to the recently published EFSA opinion, the ministry of VROM asked COGEM whether the comments in her previous advice were sufficiently answered by the currently available information.
Since 2008, COGEM abstains from advice on the risks of incidental consumption when food safety is already assessed by a different authority. Moreover, COGEM has gathered extensive experience with the risk assessment for commercial releases of genetically modified crops. In view of this, COGEM recently reconsidered the elements of the molecular characterization which are needed for the environmental risk analysis.

In January 2009, COGEM concluded that the molecular characterization of MON89034 fulfilled the requirements as set by COGEM for the environmental risk analysis. In addition, obtained information on the A. tumefaciens strain ABI removed previous questions on this subject by COGEM. The applicant also presented a revised general surveillance plan for import and processing of maize MON89034xNK603 which meets the requirements for import and processing of this maize line.
In view of the above, COGEM withdraws her previous objections concerning the import and processing of maize line MON89034xNK603.

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