Import and processing of BT11xGA21
In April 2008, COGEM advised on the import and processing for use in feed and food of the genetically modified maize line Bt11xGA21. This maize line was obtained by conventional cross-breeding of the two parental lines Bt11 and GA21. In response to the EFSA opinion, COGEM was asked whether the comments in her previous advice were sufficiently answered by the currently available information.
In her previous advice on maize line Bt11xGA21 COGEM questioned some aspects of the provided general surveillance plan. COGEM upholds her remarks which are meant to improve the general surveillance plan. However, the provided general surveillance plan meets the minimal requirements for import and processing of maize Bt11xGA21.
In conclusion, COGEM remains of the opinion that import and processing of maize Bt11xGA21 poses a negligible risk to the environment and has no objections against an authorization for import and processing of Bt11xGA21.
Advice

Additional advice on the import and processing of MON89034xNK603
In October 2007, COGEM advised negatively on the import and processing for use in feed and food of genetically modified maize line MON89034xNK603.
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. 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.
Advice

Cultivation of genetically modified sugar beet H7-1
COGEM was asked to advise on the cultivation of the genetically modified sugar beet H7-1. Sugar beet H7-1 expresses the cp4 epsps gene. As a result this sugar beet is tolerant to glyphosate containing herbicides.
Sugar beet volunteers are almost never formed outside the field. However, in an agricultural environment volunteers may be formed from the seed that is produced by bolters, but also from plant crowns or portions of roots that are left on the field after harvest. In the soil, sugar beet seed can survive for a long period and may form a source of volunteer weeds. There are no indications that sugar beet can form feral populations outside an agricultural environment and there is no reason to assume that H7-1 sugar beet has an increased fitness or an increased potential to establish feral populations. Sugar beet may fertilize other beet species. Therefore, the glyphosate tolerance trait can be introduced into other cultivated beet species, weed beets and into wild sea beet. Glyphosate tolerance will only provide a selective advantage in an agricultural environment when glyphosate is used and will not provide a selective advantage under other conditions. Other herbicides will remain available that can be used to control weedy glyphosate tolerant beets. These herbicides cannot be used in a sugar beet crop, because sugar beets are also sensitive to these herbicides. COGEM points out that this situation is comparable to the current situation, where conventional weed beets cannot be controlled when sugar beet is cultivated.
COGEM is of the opinion that the molecular characterization of H7-1 sugar beet contains shortcomings. Furthermore, the General Surveillance plan should be improved on several points.
In conclusion, COGEM is of the opinion that the file concerning cultivation of sugar beet H7-1 contains inadequacies.  The applicant should provide information on the remaining issues before a decision on the authorization for cultivation of H7-1 sugar beet is taken by the competent authorities.
Advice

Revised moleculair characterization of RF3 oilseed rape
The applicant of the commercialized Brassica napus (oilseed rape) event RF3, Bayer CropScience, submitted new information regarding the molecular characterization of this genetically modified event. In 2004, COGEM advised positively on the cultivation, import and processing of oilseed rape event RF3, MS8 and the hybrid line RF3 x MS8. COGEM is of the opinion that the new information provided by the applicant regarding the molecular characterization of oilseed rape RF3 does not affect the outcome of the previous risk assessment. Therefore, COGEM sees no reason to revise its previous advice.
COGEM is surprised by the fact that this dossier contains confidential molecular information which is crucial for the risk analysis. COGEM believes that this crucial information should be available to the public. Only if information is publicly available, public trust can be maintained. COGEM is of the opinion that EFSA should reconsider its policy towards confidentiality of data provided by the applicant.
Advice

Cultivation of maize line MON89034xNK603
This notification concerns the cultivation of the genetically modified maize line MON89034xNK603. This maize line expresses the cp4 epsps and cp4 epsps L214P genes conferring tolerance to glyphosate containing herbicides. In addition, MON89034xNK603 contains the cry1A.105 and cry2Ab2 genes and is therefore resistant to certain lepidopteran insects.
COGEM is of the opinion that the molecular characterization of MON89034xNK603 is adequate. The applicant conducted several laboratory experiments to study whether maize MON89034xNK603 affects non-target organisms (NTOs) adversely. None of the laboratory experiments have been carried out with MON89034xNK603. In most cases either Cry1Ab.105 or Cry2Ab2 pure protein was used. COGEM is of the opinion that the applicant did not sufficiently demonstrate that the Cry1A.105 and Cry2Ab2 proteins do not interact. Five of the nine NTOs that were studied do not occur in the European Union and the applicant did not explain why these organisms are relevant to European maize fields. In addition, although the applicant did not show that Cry2Ab2.820 is biologically identical to Cry2Ab2 some of the experiments have been carried out with Cry2Ab2.820. The laboratory experiments also exhibit other shortcomings: the statistical power of the experiments and the obtained P value are not given, the choice for the statistical test is not explained and the applicant did not provide an explanation for the high mortality (over 15%) in certain control groups. The applicant presented three studies that describe MON89034xNK603 field trials. However, none of these field trials investigated the effect of MON89034xNK603 on NTOs in Europe. COGEM is of the opinion that the provided data are insufficient to allow a conclusion that cultivation of MON89034xNK603 exerts negligible effects on NTOs.
Based on these considerations, COGEM cannot advise positively on cultivation of maize line MON89034xNK603. COGEM is of the opinion that additional data from laboratory experiments and field trials have to be supplied to be able to make a reliable environmental risk analysis on cultivation of maize line MON89034xNK603.
Advice

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