Import and processing of glyphosate tolerant soybean MON 89788

The present application by Monsanto Europe S.A. of file EFSA/GMO/NL/2006/36, ‘Glyfosate-tolerant soybean transformation event MON 89788’, concerns the import and processing for use in feed and food of a genetically modified soybean line. Cultivation is not part of this application.
The recombinant soybean line is genetically modified by insertion of the cp4 epsps gene. As a result, MON 89788 is tolerant to herbicides containing the active ingredient glyphosate.
Recently, MON 89788 has been approved for use as food in the United States of America and Canada and for use as feed in the United States of America.
In Europe, wild relatives of soybean are not present and modern soybean cultivars do not possess any of the attributes commonly associated with problematic weeds. In addition, there is no reason to assume that the inserted gene would increase the potential of the soybean to run wild. Furthermore, establishment of feral populations in soybean producing countries has never been observed. Moreover, survival of soybean is not possible in the North-Western European climate. Survival and establishment of soybean volunteers in the wild has never been reported in Europe. Therefore, COGEM is of the opinion that incidental spillage of the soybeans will probably not pose a risk to man and the environment.
However, COGEM points out that the molecular analysis of soybean line MON 89788 is incomplete. Therefore, it cannot be excluded that new open reading frames were created due to the insertion. If new open reading frames were created, these could give rise to potential toxic or allergenic products. Considering the requirements of EU Directive 2001/18, COGEM is of the opinion that the molecular characterization was insufficiently provided. In view of the shortcomings of the molecular analyses, COGEM cannot advice positively on the application for import and processing of soybean line MON 89788. Furthermore, COGEM has some comments on the general surveillance plan.