Import and processing of herbicide tolerant soybean 356043

The present application by Pioneer Hi-Bred International Inc. of file EFSA/GMO/NL/2007/43, ‘Application for the authorization of genetically modified 356043 soybean and derived food and feed in accordance with Regulation (EC) No 1829/2003’ 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 gm-hra and gat4601 gene. As a result, 356043 is tolerant to certain herbicides.
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 not pose a risk to the environment.
However, COGEM points out that the molecular analysis of soybean line 356043 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 theoretically give rise to potential toxic or allergenic products. Feeding and toxicity studies could rule out if indeed allergens or toxins are formed. COGEM has some reservations about the quality of the studies in the dossier. Therefore, she can not advise positively on this application at the moment. COGEM realizes that also other authorities and advisory bodies are involved in this dossier which have a primary role in the assessment of the food and feed safety. This COGEM advice is given in the understanding that a final decision by the authorities will be based on an integrative interpretation of all aspects concerned.
Furthermore, in view of the different aspects which are related to the impact of the molecular characterization, COGEM is of the opinion that this topic should be discussed within a European context in order to obtain a common view on the minimum requirements as far as the molecular characterization is concerned.