Import and processing of herbicide tolerant soybean 305423

Advisory reports | 19.12.2007 | 071219-03

The present application by Pioneer Hi-Bred International Inc. of file EFSA/GMO/NL/2007/45, ‘Application for the authorization of genetically modified 305423 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 a gm-fad2-1 gene fragment resulting in a high oleic phenotype. Soybean 305423 also contains the gm-hra gene conferring tolerance 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. 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. Survival of soybean is not possible in the North-Western European climate. Therefore, COGEM is of the opinion that incidental spillage of the soybeans will not pose a risk to the environment.
COGEM points out that the molecular analysis of soybean line 305423 is incomplete. Therefore, it cannot be excluded that new open reading frames with potential adverse effects were created due to the insertion. However, COGEM is of the opinion that, based on the results of the poultry feeding study, it can be concluded that no harmful effects are caused by incidental consumption of 305423 soybean. Therefore, COGEM is of the opinion that the risks for import of soybean 305423 are negligible in case of incidental consumption.
In consideration of these aspects and because soybean cannot survive or establish itself in the Netherlands, COGEM is of the opinion that the import of soybean 305423 poses a negligible risk to humans and the environment.
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.

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