Revised moleculair characterization of RF3 oilseed rape

Advisory reports | 18.11.2009 | 091118-01

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. These oilseed events are authorized for import and processing in Europe under regulation 2001/18/EC since 2005. Furthermore, RF3 and the hybrid line RF3 x MS8 are authorized for cultivation in Australia, Canada, Japan and the US.

Event RF3 expresses the barnase gene to engineer fertility restoration and a bar gene encoding tolerance to glufosinate ammonium containing herbicides. Previous molecular characterization indicated that RF3 oilseed rape contains one insert with a partial T-DNA copy arranged in an inverted repeat structure with a second, incomplete T-DNA copy. Recent experiments in which more precise methods where used, show that one of the elements in the insert has an inverted orientation. In the opinion of COGEM, the revised molecular analysis of the insert in oilseed rape RF3 is adequately performed.
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.