EFSA gave positive opinion for GM oilseed rape MS8, RF3 and MS8×RF3 for renewal of authorisation

The European Food Safety Authority (EFSA) has given a positive safety assessment to the application EFSA-GMO-RX-004 under regulation (EC) No 1829/2003 from Bayer CropScience.

The application from Bayer CropScience is asking for the renewal of authorisation application for the genetically modified (GM) herbicide-tolerant oilseed rape MS8, RF3 and MS8×RF3. The scope of the renewal application EFSA-GMO-RX-004 covers feed containing or consisting of GM oilseed rape MS8, RF3 and MS89RF3, excluding cultivation within the European Union (EU), and products other than food and feed containing or consisting of it.

In delivering its scientific opinion, the GMO Panel took into account application EFSA-GMO-RX-004, additional information provided by the applicant, scientific comments submitted by EU Member States and relevant scientific publications. The data received in the context of this renewal application EFSA-GMO-RX-004 contain post-market environmental monitoring reports, an evaluation of the literature retrieved by systematic searches, updated bioinformatics analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorization period and not previously assessed in the context of the original application.

In conclusion, under the assumption that the DNA sequences of the events in oilseed rape MS8, RF3 and MS89RF3 considered for renewed authorisation are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in the context of this renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS89RF3 (EFSA, 2005)