Scientific opinion of revised molecular characterisation for Rf3 oilseed rape

On request of the EU Commission EFSA has to make a scientific opinion on the revised molecular characterisation for RF3 oilseed rape delivered by Bayer CropScience. The opinion is expected to be published during the first quarter of 2010.

Rf3 oilseed rape, as well as the hybrid MS8xRF3 are authorised in th EU for food, feed, import and processing (Community Register entry). An application for renewal of this authorisation was submitted in 2007 and EFSA has published a favourable opinion on this application in September 2009.

In February 2009, the consent holder Bayer CropScience informed the Belgian competent authority that the previous molecular characterisation of the the Rf3 event was not correct. Bayer CropScience provided a new molecular characterisation which was considered new information, that could have consequences for the risk of RF3 to human health and the environment. As the rapporteut member state the Belgian competent authority applied the provisions of Article 20(3) of Directive 2001/18/EC and provided an assessment report. The new information also was transmitted to the other EU member states and the Austrian competent athority responded by raising a reasoned objections. This objection was forwarded to Bayer CropScience with a request to provide a response. Bayer CropScience responded in November 2009 refering that EFSA considered the new information on the molecular characterisation of RF3 oilseed rape in its opinion published in September 2009. However, on 4 December 2009 the EU Commission requested EFSA to deliver a scientific opinion on the revised molecular characterisation for Rf3 oilseed rape.

Rf3 oilseed rape is not the only transgenic plant for which corrections of the initial molecular characterisation were reported only after commercialisation. Another case is Monsanto's Roundup Ready soybean insertion event 40-3-2. In addition to the intended EPSPS transgene described in the original application for commercial approval of 40-3-2 soybean, a 254 bp EPSPS gene fragment, a 540 bp segment of unidentified DNA, a segment of plant DNA, another 72 bp fragment of EPSPS, and evidence for additional alterations to flanking plant DNA were found in 40-3-2 soybean plants (Palevitz 2000, Windels et al. 2001, Cotter 2002, Lau et al. 2004). Independent analysis of another commercialised event, Monsanto's MON810 maize, also found evidence for initially unreported insertion-site mutations Hernandez et al. 2003) and putative recombinant proteins Rosati et al. 2008).

Question number: 
Application date: 
scientific opinion
Aplication accepted: 
in progress
European Commission - DG ENV