The oil seed rape lines Ms8, Rf3 and Ms8 x Rf3 offer a pollination control system for the production of hybrid oilseed rape and are tolerant to the glufosinate ammonium herbicides. It was developed by EuropaBio member Bayer CropScience.

The Ms8, Rf3 and Ms8 x Rf3 oilseed rape application currently going through the regulatory process is for import and processing including for animal feed use. The application was first submitted in the European Union in 1996 and is one of a number of pending applications which has been awaiting approval in the European Union.  The application excludes cultivation, thus there is no requirement for scientific information on environmental effects associated with the cultivation of the genetically modified oil seed rape.

Prior approvals:

Oil and processed meal extracted from this genetically modified oilseed rape (Ms8 x Rf3) has already been approved in the EU. 

The first commercial planting of Ms8 x Rf3 was in 2000 in Canada and it has been approved in numerous countries worldwide including Canada, USA, Australia and Japan.

EFSA Opinion on the Import dossier:

In their scientific opinion for the import of Ms8, Rf3 and Ms8 x Rf3 oilseed rape, EFSA concluded on 14^th September 2005 that

“the GMO Panel considers that the information available for oilseed rape Ms8, Rf3 and Ms8xRf3 addresses the outstanding questions raised by the Member States and therefore the placing on the market of Ms8, Rf3 and Ms8xRf3 oilseed rape for import and processing for feed and industrial purposes is unlikely to have an adverse effect on human or animal health or, in the context of its proposed uses, on the environment.  This is in addition to the present uses of oil for food purposes and processed meal for feed purposes, both derived from Ms8 x Rf3 oilseed rape, which are already lawfully placed on the market.

The Panel advises that appropriate management systems are in place to minimize accidental loss and spillage of transgenic oilseed rape during transportation, storage, handling in the environment and processing into derived products.”

EFSA Opinion: http://www.efsa.eu.int/science/gmo/gmo_opinions/1178_it.html)

Additional information on file for Ms8, Rf3 and Ms8 x Rf3

EU Notification number C/BE/96/01 for Oilseed rape lines Ms8, Rf3 and Ms8xRf3 (hybrid line).  The hybrid oilseed rape line being obtained through traditional breeding from the parental lines containing events Ms8 and Rf3.   In addition to the genes encoding for pollination control, both parents also have a gene encoding for the tolerance to glufosinate-ammonium herbicides to achieve better weed control. 

Application for import and processing of Ms8, Rf3 and Ms8 x Rf3

The Rapporteur member state was Belgium.  The application for consent for placing on the market of the oilseed rape Ms8, Rf3 and Ms8 x Rf3 was submitted in 1996 in Europe under the Directive 90/220/EEC. The file and its scope have been successively amended and upgraded according to the evolution of the legislation in Europe.  In particular it was upgraded to the requirements of the new Directive 2001/18/EC in January 2003.  The file has completed the whole safety evaluation procedure including the initial risk assessment by the lead Member State (Belgium), the comments and objections by the 24 other Member States and finally the review by the GMO panel of the European Food Safety Authority (EFSA) who delivered its opinion on 14 September 2005. 

Oil and meal derived from Ms8, Rf3 and Ms8 x Rf3

Oil and processed meal extracted from this genetically modified oilseed rape has already been approved in the EU.  Oil extracted from hybrid oilseed rape Ms8 x Rf3 was approved in September 1999 after a positive opinion on substantial equivalence by the German BGVV (Reg. 258/97).  Oil (for food purposes) and the processed meal (for feed purposes) were notified under EU Regulation 1829/2003 and both entered into force on 18/04/2005.  Thus the food (oil) and feed (meal) derived from Ms8 x Rf3 can be legally marketed in the EU.  As such they are listed on the Community Register of GM Food and Feed.

EuropaBio, the European Association for Bioindustries, has 60 direct members operating worldwide and 25 national biotechnology associations representing some 1500 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products.