C/BE/96/01 of Bayer CropScience for the commercial release of MS8, RF3 and MS8xRF3
In 1996, the dossier C/BE/96/01 'A new hybridisation system in oilseed rape (Brassica napus L.) - Application for consent to market genetically modified organisms (MS8xRF3)' was submitted to the Belgian Competent Authority (CA) by Plant Genetic Systems (PGS) (presently Bayer CropScience) within the framework of Part C of Directive 90/220/EEC. The notification covered a spring variety of oilseed rape which had been genetically modified to introduce a pollination control system (hybrid system) linked to a herbicide tolerant trait, intended for cultivation and import in the EU for all uses (food, feed and industrial uses) as any other oilseed rape (for more information see SNIF and public dossier).
Overview on evaluation process
December 1996: The risk assessment of the initial dossier (complying at that time with the requirements of Directive 90/220/EEC) is carried out by the experts of the Scientific Committees 'Transgenic plants' and 'Novel feed/food' of the Belgian Biosafety Advisory Council a.i. Based on a positive advice of the Biosafety Advisory Council a.i., the Belgian Minister of Agriculture issues a consent supporting the placing on the market of genetically modified (GM) oilseed rape MS8xRF3. The dossier is therefore sent to the European Commission (EC) and distributed to the other Member States (MS).
During 60 days the EC and the MS make comments on the dossier. Most remarks relate to the absence of a monitoring plan (which are considered necessary to check the long-term effects of the herbicide use, the outcrossing of transgenes and the potential establishment of multiple herbicide-tolerant plants) and to the absence of a labelling proposal. Questions are also raised about the lack of legislation for the evaluation of the GM seeds for human use.
4 July 1997: The additional information handed in by the notifier as an answer to the objections and questions of the MS, is evaluated by the experts of the Scientific Committees 'Transgenic plants' and 'Novel feed/food' of the Biosafety Advisory Council a.i. Although not requested under Directive 90/220/EC, the Belgian experts ask the notifier to design a monitoring plan and guidelines for agricultural practices. Moreover, a list of institutes already involved or that would be involved in the biosafety research of MS8xRF3, as well as an overview of the biosafety research topics is requested.
May 1998: The Scientific Committee on Plants (SCP) of the EC gives a favourable opinion on the MS8, RF3 and MS8xRF3 lines. The SCP concludes that there is no evidence to indicate that the placing on the market of GM oilseed rape MS8xRF3, with the purpose to be used as any other oilseed rape, is likely to cause adverse effects on human health and the environment. The SCP also expresses the need for an agricultural code of practice and a post-market monitoring plan.
Following the positive advice of the SCP, the notifier keeps the notification C/BE/96/01 up-to-date and continues to provide the latest available data and information on the GM oilseed rape events.
19 March 1999: A 'Stewardship plan for post-market guidance and monitoring' is set up by the notifier and discussed during a meeting of the Biosafety Advisory Council a.i.
28 May 1999: The EC sent out a proposal for a Commission Decision (ref: XI/565/97-rev.2) approving the placing on the market of oilseed rape MS8xRF3. Following requests by different MS, the vote is postponed.
14 October 1999: The notifier submits an overview on the biosafety research carried out in the framework of notifications C/DE/96/5 and C/BE/96/01 (document C005583), including a monitoring plan and a labelling proposal. On 9 November 1999, an update of the document (document C005938) is submitted to the EC. The documents are presented during the meetings of the Regulatory Committee (according to Article 21 of Directive 90/220/EEC) on 29 October 1999 and 9 March 2000. Once again the vote is postponed.
Awaiting the resumption of the procedure and considering the new Directive 2001/18/EC, Aventis CropScience updates the dossier to the provisions thereof. The notifier submits a new set of documents. The 'Update 2001' contains: an environmental risk assessment (ERA) confirming the conclusions of the ERA of the original notification dossier (1996) but providing better funded scientific evidence, the requested agricultural guidelines, a monitoring plan consisting of two sections, a case-specific monitoring and a general surveillance, a SNIF, a detection and identification protocol, and a labelling proposal. As a result of more detailed requirements concerning molecular characterisation and public information at Belgian level, this information package is extended with a number of documents providing further molecular details on the events MS8 and RF3 and with a public dossier.
27 September 2001: This additional information is assessed by the Scientific Committee 'Transgenic Plants' of the Biosafety Advisory Council a.i. Further information is requested from the notifier by the Belgian experts, on the basis of which the Scientific Committee considers the new set of documents as satisfactory.
16 January 2001: On basis of Article 35 of the Directive 2001/18/EC, Bayer CropScience submits the updated notification C/BE/96/01 to the Belgian CA. The update includes the information required under Article 13, except for the information requested under Article 13.2 sections (c), (d) and (g). The notifier provides the missing information to the CA on 5 August 2003. On 6 October 2003 the notifier also provides the bio-informatic analyses of the inserts as requested in the Belgian guidelines on molecular characterisation. The Belgian experts and the Division of Biosafety and Biotechnology (SBB) approve the additional information.
8 October 2003: The updated notification is discussed by the Biosafety Advisory Council. Additional information needed for a complete environmental risk assessment according to Annex II D2 of Directive 2001/18/EC is requested. Awaiting this information the clock is stopped. The notifier provides the additional information on 12 January 2004.
2 February 2004: The Belgian Competent Ministers takes his decision. It is decided that a consent for import and processing of the transgenic oilseed rape MS8, RF3 and MS8xRF3 for feed purposes can be granted, but not a consent for cultivation. The notification is sent to the European Commission and Bayer CropScience.
25 February 2005: As required by Directive 2001/18/EC, the MS are informed via the Commission about the Belgian decision. Objections to the placing on the market of the transgenic oilseed rape MS8xRF3 are raised by the Member States during the 105-day evaluation period. Therefore, the notification is sent to the European Food Safety Authority (EFSA) for further scientific evaluation.
14 September 2005: EFSA gives a favourable opinion on the placing on the market of the oilseed rape MS8xRF3 for import and processing into feed products.
Overview on decision procedure
5 December 2005: No qualified majority is reached at the Regulatory Committee level for the placing on the market of oilseed rape products of lines Ms8, Rf3 and MS8xRF3. The draft Commission Decision is therefore forwarded to the Council.
18 September 2006: No qualified majority is reached either to approve or reject the placing on the market of the genetically engineered oilseed rape at Council level. A final decision will be taken by the European Commission.
26 March 2007: The European Commission adopts Decision 2007/232/EC for the placing on the market of the genetically engineered oilseed rape.
25 May 2007: The Belgian Competent Authority issues its final consent addressed to the notifier approving the placing on the market of the genetically engineered oilseed rape products of lines Ms8, Rf3 and MS8xRF3.