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IP/07/416

Brussels, 26 March 2007

GMOs: Three oilseed rapes authorised for import and processing in animal feed

The European Commission today authorised the placing on the market of three oilseed rapes known as Ms8, Rf3 and Ms8xRf3, genetically modified for tolerance to the herbicide glufosinate-ammonium. This decision is valid for 10 years and covers the use of the oilseed rapes for imports and processing into animal feed or for industrial purposes. It includes measures to be taken by the company who developed the GM oilseed rapes to prevent any damage to health and the environment in the event of accidental spillage. Processed oil derived from these GM oilseed rapes has already been approved for food use in 1999 and 2000 in the EU.

Today’s authorisation covers the import and the use of Ms8, Rf3 and Ms8xRf3 oilseed rapes as animal feed, but not cultivation or food uses. These genetically modified oilseed rapes are tolerant to the herbicide glufosinate-ammonium and do not contain an antibiotic resistance marker gene. They have been subject to a rigorous pre-market risk assessment and have been scientifically assessed by the Member States, as well as the European Food Safety Authority, as being as safe as any conventional oilseed rape.

When put on the market, products containing Ms8, Rf3 or Ms8xRf3 will need to be clearly labelled as containing genetically modified oilseed rape. They will be covered by the strict labelling and traceability rules in force since April 2004. The labelling will provide operators and consumers with the information they need to decide whether to buy the product or not.

Robust post-marketing rules will ensure that the product can be traced and monitored once put on the market, thanks to a unique identifier assigned to the oilseed rape products. In addition, the authorisation includes a set of guidelines to Bayer, the company who developed the oilseed rape, on how to deal appropriately with accidental spillage should it occur.

During the past six years, the EU has put in place a clear, transparent and stringent system to regulate genetically modified food, feed and crops. The authorisation procedure under this new system ensures that only genetically modified organisms (GMOs) which are safe for human and animal consumption and for release into the environment can be placed on the European market. Individual authorisations are granted following appraisal of the GMOs in question on a case by case basis. Requests for authorisations which do not fulfil all criteria have been and will continue to be rejected.

This is the sixth authorising decision[1] to be issued under the Directive of 2001 on the deliberate release into the environment of GMOs[2].

Background

In January 2003, Bayer submitted a request to the competent authorities of Belgium for placing genetically modified oilseed rapes Ms8, Rf3 and Ms8xRf3 on the market. The initial request was for import, processing, feed use and cultivation, but not food use.

The Belgian authorities came to the conclusion that Ms8, Rf3 and Ms8xRf3 oilseed rapes are as safe as conventional oilseed rapes and should be placed on the market for import and processing and for use as any other oilseed rape but not for the requested use of cultivation.

The European Food Safety Authority also appraised the application and focused on the scientific issues raised by competent authorities from the other Member States. Its opinion similarly concluded that Ms8, Rf3 and Ms8xRf3 oilseed rapes were as safe as conventional oilseed rapes.

The Regulatory Committee established under Directive 2001/18 on the deliberate release into the environment of GMOs did not give an opinion in December 2005. The Commission therefore submitted a proposal to the Council.

The proposal was considered by the Agriculture and Fisheries Council on 18 September 2006. At that meeting the Council did not reach a qualified majority either for or against the Commission proposal. Consequently, under the legal "comitology" procedure, the Commission must adopt the Decision. The Commission’s decision to approve Ms8, Rf3 and Ms8xRf3 is therefore designed to ensure that this legal framework is correctly and fully applied by Member States.

This includes post-market monitoring of the continued safety of the product once it has been placed on the market via the use of surveillance systems. This monitoring is required throughout the period of validity of the consent. Reports of this monitoring programme must be submitted to all Member States and the Commission on an annual basis.

See also Memo/07/117 on the Regulation of GMOs in the EU


[1] The first product was NK 603 maize, see IP/04/957 of 19 July 2004. The second product was maize MON 863, see IP/05/1046 of 8 August 2005. The third product was oilseed rape GT73, see IP/05/1077 of 31 August 2005. The fourth product was maize 1507, see IP/05/1366 of 3 November 2005. The fifth product was maize MON863xMON810, see Commission Decision 2006/47/EC of 16 January 2006.

[2] Directive 2001/18/EC


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