The European Commission authorised today the placing on the market of the genetically modified oilseed rape known as GT73 for import and processing. This decision is valid for 10 years and results from an application submitted by the company Monsanto. The GT73 oilseed rape, which is tolerant to the herbicide glyphosate, is already widely used in North America with no reports of any adverse effects on health or the environment. The authorisation today, which is backed by science, covers the specific use for imports of the GM oilseed rape and processing for use in animal feed or for industrial purposes. The authorisation is complemented by a Recommendation concerning the measures to be taken by the consent holder to prevent any damage to health and the environment in the event of the accidental spillage of GT73. Refined oil derived from GT73 oilseed rape has already been approved for food use in 1997 in the EU.

The GT73 oilseed rape has been subject to a rigorous pre-market risk assessment. It has been scientifically assessed by the European Food Safety Authority as being as safe as any conventional oilseed rape. Clear labelling provides farmers and consumers with the information they need to decide whether to buy the product or not. And robust post-marketing rules will ensure that the product can be traced and monitored when put on the market.

The GT73 oilseed rape is the third product [1] to be assessed and approved after the entry into force of Directive 2001/18/EC [2]. Today’s authorisation covers the import and the use as animal feed, but not cultivation or food uses. The product will be covered by the new strict labelling and traceability rules which came into force in April 2004 [3]. When put on the market, it will need to be clearly labelled as containing genetically modified oilseed rape. Its post-marketing monitoring will be assured through a unique identifier assigned to the oilseed rape to enable its traceability. In addition, the authorisation is complemented by a Recommendation containing a set of guidelines to Monsanto on how to deal appropriately with accidental spillage if it should occur.

During the past four 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 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.

Further information:
MEMO/05/104
(Questions and Answers on the regulation of GMOs in the EU)

Background:

In January 2003, Monsanto submitted a request, under Directive 2001/18/EC, to the competent authorities of the Netherlands for placing genetically modified oilseed rape GT73 on the market for import, processing for use in feed, and industrial purposes. The GT73 oilseed rape is tolerant to the herbicide glyphosate. The product involves a simple modification and does not contain an antibiotic resistance marker gene.

The Dutch competent authority came to the conclusion that GT73 oilseed rape is as safe as conventional oilseed rape. 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 GT73 oilseed rape was as safe as conventional oilseed rape.

The Regulatory Committee established under Directive 2001/18/EC did not give an opinion in June 2004. The Commission therefore submitted a proposal to the Council.

The proposal was considered by the Environment Council on 20 December 2004. At that meeting neither a qualified majority vote in favour or against approval was obtained. Consequently, the Commission under the legal procedure is obliged to adopt the Decision.

The methodology used for the safety assessment of the GT73 oilseed rape was entirely that of the new regulatory framework, notably Directive 2001/18/EC. The Directive also provides for mandatory measures to be applied to the product following approval.

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

The product will also have to be identifiable every time that it is placed on the market allowing individuals to choose whether or not to purchase and use the product. This will be ensured via the labelling and traceability provisions of the Directive and those of Regulation 1830/2003. Under this Regulation, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. Traceability provides the means to trace products containing or produced from GMOs through the production and distribution chains. The Regulation also provides for comprehensive information by its requirement for labelling of GMOs at all stages of the placing on the market. The label has to indicate "This product contains genetically modified organisms" or "This product contains genetically modified oilseed rape ".

The Commission Decision will only apply when a validated detection method and appropriate reference material is available which will allow for the physical detection of the GT73 oilseed rape in products enabling labelling claims to be verified. Guidance as to sampling and testing to verify the presence of GMOs in products has also been agreed to by Member States and this will enable their inspection and control authorities to operate in a harmonised manner throughout the EU.

In addition, further to the publication in February 2005, of a report by the Japanese Environmental Studies Institute referring to the accidental presence of oilseed rape genetically modified for tolerance to a herbicide around five of the six port facilities where sampling had been carried out, the European Commission has considered necessary to take measures to prevent the same situation arising in the European Union.

Therefore, the authorisation is complemented by a Recommendation containing a set of guidelines to the consent-holder (in this case Monsanto) on how to deal with accidental spillage if it should occur; and in particular to prevent any damage to health and the environment in the event of accidental spillage of the oilseed rape GT73 during transportation, storage, handling in the environment and processing into derived products.

[1] First product was NK603 maize, see IP/04/957 the second was MON 863 maize see IP/05/1046.

[2] Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment

[3] Regulation (EC) No 1829/2003 on GM food and feed

Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms