Brussels, 19 July 2004
The European Commission authorised today the placing on the market of the genetically modified maize known as NK603 for import and processing. This decision is valid for 10 years and results from an application submitted by the company Monsanto. Imports of the maize, whether in bulk shipments, bags or other containers, will have to be labelled as containing genetically modified maize. The NK603 maize is already widely used in other parts of the world 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 maize and processing for use in animal feed or for industrial purposes. A separate decision in terms of authorisation of the NK603 maize for use in food will be taken in the coming months.
Margot Wallström, Commissioner for the Environment, said: "The NK603 maize 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 maize. Its safety is, therefore, not in question, and neither is the question of user or consumer choice. 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 NK603 maize is the first product to be assessed and approved after the entry into force of Directive 2001/18/EC  . It will be covered by the new strict labelling and traceability rules which came into force in April  . When put on the market, it will need be clearly labelled as containing genetically modified maize. Its post-marketing monitoring will be assured through a unique identifier assigned to the maize to enable its traceability. Today’s authorisation covers the import and the use as animal feed, but not cultivation or food uses.
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.
Today’s decision grants approval for the use of NK603 maize in animal feed. However, imports for this use can only commence once the equivalent approval has also been granted for food use. A separate decision under the Novel Foods Regulation is currently being considered by the Agriculture Council. A decision is expected in the coming months.
See annex for lists of approved and pending GM products.
(Questions and Answers on the regulation of GMOs in the EU)
Note to the editors:
In January 2001, Monsanto submitted a request, under Directive 2001/18/EC , to the competent authorities of Spain for placing genetically modified maize line NK603 on the market for import and processing for use in feed and for industrial purposes. The NK603 maize is tolerant to the herbicide glyphosate. The product involves a simple modification and does not contain an antibiotic resistance marker gene.
The Spanish competent authority came to the conclusion that NK603 maize is as safe as conventional maize. The European Food Safety Authority also appraised the application and focused on the limited number of scientific issues raised by competent authorities from the other Member States. Its opinion similarly concluded that NK603 maize was as safe as conventional maize.
The Regulatory Committee established under Directive 2001/18/EC did not give an opinion. The Commission therefore submitted a proposal to the Council on 29 March 2004. The Council was required to act within 3 months.
The proposal was considered by the Environment Council on 28 June 2004. At that meeting, which included Ministers from the new Member States, neither a qualified majority vote in favour or against approval was obtained. This deemed that the Council did not act within the requisite time limit and consequently, the Commission under the legal procedure is obliged to adopt the Decision.
The methodology used for the safety assessment of the NK603 maize 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 maize".
A validated detection method and appropriate reference material is available and will allow for the physical detection of the NK603 maize 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.