The Chairman mentioned other members of my team. As on previous occasions when I have appeared before the committee, I would like to make a brief opening presentation and then deal with questions as best we can on the basis that as the different members of the team have different relevant expertise, they will informally come in and answer questions depending on the area on which the questions are posed. The short presentation I will make has been circulated for the assistance and reference of members of the committee. I want to place document COM (2004) 193 in the context of the process from which it emerged and to update the committee on developments since its publication because, essentially, that document has been overtaken by events.
An EU directive sets out the procedures for dealing with any application to place on the market a product consisting of, or containing, GMOs. It is an inclusive process, involving all member states. A company wishing to market a GM product submits a notification to the competent authority of the member state in which it proposes to market it. That lead competent authority examines the notification for completeness and summary information on the notification is made available to all other competent authorities in the European Union and the European Commission.
Following detailed assessment of the notification, the lead competent authority can conclude that the product is either unfit or fit for marketing. If the conclusion is that the product is unfit, the process is completed and the application is refused. However, if the lead competent authority considers the product fit for marketing, the process moves forward to obtain a detailed, Community-wide view. To achieve this, the full notification and the lead competent authority's assessment of it are made available to all competent authorities and the Commission for their consideration.
It is then open to each competent authority and the Commission to seek further information or to indicate objections. In this process, it is open to all parties to discuss and possibly resolve outstanding issues. At this stage the public can also participate in the process through the Commission sponsored website, which contains summary information on each notification. The website address is in the documentation I have circulated.
At the end of this process, if any competent authority remains dissatisfied as to the appropriateness of the conclusion drawn by the lead competent authority that the product is fit to place on the market, the notification is referred by the Commission to the regulatory committee of all member states, which was established for the purposes of the directive. Before the regulatory committee considers the notification, the Commission obtains an opinion on the notification and the objections raised by competent authorities from the European Food Safety Authority. The opinion of the European Food Safety Authority is, therefore, also available to the regulatory committee.
In dealing with a notification, the regulatory committee operates on the basis of qualified majority voting. If a qualified majority is obtained either to reject or approve the proposal, the process is finalised. However, if no qualified majority emerges from the committee, the Commission must then refer the proposal to a meeting of the Council. The Council also operates on the basis of qualified majority voting. If a qualified majority does not emerge from the Council, under the terms of the directive, responsibility for approving the proposal reverts to the Commission. The sequence I have just described is what happened in this case.
The case to which the document refers is a proposal to import and market a particular line of maize, maize line NK 603, for industrial and animal feed use, but not for cultivation. This proposal was originally made to the Spanish competent authority. The maize in question is genetically modified to provide resistance to a particular herbicide.
The Environmental Protection Agency, as competent authority here for the purposes of the directive, raised no objection to the proposal having consulted with the Departments of Health and Children and Agriculture and Food, Teagasc; and the GMO and novel foods sub-committee under the scientific committee of the Food Safety Authority of Ireland. However, in other countries, objections were maintained by their competent authorities. Those countries were Austria, Denmark, Italy, France and Germany.
Accordingly, the notification came before the regulatory committee, attended by officials from my Department on Ireland's behalf on 18 February 2004. At that time, before the accession of the ten new member states, 87 votes were shared between the then 15 member states with Ireland having three votes. To achieve a qualified majority, 62 votes would have been required. The product in question received 53 votes in favour. In the document I circulated I have listed the countries that voted in favour. Some 24 votes were cast against the proposal from Austria, Denmark, Greece, Italy and Luxembourg, while Germany abstained.
As the proposal failed to get a qualified majority, under the next stage of the process I have outlined, it was brought by the Commission before the Council of Environment Ministers on 28 June 2004. That is where this document comes into place. This was the document prepared by the Commission for consideration by the Council of Ministers at that meeting. The Environment Council, which now comprises the 25 member states, did not reach a qualified majority on the proposal. In accordance with the procedure I have outlined, responsibility for approving or rejecting the proposal reverted to the Commission, which approved the notification on 19 July 2004.
The Commission approval of the product, NK 603, cannot take effect until an equivalent authorisation has been granted for food use. A separate decision under the Novel Foods Regulation, which is overseen in Ireland by the Department of Health and Children and the Food Safety Authority of Ireland, is being considered by the Commission because that proposal had been considered at the Agriculture and Fisheries Council in July again without reaching a qualified majority.
In summary, the document before the committee today has been overtaken by events. It was a document prepared for the Council of Ministers, which failed to reach a majority on it. Therefore, the process moved on beyond the document and, as I said, the Commission approved the proposal on 19 July. Notwithstanding this, I hope that the information I have given to the committee on how the approval process works and how this particular product went through that process is of some assistance.