Thank you, Chairman. I am a principal officer in the environment policy section of the Department of the Environment, Heritage and Local Government. My Department is responsible for the national legislative framework that applies in relation to the deliberate release of genetically modified organisms into the environment under Directive 2001/18 of the European Parliament and the Council and for policy input into the decision-making process under the directive.
As this is the first time, to my knowledge, that the joint committee has considered issues relating to Directive 2001/18, it might be useful if I were to place COM (2006) 78 in the context of the process from which it emerged. I will also try to update the committee on developments since its publication. Directive 2001/18 is one of two key pieces of current European legislation relating to the approval of genetically modified organisms, the second being the more recent Regulation 1829/2003 on genetically modified food and feed. While all new proposals to market genetically modified food and animal feed will fall to be considered under Regulation 1829/2003, a small number of proposals relating to animal feed made before Regulation 1829/2003 was finalised fell to be considered under Directive 2001/18.
Directive 2001/18 as well as Regulation 1829/2003, 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 is first proposed to market it. That competent authority then becomes lead competent authority for the purposes of that application. The lead competent authority examines the notification for completeness and makes summary information on the notification available to all other competent authorities 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. If, however, the lead competent authority considers that the product is 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. In this context, in coming to a view on any proposal under the Directive the Irish competent authority, the Environmental Protection Agency, consults other relevant bodies, including the Departments of Agriculture and Food and Health and Children, Teagasc, the GMO and novel foods sub-committee under the Food Safety Authority of Ireland's scientific committee and the EPA's GMO advisory committee. The public can also participate in the process through the Commission sponsored website which contains summary information on each notification.
Should a competent authority remain unsatisfied as to the appropriateness of the conclusion drawn by the lead competent authority that the product is fit to place on the market, and in practice, this is what usually happens, the notification is referred by the Commission to the regulatory committee of all member states 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, EFSA. The opinion of EFSA is, therefore available to the regulatory committee.
In dealing with a notification, the regulatory committee operates on the basis of qualified majority voting. Should a qualified majority be obtained to approve the proposal, the proposal is adopted. However, if no qualified majority in favour of the proposal emerges from the committee, the Commission must formally make its proposal to the Council.
Should the Council, acting by qualified majority, agree with the Commission's proposal, the proposal is adopted. Where the Council, also by qualified majority, opposes the proposal, it is open to the Commission to abandon its proposal or produce an amended proposal. Should no opinion emerge from Council, the Commission may proceed with its proposal. The role of the European Parliament in the process is confined to a form of legal scrutiny of proposals rather than a wider assessment of their actual merit.
COM (2006) 78 is a proposal by the Commission to the Council to approve genetically modified oilseed rape Ms8, Rf3 and their hybrid Ms8XRf3, which are resistant to the herbicide glufosinate-ammonium. The proposal covers the import of the varieties for animal feed and industrial processing. It does not propose cultivation. Use of these varieties for food purposes is not at issue either — although the committee may wish to know that the use of refined oil from these varieties for food use has already been approved throughout the European Union since 2000 under the novel food regulation, the forerunner of the GM food and feed regulation which dealt exclusively with food for human consumption.
The original notification in this case was made to the Belgian competent authority. The Belgian authority, following its assessment, indicated that it was satisfied that the importation of the product for the uses specified and under the conditions required by Directive 2001/18/EC would not adversely impact on the environment or on human health. As this view was not shared by the competent authorities of all other member states, the proposal came before the regulatory committee under the process I outlined earlier.
The majority of objections raised to the proposal had centred on the possible consequences of the establishment of feral colonies of oilseed rape and consequent gene transfer in the event of accidental spillage of viable seed. EFSA's opinion which was made available to the regulatory committee concluded that the product "is as safe as conventional oilseed rape for humans and animals and in the context of the proposed uses for the environment". EFSA recommended that "appropriate management systems should be in place to minimise accidental loss and spillage of transgenic oilseed rape during transportation, storage, handling in the environment and processing into derived products".
The Commission proposal that came before the regulatory committee sought to take account of EFSA's recommendations on management systems. Notwithstanding this, the outcome of the vote of the regulatory committee was inconclusive, as is indicated in the information note.
Ireland abstained during the vote of the regulatory committee. This abstention took a number of considerations into account, not least the abstention recorded by the Minister for the Environment, Heritage and Local Government at the Environment Council in December 2004 on oilseed rape GT73, a virtually identical product.
On the question of accidental seed spillage and gene flow from feral colonies of GM oilseed rape, it is useful to point out that this concern does not arise to the same extent in Ireland as in certain other countries, given that imports to Ireland of oilseed rape for feed use, either from inside or outside the Community, are pulped before arrival, leaving only a remote possibility of unprocessed seeds surviving the process, remaining viable, escaping and then establishing themselves. In the case of GT73, the Department of Agriculture and Food agreed to put in place appropriate measures to ensure that any obligations placed on feed business operators by the Commission to minimise the accidental spillage of GM oilseed rape for animal feed are complied with.
One will see from the information note that it was legally necessary for the proposal to be brought before Council within three months of publication. As the scheduled meeting of the Environment Council fell outside the three-month deadline the matter was taken at the Agriculture and Fisheries Council on 18 September 2006. The Minister for Agriculture and Food, at the behest of the Minister for the Environment, Heritage and Local Government abstained in the vote and maintained consistency in Ireland's voting pattern under directive 2001/18.
The Council comprising the 25 member states did not reach qualified majority on the proposal. In accordance with the procedure outlined Ireland's input and the input of all other member states to the decision making process has concluded and the responsibility for the matter now reverts to the European Commission.
In summary, document COM (2006) 78 has been overtaken by events which occurred on 18 September 2006. Notwithstanding this, I hope the information I have given to the committee in regard to the approval process under directive 2001/18/EC, and the progress of the particular product through that process, is helpful. I and my colleagues will endeavour to assist the committee in responding to any questions members may have. If we do not have the answers directly to hand we will be happy to communicate the information to the committee subsequently.