I thank the Chairman. There are nine proposals for a Council decision, but eight can be taken together, since they deal with national bans in several member states on individual products approved for marketing on an EU-wide basis in the period from 1996 to 1998. I am sure that they will be dealt with at the Environment Council as a single item, and, with the Chairman's approval, I propose to do the same.
The other matter, with which I propose to deal first, is a proposal for a Council decision to authorise a new product, a genetically modified maize under the code name MON 863, the letters "MON" being for "Monsanto". It might be useful for me to place the proposal in the context of the process from which it emerged. EU Directive 2001/18/EC 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 is first proposed 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 all member states, as well as to the European Commission. Following detailed assessment of the notification, the lead competent authority may conclude that the product is unfit or fit for marketing. If the conclusion is that the product is unfit, that will be the end of the matter, since the process will be complete, and the application refused.
If, however, the lead competent authority considers the product fit for marketing, the process moves forward to obtain a detailed, Community-wide view. To achieve that, the full notification, and the lead competent authority's assessment of it, are made available to all competent authorities and the Commission. It is then open to each competent authority and the Commission to seek further information or indicate objections. It is open to all parties to discuss, and possibly resolve, outstanding issues. The public can also participate in the process through the Commission-sponsored website which contains summary information on each notification.
Should any competent authority remain unsatisfied at the end of the process of 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. 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 the EFSA is, therefore, also available to the regulatory committee.
The regulatory committee operates on the basis of qualified majority voting. Should a qualified majority be obtained to reject or approve the proposal, the process is finalised. However, if no qualified majority emerges from the committee, the Commission must refer the proposal to a meeting of the Environment Council. The Council also operates on the basis of qualified majority voting. Should a qualified majority not emerge from the Council, responsibility for approving the proposal reverts to the Commission.
This proposal is for the Council to authorise a genetically modified maize product for import into the Community and its subsequent use for animal feed and industrial processing. The proposal does not include cultivation. The product is a maize that has been genetically modified for resistance to the corn rootworm. In this case, the competent authority was Germany, which gave a positive assessment of the notification. The proposal was considered by each national competent authority, which in Ireland's case was the Environmental Protection Agency.
The EPA, following consultations with other relevant bodies, including the Departments of Agriculture and Food and Health and Children, Teagasc, and the GMO and novel foods sub-committee under the Food Safety Authority of Ireland's scientific committee, raised no objection to the proposal. However, several competent authorities in other member states expressed and maintained reservations. Therefore, in accordance with the directive's requirements, the proposal was brought before a meeting of the regulatory committee around the middle of last year. In advance of the regulatory committee's meeting the Commission sought the advice of the European Food Safety Authority which concluded that MON863 "is unlikely to have an adverse effect on human health and the environment in the context of its proposed use" and that the "nutritional properties of MON863 are no different from those of conventional maize".
Furthermore, the European Food Safety Authority did not find against the product, even though it includes an antibiotic resistant marker gene. EFSA held the view that the antibiotics concerned were among a group of antibiotics which are already widely distributed among soil and enteric bacteria and "have minor therapeutic relevance in human medicine" and "restricted use in defined areas of veterinary medicine".
I also draw the committee's attention to the fact that the regulatory committee was due to make a decision on MON 863 at its meeting on Monday, 20 September 2004. The Friday before the meeting took place, a paper by Dr. Árpád Pusztai querying aspects of the rat feeding study carried out on the product was circulated. Some member states, including Ireland, called for a deferral of the vote to allow the paper to be fully considered by competent authorities. On this basis, a decision was deferred to 29 November 2004.
Before the meeting on 29 November, Dr. Pusztai's paper was considered by the EPA which saw no valid reason to object to the product. In addition, the Commission referred the paper to EFSA which similarly saw no reason to change its previously expressed positive opinion on MON863.
The Minister mandated Ireland to abstain in the vote at regulatory committee on 29 November. As members can see from COM (2005) 163, the proposal did not achieve a qualified majority vote in that arena and, looking at the numbers, there is little likelihood of a qualified majority at Council. The Minister intends to finalise the Irish position on the proposal nearer to Council. I will ensure that the joint committee's views are brought to his attention so that he can take them into account.
Documents COM (2005) 161,162 and 164 to 169 relate to national bans on genetically modified maize T25 by Austria; maize MON810 by Austria; maize Bt176 by Austria, Luxembourg and Germany; swede rape Topas 19/2 by Greece and France and swede rape M1BnXRF1Bn by France. These products were originally approved on an EU-wide basis under Directive 90/220/EC in the period 1996 to 1998. As the principles underlying these documents are essentially similar, I intend to deal with them as a single item.
Directive 90/220 and its successor, Directive 2001/18, enable member states to invoke national bans on individual approved GMO products in case of emergency or where new detailed information which has environmental or health implication emerges. However, the directives also recognise the reality of the single market and the need to treat all citizens of the Union equally. Accordingly, the directives provide for examination of national bans on an EU-wide basis with the aim of ensuring that if the fears which underlie a national ban are valid, the product can be withdrawn from the market across the Community. On the other hand, single market considerations dictate that if the grounds on which a national ban was introduced are unproven, the ban should not remain in force.
As I said earlier, the products concerned were approved in the period 1996 to 1998 and the national bans were invoked in the period 1997 to 2000. The European Commission waited until the enhanced EU-wide GMO regulatory framework, which includes Directive 2001/18 on deliberate release and Regulation 1829/2003 on genetically modified food and feed, was operational before examining the rationale for the bans. In coming to its view, the Commission sought the advice of the European Food Safety Authority. The authority, which is independent of the Commission, found that there was no scientific evidence available to support the continuation of the bans.
However, the Commission's proposals to overturn the national bans also raised wider issues, including some of a political nature, for all member states, including Ireland. These included the standing legal requirement for the authorisations for the products concerned to be reviewed, starting in October 2006; Ireland's wider relationship with the member states whose decisions the Commission seeks to overturn; the need to maintain consistency in implementing the Government's "positive but precautionary" approach to the issue of GMOs and the desirability of implementing the directive both in accordance with its legal requirements and with its spirit.
Considering the matter in the round, it was decided that Ireland should abstain on each vote at the regulatory committee in relation to the bans. The outcome of the votes in the regulatory committee on the Commission's proposals to require revocation of the national bans makes it clear that a sizeable majority of member states do not wish to see a fellow member state's decision on a national ban being overturned, at least at present.
I hope my outline of the considerations the Minister will take into account in determining Ireland's voting strategy in advance of the Environment Council meeting has been helpful. I assure the joint committees that I will bring any views members have on the matter to the Minister's attention.