Obtaining Approval to Market GMOs in the European Union
--by Michael T. Maurer and Neil E. Harl**
The European Union requires genetically modified organisms (GMOs) to obtain approval before either the GMO or products containing the GMO can be placed on the market. To illustrate how the EUís review process works, this article reviews the steps undertaken to obtain approval for Monsantoís Bt corn line MON810.
Notification. Council Directive 90/220/EEC contains the procedures relating to approval of the deliberate release of GMOs into the environment for purposes of research and development and for purposes of placing the GMO on the market. Any person seeking approval to place a GMO on the market must submit a notification to the "competent authority" of the member state where the product is to be placed on the market for the first time. Accordingly, Monsanto submitted notification for MON810 to the French Ministry of Agriculture, the "competent authority" designated by France.
The notification dossier must describe the risk analysis carried out, show that the products comply with the relevant European Community product legislation, and describe the environmental risk assessment required by the directive. The notification also must include "specific conditions of use and handling and a proposal for labelling and packaging which should comprise at least the requirements laid down in Annex III" of the directive, as amended.
Review of Notice. Upon receipt of the notification, the competent authority has 90 days to either forward the notification dossier to the Commission with a favorable opinion or inform the notifier that the proposed release does not fulfill the requirements of the directive. The French Ministry of Agriculture forwarded Monsantoís notification dossier to the Commission with a favorable opinion.
After receiving a notification dossier, the Commission immediately forwards it to the competent authorities of all member states. If no objections are raised by the competent authorities of the member states within sixty days after the Commission forwards the notification dossier, then the competent authority that received the notification shall issue a written consent to the applicant and shall inform the other member states and the Commission of that consent. The notification for MON810 met with objections from the competent authorities of member states other than France and, therefore, Monsanto was required to complete additional procedures.
Handling Objections. In response to the objections, Monsanto modified its original proposal for labeling to provide a statement on the seed bag about the genetic modification and to provide information to purchasers, traders and exporting authorities about the genetic modification, its approval, and handling recommendations. Because the member states were not able to reach an agreement concerning the notification, the Commission was required to make a decision on Monsantoís notification.
Decision of the Commission. Article 21 of Council Directive 90/220/EEC contains the procedures to be followed by the Commission in reaching a decision when the member states did not reach an agreement on the GMO notification. Accordingly, with respect to MON810, the Commission formed a committee composed of representatives from the member states. Before making its decision, the Commission sought the opinion of relevant scientific committees, including the Scientific Committee on Plants. On February 10, 1998, the Scientific Committee on Plants delivered its opinion that there was no reason to believe that placing MON810 on the market would have any adverse effects on human health or the environment. Relying on this opinion of the Scientific Committee on Plants and the opinion of the committee established under Article 21, on April 22, 1998, the Commission adopted a decision approving Monsantoís modified notification.
Issuance of Consent. In its decision, the Commission directed the French Ministry of Agriculture to issue a consent to place MON810 on the market and addressed the decision to all member states. The French Ministry of Agriculture issued the required consent on August 3, 1998.
Bans of Approved GMO
In many situations, the issuance of the consent by a competent authority of a member state would be the last step in the process necessary to market a GMO in all countries of the European Union. However, Council Directive 90/220/EEC contains a "safeguard" clause. Article 16 authorizes a member state with "justifiable reasons" that an approved GMO constitutes a risk to human health or the environment to restrict or prohibit the use and sale of that product on its territory. A member state that invokes Article 16 is required to inform the Commission and the other member states of its actions and provide the reasons that action.
On June 2, 1999, Austrian authorities gave notice of their decision to invoke Article 16 with respect to MON801 and prohibit its marketing within Austria. The main reasons for Austriaís actions were (1) the undesired effect of Bt toxin on non-target organisms and (2) the possible development of resistance in the main target pest, the European corn borer.
After receiving the notice from the Austria authorities, the Commission sought the advice of the Scientific Committee on Plants (SCP) about whether the information in the Austrian notice constituted relevant scientific information not previously considered by the SCP in arriving at its earlier opinion and, if so, whether the information invalidated the original risk assessment of MON810. In addition, the SCP was asked whether Bt products constitute a risk to human health and the environment, including non-target organisms such as butterflies.
On September 24, 1999, the SCP issued an opinion that concluded (1) the information submitted by Austria did not constitute new significant information not previously considered in the original risk assessment and opinion on MON810 and (2) the previous risk assessment remained unchanged. Since the SCP delivered its opinion, the Commission has not yet taken further action.
If the Commission follows the procedures previously taken when Article 16 objections are delivered, its next step is to submit to the Regulatory Committee a draft of a Commission Decision requiring Austria to repeal its ban on MON810. The responsibility of the Regulatory Committee is to deliver an opinion on whether or not the Commission should adopt the draft. The members of the committee, but not the chair, vote on the opinion to be delivered.
If the Regulatory Committee delivers an opinion supporting the measures drafted, then the Commission is required to adopt those measures. Alternatively, if the Regulatory Committee does not deliver an opinion or delivers an opinion contrary to the measures in the draft, the Commission must submit the draft proposals to the Council of Ministers for decision. If the Council of Ministers does not act within three months from the date the matter is referred to it, the proposed measures shall be adopted by the Commission.
If the Commission adopted a decision requiring Austria to repeal the ban on MON810, but Austria did not comply, then the Commission could apply to the European Court of Justice to enforce the Commissionís decision. If a member state does not comply with a judgment obtained from the European Court of Justice, then the Commission has the right to take further legal action against that member state in the European Court of Justice and the court is empowered to impose a financial penalty on the member state.