Agricultural biotechnology developments in the EU
The EU’s authorization system for Genetically Modified Organisms (GMOs) remains extremely slow. Only two applications for import had been authorized by June, 2013. However, on September 26, the EU Court of Justice (ECJ) ruled in favor of Pioneer Hi-Bred International Inc, stating that the European Commission “had failed to meet its obligations.” As a result, the College of the Commissioners requested the Environment Council to authorize the cultivation of Pioneer Bt 1507 corn. We understand that the Ministers will probably address this issue in January 2014. The College also adopted three other import applications on November 6.
On June 25, two import applications were authorized (extension of the scope for its use) for the German company Bayer: Bayer MS8, RF3 & MS8 X RF3 and a renewal for the authorization of Bayer MS8 X RF3 rapeseed events. The EU’s authorization system for GMOs remains extremely slow and the number of applications continues to exceed the number of approvals. As of November 2013, a backlog of 68 applications (for approval of import, renewal, and cultivation) remains pending in the EU approval system, which has the effect of blocking U.S. exports of certain agricultural products. If the current rate of approval continues, the backlog of pending products will increase to 106 by 2020. About 6 applications for cultivation were already withdrawn in 2013.
The European Court of Justice’s (ECJ) Decision
Attempts to improve timelines seem to have little or no effect and product applications are usually not processed within the timeline prescribed by the comitology procedure.
However, on September 26, 2013, the ECJ ruled in favor of Pioneer Hi-Bred International Inc, regarding the authorization of its Bt 1507 corn submitted in 2001. This case dates back to May 2007, when Pioneer filed a complaint against the Commission for delaying authorization of its Bt 1507 corn despite 6 positive opinions by the European Food Safety Authority (EFSA).
The application was finally put to a vote at the Standing Committee for Food Chain and Animal Health (SCoFCAH) in the Regulatory Committee, comprised of experts from the Member States
(MS), in February 2009, which did not reach a qualified majority for or against. Further to this “no opinion” the Commission failed to put the matter to vote in Council “without delay”. The
Commission’s inaction for over four years was severely criticized by the ECJ. Furthermore, the ECJ also criticized the Commission for unnecessarily resubmitting the Pioneer application to EFSA seven times between 2001 and 2009. The Court's decision on Pioneer Bt 1507 corn confirms the urgency of reconciling strict and predictable European authorization rules for GM cultivation, with fair
consideration of national contexts.
While the ECJ ruling may result in the acceleration of the application process, it will not necessarily lead to more approvals. Even with an EU GM cultivation approval, some Member States, including
Germany, France, Hungary, Greece, Luxemburg, Bulgaria, and Hungary, which disagree with plant biotechnology for reasons other than science, still ban cultivation on spurious scientific grounds.
Only two GM events have been approved for cultivation in the EU (MON 810 and Amflora Potato) and the Pioneer cultivation application was submitted 12 years ago. For more information, please
see the following press release.
The Process for GMOs Cultivation Applications
The procedure for approving GMOs for cultivation differs slightly from the approval process for imports of GM food and feed. The main difference is that the regulations governing approval for import applications set clear timelines by which the Commission is required to put product applications on the agenda of the relevant committees. According to Regulation (EC) 1829/2003, Art 7 and Council Decision 1999/468/EC Art 5.4, the Commission has a maximum of 3 months to ask the MS to vote on events that already have a favorable EFSA opinion. If the vote does not reach the required qualified majority (260/352), another vote must be taken in the Appeal Committee within 2 months. In practice, the approval process clearly exceeds the legal limits. A recent industry assessment estimated that it takes about 48 months for a new GM event to be approved for import into the EU. On the other hand, the cultivation applications need to be put to the vote “without delay.” If no qualified majority is reached at Council, the Commission may adopt its proposal or not.
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