The European Union (EU) Health Commissioner, John Dalli, released a proposal on the regulation of biotech crops to possibly break the policy deadlock in the EU that has developed for over the last 15 years. The EU Commission would retain its authority for the strict authorization procedures currently in place based on science, safety, consumer choice and approval by the European Food Safety Agency (EFSA). The EU member states would have the freedom to allow, restrict or ban the cultivation of biotech crops in all or parts of their individual countries.

According to AFP News, in announcing the proposal Commissioner Dalli said, “The Commission is not in favor or against GMOs. But in today’s world, they are a reality and Europe cannot stand idle and deny itself the political responsibility to take decisions and implement a policy of responsible innovation.” When the new Commission took over in February they promised to have a new regulatory framework on planting biotech crops for discussion by this summer.

The proposal is not intended to speedup authorizations or weaken environmental risk assessment requirements. The Commission would continue to work with the EFSA on the science and safety of biotech crops for both cultivating in the EU and importing for feed and food use. The EU imports about 80 percent of its vegetable protein needs, most of which is produced with biotechnology. Six countries, Austria, Hungary, France, Greece, Germany and Luxembourg, have already prohibited the planting of biotech corn. Another half dozen countries generally vote against or abstain on allowing authorization of new biotech crops.

In 2009 the EU grew 234,000 acres of the one biotech corn (MON810) authorized in 1998. According to the International Service for the Acquisition of Agri-Biotech Applications (ISAAA), Spain had 187,900 acres of biotech corn, the Czech Republic 16,000 acres, Portugal 12,600 acres, Romania 8,000 acres, Poland 7,400 acres and Slovakia 2,200 acres. Germany and France had previously grown biotech corn. Romania grew 360,000 acres of biotech soybeans in 2006 before joining the EU in 2007. A biotech starch potato, known as ‘Amflora’, was authorized for cultivation and industrial processing in March 2010. Austria, Luxembourg and Hungary have already notified the Commission they will prohibit its cultivation.

Biotech crops for cultivation are already backed up in the regulatory process. Bt corn 1507 from Pioneer and Bt corn 11 from Syngenta received favorable EFSA opinions, respectively, in January 2005 and April 2005, but did not receive a qualified majority when voted on in February 2009 by the Regulatory Committee. Corn NK 603 from Monsanto received a favorable opinion from EFSA in June 2009, as did the renewal of authorization of MON810 corn from Monsanto.

Importing biotech crops for feed and food will continue to be regulated as now. Member states would not be allowed to prohibit the import and/or the marketing of authorized biotech products. The current list of authorized biotech crops for feed and food use includes one sugar beet, three soybeans, three rapeseeds, six cotton and 17 corn products.
What would change is that once a new biotech crop is authorized for cultivation, member states would be able to ban it across all or part of their country for socioeconomic, ethical and moral reasons other than those included in the health and environmental risk assessment of the EU. They would no longer need to use the safeguard clause of the current regulations and have scientific reasons for their actions. The proposal includes new legislative language applicable to all biotech crops authorized for cultivation in the EU. Member decisions would not require authorization by the Commission, but members would need to inform it and other members one month before the adoption of the measure.

The proposal includes new recommendations for the development of national co-existence rules to replace recommendations made in 2003 which made a link between co-existence rules and the 0.9 percent threshold for labeling biotech food, feed or products intended for direct processing. The Commission has determined that the potential for loss of income for non-biotech producers is not limited to exceeding the labeling threshold. The non-binding guidelines allow limiting GMO content in conventional food and feed to levels below 0.9 percent and allow member states to create biotech-free areas with restrictions proportionate to the desired protection. The European Co-existence Bureau will develop in cooperation with member states best practices and technical guidelines for co-existence.

Supporters of biotech crops oppose the Commission recommendations for co-existence rules which could be onerous enough to prevent planting of biotech crops even in countries that have approved cultivation. The current co-existence guidelines are tied to the 0.9 percent level for labeling foods as containing biotech products. The proposal invites guidelines at less than 0.9 percent which could mean zero. That would be nearly impossible to reach at a reasonable cost.
The EU is already caught in a zero tolerance position on unauthorized biotech events in imported feed, specifically U.S. soybeans and meal. At risk are annual imports from the U.S. of 2.0-3.6 million metric tons of soybeans and 160,000-600,000 metric tons of soybean meal. According to the ISAAA, the EU also suffered losses of $3.5 billion in 2007 from the loss of U.S. produced corn-gluten-meal and distillers dried grains due to the presence of not yet approved biotech events.

The proposal has a long way to go when formal deliberations begin this fall. It must be adopted through co-decision making with the European Parliament and the European Council of member states. It would then face a test in the WTO where the EU lost a case brought by the U.S. on its de facto ban on biotech crops. After 15 years of avoiding a working compromise among disparate positions, the 27 member states and three EU institutions need to find a political, economic, social and trade policy middle ground.