Genetic engineering in the European Union has varying degrees of regulation.
Regulation
History
Until the 1990s, Europe's regulation was less strict than in the United States, one turning point being cited as the export of the United States' first GM-containing soy harvest in 1996. The GM soy made up about 2% of the total harvest at the time, and Eurocommerce and European food retailers required that it be separated. Although the European Commission (EC) did eventually relent, this sparked American concerns that Europe would soon become a tighter regulatory environment - it was conditioned on sale as processed products and never as seed. The Clinton Administration was widely urged to harmonize standards in its impending second term to guarantee an open European market. In 1998, the use of MON810, a Bt expressing maize conferring resistance to the European corn borer, was approved for commercial cultivation in Europe. Shortly thereafter, the EU enacted a de facto moratorium on new approvals of GMOs pending new regulatory laws passed in 2003.
Those new laws provided the EU with possibly the most stringent GMO regulations in the world. The European Food Safety Authority (EFSA) was created in 2002 with the primary goal of preventing future food crises in Europe. All GMOs, along with irradiated food, are considered "new food" and subject to extensive, case-by-case, science-based food evaluation by the EFSA. The criteria for authorization fall into four broad categories: "safety", "freedom of choice", "labelling" and "traceability". The EFSA reports to the European Commission (EC), which then drafts a proposal for granting or refusing the authorisation. This proposal is submitted to the Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health; if accepted, it will be adopted by the EC or passed on to the Council of Agricultural Ministers. Once in the Council it has three months to reach a qualified majority for or against the proposal; if no majority is reached, the proposal is passed back to the EC, which will then adopt the proposal. However, even after authorization, individual EU member states can ban individual varieties under a 'safeguard clause' if there are "justifiable reasons" that the variety might cause harm to humans or the environment. The member state must then supply sufficient evidence that this is the case. The commission is obliged to investigate these cases and either overturn the original registrations or request the country to withdraw its temporary restriction. The laws of the EU also required that member nations establish coexistence regulations. In many cases, national coexistence regulations include minimum distances between fields of GM crops and non-GM crops. The distances for GM maize from non-GM maize for the six largest biotechnology countries are: France – 50 metres, Britain – 110 metres for grain maize and 80 for silage maize, Netherlands – 25 metres in general and 250 for organic or GM-free fields, Sweden – 15–50 metres, Finland – data not available, and Germany – 150 metres and 300 from organic fields. Larger minimum distance requirements discriminate against adoption of GM crops by smaller farms.
In 2006, the World Trade Organization concluded that the EU moratorium, which had been in effect from 1999 to 2004, had violated international trade rules. The moratorium had not affected previously approved crops. The only crop authorised for cultivation before the moratorium was Monsanto's MON 810. The next approval for cultivation was the Amflora potato for industrial applications in 2010 which was grown in Germany, Sweden and the Czech Republic that year.
The slow pace of approval was criticized as endangering European food safety although as of 2012, the EU had authorized the use of 48 genetically modified organisms. Most of these were for use in animal feed (it was reported in 2012 that the EU imports about 30 million tons a year of GM crops for animal consumption.), food or food additives. Of these, 26 were varieties of maize. In July 2012, the EU gave approval for an Irish trial cultivation of potatoes resistant to the blight that caused the Great Irish Famine.