Substantial Equivalence - By Continent - Europe

Europe

See also: Regulation of genetically modified organisms in the European Union and Regulation of genetically modified organisms in Switzerland

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. 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 European Union (EU) with possibly the most stringent GMO regulations in the world. All GMOs, along with irradiated food, are considered "new food" and subject to extensive, case-by-case, science based food evaluation by the European Food Safety Authority (EFSA). The criteria for authorization fall in four broad categories: "safety," "freedom of choice," "labelling," and "traceability." The EFSA reports to the European Commission who then draft 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 and 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 who 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 may 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 stipulated that member nations establish 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 meters, Britain: 110 meters for grain maize and 80 for silage maize, Netherlands: 25 meters in general and 250 for organic or GM-free fields, Sweden: 15–50 meters, Finland: data not available, and Germany: 150 meters and 300 from organic fields.

In 2006, the World Trade Organization concluded that the EU moratorium, which had been in effect from 1998 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 has been criticized as endangering European food safety although as of 2012, the EU has 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. 26 of these 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.

The safeguard clause mentioned above has been applied by many member states in various circumstances, and in April 2011 there were 22 active bans in place across six member states: Austria, France, Germany, Luxembourg, Greece, and Hungary. However, on review many of these have been considered scientifically unjustified.

• In January 2005, the Hungarian government announced a ban on importing and planting of genetic modified maize seeds, which was subsequently authorized by the EU.
• In February 2008 the French government used the safeguard clause to ban the cultivation of MON810 after Senator Jean-François Le Grand, chairman of a committee set up to evaluate biotechnology, said there were "serious doubts" about the safety of the product (although this ban was declared illegal in 2011 by the European Court of Justice and the French Conseil d'État). The French farm ministry reinstated the ban in 2012, but this was rejected by the EFSA.
• In 2009 German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause.
• In March 2010, Bulgaria imposed a complete ban on genetically modified crop growing either commercially or for trials. The cabinet of Boyko Borisov initially imposed a 5-year moratorium, but later extended it to a permanent ban after widespread public protests against the introduction of genetically modified crops in the country. And in recent years, France and several other European countries banned cultivation of Monsanto's MON-810 corn and similar genetically modified food crops.

In 2012, the European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO) released a "Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis" in a response to a request from the European Commission. The opinion was, that while "the frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case," "similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants." In other words, cisgenic genetic engineering approaches should be considered similar in risk to conventional breeding approaches, each of which are more risky than transgenic approaches.