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The European Union (EU) may have the most stringent GMO regulations in the world. All GMOs, along with irradiated food, are considered "new food" and are subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority (EFSA). The EFSA reports to the European Commission, which then drafts proposals for granting or refusing authorisation. Each 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 is either adopted by the EC or passed on to the Council of Agricultural Ministers. The Council 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 then adopts the proposal.
As of August 2012, the European Union had authorised 48 GMOs. Most of these were for animal feed imports or for feed and food processing. There is also a safeguard clause that Member States may invoke to temporarily restrict or prohibit the use and/or sale of a GMO within their territory if they have justifiable reasons to consider that the approved GMO constitutes a risk to human health or the environment.
The EC is obliged to investigate these cases and either overturn the original registrations or ask the country to withdraw its temporary restriction. By 2012, seven countries had submitted safeguard clauses. The EC investigated and rejected those from six countries ("...the scientific evidence currently available did not invalidate the original risk assessments for the products in question...") and one (the UK) withdrew.
In 2010 Austria, Bulgaria, Cyprus, Hungary, Ireland, Latvia, Lithuania, Malta, Slovenia and the Netherlands wrote a joint paper requesting that individual countries should have the right to decide whether to cultivate GM crops. By the year 2010, the only GMO food crop with approval for cultivation in Europe is MON 810, a Bt expressing maize conferring resistance to the European corn borer that gained approval in 1998. On 2 March 2010 a second GMO, a potato called Amflora, was approved for cultivation for industrial applications in the EU by the European Commission and was grown in Germany, Sweden and the Czech Republic that year. Gene flow will occur between related crops and the EC issued new guidelines in 2010 regarding the co-existence of GM and non-GM crops.
Co-existence is regulated by the use of buffer zones and isolation distances between the GM and non-GM crops. The guidelines are not binding and each Member State can implement its own regulations, which has resulted in buffer zones ranging from 15 metres (Sweden) to 800 metres (Luxembourg). Member States may also designate GM-free zones, effectively allowing them to ban cultivation of GM crops in their territory without invoking a safeguard clause.
The regulations concerning the import and sale of GMOs for human and animal consumption grown outside the EU involve providing freedom of choice to the farmers and consumers. All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled. Twice GMOs unapproved by the EC have arrived in the EU and been forced to return to their port of origin. The first was in 2006 when a shipment of rice from America containing an experimental GMO variety (LLRice601) not meant for commercialisation arrived at Rotterdam. The second in 2009 when trace amounts of a GMO maize approved in the US were found in a "non-GM" soy flour cargo. It was reported in 2012 that the EU imports about 30 million tons a year of GM crops for animal consumption.
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France adopted the EU laws on growing GMOs in 2007 and were fined €10 million by the European Court of Justice for the six-year delay in implementing the laws. In February 2008 the French government used the safeguard clause to ban the cultivation of MON 810 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. Twelve scientists and two economists on the committee accused Le Grand of misrepresenting the report and say they did not have "serious doubts" although questions remained concerning the impact of Bt-maize on health and the environment.
The French government submitted a number of studies to back up its claim to the EU. These were given to the EFSA who concluded that there was no new evidence to undermine the previous safety findings and considered the decision "scientifically unfounded". The High Council for Biotechnology subcommittee dealing with economic, ethical and social aspects recommended an additional "GMO-free" label for anything containing less than 0.1% GMO which is due to come in late 2010. In 2011 the European Court of Justice and the French Conseil d'État ruled that the French farm ministry ban on MON 810 was illegal (They failed "to give proof of the existence of a particularly high level of risk for the health and the environment").
In April 2009 German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON 810 maize under the safeguard clause. The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON 810 maize presents a danger to the environment. Three French scientists reviewing the scientific evidence used to justify the ban concluding that it did not use a case-by-case approach, confused potential hazards with proven risks and ignored the meta-knowledge on Bt expressing maize, instead focusing on selected individual studies.
Spain is the largest producer of GM crops in Europe with 76,000 hectares (190,000 acres) of GM maize planted in 2009 (20% of Spain's maize production). Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland. France and Germany are the major opponents of genetically modified food in Europe, although Germany has approved Amflora a potato modified with higher levels of starch for industrial purposes. In addition to France and Germany, other European countries that placed bans on the cultivation and sale of GMOs include Austria, Hungary, Greece, and Luxembourg. Poland has also tried to institute a ban, with backlash from the European Commission. Bulgaria effectively banned cultivation of genetically modified organisms on 18 March 2010.