Regulation of genetically modified organisms in the European Union
The regulation of genetically modified organisms in the European Union is varied.
Overview of regulatory process
In its regulations the European Union considers genetically modified organisms only to be food and feed for all intents and practical purposes, in difference to the definition of genetically modified organisms which encompasses animals.
The EU uses the precautionary principle demanding a pre-market authorisation for any GMO to enter the market and a post-market environmental monitoring. Both the European Food Safety Authority (EFSA) and the member states author a risk assessment. This assessment must show that the food or feed is safe for human and animal health and the environment "under its intended conditions of use".
As of 2010, the EU treats all genetically modified crops (GMO crops), along with irradiated food as "new food". They are subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority (EFSA). This agency 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.
The EFSA uses independent scientific research to advise the European Commission on how to regulate different foods in order to protect consumers and the environment. For GMOs, the EFSA's risk assessment includes molecular characterization, potential toxicity and potential environmental impact. Each GMO must be reassessed every 10 years. In addition, applicants who wish to cultivate or process GMOs must provide a detailed surveillance plan for after authorization. This ensures that the EFSA will know if risk to consumers or the environment heightens and that they can then act to lowed the risk or deauthorize the GMO.
As of September 2014[update], 49 GMO crops, consisting of eight GM cottons, 28 GM maizes, three GM oilseed rapes, seven GM soybeans, one GM sugar beet, one GM bacterial biomass, and one GM yeast biomass have been authorised.
Member States may invoke a safeguard clause to temporarily restrict or prohibit use and/or sale of a GMO crop within their territory if they have justifiable reasons to consider that an approved GMO crop may be a risk to human health or the environment. The EC is obliged to investigate 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.
The EC Directorate-general for agriculture and rural development states that the regulations concerning the import and sale of GMOs for human and animal consumption grown outside the EU provide freedom of choice to farmers and consumers. All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled. As of 2010 GMOs unapproved by the EC had been found twice and returned to their port of origin: First in 2006 when a shipment of rice from the U.S. containing an experimental GMO variety (LLRice601) not meant for commercialisation arrived at Rotterdam, the second time in 2009, when trace amounts of a GMO maize approved in the US were found in a non-GM soy flour cargo. In 2012, the EU imported about 30 million tons of GM crops for animal consumption.
Adoption of GMO crops
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.
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 was MON 810, a Bt expressing maize conferring resistance to the European corn borer that gained approval in 1998.
In 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.
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.
Implementation in the member states
France adopted the EU laws on growing GMOs in 2007 and was 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 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 said they did not have "serious doubts", although questions remained concerning the impact of Bt-maize on health and the environment. The EFSA reviewed studies the French government had submitted to back up its claim, and concluded that there was no new evidence to undermine its prior 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 of MON 810 was illegal, as it failed "to give proof of the existence of a particularly high level of risk for the health and the environment".
On September 17, 2015 the French government announced it would effectively continue to ban GMO crops by enacting an "opt-out" provision, previously agreed to for the 28 EU member states in March 2015, by asking the European Commission for France to extend the GMO ban on nine additional strains of maize. The policy announcement was made simultaneously by the French farm and environment ministries. 
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[clarification needed].
In August 2015 Germany announced to ban genetically modified crops.
In August 2015, the Scottish government announced that it would "shortly submit a request that Scotland is excluded from any European consents for the cultivation of GM crops, including the variety of genetically modified maize already approved and six other GM crops that are awaiting authorisation."
Notes and references
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- European Commission Fact Sheet: Questions and Answers on EU's policies on GMOs Press release Database, 22 April 2015, retrieved 25 October 2015
- "European Food Safety Authority".
- "GMO FAQ".
- "Post Authorization Plans".
- Staff EU register of genetically modified food and feed European Commission, Health and Consumers, EU register of authorised GMOs, Retrieved 30 September 2014
- European Commission. "Food Safety: From the farm to the fork (What are the National safeguard measures)". EUROPA. Archived from the original on 15 May 2010.
- Directorate-general for agriculture and rural development. "Economic impact of unapproved gmos on eu feed imports and livestock production" (PDF). European Commission.
- Hogan, Michael (5 April 2012) BASF to undertake GMO potato trials in Europe Reuters, Retrieved 30 August 2012
- James, Clive (February 2014) Global Status of Commercialized Biotech/GM Crops: 2013 ISAAA Brief 46-2013, Retrieved 11 November 2014
- Clive James (2009). "ISAAA Brief 41-2009: Executive Summay: Global Status of Commercialized Biotech/GM Crops The first fourteen years, 1996 to 2009".
- Elisabeth Rosenthal (24 July 2007). "A Genetically Modified Potato, Not for Eating, Is Stirring Some Opposition in Europe". The New York Times.
- "Germany joins ranks of anti-GMO countries". EurActiv. Retrieved 2014-08-03.
- "EU lawyers take action against Poland over GMO ban | Green Business | Reuters". Uk.reuters.com. 31 January 2008. Retrieved 2010-03-08.
- "Bulgaria parliament bans GMO crops to soothe fears". Reuters. 18 March 2010.
- "European Commission approves Amflora starch potato". BASF – BASF – The Chemical Company. March 2010. Retrieved 2010-09-24.
- Scientific background report AMFLORA potato VIB (Flemish Institute for biotechnology), Belgium, Retrieved 20 October 2010
- GMO Safety. "New coexistence – Guidelines in the EU: Cultivation bans are now permitted".
- Reuters (2 October 2015). "Bulgaria opts out of growing genetically modified crops".
- Sybille de La Hamaide (20 March 2007). "France adopts disputed EU laws on GMO crop growing". Reuters.
- Zoë Casey (09.12.2008). "France fined over GM law". Check date values in:
- "AFP: French GM ban infuriates farmers, delights environmentalists". Afp.google.com. AFP. 13 February 2008. Archived from the original on 13 February 2008. Retrieved 2010-03-13.
- GMO Compass. "Maize MON 810: France triggers safeguard clause".
- GMO Compass. "EFSA: ban on cultivating MON 810 maize in France is unfounded".
- Caroline Scott-Thomas (30 November 2009). "France defines GMO-free labelling threshold".
- French ban on biotech Monsanto corn ruled illegal Agrimony UK, 28 November 2011, Retrieved 30 December 2011
- Sybille de La Hamaide, Gus Trompiz and Valerie Parent (17 September 2015). "France bolsters ban on genetically modified crops".
- Thorsten Severin and Michael Hogan (14 April 2009). "Germany to ban cultivation of GMO maize-Minister". Reuters. Retrieved 2010-03-08.
- GMO compass. "German ban on MON 810 maize: will the courts now decide?".
- Agnès Ricroch, J. B. B. A. M. K.; Bergé, J. B.; Kuntz, M. (2009). "Is the German suspension of MON810 maize cultivation scientifically justified?". Transgenic Research. 19 (1): 1–12. doi:10.1007/s11248-009-9297-5. PMC . PMID 19548100.
- Reuters (24 August 2015). "Germany starts move to ban GMO crops: ministry letter".
- BBC (21 September 2015). "GM crop-growing banned in Northern Ireland".