Genetic engineering in the European Union has varying degrees of regulation. [1]
Genetic engineering in the European Union has varying degrees of regulation. [1]
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. [2] 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. [3] The Clinton Administration was widely urged to harmonize standards in its impending second term to guarantee an open European market. [3] 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. [1] 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". [4] 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. [1] [5] 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. [6] 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. [7] 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. [8] Larger minimum distance requirements discriminate against adoption of GM crops by smaller farms. [9] [10] [11]
In 2006, the World Trade Organization concluded that the EU moratorium, which had been in effect from 1999 to 2004, [12] had violated international trade rules. [13] [14] 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 [15] [16] which was grown in Germany, Sweden and the Czech Republic that year. [17]
The slow pace of approval was criticized as endangering European food safety [18] [19] 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. [20] ), food or food additives. Of these, 26 were varieties of maize. [21] In July 2012, the EU gave approval for an Irish trial cultivation of potatoes resistant to the blight that caused the Great Irish Famine. [22]
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. [23] However, on review many of these have been considered scientifically unjustified. [6] [24]
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. [31] 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 approaches, which introduce genes from the same species, should be considered similar in risk to conventional breeding approaches, whilst transgenic plants can come with new hazards.
In 2014, a panel of experts set up by the UK Biotechnology and Biological Sciences Research Council argued that "A regulatory system based on the characteristics of a novel crop, by whatever method it has been produced, would provide a more effective and robust regulation than current EU processes , which consider new crop varieties differently depending on the method used to produce them." They said that new forms of "genome editing" allow targeting specific sites and making precise changes in the DNA of crops. In the future it would become increasingly difficult if not impossible to tell which method has been used (conventional breeding or genetic engineering) to produce a novel crop. They proposed that existing EU regulatory system should be replaced with a more logical system like that used for new medicines. [32]
In 2015, Germany, Poland, France, Scotland and several other member states opted out of cultivating GMO crops in their territory.[ citation needed ]
A Eurobarometer survey has indicated that "level of concern" about genetically engineered food in Europe has decreased significantly, from 69% in 2010 to 27% in 2019. [33]
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. [34] All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled. On two occasions, GMOs unapproved by the EC have arrived in the EU and been forced to return to their port of origin. [1] 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. [1]
The coexistence of GM and non-GM crops has raised significant concern in many European countries and so EU law also requires that all GM food be traceable to its origin, and that all food with GM content greater than 0.9% be labelled. [35] Due to high demand from European consumers for freedom of choice between GM and non-GM foods. EU regulations require measures to avoid mixing of foods and feed produced from GM crops and conventional or organic crops, which can be done via isolation distances or biological containment strategies. [36] [37] (Unlike the US, European countries require labeling of GM food.) European research programs such as Co-Extra, Transcontainer, and SIGMEA are investigating appropriate tools and rules for traceability. The OECD has introduced a "unique identifier" which is given to any GMO when it is approved, which must be forwarded at every stage of processing. [38] Such measures are generally not used in North America because they are very costly and the industry admits of no safety-related reasons to employ them. [39] The EC has issued guidelines to allow the co-existence of GM and non-GM crops through buffer zones (where no GM crops are grown). [36] These are regulated by individual countries, and vary from 15 metres in Sweden to 800 metres in Luxembourg. [1] All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled.
In its regulations the European Union considers genetically modified organisms only to be food and feed for all intents and practical purposes, [40] 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". [40]
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. [1]
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. [41] For GMOs, the EFSA's risk assessment includes molecular characterization, potential toxicity and potential environmental impact. [42] Each GMO must be reassessed every 10 years. [43] 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. [44]
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. [45]
Member States of the EU 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. [46]
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. [47] 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: [1] 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. [1] In 2012, the EU imported about 30 million tons of GM crops for animal consumption. [20]
As of 2014 [update] Spain has been the largest producer of GM crops in Europe with 137,000 hectares (340,000 acres) of GM maize planted in 2013 equaling 20% of Spain's maize production. [48] [49]
Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland. [49] 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. [50] 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. [51] Poland has also tried to institute a ban, with backlash from the European Commission. [52] Bulgaria effectively banned cultivation of genetically modified organisms on 18 March 2010. [53]
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 [54] and was grown in Germany, Sweden and the Czech Republic that year. [17] Amflora was withdrawn from the EU market in 2012, and in 2013 its approval was annulled by an EU court. [55]
Fearing that gene flow could occur between related crops, the EC issued new guidelines in 2010 regarding the co-existence of GM and non-GM crops. [36] [ failed verification ]
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). [1] 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. [36]
In October 2015, Bulgaria announced it has opted out of growing genetically modified crops, effectively banning the cultivation of different types of GMO corn and soybeans. [56]
France adopted the EU laws on growing GMOs in 2007 [57] and was fined €10 million by the European Court of Justice for the six-year delay in implementing the laws. [58] 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. [59] 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. [60] 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". [61] 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. [1] [62] 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". [63]
On 17 September 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. [64]
In April 2009, German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON 810 maize under the safeguard clause. [28] The ban was based on "expert opinion" that suggested there were reasonable grounds to believe that MON 810 maize presents a danger to the environment. [65] Three French scientists reviewing the scientific evidence used to justify the ban concluded 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 ]. [66]
In August 2015, Germany announced its intention to ban genetically modified crops. [67]
In September 2015, Northern Ireland announced a ban on genetically modified crops. [68]
Romania grew GM soybeans in 1999, increasing the crop's yield by 30%, permitting the export of excess product. When the country joined the European Union in 2007 it was no longer allowed to grow the GM crop, resulting in the total area planted in soybeans dropping by 70%. [69] [70] The next year, this produced a trade deficit of €117.4m for purchase of replacement products. Romanian farmers have been very much in favour of relegalisation of GM soy. [70]
In 1992, Switzerland voted in favour of the introduction of an article about assisted reproductive technologies and genetic engineering in the Swiss Federal Constitution. [71] [72] In 1995, Switzerland introduced regulations requiring labelling of food containing genetically modified organisms. [71] It was one of the first countries to introduce labelling requirements for GMOs. [71] In 2003, the Federal Assembly adopted the "Federal Act on Non-Human Gene Technology". [73]
A federal popular initiative introducing a moratorium on genetically modified organisms in the Swiss agriculture was introduced from 2005 to 2010. [74] Later, the Swiss parliament extended this moratorium to 2013. [75] Between 2007 and 2011, the Swiss Government funded thirty projects to investigate the risks and benefits of GMOs. These projects concluded that there were no clear health or environmental dangers associated with planting GMOs. However, they also concluded that there was little economic incentive for farmers to adopt GMOs in Switzerland. [75] [74] The Swiss parliament then extended the moratorium to 2017, and then to 2021. [76]
As of 2016, six cantons (Bern, Fribourg, Geneva, Jura, Ticino and Vaud) have introduced laws against genetically modified organisms in agriculture. [77] More than one hundred communes have declared themselves free of genetically modified organisms. [77] The cantons of Switzerland perform tests to assess the presence of genetically modified organisms in foodstuffs. In 2008, 3% of the tested samples contained detectable amounts of GMOs. [78] In 2012, 12.1% of the samples analysed contained detectable amounts of GMOs (including 2.4% of GMOs forbidden in Switzerland). [78] All the samples tested (except one) contained less than 0.9% of GMOs, which is the threshold that imposes labelling indicating the presence of GMOs in food. [78]
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". [79] [80]
Table 1: National bans currently implemented under the 'safeguard clause'
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Genetically modified maize (corn) is a genetically modified crop. Specific maize strains have been genetically engineered to express agriculturally-desirable traits, including resistance to pests and to herbicides. Maize strains with both traits are now in use in multiple countries. GM maize has also caused controversy with respect to possible health effects, impact on other insects and impact on other plants via gene flow. One strain, called Starlink, was approved only for animal feed in the US but was found in food, leading to a series of recalls starting in 2000.
A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. The exact definition of a genetically modified organism and what constitutes genetic engineering varies, with the most common being an organism altered in a way that "does not occur naturally by mating and/or natural recombination". A wide variety of organisms have been genetically modified (GM), including animals, plants, and microorganisms.
Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novel organisms. New DNA is obtained by either isolating and copying the genetic material of interest using recombinant DNA methods or by artificially synthesising the DNA. A construct is usually created and used to insert this DNA into the host organism. The first recombinant DNA molecule was made by Paul Berg in 1972 by combining DNA from the monkey virus SV40 with the lambda virus. As well as inserting genes, the process can be used to remove, or "knock out", genes. The new DNA can be inserted randomly, or targeted to a specific part of the genome.
Genetically modified foods, also known as genetically engineered foods, or bioengineered foods are foods produced from organisms that have had changes introduced into their DNA using various methods of genetic engineering. Genetic engineering techniques allow for the introduction of new traits as well as greater control over traits when compared to previous methods, such as selective breeding and mutation breeding.
Genetically modified crops are plants used in agriculture, the DNA of which has been modified using genetic engineering methods. Plant genomes can be engineered by physical methods or by use of Agrobacterium for the delivery of sequences hosted in T-DNA binary vectors. In most cases, the aim is to introduce a new trait to the plant which does not occur naturally in the species. Examples in food crops include resistance to certain pests, diseases, environmental conditions, reduction of spoilage, resistance to chemical treatments, or improving the nutrient profile of the crop. Examples in non-food crops include production of pharmaceutical agents, biofuels, and other industrially useful goods, as well as for bioremediation.
Since the advent of genetic engineering in the 1970s, concerns have been raised about the dangers of the technology. Laws, regulations, and treaties were created in the years following to contain genetically modified organisms and prevent their escape. Nevertheless, there are several examples of failure to keep GM crops separate from conventional ones.
The traceability of genetically modified organisms (GMOs) describes a system that ensures the forwarding of the identity of a GMO from its production to its final buyer. Traceability is an essential prerequisite for the co-existence of GM and non-GM foods, and for the freedom of choice for consumers.
Genetically modified food controversies are disputes over the use of foods and other goods derived from genetically modified crops instead of conventional crops, and other uses of genetic engineering in food production. The disputes involve consumers, farmers, biotechnology companies, governmental regulators, non-governmental organizations, and scientists. The key areas of controversy related to genetically modified food are whether such food should be labeled, the role of government regulators, the objectivity of scientific research and publication, the effect of genetically modified crops on health and the environment, the effect on pesticide resistance, the impact of such crops for farmers, and the role of the crops in feeding the world population. In addition, products derived from GMO organisms play a role in the production of ethanol fuels and pharmaceuticals.
MON 863 is a genetically engineered variety of maize produced by Monsanto. It is genetically altered to express a modified version of Cry3Bb1, a delta endotoxin which originates from Bacillus thuringiensis. This protects the plant from corn rootworm. Unlike MON 810, Bt 11, and Bt 176 which each produce a modified Cry1Ab, MON 863 instead produces a modified Cry3Bb1 toxin and contains nptII, a marker gene for antibiotic resistance.
The MON 810 corn is a genetically modified maize used around the world. It is a Zea mays line known as YieldGard from the company Monsanto. This plant is a genetically modified organism (GMO) designed to combat crop loss due to insects. There is an inserted gene in the DNA of MON 810 which allows the plant to make a protein that harms insects that try to eat it. The inserted gene is from the Bacillus thuringiensis which produces the Bt protein that is poisonous to insects in the order Lepidoptera, including the European corn borer.
The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.
Waxy potato starch is a variety of commercially available starch composed almost entirely of amylopectin molecules, extracted from new potato varieties. Standard starch extracted from traditional potato varieties contains both amylose and amylopectin.
A genetically modified soybean is a soybean that has had DNA introduced into it using genetic engineering techniques. In 1996, the first genetically modified soybean was introduced to the U.S. by Monsanto. In 2014, 90.7 million hectares of GM soybeans were planted worldwide, this is almost 82% of the total soybeans cultivation area.
Genetically modified canola is a genetically modified crop. The first strain, Roundup Ready canola, was developed by Monsanto for tolerance to glyphosate, the active ingredient in the commonly used herbicide Roundup.
The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation or have provisions for cultivation, but no GM products are yet produced. Most countries that do not allow for GMO cultivation do permit research. Most (85%) of the world's GMO crops are grown in the Americas. One of the key issues concerning regulators is whether GM products should be labeled. Labeling of GMO products in the marketplace is required in 64 countries. Labeling can be mandatory up to a threshold GM content level or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%. In Canada and the USA labeling of GM food is voluntary, while in Europe all food or feed which contains greater than 0.9% of approved GMOs must be labelled.
The Séralini affair was the controversy surrounding the publication, retraction, and republication of a journal article by French molecular biologist Gilles-Éric Séralini. First published by Food and Chemical Toxicology in September 2012, the article presented a two-year feeding study in rats, and reported an increase in tumors among rats fed genetically modified corn and the herbicide RoundUp. Scientists and regulatory agencies subsequently concluded that the study's design was flawed and its findings unsubstantiated. A chief criticism was that each part of the study had too few rats to obtain statistically useful data, particularly because the strain of rat used, Sprague Dawley, develops tumors at a high rate over its lifetime.
Gilles-Éric Séralini is a French molecular biologist, political advisor and activist on genetically modified organisms and foods. He is of Algerian-French origin. Séralini has been a professor of molecular biology at the University of Caen since 1991, and is president and chairman of the board of CRIIGEN.
India and China are the two largest producers of genetically modified products in Asia. India currently only grows GM cotton, while China produces GM varieties of cotton, poplar, petunia, tomato, papaya and sweet pepper. Cost of enforcement of regulations in India are generally higher, possibly due to the greater influence farmers and small seed firms have on policy makers, while the enforcement of regulations was more effective in China. Other Asian countries that grew GM crops in 2011 were Pakistan, the Philippines and Myanmar. GM crops were approved for commercialisation in Bangladesh in 2013 and in Vietnam and Indonesia in 2014.
Genetic engineering in North America is any genetic engineering activities in North America