Biotechnology Law ReportVol. 38, No. 6 Original ArticlesOpen AccessCreative Commons licenseDisharmonization in the Regulation of Transgenic Plants in EuropeBy Ramesh Bikram Karky and Mark PerryBy Ramesh Bikram KarkyDr. Ramesh Karky is Professor of Law at Conestoga College School of Business, Kitchener, Canada.Search for more papers by this author and Mark PerryProfessor Perry: E-mail Address: mperry21@une.edu.auProfessor Mark Perry is Professor of Law at the University of New England, Australia.Search for more papers by this authorPublished Online:9 Dec 2019https://doi.org/10.1089/blr.2019.29135.rbkAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail EUROPEAN UNION REGULATION ON GENETICALLY MODIFIED PLANTSIn the European Union (EU), anti-GMO (genetically modified organisms) groups have a strong presence. The EU market is not favorable to GM products. Retailers are hesitant to sell products with GM labelling. Conventional and organic farmers, environmentalists, and nongovernmental organizations (NGOs) are working to enlarge GM-free zones. Although there are scientific societies arguing for the benefits of biotechnology or GMOs, many major EU member states like Italy, France, and Germany have banned GM maize crop for cultivation.The EU has 28 member states,1 and the legislation issued by the EU has supranational effect on all member states. EU regulations are directly applicable to each member state, and EU directives are to be implemented by member states by incorporation into their domestic law. The European Commission (the Commission), Council of Ministers, and Parliament are involved in the legislative process, and the European Court of Justice (ECJ) interprets EU treaties and legislation. The courts of member states may refer any EU-related legal issues before the ECJ and it may deliver its opinion. In Europe, genetically modified technology is strictly regulated. Neither the U.S. nor Canada have enacted any specific laws pertaining to biotechnology or genetically modified organisms. On the other hand, the European Economic Community (EEC), the predecessor of the EU, had passed Community law on genetically modified technology starting in the early 1990s. The main objectives of EU biotechnology legislation are to protect human health and the environment and to ensure the free movement of genetically modified products in the EU.In pursuance of the above objectives, the framework of European laws on genetically modified plants includes three important principles: safety, freedom of choice, and case-by-case evaluations. Regarding genetically modified plants, Directive 90/220 on the deliberate release into the environment of GMOs2 was the first regulatory framework governing genetically modified plants in Europe. In 2001, the EU repealed Directive 90/220 and issued Directive 2001/18 on the deliberate release into the environment of GMOs.3 Directive 2001/18 covers all major aspects of genetically modified plants. There is a particular emphasis on the authorization procedure, scientific assessment of the risks to human and animal health and environment, experimental release into the environment (field trials), and cultivation or placing on the market. However, the EU has left authority with member states when there is an issue of coexistence between genetically modified crops, conventional crops, and organic crops. In this regard, on July 23, 2003, the Commission adopted a Recommendation (2003/556/EC) on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming (“2003 Commission Recommendation”).4 On July 13, 2010, the Commission repealed the 2003 guidelines and adopted a new Recommendation (2010/C 200/01) on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops (“2010 Co-existence Recommendation”).5 The 2010 guidelines enable member states to develop national measures for coexistence in line with Directive 2001/18/EC. In case such measures do not work, member states or regions may declare GM-free zones. So far, 16 EU member states have enacted coexistence laws.In the EU, nobody can conduct the experimental release of genetically modified plants into the environment without authorization from the competent national authority. Two different authorizations are required, one for field trials and one for marketing. After successful field trials, genetically modified plants require authorization from a competent EU authority (EU Commission) before releasing it onto the market or beginning cultivation. In this process, all EU member states must give their consent. Directive 2001/18/EC requires written authorization before commercial use, cultivation, or importation of genetically modified plants. Authorization and procedures (under this Directive) are different depending on if the GM product is capable of being propagated or if the GM product is processed and therefore not made of living materials. This Directive does not require authorization for the importation of processed products that are not capable of growing (not considered organisms), such as corn starch or rapeseed (canola) oil which are made from genetically modified plants. However, there is an authorization requirement when imported crops are living and have the potential for growth (and thus are considered organisms) such as GM maize kernels or GM rapeseed.Part B of Directive 2001/18/EC contains provisions that govern the authorization procedure for the field trials. Under this Directive, the applicant (“the notifier”) needs to submit an application (“the notification”) for authorization to the competent authority of the member state where such experimental release will take place. The notification needs to contain an environmental risk evaluation carried out by the notifier. Then, the competent national authority examines the contents of the application and risk evaluation and if it thinks that the application meets the requirements prescribed by the Directive 2001/18/EC, it delivers a decision and authorizes the field trial.The authorization procedure for placing onto the market or cultivation is complex and long in duration. Part C of Directive 2001/18/EC governs the authorization procedure for commercialization of genetically modified plants. As GM products may go all over the EU, the authorization procedure involves all EU member states. To obtain an authorization for commercialization, an application is required (notification). The application must contain a full environmental risks evaluation and be presented to the competent national authority of the member state where the product will first be marketed or cultivated. After its evaluation, the competent national authority issues an assessment report. If the assessment report is not favorable to the applicant, the applicant may submit a new notification to the competent national authority of another member state. The competent national authority of this member state may issue a different assessment report if the assessment report is in favor of the applicant. That member state informs other EU member states of its opinion through the European Commission. The Commission and the Member States Working Group examine the assessment report and if the report is not objectionable, the competent national authority authorizes the cultivation or placing on the market. Such authorization shall be for a period of ten years, and it may be renewed again if it meets all requirements. If the report is objectionable, the Member States Working Group, Commission, and the notifier enter into a conciliation phase and try to resolve outstanding issues. If objections are maintained, the authorization decision shall take place at the European level.During the authorization process at the European level, the Commission asks the opinion of the European Food Safety Authority (EFSA). The EFSA is composed of highly qualified scientists and published a guidance document on the environmental risks assessment of GM plants in 2010. The EFSA conducts a risk assessment and submits its opinion to the Commission. During this time, the Commission also asks for public opinion and collects comments from the public. The Commission prepares a draft decision and asks for an opinion from its Regulatory Committee which is composed of representatives of the member states. If the Regulatory Committee is in favor of the authorization by qualified majority, the Commission's draft decision will be adopted, published in an official journal, and will also be included in the GMO register. If the Regulatory Committee is against the draft decision by qualified majority, then the Commission informs the European Parliament and submits the draft decision to the European Council of Ministers. If the Council is in favor or the Council is not able to present an opinion within three months, the Commission's draft decision will be adopted. In a situation where the Council gives an opinion against the draft decision by a qualified majority, the draft decision will go back to the Commission to redraft.After authorization for commercialization, genetically modified plants can be cultivated or brought for marketing. However, EU member states may temporarily ban the cultivation of authorized genetically modified plants in their jurisdiction. An EU member state may ban the cultivation of genetically modified plants or products in two ways. They may invoke the “safeguard clause” under Directive 2001/18/EC or they may declare GM-free zones under coexistence law. Time and again EU member states have invoked the safeguard clause and banned the cultivation of genetically modified plants. There are currently such bans in place in EU member states such as Italy, France, and Germany. Even the ECJ and domestic courts of a few member states have supported and justified the invocation of a safeguard clause.EU member states' ability to invoke safeguard provisions under Directive 2001/18/EC and to declare a GM-free zone under co-existence law is controversial. The EU has no plans for EU-wide legislation on the coexistence of genetically modified, conventional, and organic crops. The EU Commission considers member states to be in a better position than the EU to identify effective and efficient coexistence measures. On July 5, 2011, the European Parliament voted in favor of a proposal that would make it possible for member states to ban the cultivation of GM crops. To date, Germany, Denmark, France, Portugal, the Netherlands, Belgium, Austria, and some Eastern European countries have legislated on coexistence. Other countries have submitted draft proposals or are still working on proposals. Some member states are not planning to develop coexistence legislation in the near future because they believe that it is highly unlikely that GM crops will be cultivated in their country. Coexistence measures can vary considerably from one country to another. These differences are due to regional differences in agriculture, such as field size or climate. Six member states (Germany, the Czech Republic, Ireland, the Netherlands, Portugal, and Slovakia) have applied more stringent measures to the segregation of GM fields and organic fields than to the segregation of GM fields and conventional fields. Some member states prescribe special measures for the cultivation of GM crops close to nature reserves or prohibit the cultivation of GM crops in these areas altogether. Since these special regulations are not linked to the concept of coexistence, in the view of the Commission, the legal position still remains unclear.6In 2015, the European Union enacted new law. Directive (EU) 2015/412—on allowing EU countries to restrict or prohibit the cultivation of genetically modified organisms in their territory—amends the 2001 EU Directive so that individual EU countries can ban or restrict GMO cultivation in their territory.7 Commission Directive (EU) 2018/350 of March 8, 2018, amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms,8 obligates EU countries to bring into force the laws, regulations, and administrative provisions necessary to comply with this Directive by September 29, 2019, at the latest. Commission Implementing Decision (EU) 2018/1790 of November 16, 2018, repealing Decision 2002/623/EC establishing guidance notes on the environmental risk assessment of genetically modified organisms (notified under document C [2018] 7513) (text with EEA relevance),9 repeals the guidance notes of 2002, which have become obsolete. The repeal reduces the number of guidance documents that operators and competent authorities need to take into account when carrying out an environmental risk assessment under Annex II to Directive 2001/18/EC.GM plants authorized for cultivation are subject to labelling and traceability as well. Only plants or products consisting of or containing GMOs (more than 0.9 percent GMO) are subject to the labelling requirements. The labelling requirements are governed by Regulation 1829/2003 on GM food and feed (“Food and Feed Regulation”),10 and Regulation 1830/2003 on the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs.11 Likewise, GM plants or products, and plants or products with more than 0.9 percent GMO content, that are authorized for commercialization are subject to traceability requirements. The traceability requirement is governed by Regulation 1830/2003 on the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs.There are only a few exemptions to the labelling and traceability requirements mentioned above. There are no such requirements on products such as milk, eggs, or meat obtained from animals fed with GM feed. Conventional or organic plants or products contaminated by GM plants or products below 0.9 percent are also not subject to labelling and traceability provided that such presence of GMO is adventitious or technically unavoidable. There is no threshold for adventitious presence (AP) of GMOs in seeds and there is therefore zero tolerance for GMO content in conventional or organic seeds. Any authorized (for cultivation) conventional or organic seed lots containing GMOs have to be labelled. A seed lot containing GM seed not authorized for cultivation cannot be marketed in the EU.The EU legal regime and practices regarding genetically modified plants and products are not without criticism. The critics have said that the EU has been protecting its market (agricultural products) from foreign GM agricultural products. This issue was raised before the World Trade Organization (WTO) Dispute Settlement Body in EC—Approval and Marketing of Biotech Products (“EC-Biotech”).12 In June 1999, the EU had imposed a moratorium on the approval of additional transgenic crops in Europe. In August 2003, the United States, Canada, and Argentina brought a case against the EU before the WTO Dispute Settlement Body claiming that the EU had failed to grant final approval on the marketing of a number of GM crops. It was also claimed that the imposition of national import and marketing bans of GM crops by individual EU member states were not in compliance with the provisions of the WTO agreement. In September 2006, the WTO Panel found that the European Communities applied a general de facto moratorium on the approval of biotech products between June 1999 and August 2003. It had acted inconsistently with its obligations under Annex C(1)(a), first clause, and Article 8 of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) in respect of the approval procedures, and there were undue delays in the completion of the approval procedures. However, the WTO Dispute Settlement Body neither examined the EU regulatory framework on its merit nor said anything on genetically modified organisms and their effect on health and environment.Any foreign GM plants or products intended for sale or cultivation in the EU market need to fulfil all GMO-related requirements prescribed by EU regulations and directives. There is an assumption that the legal basis for a national cultivation ban will bring a new trade dispute before the WTO Dispute Settlement Body.In 2016, the French government asked the European Court of Justice (ECJ) to interpret the provisions of the 2001 EU Directive and decide whether the 2001 EU Directive regulates the new gene-editing technology, such as CRISPR-Case9, or not. On July 25, 2018, the ECJ in Case C-528/16 decided that organisms including the gene-editing technology obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.13 Other nations, such as the USA and Australia, have taken a different approach to organisms so created by either accepting them as non-GMO or “taking the middle ground” of light-touch regulation.14 In this case, the ECJ interpreted that only mutagenesis techniques that have conventionally been used in some applications and have a long safety record are exempted from 2001 EU Directive obligations. The court further stated that organisms made using mutagenesis techniques developed after 2001, including gene editing, are not exempted from the Directive.15Furthermore, the EU played an important role in developing the Cartagena Protocol on Biosafety (Protocol)16 and ratified the Protocol. The EU has given effect to the requirements of the Protocol by making Regulation 1946/2003 on transboundary movements of GMOs.17EU MEMBER STATE REGULATIONSThe related rules and regulations of eight EU member state jurisdictions (France, Germany, Spain, the United Kingdom, Portugal, the Netherlands, Belgium, and Italy) are discussed in the following paragraphs.FranceThe subject of GMOs is controversial in France. The issue has been influencing French society and politics from the beginning of GMOs and the country has been divided on this issue. French farmers do not agree with the coexistence of genetically modified and conventional crops. French movements like the Confédération Paysanne consider coexistence as a form of accepting GMOs. On the other side of the argument, French seed producers and chemical companies are in favor of coexistence. They consider GM plants as the key to the future. French consumers support “freedom of choice” and the labelling and traceability for GMOs.18 The government of France banned the cultivation of the maize variety MON810 on February 7, 2008,19 and the ban has been maintained despite pressure from the European Commission to reverse the ban.After an extended trial period, France adopted a new biotechnology law in 2008 which guaranteed farmers “the freedom to produce with or without genetically modified organisms.”20 The new French law contains general provisions for the coexistence of genetically modified and conventional crops. France enacted the new biotechnology law to incorporate European Union directives on GMOs into their domestic law. The European Union had adopted a Directive on the deliberate release of GMOs into the environment in 2001.21 Member states were supposed to incorporate this Directive into their national law before October 17, 2002. France was frequently condemned for not meeting this Community obligation.22 France was subjected to action for its failure to incorporate Community GM legislation.23 The European Commission referred France to the European Court of Justice for not complying with this obligation and the European Court of Justice in Commission v. France24 imposed a €10 million fine on France for delaying adoption of the GMO Directive. France finally complied with this Community obligation by enacting biotechnology law in 2008. At this juncture, it is relevant to mention that with regards to coexistence rules and the responsibility regime, Directive 2001/18 is silent. … It is up to the [member] states to set up their own rules of coexistence and responsibility. Ultimately, whilst some provisions contained in the law correspond to required incorporation of the directive, the main points of this law (High Council, rules of coexistence and responsibility) are not a Community obligation.25The new biotechnology law enacted by the French National Assembly and Senate went into effect on June 26, 2008. This new law established the right to produce “with or without GMOs” and it has brought three major changes: the creation of a new mechanism of GMO evaluation in France, the required adoption of “rules of coexistence,” and the creation of a special responsibility regime in the case of crop contamination by GMOs.26 It guarantees the use of GMOs “with the respect to common prescriptions,” indicating that agricultural products with less than 0.9% genetically modified organisms will be regarded as GMO free. If the threshold of 0.9% is exceeded, by cross-pollination for example, a neighboring farmer or beekeeper will be entitled to compensation for his or her loss of income. Minimum distances that ensure the coexistence of genetically engineered and conventional or organic cultures will be defined by decree of the Minister of Agriculture. Such distances will be reviewed every other year. The Senate also has introduced a new clause into the draft law that makes the destruction of GMO cultures a punishable offense. Two to three years of imprisonment and a penalty of €75,000 to €150,000 may be imposed upon so-called “field liberators.”27 The French government has issued a decree and set 50 meters as a minimum distance buffer for GM maize cultivation.28 The newly created “High Council of Biotechnology” (HCB) is an expert board which deals exclusively with GMOs. The HCB hears all questions pertaining to GMOs and has experts who answer each question. The HCB has two committees: a scientific committee and a social and ethical committee.Regarding the executing agencies, the Ministry of Agriculture and Fisheries is responsible for authorizing the release of new crops into the environment for commercial use with approval of the Ministry of Ecology, Energy, Sustained and Territory Development. The Ministry of Research is responsible for authorizing the use of GMOs in research and development. GMO appraisals and authorizations are conducted by the HCB when related to the environment and public health. Appraisals and authorizations are conducted by the French Agency for Food Security when related to food sanitation and security (human and animal food). Controls are carried out by the General Directorate for Fair Trading, Consumer Affairs and Fraud Controls (all food and feed products and EU produced seeds), the General Directorate for Food (Ministry of Agriculture and Fisheries, DGAL, imported seeds), and by the Group for the Control and Certification of Seed Varieties (GEVES) for seed certification.29The new biotechnology law creates a notification obligation for farmers who intend to grow GMOs. They must inform neighboring plot owners of their intention. It also contains a provision of liability for any loss of income by cross-pollination: however, there are no insurance policies to cover such risks in France.30 Regarding public participation, Article 24 of the new law has an identical provision to the Aarhus Convention provision that states, “The State ensures, at an early stage, public information and participation, before making decisions related to GMO cultivation and its marketing.”31 There is nothing in the law which specifies how this obligation will be met.32 The courts have already declared Internet consultation with the public on the trials insufficient.33The new biotechnology law sets rules concerning the different varieties of GMO plants authorized in France, but at the same time, it does not define “GMO-free.”34 It further requires decree and bylaw notice regarding the final definition of “GMO-free” products and technical conditions of coexistence.35 In this context, “two decrees have been published regarding the High Council of biotechnologies and committee of national biological surveillance functioning. … A third decree concerning labelling of GMO for the use of a third party within a confined use only has been published in January 2009.”36 “In the absence of decrees specifying how the law should be enforced, it is difficult to draw up a complete summary of the implications of this text, and important notions remain to be defined (e.g., ‘GMO-free,’ the functioning of the High Council, the rules of coexistence, responsibility, seed labelling).”37In Europe, the future of transgenic plants has not been decided.38 France lacks regulation in the area of seeds because the EU also lacks regulations on seeds in terms of biotech traceability, labelling, and thresholds. Article 21 of the new law allows the French administration to set thresholds under which seeds containing GMOs will have to be labelled. Regarding the Cartagena Bio-Safety Protocol,39 France is in line with the EU.In France, the majority of consumers are not in favor of GMOs. Agricultural biotechnology has been facing market acceptance issues, and GMO-labelled food products are generally not available.40 “The Ministry of Agriculture plans to issue more concrete, crop-specific cultivation rules, such as minimum separation distances. It also plans to continue the production and marketing of products with the special designation ‘GMO-free.’” The Ministry ensures that restrictions will be implemented on cultivation of GM varieties where regional products with quality signs, such as AOC certification (the French “certified origin” label) are grown and a cultivation prohibition in national and regional parks.41 In France, several anti-GMO groups have destroyed transgenic corn plantations and there is also a call for the discontinuation of civil disobedience. In response to the demands of anti-GMO movements, several local authorities banned GMO field trials and commercial use. The French Administrative Court has cancelled most of those bylaws.In France, domestic courts have always favored GM cultivation. An organic beekeeper whose hives were situated near GM maize–cultivated land filed a lawsuit for cross-pollination before a court. In 2007, the court turned downed the application of the beekeeper on the ground that the GM crop concerned was properly authorized and the production was lawful.42 In another case, Land Oberosterreich v. Commission,43 a local authority banned GMOs within its territory, but a French court found no legitimacy to “GM-free” zones in Community law. French law also, except in the case of national parks or regional natural parks, does not allow local bans on GMO cultivation. The French administrative judges also annulled many municipal decisions to declare “GM-free” zones and to ban GMO cultivation.44 Since the enactment of the biotechnology law in France, change can be seen in judicial direction. On December 5, 2008, the Administrative Tribunal of Nimes did not annul the ban imposed by the Municipal Council of the Commune of Le Thor.45In Europe, the campaign following the “Charter of Florence” promotes GM-free agriculture. In France, regions like Aquitaine, Bretagne, Île de France, Limousin, and Poitou-Charente are members of the Charter. However, the European Commission has decided that regional governments have no competency to ban GMOs.46The ECJ, in Association Greenpeace France v. Ministere de l'Agriculture et de la Peche,47 examined whether a member state (France), having transmitted a favorable opinion to the European Commission during the authorization procedure for placing a GMO on the market, was then obliged to issue written consent allowing the product to be placed on the market. In this case, the ECJ ruled that a member state (France) could withhold consent provided that it had received new information indicating a possible risk to human health and the environment.On September 8, 2011, the ECJ, in Monsanto SAS and Others v. French Minister for Agriculture and Fisheries,48 ruled that a French ban on the cultivation of genetically modified crops is procedurally incorrect. In this case, the French government invoked a safeguard clause in Directive 2001/18 on the deliberate release into the environment of GMOs49 and banned the cultivation of MON810 maize in 2008. In accordance with the safeguard clause, a member state can ban cultivation of a GMO on its own initiative provided new findings about a potential risk to humans or the environment are present. At the same time, France had maintained experimental crops. Monsanto and a number of seed producers challenged the measures taken by the French administration before the Conseil d'Etat (the highest French administrative court). The Conseil d'Etat referred the case to the ECJ.A decision on April 22, 1998, by the European Commission authorized MON810 maize to be placed on the market at the request of Monsanto Europe, on the basis that Directive 90/220/EEC on the deliberate release into the environment of GMOs was in force. Pursuant to the European Commission decision, France also authorized MON810 maize to be placed on the market. On May 4, 2007, Monsanto Europe applied for renewal of the authorization to place MON810 maize on the market pursuant to Regulation No. 1829/2003 on genetically modified food and feed.50 Monsanto Europe put forward to the Commission that MON810 maize was an existing product and had been lawfully placed on the market.In this Monsanto case, the ECJ stated that, when a member state is wanting to adopt emergency measures under Regulation No. 178/2002, it must comply not only with the substantive