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Lack of Sherpas for a GMO Escape Route in the EU

Published online by Cambridge University Press:  06 March 2019

Javier Guillem Carrau

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The foodborne disease and other incidents of food contamination, such as the dioxins crisis, have tested the internal market of the European Union (EU) in relation to the free movement of goods. The protective measures adopted under the safeguard clause obliged EU Member States to act in co-ordination with the European Commission and, in fact, to modify elements of their food chain structure. Certainly the agrofood safety crisis of the 1990s and the review of European food law have resulted in a system in which the European Food Safety Authority (EFSA) plays a key role.

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Articles
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German Law Journal , Volume 10 , Issue 8 , 01 August 2009 , pp. 1169 - 1200
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Copyright © 2009 by German Law Journal GbR 

References

1 In Rome, member states agreed to a common market supported by several pillars, initially adopting the free movement of goods and other production factors, and later adopting the Single European Act (SEA) to reach an internal market by revising the concept common market into the single market. Looking for a stronger common market and a more efficient economic integration, the Maastricht and Amsterdam Treaties have added relevant rules to get the Internal Market throughout two basic and complementary principles: free movement of goods and free competence. Harmonisation of national laws, the third dimension of the internal market, is the pathway of execution of both principles. Jean-Marc Favret, Droit Communautaire du marché intérieur 17 (Gaulino ed., 2000) In the context of the strategy of internal market implementation, the European Commission develops very important tasks, basically, in terms of prevention and sanction, promoting the co-operation between national authorities, notification of national technical rules, and derogatory measures. P.P. Craig & Grainne De Búrca, EU Law 548 (2d ed. 1998)Google Scholar

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9 At this point, Zarrilli considers that, given the lack of scientific evidence of the actual or potential impact of agricultural biotechnology on human and animal health and on the environment, the debate on GMOs continues to be vocal and emotional. See Simonetta Zarrilli, International Trade in GMOs and GM products: National and Multilateral Legal Frameworks, 29 Pol'y Issues in Int'l Trade & Commodities, Studies Series, 2 (2005). Slovic points out that “Danger is real, risk is socially constructed.” See Paul Slovic, Trust, Emotion, Sex, Politics and Science: Surveying the Risk-assessment Battlefield in The perception of risk 390 (2000). Consequently, in order to define the “risk” associated with biotechnology, we should also take into account public opinion. This is a critical point, since public debate does not normally follow the same rules as scientific discussion. Once the item is explained to the public, the scientific facts are opened to a great number of different social agents. See Robert F. Durant & Jerome S. Legge, Jr., Public Opinion, Risk Perceptions, and Genetically Modified Food Regulatory Policy: Reassessing the Calculus of Dissent among European Citizens, 6 European Union Politics 181, 197 (2005). Public opinion covers, as has been mentioned above, environmental, ethical and religious factors. Experience and education are key points to understand the perception of risks associated with biotechnological products. See Mercedes Sánchez & Ramo Barrena, El consumidor ante los alimentos de nueva generación: alimentos funcionales y alimentos transgénicos, 204 Estudios Agrosociales y Pesqueros 95 (2004).Google Scholar

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12 In EU food law, Article 6 of Regulation EC number 178/2002 says that in order to achieve the general objective of a high level of protection of human health and life, “food law shall be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure. …” Therefore, risk assessment shall be based on “the available scientific evidence and undertaken in an independent, objective and transparent manner” and risk management “shall take into account the results of risk assessment”, and, in particular, the opinions of the EFSA (European Food Safety Authority), other factors legitimate to the matter under consideration and the precautionary principle “where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5”. Commission Regulation 178/2002, art. 6, 2002 O.J. (L 31) 8.Google Scholar

13 In relation to GMO, among other factors, the health risk is assessed in terms of toxicity, allergies and other pathological elements. However, it is known that allergic reactions to tacos made from “Star Link” GM corn in the USA have been detected. See Colin Carter & Allen Smith, Univ. of California, Dept. of Agricultural and Resource Economics, The Market Effect of a Food Scare: The Case of GM StarLink Corn, Paper No. 04/012, 2004). It is also true that there is the lengthy question of genetic transfer to bacterial and antibiotic resistance, and it is obviously difficult to prove that there are no long-term effects.Google Scholar

14 See Christofourou, Theofanis, The Regulation of Genetically Modified Organisms in the European Union: The Interplay of Science, Law and Politics, 41 Common Mkt. L. Rev. 637, 709 (2003); Christofourou, Theofanis, The Precautionary Principle in European Community Law and Science, in Precaution, Environmental Science and Preventive Public Policy 243 (J.A. Tickner ed., 2003).Google Scholar

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16 German legal scientists have configured the Vorsongeprinzip as the necessary intervention of public administration, although scientific evidence may not be certified. In the USA, the Delaney clause of section 409 of the 1958 Federal Food, Drug and Cosmetic Act included a zero risk concept: “the Secretary of the Food and Drug Administration shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals”. Principle 15 of Rio Declaration 1992 and Cartagena Protocol has fixed the precautionary principle in the context of environmental policies. See Peter Montague, The Precautionary Principle, Rachel's Environment and Health Weekly, Feb. 19, 1998.Google Scholar

17 The application of the precautionary principle in matters concerning human health has been declared by ECJ, among others, in Case C-180/96, United Kingdom v. Commission, 1998 E.C.R. I-02265, and T-33/99, Pfizer Animal Health v. Council, 2002 E.C.R. II-3305. In particular, we must highlight the simultaneous application of the precautionary principle and proportionality by the ECJ in United Kingdom v. Commission and Great Britain's beef embargo by resolution of 12 July, 1996.Google Scholar

18 The General Principles of Food Law in the European Union, COM (1997) 176 (April 30, 1997).Google Scholar

19 In the Communication, the European Commission states that “The precautionary principle is not defined in the Treaty, which prescribes it only once - to protect the environment. But in practice, its scope is much wider, and specifically where preliminary objective scientific evaluation, indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.” Communication on the Precautionary Principle, COM (2000) 1 final (Feb. 2, 2000).Google Scholar

20 General principles and new requirements of food law are contained in Regulation 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the EFSA and laying down the procedures in matters of food safety. See Commission Regulation, supra note 12. The EFSA is in charge of scientific risk assessment and has no powers of risk management. Risk management is the power of public authorities, as is risk communication.Google Scholar

21 For instance, ECJ has confirmed the validity of several articles of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Joined Cases C-154/04 & C-155/04, The Queen ex parte Alliance for Natural Health v. Secretary of State for Health and National Assembly of Wales, 2005 E.C.R. 1–06451.Google Scholar

22 Lezaun, Javier, Creating a New Object of Government: Making Genetically Modified Organisms Traceable, 36 Soc. Stud. Sci. 500 (2006).Google Scholar

23 Vaque, González, El TJCE confirma su jurisprudencia relativa al principio de precaución: la Sentencia “Monsanto agricultura Italia SpA y otros, 6 Unión Europea Aranzadi 5, 5–15 (2004).Google Scholar

24 US policy-makers have expressed that “there are two major perils associated with an extreme approach to precaution. One is that technological innovation will be stifled, and we all recognize that innovation has played a major role in economic progress throughout the world. A second peril, more subtle, is that public health and the environment would be harmed as the energies of regulators and the regulated community would be diverted from known or plausible hazards to speculative and ill-founded ones.” John D. Graham, The Heritage Foundation Washington, D.C., The Perils of the Precautionary Principle: Lessons from the American and European Experience, Regulatory Forum, Oct. 20, 2003, available at http://www.whitehouse.gov/omb/inforeg/speeches/031020graham.pdf. The deepest objection to the precautionary principle is methodological: the precautionary principle focuses on risks in isolation. Sunstein categorizes it among approaches to environmental protection that are “unhelpful, sometimes, even, ludicrous”. The legitimacy of the precautionary principle will be undermined if it comes to apply to just any fear that people happen to have in regard to new technologies. Sunstein, supra note 11, at 55, 100, 120. Nevertheless, some authors have supported a precautionary principle interpretation more connected to the European one. Lisa Heizerling, Climate Change, Human Health, and the Post-Cautionary Principle, 96 Geo. L.J. 445 (2008).Google Scholar

25 See López, Compés & Carrau, Guillem, Regulation of GMOs: The Commercial Conflict Between the United States and the European Union, 3 New Medit 3, 3–10 (2002).Google Scholar

26 The US is the world's primary producer of genetically modified agricultural products and has not committed to the Cartagena Protocol. One of the principal reasons for US leadership in GMOs is the flexibility of their regulation. The regulatory procedures for the approval of GMOs in the EU differ significantly from those of exporting third-party countries, including differences in the time for processing authorisation dossiers. The time it takes for GMO authorisations to be completed in the EU is over 2 1/2 years, as opposed to a US average of fifteen months. The growth of this technique in the second half of the 90s has been so spectacular that, at the present time, a very high percentage of its production of maize, soya or cotton is already organic. The first GM product on the world market was a variety of herbicide-resistant soya exported from the US to Europe and Australia during 1996 Following the 2007 International Service for the Acquisition of Agri-biotech Applications (ISAAA) information, in 2006, the first year of the second decade of commercialization of biotech crops 2006–2015, the global area of biotech crops continued to grow for the tenth consecutive year at a sustained double-digit growth rate of 13%, or 12 million hectares, reaching 102 million hectares. GMO producers are 10.3 million people in 22 States and, nowadays, 29 countries have authorised the imports of GMO as food. The value is US$6.15 billion; more or less 16 per cent of the global crop market. The US is the primary producer, followed by Argentina, Brazil, Canada, India and China. In this context, Spain continues to lead the European continent, planting 60,000 hectares in 2006. Clive James, Global Status of Commercialized Biotech/GM Crops: 2006, ISAAA Brief 35–2006: Highlights (2006), http://www.isaaa.org/resources/publications/briefs/35/highlights/default.html. Critics have expressed concern that the ISAAA makes outrageous claims, inflates its figures and ignores negatives. For instance, the report emphasises that 10.3 million farmers grew GM crops in 2006, but this is just 0.7% of farmers world-wide. And just 600,000 farmers grew 85% of all GM crops on industrial farms in North and South America. Small third world farmers are abused and misused as fodder for ISAAA's PR.Google Scholar

27 See Dabrowska, Patrycja, Risk, Precaution and the Internal Market: Who Won the Day in the Recent Monsanto Judgement of ECJ on GM foods, 5 Germ. L.J. 151 (2004).Google Scholar

28 In 1992, as a general rule, the USA considered that transgenic food did not need a particular regulation separate from the standards of food commercialization. Statements of Policy: Foods Derived from New Plant varieties, 52 Fed. Reg. 22984 (U.S. Food and Drug Administration, May 29, 1992). This position is based on the affirmation of the Science National Academy, which considers that the transgenic products have the same risks that a conventional one. The basic institutional structure for regulation of all biotechnology products in the US is the “Coordinated Framework for Regulation of Biotechnology” established in 1986. See GianCarlo Moschini, Iowa State Univ., Working Paper No. 06-WP 429, 2006, Pharmaceutical and Industrial Traits in GM crops: Co-existence with Conventional Agriculture, 8, available at http://www.card.iastate.edu (last visited Sept. 12, 2007). The US federal agencies working jointly on the approval of GMOs, are APHIS (Animal and Plant Health Inspection Service), the EPA (Environmental Protection Agency) and the FDA (Food and Drug Administration). By mandate of the National Institute of Health (NIH), a Biosecurity Committee evaluates every genetic improvement's project before its launch and it is able to recommend that a project is not developed. These agencies are those responsible in the main for the environment and consumer health protection. On the one hand, when an application is presented, APHIS should deliver authorizations in order to: be able to use some facilities (greenhouses) to develop the cultivation; carry out trials in fields; transport seeds from the greenhouse to the trial fields; and to determine the status of “not regulated” that allows cultivation, use and marketing of the product. The process lasts approximately ten months. On the other, the EPA is responsible for authorizing release in the environment and authorizing pesticides obtained by means of genetic manipulation and plants modified to have pesticide characteristics. In particular, the EPA should authorize the following acts: trials in exploitations over 10 acres; establishing tolerance thresholds (maximum limits of modified proteins in food from the plant); registering products for commercial use. Finally, the FDA, as the agency responsible for the security of all foods, advises and supervises companies in the GMOs’ development phase. The advice process is voluntary, but the requirements are compulsory, and all the companies involved tend to keep on it. Labelling is also ruled by the general principle that products obtained by means of genetic manipulation are not different the conventional products (they are “substantially equivalent”, according to the concept coined by the OECD and the WHO) and, because of this, they are regulated by identical norms. The FDA only requires specific labelling of GM content when the product carries with it some element of risk (an allergic reaction, for example) or if its nutritional characteristics or composition are significantly different from its equivalent conventional one; in this case, the difference should be indicated on the label. This regulation, however, may change in the near future. Food scandals, like the one unleashed by the appearance of GMOs in certain foods of the Taco Bell chain of restaurants, have opened a debate on the segregation of GMOs from conventional foods in the North American food chain. In this sense, certain opinion groups have made Congress admit legislation establishing a compulsory pre-marketing test for GMOs, which ought to be carried out by the FDA, a GMO product labelling and an obligation for biotechnological companies to assume responsibility for problems derived from their products. In this line, the FDA has presented in February of this year a proposal that determines the mandatory communication of foods coming from biotechnology, prior to their commercialization, with the purpose of highlighting its coherence with the FFDCA. Concerning co-existence, US regulation in this area at present presumes a zero tolerance level in the food supply. Moschini considers that for first-generation GM products co-existence does not carry health or environmental risks because the health and environmental safety of GM products is assessed prior to approval. The additional risk of second generation products points out that the coexistence of traditional agriculture with crops transformed to express pharmaceutical and industrial traits will, in his opinion, take quite a different form than the first generation of GM products in the US.Google Scholar

29 See Gruszczynski, Lukasz A., Science in the Process of Risk Regulation under the WTO Agreement on Sanitary and Phytosanitary Measures, 7 Germ. L. J. 371 (2006).Google Scholar

30 The difficulties of admitting the patentability of microorganisms were solved by the US Supreme Court on June 16th 1980 in Diamond v. Chakrabarty because the microorganism was an invention of the laboratory and not of nature. See Diamond v. Chakrabarty, 447 U.S. 303 (1980). In particular, the Court declared that living organisms which are products of human ingenuity are patentable. See id. In the EU, Directive 98/44, on the legal protection of biotechnological inventions, has stated the common provisions for patentability of biotech inventions by EU Law. Council Directive 98/44, 1998 O.J. (L 213) 13, 13–21. For Romero, this exposes the main elements of the EU evolution in the context of the Munich Convention. See Romero Fernández, La patentabilidad de las invenciones biotecnológicas, 5829 LA LEY: Revista jurídica española de doctrina, jurisprudencia y bibliografía 1, 3 (2003), available at http://www.epo.org/patents/law/legal-texts/html/epc/1973/e/ma1.html.Google Scholar

31 To date, 142 instruments of ratification or accession have been deposited with the UN Secretary-General from the following Parties to the Convention on Biological Diversity. See Convention on Biological Diversity, http://www.cbd.int/biosafety/default.shtml.Google Scholar

32 See Fuentes, Cara, Riesgo y Derecho comunitario: modificaciones genéticas en el ámbito de lo agrícola, 33 Actualidad Administrativa 963 (2000).Google Scholar

33 See Mahieu, , supra note 7, at 415.Google Scholar

34 See Scott, Joanne, European Regulation of GMOs and the WTO, 9 Colum. J. Eur. L. 213 (2003).Google Scholar

35 See Germano, Alberto, Corso di diritto agrolimentare, G. Giappichelli Editore 94 (2007).Google Scholar

36 Related to the legal basis, some debates have been finally solved by ECJ concerning the legal basis of the so-called Biotech Directive. Malcolm MacLaren, Patently Unsatisfactory? Community Legislative Competence and the ECJ Biotech Decision, 2 Germ. L.J. 18 (2001).CrossRefGoogle Scholar

37 It should be highlighted that, for a long time, those who have exercised prominent influence on biotechnology policy were France, the UK, and (in part) Germany, but also smaller countries such as Denmark and the Netherlands. Austria, in contrast, was hardly visible in terms of political influence, although in retrospect, the Austrian policy seems to anticipate early elements of what was to come later in other European countries See Helge Torgensen, Austria and the Transatlantic Agricultural Biotechnology Divide, 24 Sci. Comm. 174 (2002). The ministers of the new partners participated for the first time at the Environment Council of Ministers of June 2004, and on the agenda was the debate about the controversial point of commercialisation of another strain of GM maize, NK603. On the one hand, Cyprus, Hungary, Latvia, Malta and Lithuania were against the authorisation of GM maize NK603; on the other, the Czech Republic, Poland and Estonia were in favour and Slovakia and Slovenia abstained. Following the scheme of the transitional voting system, applied at the Council of Ministers until October 2004, the majority was against the authorisation and commercialisation (16 in favour/15 against/6 abstentions). See also Dabrowska, supra note 27.Google Scholar

38 In the Council of Ministers of 24th and 25th June 1999, the French, Greek, Italian, Luxembourg and Danish delegations passed a declaration deciding to block any new commercialization application whilst the system did not warrant transparency and perfect traceability. Therefore, a moratorium was actually decided and revision process of the system began. From October 1991, when the Directive came into force until July 2000, 18 authorizations were approved, with 14 pending, with no authorization from 1998. In fact, no product had been authorized until March 2003.Google Scholar

39 The most relevant affairs have been Novartis maize and Monsanto soya. See David Kelch, Mark Simone & Madell, Biotechnology in Agriculture Confronts Agreements in the WTO, WTO/WRS/98/44 (Dec. 1998).Google Scholar

40 U.S. Food and Drug Administration, Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (2001) (draft released for comment), http://www.fda.gov/OHRMS/DOCKETS/98fr/001598gd.pdf.Google Scholar

41 The US, Canada and the European Union have agreed that the reasonable period of time for the EU to implement the recommendations expires on 21 November 2007. See WT/DS291/35, June 26, 2007.Google Scholar

42 First, the European Community has adopted Regulation EC 1829/2003 on genetically modified food and feed; Regulation EC 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, amending Directive 2001/18/EC; Regulation EC 65/2004, of January 14th 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms; and Commission Recommendation 2004/787/EC of October 4th 2004 on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation EC 1830/2003. Secondly, at execution level, to be precise, twelve GMO dossiers have been authorised in EU up until June 2007 (maize NK603, maize MON863, maize 1507, maize MON 863 x MON 810, carnation 123.2.38, rape GT73, rape MS8, RF3 and MS8 x RF3, maize Bt11, maize NK603, maize MON 863, maize GA21 and maize 1507). Thirdly, the European Commission has sent to ten Member States a letter of “mise en demeure” because of they had not implemented Directive EC/2001/18 in time. See Case C-419/03, Comm'n v. France, 2004 E.C.R. The European Commission has claimed that the French Republic failed to comply with the judgment of the Court of July 15th, 2004 and the Court ordered France to pay a lump sum for failing to comply swiftly with the 2004 Judgement of the Court establishing its failure to fulfil obligations concerning GMOs. See Case C-121-07, Comm'n v. France, 2008 E.C.R. Recently, the ECJ has dismissed an appeal of Austria and its Land Oberösterreich seeking to have set aside the Judgment in Joined Cases T-366/03 & T-235/04, Land Oberösterreich and Austria v Comm'n, 2005 E.C.R. 4005, by which the Court of First Instance dismissed their actions seeking the annulment of Commission Decision 2003/653/EC of September 2nd, 2003, relating to national provisions on banning the use of genetically modified organisms in the region of Upper Austria notified by the Republic of Austria pursuant to Article 95(5) of the EC Treaty. See Joined Cases C-439/05 P & C-454/05 P, Land Oberösterreich and Austria v. Commission, 2007 E.C.R. See also Commission Recommendation on Guidelines for the Development of Strategies and Best Practices to Ensure the Co-Existence of Genetically Modified (GM) Crops with Conventional and Organic Farming, DG AGRI Report (2003), available at http://ec.europa.eu/agriculture/publi/reports/coexistence2/guide_en.pdf.Google Scholar

43 See Vaque, , supra note 23, at 9. González Vaque says that this means that the compulsory labelling would be justified if the GM product were substantially equivalent to the conventional product. If the products were “alike” or “similar”, obligation would not be justified, because the only difference would reside in a characteristic of the productive process—the transgenic techniques—that does not influence the appreciable characteristics of the final product or its safety, and this would also suppose a treatment discrimination that is not accepted by the Agreement. Therefore, if it is not possible to demonstrate that the products are different or that the transgenic is not safe, then the products are “similar”, and it the compulsory label is not justified—although the voluntary one is—nor any other measure restricting imports. See Case C-236/01, Monsanto Agricoltura Italia, 2003 E.C.R. II-8105; Case C-296/01, Comm'n v. France, 2003 E.C.R. I-13909 and Joined Cases C-439/05 P & C-454/05P, Land Oberösterreich and Austria v. Comm'n, 2004 E.C.R. I-07141. Related to ECJ resolutions, among others, see also EFIC Judgement of May 10th, joined cases T-366/03 & T-235/04 Land Oberösterreich and Austria v. Comm'n, 2005 E.C.R. II-4005; Case C-132/03 Ministero della Salute v Codacons and Federconsumatori 2005 E.C.R. I-4167; Case C-456/03 Comm'n v Italy 2005 E.C.R. I-5335. Related to this approach, Dabrowska considered that in the Monsanto case “the Court has perhaps sought to prevent Member States supporting the moratorium on all GM products from using the safeguard clause for purely political reasons.” In her view, this Judgment is the first case in which the Court has directly invoked the precautionary principle regarding Member States’ power to adopt a provisional prohibition on the marketing of GMO-derived novel foods. See Dabrowska, supra note 26, at 4 and 7; but see Thijs Etty & Han Somsen, Case C-236/01: Monsanto Agricoltura Italia SPA and others vs. Presidenza del Consiglio dei Ministeri and others, 13 Eur. Envtl. L. Rev. 14 (2004).Google Scholar

44 See Lezaun, , supra note 22, at 500.Google Scholar

45 See Communication from the Commission to the Council, the EP, the European Economic and Social Committee and the Committee of Regions on the Mid Term Review of the Strategy on Life Sciences and Biotechnology, at 441, COM (2007) 175 final (Oct. 4, 2007).Google Scholar

46 See Consequences, Opportunities and Challenges of Modern Biotechnology for Europe (April 20, 2007), available at http://bio4eu.jrc.ec.europa.eu/documents/eur22728en.pdf; Economic Impacts of Genetically Modified Crops on the Agri-Food Sector (Commission of the European Communities, Working Document No. Rev.2 DG AGRI, 2000).Google Scholar

47 See Case C-552/07, Commune de Sausheim v. Pierre Azelvandre, 2009 E.C.R. 00000; Case T-42/05, Williams v. Comm'n, 2008 E.C.R.Google Scholar

48 See Report on the implementation of Regulation EC 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, COM (2008) 560 final (Sept. 17, 2008).Google Scholar

49 Eur. Voice, May 8, 2008, at 8.Google Scholar

50 See Mahieu, , supra note 7, at 400.Google Scholar

51 Historically, the EU Food Safety system may be understood in the context of the Common Market and the goals of the Common Agriculture Policy (CAP). The objectives of the CAP are the following: ensure availability of supply; increase productivity; stabilize markets; reasonable prices; and fair standard of living for farmers. Nowadays, the CAP reforms and the internal market strategy are the keys to explain the EU Food Safety. Certainly, the agro food safety crisis on the 90's and the review of the European food law has developed a system where the European Food Safety Authority (EFSA) plays a key role. Aiming for a higher level of consumer protection, the European Commission's White Paper on a Common Food Safety Strategy was the new approach to the food sector known “from farm to the table” that assures traceability throughout the food chain and states a Rapid Alert System for Food and Feed (RASFF). The EU integrated approach to food safety aims to assure a high level of food safety, animal health, animal welfare and plant health within the European Union through coherent farm-to-table measures and adequate monitoring, while ensuring the effective functioning of the internal market. The European Commission continues the enforcement of its mission to determine legislative and other actions: to assure effective control systems and evaluate compliance with EU standards in the food safety and quality, animal health, animal welfare, animal nutrition and plant health sectors within the EU and in third countries in relation to their exports to the EU; to manage international relations with third countries and international organisations concerning food safety, animal health, animal welfare, animal nutrition and plant health; to manage relations with the European Food Safety Authority (EFSA) and ensure science-based risk management. Paul Nihoul & Stephanie Mahieu, La sécurité alimentaire et la réglementation des OGM: perspectives nationale, européenne et internationale 182 (2005); Lezaun, , supra note 22, at 502.Google Scholar

52 Mahieu has explained that the applicants for a GMO authorization whose products are not going to feed humans or animals will be concerned only by Directive 2001/18/EC and the applicants for a GMO authorization whose products are intended to feed humans or animals will be subjected to the Regulation EC 1829/2003/EC. Mahieu has stated that the applicants can introduce files by both administrative ways and, indeed, many of the applicants use both procedures. Mahieu, supra note 7, at 455, 456.Google Scholar

53 The European Commission has invited Member States to act at the domestic level in order to regulate compensations for damages due to cross border contamination. See Commission Recommendation 556 of March 5th, 2003. However, it would be inexact to state the evolution of Member States’ decisions without a mention of some restrictive administrations. EU Policy in Biotechnology, DG ENVI (2006), available at http://ec.europa.eu/environment/biotechnology/pdf/eu_policy_biotechnology.pdf. At the EU level, the GMO legal framework is not acceptable for Member States or local and regional authorities. Particularly, there has been a reply to the EC Recommendation. In November 2003, a group of “GM-free regions” was created and now comprises 164 European regions. For instance, in France, close to 38 million people live in areas whose local authorities have declared their opposition to GMOs. For instance, in Italy, the Act 5 2005 about co-existence has produced constitutional problems, since the division of powers between National and Regional Administrations has not made it possible. Corte Costituzionale [Constitutional Court] 150 (2006); Corte Costituzionale [Constitutional Court] 116 (2006). In that context, the goal of the EU is the harmonization of national laws. Taking into account commercial goals, the harmonization will be more efficient if the National Administration is the body empowered to regulate coexistence. The main issue, therefore, is to know how national and regional systems are coordinated and the degree of collaboration between the different bodies and institutions of each administration. Always based on the identity of traditional production and regional peculiarities, these authorities are against the homogenization and expansion of GM crops because it is not compatible with respect for ethnographic heritage. None of these regional governments have forbidden GM crops, but have conferred powers to farmers for the creation of non-GM areas establishing a special administrative authorisation to those producers interested in the use of GM seeds. 10 Eur. Voice 30, 20 (2004).Google Scholar

54 Ruiz, , supra note 15, at 289.Google Scholar

55 For instance, in German law, the authorization must be conferred when, according to the state of the art, damage expected for health and environment is justified in order to comply with marketing goals. GenTG (Gesetz zur Reglung der Gentechnik) [Law Regulating Genetic Engineering] ¶ 16(2) (1993) (F.R.G.). The justifiability clause has been criticised by Mir Puigpelat because the rule legitimates some kind of damage, which is always expected in medicines (side effects listed in the prospectus) but not in food. Oriol Mir Puigpelat, Transgénicos y derecho: la nueva regulación de los organismos modificados genéticamente 205 (2004).Google Scholar

56 As Germany, France, Luxembourg, Portugal and Austria have done in Novartis BT grain case. First and foremost, it should be stressed that a political agreement at the European Council could have the power to silence the technical objections laid down by Member States’ competent authorities. Mellado has a critical view of the European phase of the process, considering that risk assessment and risk management should not be matters of transaction. Mellado, supra note 15, at 174.Google Scholar

57 Case C-6/99, Greenpeace et al., 2000 E.R.C. 1–1651.Google Scholar

58 See Council Directive 01/18, arts. 4.5, 8.2, 19.4, 20.3 and 23, 2001 (EC).Google Scholar

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60 The safeguard clause was invoked on nine separate occasions under Directive 90/220/EEC, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom. The scientific evidence provided by these Member States as justification for their measures was submitted to the Scientific Committee(s) of the EU for opinion. In all of these cases, the Committee(s) deemed that there was no new evidence justifying overturning the original authorisation decision. In spite of the repeal of Directive 90/220/EEC, eight of the nine bans remained in place (the UK withdrew its ban) and were considered under the safeguard provision (Article 23) of Directive 2001/18/EC. The GMOs in question (Bt 176, T25 and MON 810 maize, Ms1xRf1 and Topas 19/2 oilseed rape) had been authorised under Directive 90/220 for all uses (including cultivation) with the exception of Topas 19/2 (import and processing). The Commission examined the additional information provided by certain Member States, which was also reviewed by EFSA. In addition, in January 2005, Hungary invoked the safeguard clause in order to prohibit the cultivation of MON 810 in its territory. In June 2005, the Environment Council reached a qualified majority against eight proposals to lift the eight bans invoked by five Member States. As a result, DG for the Environment consulted EFSA again in order to obtain an updated opinion. The Commission now has three options, namely to submit either the same or amended proposals back to the Council or to submit proposals for adoption through co-decision, on the basis of EFSA's awaited opinion. See EU Policy, supra note 53.Google Scholar

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64 Specific dispositions exist for the forest material of reproduction and for the vineyard, for medical products for human and veterinary use, workers’ protection and transport. Plants authorised before 1997 were not subjected to compulsory labelling (one soya, one maize and two rapeseed plants).Google Scholar

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66 See supra note 42.Google Scholar

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69 After a period of decline in optimism about biotechnology, the 2005 Euro-barometer showed an increase in optimism since 1999 (52% say biotechnology will improve their life), and an overall support for many biotech applications (such as gene therapy, biofuel and bioplastics). It also shows that knowledge about biotechnology and genetics, although improved, remains limited. However, 58% of respondents oppose GM food while 42% do not. The Euro-barometer also confirmed that there were major differences in acceptance levels between Member States, in that 50% or more say they would buy GM food if it were healthier, if it contained less pesticide residues, or if were more environmentally friendly. See Europeans and Biotechnology in 2005: Patterns and Trends (2006), available at http://www.ec.europa.eu/research/press/2006/pdf/pr1906_eb_64_3_final_report-may2006_en.pdf.Google Scholar

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73 Id. Google Scholar

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76 The StarLink case is a clear example of the need for appropriate rules for authorisation and traceability of a GMO (Declaration of European Union Trade Directorate, available at http://europa.eu.int/comm/trade/goods/agri/pr130503_en.htm).Google Scholar

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78 Id. at 6.Google Scholar

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