Genetic Technology in the Light of Food Security and Food Safety – General Report

Norer, Roland; Preisig, Christa

doi:10.1007/978-3-319-23995-8_1

Roland Norer⁴ &
Christa Preisig⁴

Part of the book series: Ius Comparatum - Global Studies in Comparative Law ((GSCL,volume 14))

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Abstract

Genetically modified organisms have been discussed controversially ever since they were subject of legislation and regulation. This reports sheds light on the question how different countries from all over the world have reacted to the emergence of the new technology of genetic engineering and how the law should respond to it. The answers to these questions of principle are highly dependent on the political and social discussions within a legal community. This is especially true for the use of GMOs in food production. What one government considers an evil to avoid is a welcome expansion of alimentary diversification to the other. Thus, there is a variety of interesting and differentiated width of legal frameworks on international, supranational (EU) and national level to be found. It is these frameworks the article will examine, primarily on the basis of the national reports that were handed in.

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Notes

1.
A definition of GMO can be found in the Canadian Report, p. 339: “All organisms, and products thereof, produced through techniques of genetic engineering and modification including, but not restricted to recombinant DNA, cell fusion, encapsulation, macro and micro injection, gene deletion or magnification, and other techniques for altering the genetic composition of living organisms in ways, or with results, that do not occur in nature through mating or through traditional breeding techniques such as conjugation, hybridization, or transduction”; definition by the Canadian General Standards Board’s Organic Agriculture Standards.
2.
Reporters are – in alphabetical order of the states – the following: Luc Lavrysen/Frank Maes/Piet van der Meer for Belgium; Marie-Ève Arbour for Canada; Erkki J. Hollo for Finland; Hans-Georg Dederer for Germany; Mary Dobbs for Ireland; Alberto Germanò/Eva Rook Basile for Italy; Rostam Neuwirth for Macau SAR; Claudia Colmenarez Ortiz/Sol Ortiz García for Mexico; Hans Morten Haugen for Norway; Christoph Errass for Switzerland; Anton Mingh-Zhi Gao for Taiwan; Margaret Rosso Grossman for the USA. The General Reporter thanks all the participating National Reporters for their excellent work. It is the basis for this summary which compiles the National Reports.
3.
Report USA, p. 291, quoting Pamela Ronald, Plant Genetics, Sustainable Agriculture and Global Food Security, 188 Genetics (May 2011), pp. 11 f.
4.
Report USA, p. 291, quoting Gary Marchant et al., Impact of the Precautionary Principle on Feeding Current and Future Generations (CAST Issue Paper No. 52, June 2013), p. 11.
5.
Report USA, p. 292, quoting Pamela Ronald, p. 12. “A European organization recently indicated that ‘the potential benefits of crop genetic improvement technologies are very significant,’ and recommended improvements in EU policy to capture those benefits”. Report USA, p. 292, quoting European Academies Science Advisory Council (EASAC), Planting the future: opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture (2013), p. 2.
6.
Report USA, p. 292.
7.
Report Canada, p. 339.
8.
See Report USA, p. 293, with further references. According to the report, “[i]n 2012, GM varieties made up 88 % of all corn, 93 % of soy and 94 % of upland cotton”.
9.
Report USA, p. 293, stating that GM-events are approved for release into the environment, cultivation, food and feed.
10.
Report Belgium, p. 128.
11.
Report Ireland, p. 177.
12.
See http://www.lag-gentechnik.de/index.html
13.
Report Germany, p. 75.
14.
http://www.stmug.bayern.de/umwelt/gentechnik/bayern/anlagen.htm
15.
Report Germany, p. 76.
16.
http://www.transgen.de/anbau/deutschland/1714.doku.html
17.
http://www.bvl.bund.de/DE/06_Gentechnik/01_Aufgaben/02_ZustaendigkeitenEinzelneBereiche/04_Standortregister/Auswertung_Stareg/gentechnik_standortregister_HG_Auswertung_Stareg_node.html
18.
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL.
19.
Report Switzerland, pp. 260 ff.
20.
Cf. http://www.bafu.admin.ch/biotechnologie/01760/08936/index.html?lang=de
21.
Cf. http://www.bag.admin.ch/themen/lebensmittel/04858/04863/04883/index.html?lang=de
22.
Cf. Macau SAR, where due to the size of the territory and its economic structure there is hardly any agriculture nor much food production. This means that there are no or only few facts and figures available on the use of GMOs. So the local concerns in Macau are usually about food quality und food safety in general and less about the specific role of GMOs applied to food processing; Report Macau SAR, pp. 424 ff.
23.
Report USA, p. 292, quoting Gurdev S. Khush, Genetically modified crops: the fastest adopted crop technology in the history of modern agriculture, Ag. & Food Security 1, (2012), passim.
24.
Report USA.
25.
The numbers and figures in this paragraph are all taken from the Report USA, pp. 292 f.
26.
Daniela Nowotny, Gentechnikrecht, in: Roland Norer (ed.), Handbuch des Agrarrechts, 2nd edition (2012), p. 392 with further references. A list of GMOs authorised for GM food and feed products in the EU is available at http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
27.
Report Taiwan, p. 387.
28.
Report Belgium, pp. 128 f.
29.
Report Germany, pp. 75 ff.
30.
http://www.beuc.org/Content/Default.asp
31.
http://www.copa-cogeca.be
32.
European Commission (ed.), Eurobarometer 73.1: Biotechnology (2010) (Special Eurobarometer 341).
33.
European Commission (ed.), Eurobarometer 73.5: Risiken im Lebensmittelbereich (2010), p. 2.
34.
Accordingly, an opinion poll illustrates that 82 % of the respondents in Germany consider the label “ohne Gentechnik” (“without genetic engineering”) a good choice, which means that the majority of the German public is highly interested in consumer information on whether products are free of GMOs or not; available at http://www.gentechnikfreie-regionen.de/hintergruende/studien/umfragen.html. Report Germany, p. 78.
35.
Eurobarometer 73.1, p. 18 (n. 32).
36.
Report Belgium, p. 129.
37.
Report Canada, p. 340. The Canadian Government made a public consultation in 2012–2013 in order to evaluate the prospect of importing “low level presence” of GM foods on a new level. The consultation aimed at gathering the outlooks of all Canadian citizens, both public and stakeholders, on this controversial subject. The survey made clear that there is a wide array of opinions expressed by different stakeholders, each representing a variety of interests which make the task of reaching a compromise difficult, Report Canada, pp. 339 f.
38.
Report Taiwan, pp. 388 f.
39.
The Department of Health (衛生署) (2000), The Study on Public Perception on Biotechnology and GMO Food (民眾對生物科技及基因改造食品的認知及態度), available at http://food.doh.gov.tw/gmo/gallup.htm
40.
Cf. http://www.srf.ch/news/schweiz/wovor-haben-sie-angst
41.
Report Switzerland, p. 263.
42.
Michael Cardwell, Public Participation in the Regulation of Genetically Modified Organisms: A Matter of Substance or Form?, 12 Envtl L. Rev. (2010), p. 25.
43.
Report USA, p. 296.
44.
Report USA, p. 295, citing Alan McHughen, Public Perceptions of Biotechnology, 2 Biotechnology J. (2007), pp. 1105 f.
45.
Report USA, p. 296.
46.
Report USA, p. 293.
47.
Report USA, p. 294, citing Margaret Rosso Grossman, The Coexistence of GM and Other Crops in the European Union, 16 Kan. J.L. & Pub. Pol’y (2007), p. 324.
48.
Report Canada, p. 339.
49.
Report USA, p. 297.
50.
Report USA, p. 297, citing a link from http://www.fas.usda.gov/itp/biotech/biotech_trade.asp. Other supporting governments are Australia, Brazil, Canada, Argentina and Paraguay according to the Report USA.
51.
Report USA, p. 297, quoting Codex Alimentarius, Foods derived from modern biotechnology, 2nd ed. (2009) (collecting principles and guidelines), ftp://ftp.fao.org/docrep/fao/011/a1554e/a1554e00.pdf
52.
Report Ireland, p. 177.
53.
See section “Opt-out” below.
54.
See overview in Daniela Nowotny, pp. 393 f. (n. 26).
55.
Cf. in detail Report Germany, pp. 78 ff.
56.
BT-Drs. 17/8819 of March 1, 2012, p. 4.
57.
On the basis of the different coalition agreements of the German federal government since 1998, cf. Report Germany, p. 79.
58.
Deutschlands Zukunft gestalten. Koalitionsvertrag zwischen CDU, CSU und SPD, 18. Legislaturperiode (2013), pp. 19 and 123 ff.
59.
Report Belgium, pp. 128 f.
60.
Report Taiwan, p. 389.
61.
German: „Ernährungssicherheit“; French: „sécurité alimentaire“. The notion must be distinguished from the term „food sovereignity“ (German: „Ernährungssouveränität“; French: “souveraineté alimentaire“) that is currently being discussed intensively as political concept. See Roland Norer, Ernährungssouveränität – vom politischen Modewort zum Rechtsbegriff?, BlAR (2011), pp. 13 ff.; see also Christian Häberli, Rechtliche Grundlagen für die Ernährungssicherheit in der Schweiz, BlAR (2013), pp. 181 ff.
62.
Cf. Report USA, p. 307, quoting UN Special Rapporteur on the Right to Food Olivier de Schutter: “The right to food is a human right recognized under international law which protects the right of all human beings to feed themselves in dignity, either by producing their food or by purchasing it.” Elements of this right include availability of food, accessibility (both economic and physical), and adequacy (to satisfy dietary needs). Article available at http://www.srfood.org/en/right-to-food. Quote taken from the Report USA.
63.
See Report Macau SAR, p. 426.
64.
Art. 25(1) of the Universal Declaration of Human Rights, GA Res. 217(III), UN GAOR, 3d Sess., Supp. No. 13, UN Doc. A/810 (1948).
65.
Art. 11(1) of the International Covenant on Economic, Social and Cultural Rights (ICESCR), adopted on December 16, 1966, 993 UNTS 3 (1966).
66.
See Food and Agriculture Organisation of the United Nations, Rome Declaration on World Food Security and World Food Summit Plan of Action (1998) [http://www.fao.org/docrep/003/w3613e/w3613e00.HTM].
67.
See Art. III(9) FAO Constitution; http://www.fao.org/cfs/en/
68.
FAO, An Introduction to the Basic Concepts of Food Security (2008): http://www.fao.org/docrep/013/al936e/al936e00.pdf
69.
Report USA quoting ERS, USDA, Definitions of Food Security; http://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/definitions-of-food-security.aspx-assistance/food-security-in-the-us/definitions-of-food-security.aspx. See Report USA, p. 299.
70.
Report USA, p. 300, citing Economist Intelligence Unit, Global food security index 2013 (2013), p. 6.
71.
German: „Nahrungsmittelsicherheit“; French: „sécurité sanitaire des aliments“.
72.
Report Germany, pp. 80 f.
73.
It has been defined as follows: “Food safety is generally recognized as the biological, chemical or physical status of a food that will permit its consumption without incurring excessive risk of injury, morbidity or mortality.” Christine Boisrobert et al. (eds.), Ensuring Global Food Safety: Exploring Global Harmonization (2010).
74.
See Report Macau SAR, p. 426.
75.
See Report Macau SAR, pp. 426 f.
76.
See e.g. Stefania Negri, Food Safety and Global Health: An International Law Perspective, 3 Global Health Governance 1 (2009); George Kent, Freedom from Want: The Human Right to Adequate Food (2005); Kerstin Mechlem, Food Security and the Right to Food in the Discourse of the United Nations, (2004) 10 European Law Journal 631; Jean Ziegler/Christophe Golay/Claire Mahon/Sally-Anne Way, The Fight for the Right to Food: Lessons Learned (2011).
77.
Committee on Economic, Social and Cultural Rights, General Comment No. 12, E/C.12/1999/5 (May 12, 1999), para. 8.
78.
Report Ireland, p. 175.
79.
Geneviève Parent, Droit économique et sécurité alimentaire: un couple mal assorti?, (2012) 4 Rev. int. de droit écon., p. 15 (at p. 16). According to Parent, this definition is sufficiently broad to address problems that are specific to economically developed countries, such as obesity, and, for our purpose, GM product’s consumption.
80.
See Report Macau SAR, p. 428.
81.
Art. 1 Macau Food Safety Law (MFSL) [食品安全法(第5/2013 號法律) or Lei de segurança alimentar (Law No. 5/2013)], Official Bulletin No. 17/2013, Series I (April 22, 2013), pp. 259–69.
82.
See the White Book about Agriculture of Flanders, Report Belgium, p. 129; The White Paper on Irish Aid in 2006, Report Ireland, p. 175; Strategic Project for Food Security (SPFS) [Proyecto Estratégico para la Seguridad Alimentaria (PESA)] in connection with the Food and Agriculture Organisation’s (FAO) Special Program for Food Security, Report Mexico, p. 364.
83.
Grundgesetz für die Bundesrepublik Deutschland (BGBl. 1949 p. 1).
84.
See Art. 74(1)(17) GG which confers concurrent legislative powers upon the Federation in the area of “ensuring the adequacy of food supply”, Report Germany, p. 81.
85.
Verfassung des Freistaates Bayern (GVBl. 1946 p. 333), Report Germany, p. 81.
86.
See Art. 83(1) BV which provides that food security facilities are within the realm of municipal self-government, Report Germany, p. 81.
87.
See for instance in Germany Sec. 1(1)(1) Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch LFGB, BGBl. 2013 I p. 1426 („German Food, Consumer Good and Feed Act“). In Taiwan the Act Governing Food Sanitation, amended June 19, 2013, contains numerous – sometimes explicit – references to food safety. As to the relation between the terms food sanitation and food safety, see Report Taiwan, pp. 390 ff. In Canada food safety is well alive in federal and provincial legislation, case-law and scholarship, Report Canada, p. 341.
88.
Report Norway, p. 251.
89.
N. 64.
90.
N. 77.
91.
Cf. Christine Breining-Kaufmann, Hunger als Rechtsproblem – völkerrechtliche Aspekte eines Rechtes auf Nahrung (1991), relating to Art. 11 UNO Pact I, pp. 59 ff. See also Marco Borghi/Letizia Postiglione Blommestein (eds.), For an effective Right to adequate food (2002); Marco Borghi/Letizia Postiglione Blommestein (eds.), The right to adequate food and access to justice (2006); Christophe Golay/Melik Özden, Le droit à l’alimentation (2006).
92.
Report Switzerland, p. 266.
93.
Convention on the Rights of the Child, adopted by the General Assembly of the United Nations on November 20, 1989, 1577 UNTS 3 (1989).
94.
Cf. General Comment No. 14 (2000) of the CESCR (n. 77).
95.
International treaty on plant genetic resources for food and agriculture, FAO, available at ftp://ftp.fao.org/docrep/fao/011/i0510e/i0510e.pdf
96.
See Christoph Errass, Elemente zum Verständnis von Art. 7 GTG. Auslegung des schweizerischen Rechts einschliesslich gewisser völkerrechtlicher Bestimmungen, in: Rainer J. Schweizer/Christoph Errass/Stefan Kohler, Koexistenz der Produktion mit und ohne gentechnisch veränderte Organismen in der Landwirtschaft (2012), pp. 188 f.
97.
Constitution of the Food and Agriculture Organization of the United Nations.
98.
Preamble of the FAO Constitution.
99.
http://www.codexalimentarius.org/codex-home/en/
100.
Cf. comprehensively Tilman Makatsch, Gesundheitsschutz im Recht der Welthandelsorganisation (WTO). Die WTO und das SPS-Übereinkommen im Lichte von Wissenschaftlichkeit, Verrechtlichung und Harmonierung (2004), pp. 204 ff.
101.
Report Switzerland, p. 267, with further references.
102.
Appendix 1A.4 of the Agreement establishing the World Trade Organization.
103.
See Makatsch (n. 100), pp. 218 ff.; Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion. Naturwissenschaftliche, rechtliche und ethische Aspekte (2011), pp. 57, 84.
104.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity adopted on January 29. See the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (NKP).
105.
See Errass, pp. 185 ff. (n. 96).
106.
See for instance Ruth Mackenzie/Françoise Burhenne-Guilmin/Antonio G.M. La Viña/Jacob D. Werksman, An explanatory Guide to the Cartagena Protocol on Biosafty, IUCN Environmental Policy and Law Paper No. 46 (2003), pp. 63 ff.; Martin Scheyli, Das Cartagena-Protokoll über die biologische Sicherheit zur Biodiversitätskonvention, ZaöRV (2000), pp. 771 ff., 785 ff.; Katja Loosen, Das Biosafety-Protokoll von Cartagena zwischen Umweltvölkerrecht und Welthandelsrecht (2005), pp. 6 ff.
107.
N. 104.
108.
Agreement on the Application of Sanitary and Phytosanitary Measures.
109.
Agreement on Technical Barriers to Trade.
110.
WTO Panel Report European Communities – Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R, para. 8.13 ff.
111.
For more details on the TBT Agreement, see Report Italy, pp. 226 ff.
112.
General Agreement on Tariffs and Trade 1994, April 15, 1994.
113.
See Report Switzerland, p. 269.
114.
Thereto Jan Neumann, Die Koordination des WTO-Rechts mit anderen völkerrechtlichen Ordnungen (1994), pp. 112 ff., in particular pp. 250 ff.
115.
Report Germany, p. 87.
116.
Charter of Fundamental Rights of the European Union (OJ C 303, 14.12.2007, p. 1).
117.
Art. 2(1) ChFR.
118.
Art. 3(1) ChFR.
119.
Art. 16 ChFR.
120.
Art. 17 ChFR.
121.
Report Germany, pp. 87 f.
122.
Art. 35(2) ChFR.
123.
Art. 37 ChFR.
124.
Art. 38 ChFR.
125.
Art. 192(2) TFEU.
126.
Art. 114(1)(2) TFEU.
127.
Art. 169(2) TFEU.
128.
Cf. also Streinz, p. 58 (n. 103).
129.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75).
130.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
131.
Regulation (EC) No. 1830/2003 of the European Parliament and of the Council of 22 September 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 (OJ L 268, 18.10.2003, p. 24).
132.
Regulation (EC) No. 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1).
133.
See Matthias Herdegen/Hans-Georg Dederer, Internationales Biotechnologierecht, EU-Recht/Regelungen (Stand 2012).
134.
About the three stages in the evolution of EU policy on GMOs see Report Italy, pp. 218 f.
135.
Proposal for a Regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory, COM(2010) 375 final, 13 July 2010.
See the current Progress Report, Council of the EU, 2010/0208 (COD), Brussels, 3 June 2012, available at: http://register.consilium.europa.eu/pdf/en/12/st10/st10883-re01.en12.pdf at 5.
136.
See Mary Dobbs, Legalising General Prohibitions on Cultivation of Genetically Modified Organisms (2010), 11 German Law Journal 1347; José Martinez, Grenzen einer Renationalisierung des Agrarbinnenmarktes. Zum Vorschlag der Kommission zur Änderung der EU-Freisetzungsrichtlinie, in: Roland Norer/Gottfried Holzer (eds.), Agrarrecht Jahrbuch 2011 (2011), pp. 152 f.
137.
Consequently, if the proposed amendment is eventually passed and if the Member States wish to avail of it, they will have to identify a relevant objective justification that makes a national or regional prohibition proportionate. One such objective justification could be that of public morality, which is an acceptable justification within WTO law also (Art. XX of GATT); it would avoid the SPS Agreement being raised and the treatment of this justification may be sufficiently flexible to allow prohibitions to be accepted by the Dispute Panel and Appellate Board as proportionate; Report Ireland, pp. 191 ff.
138.
Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions on the freedom for Member States to decide on the cultivation of genetically modified crops, COM(2010) 380 final.
139.
Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
140.
Council Regulation (EC) No. 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No. 2092/91 (OJ L 189, 20.7.2007, p. 1).
141.
Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29). This Directive will expire on 13 December 2014 and will be substituted by Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No. 1924/2006 and (EC) No. 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No. 608/2004 (OJ L 304, 22.11.2011, p. 18).
142.
Thus, it does not apply to food produced “with” GMOs. See Art. 3(1) Regulation (EC) No. 1829/2003 (n. 143).
143.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
144.
Art. 1(a) Regulation (EC) No. 1829/2003 (n. 143). Concerning the change of the EU legislator’s regulatory philosophy which was to ensure environmental and health protection at the beginning in 1990 but which has been extended to include consumer interest protection as well in 2001/2003, see Hans-Georg Dederer, Neues von der Gentechnik, ZLR 2005, pp. 308 ff.; Gernot Schubert, Paradigmenwechsel im Gentechnikrecht?, GenTechnik & Recht (2003), p. 53.
145.
N. 131.
146.
Art. 1 Regulation (EU) No. 1830/2003 (n. 131).
147.
N. 132.
148.
Art. 1 and 9–10 Regulation (EC) No. 1946/2003.
149.
See e.g. Art. 2(1) Regulation (EC) No. 1829/2003 (n. 143) referring to general food law for the purpose of the definitions of “food” and “feed”; Art. 2(5) referring to general genetic engineering law for the purpose of the definition of “GMO”.
150.
See e.g. Art. 5(5)(a) Regulation (EC) No. 1829/2003 (n. 143) referring to general genetic engineering law.
151.
See Art. 34 Regulation (EC) No. 1829/2003 (n. 143) referring to general food law.
152.
Report Germany, p. 92, concludes that the regulatory framework for GM food seems to rest on the two pillars genetic engineering law and food law. Nevertheless, from a systematic point of view, GM-food law has to be regarded as being part of genetic engineering law. This holds true all the more as both Regulation (EC) No. 1830/2003 (e.g. Art. 5) (n. 131) and Regulation (EC) No. 1946/2003 (e.g. Art. 9–10) (n. 132), which belong to the general legal framework for GMOs, also refer to particular regulatory aspects of GM food.
153.
Art. 16(2) and Art. 17(6) GTA for example that apply in particular to food refer on the international recommendations and foreign trade relations, meaning according to the parliamentarian debate the EU law; Report Switzerland, p. 270. In general see Roland Norer, Europäisierung des Schweizer Agrarrechts. Zwischen Bilateralen Abkommen und autonomem Nachvollzug, in: Festschrift Richli (2011), pp. 569 ff.
154.
Agreement between the European Community and the Swiss Confederation of in trade with agricultural products (OJ L 114, 30.4.2002, p. 132; SR 0.916.026.81).
Thereto Richard Senti, Abkommen über den Handel mit landwirtschaftlichen Erzeugnissen, in: Daniel Thürer/Rolf H. Weber/Wolfgang Portmann/Andreas Kellerhals (eds.), Bilaterale Verträge I & II Schweiz – EU. Ein Handbuch (2007), pp. 731 ff.
155.
Agreement between the European Community and the Swiss Confederation amending the Agreement between the European Economic Community and the Swiss Confederation of 22 July 1972 as regards the provisions applicable to processed agricultural products (OJ L 23, 26.1.2005, p. 17; SR 0.916.026.82).
Thereto Richard Senti, Abkommen über landwirtschaftliche Verarbeitungserzeugnisse, in: Daniel Thürer/Rolf H. Weber/Wolfgang Portmann/Andreas Kellerhals (eds.), Bilaterale Verträge I & II Schweiz – EU. Ein Handbuch (2007), pp. 789 ff.
156.
For the reasons see Report Norway, pp. 247 f.
157.
Nevertheless, the Norwegian EEA Agreement Annex XX (Environment) Art. 25.d(c) gives a basis not to approve living GMOs in Norway that have been approved in the EU.
158.
Federal Constitution of the Swiss Confederation of 18 April 1999 (SR 101).
159.
As to the history of its legislatory evolution see Report Switzerland, p. 261.
160.
German: “Auswüchse der Gentechnologie“; see Report Switzerland, p. 263.
161.
See Christoph Errass, Öffentliches Recht der Gentechnologie im Ausserhumanbereich (2006), pp. 59 ff.; Christoph Errass, 20 Jahre Würde der Kreatur, ZBJV 2013, pp. 187 ff. Cf. Also Astrid Epiney/Bernhard Waldmann/Magnus Oeschger/Jennifer Heuck, Die Ausscheidung von gentechnikfreien Gebieten in der Schweiz de lege lata et de lege ferenda. Unter besonderer Berücksichtigung der Rechtslage in der EU (2011), pp. 73 ff.
162.
Report Switzerland, p. 265.
163.
Anikó Raisz/János Ede Szilágyi, Report Hungary, in: Paul Richli (ed.), L’agriculture et les exigences du développement durable. XXVIe Congrès et Colloque Européen de Droit Rural, Bucarest, 21–24 septembre 2011 (2013), pp. 545 f.
164.
See e.g. Report Canada, p. 343; Report Germany, pp. 83 ff.; Report Ireland, pp. 175 f.; Report Taiwan, pp. 392 f. In Finland the Constitution has enacted a provision on environmental liability; Report Finland, p. 157.
165.
See Report Norway, p. 253, where the Nature Diversity Act 2009 regulates also the benefits arising out of the utilisation of genetic material.
166.
See Report Norway, p. 252, about genetic modified fish in the Aquaculture Act 2005.
167.
See Report Belgium, pp. 129 f.
168.
E.g. Report Belgium, p. 130; Report Germany, p. 85.
169.
Report Germany, pp. 85 ff.; cf. also Report Ireland, pp. 179 f.
170.
German EC Genetic Engineering Implementation Law (EG-Gentechnik-Durchführungsgesetz, EGGenTDurchfG), BGBl. 2004 I p. 1244.
171.
Federal Act on Non-Human Gene Technology (Gene Technology Act, GTA) of 21 March 2003 (SR 814.91); Report Switzerland, pp. 273 ff.
172.
See also Report Canada, pp. 345 f.; Environmental Protection Agency in Ireland, Report Ireland, p. 184.
173.
Cf. Report Belgium, p. 131.
174.
Report Belgium, p. 131.
175.
Report Germany, p. 88.
176.
Report Macau SAR, pp. 431 f.
177.
Report USA, p. 309, citing Office of Science and Technology Policy (OSTP), Coordinated Framework for Regulation of Biotechnology Products, 51 Fed. Reg. 23,302 (June 26, 1986) (drafted in cooperation with administrative agencies).
178.
Report USA, p. 309.
179.
Report USA, p. 313, stating that a “GM food product is considered substantially equivalent to its conventional counterpart if their nutritional components do not differ”.
180.
Report USA, p. 315, citing Erica Seiguer/John J. Smith, Perception and Process at the Food and Drug Administration: Obligations and Trade-Offs in Rules and Guidances, 60 Food & Drug L.J. 17, 20 (2005).
181.
E.g. Art. 191 TFEU contains prevention and precaution in relation to the environment (but with mention of health and Art. 11 requires environmental protection components to be integrated across EU law); Case T-147/00 Laboratoires Servier v Commission [2003] ECR II-85, para 52; Joined Cases T-74/00, T-76/00, T-83/00, T-84/00, T-85/00, T-132/00, T-137/00, & T-141/00, Artegodan GmbH v. Commission [2002] ECR 11–4945, para 184; and Case C-132/03 Ministero della Salute v Coordinamento delle Associazioni per la Difesa dell’Ambiente e dei Diritti degli Utenti e dei Consumatori (Codacons) [2005] ECR I-416, para 35. Proportionality has long been accepted as a general principle of EU law: Case C-11/70 Internationale Handelsgesellschaft [1970] ECR 1125.
182.
Art. 7 Regulation (EC) No. 178/2002/EC (n. 139) deals with the precautionary principle directly, whilst prevention can be seen throughout the Regulation. Similarly, proportionality is reflected in various elements of the Regulation, including regarding the precautionary principle and in relation to national enforcement of the Regulation.
183.
See Report Ireland, p. 182.
184.
For example in Switzerland Art. 74(2) phrase 1 FC (n. 158); Art. 1(2) Federal Act on the Protection of the Environment (Environmental Protection Act, EPA) of 7 October 1983, SR 814.01.
185.
In his risk assessment, the notifier must ensure that an accurate assessment is made on a case-by-case basis of the potential adverse effects on human health and the environment, which may occur directly or indirectly. This assessment must be conducted according to the nature of the organism introduced, the intended use and the receiving environment; Report Belgium, pp. 132 f.
186.
See above section “Position of the government on GMOs.” See e.g. Report Macau SAR, pp. 434 f., where the law – focussed on the commercialisation or the import of foodstuff – contains no specific references to GMOs. Report Taiwan, p. 397, where there is no general prohibition of GMOs, but restrictions exist in form of certain rules for the approval of GMO research and development initiatives.
187.
Report Canada, p. 345.
188.
See the Schmeiser case (Monsanto Canada Inc. v. Schmeiser [2004] 1 S.C.R. 902); for details see Report Canada, pp. 351 ff.
189.
Report USA, pp. 316 f.: “To protect intellectual property, seed developers prohibit saving and replanting seeds. Bowman v. Monsanto Co., 569 U.S. __, 133 S. Ct. 1761 (2013) (without permission of the patent holder, a farmer cannot reproduce patented seeds by planting and harvesting).”
190.
Report USA, p. 317.
191.
Report USA, p. 317, citing the example of Michigan Organic Products Act of 2000, Mich. Comp. Laws § 286.907(d) (excluding use of GM organisms from definition of organic agriculture).
192.
In detail see Report USA, pp. 317 ff.
193.
Report Italy, p. 221.
194.
Commission Decision No. 98/292/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line Bt-11), pursuant to Council Directive 90/220/EEC (Text with EEA relevance) (OJ L 131, 5.5.1998, p. 28) and Commission Decision No. 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC (Text with EEA relevance) (OJ L 131, 5.5.1998, p. 32).
195.
Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 043, 14.2.1997, p. 1) established that in the case of novel foods held to be equivalent to traditional products, the procedure to be followed was the “simplified” version that required only a simple communication to the Commission by the importing company.
196.
^Case C-236/01 Monsanto Agricoltura Italia SpA and Others v. Presidenza del Consiglio dei Ministri and Others [2003] ECR I-08105.
197.
Case C-58/10 Monsanto SAS and Others v. Ministre de l’Agriculture et de la Pêche [2011] ECR I-07763.
198.
For further information see Matthias Herdegen/Hans-Georg Dederer, (n. 133), 2. Richtlinie 2001/18/EG, para. 1 (2010); Daniela Nowotny, pp. 393 f (n. 26).
199.
WTO, Reports of the Panel, European Communities – Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291, WT/DS292, and WT/DS293 (September 29, 2006). In detail Report Italy, pp. 228 ff.; Lorenz Stökl, Der welthandelsrechtliche Gentechnikkonflikt. Die europarechtlichen Handelsbeschränkungen für gentechnisch veränderte Lebensmittel und ihre Vereinbarkeit mit Welthandelsrecht (2003).
200.
The Regulations (EC) No. 1829/2003 (n. 143), No. 1830/2003 (n. 131) and No. 1946/2003 (n. 132) were passed forming henceforward the revised legal framework for a stricter regulation of GMOs (together with Directive 2001/18/EC adopted earlier in 2001).
201.
The first GM product approval was issued again in May 2004; see Commission Decision 2004/657/EC of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 300, 25.9.2004, p. 48).
202.
See also section “Safeguard clauses” below.
203.
In detail Report Switzerland, pp. 277.
204.
Report Switzerland, p. 261.
Cf. Art. 197 Section 7 BV Transitional Provision to Article 120 (Non-human gene technology) Swiss agriculture shall remain free of gene technology for a period of 5 years following the adoption of this constitutional provision. In particular, the following may neither be imported nor placed on the market:
1. (a)
  genetically modified plants that are capable of propagation, parts of plants and seeds that are intended for agricultural, horticultural or silvicultural use in the environment;
2. (b)
  genetically modified animals that are intended for the production of foodstuffs and other agricultural products
205.
Cf. Art. 37a GTA (n. 171) Transitional period for putting genetically modified organisms into circulation
No authorisations may be granted until 31 December 2017 for putting into circulation genetically modified plants and parts of plants, genetically modified seeds and other plant propagation material and genetically modified animals for agricultural, horticultural or silvicultural purposes. The Federal Council issues the required implementing provisions for this period.
206.
For further information cf. Rainer J. Schweizer/Isabelle Wildhaber/David Rechsteiner, Vorschläge für eine Schweizer Koexistenzordnung, in: Rainer J. Schweizer/Christoph Errass/Stefan Kohler, Koexistenz der Produktion mit und ohne gentechnisch veränderte Organismen in der Landwirtschaft – Rechtsvergleich sowie Grundlagen und Vorschläge für die knftige Regulierung in der Schweiz (2012), pp. 242 ff.
207.
Federal Law on Agriculture (LAgr) of 29 April 1998 (SR 910.1).
208.
Roland Norer, “Gentechnikfreie Zonen“ in Österreich, RdU 5 (2006), pp. 188 f.
209.
Report Ireland, p. 186.
210.
See Report Germany, pp. 95 ff.
211.
See e.g. Art. 53(1)(a)(i) Regulation (EC) No. 178/2002 (n. 139).
212.
See Art. 54(1)(1) Regulation (EC) No. 178/2002 (n. 139).
213.
See Art. 23(2) and 30(2) Directive 2001/18/EC (n. 130).
214.
Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 13.6.2002, p. 1). Art. 16(2) of the Directive also provides scope for unilateral national measures along the same lines as Art. 18.
215.
Report Ireland, p. 186.
216.
Cf. Commission Decision 2006/10/EC of 10 January 2006 concerning the provisional prohibition in Greece of the marketing of seeds of maize hybrids with the genetic modification MON 810 inscribed in the common catalogue of varieties of agricultural plant species, pursuant to Directive 2002/53/EC (OJ L 7, 10.1.2006, p. 27).
217.
Report Ireland, p. 187.
218.
Commission Decision 2006/335 of 8 May 2006 authorising the Republic of Poland to prohibit on its territory the use of 16 genetically modified varieties of maize with the genetic modification MON810 listed in the Common catalogue of varieties of agricultural plant species, pursuant to Council Directive 2002/53/EC (OJ L 124, 8.5.2006, p. 26).
219.
Nonetheless, the previous comitology procedure made the lifting of national prohibitions based on Art. 23 Directive 2001/18/EC impossible in practice for the Commission, as the Council were able to block proposals to lift the prohibitions. The Commission did succeed in lifting prohibitions relating to GM food and feed, as well as Greece’s prohibition regarding seeds (Commission Decision No. 2006/10/EC of 10 January 2006 concerning the provisional prohibition in Greece of the marketing of seeds of maize hybrids with the genetic modification MON 810 inscribed in the common catalogue of varieties of agricultural plant species, pursuant to Directive 2002/53/EC (OJ L 7, 12.1.2006, p. 27)).
220.
E.g. Nicolas de Sadeleer, Procedures for Derogations from the Principle of Approximation of Laws under Article 95 EC, (2003) CMLRev 40, 889; Floor M. Fleurke, What Use for Article 95 (5)? An Analysis of Land Oberösterreich and Republic of Austria v Commission, (2008) 20 Journal of Environmental Law 267.
221.
Case C‐6/99, Association Greenpeace France and Others v Ministère de l’Agriculture et de la Pêche and Others, [2000] ECR I‐1651, para. 44.
222.
Joined Cases T‐366/03 and T‐235/04 Land Oberösterreich and Republic of Austria v Commission, [2005] ECR II‐4005; Case C‐121/07 Commission v France [2008] ECR I-9159; and the Opinion of Advocate General Mazák of 5 June 2008 in Case C-121/07 Commission v France at pt. 44.
223.
Sec. 20(2) GenTG, Gesetz zur Regelung der Gentechnik (BGBl. 1993 I p. 2066).
224.
Report Germany, pp. 96 f.
225.
Cf. WTO Panel Report European Communities – Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R, pp. 1037 ff. See also Hans-Georg Dederer, Die Nutzung der Gentechnik, in: Reinhard Hendler/Peter Marburger/Peter Reiff/Meinhard Schröder (eds.), Landwirtschaft und Umweltschutz (2007), p. 185.
226.
See n. 196.
227.
Case T-366/03 (n. 222).
228.
Joined Cases C-439/05 P and C-454/05 P Land Oberösterreich [2007] ECR I-7141.
229.
See for example in Germany: Sec. 20(2) GenTG, Report Germany, pp. 95 f.; Belgium: Art. 42 Royal Decree of 21 February 2005; Report Belgium, pp. 137 f.
230.
See Report Germany, p. 97.
231.
N. 140.
232.
Recital 30, Art. 4(a)(iii) and Art. 9 Regulation (EC) No. 834/2007 (n. 140).
233.
Regulation (EU) No. 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487).
234.
Roland Norer, pp. 194 f (n. 208).
235.
For details on a respective attempt in Slovenia, see the Commission report dating from 9 March 2006 „Report on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming“, COM(2006)104 final, p. 5.
236.
For examples see Roland Norer, p. 194 (n. 208).
237.
http://www.gmo-free-regions.org
238.
Report Belgium, p. 142.
239.
Saatgutverkehrsgesetz – SaatG, BGBl. 2004 I p. 1673.
240.
Sec. 29 SaatG (n. 239). Report Germany, p. 98.
241.
Gesetz zum Schutz der Erzeugung von Saatgut in geschlossenen Anbaugebieten (SaatErzG), GBl. 1969 p. 80.
242.
Cf. Sec. 1(1) and (2), 2(1)(1) SaatErzG (n. 241).
243.
Art. 7(2) in connection with Art. 6(5)(e) Regulation (EU) No. 1829/2003 (n. 143). A similar provision is laid down in Art. 19(3)(c) Directive 2001/18/EC in connection with Sec. 16d(1)(3) GenTG (n. 223).
244.
Sec. 35(2) in connection with Sec. 34(1), (2) Nature Protection Act (Bundesnaturschutzgesetz, BNatSchG). Report Germany, pp. 98 f.; Hans-Georg Dederer, Gentechnikrecht, in: Ines Härtel (ed.), Handbuch des Fachanwalts Agrarrecht (2012), Kapitel 20, para 91 ff.; Christoph Palme/Jochen Schumacher, Die Regelungen zur FFH-Verträglichkeitsprüfung bei Freisetzung oder Inverkehrbringen von gentechnisch veränderten Organismen in § 34a BNatSchG, NuR 2007, p. 16.
245.
In Bavaria, more than 200 municipalities and counties have committed themselves to GMO-free agriculture on their territories. See http://www.stmuv.bayern.de/umwelt/gentechnik/index.htm, Report Germany, p. 99.
246.
Report Ireland, p. 193. Map and details of self-declared GM-free areas in Ireland in 2010: http://www.gmfreeireland.org/map/index.php
247.
For instance the Regions of Latium (with Law No. 53 dated 1 March 2000); Tuscany (with Law No. 53 dated 6 April 2000); Abruzzo (with Law No. 6 dated 16 March 2001); Umbria (with Law No. 21 dated 20 August 2001).
248.
The Regions of Marche (with Law No. 5 dated 3 March 2004) and Puglia (with Law No. 26 dated 4 December 2003).
249.
Report Italy, pp. 229 f.
250.
Report Italy, pp. 230 f.
251.
See Roland Norer, pp. 192 ff (n. 208).
252.
Oberösterreichisches Gentechnik-Verbotsgesetz, draft dating from 2002.
253.
Commission Decision No. 2003/653/EC of 2 September 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 (OJ L 230, 16.9.2003, p. 34).
254.
Joined Cases T-366/03 und T-235/04 (n. 222). See Christoph Palme, Bans on the Use of Genetically Modified Organisms (GMOs) – the Case of Upper Austria, JEEPL 2006, p. 22; Christoph Palme, Das Urteil des Europäischen Gerichts zum oberösterreichischen Gentechnikverbotsgesetz, StoffR 2005, p. 222.
255.
Joined Cases C-439/05 P and C-454/2005 (n. 228).
256.
Gentechnik-Vorsorgegesetze. See also legislation in other federal provinces: Burgenländisches Gentechnik-VorsorgeG (LGBl 2005/64); Kärntner Gentechnik-VorsorgeG (LGBl 2005/5); Niederösterreichisches Gentechnik-Vorsorgegesetz (LGBl 6180–1); Oberösterreichisches Gentechnik-Vorsorgegesetz 2006 (LGBl 2006/79); Salzburger Gentechnik-VorsorgeG (LGBl 2004/75); Steiermärkisches Gentechnik-Vorsorgegesetz (LGBl 2006/97); Tiroler Gentechnik-Vorsorgegesetz (LGBl 2005/36); Vorarlberger Gesetz über Naturschutz und Landschaftsentwicklung (LGBl 1997/22); Wiener Gentechnik-Vorsorgegesetz (LGBl 2005/53).
257.
Roland Norer, pp. 193 f. (n. 208).
258.
Report Canada, p. 345. See http://www.cban.ca/Resources/Topics/GE-Free-Zones
259.
All quotes in this paragraph are taken from the Report USA, p. 319.
260.
Art. 86–90 Law on Biosafety of Genetically Modified Organisms.
261.
Report Mexico, p. 377.
262.
In Centres of Origin and Genetic Diversity the release of GMOs is permitted when the GMOs intended to be released are distinct from native animal and plant species provided that these releases do not cause any negative effects on human health or biological diversity.
263.
In Natural Protected Areas activities with GMOs will only be permitted for remediation purposes in the cases that plagues or polluters could put at danger the existence of animal, aquatic or plant species and these GMOs where specifically created to avoid or combat that situation. However, activities with GMOs are banned in core areas of the Natural Protected Areas.
264.
GMO-free zones may be established for the protection of organic agricultural products and others of interest to the soliciting community. The zones will be established when GMOs of the same species to the ones resulting from production of organic agricultural products coincide, and when it is scientifically and technically demonstrated that their coexistence is not viable or that they would not comply with the normative requirements for their certification.
265.
Report Switzerland, p. 278. See ECNH, Opinion of 19 February 2013 (in German): Koexistenzregelung: Änderung des Bundesgesetzes über die Gentechnik im Ausserhumanbereich, GTG (Vernehmlassungsentwurf vom 30. Januar 2013) und Verordnung über Koexistenzmassnahmen beim Anbau von gentechnisch veränderten Pflanzen sowie beim Umgang mit daraus gewonnenem Erntegut, Koexistenzverordnung, KoexV (Vernehmlassungsentwurf vom 15. Januar 2013), pp. 7 ff.
266.
For example Report Canada, p. 345; Report Belgium, p. 142; Report Germany, pp. 99 f.
267.
Roland Norer, p. 194 (n. 208).
268.
Report Germany, p. 99. See Michael Greiner, Befassungskompetenz kommunaler Gremien mit Fragen der Gentechnik („Gentechnikfreie Zone“), KommunalPraxis BY (2004), p. 376; Hans-Dieter Laser, Ausbringen von genetisch veränderten Organismen und Pflanzen auf gemeindeeigenen Grundstücken, KommunalPraxis BY (2005), p. 384.
269.
Report Germany, p. 99.
270.
Cf. Erika Wagner/Richard Volgger, Die Errichtung von GVO-freien Zonen in der Europäischen Union (2013); Astrid Epiney/Bernhard Waldmann/Magnus Oeschger/Jennifer Heuck, Die Ausscheidung von gentechnikfreien Gebieten in der Schweiz de lege lata et de lege ferenda (2011); Hans-Georg Dederer, Weiterentwicklung des Gentechnikrechts – GVO-freie Zonen und sozioökonomische Kriterien der GVO-Zulassung (2010); Roland Norer, pp. 187 ff. (n. 208).
271.
Barbara Eggers, Die Entscheidung des WTO Appellate Body im Hormonfall, EuZW 1998, 148; Sabine Blacke, Risikoentscheidungen im europäischen Lebensmittelrecht (1998), pp. 862 f; Ferdinand Kerschner/Erika Wagner, Koexistenz zwischen Gentechnik, Landwirtschaft und Natur – rechtliche Rahmenbedingungen (2003), p. 100.
272.
Roland Norer, p. 189 (n. 208).
273.
Report Germany, pp. 99 f.
274.
Joined Cases T-366/03 and T-235/04, Land Öberösterreich, ECR 2005, p. II-4005, para 36 ff. This judgment was upheld by the ECJ, Joined Cases C-439/05 P and C-454/05 P Land Oberösterreich [2007] ECR I-7141, par. 60 ff.
275.
Commission Recommendation No. 2010/C 200/01 of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops (OJ C 200, 22.7.2010, p. 1).
276.
Para. 2.4 Commission Recommendation No. 2010/C 200/01 (n. 275).
277.
Report Germany, p. 97. For the purpose of coexistence measures is to avoid the unintended presence of GMOs in conventional or organic crops.
278.
Report Germany, p. 98.
279.
For an in-depth analysis see Hans-Georg Dederer, pp. 12 ff. (n. 270).
280.
N. 130.
281.
N. 135.
282.
Report Italy, p. 231.
283.
See e.g. Ferdinand Kerschner/Erika Wagner, Koexistenz zwischen Gentechnik, Landwirtschaft und Natur – rechtliche Rahmenbedingungen (2003); Rainer J. Schweizer/Christoph Errass/Stefan Kohler (eds.), Koexistenz der Produktion mit und ohne gentechnisch veränderte Organsimen in der Landwirtschaft (2012).
284.
Commission Recommendation 2003/556/EG of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming (OJ L 189, 29.7.2003, p. 36), repealed by Commission Recommendation No. 2010/C 200/01 of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops (OJ C 200, 22.7.2010, p. 1).
285.
Report Ireland, p. 189.
286.
E.g. the creation of a Coexistence Network – Commission Decision No. 2005/463/EC of 21 June 2005 establishing a network group for the exchange and coordination of information concerning coexistence of genetically modified, conventional and organic crops (OJ L 164, 24.6.2005, p. 50) – and a Coexistence Bureau – Maria Lee, Multi‐Level Governance of GMOs in the EU: ambiguity and hierarchy, in: Luc Bodiguel/Michael Cardwell (eds.), The Regulation of GMOs: Comparative Approaches (2010), pp. 101 ff.
287.
N. 275. See Mary Dobbs, Excluding Coexistence of GMOs? The impact of the EU Commission’s 2010 Recommendation on Coexistence, RECIEL 2011, p. 180.
288.
See Art. 288(5) TFEU.
289.
Report Ireland, p. 189.
290.
Report Ireland, p. 189.
291.
Generally coexistence measures will favour one agri-type over another; Les Levidow/Karin Boschert, Coexistence or contradiction? GM crops versus alternative agricultures in Europe?, 39 GEOFORUM 174, 174, 181, 187 (2008).
292.
Report Belgium, pp. 141 ff.
293.
Available at: http://www.agriculture.gov.ie/media/migration/publications/2005/coexistenceofgmandnon-gmcropsinireland/report.pdf. Report Ireland, p. 189.
294.
Report Finland, pp. 156 f.
295.
Report Switzerland, p. 278.
296.
See Rainer J. Schweizer/Isabelle Wildhaber/David Rechsteiner, Vorschläge für eine Schweizer Koexistenzordnung, in: Rainer J. Schweizer/Christoph Errass/Stefan Kohler, pp. 209 ff. (n. 206).
297.
Macau SAR however is an exception since there is no explicit mention of GMOs in the legal regime governing food safety. Therefore it must be generally concluded that GMOs are admitted, both in terms of local production and the import of foreign products containing GMOs; Report Macau SAR, pp. 434 f.
298.
E.g. in Switzerland the Federal Biosafety Committee (FBSC) and the Federal Ethics Committee on Non-Human Biotechnology (ECNH); Report Switzerland, p. 275. In the EU (on a voluntary basis) the European Group on Ethics in Science and New Technologies; Report Germany, pp. 107 f.
299.
I.e. the person placing food on the market is fully and solely responsible that the food safety requirements are fulfilled and consumers are not misled. See Art. 14 Regulation (EC) No. 178/2002 and Report Germany, pp. 100 f. with further references.
300.
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).
301.
Recital 11 Regulation (EU) No. 1829/2003 (n. 143).
302.
See Annex I A, Part 2 Directive 2001/18/EC (n. 130); Report Italy.
303.
Art. 3(1)(a-c) Regulation (EC) No. 1829/2003 (n. 143).
304.
GM processing aids or food produced with the help of GM processing aids are not covered by Regulation (EC) No. 1829/2003 (n. 143). Also, milk from cows fed with GM plants is not subject to the regulation’s authorisation requirement. If, on the other hand, material from GMOs is present in the food, such food is considered GM food and, hence, covered by the market authorisation requirement under Regulation (EC) No. 1829/2003 even if the presence of the GMO or any GM material is undetectable. See Report Germany, p. 101 f.
305.
Art. 3(2) Regulation (EC) No. 1829/2003 (n. 143).
306.
See Recital 33, Art. 5–7 Regulation (EC) No. 1829/2003 (n. 143).
307.
Any information which the applicant has classed as confidential will be deleted, see Art. 6(7)(1) in connection with Art. 30 Regulation (EC) No. 1829/2003 (n. 143).
308.
In detail Report Germany, pp. 108 f.; Report Ireland, pp. 183 ff.
309.
The implementation in Ireland for instance attributes a somewhat greater role to the initial competent authority in comparison with the authorisation procedure in Regulation (EC) No. 1829/2003 (n. 143); Report Ireland, p. 185. The rules of the German GenTG governing the placing on the market of products containing or consisting of GMOs (Sec. 14 ff. GenTG) are inapplicable; Report Germany, p. 101.
310.
Report Switzerland, pp. 279 f.
311.
Annex 2 Ordinance of the FDHA about genetically modified foodstuffs (OGMF) of 23 November 2005 (SR 817.022.51). See the summary of the appraisals: http://www.bag.admin.ch/themen/lebensmittel/04858/04863/10021/index.html?lang=de
312.
Report Norway, p. 255.
313.
Division 28 of Part B of the Food and Drugs Regulations; Report Canada, p. 345.
314.
See e.g. CFIA, “DD2005-53: Determination of the Safety of Monsanto Canada Inc.’s Roundup Ready® Alfalfa (Medicago sativa L.) Events J101 and J163”, http://www.inspection.gc.ca/plants/plants-with-novel-traits/approved-under-review/decision-documents/dd2005-53/eng/1311630531051/1311631992012
315.
Report Mexico, p. 375.
316.
Isabelle Wildhaber, Ungewollte Auskreuzungen und die Schwellenwerts-Debatte im Gentechnikrecht, AJP/PJA (2009), pp. 852 ff.; Report Germany, pp. 110 ff.
317.
Commission Regulation (EU) No. 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired (OJ L 166, 25.6.2011, p. 9).
318.
Art. 6(2)(1) Regulation (EU) No. 619/2011 (n. 317).
319.
Recital 18 and Art. 6(3) Regulation (EU) No. 619/2011 (n. 317) in connection with Art. 53, 54 Regulation (EC) No. 178/2002 (n. 137).
320.
Art. 6(1)(1), Annex II B 2 Regulation (EU) No. 619/2011 (n. 317).
321.
Art. 16(2) Regulation (EC) No. 1829/2003 (n. 143).
322.
See Art. 47(5) in connection with Art. 49 (5) Regulation (EC) No. 1829/2003; Art. 12a(2) Directive 2001/18/EC.
323.
Art. 4(2) Regulation (EC) No. 1829/2003.
324.
Art. 13(1)(1) Directive 2001/18/EC.
325.
See Art. 47(1) Regulation (EC) No. 1829/2003 (n. 143); Art. 12a(1) Directive 2001/18/EC. As to the history of the norm, see Report Ireland, pp. 182 ff.; Isabelle Wildhaber (n. 316), p. 852.
326.
Art. 4(8) Regulation (EU) No. 1830/2003 (n. 131).
327.
Council Regulation (EEC) No. 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs (OJ L 198, 24.6.1991, p. 1).
328.
Commission Recommendation on guidelines for the development of national strategies and best practices to ensure the co-existence of genetically modified crops with conventional and organic farming, 2.2.3 (n. 284). For criticism expressed in literature, see Isabelle Wildhaber (n. 316), p. 855.
329.
Regulation (EC) No. 834/2007 on organic production and labelling of organic products and repealing Regulation (EEC) No. 2092/1991 (n. 327).
330.
Art. 4(a)(iii), Art. 9(1) Regulation (EC) No. 834/2007 (n. 140).
331.
Art. 22(1) and (2)(g) Regulation (EC) No. 834/2007 (n. 140).
332.
Recital 10 and 30, Art. 23 Regulation (EC) No. 834/2007 (n. 140).
333.
Daniela Nowotny, p. 406 (n. 25); Isabelle Wildhaber (n. 316), pp. 855 f.
334.
In detail Isabelle Wildhaber (n. 316), pp. 855 f.
335.
Report Mexico, pp. 376 f.; Report Macau SAR, p. 435; Report Taiwan, p. 413, with the exception of a 5 %-threshold for triggering the mandatory labelling requirement.
336.
Report Norway, pp. 255 f.
337.
N. 311.
338.
Report Switzerland, p. 286.
339.
Art. 7(7bis) OGMF (n. 311).
340.
7 U.S.C. §§ 6501–6523; 7 C.F.R. part 205.
341.
Report USA, p. 294.
342.
Report USA, p. 294, citing 7 C.F.R. § 205.105. “The unintentional presence of a detectable GM residue may not affect organic status, if the operator did not use genetic modification and took reasonable steps to avoid contacts with GMOs.”
343.
Report USA, p. 294, quoting 7 U.S.C. § 6508; 7 C.F.R. §§ 205.236, 205.237.
344.
Report USA, p. 294.
345.
Cf. Art. 5(2)(1) Regulation (EC) No. 1829/2003 (n. 143).
346.
Art. 6(2) Regulation (EC) No. 1829/2003 (n. 143).
347.
Art. 6(3)(b) Regulation (EC) No. 1829/2003 (n. 143).
348.
Art. 6(3)(c) Regulation (EC) No. 1829/2003 (n. 143).
349.
Art. 6(4)(3) Regulation (EC) No. 1829/2003 (n. 143).
350.
For example German Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL), Report Germany, p. 111; Norwegian Food Safety Authority, Report Norway, p. 255; Belgian Directorate General for the Protection of Public Health, Report Belgium, p. 146; Food Safety Center in Macau SAR, in planning, Report Macau SAR, p. 432.
351.
Art. 9(1)(2) Regulation (EC) No. 1829/2003 (n. 143).
352.
Art. 9(1)(3) Regulation (EC) No. 1829/2003 (n. 143).
353.
For example the German “Länder”, Report Germany, p. 114; Belgian Federal Agency for the Safety of the Food Chain, Report Belgium, p. 146.
354.
Report Belgium, p. 146.
355.
See Darren Abrahams, Legal Considerations related to the Authorisation, Import and Cultivation of GM Crops in the European Union: A Precedent for other regulated Industries?, 13 BSLR 5, pp. 155 ff.
356.
Report Mexico, pp. 380 f.
357.
This chain can be decomposed into the following phases: the phase of utilisation purely for research and for study of the biotechnological material; the potential phase of patenting the procedure and the biotechnological product; the subsequent phase in which debate has decided in favour of deliberate emission of the genetically modified organism into the environment for the purpose of growing crops; and finally the phase of introducing onto the market the genetically modified foodstuffs that it has been possible to grow and produce. All these stages require specific authorisations; Report Italy, p. 235.
358.
Report Ireland, p. 197.
359.
Cf. Art. 13(1)(a-c) Regulation (EC) No. 1829/2003 (n. 143). In detail Report Germany, p. 116.
360.
Art. 12(2) Regulation (EC) No. 1829/2003 (n. 143); Art. 4(8), 5(3) Regulation (EC) No. 1830/2003 (n. 131).
361.
Report Belgium, p. 147; also Report Finland, pp. 167 f.
362.
Sec. 3a(1)(2) EGGenTDurchfG (n. 170). The label “ohne Gentechnik” signifies that the food was produced without the use of genetic engineering techniques; Report Germany, pp. 114 f.
363.
Report Germany, p. 115.
364.
Sec. 3a(4)(2) EGGenTDurchfG (n. 170).
365.
http://www.transgen.de/recht/kennzeichnung/280.doku.html, Report Germany, p. 115.
366.
Report Switzerland, p. 285.
367.
Art. 5(1) and 17(1) GTA (n. 171).
368.
Traces of genetically modified organisms are considered to be unintentional if the person responsible for providing labelling proves that the product flows have been carefully monitored and recorded; Art. 17(3) GTA.
369.
Art. 17(2) GTA (n. 171).
370.
Ordinance on organic farming and the labelling of organic products and foods of 22 September 1997 (SR 910.18).
371.
See Judgement of the Federal Court 2A.357/2002 of 13 February 2003, considerations 3 and 4; Report Switzerland, p. 286.
372.
Sec. 4b 1st part Feed Regulation; Section 10c 1st part Labelling Regulation. Report Norway, p. 256.
373.
Sec. 10c 2nd part Foodstuff regulation; Section 4b 2nd part Feed regulation.
374.
Report Mexico, p. 379.
375.
Report Taiwan, p. 414.
376.
Art. 1 Ordinance on the Labelling of Food Whose Source is From GM Soybean and Corn.
377.
Art. 5 Ordinance on the Labelling of Food Whose Source is From GM Soybean and Corn.
378.
Art. 2 and 7 Ordinance on the Labelling of Food Whose Source is From GM Soybean and Corn.
379.
Art. 3 Ordinance on the Labelling of Food Whose Source is From GM Soybean and Corn.
380.
Ordinance of Packaging and labelling for GM Plants; Report Taiwan, p. 415.
381.
Report Canada, pp. 347 ff.
382.
Report Macau SAR, p. 437 ff.
383.
Report USA, p. 320: “GM food products need not be labelled as GM unless the food itself differs materially from similar foods”.
384.
Report USA, p. 320.
385.
Report USA, p. 321: “Because the FDA had determined that genetic modification does not alter foods materially, a determination to which the court granted deference, the FDA lacked a legal basis for requiring labels, even in the face of consumer demand”.
386.
Report USA, p. 322.
387.
See Report USA, pp. 323 ff., also to constitutional issues, natural labels and voluntary labelling.
388.
In detail Report Canada, pp. 348 ff.
389.
Cf. Report Ireland, pp. 195 f.
390.
See for example in Germany Sec. 7(2)(4), (3)(3) EGGenTDurchfG (n. 170) in connection with Art. 12(1), 13(1), (2)(a) Regulation (EC) No. 1829/2003 (n. 143) and Art. 4(6)(1) Regulation (EC) No. 1830/2003 (n. 131), Report Germany, p. 119.
391.
Member States shall notify those provisions to the Commission, not later than 18 April 2004 and shall notify it without delay of any subsequent amendment affecting them.
392.
Directive no. 2000/13/EC of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L109, 6.5.2000, p. 29).
393.
For details on the legislation addressing labelling fraud, see e.g. Report Belgium, pp. 147 f.
394.
Gesetz gegen den unlauteren Wettbewerb UWG (BGBl. 2010 I p. 254).
395.
Report Germany, pp. 119 f.
396.
Report Ireland, p. 197.
397.
See also Report Macau SAR, pp. 440 f.
398.
Art. 17 GTA (n. 171); Report Switzerland, p. 286.
399.
Report Taiwan, p. 418.
400.
Art. 56 Consumer Protection Act.
401.
Art. 15 Products Labelling Act.
402.
Art. 45(1), (2) Regulation (EC) No. 1829/2003 (n. 143); Art. 11(1), (2) Regulation (EC) No. 1830/2003 (n. 131).
403.
EGGenTDurchfG. For more details on the individual norms, see Report Germany, pp. 120 ff.
404.
Art. 33(1), (2) Directive 2001/18/EC.
405.
Sec. 38, 39 GenTG. Report Germany, p. 120.
406.
Report Italy, p. 239.
407.
Directive 2004/35/EC of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56).
408.
Report Belgium, p. 149. In Belgium the federal legislation is applicable for environmental damage that is caused by the deliberate release into the environment, the transport and placing on the market of GMOs. The regional legislation is applicable when environmental damage is caused by any contained use, including transport, involving GM micro-organisms. See also Report Finland, p. 170.
409.
Cf. § 2 in connection with Annex 1 sec. 10 Bundes-Umwelthaftungsgesetz. In the federal provinces, the Environmental Liability Acts in Burgenland, Lower Austria, Styria and Upper Austria explicitly include the cultivation of GMOs as defined in their respective Acts on Genetic Engineering Precautionary Measures (see section “Inventory” above).
410.
On possibly competing claims see e.g. Christian Hediger, Die Haftungsbestimmungen des Gentechnikgesetzes (Art. 30–34 GTG). Beurteilung und Vergleich mit der Haftungsregelung des deutschen Gentechnikgesetzes (2009), pp. 128 ff., 153, 176 f. Report Switzerland, pp. 286 f.
411.
See Report Switzerland, p. 287, with further references.
412.
Report Norway, pp. 256 f.
413.
Report Mexico, pp. 380 f.
414.
E.g. Report Germany, pp. 120 ff.; Report Taiwan, pp. 420 f.; Report Italy, p. 241.
415.
Cf. Report Ireland, p. 211.
416.
Report Belgium, p. 148. In this context cf. the cases of Hoffmann v. Monsanto Canada Inc. as well as the comparably famous case Schmeiser (n. 188), the latter one albeit under reversed premises; Report Canada, pp. 351 ff.
417.
Sec. 32 ff. GenTG (n. 223); Report Germany, p. 121.
418.
Sec. 34(1) GenTG (n. 223).
419.
See Sec. 35 GenTG (n. 223).
420.
37(3) German GenTG (n. 223).
421.
Cf. Sec. 906(2)(2) BGB.
422.
See Sec. 36a GenTG (n. 223). See Jürgen Kohler, Schadensausgleich in Fällen des §36a Gentechnikgesetz, NuR 2005, p. 566; Gerhard Wagner, Nachbarhaftung für gentechnische Immissionen, Versicherungsrecht 2007, p. 1017.
423.
The recovery of damages requires that the GM immissions occurred despite the fact that the GM farmer has complied with the standards of good professional practice; Sec. 36a(2) GenTG (n. 223).
424.
Cf. § 364(2) ABGB and § 79 h GTG.
425.
Daniela Nowotny, p. 419 (n. 26).
426.
Cf. §§ 79a ff. GTG.
427.
Ferdinand Kerschner, Neue Gentechnikhaftung in der Landwirtschaft (§§ 79k-m GTG), in: Roland Norer/Anton Reinl (eds.), Haftungsfragen in der Land- und Forstwirtschaft (2005), p. 37, and RdU 2005, p. 112; Ferdinand Kerschner/Eva Claudia Lang/Gabriele Satzinger/Erika Wagner, Kommentar zum Gentechnikgesetz (2007), §§ 79a ff.
428.
§ 79 m GTG.
429.
Report Italy, p. 241.
430.
Report Ireland, p. 203.
431.
The quotes in this paragraph are all taken from Report USA, pp. 329 ff.
432.
Directive No. 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
433.
In this sense Report Belgium, p. 150; Report Ireland, p. 209 where apart from the Liability for Defective Products Act 1991 the common law may be applied in addition.
434.
Report Italy, p. 243.
435.
Product Liability Act, Gesetz über die Haftung für fehlerhafte Produkte (Produkthaftungsgesetz – ProdHaftG) (BGBl. 1989 I p. 2189).
436.
Report Germany, p. 123.
437.
Sec. 37(2)(2) GenTG (n. 223).
438.
Report Italy, p. 243.
439.
Report Canada, pp. 350 ff.; Report Macau SAR, pp. 443 f.
440.
Report Switzerland, pp. 289 f.
441.
Assessment according to the Report Canada, p. 356.

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Roland Norer & Christa Preisig

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Norer, R., Preisig, C. (2016). Genetic Technology in the Light of Food Security and Food Safety – General Report. In: Norer, R. (eds) Genetic Technology and Food Safety. Ius Comparatum - Global Studies in Comparative Law, vol 14. Springer, Cham. https://doi.org/10.1007/978-3-319-23995-8_1

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