Genetic Technology and Food Security: Country Report – Germany

Dederer, Hans-Georg

doi:10.1007/978-3-319-23995-8_2

Hans-Georg Dederer⁴

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

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Abstract

In 2013 and 2014, no GM plants were released into the environment in Germany, neither for research nor for commercial purposes. Political as well as legal grounds may have contributed to this development. In fact, the German public tends to be much more critical about agricultural biotechnology than the EU average. Politicians seem to have bowed to the public’s distrust against GMOs. Both the executive and the legislature have exercised almost any margin of discretion left by EU law to the Member States in order to strangle GM plant cultivation. Examples include the Federal Ministry of Agriculture’s order suspending the cultivation of the GM variety MON810 and strict liability provisions which prompted the German Farmers’ Association to advise every farmer against GM crop cultivation.

This article was first published in: Martin Schmidt-Kessel (ed.), German National Reports on the 19th International Congress of Comparative Law, 2014.

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Notes

1.
See http://www.lag-gentechnik.de/index.html
2.
Gesetz zur Regelung der Gentechnik (BGBl. 1993 I p. 2066), last amended by law of 7 August 2013 (BGBl. 2013 I p. 3154).
3.
Sec. 31(1) GenTG.
4.
http://www.stmug.bayern.de/umwelt/gentechnik/bayern/anlagen.htm
5.
Concerning the classification of contained uses in four classes or safety levels respectively see Art. 4(3) Directive 2009/41/EC (with regard to classes) and Sec. 7(1)(1) GenTG (with regard to safety levels).
6.
http://www.stmug.bayern.de/umwelt/gentechnik/bayern/anlagen.htm
7.
http://apps2.bvl.bund.de/stareg_web/showflaechen.do; http://apps2.bvl.bund.de/stareg_visual_web/localeSwitch.do?language=de&page=/data.do
8.
http://apps2.bvl.bund.de/stareg_web/showflaechen.do?year=2013
9.
http://www.transgen.de/anbau/deutschland/1714.doku.html
10.
http://www.bvl.bund.de/DE/06_Gentechnik/01_Aufgaben/02_ZustaendigkeitenEinzelneBereiche/04_Standortregister/Auswertung_Stareg/gentechnik_standortregister_HG_Auswertung_Stareg_node.html
11.
See infra at section “Restriction of GMO” (in and at fn. 207–211).
12.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341).
13.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 14.
14.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 16.
15.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), P. 17.
16.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 21.
17.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 22.
18.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 24.
19.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 25.
20.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 26.
21.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 27.
22.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 29.
23.
European Commission (ed.), Eurobarometer 73.5: Risiken im Lebensmittelbereich, 2010, p. 2.
24.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 30.
25.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 32.
26.
European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), p. 18.
27.
Gesellschaft für Sozialforschung und statistische Analysen mbH.
28.
http://www.gentechnikfreie-regionen.de/hintergruende/studien/umfragen.html
29.
BT-Drs. 17/8819, p. 5.
30.
See BT-Drs. 17/8819 of 1 March 2012, providing the Federal Government’s answer to an enquiry made by some Members of Parliament (MPs) of the Green Party (Bündnis 90/Die Grünen). The questions raised by the MPs concerned the Federal Government’s attitude towards the relevance of agro genetic engineering and the EU’s agricultural policy for global food security.
31.
BT-Drs. 17/8819, p. 4.
32.
BT-Drs. 17/8819, p. 5.
33.
BT-Drs. 17/8819, p. 4.
34.
BT-Drs. 17/8819, p. 4.
35.
BT-Drs. 17/8819, p. 6.
36.
BT-Drs. 17/8819, p. 7.
37.
BT-Drs. 17/8819, p. 9.
38.
Aufbruch und Erneuerung – Deutschlands Weg ins 21. Jahrhundert. Koalitionsvereinbarung zwischen der Sozialdemokratischen Partei Deutschlands und BÜNDNIS 90/DIE GRÜNEN, 1998, p. 18–19.
39.
Koalitionsvertrag 2002–2006: Erneuerung – Gerechtigkeit – Nachhaltigkeit, 2002, p. 47.
40.
Wachstum. Bildung. Zusammenhalt. Koalitionsvertrag zwischen CDU, CSU und FDP, 17. Legislaturperiode, 2009, p. 48–50.
41.
Deutschlands Zukunft gestalten. Koalitionsvertrag zwischen CDU, CSU und SPD, 18. Legislaturperiode, 2013, p. 19.
42.
Deutschlands Zukunft gestalten. Koalitionsvertrag zwischen CDU, CSU und SPD, 18. Legislaturperiode, 2013, p. 123.
43.
Deutschlands Zukunft gestalten. Koalitionsvertrag zwischen CDU, CSU und SPD, 18. Legislaturperiode, 2013, p. 124, 127.
44.
Deutschlands Zukunft gestalten. Koalitionsvertrag zwischen CDU, CSU und SPD, 18. Legislaturperiode, 2013, p. 124.
45.
Bayerisches Staatsministerium für Umwelt und Gesundheit, Pressemitteilung Nr. 63/11, 04. Mai 2011.
46.
http://www.spiegel.de/schulspiegel/wissen/gentechnik-unterricht-in-niedersachsen-rot-gruen-macht-schullabor-dicht-a-886140.html
47.
See BVerfGE 128, 1; very critical review by Hans-Georg Dederer, Verfassungskonforme Übermaßregulierung der „Grünen Gentechnik“ – Zum Urteil des BVerfG vom 24.11.2010 – 1 BvF 2/05, Juristische Ausbildung 2012, p. 218; Winfried Kluth, Das Gentechnik-Urteil, 2012.
48.
The BLV is a federal agency subject to the BMELV and competent for the implementation and the enforcement of the GenTG as far as it concerns the deliberate release of GMOs into the environment or the placing on the market of products containing or consisting of GMOs (cf. Sec. 31(2) GenTG). Concerning the BVL’s competence in the field of GM food law see infra at section “Implementation and enforcement, controlling regime” (in and at fn. 365–369).
49.
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Stellungnahme der ZKBS zur Risikobewertung von MON810 – Neue Studien zur Umweltwirkung von MON810, Kurzfassung, Az. 6788-02-13, 7 July 2009.
50.
http://www.bvl.bund.de/EN/01_Food/lm_food_node.html
51.
http://www.bvl.bund.de/EN/01_Food/lm_food_node.html
52.
Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch (BGBl. 2013 I p. 1426), last amended by law of 7 August 2013 (BGBl. 2013 I p. 3154).
53.
Sec. 1(1)(1) LFGB.
54.
See Art. III(9) FAO Constitution.
55.
http://www.fao.org/cfs/en/
56.
Grundgesetz für die Bundesrepublik Deutschland (BGBl. 1949 p. 1). For a quasi-official translation into English see http://www.gesetze-im-internet.de/englisch_gg/basic_law_for_the_federal_republic_of_germany.pdf
57.
See Art. 74(1)(17) GG which confers concurrent legislative powers upon the Federation in the area of “ensuring the adequacy of food supply”.
58.
Verfassung des Freistaates Bayern (GVBl. 1946 p. 333).
59.
See Art. 83(1) BV which provides that food security facilities are within the realm of municipal self-government.
60.
See, e.g., http://www.bundesregierung.de/Webs/Breg/DE/Themen/Entwicklungspolitik/3-Armut-bekaempfen/ernaehrung/_node.html; http://www.bundesregierung.de/Webs/Breg/DE/Themen/Entwicklungspolitik/4-LaendlicheEntwicklung/ernaehrungssicherheit/_node.html
61.
See BT-Drs. 17/8819 and supra at section “Use of GMO in food production” (in and at fn. 29–37).
62.
UNTS vol. 999, p. 171; BGBl. 1973 II p. 1543.
63.
UNTS vol. 993, p. 3; BGBl. 1973 II p. 1570.
64.
UNTS vol. 1249, p. 13; BGBl. 1985 II p. 648.
65.
UNTS vol. 1577, p. 3; BGBl. 1992 II p. 121.
66.
http://www.unhchr.ch/tbs/doc.nsf/0/3d02758c707031d58025677f003b73b9
67.
Cf. General Comment No. 14 (2000) of the CESCR.
68.
See Art. 6(1)(2) ICCPR.
69.
A/Res/64/292.
70.
General Comment No. 15 (2002) of the CESCR.
71.
States shall ensure the right to “enjoy adequate living conditions, particularly in relation to … water supply”.
72.
States shall “combat disease and malnutrition … through the provision of adequate nutritious foods and clean drinking-water”.
73.
Concerning the ICCPR see BGBl. 1973 II p. 1534, concerning the ICESCR see BGBl. 1973 II p. 1570, concerning the CEDAW see BGBl. 1985 II p. 648, and concerning the CRC see BGBl. 1992 II p. 121.
74.
Cf. Art. 59(2)(1) GG and BVerfGE 111, 307, at 316–217 = BVerfG, Order of 14 October 2004, 2 BvR 1481/04, para. 31 (http://www.bverfg.de/entscheidungen/rs20041014_2bvr148104en.html).
75.
BGBl. 1971 II p. 1033.
76.
Preamble of the FAO Constitution.
77.
BGBl. 2010 II p. 1198.
78.
Art. 2(1)(1) ECHR.
79.
Art. 1(1)(1) of the (first) Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms (BGBl. 2010 II p. 1198).
80.
See BGBl. 1952 II p. 685.
81.
OJ C 303, 14.12.2007, p. 1.
82.
Art. 2(1) ChFR.
83.
Art. 3(1) ChFR.
84.
Art. 17 ChFR.
85.
Art. 16 ChFR.
86.
Art. 35(2) ChFR.
87.
Art. 38 ChFR.
88.
Art. 51(1) ChFR.
89.
ECJ, Case C-617/10, Åkerberg Fransson, para. 21.
90.
See Art. 38 et seq. of the Treaty on the Functioning of the European Union (TFEU) (OJ C 115, 9.5.2008, p. 47).
91.
Art. 114(1) TFEU. Both competences, i.e. the EU’s competences in the areas of ‘internal market’ and ‘agriculture and fisheries’, form so called ‘shared competences’ between the EU and its Member States (Art. 4(2)(a), (d) TFEU).
92.
Art. 26(2), 34 et seq. TFEU.
93.
Concerning the duty to protect arising from fundamental rights under the German constitution see BVerfGE 39, 1, at 41.
94.
Art. 2(2)(1) GG.
95.
Art. 14(1)(1) GG.
96.
Art. 12(1) GG.
97.
Art. 1(1) GG.
98.
Art. 20(1), 28(1)(1) GG.
99.
BVerfGE 125, 175, at 222 = BVerfG, Judgment of 9 February 2010, 1 BvL 1, 3 and 4/09, para. 133 (http://www.bverfg.de/entscheidungen/ls20100209_1bvl000109en.html).
100.
BVerfGE 125, 175, at LS 1 = BVerfG, Judgment of 9 February 2010, 1 BvL 1, 3 and 4/09, headnote 1 (http://www.bverfg.de/entscheidungen/ls20100209_1bvl000109en.html).
101.
See Art. 30, 70 et seq., 83 et seq. GG.
102.
“[E]nsuring the adequacy of food supply”.
103.
Art. 72(1), 74(1)(17) GG.
104.
Art. 74(1)(17) GG.
105.
Art. 74(1)(20) GG.
106.
Art. 83, 84 GG.
107.
Art. 87(1)(1) GG.
108.
OJ L 309, 13.12.1993, p. 3; BGBl. 1993 II p. 1742.
109.
OJ L 201, 31.7.2002, p. 48; BGBl. 2003 II S. 1506.
110.
OJ L 46, 19.2.2013, p. 4; BGBl. 2013 II p. 618.
111.
Cf. Art. 8(g), 19(3), (4) CBD.
112.
Concerning the right to life see Art. 6 (1)(1) ICCPR, Art. 2(1)(1) ECHR; concerning the right to health see Art. 12(1) ICESCR; concerning the right to property see Art. 1(1)(1) of the (first) Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms, Art. 15(2), 16(1)(h) CEDAW, Art. 5(d)(v) of the International Convention on the Elimination of All Forms of Racial Discrimination (CERD; BGBl. 1969 II p. 961).
113.
Art. 8(1) ECHR.
114.
For a more detailed analysis see, e.g., Julia Iliopoulos-Strangas, Soziale Grundrechte, in: Dieter Merten/Hans-Jürgen Papier (eds.), Handbuch der Grundrechte, Vol. VI/1, 2010, § 145, para. 62 et seq.; Roman Schmidt-Radefeldt, Ökologische Menschenrechte, 2000, p. 66 et seq.
115.
General Agreement on Tariffs and Trade (GATT 1947: BGBl. 1952 II p. 173; GATT 1994: OJ L 336, 23.12.1994, p. 11).
116.
Agreement on the Application of Sanitary and Phytosanitary Measures (OJ L 336, 23.12.1994, p. 40).
117.
Agreement on Technical Barriers to Trade (OJ L 336, 23.12.1994, p. 86).
118.
See also infra at section “Restriction of GMO” (in and at fn. 195–197).
119.
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 et seq.
120.
ICJ, Legality of the Threat or Use of Nuclear Weapons, ICJ Reports 1996, p. 226, para. 29.
121.
ICJ, Legality of the Threat or Use of Nuclear Weapons, ICJ Reports 1996, p. 226, para. 29.
122.
PCA-Arbitration Regarding the Iron Rhine (“Ijzeren Rijn”) Railway between the Kingdom of Belgium and the Kingdom of the Netherlands, Award of the Arbitral Tribunal, 24 May 2005, para. 59; see also ICJ, Pulp Mills on the River Uruguay (Argentina v. Uruguay), Judgment, ICJ Reports 2010, p. 14, para. 101: “the principle of prevention, as a customary rule”.
123.
Art. 3 ILC Draft Articles on Prevention of Transboundary Harm from Hazardous Activities 2001, in: Official Records of the General Assembly, Fifty-sixth Session, Supplement No. 10 (A/56/10).
124.
ICJ, Case concerning pulp mills on the River Uruguay (Argentina v. Uruguay), ICJ Reports 2010, p. 14, para. 204.
125.
According to which a “balance between economic development and environmental protection” has to be struck what “is the essence of sustainable development” (ICJ, Case concerning pulp mills on the River Uruguay [Argentina v. Uruguay], ICJ Reports 2010, p. 14, para. 177).
126.
According to which “lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation” (Principle 15 of the Rio Declaration on Environment and Development of 1992).
127.
According to which “the polluter should, in principle, bear the cost of pollution” (Principle 16 of the Rio Declaration on Environment and Development of 1992).
128.
According to which “environmental damage should as a priority be rectified at source” (Art. 191(2)(2) TFEU).
129.
According to which the international community has a common interest in the conservation of, inter alia, biological diversity (see para. 3 of the CBD preamble). Concerning the ‘common concern’ concept see, e.g., Alexandre Kiss/Dinah Shelton, Guide to International Environmental Law, 2007, p. 13 et seq.
130.
According to which the environment of areas beyond national jurisdiction (e.g., high seas, deep sea bed, Antarctica) must not be adversely affected in the course of activities carried out in the area concerned. See also Rüdiger Wolfrum, Common heritage of mankind, in: Rüdiger Wolfrum (ed.), The Max Planck Encyclopedia of Public International Law, 2009, online edition (www.mpepil.com).
131.
Concerning its scope of application see supra in and at fn. 88–89.
132.
Art. 2(1) ChFR.
133.
Art. 3(1) ChFR.
134.
Art. 16 ChFR.
135.
Art. 17 ChFR.
136.
Art. 35(2) ChFR.
137.
Art. 37 ChFR.
138.
Art. 38 ChFR.
139.
Art. 192(2) TFEU.
140.
Art. 114(1)(2) TFEU.
141.
Art. 169(2) TFEU.
142.
Art. 2(2)(1) GG.
143.
Art. 5(3)(1) GG.
144.
Art. 14(1)(1) GG.
145.
Art. 12(1) GG.
146.
Art. 20a GG.
147.
Art. 20(1), 28(1)(1) GG.
148.
Art. 72(1), 74(1)(26) GG and BVerfGE 128, 1, at LS 1 = BVerfG, Judgment of 24 November 2010, 2 BvF 2/05, headnote 1 (http://www.bverfg.de/entscheidungen/fs20101124_1bvf000205en.html).
149.
Art. 30, 83, 84(1)(1) GG.
150.
Cf. Art. 87(3)(1) GG and Sec. 31 GenTG.
151.
ECJ, Case 6/64, Costa ./. E.N.E.L., ECR 1964, p. 1253, at 1269 et seq.
152.
Art. 1(3), 20(3) GG.
153.
See BVerfGE 111, 307, at 318 = = BVerfG, Order of 14 October 2004, 2 BvR 1481/04, para. 34 (http://www.bverfg.de/entscheidungen/rs20041014_2bvr148104en.html).
154.
See also BVerfGE 112, 1, at 26 = BVerfG, Order of 26 October 2004, 2 BvR 955/00, 1038/01, para. 93 (http://www.bverfg.de/entscheidungen/rs20041026_2bvr095500en.html).
155.
See BVerfGE 111, 307, at 319 = BVerfG, Order of 14 October 2004, 2 BvR 1481/04, para. 35–36 (http://www.bverfg.de/entscheidungen/rs20041014_2bvr148104en.html).
156.
BVerfGE 123, 267, at 354 = BVerfG, Judgment of 30 June 2009, 2 BvE 2 and 5/08, 2 BvR 1010, 1022 and 1259/08, 182/09, para. 240 (http://www.bverfgde/entscheidungen/es20090630_2bve000208en.html).
157.
According to the Federal Constitutional Court, the breach of competences on the part of the EU must be “sufficiently qualified”, i.e. “manifestly” and “leading to a structurally significant shift to the detriment of the Member States in the structure of competences” (BVerfGE 126, 286, at LS 1a = BVerfG, 2 BvR 2662/06 of 6 July 2010, headnote 1a, http://www.bverfg.de/entscheidungen/rs20100706_2bvr266106en.html).
158.
BVerfGE 7, 198, at 208.
159.
ECJ, Case 14/83, Von Colson and Kamann, ECR 1984, p. 1891, para. 26, 28.
160.
BVerfGE 74, 358, at 370.
161.
Cf. also Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 58.
162.
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).
163.
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).
164.
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).
165.
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).
166.
Concerning the Cartagena Protocol see supra at section “Legal superstructure” (in and at fn. 111).
167.
Art. 288(5) TFEU.
168.
See Matthias Herdegen/Hans-Georg Dederer, Internationales Biotechnologierecht, EU-Recht/Regelungen, 2. Richtlinie 2001/18/EG, fn. 1, 4. Verordnung (EG) Nr. 258/97, fn. 1, 5. Verordnung (EG) Nr. 1829/2003, fn. 1, 7. Verordnung (EG) Nr. 1830/2003, fn. 1.
169.
Art. 288(2) TFEU.
170.
For exceptions see ECJ, Case 41/74, Van Duyn, ECR 1974, p. 1337, para. 12.
171.
Cf. Art. 288(3) TFEU.
172.
For a full list see Wolfram Eberbach/Peter Lange/Michael Ronellenfitsch, Recht der Gentechnik und Biomedizin (GenTR/BioMedR), Teil I, C.
173.
See preamble cl. 2 GG.
174.
For a full list see Wolfram Eberbach/Peter Lange/Michael Ronellenfitsch, Recht der Gentechnik und Biomedizin (GenTR/BioMedR), Teil I, E.
175.
Gesetz zur Durchführung der Verordnungen der Europäischen Gemeinschaft oder der Europäischen Union auf dem Gebiet der Gentechnik und über die Kennzeichnung ohne Anwendung gentechnischer Verfahren hergestellter Lebensmittel (BGBl. 2004 I p. 1244), last amended by law of 9 December 2010 (BGBl. 2010 I p. 1934).
176.
Gesetz über Naturschutz und Landschaftspflege (BGBl. 2009 I p. 2542), last amended by law of 7 August 2013 (BGBl. 2013 I p. 3154).
177.
See Sec. 34, 35 BNatSchG. Sec. 34 BNatSchG implements Art. 6 of the Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora, OJ L 206, 22.7.1992, p. 7.
178.
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).
179.
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).
180.
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 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).
181.
Verordnung über die Kennzeichnung von Lebensmitteln (BGBl. 1999 I p. 2464), last amended by law of 25 July 2013 (BGBl. 2013 I p. 2722).
182.
See Art. 3(1) Regulation (EC) No. 1829/2003.
183.
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).
184.
See, e.g., Art. 2(1) Regulation (EC) No. 1829/2003 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’.
185.
See, e.g., Art. 5(5)(a) Regulation 1829/2003 referring to general genetic engineering law.
186.
See Art. 34 Regulation (EC) No. 1829/2003 referring to general food law.
187.
See, e.g., Art. 5 Regulation (EC) No. 1830/2003; Art. 9–10 Regulation (EC) No. 1946/2003.
188.
Art. 1(a) Regulation (EC) No. 1829/2003. 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 (particularly with regard to ensuring that consumers can make an informed choice), see Hans-Georg Dederer, Neues von der Gentechnik, Zeitschrift für das gesamte Lebensmittelrecht 2005, p. 307, at 308–310; Gernot Schubert, Paradigmenwechsel im Gentechnikrecht?, GenTechnik & Recht 2003, p. 47, at 53.
189.
Art. 1 Regulation (EC) No. 1830/2003.
190.
Art. 1 Regulation (EC) No. 1946/2003.
191.
See Art. 9–10 Regulation (EC) No. 1946/2003.
192.
In detail infra at section “Admission of GMO in food production” (in and at fn. 251–256).
193.
For rare exceptions see infra at section “Admission of GMO in food production” (in and at fn. 337).
194.
See Art. 10(3)(2) Regulation (EC) No. 1946/2003.
195.
For further information see Matthias Herdegen/Hans-Georg Dederer, in: Internationales Biotechnologierecht, EU-Recht/Erläuterungen, 2. Richtlinie 2001/18/EG, para. 1 (2010).
196.
When the Regulations (EC) No. 1829/2003, 1830/2003 and 1946/2003 were passed forming henceforward the revised legal framework for a stricter regulation of GMOs (together with Directive 2001/18/EC adopted earlier in 2001).
197.
When the Regulations (EC) No. 1829/2003, 1830/2003 and 1946/2003 became applicable (on 18 April 2004) or when the first GM product approval was issued again (on 19 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]) respectively.
198.
See Art. 34 Regulation (EC) No. 1829/2003; Art. 53, 54 Regulation (EC) No. 178/2002.
199.
See Art. 23 Directive 2001/18/EC.
200.
See Sec. 20(2) GenTG.
201.
See Art. 34 Regulation (EC) No. 1829/2003.
202.
See, e.g., Art. 53(1)(a)(i) Regulation (EC) No. 178/2002.
203.
See Art. 54(1)(1) Regulation (EC) No. 178/2002.
204.
Art. 23(1)(1) Directive 2001/18/EC.
205.
See Art. 23(2), 30(2) Directive 2001/18/EC.
206.
See Sec. 20(2), 26(5)(2)-(3) GenTG.
207.
Art. 23 Directive 2001/18/EC.
208.
Sec. 20(2) GenTG.
209.
Art. 34 Regulation (EC) No. 1829/2003.
210.
http://www.bvl.bund.de/SharedDocs/Downloads/08_PresseInfothek/mon_810_bescheid.pdf?__blob=publicationFile
211.
Verwaltungsgericht Braunschweig, Order of 4 May 2009, 2 B 111/09, Gewerbearchiv 2009, p. 412; Oberverwaltungsgericht Lüneburg, Order of 28 May 2009, 13 ME 76/09, Natur und Recht 2009, p. 566. Finally, the claimant withdrew its action (see Verwaltungsgericht Braunschweig, Order of 11 February 2010, 2 A 110/09). As a result, there will be no decision on the merits.
212.
Cf. WTO Panel Report European Communities – Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R, p. 1037 et seq. See also Hans-Georg Dederer, Die Nutzung der Gentechnik, in: Reinhard Hendler/Peter Marburger/Peter Reiff/Meinhard Schröder (eds.), Landwirtschaft und Umweltschutz, 2007 (UTR vol. 92), p. 185.
213.
See, e.g., with regard to Bavaria https://www.stmelf.bayern.de/agrarpolitik/foerderung/001007/
214.
Recital 30, Art. 4(a)(iii), Art. 9 Regulation (EC) No. 834/2007.
215.
For an in-depth analysis see Hans-Georg Dederer, Weiterentwicklung des Gentechnikrechts – GVO-freie Zonen und sozioökonomische Kriterien der GVO-Zulassung, 2010, p. 12 et seq.
216.
Commission Recommendation 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).
217.
Art. 26a(2) Directive 2001/18/EC.
218.
See Art. 288(5) TFEU.
219.
Para. 2.4 Commission Recommendation No. 2010/C 200/01.
220.
Cf. Art. 26a(1) Directive 2001/18/EC.
221.
Sec. 16b(1)(1) GenTG.
222.
Sec. 16b(2) GenTG.
223.
Verordnung über die gute fachliche Praxis bei der Erzeugung gentechnisch veränderter Pflanzen (Gentechnik-Pflanzenerzeugungsverordnung – GenTPflEV). In detail see Hans-Georg Dederer, Gentechnikrecht, in: Ines Härtel (ed.), Handbuch des Fachanwalts Agrarrecht, 2012, Kapitel 20, para 25 et seq.
224.
BGBl. 2004 I p. 1673, last amended by law of law of 7 August 2013, BGBl. 2013 I 3154.
225.
Sec. 29 SaatG.
226.
Gesetz zum Schutz der Erzeugung von Saatgut in geschlossenen Anbaugebieten (SaatErzG), GBl. 1969 p. 80.
227.
Sec. 1(1) SaatErzG.
228.
Cf. Sec. 1(2) SaatErzG.
229.
Cf. Sec. 2(1)(1) SaatErzG.
230.
Art. 7(2) in connection with Art. 6(5)(e) Regulation (EC) No. 1829/2003. A similar provision is laid down in Art. 19(3)(c) Directive 2001/18/EC in connection with Sec. 16d(1)(3) GenTG.
231.
Sec. 35(2) in connection with Sec. 34(1), (2) BNatSchG; similarly Art. 21(2) of the Bavarian Nature Conservation Law (Gesetz über den Schutz der Natur, die Pflege der Landschaft und die Erholung in der freien Natur [Bayerisches Naturschutzgesetz – BayNatSchG], GVBl. 2011 p. 82; last amended by law of 8 April 2013, GVBl. 2013 p. 174). In detail see, e.g., Hans-Georg Dederer, Gentechnikrecht, in: Ines Härtel (ed.), Handbuch des Fachanwalts Agrarrecht, 2012, Kapitel 20, para 91 et seq.; Christoph Palme/Jochen Schumacher, Die Regelungen zur FFH-Verträglichkeitsprüfung bei Freisetzung oder Inverkehrbringen von gentechnisch veränderten Organismen in § 34a BNatSchG, Natur und Recht 2007, p. 16.
232.
In Bavaria, more than 200 municipalities and counties have admitted to GMO-free agriculture on their territories. See http://www.stmuv.bayern.de/umwelt/gentechnik/index.htm
233.
Cf. Art. 28(2) GG. See Michael Greiner, Befassungskompetenz kommunaler Gremien mit Fragen der Gentechnik („Gentechnikfreie Zone“), KommunalPraxis BY 2004, p. 376.
234.
See Hans-Dieter Laser, Ausbringen von genetisch veränderten Organismen und Pflanzen auf gemeindeeigenen Grundstücken, KommunalPraxis BY 2005, p. 384.
235.
Only under very exceptional circumstances one could imagine that a Member State is obliged to intervene, e.g., by nullifying such private agreements, for the purpose of guaranteeing the free circulation of authorized GMOs on the basis of Art. 22 Directive 2001/18/EC (cf. also Art. 7(5)(1) Regulation (EC) No. 1829/2003), Art. 34 TFEU in connection with Art. 4(3) TEU. See also ECJ, Case C-265/95, Commission ./. France, ECR 1997, p. 6959, para. 32.
236.
Art. 114(5) TFEU.
237.
Art. 114(5) TFEU.
238.
Court of First Instance, Joined Cases T-366/03 and T-235/04, Land Öberösterreich, ECR 2005, p. II-4005, para 36 et seq. This judgment was upheld by the ECJ, Joined Cases C-439/05 P and C-454/05 P, Land Oberösterreich, ECR 2007, p. I-7141, para. 60 et seq.
239.
In detail see, e.g., Nina Bergmann/Hans-Georg Dederer, in: Matthias Herdegen/Hans-Georg Dederer, Internationales Biotechnologierecht, EU-Recht/Erläuterungen, 5. Verordnung (EG) Nr. 1829/2003 (2012).
240.
Art. 4(2) Regulation (EC) No. 1829/2003.
241.
See Art. 14 Regulation (EC) No. 178/2002, Sec. 5, 11 LFGB, and Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 66.
242.
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.
243.
Recital 11 Regulation (EC) No. 1829/2003.
244.
Sec. 14 et seq. GenTG.
245.
Cf. Sec. 14(2) GenTG.
246.
See Art. 3(1) Regulation (EC) No. 1829/2003: GMOs for food use, food containing or consisting of GMOs, or food produced from or containing ingredients produced from GMOs. The term ‘genetically modified food’ as defined in Art. 2(6) Regulation (EC) No. 1829/2003 is restricted to “food containing, consisting of or produced from GMOs” only.
247.
Cf. also the legal definition of ‘genetically modified organism for food use’ in Art. 2(8) Regulation (EC) No. 1829/2003: “a GMO that may be used as food or as a source material for the production of food”.
248.
Art. 3(1)(a) Regulation (EC) No. 1829/2003.
249.
Art. 3(1)(b) Regulation (EC) No. 1829/2003.
250.
Art. 3(1)(c) Regulation (EC) No. 1829/2003.
251.
Recital 16 Regulation (EC) No. 1829/2003; in detail Hans-Georg Dederer, Neues von der Gentechnik, Zeitschrift für das gesamte Lebensmittelrecht 2005, p. 307, at 310–312; see also Armin Werner/Bärbel Kniel/Udo Berg, DLR 2004, p. 165, at 167 et seq.; Marcus Girnau, Die neuen Regelungen zur Kennzeichnung und Rückverfolgbarkeit von gentechnisch veränderten Lebensmitteln (Verordnung [EG] Nr. 1829/2003 und 1830/2003), Zeitschrift für das gesamte Lebensmittelrecht 2004, p. 343, at 349 et seq.
252.
The production of GM processing aids with the help of GMMs constitutes contained use of GMOs. The contained use of GMMs is regulated by the GenTG which implements Directive 2009/41/EC. Accordingly, the production of, e.g., GM processing aids with GMMs in a fermenter would have to be classified usually only as a class 1-activitiy (Art. 4(3) Directive 2009/41/EC) or a safety level 1-activity (Sec. 7(1)(1)(1) GenTG) respectively. Thus, the production premise as well as the first contained use therein would have to be solely notified to the competent authority (Art. 6 Directive 2009/41/EC, Sec. 8(1)(1), (2)(1) GenTG). Subsequent class 1-activities or safety level 1-activities in the same premise could be carried out without any further notification (Art. 7(1) Directive 2009/41/EC, Sec. 9(1) GenTG).
253.
Recital 16 Regulation (EC) No. 1829/2003.
254.
See Recital 16 Regulation (EC) No. 1829/2003.
255.
See also Art. 2(10) Regulation (EC) No. 1829/2003 according to which ‘produced from GMOs’ means “derived, in whole or in part, from GMOs, but not containing or consisting of GMOs” as such. Cf. also Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 65.
256.
Art. 3(2) Regulation (EC) No. 1829/2003.
257.
Art. 13(1)(1) Directive 2001/18/EC; Sec. 14(1)(2)-(3) GenTG.
258.
Sec. 14(1)(4) GenTG; see Art. 6(9) Directive 2001/18/EC.
259.
As defined in Art. 2(4) Regulation (EC) No. 1829/2003 in connection with Art. 2(1) Directive 2001/18/EC.
260.
Art. 2(5) Regulation (EC) No. 1829/2003 in connection with Art. 2(2) Directive 2001/18/EC.
261.
See Annex I A, Part 2 Directive 2001/18/EC.
262.
See Art. 2(5) Regulation (EC) No. 1829/2003 in connection with Annex I B Directive 2001/18/EC.
263.
Art. 4(1)(a) Regulation (EC) No. 1829/2003.
264.
Art. 4(1)(b) Regulation (EC) No. 1829/2003.
265.
Art. 4(1)(c) Regulation (EC) No. 1829/2003.
266.
See Art. 14, 16 Regulation (EC) No. 178/2002 and Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 65.
267.
Art. 4(3) Regulation (EC) No. 1829/2003.
268.
Art. 4(4) Regulation (EC) No. 1829/2003.
269.
See Art. 27 Regulation (EC) No. 1829/2003.
270.
See Recital 33, Art. 5(5), 6(3)(c), (4) Regulation (EC) No. 1829/2003.
271.
According to Art. 4(6) Regulation (EC) No. 1829/2003, the applicant has to be established in the European Union.
272.
In case of the GM maize line MON810, e.g., “MON810” denotes the transformation event.
273.
Cf., especially, Art. 4(3), 5(3), (5) Regulation (EC) No. 1829/2003.
274.
See Art. 5(3)-(5) Regulation (EC) No. 1829/2003.
275.
Art. 5(3)(a) Regulation (EC) No. 1829/2003.
276.
Art. 5(3)(b) Regulation (EC) No. 1829/2003.
277.
Art. 5(3)(d) Regulation (EC) No. 1829/2003.
278.
Art. 5(3)(b) Regulation (EC) No. 1829/2003.
279.
Art. 5(3)(i) Regulation (EC) No. 1829/2003.
280.
Art. 5(3)(e) Regulation (EC) No. 1829/2003.
281.
Art. 5(3)(k) Regulation (EC) No. 1829/2003.
282.
Implemented, in Germany, by Sec. 14 et seq. GenTG.
283.
Art. 5(5)(1) Regulation (EC) No. 1829/2003.
284.
See Art. 5(3)(c) Regulation (EC) No. 1829/2003 in connection with Art. 11(1)(1)-(2), Annex II Cartagena Protocol.
285.
Art. 5(3)(h) Regulation (EC) No. 1829/2003.
286.
Art. 5(3)(f) Regulation (EC) No. 1829/2003.
287.
Art. 5(3)(g) Regulation (EC) No. 1829/2003.
288.
Art. 5(2)(1) Regulation (EC) No. 1829/2003.
289.
Sec. 1(1)(1) EGGenTDurchfG.
290.
Art. 5(2)(2)(a) Regulation (EC) No. 1829/2003.
291.
Art. 5(2)(2)(b)(i) Regulation (EC) No. 1829/2003.
292.
Cf. Art. 5(3)(l) Regulation (EC) No. 1829/2003.
293.
Art. 5(2)(2)(b)(ii) Regulation (EC) No. 1829/2003.
294.
Art. 6(3)(a) Regulation (EC) No. 1829/2003.
295.
Concerning food safety assessment, cf. also the guidance provided by the Codex Alimentarius Commission: WHO/FAO (ed.), Foods Derived from Biotechnology, 2nd ed., 2009.
296.
Art. 6(3)(b) Regulation (EC) No. 1829/2003. According to Art. 6(3)(b) Regulation (EC) No. 1829/2003, the national authority must be part of the networking provided for in Art. 36 Regulation (EC) No. 178/2002.
297.
Sec. 1(1)(2) EGGenTDurchfG.
298.
Art. 6(3)(c) Regulation (EC) No. 1829/2003 in connection with Art. 4(4)(1) Directive 2001/18/EC.
299.
Sec. 1(1)(3) EGGenTDurchfG.
300.
Sec. 1(1)(3) EGGenTDurchfG.
301.
Art. 6(3)(c) Regulation (EC) No. 1829/2003.
302.
Art. 6(4)(1) Regulation (EC) No. 1829/2003.
303.
Cf. Annex II, III and IV Directive 2001/18/EC.
304.
Sec. 1(1)(4) EGGenTDurchfG.
305.
Art. 6(4)(2)-(3) Regulation (EC) No. 1829/2003.
306.
Art. 6(3)(e) Regulation (EC) No. 1829/2003.
307.
Art. 6(3)(d) Regulation (EC) No. 1829/2003.
308.
http://www.efsa.europa.eu/en/topics/topic/gmo.htm
309.
Art. 6(5)(b) Regulation (EC) No. 1829/2003.
310.
Art. 6(5)(c) Regulation (EC) No. 1829/2003.
311.
Art. 6(5)(d) Regulation (EC) No. 1829/2003.
312.
Art. 6(5)(e) Regulation (EC) No. 1829/2003.
313.
Art. 6(5)(f) Regulation (EC) No. 1829/2003.
314.
Art. 6(5)(g) Regulation (EC) No. 1829/2003.
315.
Art. 6(1)(1) Regulation (EC) No. 1829/2003.
316.
Art. 6(1)(2), (2) Regulation (EC) No. 1829/2003.
317.
http://www.efsa.europa.eu/en/topics/topic/gmo.htm
318.
Art. 6(6) Regulation (EC) No. 1829/2003.
319.
Art. 6(7)(1) Regulation (EC) No. 1829/2003. 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.
320.
Art. 6(7)(2) Regulation (EC) No. 1829/2003.
321.
Art. 7(1)(1) Regulation (EC) No. 1829/2003.
322.
Art. 7(1)(2) Regulation (EC) No. 1829/2003.
323.
Art. 7(1)(1) Regulation (EC) No. 1829/2003.
324.
Recital 19 Regulation (EC) No. 178/2002; see Hans-Georg Dederer, Weiterentwicklung des Gentechnikrechts – GVO-freie Zonen und sozioökonomische Kriterien der GVO-Zulassung, 2010, p. 189 et seq.
325.
See Art. 6(7)(2) Regulation (EC) No. 1829/2003.
326.
See Art. 33(1) Regulation (EC) No. 1829/2003.
327.
Art. 7(2) in connection with Art. 6(5) Regulation (EC) No. 1829/2003.
328.
Art. 7(2) Regulation (EC) No. 1829/2003.
329.
Art. 3(4) Regulation (EC) No. 1830/2003. E.g., the unique identifier of the GM maize line MON810 is MON-00810-6 (see http://ec.europa.eu/food/dyna/gm_register/gm_register_auth.cfm?pr_id=11).
330.
Cf. Art. 7(3) Regulation (EC) No. 1829/2003.
331.
See Art. 7(3) in connection with 35(1) Regulation (EC) No. 1829/2003.
332.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(2)(1) Decision 1999/468/EC.
333.
Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 69.
334.
Art. 58(1)(1) Regulation (EC) No. 178/2002; Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(1) Decision 1999/468/EC.
335.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(3) Decision 1999/468/EC.
336.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(4) Decision 1999/468/EC.
337.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(6)(1) Decision 1999/468/EC; see Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 69.
338.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(6)(3) Decision 1999/468/EC.
339.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(6)(2) Decision 1999/468/EC.
340.
See also Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 69–70.
341.
Art. 35(2)(1) Regulation (EC) No. 1829/2003 in connection with Art. 5(4), (5), Art. 8 Decision 1999/468/EC.
342.
Art. 7(4) Regulation (EC) No. 1829/2003.
343.
Art. 7(5) Regulation (EC) No. 1829/2003.
344.
Art. 11(1) Regulation (EC) No. 1829/2003.
345.
Cf. Art. 11(3) Regulation (EC) No. 1829/2003.
346.
See Art. 11(2) Regulation (EC) No. 1829/2003.
347.
Art. 11(2)(b) Regulation (EC) No. 1829/2003.
348.
Art. 11(2)(c) Regulation (EC) No. 1829/2003.
349.
Art. 11(2)(d) Regulation (EC) No. 1829/2003.
350.
GM specific labelling means that the label has to indicate explicitly that, e.g., the food is “genetically modified” or “contains GMOs”. See Art. 13(1) Regulation (EC) No. 1829/2003 and infra at section “Labelling” (in and at fn. 421–424).
351.
Art. 12(2) Regulation (EC) No. 1829/2003.
352.
Art. 4(8) Regulation (EC) No. 1830/2003.
353.
Art. 16(2) Regulation (EC) No. 1829/2003.
354.
Meaning, in this case, “material which contains, consists of or is produced from GMOs”, Art. 1(1)(3) Regulation (EU) No. 619/2011.
355.
See, in detail, Art. 2 Regulation (EU) No. 619/2011.
356.
Art. 6(2)(1) Regulation (EU) No. 619/2011.
357.
Recital 18 and Art. 6(3) Regulation (EU) No. 619/2011 in connection with Art. 53, 54 Regulation (EC) No. 178/2002.
358.
Art. 6(1)(1), Annex II B 2 Regulation (EU) No. 619/2011.
359.
Art. 16(2) Regulation (EC) No. 1829/2003.
360.
See Art. 47(5) in connection with Art. 49 (5) Regulation (EC) No. 1829/2003; Art. 12a(2) Directive 2001/18/EC.
361.
Art. 4(2) Regulation (EC) No. 1829/2003.
362.
Art. 13(1)(1) Directive 2001/18/EC.
363.
See Art. 47(1) Regulation (EC) No. 1829/2003; Art. 12a(1) Directive 2001/18/EC.
364.
Cf. Art. 5(2)(1) Regulation (EC) No. 1829/2003.
365.
Sec. 1(1)(1) EGGenTDurchfG.
366.
Sec. 1(1)(1) EGGenTDurchfG in connection with Art. 6(2) Regulation (EC) No. 1829/2003.
367.
Sec. 1(1)(2) EGGenTDurchfG in connection with Art. 6(3)(b) Regulation (EC) No. 1829/2003. For the purposes of its opinion, the BVL has to consult both the Robert Koch-Institut and the Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Sec. 3(1) EGGenTDurchfG.
368.
Sec. 1(1)(3) EGGenTDurchfG in connection with Art. 6(3)(c) Regulation (EC) No. 1829/2003. For the purposes of its opinion, the BVL has to consult both the Bundesamt für Naturschutz (Federal Agency for Nature Conservation) and the Robert Koch-Institut, Sec. 3(2)(1) EGGenTDurchfG. In addition, the BVL has to ask the Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), the Bundesfoschungsinstitut für Kulturpflanzen (Federal Research Centre for Cultivated Plants) and, if need be, the Bundesforschungsinstitut für Tiergesundheit (Federal Research Institute for Animal Health) for their expert opinions, Sec. 3(2)(2) EGGenTDurchfG.
369.
Sec. 1(1)(4) EGGenTDurchfG in connection with Art. 6(4)(3) Regulation (EC) No. 1829/2003. For the purposes of its opinion, the BVL has to consult both the Bundesamt für Naturschutz (Federal Agency for Nature Conservation) and the Robert Koch-Institut, Sec. 3(2)(1) EGGenTDurchfG. In addition, the BVL has to ask the Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), the Bundesfoschungsinstitut für Kulturpflanzen (Federal Research Centre for Cultivated Plants) and, if need be, the Bundesforschungsinstitut für Tiergesundheit (Federal Research Institute for Animal Health) for their expert opinions, Sec. 3(2)(2) EGGenTDurchfG.
370.
Art. 9(1)(1) Regulation (EC) No. 1829/2003.
371.
See Art. 3(5) Regulation (EC) No. 1830/2003.
372.
See Art. 3(5) Regulation (EC) No. 1830/2003.
373.
See supra at section “Admission of GMO in food production” (in and at fn. 270).
374.
Recital 35 cl. 2 (“compulsory”), Art. 9(1)(2) in connection with Art. 5(5)(1)(b), 6(5)(e) Regulation (EC) No. 1829/2003; Art. 19(3)(f) Directive 2001/18/EC.
375.
Recital 35 cl. 1, Art. 9(1)(2) in connection with Art. 5(3)(k), 6(5)(e) Regulation (EC) No. 1829/2003.
376.
Art. 9(1)(2) Regulation (EC) No. 1829/2003.
377.
Art. 9(1)(2) Regulation (EC) No. 1829/2003. See also Sec. 21(4a) GenTG which imposes a corresponding reporting requirement on the authorisation-holder vis-à-vis the BVL.
378.
Art. 9(1)(3) Regulation (EC) No. 1829/2003.
379.
Art. 9(3)(1) Regulation (EC) No. 1829/2003. See also Sec. 21(5) GenTG. See additionally Sec. 21(3)(1) GenTG according to which the authorisation-holder has to inform the Commission and the competent German authorities without delay of any incident which does not correspond to the expected course of the placing on the market of a GMO if the incident is suspected of endangering human health or the environment. See furthermore Sec. 21(5a) GenTG which provides that the authorisation-holder has to report to the BVL any new information on risks to human health or the environment or to coexistence.
380.
Art. 9(3)(2) Regulation (EC) No. 1829/2003.
381.
Art. 9(4) Regulation (EC) No. 1829/2003.
382.
Art. 10(1)(1) Regulation (EC) No. 1829/2003; Sec. 1(1)(5) EGGenTDurchfG.
383.
Art. 10(1)(2) Regulation (EC) No. 1829/2003.
384.
Art. 10(1)(3)-(4) Regulation (EC) No. 1829/2003.
385.
Art. 10(2)(2) Regulation (EC) No. 1829/2003.
386.
See Art. 10(2)(2), 34 Regulation (EC) No. 1829/2003 in connection with Art. 53, 54 Regulation (EC) No. 178/2002.
387.
Sec. 1(2) EGGenTDurchfG in connection with Art. 34 Regulation (EC) No. 1829/2003, Art. 54 Regulation (EC) No. 178/2002.
388.
Sec. 4(2)(1) EGGenTDurchfG in connection with Art. 34 Regulation (EC) No. 1829/2003, Art. 54 Regulation (EC) No. 178/2002.
389.
Sec. 4(2)(2) EGGenTDurchfG.
390.
Commission Decision of 18 April 2005 on emergency measures regarding the non-authorised genetically modified organism Bt10 in maize products (2005/317/EC) (OJ L 101, 21.4.2005, p. 14).
391.
Commission Decision of 5 September 2006 on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products (2006/601/EC) (OJ L 244, 7.9.2006, p. 27).
392.
Sec. 4(1) EGGenTDurchfG.
393.
See Sec. 4(2) EGGenTDurchfG.
394.
Sec. 4(3)(a) EGGenTDurchfG in connection with Sec. 38, 39(1), (2) and (7), 40, 42–44 LFGB.
395.
See Sec. 42(2)(1) LFGB.
396.
See Sec. 44(1) LFGB.
397.
Art. 34 et seq. TFEU.
398.
Rudolf Streinz, Rechtliche Aspekte, in: Dieter Sturma/Dirk Lanzerath/Bert Heinrichs (eds.), Gentechnik in der Lebensmittelproduktion, 2011, p. 80.
399.
Sec. 3a(1)(2) EGGenTDurchfG.
400.
Cf. Sec. 3a(1)(1) EGGenTDurchfG.
401.
Sec. 3a(2) EGGenTDurchfG.
402.
Sec. 3a(3) EGGenTDurchfG.
403.
Within the meaning of Sec. 5(2) LMKV.
404.
Sec. 3a(5)(1) EGGenTDurchfG.
405.
Sec. 3a(5)(2) EGGenTDurchfG.
406.
Sec. 3a(4)(1) EGGenTDurchfG.
407.
Sec. 3a(4)(2) EGGenTDurchfG.
408.
See Annex to Sec. 3a(4)(2) EGGenTDurchfG.
409.
http://www.transgen.de/recht/kennzeichnung/280.doku.html
410.
http://www.transgen.de/recht/kennzeichnung/280.doku.html
411.
See Sec. 3b EGGenTDurchfG.
412.
Recital 9 cl. 1.
413.
Recital 30 cl. 1; Art. 4(a)(iii).
414.
Art. 4(a)(iii) Regulation (EC) No. 834/2007.
415.
Art. 9(1) Regulation (EC) No. 834/2007.
416.
See 9(2) Regulation (EC) No. 834/2007.
417.
Cf. Recital 10, Art. 23(1) Regulation (EC) No. 834/2007.
418.
Art. 22(2)(g) Regulation (EC) No. 834/2007.
419.
Cf. Art. 22(1) Regulation (EC) No. 834/2007 (“exceptions from the production [sic!] rules”).
420.
Recital 30 cl. 2, Art. 23(3) Regulation (EC) No. 834/2007.
421.
Cf. Art. 13(1)(a)-(c) Regulation (EC) No. 1829/2003.
422.
The term ‘ingredient’ includes additives and enzymes used in the manufacture or preparation of food and still present in the finished product, even if in altered form (Art. 2(13) Regulation (EC) No. 1839/2003 in connection with Art. 6(4)(a) Directive 2000/13/EC). Thus, foods containing additives produced from GM plants, e.g., Lecithin from GM soybeans, are subject to the labelling requirements of Art. 12 et seq. Regulation (EC) No. 1829/2003. On the other hand, foods containing additives produced from GM plants and used as processing aids only, need not be labeled in accordance with Art. 12 et seq. Regulation (EC) No. 1829/2003 (see Art. 2(13) Regulation (EC) No. 1829/2003 in connection with Art. 6(4)(c)(ii) Directive 2000/13/EC).
423.
Art. 13(1)(a), (b), (d) Regulation (EC) No. 1829/2003.
424.
Art. 13(1)(e) Regulation (EC) No. 1829/2003.
425.
Recital 21 cl. 2 Regulation (EC) No. 1829/2003.
426.
Art. 2(16), 12(1) Regulation (EC) No. 1829/2003 in connection with Art. 1(2) Directive 2000/13/EC. As a consequence, e.g., GM foods delivered by mass caterers to final consumers are not subject to GM specific labelling if the foods have been prepared or processed (Report from the Commission to the Council and the European Parliament on the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed, COM/2006/0626 final, p. 28).
427.
Art. 12(1) Regulation (EC) No. 1829/2003.
428.
Cf. Art. 3(1) and 12(1) Regulation (EC) No. 1829/2003.
429.
See also http://www.transgen.de/recht/kennzeichnung/278.doku.html
430.
I.e. natural or legal persons who place a product on the market or who receive a product that has been placed on the market in the European Union, either from a Member State or from a third country, at any stage of the production and distribution chain (Art. 3(5) Regulation (EC) No. 1830/2003).
431.
Art. 4(6)(a) Regulation (EC) No. 1830/2003.
432.
Art. 5(1)(a), (c) Regulation (EC) No. 1830/2003.
433.
Thus, if the food consists of more than one ingredient, the 0.9 %-threshold applies to each ingredient individually. See Report from the Commission to the Council and the European Parliament on the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed, COM/2006/0626 final, p. 27.
434.
Art. 12(2) Regulation (EC) No. 1829/2003; Art. 4(8), 5(3) Regulation (EC) No. 1830/2003.
435.
Art. 12(3) Regulation (EC) No. 1829/2003.
436.
Art. 13(3) Regulation (EC) No. 1829/2003.
437.
Art. 13(2)(a) Regulation (EC) No. 1829/2003.
438.
Art. 13(2)(b) Regulation (EC) No. 1829/2003.
439.
See Recital 18 Regulation (EC) No. 1829/2003.
440.
Cf. Art. 2(1) Directive 2000/13/EC; Sec. 11(1) LFGB.
441.
Report from the Commission to the Council and the European Parliament on the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed, COM/2006/0626 final, p. 28.
442.
Cf. Sec. 11(1)(3) LFGB.
443.
Cf. Oberverwaltungsgericht Koblenz, Zeitschrift für das gesamte Lebensmittelrecht, 2003, p. 750, at 752 et seq.
444.
Sec. 6(3a) EGGenTDurchfG.
445.
Sec. 59(1)(7), (1)(9) LFGB.
446.
See Sec. 7(2)(4), (3)(3) EGGenTDurchfG in connection with Art. 12(1), 13(1), (2)(a) Regulation (EC) No. 1829/2003 and Art. 4(6)(1) Regulation (EC) No. 1830/2003.
447.
Gesetz gegen den unlauteren Wettbewerb (BGBl. 2010 I p. 254), last amended by law of 1 October 2013 (BGBl. 2013 I p. 3714).
448.
See Sec. 3(1) UWG.
449.
Art. 45(1), (2) Regulation (EC) No. 1829/2003; Art. 11 (1), (2) Regulation (EC) No. 1830/2003.
450.
Art. 4(2) Regulation (EC) No. 1829/2003.
451.
Sec. 6(1)(1) EGGenTDurchfG.
452.
Sec. 6(5) EGGenTDurchfG.
453.
Sec. 6(3)(1) EGGenTDurchfG.
454.
Sec. 6(6) EGGenTDurchfG.
455.
Sec. 6(7) EGGenTDurchfG.
456.
Sec. 6(4) EGGenTDurchfG.
457.
Sec. 6(3a) EGGenTDurchfG.
458.
Sec. 7(1), (7) EGGenTDurchfG.
459.
Sec. 7(6)(2)-(3), (7) EGGenTDurchfG.
460.
Sec. 7(6)(1), (7) EGGenTDurchfG.
461.
Cf. 7(2), (3), (7) EGGenTDurchfG.
462.
Art. 33(1) Directive 2001/18/EC.
463.
Art. 33(2) Directive 2001/18/EC.
464.
Sec. 38, 39 GenTG.
465.
Sec. 32 et seq. GenTG.
466.
Sec. 32(1) GenTG.
467.
Sec. 3(7) GenTG.
468.
Sec. 33(1) GenTG.
469.
See Sec. 35 GenTG.
470.
Sec. 34(1) GenTG.
471.
Sec. 34(2) GenTG.
472.
See Sec. 35 GenTG.
473.
Sec. 37(2) GenTG.
474.
See Sec. 37(1)(1) in connection with Sec. 37(1) GenTG and Jürgen Kohler, in: Staudinger, BGB, 2010, § 32 GenTG, para. 47.
475.
Sec. 37(3) GenTG.
476.
Cf. Sec. 906(2)(2) BGB.
477.
See Sec. 36a GenTG. In detail see, e.g., Hans-Georg Dederer, Die Nutzung der Gentechnik, in: Reinhard Hendler/Peter Marburger/Peter Reiff/Meinhard Schröder (eds.), Landwirtschaft und Umweltschutz, 2007 (UTR vol. 92), p. 222 et seq.; Jürgen Kohler, Schadensausgleich in Fällen des §36a Gentechnikgesetz, Natur und Recht 2005, p. 566; Gerhard Wagner, Nachbarhaftung für gentechnische Immissionen, Versicherungsrecht 2007, p. 1017.
478.
E.g., because of the presence of GM material from GMOs the placing on the market of which has not been authorized so far.
479.
E.g., because the traces of GM material exceed the 0.9 %-threshold.
480.
E.g., because the product may not be labeled, e.g., ‘bio’ or ‘organic’ as the presence of GM material exceeds the 0.9 %-threshold.
481.
See Sec. 36a(1), (3) GenTG.
482.
See Sec. 36a(2) GenTG.
483.
Gesetz über die Haftung für fehlerhafte Produkte (BGBl. 1989 I p. 2189), last amended by law of 19 July 2002 (BGBl. 2002 I p. 2674).
484.
Jürgen Kohler, in: Staudinger, BGB, 2010, § 37 GenTG, para. 14.
485.
See Sec. 37(2)(2) GenTG and Jürgen Kohler, in: Staudinger, BGB, 2010, § 32 GenTG, para. 50; Gerhard Wagner, in: Münchener Kommentar zum BGB, 6th ed., 2013, § 4 ProdHaftG, para. 16.
486.
BT-Drs. 11/5622, p. 37.
487.
See Sec. 37(2)(2) GenTG.
488.
Sec. 37(2)(2) GenTG.
489.
Sec. 1(1) ProdHaftG.
490.
Sec. 1(2)(4) ProdHaftG.
491.
Gerhard Wagner, in: Münchener Kommentar zum BGB, 6th ed., 2013, § 1 ProdHaftG, para. 43.
492.
http://media.repro-mayr.de/75/543375.pdf
493.
Cf. http://www.faz.net/aktuell/wirtschaft/unternehmen/genpflanzen-monsanto-verabschiedet-sich-von-europa-als-markt-12203300.html
494.
See BASF, Presse-Information of 16 January 2012: BASF konzentriert Pflanzenbiotechnologie-Aktivitäten auf Hauptmärkte in Nord- und Südamerika (http://www.basf.com/group/corporate/de/function/conversions:/publish/content/news-and-media-relations/news-releases/downloads/2012/P109d-Pflanzenbiotechnologie.pdf).
495.
European Commission (ed.), EU policy on biotechnology, 2006, p. 6, 8.
496.
Sec. 1(3) GenTG refers only to the “advancement of the scientific, technical and economic potentials of genetic engineering”.
497.
See, e.g., Hans-Georg Dederer, Neues von der Gentechnik, Zeitschrift für das gesamte Lebensmittelrecht 2005, p. 307, at 326 et seq.

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Hans-Georg Dederer

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Dederer, HG. (2016). Genetic Technology and Food Security: Country Report – Germany. 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_2

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