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European Union Biotechnology Law

Compiled and edited by Prof. Dr. Siegfried Fina

Director, Vienna Technology Law Program, University of Vienna School of Law

Genetics and Law

Contained use

  • Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms [European Contained GMO Use Directive], [1990] OJ L 117/1 as amended
    • Commission Decision 91/448/EEC of 29 July 1991 concerning the guidelines for classification referred to in Article 4 of Directive 90/219/EEC, [1991] OJ L 239/23 as amended
    • Commission Decision 2005/174/EC of 28 February 2005 establishing guidance notes supplementing part B of Annex II to Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms, [2005] OJ L 59/20, corrected by [2005] OJ L 65/39

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Deliberate release

  • 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 [European GMO Release Directive],[2001] OJ L 106/1 as amended [repealing Directive 90/220/EEC]
    • Commission Decision 91/274/EEC of 21 May 1991 concerning a list of Community legislation referred to in Article 10 of Council Directive 90/220/EEC, [1991] OJ L 135/56
    • Council Decision 91/596/EEC of 4 November 1991 concerning the Summary Notification Information Format referred to in Article 9 of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, [1991] OJ L 322/1 as amended
    • Commission Decision 92/146/EEC of 11 February 1992 concerning the summary notification information format referred to in Article 12 of Council Directive 90/220/EEC, [1992] OJ L 60/19
    • Commission Decision 93/584/EEC of 22 October 1993 establishing the criteria for simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6 (5) of Council Directive 90/220/EEC, [1993] OJ L 279/42
    • Commission Decision 94/730/EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6.5 of Council Directive 90/220/EEC, [1994] OJ L 292/31
    • Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, [2002] OJ L 200/22
    • Council Decision 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products, [2002] OJ L 280/37
    • Council Decision 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market, [2002] OJ L 280/62 as amended
    • Commission Decision 2003/701/EC of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market, [2003] OJ L 254/21
    • Commission Decision 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council, [2004] OJ L 65/20
  • GM products:
    • Commission Decision 93/572/EEC of 19 October 1993 concerning the placing on the market of a product containing genetically modified organisms pursuant to Article 13 of Council Directive 90/220/EEC, [1993] OJ L 276/16
    • Commission Decision 94/385/EC of 8 June 1994 concerning the placing on the market of a product consisting of a genetically modified organism, seeds of herbicide- resistant tobacco variety ITB 1000 OX, pursuant to Article 13 of Council Directive 90/220/EEC, [1994] OJ L 176/23
    • Commission Decision 94/505/EC of 18 July 1994 amending the Decision of 18 December 1992 concerning the placing on the market of a GMO containing product, the vaccine Nobi-Porvac Aujeszky live (gI,tk), pursuant to Article 13 of Council Directive 90/220/EEC, [1994] OJ L 203/22
    • Commission Decision 96/158/EC of 6 February 1996 concerning the placing on the market of a product consisting of a genetically modified organism, hybrid herbicide-tolerant swede-rape seeds (Brassica napus L. oleifera Metzq. MS1Bn x RF1Bn), pursuant to Council Directive 90/220/EEC, [1996] OJ L 37/30
    • Commission Decision 96/281/EC of 3 April 1996 concerning the placing on the market of genetically modified soya beans (Glycine max L.) with increased tolerance to the herbicide glyphosate, pursuant to Council Directive 90/220/EEC, [1996] OJ L 107/10
    • Commission Decision 96/424/EC of 20 May 1996 concerning the placing on the market of genetically modified male sterile chicory (Cichorium intybus L.) with partial tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC, [1996] OJ L 175/25
    • Commission Decision 97/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC, [1997] OJ L 31/69
    • Commission Decision 97/392/EC of 6 June 1997 concerning the placing on the market of genetically modified swede- rape (Brassica napus L. oleifera Metzg. MS1, RF1), pursuant to Council Directive 90/220/EEC, [1997] OJ L 164/38
    • Commission Decision 97/393/EC of 6 June 1997 concerning the placing on the market of genetically modified swede- rape (Brassica napus L. oleifera Metzg. MS1, RF2), pursuant to Council Directive 90/220/EEC, [1997] OJ L 164/40
    • Commission Decision 97/549/EC of 14 July 1997 concerning the placing on the market of T102-test (Streptococcus thermophilus T102) pursuant to Council Directive 90/220/EEC, [1997] OJ L 225/34
    • Commission Decision 98/291/EC of 22 April 1998 concerning the placing on the market of genetically modified spring swede rape (Brassica napus L. ssp. oleifera), pursuant to Council Directive 90/220/EEC, [1998] OJ L 131/26
    • Commission Decision 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, [1998] OJ L 131/28
    • Commission Decision 98/293/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T25), pursuant to Council Directive 90/220/EEC, [1998] OJ L 131/30
    • Commission Decision 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, [1998] OJ L 131/32
    • Commission Decision 2004/643/EC of 19 July 2004 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance, [2004] OJ L 295/35
    • Commission Decision 2005/608/EC of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm, [2005] OJ L 207/17
    • Commission Decision 2005/635/EC of 31 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate, [2005] OJ L 228/11
      • Commission Recommendation 2005/637/EC of 16 August 2005 concerning the measures to be taken by the consent holder to prevent any damage to health and the environment in the event of the accidental spillage of an oilseed rape (Brassica napus L., GT73 line - MON-00073-7) genetically modified for tolerance to the herbicide glyphosate, [2005] OJ L 228/19
    • Commission Decision 2005/772/EC of 3 November 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium, [2005] OJ L 291/42
    • Commission Decision 2006/47/EC of 16 January 2006 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., hybrid MON 863 x MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize, [2006] OJ L 26/17

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Food and feed

  • Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [European GM Food and Feed Regulation],[2003] OJ L 268/1
    • Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation, [2004] OJ L 102/14
    • Commission Decision 2006/197/EC of 3 March 2006 authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-O15O7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council, [2006] OJ L 70/82
  • Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [European Novel Foods Regulation], [1997] OJ L 43/1 as amended
    • Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council, [1997] OJ L 253/1
    • 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, [2004] OJ L 300/48
    • Commission Decision 2005/448/EC of 3 March 2005 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council, [2005] OJ L 158/20
    • Commission Decision 2006/68/EC of 13 January 2006 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council, [2006] OJ L 34/26
    • Commission Decision 2006/69/EC of 13 January 2006 authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council, [2006] OJ L 34/29
    • Summary of notifications received by the Commission until 31 December 2004 pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council, [2005] OJ C 208/2
  • 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, [2002] OJ L 31/1 as amended
    • Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority's mission, [2004] OJ L 379/64
    • Commission Decision 2005/317/EC of 18 April 2005 on emergency measures regarding the non-authorised genetically modified organism Bt10 in maize products, [2005] OJ L 101/14

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Traceability and labelling

  • 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 [European GMO Traceability and Labelling Regulation],[2003] OJ L 268/24
    • Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms [European GMO Identifier Regulation], [2004] OJ L 10/5
    • Commission Recommendation 2004/787/EC of 4 October 2004 on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation (EC) No 1830/2003, [2004] OJ L 348/18

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Plants and seeds

  • Council Directive 98/95/EC of 14 December 1998 amending, in respect of the consolidation of the internal market, genetically modified plant varieties and plant genetic resources, Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plant species, [1999] OJ L 25/1 as amended (see in this context also Directives 68/193/EEC and 1999/105/EC)
  • Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species, [2002] OJ L 193/1 as amended
    • Commission Decision 2004/297/EC of 29 March 2004 authorising the Czech Republic, Estonia, Lithuania, Hungary, Poland and Slovakia to postpone the application of certain provisions of Council Directives 2002/53/EC and 2002/55/EC with regard to the marketing of seeds of certain varieties, [2004] OJ L 97/66
    • 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, [2006] OJ L 7/27
    • Commission Decision 2006/335/EC 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 MON 810 listed in the Common catalogue of varieties of agricultural plant species, pursuant to Council Directive 2002/53/EC, [2006] OJ L 124/26
  • Commission Recommendation 2003/556/EC 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, [2003] OJ L 189/36
  • Commission Decision 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, [2005] OJ L 164/50
  • Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs, [1991] OJ L 198/1 as amended, also amended by [2005] OJ L 205/16, [2005] OJ L 210/11, [2005] OJ L 211/11, [2005] OJ L 252/1, [2005] OJ L 307/10, [2006] OJ L 137/9
  • Council Decision 2004/869/EC of 24 February 2004 concerning the conclusion, on behalf of the European Community, of the International Treaty on Plant Genetic Resources for Food and Agriculture, [2004] OJ L 378/1
    • International Treaty on Plant Genetic Resources for Food and Agriculture, [2004] OJ L 378/3
  • Council Regulation (EC) No 870/2004 of 24 April 2004 establishing a Community programme on the conservation, characterisation, collection and utilisation of genetic resources in agriculture and repealing Regulation (EC) No 1467/94, [2004] OJ L 162/18, corrected by [2005] OJ L 117/22
  • Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, [1991] OJ L 230/1 as amended, also amended by [2005] OJ L 90/1

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Medical products

  • Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, [1993] OJ L 214/1 as amended
  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, [2001] OJ L 311/67 as amended
  • Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, [2001] OJ L 311/1 as amended

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Intellectual Property

  • Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions [European Biotechnology Directive], [1998] OJ L 213/13
  • Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights [European Community Plant Variety Rights Regulation], [1994] OJ L 227/1 as amended
  • Council Decision 2005/523/EC of 30 May 2005 approving the accession of the European Community to the International Convention for the Protection of New Varieties of Plants, as revised at Geneva on 19 March 1991, [2005] OJ L 192/63
    • International Convention for the Protection of New Varieties of Plants, [2005] OJ L 192/64

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Protection of workers

  • Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work, [2000] OJ L 262/21

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Transport of dangerous goods

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Environmental liability

  • Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage, [2004] OJ L 143/56

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Cartagena Protocol on Biosafety

  • Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety, [2002] OJ L 201/48

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Exports to non-EU Member States

  • Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms, [2003] OJ L 287/1

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Life sciences and biotechnology strategy

  • Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions - Life sciences and biotechnology - A Strategy for Europe (COM(2002) 27 final), [2002] OJ C 55/3
    • Communication from the Commission to the European Parliament, to the Council and to the European Economic and Social Committee - Life Sciences and Biotechnology - A strategy for Europe progress report and future orientations (COM(2003) 96 final)
    • Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Life sciences and biotechnology - A strategy for Europe - Second progress report and future orientations (COM(2004) 250 final)

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