* I am very grateful to Prof. Grainne de Burca for all her useful comments and constant support. I also thank my friends Sharon, Karolina and Przemek for their help. Google Scholar

(1) Council Directive 219/90/EEC on the contained use of genetically modified micro-organisms (hereinafter the Contained Use Directive) OJ 1990 L117/1 as amended by Directive 98/81/EC [1998] OJ L330/13; Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (hereinafter the old Directive) OJ 1990 L117/15. The old Directive 90/220 will be repealed by Directive 2001/18/EC on 17 October 2002.(hereinafter the new Directive), OJ 2001 L106/1, 17 April 2001.Google Scholar

(2) The last approval dates from 20 October 1998; see Annex 1, MEMO/01/277 Revised,Google Scholar

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(10) Especially, GM foodstuffs cause extended public debates, therefore, the food safety, including GM products, was made one of the priorities during the Belgian Presidency in the EU, the European Commission press releases, 2 July 2001.Google Scholar

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(13) Namely Denmark, France, Greece, Italy and Luxembourg (later joined by Austria); cf. Draft Minutes of the 2194 Council meeting (Environment) held in Luxembourg on 24 and 25 June 1999, 9433/1/99 REV 1, annex III, 14; cf. J. Kioussi, The evolution of the EU regulatory system for GMOs, Proceedings of 6th International Symposium on the Biosafety of GMOs, University of Saskatchewan, 2000, 3, http://www.ag.usask.ca/isbr/Symposium.Google Scholar

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(18) Cf. L. Krämer EC Environmental Law, 4th edition, Sweet & Maxwell, 2000, 74; Art. 2, 3 (l),6 and title XIX EC ensure the importance of environmental protection within the Treaty framework.Google Scholar

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(20) Cf. AG Opinion, case C-6/99, Association Greenpeace France and Others v Ministere d l'Agriculture et de la Peche and Others, ECR French edition [2000] I-1651, par. 67, this case was decided under the old Directive 90/220, but the citations remain applicable.Google Scholar

(21) Cf. Vos, E., Differentiation, Harmonisation and Governance, in: B. de Witte, D. Hanf, E. Vos (eds), The many faces of differentiation in EU law, Intersentia, 2001, 146-147.Google Scholar

(22) Cf. joined cases C-164/97 and C-165/97, European Parliament v. Council, [1993] ECR I-939, par. 14.Google Scholar

(23) Cf. e.g. joined cases C-164/97 and C-165/97, European Parliament v. Council, supra n. 22, par. 12, case C-155/91 Commission v. Council [1993] ECR I-939, par. 7; case C-42/97 Parliament v. Council [1999] ECR I-0869, par.36.Google Scholar

(24) Cf. case C-377/98, The Netherlands v European Parliament and Council, [2001] ECR I-07079, par. 27, quoting the case C-155/91, Commission v. Council, supra n. 23, pars 19-21.Google Scholar

(25) It means giving the priority of production method (all products resulting from genetic modification must be subject to authorisation) rather than to the characteristics of the final product. It confirms precaution with regard to genetic engineering, M. Matthee, D. Vermersch, supra n. 9, 185.Google Scholar

(26) Explanatory Memorandum for the new Directive 2001/18, supra n. 3, 3. The current Community legislation on GMOs consists of general (horizontal) measures, Directive 2001/18 on deliberate release into environment of GMOs repealing Directive 90/220 and Directive 90/219 on contained use of GMOs, supra n. 1; and specific (product-related) acts, inter alia, Regulation 258/97 concerning novel foods and novel food ingredients OJ 1997 L 43/1; Regulation 2309/93/EEC laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use OJ 1993 L 214/1; cf. T.K. Hervey, Regulation of Genetically Modified Products in a Multi – Level System of Governance: Science or Citizens?, RECIEL 10 (3) 2001, 321; I.- I.-J. Sand, The legal regulation of the environment and new technologies - in view of changing relations between law, politics and science. The case of applied genetic technology, 22 Zeitschrift für Rechtsoziologie (2001), Heft 2, 16; S. Francescon, supra, n. 6, 309.Google Scholar

(27) Cf. Art. 12 of the new Directive.Google Scholar

(28) Cf. D. Lawrence, J. Kennedy and E. Hattan, “The new Directive, the main aim of which is to harmonise bio – safety measures across the EU and to clarify and tighten the regime…”, supra n. 11, 51.Google Scholar

(29) Cf. recitals 4, 5, 6, 8, 10, 11,18-25 of the Preamble to the new Directive 2001/18 (first three recitals refer to the amendment of the old Directive 90/220).Google Scholar

(30) Cf. recital 4 of the Preamble to the old Directive 90/220, supra n. 1; J. Sand, supra n. 30, 15.Google Scholar

(31) Cf. Explanatory Memorandum for the proposal for a Council Directive 2001/18, supra n. 3; when Explanatory Memorandum for the proposal for a Council Directive 90/220 on the deliberate release to the environment of genetically modified organisms to the contrary, COM (1988), 160 final, 2.Google Scholar

(32) Recital 8; Cf. also Opinion 2/00 of the Court of 6th December 2001, not yet reported, par. 29; see however AG Opinion, case C-6/99, supra, par. 70, saying “no one dares to suggest… that it [the precautionary principle] may be disregarded in cases where Art. 95 provides legal basis”.Google Scholar

(33) Cf. Art. 13-14, 20, 28-29 of the new Directive; cf. D. Lawrence, J. Kennedy and E. Hattan, supra n. 11, 51.Google Scholar

(34) Cf. Iwañska, B., Podstawy prawne dzia³ania Wspólnoty Europejskiej w prawie techniki genetycznej [Community competence to act in the law of genetic engineering], in S. Biernat (ed.), Studia z Prawa Unii Europejskiej [Studies on EU Law], Kraków, 2000, 537.Google Scholar

(35) Recital 4 of the Preamble to the Directive 90/220, supra n. 1; as to the disparities between Member States’ legislation before adopting this act cf. Explanatory Memorandum for the Directive 90/220, supra n. 31, 3.Google Scholar

(36) Art. 15.4. and 17 of the new Directive.Google Scholar

(37) Sheridan, B., supra n. 14, 34. The possibility is expressed in recitals 36, 38 of the Preamble but, interestingly, not stated in the text of the new DirectiveGoogle Scholar

(38) The first national part of the authorisation procedure takes place in the Member State where a GMO is to be first placed on the market. The producer of a GMO has the obligation of the relevant notification, cf. Art. 13 of the new Directive.Google Scholar

(39) Recitals 57-58 of the Preamble, Art. 29 of the new Directive.Google Scholar

(40) Cf. Art. 21 and annex IV of the new Directive; A. Dashwood, supra n. 17, 121.Google Scholar

(41) Due to the safety concerns the governments of the Member States make ending their opposition for approvals of GMOs conditional upon, inter alia, establishment of the detailed labelling rules, M. Mann, supra n. 15.Google Scholar

(42) Krämer, L., supra n. 18, 56, 59; I.-J. Sand, supra n. 30, 11.Google Scholar

(43) Cf. the problem of moratorium, supra n. 14, 15.Google Scholar

(44) Case C-300/89, Commission v. Council [1991] ECR 2867; J. Scott, EC Environmental Law, London and New York, 1998, 8.Google Scholar

(45) Dashwood, A., supra n. 17, 121; L. Krämer, supra n. 18, 58. However, J. Scott calls Titanium Dioxide case temporary aberration in the legal basis debate, supra n. 44, 9. Cf. as well P. Craig and G. de Burca, EU Law. Text, Cases and Materials, 2nd Ed., Oxford University Press, 1998, 1120.Google Scholar

(46) Scott, J., supra n. 44, 9; case C-155/91 Commission v Council, supra n. 22; joined cases C-164/97 and C-165/97, European Parliament v. Council, supra n. 22, par.15.Google Scholar

(47) See hereto MacLaren, M., Patently Unsatisfactory:? Community Legislative Competence and the ECJ Biotech Decision, 2 German L. J. No. 18 (1 December 2001), http://www.germanlawjournal.com, search Biotech, or directly at: http://www.germanlawjournal.com/past_issues.php?id=114.Google Scholar

(48) Case C-377/98 The Netherlands v European Parliament and Council, supra n. 24, par. 15, 20, 27 - 28; in view of such reasoning to my opinion it can always be argued that approximation of legislation is essential purpose of a directive.Google Scholar

(49) Cf. A. Dashwood, supra n. 17, 121.Google Scholar

(50) Cf. Opinion 2/00 of the Court of the 6th December 2001 on the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, not yet reported, The Protocol was adopted on the 29th January 2000 and signed on behalf of the European Community and the Member States on the 24th May 2000. The Protocol regulates transboundary movement of GMOs and ensures an adequate level of protection in the field of safe transfer, handling and use of GMOs that may have adverse effects on the environment, taking into account risks to human health. See further, e.g. B. Eggers and R. Mackenzie, The Cartagena Protocol on Biosafety, Journal of International Economic Law, 2000, 525 – 527ff; V. Koester, Cartagena Protocol, A new Hot Spot in the Trade-Environment Conflict, Environmental Policy and Law, 31/2 (2001), 82.Google Scholar

(51) The Court considered the question of the legal basis for the conclusion of the Protocol on behalf of the Community. The Commission proposed Art. 133 (Common Commercial Policy) and 174(4) EC in conjunction with the first subparagraph of Article 300(2) claiming that the Protocol essentially falls within the field of regulation of international trade; the Council adopted the decision concluding the Protocol on the basis of Art. 175(1) and 300(2) as the environmental protection measure. Further see, Ch. Pitschas, EuGH: Zuständigkeit zum Abschluss des Protokolls von Cartagena, EuZW, Heft 4/2002, 113.Google Scholar

(52) Cf. par. 34, 37 – 40 of the Opinion 2/00, supra n. 50; LMO is the international law notion for GMO.Google Scholar

(53) Cf. supra n. 1; cf. par. 46 of the Opinion 2/00, supra n. 50.Google Scholar

(54) Cf. also Scott, J., supra n. 44, 40.Google Scholar

(55) To lawfully differentiate from the Community provisions under the present system Member States have to use either a procedure of Art. 95.4–8 or the safeguard clause from the new Directive, cf. section IV.Google Scholar

(56) Cf. Legislative Observatory of the European Parliament, Stages in the procedure, the new Directive 2001/18; http://wwwdb.europarl.eu.int/oeil/oeil_ViewDNL.Procedure.Google Scholar

(57) Cf. the centralisation envisaged in the Art. 12 of the new Directive and the Proposal for a European Parliament and Council Regulation on Genetically Modified Food and Feed, COM (2001) 425 final.Google Scholar

(58) Through the regulatory comitology procedure, cf. Art. 18 in conjunction with 30 of the new Directive. On the basis of Article 202 EC the Council issued decision laying down the procedures for the exercise of implementing powers conferred on the Commission (1999/468/EC), OJ 1999 L184/23.Google Scholar

(59) See as well, Francescon, S., supra n. 6, 311ff; T. K. Hervey, supra n. 26; M. Matthee, Greenpeace v. France, Case 6/99, (Genetically Modified Maize Case), RECIEL 9 (2) 2000, 192.Google Scholar

(60) Ross, H., Tenant, D., Definitive guide for GMOs, Suffolk, 2000, 12; case C-6/99, Association Greenpeace France and Others v Ministere d l'Agriculture et de la Peche and Others, ECR French edition [2000] I-1651, par. 14; T. K. Hervey, supra n. 26, 328; A. Mastromatteo, A lost opportunity for European Regulation of genetically modified organisms, 25 ELRev. 2000, 425.Google Scholar

(61) Case C-6/99, supra n. 60, par. 39-42; cf. T. K. Hervey, supra n. 26, 325.Google Scholar

(62) Opinion of AG Mischo in the case C-6/99, supra n. 20, par. 48.Google Scholar

(63) Ibid., par. 49.Google Scholar

(64) Cf. case C-6/99, supra n. 60, par. 33.Google Scholar

(65) Jacque, J.P., Implementing powers and Comitology, in C. Joerges and E. Vos (eds) EU Committiees: Social Regulation, Law and Politics, 1999, 59-61; G. Winter, On the Effectiveness of the EC Administration: the Case of Environmental Protection, 33 CMLRev. 1996, 689.Google Scholar

(66) Cf. Francescon, S., supra n. 6, 312; M. Matthee, supra n. 59, 193.Google Scholar

(67) Cf. annex 1, MEMO/43/00/EC, “Facts on GMOs in the EU”, 13.07.00; http://www.europa.eu.int/comm/dgs/health_consumer/library/press/press63-en.pdf. However, Matthee states there have always been objections, supra n. 59, 193.Google Scholar

(68) Cf. Art. 15, 18 of the new Directive, B. Sheridan, supra n. 14, 47.Google Scholar

(69) Cf. below, section IV.Google Scholar

(70) Cf. Francescon, S., supra n. 6, 312; B. Sheridan, supra n. 14, 46–48; A. Mastromatteo, supra n. 60, 428–429.Google Scholar

(71) Cf. Francescon, S., supra n. 6, 312 - 313.Google Scholar

(72) Art. 30 of the new Directive, Art. 5, 7 of the Decision 1999/468/EC, supra n. 58. With regard to committees cf. E. Vos, supra n. 21, 170ff; E. Vos, EU Committees: the Evolution of Unforeseen Institutional Actors in European Product Regulation, in: Ch. Joerges and E. Vos (eds), supra n. 65, 24.Google Scholar

(73) Art. 28 of the new Directive; cf. scientific opinions on GMOs available at: http://www.europa.eu.int/comm/food/fs/sc/scp/outcome_gmo_en.html. E.g. Scientific Committee on Plants (SCP) issues opinions on GM plants, Scientific Committee on Food – opinions on GM food. Very soon, all the responsibilities of the different scientific committees relating to GMOs will be taken over by the Panel on genetically modified organisms established within the European Food Authority, cf. Art. 22.5 and 28.4 (d) of the Regulation 178/2002/EC laying down the general principles and requirements of food law, establishing the European Food Authority and laying down procedures in matters of food safety, OJ 2002 L31/1.Google Scholar

(74) E. Vos, supra n. 21, 174.Google Scholar

(75) B. Sheridan, supra n. 14, 60.Google Scholar

(76) Ibidem, for more detailed description of the procedure and new possible role of European Parliament, 61ff; Art. 5.4. of the Decision 1999/468/EC, supra n. 58.Google Scholar

(77) Art. 5.6. of the Decision 1999/468/EC, ibid.Google Scholar

(78) Although the requirement of unanimity did not reflect the language of Art. 21 of the old Deliberate Release Directive, such was the interpretation of the Commission, cf. S. Francescon, supra n. 6. First, in order to increase the role of Member States in the decision-making process the Commission proposed application of IIIb comitology procedure allowing the Council to reject the Commission proposal by only simple majority, Art. 2 of the old Decision 87/373/EEC, now repealed by Decision 1999/468/EC, supra n. 58. That proposal is not valid any more as the new Decision 1999/468/EC does not provide a procedure equivalent to the old IIIb; cf. Explanatory Memorandum for the new Directive 2001/18, supra n. 3, 5-6; Opinion of the Economic and Social Committee for the new Directive 2001/18, CES 1117/1998, 2.Google Scholar

(79) Cf. Krämer, L., supra n. 18, 170, S. Francescon, supra n. 6, 313; T. K. Hervey, supra n. 26, 328.Google Scholar

(80) Case C-6/99, supra n. 60, par. 27-29; AG Opinion, case C-6/99, supra n. 20, par. 65.Google Scholar

(81) Cf. Mastromatteo, A., supra n. 60, 428.Google Scholar

(82) Hervey, T. K., ibidem.Google Scholar

(83) Main countries behind the present moratorium for GMO together 34 votes; cf. supra n. 13.Google Scholar

(84) Winter, G., supra n. 65, 696.Google Scholar

(85) Cf. Annex 2, MEMO/01/277, supra n. 2.Google Scholar

(85) Art. 18.1 of the new Directive; on the contrary Art. 13 of the old Directive 90/220, supra n. 1, does not specify any procedural time-limit for adoption of decision, it says the Commission shall adopt it.Google Scholar

(87) Cf. supra n. 1.Google Scholar

(88) Cf. Opinion 2/00, supra n. 32, par. 46.Google Scholar

(89) Art. 249 EC, cf. Art. 34 of the new Directive 2001/18.Google Scholar

(90) Cf. Sheridan, B., supra n. 14, “complete harmonisation”, 87; A. R. Ziegler, Trade and Environmental Law in the European Community, Oxford, 1996, “extensive harmonisation”, 156.Google Scholar

(91) Cf. L.Krämer, supra n. 18, 93.Google Scholar

(92) Locus classicus is: Case 6/64, Costa v ENEL, [1964] ECR 1141.Google Scholar

(93) Consultations with European ethical committees “shall be without prejudice to the competence of Member States as regards ethical issues”, recital 57 of the Preamble and Art. 29 of the new Directive.Google Scholar

(94) Even though some authors see derogation possibilities under Art. 95 rather in the context of minimum harmonisation only, cf. M. Dougan, Minimum Harmonisation and the Internal Market, 37 CMLRev. 2000, 855, 868; see also L. Krämer, supra n. 18, 101. S. Weatherill says that this provision subverts the traditional doctrine of preemption and establishes within the Treaty the legitimate importance of national regulatory measures…; shared competence, Beyond Preemption? Shared Competence and Constitutional Change in the European Community, in D. O'Keeffe, P. Twomey (eds), Legal Issues of the Maastricht Treaty, London, 1994, 22–23.Google Scholar

(95) For systematic analysis of conditions under Art. 95.4-5. as amended by the Amsterdam Treaty together with tests applied by the Commission in the particular cases, see above all E. Vos, supra n. 21, 150ff, 160ff; L. Krämer, supra n. 18, 98ff; B. Iwañska, supra n. 34, 545ff.Google Scholar

(96) Cf. Draft minutes of the 2194th Council meeting, supra n. 13, 15.Google Scholar

(97) L.Krämer, supra n. 18, 102.Google Scholar

(98) Cf. Vos, E., supra n. 21, 166 –167.Google Scholar

(99) It appeared after Member States invoked the safeguard clauses under Art. 16 of the old deliberate release Directive, see below. The problem of the “objectivity of science” is not new as such and it has already caused many controversies; cf. J. Scott, E. Vos, The Juridification of Uncertainty: Observations on the Ambivalence of the Precautionary Principle within the EU and the WTO, in: Ch. Joerges and R. Dehousse (eds), Good Governance in Europe's Integrated Market, Oxford, 2002, 258ff.Google Scholar

(100) That is why incoherence between EU and national legislation, at least in theory, should not remain for long.Google Scholar

(101) Cf. Winter, G., supra n. 65, 690.Google Scholar

(102) Adaptation of the Annexes to technical progress is pursued through comitology procedure, save for Annexes II AB, VII AB (general basis principles of environmental risk assessment, principles for monitoring plan) which as regulating crucial issues are subject to the full co-decision procedure. This is due to the amendment made by the Council while adopting the common position, Communication from the Commission to the European Parliament concerning the Common Position adopted by the Council, SEC/99/2180 final - COD 98/0072, comment on Article 26.Google Scholar

(103) Art. 8 of the new Directive.Google Scholar

(104) Art. 23 of the new Directive, cf. A. Mastromatteo, supra n. 81, 429.Google Scholar

(105) Vos, E., supra n. 21, 167.Google Scholar

(106) Case C-6/99, supra n. 60, par. 44-47, cf. somehow critically J. Scott, E. Vos, supra n. 99, 258.Google Scholar

(107) Cf. Sheridan, B., supra n. 14, 82 – Austria (3), France (2), Germany, Greece, Luxembourg (1).Google Scholar

(108) Cf. Art. 16 of the old Directive, supra n. 1.Google Scholar

(109) Hervey, T. K., supra n. 26, 323.Google Scholar

(110) Sand, I.-J., supra n. 30, 16; T. K. Hervey, supra n. 26, 324.Google Scholar

(111) Ibidem, 324.Google Scholar

(112) Hervey, T. K., supra n. 26, 324; E. Vos, supra n. 21, 168; cf. as well I.-J. Sand, supra n. 30, 16–17.Google Scholar

(113) Cf. Sheridan, B., supra n. 14, 82, 84; I.-J. Sand, supra n. 30, 16; L. Krämer, supra n. 18,171.Google Scholar

(114) Sheridan, B., supra n. 14, 83; none of the opinions of the relevant Scientific Committee within the Commission confirm the reasons for GMOs ban invoked by Member States; cf. opinions at http://www.europa.eu.int/comm/food/fs/sc/scp/outcome_gmo_en.html. In the future as stated above the tasks of these committees will be taken over by the European Food Authority, cf. supra n. 73Google Scholar

(115) Generally on the subject, see Ch. Joerges, Integrating Scientific Expertise into Regulatory Decision-Making, EUI Working Paper, RSC No. 96/10.Google Scholar

(116) The same Lawrence, D., Kennedy, J. and Hattan, E., supra n. 11, 52; S. Francescon, supra n. 6, 313; cf. as well T. K. Hervey, supra n. 26, 323.Google Scholar

(117) Art. 23.2. of the new Directive.Google Scholar

(118) The same Sheridan, B., supra n. 14, 82.Google Scholar

(119) Cf. AG Opinion, case C-6/99, supra n. 20, par. 82. The influence may be surprisingly strong, see above and cf. E. Vos, supra n. 21, 170.Google Scholar

(120) Cf. data showing general negative public attitude in Europe towards GMO in Vogel, D., Ships passing in the night: The Changing Politics of Risk Regulation in Europe and the United States, EUI Working Paper, RSC No. 2001/16, 11-13; T. K. Hervey, supra n. 26, 324ff.Google Scholar

(121) With the abstention of the Italian and the French delegates, cf. Legislative Observatory of the European Parliament, Stages in the procedure, the new Directive 2001/18, 2; http://wwwdb.europarl.eu.int/oeil/oeil_ViewDNL. Procedure. Anyway, Statement of the Council's Reasons after adoption of the common position also does not reveal that legal base has been a matter of discussion, OJ 2000, C64/40.Google Scholar

(122) Although not expressly stated by the ECJ it is regarded as such by the Commission, D. Chalmers, EU Law, Vol. I, Ashgate Dartmouth 1998, 222.Google Scholar

(123) This is true for all the fields where the regulatory comitology procedure is applicable, not exclusively for GMOs deliberate release.Google Scholar