1 See for discussion of the pre-Lisbon situation, for instance, Arnull, Anthony, ‘Private applicants and the action for annulment under Article 173 of the EC Treaty’ (1995) 32 Common Market Law Review, Issue 1, pp. 7–49 Google Scholar. Ewa Biernat, The Locus Standi of Private Applicants under article 230 (4) EC and the Principle of Judicial Protection in the European Community, Jean Monnet Working Paper 12/03, NYU School of Law, 2003. Albertina Albors-Llorens (2003). The Standing of Private Parties to Challenge Community Measures: Has The European Court Missed the Boat?. The Cambridge Law Journal, 62, pp 72-92. Craig, Paul, Standing, Rights, and the Structure of Legal Argument (2003) 9 European Public Law, Issue 4, pp. 493–508 Google Scholar. Crossen, Teall and Niessen, Veronique, NGO Standing in the European Court of Justice – Does the Aarhus Regulation Open the Door? Reciel 16 (3) 2007, pp. 332–340 Google Scholar. Varju, Marton, ‘The Debate on the Future of the Standing under Article 230(4) TEC in the European Convention’ (2004) 10 European Public Law, Issue 1, pp. 43–56 Google Scholar. Ward, Angela, Judicial Review and the Rights of Private Parties in EU Law (Oxford European Union Law Library), Oxford University Press, 2007 CrossRefGoogle Scholar.

2 For a discussion of the post-Lisbon rules, see, for instance, Stephan Balthasar, Locus standi rules for challenges to regulatory acts by private applicants: the new art. 263(4) TFEU, E.L. Rev. 2010, 35(4), 542-550. M. Eliantonio, Ch.W. Backes , C.H. van Rhee, T.N.B.M. Spronken, Anna Berlee, Standing up for your right(s) in Europe: A Comparative study on Legal Standing (Locus Standi) before the EU and Member States’ Courts, European Parliament, Committee on Legal Affairs, 2012. Pieter-Augustijn Van Malleghem and Niels Baeten, Before the law stands a gatekeeper – Or, what is a “regulatory act” in Article 263(4) TFEU? Inuit Tapiriit Kanatami, Common Market Law Review 51: 1187–1216, 2014.

3 In 2002, Stone argued that, in Europe, “the formal legitimacy of review is simply a non-issue.” A Stone Sweet, Why Europe Rejected American Judicial Review - and Why it May Not Matter, 101 Mich. L. Rev. 2744 2002-2003, pp. 2744-2780. Cf. Caldeira, Gregory A. & Gibson, James L., The Legitimacy of the Court of Justice in the European Union: Models of Institutional Support, 89 Am. Pol.Sci. Rev. 356 (1995) (arguing that high levels of trust may not be based on actual experience and thus may be vulnerable to new information)CrossRefGoogle Scholar. Gibson, James L. & Caldeira, Gregory A., The Legitimacy of Transnational Legal Institutions: Compliance, Support, and the European Court of Justice, 39 Am. J. Pol. Sci. Rev. 459 (1995)CrossRefGoogle Scholar. Gibson, James L. & Caldeira, Gregory A., Changes in the Legitimacy of the European Court of Justice: A Post-Maastricht Analysis, British Journal of Political Science, 28(1), 63–91 (1998)CrossRefGoogle Scholar. For recent data on public trust in the European courts, see Voeten, Erik, Public Opinion and the Legitimacy of International Courts, Theoretical Inquiries in Law, Vol. 14:411, 2013, pp. 411–436 CrossRefGoogle Scholar.

4 After all, the precautionary principle applies to environmental and health and safety risk, i.e. risk regulation. For a discussion of the various possible meaning of the precautionary principle, see L. Bergkamp, Understanding the Precautionary Principle, Parts I and II, Environmental Liability, 2002, pp. 18-30 and pp. 67-82.

5 Articles 1 and 11, Treaty on European Union (TEU), and Article 15 Treaty on the Functioning of the European Union (TFEU).

6 This article does not discuss specific rights of action for nongovernmental organizations (NGO’s) to challenge generally binding regulations or the implementation and enforcement thereof. For further discussion, see L. Bergkamp, Are Standing Rights for Environmental Groups in the Public Interest?, Tijdschrift voor Milieuaansprakelijkheid, 2001, pp. 153-157.

7 Article 263(1), TFEU.

8 Article 263(4), TFEU.

9 Case 25/62, Plaumann v Commission [1963] ECR 95, 107.

10 Case 789 and 790/79, Calpak SA v Commission, [1980] ECR 1949.

11 Craig, Paul, EU Administrative Law, 2nd Edition, Oxford: Oxford University Press, 2012, p. 307 CrossRefGoogle Scholar.

12 Pfizer, Court of First Instance, T-13-99, 11 September 2002, ECLI:EU:T:2002:209, paras. 104-105.

13 Relevant cases are Case T-339/00, Bactria v. Commission, 2001 E.C.R. 11-1721, 151. Case T-109/97, Molkerei Grossbraunshain v. Commission, 1998 E.C.R. 11-3533, 1160, 68.

14 According to Scott and Sturm, the European courts have developed a doctrine which may be viewed as giving rise to a “participation exception.” That is to say, persons would enjoy standing to sue before the European courts, where they enjoy “specific procedural guarantees conferring upon them a right to participate in the political process.” Joanne Scott & Susan Sturm, Courts as Catalysts: Rethinking the Judicial Role in New Governance, 13 Columbia Journal of European Law 565 (2007), pp. 565-594, at 579.

15 Article 263(4), TFEU.

16 Case C-583/11, P Inuit Tapiriit Kanatami and others v European Parliament and Council, para. 50. Cf. Advocate-General Opinion in C-456/13 P, T & L Sugars Ltd and Sidul Açúcares Unipessoal Lda v European Commission, para. 18.

17 This is an old theme, which was analyzed thoroughly by Advocate- General Jacobs in C-50/00 P, Unión de Pequeños Agricultores v Council of the European Union( UPA).

18 But see Case T-346/10, Borax Europe v ECHA; Case T-343/10, Etimine and Etiproducts v ECHA.

19 Case T-262/10, Microban International Ltd and Microban (Europe) Ltd v European Commission, para. 27. Case C-386/96, P Dreyfus v Commission, [1998] ECR I-2309, para. 43, and Joined Cases C-445/07 P and C-455/07 P Commission v Ente per le Ville vesuviane and Ente per le Ville vesuviane v Commission [2009] ECR I-7993, para. 45).

20 Pursuant to the US Administrative Procedure Act, the right to seek judicial review is conditioned on suffering legal wrong due to agency action, or being adversely affected or aggrieved by agency action. 5 USCS § 702. A claimant may be required to show also that the interest it seeks to protect fall within the zone of interests to be protected or regulated by the instrument in question. Dismas Charities, Inc. v. United States DOJ, 401 F.3d 666 (6th Cir. Ky 2005).

21 In the context of civil actions, Holderness has argued that an open class of potential plaintiffs impairs or even destroys the alienability of resources and thus reduces their value. CG, Holderness. Standing. In: P, Newman (editor). The New Palgrave Dictionary of Economics and the Law. London: Macmillan. Volume 3, pp. 505–509 Google Scholar. The injury requirement serves to keep the class of potential plaintiffs limited.

22 The Court of First Instance dismissed an application made by a scientific expert on the grounds that her opinion had been taken into account and her reputation had not been damaged, and, thus, she had no legally protected interest. Case T-32/99, Nancy Fern Oliveri v. Commission and EMEA, [2003] ECR II-6053.

23 Article 288, TFEU provides that a “regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.”

24 Article II-365(4), Treaty establishing a Constitution for Europe (Constitutional Treaty).

25 Case C-583/11, P Inuit Tapiriit Kanatami and others v European Parliament and Council, para. 61.

26 It is conceivable, albeit unlikely, that legislation could be deemed a “decision” of “direct and individual concern” to an applicant, and, thus, give an applicant standing rights. Rose-Ackerman, Susan, Egidy, Stefanie & Fowkes, James, Due Process of Lawmaking: The United States, South Africa, Germany, and the European Union, Cambridge University Press, 2015, p. 239 CrossRefGoogle Scholar. Cf. Craig, Paul, EU Administrative Law, 2nd Edition, Oxford: Oxford University Press, 2012, p. 316 Google Scholar.

27 For a discussion of problems associated with making this distinction, see Paul Craig. Delegated Acts, Implementing Acts and the New Comitology Regulation. European Law Journal, 2011, Vol. 36(5), pp. 671-687. The Commission notes that “an act cannot be classified under two different headings at the same time: an act based on Article 290 is by definition excluded from the scope of Article 291, and vice versa. The authors of the new Treaty clearly intended the two articles to be mutually exclusive, and indeed the resulting acts have different legal names.” Communication from the Commission to the European Parliament and the Council. Implementation of Article 290 of the Treaty on the Functioning of the European Union. Brussels, 9.12.2009, COM(2009) 673 final, p. 3. Each of these two acts can be made in the form of a regulation, directive or decision.

28 Article 290, TFEU.

29 Article 291(2), TFEU.

30 Article 263(5), TFEU.

31 C-456/13 P, T & L Sugars Ltd and Sidul Açúcares Unipessoal Lda v European Commission, para. 29.

32 C-456/13 P, T & L Sugars Ltd and Sidul Açúcares Unipessoal Lda v European Commission, para. 29 (referring to C-274/12 P, Telefonica v Commission, para. 27).

33 See, e.g., C-50/00 P, Unión de Pequeños Agricultores v Council of the European Union; and Case T-177/01, Jégo-Quéré & Cie SA v Commission of the European Communities.

34 Advocate-General Cruz Villalón, Opinion in Case Case C-456/13 P, T & L Sugars Ltd et al. v European Commission, para. 46.

35 C-456/13 P, T & L Sugars Ltd and Sidul Açúcares Unipessoal Lda v European Commission, paras. 41-42. Whether or not the national decisions are of a “mechanical nature” is “irrelevant in ascertaining whether those regulations entail implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.”

36 Advocate-General Jacobs in Unión de Pequeños Agricultores v Council of the European Union (UPA).

37 See, for instance, Joined Cases C-503/13 and C-504/13, preliminary ruling in the proceedings Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13). For discussion of the discrepancies, see L. Bergkamp, Is There a Defect in the European Court's Defect Test? Musings about Acceptable Risk, EJRR 2015, pp. 309-322.

38 Craig, Paul, EU Administrative Law, 2nd Edition, Oxford: Oxford University Press, 2012, p. 313 CrossRefGoogle Scholar.

39 Cf. Ward, Angela, Judicial review and the rights of private parties in EC law, Oxford: Oxford University Press, 2007 CrossRefGoogle Scholar. Fordham, Michael, Judicial Review Handbook, Oxford: Hart, 2008 Google Scholar. Moules, Richard, Environmental Judicial Review, London: Hart Publishing, 2011 Google Scholar.

40 Dyevre, Arthur, Technocracy and Distrust: Revisiting the Rationale for Judicial Review, International Journal of Constitutional Law, 2015, Vol. 13, No. 1, pp. 30–60 CrossRefGoogle Scholar.

41 Article 288-299, TFEU.

42 See, for instance, Article 290, TFEU. Case 9-56, Meroni & Co., Industrie Metallurgiche, SpA v High Authority of the European Coal and Steel Community, English Special Edition 1957-1958 00133. Case C-270/12, United Kingdom v Council and European Parliament.

43 Only in a few cases has the court found legislative acts inconsistent with the proportionality requirement. Rose-Ackerman, Susan, Egidy, Stefanie & Fowkes, James, Due Process of Lawmaking: The United States, South Africa, Germany, and the European Union, Cambridge University Press, 2015, p. 238 CrossRefGoogle Scholar.

44 See, for instance, Lucas Bergkamp and Guangdong Xu, Design and Implementation of a Governance System for the Protection of the Environment and Public Health in China: International Models and Best Practices (2016, forthcoming).

45 In the US, the Administrative Procedure Act provides such a framework. Cf. European Risk Forum, Law of Administrative Procedures – Observations on the European Commission’s Response to the European Parliament Resolution, August 2013, http://ec.europa.eu/smart-regulation/consultation_2012/docs/registered_organisations/erf_en.pdf.

46 See Article 1 TEU, which requires that decision are made “as openly as possible,” Article 10(3), which provides that “every citizen shall have the right to participate in the democratic life of the Union,” Article 11(2) TEU, which requires that the institutions maintain “an open, transparent and regular dialogue” with representative associations and civil society, and Article 15 TFEU, which grants a right of access to documents and imposes a transparency obligation, and states that the institutions have a duty to conduct their work “as openly as possible (…) in order to promote good governance and ensure the participation of civil society.

47 Advocate-General Cruz Villalón, Opinion in Case Case C-456/13 P, T & L Sugars Ltd et al. v European Commission, para. 24. “After all,” he explains, “the condition of direct concern, as interpreted by the Court in relation to the pre-Lisbon version of the Treaty, was already based on the understanding that where implementation was purely automatic there was no obstacle to the recognition of standing to bring proceedings. It could be argued, therefore, that the condition relating to the absence of implementing measures — in other words, the absence of acts going beyond purely automatic implementation — is inherent in the condition relating to direct concern.” Id., para. 25.

48 C-50/00 P, Unión de Pequeños Agricultores v Council of the European Union( UPA), para. 44.

49 C-50/00 P, Unión de Pequeños Agricultores v Council of the European Union( UPA), para. 45.

50 Craig, Paul, EU Administrative Law, 2nd Edition, Oxford: Oxford University Press, 2012, p. 314 CrossRefGoogle Scholar.

51 Majone argues that the Commission does not suffer from a democratic deficit because it deals with technical regulatory matters. Democratic legitimacy would apply only to redistributive legislation. Majone, Giandomenico, Regulating Europe, Abingdon: Routledge, 1996 CrossRefGoogle Scholar. Note that Majone does not make the argument set out in the text above.

52 Cf. Porter, G., Trade competition and pollution standards: ‘Race to the bottom’ or ‘Stuck at the bottom’?, Journal of Environment & Development, 1999, Vol. 8, No. 2, pp. 133–151 CrossRefGoogle Scholar. Neumayer, E., Do countries fail to raise environmental standards? An evaluation of policy options addressing “regulatory chill,” International journal of sustainable development, 2001, 4(3). pp. 231–244 CrossRefGoogle Scholar.

53 Keleman has argued that the restricted standing rights of private plaintiffs and other legal impediments “will continue to channel and restrain the development of adversarial legalism in Europe, but will not halt it.” Keleman, R. Daniel, Eurolegalism: The Transformation of Law and Regulation in the European Union, Cambridge: Harvard University Press, 2011, p. 10 and 32CrossRefGoogle Scholar.

54 Scott, Joanne & Sturm, Susan, Courts as Catalysts: Rethinking the Judicial Role in New Governance, 13 Columbia Journal of European Law 565 (2007), pp. 565–594, at 579Google Scholar.

55 Already in 1998, Rasmussen expressed the fear that that “the price of too many years of too unmitigated activism will be a decline in judicial authority and legitimacy.” H. Rasmussen, Hjalte. (1998). European Court of Justice. Copenhagen: GadJura, p. 301 Google Scholar. The legitimation and authority of the European Courts of Human Rights is now directly called into question in the UK. “British judges not bound by European court of human rights, says Leveson,” The Guardian, 24 May 2015, available at http://www.theguardian.com/law/2015/may/24/british-courts-echr-leveson.

56 Examples of poor legal reasoning include (1) Case 1/03, Van de Walle and Others, [2004] ECR I-7613. For a critique, see Bergkamp, L., A new court-made environmental liability regime for Europe, Env. Liability 12 [2004] 4, 171 Google Scholar; (2) Case T-333/10, ATC and Others v Commission. For a critique, see Bergkamp, L., The Quiet Revolution in EU Administrative Procedure: Judicial Vetting of Precautionary Risk Assessment, European Journal of Risk Regulation, Volume 5 (2014), Issue 1, pp. 102–110 CrossRefGoogle Scholar; (3) Joined Cases C-503/13 and C-504/13, preliminary ruling in the proceedings Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13). For a critique, see Bergkamp, L., Is There a Defect in the European Court’s Defect Test? Musings about Acceptable Risk, European Journal of Risk Regulation, Volume 6 (2015), Issue 2, pp. 309–322 CrossRefGoogle Scholar. Cf. Conway, Gerard, The Limits of Legal Reasoning and the European Court of Justice, Cambridge: Cambridge University Press, 2014 Google Scholar.