Legal remedies under the EC'S new chemicals legislation reach: Testing a new model of European governance

Common Market Law Review

Volumn 46, Issue 6, 2009, Pages 1823-1871

  Bronckers, Marco ^a   van Gerven, Yves ^a  

^a LEIDEN UNIVERSITY   (Netherlands)

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EID: 77954224153     PISSN: 01650750     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (271)

1. Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 Dec. 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, O.J. 2006, L 396/1; corrigenda in O.J. 2007, L 136/3.
2. See the Commission's Extended Impact Assessment in 2003, accompanying its proposal for REACH legislation: ec.europa.eu/enterprise/reach/docs/reach/eia-sec-2003_1171_en.pdf (see p. 11, point 5.2).
3. See Verband der Chemischen Industrie (VCI), Der Entstehungsprozess von REACH, p. 18-20 (Stand: Feb. 2007).
4. See e.g. Hartung and Rovidar, "Chemical regulators have overreached", 460 Nature (2009), 1080-1081.
5. ECHA, "New Study inaccurate on the number of test animals for REACH", (2008), available at: echa.europa.eu/doc/press/pr_09_11_animal_testing_20090828.pdf.
6. An analysis of the legal remedies that may be available to public authorities amongst themselves, or to civil society, falls outside the scope of this article.
7. See references throughout this article.
8. ECHA's website contains many useful details, see echa.europa.eu. ECHA's mandate covers environmental safety issues linked to chemical safety. It is noted that the European Environmental Agency (EEA) website contains a video tutorial on REACH, and contains an external link to ECHA's website.
9. See www.eea.europa.eu/themes/chemicals/links/eu-institutions/european-chemic als-agency-echa. Unlike ECHA, the EEA does not take binding decisions.
10. REACH, Art. 100.
11. Ibid., Arts. 75 et seq.
12. Figures obtained from ECHA's Budget and Establishment Plan for 2009, available at echa.europa.eu/doc/about/organisation/mb/mb_68_2008_budget_establishment_plan_2009. pdf.
13. REACH, Arts. 83-84.
14. The operation of this Board will be analysed in more detail below, in section 3.
15. REACH, Arts. 125-126.
16. Memorandum of Understanding between the European Chemicals Agency and the European Food Safety Authority (signed 20 May 2009), at 2. Available at: echa.europa.eu/doc/ECHADocuments/mou_echa_efsa.pdf.
17. The minutes to the meeting of the Management Board of 23/24 April 2009 reveal that some Board members and ECHA's Executive Director "supported the need for close cooperation and indicated that first steps to intensify cooperation had already been made, not only with the EEA but also with EFSA and EMEA.".
18. See Minutes of the Meeting of the Management Board 23/24 April 2009, MB/M/02/2009 final, at 16. Available at: echa.europa.eu/doc/about/organisation/mb/meetings/mb_meet_min_20090423.p df.
19. ECHA has taken over the more limited role of the European Chemicals Bureau ("ECB") which started its work in Jan. 1993 and was part of the Institute for Health and Consumer Protection (IHCP), one of the 7 scientific institutes in the European Commission's Joint Research Centre (JRC). Institutionally, it therefore formed part of the Commission. Its mission was to provide scientific and technical support to the conception, development, implementation and monitoring of EU policies on chemicals and consumer products.
20. REACH, preamble 95.
21. See, supra text at notes 7-9.
22. REACH, Art. 83(1).
23. The growing number of European agencies, mostly only with advisory powers, represents a notable new feature of the EU's evolving institutional structure, which for the time being lacks a basis in the European treaties. This development has been dealt with elsewhere.
24. See e.g. Curtin, Executive Power of the European Union (OUP, Oxford, 2009), pp. 140-174 (who ascribes "satellite executive power" to European agencies).
25. Curtin, "Holding (quasi-) autonomous EU administrative actors to public account", 13 ELJ (2007), 523.
26. Geradin and Petit, "The Development of Agencies at EU and National Levels: Conceptual Analysis and Proposals for Reform", Jean Monnet Working Paper 01/04 (NYU School of Law, available at www.jeanmon-netprogram.org/papers/04/040101.pdf). The latest views of the Commission on this new trend are found in its Communication to the Parliament and the Council of 11 March 2008 entitled European Agencies - The Way Forward, COM(2008)135 final.
27. For an update, see the official online portal, accessible at: europa.eu/agencies/.
28. See, supra text at note 16.
29. These are decisions notably on dossier and substance evaluations, identifying substances of very high concern, and appointing Competent Authorities.
30. See infra text at notes 52-62.
31. See Council Decision 1999/468/EC (the Comitology Decision), O.J. 1999, L 184/23, as amended.
32. More influence was accorded to the European Parliament in the recent amendment to the comitology procedures introduced in 2006.
33. See Council Decision 2006/512/EC, O.J. 2006, L 200/11.
34. See Schusterschitz and Kotz, "The Comitology Reform of 2006: Increasing the powers of the European Parliament without changing the Treaties", 3 EuConst (2007), 68.
35. We thank Jorrit Rijpma for pointing out that there appears to be a "double" comitology at work in respect of ECHA.
36. See Art. 5 of Council Decision 1999/468/EC, cited supra note 30.
37. Although the Member State Committee can overrule ECHA, presumably the Committee cannot simply ignore the scientific findings on which ECHA's escalated draft decision was based.
38. The Commission's role is somewhat more circumscribed in the most far-reaching comitology procedure, which gives a bigger role to the European Parliament, the so-called "regulatory procedure with scrutiny" (see Art. 5a Council Decision 1999/468/EC, as amended).
39. See Vogelezang-Stoute, "De regulering van chemische stoffen: na 40 jaar een begin met REACH", 56 SEW (2008), 89, at 94. For instance, where all 27 Member States are represented on ECHA's Management Board, this is not the case for EFSA. Cf. Recital 41 and Art. 25 of Reg. (EC) 178/2002 of the European Parliament and of the Council 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, O.J. 2002, L 31/1.
40. See Chiti, "An important part of the EU's institutional machinery: Features, problems and perspectives of European agencies", 46 CML Rev. (2009), 1395-1442.
41. We will discuss our proposal, infra text at notes 211-213.
42. See Heyvaert, "The EU Chemicals Policy: Towards inclusive governance?" in Vos (Ed.), European Risk Governance: Its Science, its Inclusiveness and its Effectiveness (The CONNEX Report Series No. 6, 2008), p. 185, at p. 195.
43. REACH, Art. 5.
44. Ibid., recital 19; Arts. 6 (addressing manufacturers and importers of chemical substances) and 7 (the latter Article extending the registration obligation under certain circumstances to manufacturers and importers of articles, containing chemical substances).
45. The obligation to register new substances started 12 months after the entry into force of REACH, i.e. 1 June 2008.
46. REACH, Arts. 28(2) and 23. All in all, 65,000 companies pre-registered some 150,000 substances, generating 2.75 million pre-registrations.
47. See Eckstein, "ECHA publishes list of pre-registered substances", Europolitics, 7 Jan. 2009 at 5.
48. REACH, Arts. 29-30. Each SIEF shall remain operational until 1 June 2018 which is the last deadline for phase-in substances.
49. See generally, ECHA, Guidance Document on Data Sharing (2007).
50. ECHA will adopt decisions requiring participants to repeat available tests on vertebrate animals if the owner of the test study persists in refusing to provide the study to them (REACH, Art. 30(3)) as well as decisions specifying which registrant must perform a test which is not available within the SIEF (REACH, Art. 30(2)).
51. REACH, preamble recital 48, as discussed, e.g., by Forbes, "The long arm of REACH: How to navigate through the compliance process", 18 European Energy and Environmental Law Review (2009), 34, at 46-48.
52. If no agreement on data sharing can be reached, ECHA shall give the potential registrant permission to refer to the information requested by him in his registration dossier, subject to the potential registrant providing proof that he has paid the previous registrant for that information a share of cost incurred (REACH, Art. 27(6)).
53. REACH, Art. 20(2).
54. ECHA's website does not presently list these national laws. An ECHA "Frequently Asked Questions on REACH by Industry" document refers industry to the relevant customs authorities or national helpdesk for more information on these laws. Contact details for national helpdesks can be accessed on the following website: echa.europa.eu/reach/helpdesk/nationalhelp_contact_en.asp.
55. ECHA, Guidance Document on Dossier and Substance Evaluation (2007), p. 48. Available at: guidance.echa.europa.eu/docs/guidance_document/evaluation_en.pdf.
56. REACH, Art. 40.
57. REACH, Art. 41(3).
58. ECHA must submit the first draft CRAP to the Member States by 1 Dec. 2011.
59. REACH, Art. 46(1).
60. See, supra text following note 28.
61. REACH, Art. 51(6) and (7). On comitology see supra text at note 30.
62. REACH, Art. 55.
63. On the escalation procedure see supra text following note 28.
64. REACH, Arts. 7(2) and 33.
65. See supra note 35. It has been stated that the Commission is not bound by the prioritization given in ECHA's recommendation and that the decision will be taken in the form of a Commission Regulation.
66. See ECHA, Guidance Document on inclusion of substances in Annex XIV (2008), 27. Available at: guidance.echa.europa.eu/docs/guidance_document/annex_xiv_en.pdf?vers=12_ 08_08.
67. See Recommendation of ECHA of 1 June 2009 for the inclusion of substances in Annex XIV (the list of substances subject to authorization) of Reg. (EC) 1907/2006. Available at: echa. europa.eu/doc/authorisation/annex_xiv_rec/annex_xiv_subst_inclusion.pdf.
68. REACH, Art. 62(1) and (4).
69. See supra text at notes 31-33.
70. REACH, Art. 60(2), provides that an authorization "shall" be granted.
71. See REACH Annex XVII. Council Directive 76/769 regulating dangerous substances expired on 1 June 2009.
72. See REACH, Art. 139.
73. REACH, preamble recital 91.
74. REACH, preamble para 14.
75. The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the PIC Convention), done in Rotterdam, Netherlands on 10 Sept. 1998.
76. REACH, Art. 119(1). Compared to previous chemicals legislation of the EC, REACH treats less information about chemical substances as being confidential to the producing companies.
77. See Fluck, "REACH, Vertraulichkeit von Informationen versus Transparanz und Wirbeltierschutz", 1 Stoffrecht (2004), 59, at 62-63 (note that the author discusses an early draft of the REACH legislation which went further in some respects than the final text).
78. REACH, Art. 77(2)(f).
79. Ibid., Arts. 119(2), 77(2)(e), and 10(a)(xi).
80. The REACH Regulation does not contain express provisions granting companies the right to claim confidentiality with respect to information provided in the context of authorization applications. However, it is a general principle that EU institutions must take into account the legitimate interest of companies in the protection of their business secrets (see e.g. Case 53/85, Akzo Chemie v. Commission, [1986] ECR 1965, paras. 28-30).
81. Parliament and Council Regulation 1049/2001, O.J. 2001, L 145/43.
82. See REACH, Art. 118(1).
83. See Decision on the Implementation of Regulation (EC) No. 1049/2001 of the European Parliament and of the Council Regarding Public Access to Documents to European Parliament, Council and Commission Documents, MB/12/2008 final (Helsinki, March 2009). Available at: echa.europa.eu/doc/about/organisation/mb/mb_12_2008_final_implementing_r ules_access_to_documents.pdf.
84. See Arts. 4(1) and (2) of Regulation 1049/2001, cited supra note 91.
85. REACH, Art. 118(2). The grounds for confidentiality listed here appear to be enumerative rather than limitative.
86. See Decision on the Implementation of Regulation (EC) No. 1049/2001, cited supra note 92. This decision might be taken by the Director of the Directorate that holds the document.
87. Ibid., at Arts. 3-4, notably at Art. 4(1).
88. This decision is not mentioned in REACH, Art. 91. We note the Management Board, in its 13th meeting of 25-26 June 2009, approved a document on the "Readiness of the Board of Appeal" which lists the "drafting of internal guidelines to facilitate the decision process on difficult aspects linked to potential appeals, such as requests of confidentiality, access to public documents, proportionality, etc," as a project "in which the Board of Appeal is currently involved.".
89. See 13th Meeting of the Management Board 25-26 June 2009: Readiness of the Board of Appeal, MB/50/2009 final (Helsinki, 25 June 2009). Available at: echa.europa.eu/doc/about/organisation/mb/mb_50_2009_readiness_of_boa.pdf . We discuss this below at, infra text at notes 141-142.
90. ECHA is not obliged to consult the author if it determines that full or partial disclosure would "obviously not affect one of the interests" referred to in Reg. 1049/2001.
91. See Decision on the Implementation of Regulation (EC) No. 1049/2001, cited supra note 92, at Art. 5(3)(b).
92. Ibid., at Arts. 5(4)-5(6).
93. See infra text at note 144.
94. Regulation (EC) No. 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals, O.J. 2008, L 204/1.
95. REACH, Art. 120.
96. Art. 19(3) of Regulation 689/2008, cited supra note 102.
97. The Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, done in Aarhus, Denmark on June 25, 1998 (entered into force on 30 Oct. 2001.) The Convention was ratified by all EC Member States, with the exception of Ireland (the last Member State to ratify being Germany on 15 Jan. 2007). Available at: treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&id=531&chapter =27&lang=en.
98. Parliament and Council Directive 2003/4, O.J. 2003, L 41/26.
99. Parliament and Council Directive 2003/35, O.J. 2003, L 156/17.
100. Parliament and Council Regulation 1367/2006, O.J. 2006, L 264/13.
101. Ibid., at preamble 15 and Arts. 3 and 6.
102. REACH, Art. 118(2).
103. E.g., in its detailed report to UNECE on the EC's implementation of the Aarhus Convention, of June 2008, the Commission refers to a wide variety of EC environmental measures affected by the Convention, but REACH is not mentioned once.
104. See Implementation Report by the European Community, submitted to the UN Economic and Social Council at the Meeting of the Parties to the Convention on Access to Information, Public Participation in Decision-Making.
105. See Proposal for a Regulation of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents, COM(2008)229 final (30 April 2008). In its report of 19 Feb. 2009 on this proposal the European Parliament emphasized that all European institutions, including European agencies, should apply these transparency principles.
106. See A6-0077/2009. But see de Abreu Ferreira, "Passive access to environmental information in the EU, an analysis of recent legal developments", 17 European Energy and Environmental Law Review (2008), 186, at 189 (implying that the Commission's proposals will not encompass European agencies, though the author may have based this assessment on an earlier version of COM(2008)229 which did not specifically address agencies).
107. See ECHA Work Programme 2008, MF/18/2007 final (Helsinki, 17 Oct. 2007), at 7. Available at www.okbi.hu/reach/english/echa_work_programme_2008.pdf. It was agreed in the minutes of the 1st Management Board meeting that ECHA's Interim Executive Director would "at the appropriate stage, draft rules for implementing the Regulation (EC) N( 1367/2007 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies.".
108. See Minutes of the Meeting of ECHA's Management Board held 27-29 June 2007, MB/M/01/2007 final (Helsinki, no date specified), at 13. Available at: echa.europa. eu/doc/MB__M_01_2007%20Minutes%20of%20Management%20Board%20meeting2027-2 9%20June.pdf.
109. This document was approved by the Management Board on 23 April 2008, and amended on 25 March 2009 to include an email address dedicated to the submission of access requests to documents (access-to-documents@echa.europa.eu).
110. See Decision on the Implementation of Regulation (EC) No. 1049/2001 of the European Parliament and of the Council Regarding Public Access to Documents to European Parliament, Council and Commission Documents, MB/12/2008 final (Helsinki, 25 March 2009), available at: echa.europa.eu/doc/about/organisation/mb/mb_12_2008_final_implementing_r ules_access_to_documents.pdf.
111. Work Programme of the European Chemicals Agency for 2009, MB/57/2008 final (Helsinki, 25 Sept. 2008). Available at: echa.europa.eu/doc/work_programme/2009/echa_wp_2009_ en.pdf.
112. See Minutes of the Meeting of ECHA's Management Board held no 13/14 Feb. 2008, MB/M/01/2008 final (Helsinki, no date specified), at p. 14. Available at: echa.europa eu/doc/about/organisation/mb/meetings/mb_m_01_2008_meet_minut_%201302200 8%20_en_20080610.pdf.
113. See Art. 13 of Regulation 1367/2006, cited supra note 107.
114. The Commission did so in 2008/401/EC, Euratom: Commission Decision of 30 April 2008 amending its Rules of Procedure as regards detailed rules for the application of Reg. 1367/2006 of the European Parliament and of the Council on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institution and bodies, O.J. 2008, L 140/22; the EIB did so in revising its Public Disclosure Policy on 17 July 2007. Para 15 of this revised Disclosure Policy contemplates that "the Public Disclosure Policy shall be interpreted in accordance with the provisions of [the Aarhus] Regulation whenever the latter are applicable. In the event of divergence, in the environmental field, the provisions of the Aarhus Regulation shall prevail.".
115. See p. 6 of the EIB's revised Public Disclosure Policy, available at: www.eib.org/attachments/strategies/public_disclosure_policy_en.pdf.
116. See General Report of the European Chemicals Agency 2008, MB/17/2009 final (Helsinki, 24 April 2009), at 24. Available at: echa.europa.eu/doc/about/organisation/mb/mb_17_ 2009_final_echa_general_report.pdf.
117. ECHA reported in the minutes of its 4th Management Board meeting in 2007 that it had received a transparency request under Regulation 1367/2006, without further clarifying comments.
118. See Minutes of the Meeting of ECHA's Management Board held 16-17 Oct. 2007, MB/M/04/2007 final (Helsinki), at 3-4. Available at: echa.europa.eu/doc/FINALMBM04 2007 Minutes%20of%20ManagementBoardMeeting16-17October2007.pdf. This transparency re quest concerned a Commission decision of 12 Sept. 2007 adopting the list of candidates for the appointment of Executive Director of ECHA by the Management Board. The Commission (sic!) ultimately deemed the request addressed to ECHA inadmissible, as its decision of 12 Sept. 2007 did not satisfy the requirement in Art. 2(1)(g) of the Aarhus Regulation of being an "act" with "legally binding and external effects."
119. For more information, see Item 1 of DG Environment's Aarhus Internal Review portal, accessible at: ec.europa.eu/environment/aarhus/internal_review.htm.
120. Art. 39 TRIPS.
121. See e.g. the European Commission's Trade Barriers Regulation investigation into Turkish pharmaceutical laws in TBR Proceedings Concerning Turkish Practices Affecting Trade in Pharmaceutical Products, Report to the Trade Barriers Regulation Committee (13 Sept. 2004). Available at trade.ec.europa.eu/doclib/html/119478.htm.
122. See generally Bronckers and Ondrusek, "Protection of regulatory data in EU and WTO Law: the example of REACH", 8 Journal of World Intellectual Property (2005), 579-598.
123. As envisaged by the basic regulation REACH, Art. 93(4), in Aug. 2008 the Commission adopted the rules of procedure for the Board of Appeal, Commission Regulation 771/2008, O.J. 2008, L 206/5. In addition, the Board subsequently published some temporary guidelines, see echa.europa.eu/appeals/app_procedure_en.asp (Nov. 2008).
124. REACH, Art. 91.
125. Compare REACH, Art. 92 with Art. 230(4) EC (discussed, infra text at notes 177-178).
126. REACH, Art. 93(1).
127. See Art. 242 EC.
128. REACH, Art. 93(3).
129. See generally Castillo de la Torre, "Commentary on Art. 220 EC" in Smit & Herzog on the Law of the European Union (Matthew Bender & Co; looseleaf, last updated Dec. 2008), at § 318.10.
130. Jacobs, "The Role of the European Court of Justice in the protection of the environment", 18 Journal of Environmental Law (2006), 185, at 195.
131. See Art. 233 EC; Lenaerts, Arts and Maselis, Procedural Law of the European Union, 2nd ed. (Sweet & Maxwell, London, 2006), pp. 318-320.
132. Compare, ibid., Art. 9 with Art. 19 of the Protocol on the Statute of the Court of Justice annexed to the Treaty on European Union.
133. See Art. 6(6) of Commission Regulation 771/2008, cited supra note 125.
134. For similar reasons, part of the notice of appeal may not have been published on ECHA's website.
135. See, id., Art. 6(1)(g).
136. REACH, Art. 93(4).
137. Commission Regulation 771/2008, cited supra note 125.
138. See Temporary Guidelines on Appeal (Nov. 2008), available at echa.europa.eu/appeals/app_procedure_en.asp. This document clarifies, at Heading 1, that the Temporary Guidelines shall apply until the Board of Appeal adopts "additional rules of a procedural nature necessary for the efficient processing of" appeals pursuant to Art. 27 of Regulation 771/2008, ibid.
139. Except in unusual cases where the European Courts find that appellants have committed an abuse of process, e.g. by submitting pleadings which the Courts find too voluminous.
140. See Art. 72 of the Rules of Procedure of the Court of Justice of the European Communities of 19 June 1991, O.J. 1991, L 176/7, and O.J. 1992, L 383/117 (corrigenda), last amendment published in O.J. 2009, L 24/8; and Art. 90 of the Rules of Procedure of the Court of First Instance of the European Communities of 2 May 1991, O.J. 1991, L 136/1, and O.J. 1991, L 317/34 (corrigenda), last amendment published in O.J. 2009, L 24/9.
141. See Art. 10 and Annex VIII of Commission Regulation 340/2008, O.J. 2008, L 107/6.
142. See ibid., Art. 10(4).
143. See Readiness of the Board of Appeal, cited supra note 97, at 3.
144. See text above supra notes 83-84.
145. REACH, Art. 118(3). This decision is not mentioned in REACH, Art. 91.
146. See Decision establishing remedies for reviewing a partial or full rejection of a confidentiality request pursuant to Art.
147. Id., at recital 1 and Arts. 3-4. Although the Decision does not specifically cover information provided by companies in the authorization phase, we see no reason why such a review should also not be made available for this information.
148. See Decision on the Implementation of Regulation (EC) No. 1049/2001, cited supra note 92.
149. Defined as "any content whatever in electronic form or as a sound, visual or audiovisual recording) concerning a matter relating to the policies, activities and decisions falling within the institution's sphere of responsibility," at Art. 3(a) of Regulation 1049/2001, cited supra note 91.
150. See Art. 3 of Regulation 1367/2006, cited supra note 107. Art. 2(1)(d) thereof defines environmental information as "any information in written, visual, aural, electronic or any other material form on:" (i) the state of the elements of the environment; (ii) factors affecting or likely to affect the state of the elements of the environment; (iii) measures (including protective measures) affecting or likely to affect the state of the elements of the environment, and any economic analyses underlying these measures; (iv) reports on the implementation of environmental legislation; and (v) the state of human health and safety.
151. See Art. 7(1) of Regulation 1049/2001, cited supra note 91, and Art. 2 of the Decision on the Implementation of Regulation (EC) No. 1049/2001, cited supra note 92.
152. See Decision on the Implementation of Regulation (EC) No. 1049/2001, cited supra note 92, at Art. 4(1).
153. See Arts. 2(1)(f) and (g) of Regulation 1367/2006, cited supra note 107.
154. REACH, Art. 120.
155. REACH, Art. 133(2).
156. See Art. 10(1) of Regulation 1367/2006, cited supra note 107.
157. Ibid., at Arts. 10(2) and 10(3).
158. 2008/50/EC: Commission Decision of 13 Dec. 2007 laying down detailed rules for the application of Regulation (EC) No. 1367/2006 of the European Parliament and of the Council on the Aarhus Convention as regards requests for the internal review of administrative acts, O.J. 2008, L 13/24.
159. Email correspondence from ECHA's Helpdesk on 8 April 2009, on file with the authors.
160. See Art. 11(1)(a) of Regulation 1367/2006, cited supra note 107.
161. See also the explicit requirement that any entity requesting an internal review pursuant to the Aarhus regulation must produce evidence that it is a non-governmental organization. Commission Decision 2008/50/EC, cited supra note 163, at Art. 3.
162. The Commission generally takes a restrictive view of the internal review envisaged in the Aarhus Regulation.
163. See the pending appeal in Case T-338/08, Stichting Natuur en Milieu and Pesticide Network Europe v. Commission, O.J. 2008, C 301/40.
164. REACH, Art. 94(1). However, where a decision of ECHA is open to challenge before the Board, the appellant cannot by-pass the Board and immediately contest this decision before the European Courts. This follows, a contrario, from REACH, Art. 94(1).
165. Here the question will be, however, whether they constitute "decisions" or measures of a general nature.
166. REACH, Art. 94(2).
167. Art. 230(4) EC.
168. Art. 232(3) EC.
169. Art. 288 EC.
170. For an overview of the case law on this requirement, see Lenaerts et al., op. cit. supra note 132, at pp. 211-216.
171. Art. 230(4) EC.
172. For an overview of the extensive case law, see Lenaerts et al., op. cit. supra note 132, at pp. 255 et seq.
173. See supra text at notes 19 and 50.
174. See Art. 234 EC. Case 314/85, Foto-Frost v. Hauptzollamt Lübeck-Ost, [1987] ECR 4199.
175. In fact, one of the provisions itself from the basic REACH Regulation, Art. 6(3) (relating to polymers and monomers), was already challenged, albeit unsuccessfully, through such a request for a preliminary ruling from a UK Court.
176. See Case C-558/07, R (SPCM SA and Others) v. Secretary of State for Environment, Food and Rural Affairs, judgment of 7 July 2009, nyr.
177. Case C-188/92, TWD Textilwerke Deggendorf, [1994] ECR I-833.
178. See the discussion in Lenaerts et al., op. cit. supra note 132, at pp. 358-359.
179. REACH, Art. 30(3).
180. E.g. the registrants' and downstream users' right to comment on draft decisions of ECHA under dossier and substance evaluation (REACH, Art. 50) and the opportunity for interested parties to submit comments on ECHA's proposed inclusion of substances on the candidate list (REACH, Art. 59(4)) or on ECHA's draft recommendation of priority substances to be included in the authorization list (REACH Art. 58(4)). Equally, companies applying for authorizations have a right to comment on the draft opinions of the Committees for Risk Assessment and for Socio-economic Analysis before the final opinions are adopted and sent to the Commission (REACH, Art. 64(5)). In the restriction phase, interested parties may also comment on draft opinions of these committees (REACH, Arts. 70-71).
181. REACH, recitals 15 and 95.
182. In its recent Communication on Regulatory Agencies, the Commission identified the need for mechanisms to ensure accountability for actions of regulatory agencies as one of the building blocks for a common approach to those agencies (supra note 27, at 7). The issue of accountability of European agencies is addressed at length in Giuffrida, "Accountability and the Reform of European Governance: Comitology and Agencies in the Regulation of GM-Food and Chemicals", doctoral thesis (Queen Mary, University of London, 2009), 394 (on file with the authors).
183. But see supra note 34.
184. See discussion, supra text at note 44.
185. See ECHA, op. cit. supra note 44, at 35 (§4.5.1). Available at: guidance.echa.europa.eu/docs/guidance_document/data_sharing_en.pdf.
186. See ECHA document, SIEF - Key Principles (13 Feb. 2009) ("ECHA will not participate in discussions between potential registrants and will not confirm or disallow the creation of a particular SIEF"). Available at: echa.europa.eu/doc/reachit/sief_key_principles.pdf. In its meeting of 23/24 April 2009, the Management Board assessed that the 13 Feb. 2009 press release "seems to have had only a limited effect" on resolving difficulties among pre-SIEF participants. The Management Board indicated that additional efforts were needed.
187. See the Minutes of the Meeting of the Management Board of 23/24 April 2009, cited supra note 21, at pp. 18-19.
188. If the concern were that ECHA might be overburdened by the responsibility of deciding all conceivable disputes regarding the chemical equivalence of substances, cooperation between ECHA and the competent CAs of the Member States could have been envisaged.
189. Compare Lenaerts and Verhoeven, "Towards a legal framework for executive rulemaking in the EU? The contribution of the new Comitology Decision", 37 CML Rev. (2000), 645, at 661-662.
190. For an in-depth overview of mechanisms to keep agencies accountable, with a case study of ECHA, see Giuffrida, op. cit. supra note 186, at 136-149 and 264-304.
191. See also the enumeration in Vos, "Reforming the European Commission: What Role to Play for EU Agencies?", 37 CML Rev. (2000), 1113, at 1126.
192. REACH, Art. 83(2)(k).
193. See discussion, infra text at notes 211-213. In any event, Member State competent authorities have prime responsibility in the risk assessment of substances (substance evaluation) with ECHA only assuming a supervisory and coordinating role. Practice will show whether ECHA's formal adoption of draft decisions prepared by the Member State competent authorities will amount to more than mere "rubber-stamping".
194. See Communication on Regulatory Agencies, cited supra note 27, at 5.
195. Case 9-56, Meroni v. High Authority, [1958] ECR 133.
196. For commentaries on the implications of this judgment, see e.g., Lenaerts, "Regulating the regulatory process: 'delegation of powers' in the European Community", 18 EL Rev. (1993), 23, at 40-43.
197. Lenaerts and Verhoeven, op. cit. supra note 192, at 656-657.
198. Meroni v. High Authority, cited supra note 197, at 152.
199. See the Commission's recent Communication on Regulatory Agencies, "European Agencies - The way forward", cited supra note 27, at 5.
200. See Chiti, op. cit. supra note 37, text at notes 79-81.
201. Curtin (2009), op. cit. supra note 27, at 54-58.
202. E.g., Dutheil de la Rochère, "EU Regulatory Agencies: What Future do They Have?" in Bulterman et al. (Eds.), Views of European Law from the Mountain - Liber Amicorum Piet Jan Slot (Kluwer Law International, 2009), p. 355, at pp. 362-364.
203. Geradin and Petit, op. cit. supra note 27, at 15; Vos, op. cit. supra note 193, at 1123-1124.
204. See the Presidency Conclusions of the Brussels European Council Meeting of 18/19 June 2009 (No. 1125/09), at para 20. Available at: www.eu2009.cz/scripts/file.php?id=57340&down=yes.
205. See the Communication from the Commission of 11 Dec. 2002 entitled "The operating framework for the European Regulatory Agencies", COM(2002)718 final, at 5.
206. See Meroni v. High Authority, cited supra note 197, at 151.
207. In the same way, Case T-311/06, FMC Chemical v. Commission, order of 17 June 2008, nyr, at para 66.
208. See discussion, supra text at notes 189-190.
209. See e.g., REACH, Art. 75(1): ECHA is "established for the purpose of managing and in some cases carrying out the technical, scientific, and administrative aspects of this Regulation and to ensure consistency at Community level in relation to these aspects.".
210. Such a decision is not listed in REACH, Art. 91.
211. See REACH, Art. 94(1).
212. Case 60/81, IBM, [1981] ECR 2639, paras. 8-9.
213. See discussion, supra text at notes 30-33.
214. See discussion, supra text at notes 129-135.
215. See more generally Curtin, op. cit. supra note 27.
216. From the start, EC trading partners have raised concerns about REACH, concerns which have often translated into claims that REACH is inconsistent with the EC's obligations in the WTO. For an early analysis see Bronckers and Charro, "REACH Reviewed under WTO Law", 2 Journal for European Environmental & Planning Law (2005), 184-194. The EC has tried to address some of these concerns in the text of the REACH Regulation, which finally entered into force on 1 June 2007.
217. See Quick, "Zur Vereinbarkeit von REACH mit dem WTO-Recht", (2007) Neues Europäisches Chemikalienrecht (REACH), 23rd Trierer Kolloquium zum Umweltund Technikrecht. Nevertheless, the complaints of trading partners have not abated. Thus, one of the first acts of the incoming Obama Administration has been to seek information from US industry on the trade-impeding impact of REACH.
218. See "USTR Collecting Information on Barriers Caused by REACH", 27 Inside US Trade (2009), 19. For an overview of current complaints from other EC trading partners about REACH see the minutes of the WTO's Technical Barriers to Trade Committee. A recent sample is contained in the minutes of the TBT's November 2008 meeting.
219. See WTO doc. G/TBT/M/46, at 29-39 (23 Jan. 2009).
220. See discussion, supra text at note 126.
221. See discussion, supra text at note 167.
222. See discussion, supra text at notes 129-135.
223. With respect to testing proposals see REACH, Arts. 40(3) and 51.
224. See discussion, supra text at note 126.
225. See discussion, supra text at note 128.
226. See discussion, supra text at notes 164-166.
227. It is not particularly clear how the "review procedure" contemplated at Art. 9(2) differs from that covered by Art. 9(3) Convention.
228. See generally Stec, Casey-Lefkowitz, Jendrośka et al., "The Aarhus Convention: An implementation guide. UN/ECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters" (United Nations, 2000), at 123-136. Available at www.unece.org/env/pp/acig.pdf. ("Aarhus Implementation Guide").
229. See Proposal for a Regulation of the European Parliament and of the Council on the Application of the Provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to EC institutions and bodies, COM(2003)622 final (Brussels, 24.10.2003), at 14.
230. The application of Art. 9(2) Convention is connected to measures covered by Art. 6 Convention. REACH-based measures could be deemed to represent or involve environmental impact assessments within the meaning of Art. 6(1)(a) and Annex I, Item 20 of the Aarhus Convention. Alternatively, REACH-related measures could perhaps also be deemed to have significant effect on the environment, within the meaning of Art. 6(1)(b) of the Aarhus Convention.
231. See Art. 3(5) of the Aarhus Convention; discussed in Aarhus Implementation Guide, supra note 224, at 128.
232. The principle that EC legislation must be interpreted consistently with Treaties to which the EC is a party is well-established in the case law of the European Court of Justice. E.g., Case C-286/90, Poulsen, [1992] ECR I-6019.
233. Case C-377/98, Netherlands v. European Parliament and Council, [2001] ECR I-7079; Joined Cases C-477 & 448/05, Thomson Multimedia, [2007] ECR I-2049.
234. Notably, REACH, Art. 91; discussed, supra text following note 128.
235. This first step, of an internal appeal within the Agency, is currently envisaged in access scenarios 1 and 2 (and the role of the Executive Director is already mentioned in respect of scenario 2).
236. See supra, text at notes 146-160.
237. See, supra text following note 158.
238. See, supra text at notes 102-104, and 158-159.
239. E.g., ECHA's role in the preparation of decisions by the Commission on applications for authorization.
240. See discussion, supra text at notes 69-74.
241. See, supra text at notes 211-213.
242. The REACH Regulation does contemplate that private parties be given the opportunity to comment on draft opinions of ECHA's Risk Assessment and Socio-economic Analysis Committees, for instance in respect of their authorization requests.
243. See REACH, Art. 63(5). However, once ECHA turns these authorization requests, together with the Committees' opinions, over to the Commission, private parties are no longer heard. Thus, they cannot express their views on how the Committees have dealt with any comments they may have submitted, or on any additional reflections the Commission's services may formulate in proposing a final decision to the Commission.
244. See discussion, supra text at notes 165-166.
245. Art. 230(4) EC.
246. Case 294/83, Les Verts v. European Parliament, [1986] ECR 1339.
247. E.g., Geradin and Petit, op. cit. supra note 27, at 53.
248. Case T-411/06, Sogelma v. European Agency for Reconstruction, judgment of 8 Oct. 2008, nyr.
249. REACH, Art. 94.
250. See, supra text at notes 177-178.
251. Art. 40(2) of the REACH Regulation provides that information relating to testing proposals involving tests on vertebrate animals shall be published on ECHA's website and third parties shall be invited to submit information and studies that address the relevant substance and hazard, before the ECHA or the Commission adopt the decision to approve or reject the testing proposals.
252. See the references in Lenaerts et al., op. cit. supra note 132, at p. 259.
253. See e.g. case law in the field of State aids regarding standing of competitors of recipients of aid to challenge decisions declaring the aid compatible with the common market (Case C-367/04 P, Deutsche Post and DHL Express (Italy) SrL v. Commission, [2006] ECR I-26, paras. 41-42.
254. Case C-525/04 P, Spain v. Lenzing AG, [2007] ECR I-9947).
255. However, the Community legislature only has this choice with respect to decisions of ECHA, as the admissibility criteria for challenging acts of the Commission are defined in the EC Treaty itself. For instance, in the area of disputes relating to intellectual property rights, private parties lodging actions before the CFI against decisions of the Board of Appeal of the Office for Harmonization in the Internal market (Trade Marks and Designs) (OHIM) and of the Community Plant Variety Office must only demonstrate that they are "adversely affected" by the contested decision. This is a less strict standing requirement. Art. 263(5) of the Lisbon Treaty expressly provides that secondary legislation may formulate specific conditions and arrangements concerning actions brought by private persons against acts of agencies intended to produce legal effects against them.
256. Recall that REACH obliges Member States to impose penalties for non-compliance that are "effective, proportionate and dissuasive".
257. See REACH, Art. 126.
258. See ECtHR, Appl. 27824/95, Posti and Rahko v. Finland, 37(1) EHHR 158-182 (2003), at para 64. The relevance of this judgment (and Art. 6 (1) ECHR) for private appeals against EC measures is discussed in Lewis, "Standing of private plaintiffs to annul generally applicable European Community Measures: If the system is broken, where should it be fixed", 30 Fordham International Law Journal (2007), 1496, at 1538.
259. Another remedy, bypassing the admissibility restrictions on direct actions, is for private parties to lodge a claim for damages against the EC institutions. Yet this can only be considered a remedy of last resort. When all is said and done, Community courts have rarely honored private damage claims; moreover, they seem inclined to narrow the circumstances in which such claims will be favourably reviewed. Recently, for instance, the ECJ held that the EC institutions were not liable for damages caused by legislative activity, in the absence of unlawful conduct (Joined Cases C-120/06 P & C-121/06 P, FIAMM and Fedion v. Council and Commission, judgment of 9 Sept. 2008, nyr, at para 175).
260. Art. 263(4) Lisbon Treaty, amending and replacing Art. 230(4) EC.
261. See Barents, Het Verdrag van Lissabon (Kluwer, Deventer, 2008), p. 508.
262. The restriction of the notion of "regulatory acts" to non-legislative acts has been criticized by Dougan, "The Treaty of Lisbon 2007: Winning minds not hearts", 45 CML Rev. (2008), 617, 677-679.
263. One question relating to importers is whether the so-called "only representative" they may have appointed for administrative purposes to register their products would be considered "directly affected" by a decision taken under REACH.
264. See REACH, Art. 8.
265. See supra note 205, and text at notes 209-210.
266. REACH, Art. 63(5).
267. See also, supra notes 69-71.
268. See IBM, cited supra note 210.
269. E.g. Joined Cases T-74/00 etc., Artegodan, [2002] ECR II-4945, para 197 (regarding opinions of the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products).
270. See more generally Alemanno, "The European Food Safety Authority before European Courts", 3 European Food and Feed Law Review (2008), 320-333.
271. Artegodan, cited previous note, at paras. 199-200.