Precautionary regulation of chemical risk: How reach confronts the regulatory challenges of scale, uncertainty, complexity and innovation

Common Market Law Review

Volumn 48, Issue 2, 2011, Pages 357-393

  Fleurke, Floor ^a   Somsen, Han ^a  

^a TILBURG UNIVERSITY   (Netherlands)

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EID: 79953072564     PISSN: 01650750     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (121)

1. See e.g. Winter (Ed.), Risk Assessment and Risk Management of Toxic Chemicals in the European Community: Experiences and Reform (Nomos, 2000).
2. Heyvaert, Coping with Uncertainty: The Regulation of Chemicals in the European Union (PhD Dissertation, European University Institute, Florence, Italy, 1999).
3. See Molyneux for annual reports on Substantive European Community Law - Chemicals, in Somsen (Ed.), Yearbook of European Environmental Law (OUP, 2005-2008).
4. Our understanding of "innovation" follows the classic notion developed by Schumpeter, i.e. that innovation denotes novel combinations of knowledge, resources etc. subject to attempts at commercialization (or carried out in practice). See Schumpeter, The Theory of Economic Development (Harvard University Press, 1934). See also the report Innovation in the Chemicals Sector and the New European Chemicals Regulation, WWF Chemicals and Health Campaign Report (2003).
5. See Lisbon EC of 23 and 24 March 2000, Presidency Conclusions available at: .
6. European Commission, "White paper laying down a strategy for a future chemicals policy", COM(2001)88, 27 Feb. 2001.
7. Reg. (EC) No. 1907/2006 of the European Parliament and of the Council of 18 Dec. 2006 concerning the Registration, Evaluation, Authorisation 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 (hereafter: REACH), O.J. 2006, L 396.
8. Presidency Conclusions, Lisbon European Council, 23 and 24 March 2000.
9. For an analysis of the constitutive elements of precautionary regulation see Fleurke, "Innovation through precaution: The case of the Dutch Wadden Sea" in Somsen and Etty (Eds.), 8 Yearbook for European Environmental Law (2008), pp. 80-132.
10. Fourteen of the world's biggest thirty chemicals companies are headquartered in the EU, and the EU's annual chemicals sales amounts to €476 billion. More than half of global exports of chemicals originate in the EU, compared to 14.3% in NAFTA. EU exports of chemicals to the NAFTA region amount to €36.5 billion, while NAFTA chemicals sales in Europe are valued at €22.9 billion. The approximately 29 000 chemical and pharmaceutical companies currently employ a total staff of about 1.84 million, which amounts to 6% of the overall workforce in the manufacturing industry. Another 3 million employees are in jobs that are directly dependent on the chemicals sector. CEFIC, available at: . These figures relate to Jan. 2009 (last visited on 2 Oct. 2010).
11. See Baldwin and Black, "Really responsive regulation", 71 MLR (2008), 59-94. The authors argue that "real" responsiveness implies awareness of attitudinal settings of regulatees, institutional environments, the logics of different regulatory tools and strategies, the regime's own performance and effects, and a responsiveness to change.
12. Gunningham, Gabrosky and Sinclair, Smart Regulation: Designing Environmental Policy (OUP, 2004), p. 143.
13. Gunningham, "Regulating small and medium sized enterprises", 14 Journal of Environmental Law (2002), 3-32.
14. Gambel, "US Environment Protection Agency, The Dutch Model: Lessons for the US" (1995) UD EPA, Washington DC, at 2.
15. See the European Chemical Industry Council, published at: .
16. According to CEFIC, the Brussels-based organization representing the European chemicals industry, between 1990 and 2006, production of the EU chemicals industry (including pharmaceuticals) rose by 67%, while total energy consumption was rather stable and greenhouse gas (GHG) emissions fell by almost 32%. CEFIC, figures available at: .
17. A well-known example is the Seveso disaster, an industrial accident that took place on 10 July 1976 in a small chemical manufacturing plant approximately 15 km north of Milan. It resulted in the highest known exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in residential populations. In response, EU legislation was adopted; Dir. 82/501/EEC ("Seveso I") of 24 June 1982 on the Major-Accident Hazards of Certain Industrial Activities, followed by Seveso II Dir. 96/82/EC.
18. Foss Hansen, Carlsen and Tickner, "Chemicals regulation and precaution: Does REACH really incorporate the precautionary principle", 10 Environmental Science and Policy (2007), 395.
19. Fromberg, Cleeman and Carlsen, "Review on persistent organic pollutants in the environment of Greenland and Faroe Islands", 38 Chemosphere (1999), 3075-3093.
20. Winter, Risk Assessment and Risk Management of Toxic Chemicals in the European Community (2000), Estabrook and Tickner, Massachusetts Precautionary Principle Project: Facing our Toxic Ignorance (2000), available at: . Toxic ignorance refers to a situation in which regulators cannot pronounce on either probabilities or outcomes ("regulators don't know what we they don't know").
21. See also Functowicz and Ravetz, "Science for the post-normal age", 25 Futures (1993), 739-756.
22. See also Case, "Corporate environmental reporting as informational regulation: A law and economics perspective", 7 (2005), 379. 6 University of Colorado Law Review.
23. Schaafsma, Kroese, Tielemans, Van de Sandt and Van Leeuwen, "REACH, non-testing approaches and the urgent need for a change in mind set", 1 Regulatory Toxicology and Pharmacology (2009), 70.
24. Available at: .
25. We ignore theoretical debates on the relative virtues of "reflexive", "responsive", "meta" and "smart" modes of regulation. Instead, we use the term "responsive regulation" in a very broad fashion to embrace notions of deliberative democracy, and the intelligent employment of actors and tools to enhance or substitute public regulatory capacities. See in similar vein Braithwaite, "Responsive regulation and developing economies", 34 World Development (2006), 884.
26. See also Black and Baldwin, "Really responsive risk-based regulation", 32 Law & policy (2010), 181-213.
27. Gunningham, "Regulating biotechnology: Lessons from environmental policy" in Somsen (Ed.), The Regulatory Challenge of Biotechnology (Edward Elgar, 2007).
28. Teubner, "Substantive and reflexive elements in modern law", 2 Law and Society Review (1983), 239-285.
29. Luhmann, Soziale Systeme: Grundriß einer allgemeinen Theorie (Suhrkamp, 1984) (English translation: Social Systems, Stanford University Press, 1995).
30. REACH, Art. 5.
31. Commercial confidentiality clauses are only allowed under strict conditions.
32. ECHA is based in Helsinki and with some 400 employees is the largest EU agency.
33. Published at: .
34. REACH, Art. 76.
35. Members of the Board of Appeal are appointed by the Commission in accordance with the procedure of regulatory committees under comitology.
36. See on legal remedies under REACH Bronkers and Van Gerven, "Legal remedies under EC's new chemicals legislation REACH: A new model of European governance", 46 CML Rev. (2009), 1823-1871.
37. Reg. (EC) No. 1049/2001/EC of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, O.J. 2001, L 145.
38. The Guidance Documents are voluminous (approx. 7000 pages) and complex. Full understanding of the contents of all Guidance Documents is almost impossible.
39. See on the role of regulatory agencies in the EU: Vos, "Independence, accountability and transparency of European regulatory agencies", in Geradin, Munoz and Petit (Eds.), Regulation through agencies: A new Paradigm of European Governance (Edward Elgar, 2005), pp. 120-1 37.
40. Kraphol, "Credible commitment in non-independent regulatory agencies: A comparative analysis of the European agencies for pharmaceuticals and foodstuffs" 10 European Law Journal (2004), 518-538.
41. Majone, Regulating Europe (Routledge, 2005).
42. REACH, Preamble, Recital 105.
43. The Forum is thereby likely to gain the same function within REACH as the Advisory Forum has within the European Food Safety Authority (EFSA).
44. The registration requirement for new chemicals has been increased from 10 kg/year to 1 tonne/year, the information requirements have been reduced.
45. See De Sadeleer, "The impact of the registration, evaluation and authorization of chemicals (REACH) regulation on the regulatory powers of the Nordic countries" in De Sadeleer (Ed.), Implementing the Precautionary Principle. Approaches from the Nordic Countries, EU and USA (Earthscan, 2007), 334.
46. REACH, Art. 3, which gives a definition of an article: "an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition." ECHA has issued a guidance document to clarify this definition, available at: .
47. Except for substances subject to authorization.
48. REACH, Art. 23.
49. A list of pre-registrations is available at: .
50. The list of dossiers being checked for compliance by ECHA is made available to the competent authorities of the Member States. The Regulation also introduces random compliance checks. To ensure high quality registration, ECHA has to select a percentage of those dossiers, no less than 5% of the total received by ECHA for each tonnage band, for compliance checking. REACH, Art. 41(5). ECHA gives priority, although not exclusively, to dossiers meeting at least one of the criteria listed; e.g. when a dossier for a substance is listed in the Community rolling plan for evaluation of a substance.
51. Member States may also notify the Agency at any time of a substance not on the Community rolling action plan, whenever they are in possession of information which suggests that the substance is a priority for evaluation. The Agency decides whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee. Art. 45(5).
52. Art. 57 lists certain categories of chemicals: vPvBs, PBTs and Carcinogens, mutagens and substances that exhibit reproductive damaging effects (CMRs). Substances exhibiting endocrine disrupting effects may also require authorization on a case by case basis. ECHA will publish a list containing such candidate substances. See on the contemporary debates on the risks of endocrine disruptions Durodié, "The true costs of precautionary chemicals regulation", 23 Risk Analysis (2003), 289-398.
53. Council Decision 2006/512/EC amending Council Decision 1999/468/EC laying down the Procedures for the Exercise of Implementing Powers conferred on the Commission, O.J. 2006, l200/11. See on this procedure Pocklington, "Comitology under greater scrutiny", (2006) European Environmental Law Review, 306-311.
54. Heyvaert, "No data, no market: The future of EU chemicals control under the REACH Regulation", 9 Environmental Law Review (2007), 204.
55. See Jasanoff, Designs on Nature: Science and Democracy in Europe and the United States, (Princeton University Press, 1990).
56. See also European Commission, Questions and answers on REACH Brussels, 2007, at 3, published at: .
57. Prior to REACH, the adoption of each new restrictive measure required Council and EP decision-making. Commission decision-making will make it more effective to take emergency measures in order to protect human health and environmental interests.
58. Functowicz and Ravetz, "Science for the post-normal age", 25 Futures (1993), 739-756.
59. Science Daily, 16 Sept. 2009. Available at: (last visited on 2 Oct. 2010).
60. The minimum 1/t threshold for triggering the most basic information requirements forms a significant problem for the regulation of nano-scale chemicals. Toxicity of substances at this scale can also be caused by other characteristics, such as shape and quantum effects. E.g., concerns relating to the inhalation of carbon nanotubes fall outside the scope of REACH, since they are not related to quantity. Donaldson et al., "Carbon nanotubes: A review of their properties in relation to pulmonary toxicology and workplace safety", 92 Journal of Toxicological Sciences (2006), 5-22. The Commission has recognized this problem, but has - for the moment - pointed to the possibility of the authorization and restriction procedures. Commission (EC), "Nanomate-rials in REACH" (Follow-Up to the Sixth Meeting of the REACH Competent Authorities, 16 Dec. 2008, CA/59/2008 rev.1: 5, published at: .
61. It also has to be noted that the Regulation occasionally offers special protection to consumers, see e.g., REACH, Art. 68(2).
62. REACH, Art. 14(1).
63. PBT= Persistent, Bioaccumulative and Toxic; vPvB= very Persistent, very Bioaccumula-tive.
64. See Warhurst, "Assessing and managing the hazards and risks of chemicals in the real world - The role of the EU's REACH proposal in future regulation of chemicals", 32 Environment International (2006), 1033.
65. Priority will be given to substances which have or may have PBT or vPvB sensitizing and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Dir. 67/548/EC above 100 tonnes per year with uses resulting in widespread and diffuse exposure.
66. See also Art. 22 for further duties of registrants.
67. Published at: .
68. REACH, Art. 22 (1). See also Art. 31 on the Safety Sheet that has to be passed down the supply chain.
69. The supplier of a substance provides the recipient of the substance with a data sheet. The data sheet has to be consistent with the chemical safety assessment in accordance with Annex II.
70. Title V sets out the obligations of the downstream users.
71. REACH does not oblige downstream users to inform producers about their uses, but if they do not, and they are not covered by an existing exposure scenario, then the downstream user must do their own assessment. If they are using 1 t/y or more of the substance then downstream users must also send ECHA a short report, which includes the identity of the substance and a general description of the use.
72. REACH, Recital 69 and Annex I.
73. Ashford, "Implementing the precautionary principle: Incorporating science, technology, fairness and accountability in environmental health and safety decisions", 5 International Journal of Risk Assessment and Management (2005), 112-124.
74. See for a description and explanation of a Chemical Safety Report REACH Annex I.
75. ECHA, "Guidance on information requirements and chemical safety assessment", Guidance for the Implementation of REACH, May 2008, at 8. Available at: .
76. Substances which have or may have PBT, vPvB, sensitizing and/or/carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Dir. 67/548/EEC above one tonnes per year with uses resulting in widespread and diffuse exposure.
77. REACH, Art. 44(2). ECHA shall submit the first draft rolling action plan to the Member States by December 2011. ECHA adopts the final Community rolling action plan on the basis of an opinion of the MSC, and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein, determined according to REACH, Art. 45.
78. REACH, Art. 44(2).
79. This can include information not required in Annexes VII-X. See also Art. 47(1) and Art. 50(4).
80. The competent authority shall inform ECHA of its conclusions as to whether or how the to use the information obtained. ECHA in turn informs the Commission, the registrant and the competent authorities of the other Member States.
81. Rudén and Hansson, "Improving REACH", 44 Regulatory Toxicology and Pharmacology (2005), 38.
82. Van Zwanenburg and Stirling, "Risk and precaution in the US and Europe: A response to Vogel", 3 YEEL (2003), 50.
83. Von Schomberg, "The precautionary principle and its normative challenges" in Fisher, Jones and Von Schomberg, Implementing the Precautionary Principle (Edward Elgar, 2006), 34.
84. REACH, Recital 60(8) and 72. The authorization list is also provisional and can be amended over time, Art. 58(4).
85. The duration for any authorization shall be determined on a case-by-case basis taking into account all relevant information.
86. In the EP version of REACH, all authorizations were to be subject to review periods and the manufacturers in this proposal had to present new plans for substitution.
87. see European Parliament Legislative Resolution on the Proposal for a Regulation of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC)..../... [on Persistent Organic Pollutants] 2005, (COM(2003)0644-C5-0530/2003-2003/0256(COD), Amendment 235.
88. Also when an authorization has been granted or refused or a restriction has been imposed. See Arts. 37 (7) and 38 for monitoring obligations of downstream users.
89. The first reports were due by 1 June 2010.
90. Title XIV and Arts. 125 and 126.
91. The first report shall be submitted by 1 June 2011. In addition, every three years ECHA has to submit a report to the Commission on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of the Regulation.
92. The Commission then takes a decision in accordance with the procedure referred to in Art. 133(2) within 60 days, either authorizing that provisional measure or requiring the Member State to revoke it.
93. European Commission, Questions and answers on REACH Brussels, 2007, at 3, available at: . 126. REACH Art. 61(3).
94. A case study has been conducted on the "announcement effect" of substance lists. It was concluded that a candidate list of substances subject to authorization could have the effect on downstream users wishing the substance to be excluded from the product they purchase. Heitmann and Reihlen, "Case study on the 'announcement effect' in the market related to the candidate list of substances subject to authorisation: Final report", (Okopol, 2007). Available at: .
95. Dir. 2008/1/EC of the European Parliament and of the Council concerning Integrated Pollution Prevention and Control, O.J. 2008, L 24.
96. Dir. 2004/35/EC of the European Parliament and of the Council on Environmental Liability with regard to the Prevention and Remedying of Environmental Damage, O.J. 2004, L 143, Art. 3 referring to Activities listed in Annex III.
97. See for a discussion on discretion of Member States in European environmental law: Somsen, "Discretion in European Community environmental law", 40 CML Rev. (2003), 1413-1 453.
98. Council Dir. 85/374/EEC Concerning Liability for Defective Products, O.J. 1985, L 210.
99. O.J. 1998, L 328/28.
100. See e.g. REACH, Arts 40(2), 64(3), 70, and 71(2).
101. Pursuant to Article 119(2) registrants may try to prevent public access to certain other types of information, including summary safety information, but it is not allowed to exclude the full reports.
102. See Koch and Ashford, "Rethinking the role of information in chemicals policy: Implications for TSCA and REACH", 14 Journal of Cleaner Production (2006), 37.
103. Scott, "From Brussels with love: The transatlantic travels of European Law and the chemistry of regulatory attraction", 57 AJCL (2009), 929.
104. REACH, Art. 60(4)(b).
105. Heyvaert points out that it is pertinent that ECHA is allowed to select the body of information to be disclosed, Heyvaert, "The EU chemicals policy: Towards inclusive governance?" in Vos, European Risk Governance- Science, Its Inclusiveness and Its Effectiveness (CONNEX - Network of Excellence, Mannheim, Germany, 2008), 203.
106. ECHA has to set a deadline on its website by which the information on alternatives has to be submitted.
107. Title III on Data Sharing and the Avoidance of Unnecessary Testing.
108. See UNECE, UNECE - Dangerous Goods and Special Cargoes Section - GHS, available at: and Reg. (EC) No 1272/2008 on Classification, Labelling and Packaging of Chemical Substances and Mixtures, the so called CLP Regulation entered into force on 20 Jan. 2009. The CLP Regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC). Both Directives will be repealed on 1 June 2015.
109. REACH, Art. 114. Thus, if the thresholds for registration or notification of substances are not met, or if in relation to SVHC it has been demonstrated that exposure to humans or the environment will be excluded during normal or reasonable foreseeable conditions of use. In such cases, consumers must file a specific request that the supplier provide this information in accordance with Art. 33(2).
110. The Safe Drinking Water and Toxic Enforcement Act of 1986 of the State California USA, commonly known as Proposition 65.
111. Rechtschaffen and Williams, "The continued success of proposition 65 in reducing toxic exposures", 35 Environ. Lit. Rep. (2005), 10850.
112. Tickner and Geiser, "The Precautionary Principle stimulus for solutions-and alternatives-based environmental policy", 24 Environmental Impact Assessment (2004), 801-824, However, the element of safer alternatives is not included in EC Communication on the Precautionary Principle, COM(2000)1.
113. REACH, Recital 12, 72, 73. Some 1500 substances subject to substitution requirements are already identified in the Regulation, see European Environmental Law Website, available at: .
114. REACH, Art. 60(4).
115. Wagner, "Using competition-based regulation to bridge the toxic data gap", 83 Indiana Law Journal (2008), 629-659. Although, as Wagner rightfully points out the competitive advantage is not exclusive; all other manufacturers, users and importers using the safer substance will benefit from the decision to reject authorization.
116. REACH, Art. 69(1). Annex XV also requires the authorities to document the available information on alternative substances and techniques in the restriction proposal.
117. European Trade Union Confederation Declaration on REACH, the proposed reform of EU policy on chemicals, 2004, available at: . Warhurst, The REACH Files: A Policy Guide. (Brussels: 2005), available at: .
118. See e.g. Title III, Arts. 25-30 on Data Sharing and Avoidance of Unnecessary testing. Art. 25 states that in order to avoid animal testing, testing on vertebrate animals for the purpose of this Regulation has to be undertaken only as a last resort. It is also necessary to take measures limiting duplication of tests.
119. Sunstein, Laws of Fear: Beyond the Precautionary Principle (Cambridge University Press, 2005).
120. REACH, Recital 115.
121. REACH, Title III.