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Risk and the Precautionary Principle in the Implementation of REACH

The Inclusion of Substances of Very High Concern in the Candidate List

Published online by Cambridge University Press:  20 January 2017

Christoph Klika
Christoph Klika*
Affiliation:
Faculty of Arts and Social Sciences of Maastricht University
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Abstract

The adoption of the REACH regulation, setting out to reformchemicals policy of the European Union (EU), was accompanied by intense controversy over the role of the precautionary principle. Analysing decision making on so called Substances of Very High Concern (SVHCs), this article demonstrates that despite legal underpinning, precaution plays a limited role in the implementation of the REACH authorisation procedure. Due to ambiguous legislative provisions, the controversiesof the legislativeprocessare carriedover tothe implementationprocess.

Type
Articles
Information
European Journal of Risk Regulation , Volume 6 , Issue 1 , March 2015 , pp. 111 - 120
Copyright
Copyright © Cambridge University Press 2013

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References

1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, (…), OJ L 396/1.

2 Selin, Henrik, “Coalition Politics and Chemicals Management in a Regulatory Ambitious Europe”, 7 Global Environmental Politics (2007), pp. 63 et sqq.CrossRefGoogle Scholar; Pesendorfer, Dieter, “EU Environmental Policy under Pressure: Chemicals Policy Change between Antagonistic Goals?”, 15 Environmental Politics (2006), pp. 95 et sqq.CrossRefGoogle Scholar

3 See e.g. KEMI, “REACH Regulation – response to the public internet consultation”, 4 July 2003, available on the Internet at http://ec.europa.eu/enterprise/sectors/chemicals/reach/index_en.htm (last accessed on 15 February 2014).

4 See Regulation (EC) 1907/2006, supra note 1, Art. 1.

5 Løkke, Søren, “The Precautionary Principle and Chemicals Regulation. Past Achievements and Future Possibilities”, 13 Environmental Science and Pollution Research (2006), pp. 342 et sqq.CrossRefGoogle Scholar; Heyvaert, Veerle, “Guidance without Constraint: Assessing the Impact of the Precautionary Principle on the European Community’s Chemicals Policy”, in Etty, Thijs F.M. and Somson, Han (eds.) Yearbook of European Environmental Law, (Oxford: Oxford University Press, 2006), pp. 27 et sqq., at p. 57.Google Scholar

6 See Regulation (EC) 1907/2006, supra note 1, Recital 69.

7 Koch, Lars and Ashford, Nicholas, “Rethinking the role of information in chemicals policy: implications for TSCA and REACH”, 10 Journal of Cleaner Production (2006), pp. 31 et sqq., at p. 40;CrossRefGoogle Scholar Hansen, Steffen Foss, Carlsen, Lars and Tickner, Joel A., “Chemicals Regulation and Precaution: does REACH really incorporate the Precautionary Principle”, 10 Environmental Science and Policy (2007), pp. 395 et sqq.CrossRefGoogle Scholar

8 For similar approaches see Eckley, Noelle and Selin, Henrik, “All talk, little action: precaution and European chemicals regulation”, 11 Journal of European Public Policy (2004),pp. 78 et sqq.CrossRefGoogle Scholar; also Levidow, Les, Carr, Susan and Wield, David, “European Union regulation of agri–biotechnology: precautionary links between science, expertise and policy”, 32 Science and Public Policy (2005), pp. 261 et sqq.CrossRefGoogle Scholar

9 Commission Roadmap for SVHCs identification and implementation of REACH Risk Management measures from now to 2020, CA/2/2013, Brussels, 08/02/2013.

10 Weiss, Robert S., Learning from strangers: The art and method of qualitative interview studies, (New York et al.: The Free Press)Google Scholar; Guest, Greg, Bunce, Arwen and Johnson, Laura, “How many interviews are enough?: An experiment with data saturation and variability”, Field Methods (2006), pp. 59 et sqq.CrossRefGoogle Scholar

11 See Regulation (EC) 1907/2006, supra note 1, Art. 5.

12 See Regulation (EC) 1907/2006, supra note 1, Art. 55.

13 Veerle, Heyvaert, “Coping with Uncertainty. The Regulation of Chemicals in the European Union”, Ph.D thesis on file at the European University Institute, (1999).

14 European Commission,“MEMO/06/488”, Brussels, 13th December 2006.

15 See Regulation (EC) 1907/2006, supra note 1, Art. 7 and 33.

16 Commission White Paper Strategy for a future Chemicals Policy, COM(2001) 88 final, Brussels, 27.2.2001.; also Lars Koch and Nicholas Ashford, “Rethinking the role of information in chemicals policy”, supra note 7.

17 See Regulation (EC) 1907/2006, supra note 1, Recital 77.

18 See Regulation (EC) 1907/2006, supra note 1, Recital 9.

19 Ibid., Art. 68 and 69 regarding restrictions.

20 The intricate relation between restrictions and the new authorisation procedure, and decisions for one or the other instrument are not prescribed by law. Instead, decision making processes depend on a number of factors such as type and use of targeted substance, as well as resources and goals of the regulatory authorities; see ECHA, “Workshop on the Candidate List and the Authorisation as Risk Management Instruments”, 21-22 January 2009.

21 See Regulation (EC) 1907/2006, supra note 1, Art. 75.

22 Ibid., Art. 58.

23 Ibid., Art. 59. The MSC is comprised of representatives of the Member States, usually staff of ministries or national regulatory agencies dealing with chemicals policy.

24 Sandin, Per et al., “Five charges against the precautionary principle”, 5 Journal of Risk Research (2002), pp. 287 et sqq., at p. 288.CrossRefGoogle Scholar

25 See Sandin, Per, “Dimensions of the Precautionary Principle”, 5 Human and Ecological Risk Assessment: An International Journal (1999), pp. 889 et sqq.CrossRefGoogle Scholar

26 In his discussion of these four dimensions, Sandin forms ifclauses, linking certain threats with subsequent action. By drawing on Sandin's dimensions, I form similar clauses, yet I prefer to speak of decision rule.

27 Per Sandin, “Dimensions”, supra note 25, at p. 891.

28 See Regulation (EC) 1907/2006, supra note 1, Art. 57. Among the latter type of ECs are endocrine disrupting or respiratory sensitisers for instance.

29 Hansen, Bjorn G. and Blainey, Mark, “REACH: A Step Change in the Management of Chemicals”, 15 Review of European, Comparative & International Environmental Law (2006), pp. 270 et sqq;CrossRefGoogle Scholar Gebel, Tom, Lechtenberg–Auffarth, Eva and Guhe, Christine, “About hazard and risk assessment: Regulatory approaches in assessing safety in the European Union chemicals legislation”, Reproductive Toxicology (2009), pp. 188 et sqq.CrossRefGoogle Scholar

30 Lofstedt, Ragnar E., “Risk versus Hazard – How to Regulate in the 21st century”, European Journal of Risk Regulation (2011), pp. 149 et sqq.CrossRefGoogle Scholar

31 Per Sandin, “Dimensions”, supra note 25, at p. 893.

32 Harmonised classification of substances is the most important hazard–based instrument in EU chemicals policy and continues to be an important regulatory instrument complementary to REACH. See Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353.

33 See Regulation (EC) 1907/2006, supra note 1, Art. 57 (a-c).

34 Ibid., Art. 57 (d,e); also Annex XIII.

35 Ibid,, Art. 57 (f).

36 Koch and Ashford, “Rethinking the role of information in chemicals policy”, supra note 7.

37 The so called SIN list (Substitute It Now), for instance, contains over 600 substances that according to the green coalition should be included in the Candidate List; see ChemSec, “SIN List 2.1 update: new information from REACH registrations extends the SIN List”, 14 February 2013, available on the Internet at: http://www.chemsec.org/images/stories/2013/Press_release_SIN_2.1_update.pdf (last accessed on 20 February 2014)

38 Tatiana Santos, Dolores Romano and Rafael Gadea, “Trade Union Priority List for REACH Authorisation”, Version 2.0, June 2010, available on the Internet at: http://www.etuc.org/sites/www.etuc.org/files/TUListREACH.pdf (last accessed on 20 February 2014)

39 European Parliament Report on the proposal for a Regulation of the European Parliament and of the Council concerning (…) (REACH), establishing a European Chemicals Agency, A6-0315/2005 FINAL, Amendment 214.

40 Ibid., Amendment 215 and 216.

41 Council Common Position (EC) No 17/2006 adopted by the Council on 27 June 2006 with a view to adopting Regulation (EC) No …/2006 of the European Parliament and of the Council of… concerning (…) (REACH), establishing a European Chemicals Agency, (…) (2006/C 276 E/01).

42 See Regulation (EC) 1907/2006, supra note 1, Art. 57.

43 The evidence presented in this paragraph is derived from the minutes of the Member State Committee and ECHA decisions on SVHC inclusion.

44 Unsurprisingly, this risk–based approach is heavily criticized by the green coalition. ChEMTrust et al., “First REACH hazardous chemicals list is a drop in the ocean”, Brussels 22 October 2008; European Parliament, “Question for Question Time in committee 2008/8 under Rule 187 of the Rules of Procedure by Satu Hassi”, Notice to Members, 19 November 2008.

45 ECHA, “Guidance on inclusion of substances in Annex XIV”, August 2008.

46 Most of the proposals are lengthy and elaborate documents and only a limited number of Member States is responsible for a large share of all submitted proposals.

47 Interview with a member of the green coalition.

48 See Regulation (EC) 1907/2006, supra note 1, Art. 55.

49 Commission Staff Working Document, General Report on REACH, SWD(2013)25 final, at p. 118.

50 Kristina Nordlander, Carl-Michael Simon and Hazel Pearson, “Hazard v. Risk in EU Chemicals Regulation”, 1 European Journal of Risk Regulation, pp. 239 et sqq.

51 Action brought on 4 January 2010 – PPB and SNF v ECHA (Case T-1/10), OJ C 63/48.

52 See Charlotte de Roo, “BEUC response to the consultation document concerning (…) (REACH)”, 2003, available on the Internet at http://ec.europa.eu/enterprise/sectors/chemicals/reach/index_en.htm (last accessed on 15 February 2014); CEFIC, “Consultation Document concerning (…) (REACH), Volume 1, Cefic Comments”, 8 July 2003, available on the Internet at http://ec.europa.eu/enterprise/sectors/chemicals/reach/index_en.htm (last accessed on 15 February 2014).

53 See European Parliament Report, supra note 39.

54 See Council Common Position, supra note 41.

55 See Regulation (EC) 1907/2006, supra note 1, Art. 59; also ECHA, “Guidance on inclusion”, supra note 45.

56 ECHA, “Co–ordination of activities related to the preparation of Annex XV dossiers”, CA/10/2010, Helsinki, 20/01/2010.

57 ECHA, “Workshop on the Candidate List”, supra note 20.

58 Interview with a Member State representative.

59 See Regulation (EC) 1907/2006, supra note 1, Recital 9.

60 Interviews with various members of the green coalition; see also EEB and ClientEarth, “Identifying the bottlenecks in REACH implementation”, October 2012.

61 ECHA, Format for Risk Management Option (RMO) analysis, CA/29/2010, Helsinki, 18/1/2010.

62 Interview with a Member State representative.

63 European Commission, “Chemicals: New European Commission determined to make REACH a success”, 25 March 2010, IP/10/360.

64 Interviews with Commission officials.

65 Interview with a Member State representative.

66 Chemical Watch, “Industry and NGOs want greater transparency on SVHC roadmap. Availability of RMO information and lack of consultation worry stakeholders”, 14 February 2013.

67 Commission Roadmap for SVHCs identification, supra note 9.

68 ECHA, “SVHC Roadmap to 2020 Implementation Plan”, 9 December 2013.

69 Veerle Heyvaert, “Guidance without Constraint”, supra note 5, at p. 42.

70 As pointed out by one of the anonymous reviewers.

71 ECHA, “SVHC Roadmap”, supra note 68.

72 Regarding the legitimacy of the authorisation procedure see Christoph Klika, “The Implementation of the REACH Authorisation Procedure on Chemical Substances of Concern: What Kind of Legitimacy?”, 3 Politics and Governance (2015), forthcoming.