Regulating Chemical Substances under REACH: The Choice between Authorization and Restriction and the Case of Dipolar Aprotic Solvents

Published date01 July 2014
Date01 July 2014
Regulating Chemical Substances under REACH:
The Choice between Authorization and Restriction
and the Case of Dipolar Aprotic Solvents
Lucas Bergkamp and Nicolas Herbatschek
The REACH Regulation establishes several chemical
regulatory regimes, which operate, by and large, as
stand-alone, but ostensibly complementary pro-
grammes. The two key REACH programmes for direct
‘command and control’ regulation of chemical risk are
‘restriction’ and ‘authorization’. In the case of sub-
stances of very high concern, both restriction and
authorization are available as risk management mea-
sures. Because REACH fails to establish an indepen-
dent, coherent and unbiased framework for chemical
risk assessment and policy analysis of these alterna-
tive regulatory options, their deployment has been
fraught with difficulties. This article reviews the
REACH provisions governing the restriction and
authorization programmes, and the differences, simi-
larities and interrelations between them. In the second
part, the problems arising in the application of the two
regimes are illustrated with reference to the case of
dipolar aprotic solvents. This case study demonstrates
that the most appropriate regulatory instrument may
be a regime other than REACH. The third part sets
forth some recommendations to improve current prac-
tice and move towards a predictable, reasonable and
balanced REACH application.
This article reviews key issues associated with the regu-
lation of chemical substances under the REACH Regu-
lation,1and illustrates these issues with particular
reference to the recent case of dipolar aprotic solvents.
The REACH Regulation establishes two stand-alone
regimes for the regulation of chemical risk – authoriza-
tion and restriction – which differ in important
respects.2To coordinate between these two regimes, it
provides no more than a few rudimentary rules. The
issue arises how the choice between authorization and
restriction is, and should be, made. In regulating
chemical risk, regulators do not have discretion in all
cases to pursue either authorization or restriction. This
choice is available only with respect to substances of
very high concern (SVHCs), and then only if chemical
risks are unacceptable and not adequately controlled.
Conversely, if a substance is not an SVHC (e.g., a sub-
stance posing only physico-chemical risk), authoriza-
tion is not an option and restriction is the only way to
regulate its unacceptable risks. The literature on this
issue is scant,3and this article seeks to fill the void. In
addition, beyond the four corners of REACH, the most
appropriate regulatory measure to address a specific
chemical risk may be available under another chemical
risk regulatory programme. The recent experience with
regulatory initiatives regarding dipolar aprotic solvents
provides insights into the evolving Commission prac-
tice in selecting regulatory instruments.
This article first discusses how REACH fits into the
general framework of EU chemical legislation. It
analyzes, compares and examines the interrelations
between the restriction and authorization programmes,
including with respect to imports. Specific attention is
paid to the question of how REACH coordinates the two
regimes and contemplates the choice between the two
instruments. We also assess the implications of general
principles of EU law on the choice of regulatory instru-
ment. The next part highlights these issues with refer-
ence to the case of dipolar aprotic solvents. This part
discusses the early steps in the procedure, the lessons
learned and the move toward a coherent approach.
Applying the relevant legal concepts to this case, we
identify the most suitable regulatory approach for these
solvents. The final part presents the conclusions and a
few recommendations.
1Regulation 1907/2006/EC of 18 December 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, [2006] OJ L396/1
2See L. Bergkamp (ed.), The European Union REACH Regulation for
Chemicals: Law and Practice (Oxford University Press, 2013).
3See, e.g., Milieu Ltd, Technical Assistance Related to the Scope of
REACH and Other Relevant EU Legislation to Assess Overlaps
(European Commission, 2012); L. Bergkamp, n. 2 above; D.
Drohmann and M. Townsend (eds.), REACH: Best Practice Guide to
Regulation (EC) No 1907/2006 (Hart, 2013); European Chemicals
Agency (ECHA), Workshop on the Candidate List and Authorisation
as Risk Management Instruments (ECHA, 2009).
Review of European Community & International Environmental Law
RECIEL 23 (2) 2014. ISSN 2050-0386 DOI: 10.1111/reel.12083
© 2014 John Wiley & Sons Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.
The REACH Regulation is vast and convoluted. In addi-
tion to the Regulation itself, which runs to approxi-
mately 120 pages of dense text, there is a large number
of annexes totalling some 400 pages, implementing leg-
islation – in particular on testing methods4and a
closely related Regulation on the classification, label-
ling and packaging of substances (CLP Regulation).5To
assist the authorities and industry with implementa-
tion, a series of guidance documents have been issued
by the European Chemicals Agency (ECHA).6ECHA’s
appeal board7and the European courts have already
issued a fair number of decisions on the interpretation
of REACH.8A body of literature on various aspects of
REACH is emerging,9including comparative analyses10
and examinations of technical aspects,11 and the first
books exclusively on REACH have been published.12
Further, several reports have been published in connec-
tion with the review and evaluation of the Regulation.13
We do not attempt to provide an overview of the entire
Regulation, but instead we focus on the broader policy
context in which REACH operates, its objectives and
the key programmes it establishes. We then discuss
REACH’s key regulatory programmes, authorization
and restriction, in more detail.
The EU has had chemicals legislation for decades. In
2013, the Commission listed a total of 156 separate leg-
islative instruments that address some aspect of chemi-
cal use, release or control.14 This collection of EU
instruments deals not only with chemical substances in
bulk and chemical products, but also with chemicals in
air, water, soil and waste.15 There are substance-specific
regulations for mercury, polychlorinated biphenyls
4Regulation 440/2008 of 30 May 2008 Laying Down Test Methods
Pursuant to Regulation (EC) No 1907/2006 of the European Parlia-
ment and of the Council on the Registration, Evaluation, Authorization
and Restriction of Chemicals (REACH), [2008] OJ L142/1.
5Regulation 1272/2008/EC of 16 December 2008 on Classification,
Labelling and Packaging of Substances and Mixtures, [2008] OJ
8Summaries can be found at:>.
9See, e.g., L. Bergkamp and J.C. Hanekamp, ‘The Draft REACH
Regime: Costs and Benefits of Precautionary Chemical Regulation’,
11:5 Environmental Liability (2003), 1; L. Bergkamp and T. Smith.
‘Perfect Storm in the EU: Tidal Wave of Product Regulation’, Execu-
tive Counsel (2004), 9; E. Fisher, ‘The “Perfect Storm” of REACH:
Charting Regulatory Controversy in the Age of Information, Sustain-
able Development and Globalization’, 11:4 Journal of Risk Research
(2008), 541; M. Bronckers and Y. Van Gerven, ‘Legal Remedies
Under the EC’s New Chemicals Legislation REACH: Testing a New
Model of European Governance’, 46:6 Common Market Law Review
(2009), 1823; F. Fleurke and H. Somsen, ‘Precautionary Regulation
of Chemical Risk: How REACH Confronts the Regulatory Challenges
of Scale, Uncertainty, Complexity and Innovation’, 48:2 Common
Market Law Review (2011), 35; L. Bergkamp, G. Michaux and N.
Herbatschek, ‘Nanotechnology Regulation in Europe: From REACH
and Nano-Registries to Cosmetics, Biocides and Medical Devices’,
11:1 Nanotechnology Law and Business (2014).
10 See, e.g., A.D.K. Abelkop, J.D. Graham, L.R. Wise and Á. Botos,
‘Regulating Industrial Chemicals: Lessons for US Lawmakers from
the European Union’s REACH Program’, 42:11 Environmental Law
Reporter (2012), 11042; V. Heyvaert, ‘Regulating Chemical Risk:
REACH in a Global Governance Perspective’, in: J. Eriksson, M.
Gilek and C. Rudén (eds.), Regulating Chemical Risks, European
and Global Challenges (Springer, 2010), 217; J.T.O. Reilly, ‘What
REACH Can Teach Us about TSCA: Retrospectives on America’s
Failed Toxics Statute’, 1:1 European Journal of Risk Regulation
(2010), 40; O. Renn and E.D. Elliott, ‘Chemicals’, in: J.B. Wiener,
M.D. Rogers, J.K. Hammitt and P.H. Sand (eds), The Reality of
Precaution: Comparing Risk Regulation in the United States and
Europe (Taylor & Francis, 2011), 231.
11 See, e.g., G. Schoeters, ‘The REACH Perspective: Toward a New
Concept of Toxicity Testing’, 13:2–4 Journal of Toxicology and Envi-
ronmental Health (2010), 232; G. Schaafsma et al., ‘REACH, Non-
testing Approaches and the Urgent Need for a Change in Mind Set’,
53:1 Regulatory Toxicology and Pharmacology (2009), 70; D.
Romano, T. Santos and R. Gadea, ‘Trade Union Priority List for
REACH Authorisation’, 65:1 Journal of Epidemiology and Community
Health (2011), 8.
12 See L. Bergkamp, n. 2 above; D. Drohmann and M. Townsend, n.
3 above.
13 Eurostat, The REACH Baseline Study: Five Years Update
(Eurostat, 2012); PricewaterhouseCoopers (PwC), Review of the
European Chemicals Agency (ECHA) (PwC, 2012); Gaia, REACH
Contribution to the Development of Emerging Technologies (Gaia,
2012); Milieu Ltd, Implementation and Enforcement of Restrictions
in Member States (Milieu Ltd, 2012); Centre for Strategy and Evalu-
ation Services (CSES), Interim Report: Impact of the REACH Regu-
lation on the Innovativeness of the EU Chemical Industry (CSES,
2012); Milieu Ltd, PACE and Risk and Policy Analysts, Inspections
Requirements for REACH and CLP (Milieu Ltd, 2011); CSES,
Interim Evaluation: Functioning of the European Chemical Market
after the Introduction of REACH (CSES, 2012); Milieu Ltd, Techni-
cal Assistance Related to the Scope of REACH and Other Relevant
EU Legislation to Assess Overlaps (Milieu Ltd, 2012); Risk and
Policy Analysts and Okopol, Technical Assistance to Prepare the
Commission Report on Operation of REACH (Risk and Policy Ana-
lysts, 2012); Risk and Policy Analysts, Review of the Registration
Requirements for Polymers and 1 to 10 Tonnes Substances (Risk
and Policy Analysts, 2012); DHI, Okopol and Risk and Policy Ana-
lysts, Assessment of Health and Environmental Benefits of REACH
(DHI, 2012); Joint Research Centre, Scientific Technical Support on
Assessment of Nanomaterials in REACH Registration Dossiers
and Adequacy of Available Information (Joint Research Centre,
14 European Commission, Report from the Commission to the Euro-
pean Parliament, the Council, the European Economic and Social
Committee and the Committee of the Regions in Accordance with
Article 117(4) of REACH and Article 46(2) of CLP, and a Review of
Certain Elements of REACH in Line with Articles 75(2), 138(2), 138(3)
and 138(6) of REACH, Staff Working Document SWD(2013) 25.
15 E. Stokes and S. Vaughan, ‘Great Expectations: Reviewing 50
Years of Chemicals Legislation in the EU’, 25:3 Journal of Environ-
mental Law (2013), 411, at 415–417.
© 2014 John Wiley & Sons Ltd

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