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

• Published date: 01 July 2014
• Date: 01 July 2014
• DOI: http://doi.org/10.1111/reel.12083
• Author: Nicolas Herbatschek,Lucas Bergkamp

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.

INTRODUCTION

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

(‘REACH’).

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).

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RECIEL 23 (2) 2014. ISSN 2050-0386 DOI: 10.1111/reel.12083

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REACH AUTHORIZATION

AND RESTRICTION

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.

REACH AND OTHER EU

CHEMICALS-RELATED

LEGISLATION

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

L353/1.

6<http://echa.europa.eu/support/guidance>.

7<http://echa.europa.eu/about-us/who-we-are/board-of-appeal/

decisions>.

8Summaries can be found at: <www.reachpsforum.eu>.

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,

2012).

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.

LUCAS BERGKAMP AND NICOLAS HERBATSCHEK RECIEL 23 (2) 2014

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