• Open Access

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

Authors

  • Lucas Bergkamp,

  • Nicolas Herbatschek


Abstract

The REACH Regulation establishes several chemical regulatory regimes, which operate, by and large, as stand-alone, but ostensibly complementary programmes. The two key REACH programmes for direct ‘command and control’ regulation of chemical risk are ‘restriction’ and ‘authorization’. In the case of substances of very high concern, both restriction and authorization are available as risk management measures. Because REACH fails to establish an independent, coherent and unbiased framework for chemical risk assessment and policy analysis of these alternative regulatory options, their deployment has been fraught with difficulties. This article reviews the REACH provisions governing the restriction and authorization programmes, and the differences, similarities 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 practice and move towards a predictable, reasonable and balanced REACH application.

Introduction

This article reviews key issues associated with the regulation of chemical substances under the REACH Regulation,1 and 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 – authorization and restriction – which differ in important respects.2 To 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 substance posing only physico-chemical risk), authorization is not an option and restriction is the only way to regulate its unacceptable risks. The literature on this issue is scant,3 and 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 practice 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 instrument. The next part highlights these issues with reference 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.

Reach Authorization and Restriction

The REACH Regulation is vast and convoluted. In addition to the Regulation itself, which runs to approximately 120 pages of dense text, there is a large number of annexes totalling some 400 pages, implementing legislation – in particular on testing methods4 and a closely related Regulation on the classification, labelling and packaging of substances (CLP Regulation).5 To assist the authorities and industry with implementation, a series of guidance documents have been issued by the European Chemicals Agency (ECHA).6 ECHA's appeal board7 and the European courts have already issued a fair number of decisions on the interpretation of REACH.8 A body of literature on various aspects of REACH is emerging,9 including 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 connection 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 legislative instruments that address some aspect of chemical 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 (PCBs)16 and other substances.17 The EU has also regulated the production, transportation, import and export, and use of hazardous chemicals, such as chlrofluorocarbons (CFCs).18 Our focus is on EU legislation addressing environmental and health and safety risks associated with chemicals in bulk – not chemicals in solid products or in air emissions or waste water discharges.

The initial core of EU chemical legislation was built on, in chronological order: classification and labelling of dangerous substances; the notification of substances, with the exception of existing substances;19 classification and labelling of mixtures of substances;20 a specific government-driven risk assessment programme;21 and restrictions on the marketing and use of dangerous chemicals adopted by the Commission through the comitology process.22

In recent times, however, EU chemical legislation has changed dramatically. The adoption of the REACH Regulation implied a paradigm shift in the governance of chemical risks in Europe.23 A new system of classification and labelling was introduced by the Classification, Labelling and Packaging Regulation.24 In addition to these core chemical laws, the EU adopted other legislation aimed at regulating chemical risk. First, EU occupational health and safety legislation deals specifically with chemical agents.25 Pursuant to this directive, EU-wide indicative and binding occupational exposure limit values and biological limit values can be established. Second, specific products made up of chemicals, such as biocides, pesticides, pharmaceuticals and cosmetics, are subject to product-specific legislation. Third, chemical restrictions, including maximum concentration values and outright bans, have also been included in regulations concerning products such as automobiles,26 electronics,27 toys,28 medical devices29 and cosmetics.30 In all these cases, the EU legislature chose to retain and deploy separate regulatory instruments independent of REACH. In addition, the Commission is examining selected issues, such as endocrine disruptors,31 nanotechnology32 and combined effects,33 and may adopt additional legislation outside of REACH.

Prior to REACH, EU chemical legislation was primarily risk-based, and distinguished between risk assessment and risk management.34 Subject to limited exceptions, such as pharmaceutical products,35 the burden of proof with respect to the presence of chemical risk was placed on the authorities: they had to establish that a chemical substance created an actual risk and thus should be regulated.36 The process of assessing the risks of existing substances was perceived as too slow.37 To address these shortcomings, REACH transferred the burden of production of information on chemicals to the companies that manufacture and distribute them.38 In addition, REACH also reverses the initial burden of proof39 of safety by requiring that manufacturers and importers ensure that the risks associated with the uses of their chemicals are ‘adequately controlled’. As a safety net, where an unacceptable chemical risk is found to remain, restrictions can still be imposed.40 In addition, reflecting the precautionary principle, certain hazardous substances can now be subjected to authorization, which is intended to phase out and substitute these substances.41

Reach Objectives and Regimes

The REACH Regulation followed a review of the pre-existing EU chemicals legislation. Based on this review, the Commission concluded that the prior legislation did not provide ‘a high level of protection’ as required by the Treaty on the Functioning of the European Union (TFEU).42 A major problem identified by the Commission was ‘the general lack of knowledge about the properties and the uses of existing substances’, also referred to as the ‘data gap’.43 This knowledge gap was attributable to the fact that under the Dangerous Substances Directive only new substances, not existing ones, had to be tested and notified.44 Consequently, the authorities did not possess much data on ‘existing substances’.

On the drawing board, REACH was intended as a risk-based chemical control programme.45 Hazards would continue to inform decision making, but the idea was that risk management decisions would be based on actual risk, as opposed to hazard or potential risk. While hazard, in theory, is conceived as an intrinsic property of a substance that is independent of the quantity present and the physical form of the substance,46 risk is an actual probability of adverse effects occurring in a specific situation and the magnitude of such effects at specific doses and levels of exposure.47 Risk is quantifiable to some degree or within a certain range. Compared to hazard-based regulation, the advantage of regulating risk is that measures can specifically target those factors in a causal chain that lend themselves best to regulatory interventions, thus generally decreasing the costs and increasing the benefits of such interventions. As designed and implemented, however, REACH is a mix of hazard- and risk-based regulation. For instance, regulation may be based solely on hazard or on the use of proxies or surrogates for exposure or risk (or factors influencing exposure or risk), rather than actual, proven risk.48 A hazard-triggered regime, authorization has proven to be the most controversial and unwieldy REACH programme.49

A main feature of the REACH Regulation is the creation of a comprehensive, albeit unintegrated, system of government oversight, subject to qualifications and exemptions, over all ‘existing’ and ‘new’ substances throughout their entire life cycle, including design and production, industrial and consumer use, and recycling and reuse.50 Consequently, its scope is vast; subject to limited exceptions, REACH applies to all bulk chemicals used in industrial processes and to chemicals present in mixtures and products ranging from cleaning products, and paints to clothing, furniture and electrical appliances. REACH is complicated; it is not one regulatory programme, but a collection of ‘stand-alone’ but ostensibly complementary programmes, including registration, evaluation and authorization of chemical substances, as well as generally binding restrictions on chemical substances and supply chain information. Importantly, REACH established a new European agency – the European Chemicals Agency (ECHA) – which is responsible for receiving registration dossiers, managing the huge chemical databases resulting therefrom, and issuing guidance to assist producers, importers and other authorities in implementing REACH.51 ECHA is also involved in the restriction and authorization processes.52 In addition to ECHA, the Commission and Member State authorities are in charge of administering various parts of REACH, including authorization and restriction, creating a patchwork of government powers, procedures and oversight,53 which only further adds to REACH's complexity.

The four main programmes established by REACH – registration, evaluation, authorization and restriction – can be characterized as follows. The registration programme involves the analysis and submission to ECHA of information on a given substance, and is required for substances manufactured or imported in a volume of at least 1 tonne per year per manufacturer or importer.54 Evaluation, which may focus on a dossier55 or a substance,56 is the review of that (and possibly additional) information by the authorities, which may result in queries and orders to provide additional information. Authorization is a permitting programme for specific uses of certain dangerous substances (SVHCs) and is intended to cause ‘substitution’ (replacement) of those substances by safer ones.57 Restrictions are generally binding requirements that restrict the manufacture, placing on the market and/or use of chemicals, either in bulk or as used in products, and is aimed at managing at EU-level chemical risks that are unacceptable because they are not adequately controlled.58 In addition to the four programmes, REACH sets forth rules on notification of SVHCs in articles,59 supply chain communication60 and obligations of downstream users.61

REACH's main programmes operate largely independently of each other. This implies, for instance, that substance evaluation is not a prerequisite for either authorization or restriction. Logically, a risk assessment and analysis of available regulatory instruments should precede additional regulation of the substance concerned since a thorough evaluation of the risks arising from the uses of a substance, the risk management measures implemented in practice and the regulatory options informs the decision as to whether any further measures are necessary.62 REACH, however, does not prescribe any such sequence. Substance evaluation, which falls short of full risk assessment and cost-benefit analysis of possible regulatory measures, is optional, but if it is conducted, it may trigger the authorization or restriction procedure.

To summarize, REACH is aimed at reducing the risks associated with chemical substances over their entire life cycle. To this end, it establishes several stand-alone programmes, including authorization and restriction. A basic principle is that companies manufacturing and using chemicals must ensure safe use and prevent unacceptable risks.63 The authorization and restriction procedures are important, yet distinct processes for ensuring chemical safety, raising the question what role each of these regimes plays. The following sub-sections discuss the two regimes in more detail.

Authorization

The authorization regime is intended to phase out certain hazardous substances for suitable alternatives, either chemical or technological.64 Once a substance is subject to authorization, it may not be placed on the market for a use or used on its own, in mixtures or incorporated into an article unless the use has been specifically authorized.65 Manufacturers and users of SVHCs listed in Annex XIV must apply for authorization by a deadline imposed pursuant to REACH, and must cease use of the chemical by the ‘sunset’ date unless authorization has been granted or an application for authorization is pending.66

Substantive Requirements

The Commission is in charge of making decisions on authorization applications pursuant to a procedure (discussed below).67 Authorization should be granted if the registrant demonstrates that: (i) the risks are ‘adequately controlled’, provided that the substance concerned is not a ‘non-threshold’ substance or a persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or ‘equivalent concern’ substance;68 or (ii) the substance provides socio-economic advantages that outweigh the risks and no ‘suitable alternative substances or technologies’ are available.69 The burden of proof is on the applicant. To force the substitution of the substance concerned, authorization is subject to review and potential withdrawal70 by the Commission. A review may be initiated at any time – for example, if new information on suitable alternatives becomes available.71 Downstream users may use a substance for an authorized use provided they have obtained an authorization or obtain the substance from a company to which an authorization has been granted, and stay within the conditions of that authorization.72 They must also inform ECHA,73 so that the authorities are fully aware of who is using substances requiring authorization.

The authorization regime involves three steps, each with their own criteria and levels of involvement of various authorities and stakeholders. The three phases are: listing of the substance on the Candidate List;74 listing it on the list of substances subject to authorization – REACH, Annex XIV (the ‘Authorization List’);75 and the authorization of the use itself.76 The last phase again consists of several steps, as discussed below. Each step is subject to the specific procedural and substantive requirements set out in the REACH Regulation.77

The Candidate List is primarily a list of substances to be considered for listing on Annex XIV. Additionally, listing also triggers communication requirements for suppliers of chemical substances and articles.78 Based in part on listing rendering these informational requirements applicable, some authorities have taken the position that substances may be listed on the Candidate List even if there is no intent to move them to Annex XIV.79 Any use of the Candidate List for purposes other than listing for authorization would be questionable, however, since Candidate Listing is embedded in the authorization listing process, and not a completely separate process that could serve other purposes. The ECHA is the primary decision maker with respect to the Candidate List,80 and other authorities can provide input.81 Listing on both the Candidate List and Annex XIV is based on hazard.82 Once a substance is listed on Annex XIV, the authorization requirement applies to the substance.83 At an applicant's request, the Commission must grant a renewable time-limited authorization if either risks are adequately controlled (the ‘adequate control route’)84 or the socio-economic benefits outweighs the risks and there is no suitable alternative (the ‘socio-economic route’).85

Certain substances and uses of substances are exempt from REACH authorization.86 Where an exemption applies to the whole authorization regime, as a general rule, the exemption should be deemed to apply to both the Candidate List and Annex XIV. With respect to intermediates, however, the Commission has adopted a position that substances used solely as intermediates may be added to the Candidate List and the Authorization List based on a category approach – for example, if the intermediate can be used as a substitute for a substance subject to authorization.87 Authorization does not apply to the use of substances outside the EU, such as the incorporation of substances into articles, which are subsequently imported into the EU.88

Procedure

The authorization regime imposes a very substantial regulatory burden on companies. The preparation of an authorization application takes substantial time and resources. Under the socio-economic route, the applicant must demonstrate that there are no suitable alternatives.89 If there are suitable alternatives, only the adequate control route is open and the applicant must commit to a substitution plan.90 The outcome of the procedure is uncertain as any third party may suggest a suitable alternative and the authorities have discretion.

The authorization itself does not have an expiration date, but is subject to review by a deadline determined by the authorization on a case-by-case basis.91 Such a review may result in the withdrawal of the authorization or the adoption of a further review deadline.92 If circumstances have changed or new information on substitutes becomes available, the Commission may review and, based on the results, suspend and withdraw the authorization at any time,93 which further adds to the uncertainty.

Exemptions from Authorization

Although REACH provides for the possibility of exempting specific uses from authorization obligations,94 authorities have been reluctant to entertain any exemptions. The only exemption adopted so far is the one for phthalates in the immediate packaging of medicinal products.95 This exemption, which was not recommended by ECHA, was approved by the REACH Committee at the proposal of the Commission.96

In several cases, exemptions from authorization requested by companies have been denied.97 The process of listing of trichloroethylene illustrates the issues that have arisen with respect to such requests. The requested exemption was for use in surface treatment. ECHA stated that, once a ‘binding Occupational Exposure Limit’ (bOEL) has been adopted, it will assess whether such a bOEL could be considered the binding minimum requirement for controlling risks to workers' health;98 the existing EU workers protection legislation99 could be the legal basis for the exemption. A discussion unfolded about the question of what level of regulation of a use should be considered a solid legal basis for granting an exemption from authorization for that particular use. Specifically, the issue was whether the existence of framework legislation that authorizes the adoption of specific risk management measures is sufficient, or whether the specific implementing measure should also be in place. It is unclear, however, why that would be relevant; if, under the alternative regulatory framework, there is no specific measure in place yet, it could be adopted under that framework.

Role of Authorization Regime

As of 1 April 2014, there are 151 substances on the Candidate List and 22 substances on Annex XIV. By 2020, the Commission contemplates that ‘all relevant, currently known SVHCs’ be included on the Candidate List.100 Note that SVHCs may be subjected to the REACH authorization regime based solely on hazard;101 no showing of actual exposure and risk is required. Substance evaluation does not have to precede the authorization listing procedure. Further, REACH does not require that SVHCs be added to Annex XIV. The Commission thus has discretion in making this decision, with REACH only providing some prioritization criteria to guide the decision, including PBT or vPvB properties, wide dispersive use and high volumes.102 Since the authorization programme is indiscriminate with respect to chemical uses in the listing procedure, is not risk-based and imposes high administrative cost, it is not necessarily the most appropriate measure for regulating any particular SVHC. For instance, if no suitable substitutes are likely to exist in the near future, or there already is pressure for substitution, authorization is unlikely to result in actual substitution and may therefore not be the most suitable regulatory option. Even worse, where the available substitutes are more harmful than the substance subject to authorization, the environment and human health may be positively harmed.103 If the concern is limited to one or a few uses, authorization may be overly broad, as it affects all uses. In some cases, the Commission takes these limitations of REACH authorization into account, as it did in relation to cobalt104 and dipolar aprotic solvents, as reviewed in this article. In this respect, the so-called ‘risk management option’ (RMO) analysis, discussed below, plays a useful role.

Restriction

The REACH restriction programme is intended to manage risks that are not adequately addressed by the other provisions of the REACH Regulation, including those on authorization.105 Under the restrictions regime, the manufacture and use of chemical substances, as well as their presence in products, can be subjected to generally binding limitations and conditions, including complete prohibitions.106

Restrictions adopted pursuant to the previous chemical legislation and REACH are set forth in Annex XVII, and typically set conditions on the manufacture, placing on the market or use of certain dangerous substances, preparations or articles. Restrictions are adopted or amended pursuant to a procedure that involves the Member States,107 ECHA108 and the Commission,109 and allows for input from stakeholders.110 Like authorization, the process proceeds on the basis of a structured dossier, which must meet certain quality standards.111

Compared to the pre-REACH legislation, the procedure for the adoption of restrictions has become more complicated and several substantive requirements have been added. Below, we first discuss substantive requirements and then procedure.

Substantive Requirements

A restriction is defined as ‘any condition for or prohibition of the manufacture, use or placing on the market’.112 Such a condition or prohibition may target any use of a substance on its own, in a mixture or in an article,113 with limited exceptions.114 While authorization applies only to the placing on the market and use of substances in the EU, a restriction may be imposed on the manufacturing and use of substances, and on the presence of substances in articles, including imported articles.115 A restriction may involve a complete ban, a concentration limit equal to the detection limit (e.g., 0.1% by weight), a maximum concentration or migration limit, a limitation to industrial use, etc. In terms of scope, a restriction may be limited to a particular use of a substance, a group of substances or the manufacturing and all uses of a substance. Further, a specific analytical method to determine compliance with the restriction may be imposed.116

All restrictions are listed on Annex XVII. Pursuant to REACH, a restriction must be adopted if there is an ‘unacceptable risk to human health or the environment … which needs to be addressed on a Community-wide basis’.117 ‘Unacceptable risk’ is not defined, which implies that the authorities have discretion in construing this concept. REACH provides that, if the Commission, ECHA or a Member State ‘considers’ that a risk is not ‘adequately controlled’, a restriction proposal (Annex XV dossier) must be prepared.118 Annex XV stipulates that such a proposal must meet the rules applicable to the Chemical Safety Report (CSR),119 specifically those used in connection with assessing adequate control in the registration and authorization procedures.120 This suggests that the term ‘unacceptable risk’ may encompass all inadequately controlled risks, but these terms may not be entirely synonymous as REACH seems to distinguish ‘not adequately controlled’ from ‘unacceptable risk’. There is an additional condition, however, before a restriction may be adopted: it must be necessary that the unacceptable risk identified be addressed at the EU level.121 This condition is intended to ensure that the subsidiarity principle is respected, which implies that REACH restrictions may not be imposed with respect to risks that can better be addressed at the national level, such as risks associated with specific processes in plants located in specific Member States,122 risks arising only in one or a small number of Member States or highly variable risks that are dependent on local conditions.123

Substantively, REACH does not limit the nature and design of restrictions. Although REACH references substitution only in relation to authorization, a restriction likewise has substitution effects since some uses, or ways in which a substance is used, are prohibited and thus will have to be substituted for. Depending on how a restriction is designed, such substitution pressure can be very strong; for example, like authorization, a restriction may provide for a time-limited exemption for a particular use.124 In other words, assuming that there is evidence of risks that are not unacceptable and adequately controlled, a restriction can be designed in a way that closely resembles the results of REACH authorization.

Under the REACH restriction regime, any restriction proposal must cover information on alternatives, including information on the risks to human health and the environment related to the manufacture and use of the alternatives,125 and establish that a restriction is indeed the most appropriate measure to address the risk concerned.126 To show that it is the most appropriate measure, an assessment is required of the effectiveness, practicality and enforceability of a restriction.127 Thus, although an unacceptable risk is found to exist, a restriction may not be the most appropriate measure to address this risk. Other measures could include harmonized classification and labelling or an occupational exposure limit under workers' safety law. The Commission has some discretion in selecting the most effective and proportionate measure from two or more available options.128

Finally, REACH requires that a restriction decision ‘take into account the socio-economic impact of the restriction, including the availability of alternatives’129 and recommends that a Member State conduct a socioeconomic analysis before submitting a restriction proposal.130 This information should be part of the Annex XV dossier.

Procedure

There are two procedures for the adoption of restrictions: a regular procedure131 and a fast-track procedure.132 The regular procedure can be initiated by a request from the Commission to ECHA to prepare a restriction proposal,133 by ECHA for any substance on the Authorization List after the sunset date,134 or by a Member State.135 The final decision is adopted by the Commission in a comitology procedure following public consultation and opinions from ECHA's advisory committees.136 Restrictions are adopted by the Commission pursuant to the regulatory comitology procedure with scrutiny.137 In its decision, the Commission may depart from the opinions of ECHA's Committees if it provides a detailed explanation.138 This explanation should be attached to its decision.139 The fast-track procedure may be used to adopt a restriction with respect to carcinogenic, mutagenic or teratogenic/repro-toxic (CMR) substances in consumer products or uses.140 The procedure does not involve ECHA's committees and is limited to the regulatory comitology procedure with scrutiny.141

Role of Restriction

The restriction regime is designed to impose generally applicable restrictions on the manufacture and use of substances. Unlike authorization, it is not limited to SVHCs.142 Further, while authorization requires use-specific applications that must be submitted by each company,143 the restrictions imposed by REACH apply directly and require nothing other than compliance with the specific conditions stated in Annex XVII. Restriction has a long history dating back to the Marketing and Use Directive.144 This means that there is significant experience with operating this programme. However, as discussed below, the allocation of administrative burdens under the restrictions process may correlate negatively to Member State authorities' inclination to propose restrictions, in particular in light of the other available regulatory pathways, including authorization. Like authorization requirements, restrictions are enforced by the Member States.145

The Choice between Authorization, Restriction and Other EU Chemical Laws

Authorization and restriction are the two ‘command and control’ regimes for regulating chemical risk under REACH. The substantive standards and procedures for the application of each of these instruments differ in significant ways. For instance, the restriction regime requires that the Commission prove that a substance poses an unacceptable risk to human health or the environment,146 and the restriction must be tailored to that particular risk, and it may cover any stage in the life cycle of a substance.147 In comparison, authorization is hazard-triggered, a low standard, limited to SVHCs as defined,148 and prohibits any use except as authorized. Once a substance has been listed on Annex XIV, all placing on the market and uses of that substance are subject to authorization, and substitution is encouraged, regardless of whether there is any exposure or risk to human health or the environment.149

The significant differences between the programmes suggest that the choice between the two has substantial ramifications. Remarkably, the EU authorities have not effectively engaged with this issue. In a 2011 report on the operation of REACH and the CLP Regulations, ECHA noted that ‘it is crucial to develop sufficient common understanding’ on when to initiate the authorization and restriction processes so as to enhance ‘the effective use of resources in authorities and industry, legal clarity and predictability’.150 Unfortunately, the Commission did not advance this discussion in the context of the REACH implementation review. In its 2013 general report on REACH, the Commission is silent on the issue151 and the Staff Working Document notes merely that that ‘there may be cases where it is appropriate to launch the two processes (authorization and restriction) in order to target different uses’.152 Further, it should not be forgotten that REACH is not the only framework for regulating chemical risk. There may be other laws or regulations that could offer an alternative to a measure issued pursuant to REACH.

Coordination between Authorization and Restriction under REACH

Unfortunately, REACH does not provide a set of rules to guide the choice between restriction and authorization.153 However, REACH is not entirely silent on the relation between the two regimes. It is clear, for instance, that the two programmes are not designed as mutually exclusive, which raises the issue as to when both may be applied to the same substance. REACH attempts to enhance predictability and consistency of regulation through the following provisions:

  • A restriction cannot interfere with the authorization regime. Once a substance is added to the Authorization List, a restriction can no longer target risks resulting from the hazard for which it has been subjected to authorization, insofar as such risks arise from the use of the substance on its own, in a mixture or its incorporation in an article.154
  • On the other hand, a restriction may cover risks resulting from other hazards or from the presence of the substance in an article, as well as any other risks.155 The idea is that a restriction could supplement the authorization regime to cover imported articles not subject to authorization.156 REACH therefore requires that ECHA consider whether risks resulting from a substance subject to authorization should be restricted once the sunset date has passed.157
  • An authorization may not be granted if it would constitute a relaxation of a restriction.158 Further, a substance must be taken off the Authorization List if all uses have been prohibited under REACH or other EU legislation,159 as any authorization would be a relaxation of such a prohibition. Implicitly, this provision is an acknowledgment that restriction may also have strong substitution effects.
  • An exemption from authorization may be established based on existing restrictions. If chemical risks are ‘properly controlled’ under existing specific EU legislation imposing minimum safety requirements, an exemption from authorization for the substance concerned may be granted.160 A REACH restriction or a restriction under other EU legislation could meet the condition of minimum safety, and thus justify an exemption from authorization.

From a policy perspective, the significant differences between authorization and restriction and the general principles of EU law (discussed below) demand that in each case the question be answered whether authorization would be more appropriate than alternative regulatory instruments to address a particular risk. Indeed, the Member States and the Commission increasingly conduct an assessment of available risk management options before a substance is added to the Candidate List.161 The Commission has significant discretion on whether and when to list a substance on the Authorization List; it may decide not to list a substance recommended for listing by ECHA if it believes that restriction would be a more appropriate instrument.162

Although the Commission left open the possibility that some of these substances will also be subject to restrictions,163 no clear policy on such double regulation has yet been articulated. The key policy questions still need to be answered. First, in which cases could authorization target only some of a substance's uses, while restrictions would address other uses that are exempt from authorization? With respect to imported products, double regulation surely needs to be considered: if authorization applies to a substance's use in domestic manufacture of products, the question arises whether a restriction should also be imposed with respect to imported products. Second, with respect to the same use, could authorization address some specific risks (e.g., by listing a substance only for human hazard on the Authorization List) while restrictions target other risks (e.g., environmental risks) associated with that use? Are there realistic scenarios where such risk-based differential regulation would be appropriate? Third, is double or differentiated regulation appropriate? Most, if not all, that can be achieved through authorization can also be achieved through restriction. The question therefore arises whether authorization should play the dominant role in the regulation of SVHCs that the legislature may have had in mind.164, 165 Given the substantial administrative costs associated with authorization, there would have to be clear, proven advantages. If the same results can be achieved through restriction, it is likely to be the less restrictive measure and double regulation can be avoided. An issue likely to arise in this context is the effect on substitution pressure. Again, a restriction, which can impose a substitution plan and provide for time-limited exceptions, is not necessarily inferior to authorization in this respect. Whether review of individual substitution plans, as required in connection with authorization, will have added value is an open question.

Coordination with Other Chemical Laws

REACH operates independently from other chemical regulatory programmes, subject to limited exclusions to avoid double regulation.166 For instance, active substances used in biocides and plant protection products are regarded as ‘being already registered’ and thus exempt from registration, but not from the other REACH programmes.167 The idea is that overlaps between regulations may result in inconsistencies or even conflicts, or in unnecessary regulatory burdens. The pre-existing regulations for which REACH exemptions have been established, which are more limited in scope and more specific than REACH, are deemed to address the related risks adequately. The wording of the exemptions differs. In some cases, the exemption does not reference the particular regulations concerned (e.g., transport of dangerous chemicals168 ); in other cases, the exemption refers to material as defined by a particular law (e.g., waste169 ), or a product falling within the scope of a particular law170 or ‘in the finished state, intended for the final user’.171

Restrictions continue to be imposed under other legislation of both pre- and post-REACH origin. The Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive),172 which imposes maximum concentration levels on six chemicals in electrical and electronic equipment, was adopted prior to REACH, and there are now plans to expand the number of chemicals regulated under it.173 Likewise, the Directive on end-of-life vehicles (ELV Directive),174 which aims at making vehicle dismantling and recycling more environmentally friendly including by restricting the use of four chemicals in vehicles,175 is a pre-REACH regime.

After the adoption of REACH, the EU legislature continued to adopt product group-specific chemical restrictions for products such as biocides,176 plant protection products,177 toys178 and cosmetics,179 and a proposed regime for medical devices is pending.180 These regulatory measures have been adopted on an ad hoc basis as an integrated framework for regulating product-related chemical risks does not exist. There is a serious question as to whether this is an appropriate practice since the scientific and policy analysis conducted by the EU legislature before such restrictions are adopted is generally less rigorous than the REACH Regulation requires. For instance, when the European Parliament recently adopted restrictions on CMRs and endocrine disrupters in medical devices, it did not have any risk assessment report available. In general, REACH offers a better framework for imposing the restrictions sought by the EU legislature. If the intent is to circumvent the demands imposed by the REACH restrictions procedure, the issue arises how the quality of decision making on chemical restrictions outside the REACH context is guaranteed. There is reason for concern since no general framework for science-based decision making exists outside of REACH.181

Under current EU law, EU authorities thus may have a choice of regulatory frameworks to manage risks associated with the manufacture or use of a chemical substance. The available regulatory frameworks may differ substantially in terms of scope (e.g., a concentration limit for a substance under the RoHS Directive will apply only to electronics). In addition, the specific tools available under each of these frameworks may also differ from one instrument to the next (e.g., a restriction on a specific technological use in multiple products can be imposed under REACH, but not under the RoHS Directive). If a chemical risk is best regulated through one specific tool, the lack of availability of that specific tool under a regulatory framework may render that regulatory framework less appropriate. Further, the procedure for adopting a chemical risk management measure also varies between regulatory frameworks; in some cases, a legislative amendment would be required for a particular restriction (e.g., a labelling requirement under the medical devices legislation). These and other considerations should come into play when the authorities decide on the pathway for regulating a particular chemical risk.

A policy choice of regulatory framework arises not only in relation to chemical restrictions targeting specific product groups, but also with respect to chemical risks in the workplace. Since substances in the workplace frequently give rise to a need for risk management and REACH requires that such risks be identified and managed,182 this issue is bound to come up regularly. Indeed, in the case of occupational exposure, the same restriction (e.g., a binding occupational exposure limit) could be adopted either under REACH or under the worker safety legislation. Unlike for product-related chemical risk, the EU has established an integrated overarching framework for addressing occupational risks arising from chemicals. The decision makers and applicable procedures and legal and practical aspects, however, may differ significantly. The following considerations may be relevant to the choice between regulation under REACH or regulation under the EU occupational health legislation:

  • Specificity and level of integration of framework: The EU occupational safety legislation provides a framework that has been designed specifically for the purpose of offering integrated protection of the health and safety of workers exposed to occupational risk, including risks arising from chemical agents. If a substance poses only occupational risk, the occupational legislation generally is the most suitable and appropriate regulatory framework. This appears to be also the Commission's position.
  • Procedure: Under REACH, the draft restriction must go through a lengthy procedure at ECHA before the Commission adopts the final decision by comitology in the form of a regulation. Under the EU occupational legislation on chemicals at work (Directive 98/24), a draft decision prepared by the Commission is first assessed by the Scientific Committee on Occupational Exposure Limits (SCOEL) and then goes through the legislative procedure for adoption of a directive, which, once adopted, must be transposed into national law. This procedure may take more or less time than a procedure for the adoption of a REACH restriction, depending on the facts and circumstances.
  • Effect, subsidiarity and legitimacy: A REACH restriction is directly effective, while a measure pursuant to Directive 98/24 has to be transposed by the Member States. The occupational law's decision-making process and transposition, however, may better reflect the EU's governance philosophy and the subsidiarity principle than a REACH restriction. It may also enhance the measure's legitimacy and the Member States' ‘buy-in’ or ownership. Further, the transposition process might advance the Member States' understanding of what effective implementation in their territories requires.

Important issues about the relationship between REACH and other chemicals-related laws have arisen in connection with Article 58.2 of REACH, which allows exemptions from the authorization process. In the process of listing trichloroethylene on Annex XIV, for which there already is an indicative occupational exposure level (iOEL; see below), the question came up how REACH relates to worker protection legislation.189 The Commission's Directorate-General Environment argued that worker protection legislation cannot serve as a basis for an exemption because it is not efficiently implemented.190 With the exception of Romania, the Member States agreed with the Commission and approved the listing of trichloroethylene on Annex XIV without exemptions.191 Even though the listing was agreed without exemptions this case is likely to influence future exemptions under REACH authorization. In a 2013 report, the Commission recognized the fact that there is limited experience with Article 58.2 exemptions.192 The Commission made specific reference to the workers protection legislation, echoing the trichloroethylene situation.193 Indeed, in these and other cases, the Commission should grant exemptions from authorization, as appropriate.

Another example of overlap between REACH and sector-specific legislation that would require exemptions from REACH authorization is the case of cadmium. If cadmium, currently on the Candidate List,194 is subsequently listed on Annex XIV without exemptions, it would not be available for any use unless authorization is granted unless, perhaps, one of the exemptions for cadmium granted under sector-specific legislation such as the RoHS Directive applies. Would companies be able to invoke these exemptions, or would they need to request authorization? Recognizing this overlap between RoHS exemptions and REACH authorization, the Commission has emphasized a need to consider exemptions from REACH authorization.195 It is to be hoped that, going forward, the authorities will adopt a more practical view on exemptions from authorization. This would do justice to the intent of the REACH legislation: REACH provides for possible exemptions because some uses are, or can be, subjected to efficient risk management measures pursuant to EU sector-specific or other regulation, including national regulation.

The Choice between Restriction and Authorization

Because REACH is a collection of several stand-alone regulatory regimes that loosely hang together, one and the same risk can be targeted by two or more evaluative regimes at the same time (e.g., in connection with substance evaluation and Candidate Listing) and two or more risk management measures (e.g., restriction and authorization). This can occur even before a substance evaluation has been completed, or a risk assessment and policy analysis have been conducted. Put differently, REACH does not provide an adequate framework for making risk management decisions. Logically, risk assessment and policy analysis should precede any proposal for subjecting a substance to restrictions or authorization. Further, specific rules and criteria on how the authorization and restrictions regimes relate are not set out in the REACH Regulation. A robust framework for the selection of the appropriate risk assessment procedure and risk management measure to address a specific risk would help to structure the choice between the various tools offered by REACH and other legislation, and make the process more predictable.

Authorities have only recently started to focus on the question of whether the authorization or restriction regime is the most suitable regulatory response to a particular chemical risk.196 Undoubtedly, this debate will continue for some years to come. The experience thus far has shown that authorization is not necessarily the preferred approach for all substances that meet the criteria for being classified as SVHCs or that are listed on the Candidate List or Annex XIV. There are several aspects of the authorization and restriction regimes that are relevant to making an informed choice.

First, in some cases, authorization is less comprehensive and effective than restriction. Authorization must be related to the property for which a substance was listed on Annex XIV197 and cannot target all properties of a substance and the related risks.198 Although all uses of a substance listed on Annex XIV are subject to authorization, including uses that do not expose the environment or human beings to the risks associated with the properties for which the substance was listed, the conditions attached to an authorization may not address the risks associated with other intrinsic properties, even if these other risks are not adequately controlled.199 Thus, if a substance is listed on Annex XIV for repro-toxicity, the authorization may be aimed at reducing the risks arising from repro-toxicity, but not risks associated with other properties of the same substance, such as liver toxicity. If a substance has multiple dangerous properties, only one or some of which could be addressed in the authorization process, restriction may be a more effective option.200 Put differently, a REACH restriction can impose conditions targeting properties of substances and risks arising from uses of substances that cannot be covered under the authorization regime. This flexibility of the restrictions regime can be a major advantage with respect to certain chemical risks, such as release of a chemical from a product into the environment or residues of a substance in an article.201

Second, in terms of administrative cost, authorization is much more costly and burdensome than generally binding restrictions, if the results achieved are similar. This is so because each manufacturer or user of the substance concerned must file an individual application, which is an onerous process, and authorization is subject to expiration and possible renewal.202

Third, for authorization, the availability of alternatives is not considered at all when substances are listed; it is considered only late in the process in relation to individual authorization applications.203 Consequently, substances may be subjected to the expensive and burdensome authorization programme, even though they could more efficiently be handled under the restrictions regime, for instance, when the exceptions to a restriction can be identified upfront for all entities concerned. In connection with authorization, REACH does not require that the availability of substitutes be considered, and a positive finding be made that authorization is the preferred regulatory measure, before substances are added to Annex XIV.

Fourth, authorization decreases legal certainty for the companies concerned, which are already exposed to the stigmatizing effects of the Candidate List.204 Once issued, authorization can be withdrawn at any point in time if new information becomes available or circumstances change,205 subject only to the general proportionality principle.206 The interest of legal certainty and incentives for investment, however, would tend to suggest that authorizations should have a minimum validity period during which they cannot be reviewed, altered, or withdrawn.

Fifth, the authorization regime is ambiguous. Article 56.1 of REACH stipulates that ‘a manufacturer, importer or downstream user shall not place a [Annex XIV] substance on the market for a use or use it himself if that substance is included in Annex XIV’, unless authorization for that use has been granted or an exemption applies. The problem is that the concept of ‘placing on the market for a use’ (emphasis added) is ambiguous; the manufacturer sells the substance to a customer, and the customer decides how the substance is used. If the substance is intended for export, the application of the provision becomes irrational.

Sixth, authorities may impose a restriction only if they can demonstrate that there is an unacceptable risk that needs to be addressed on a EU-wide basis, while they need to demonstrate only that a substance is an SVHC on the Candidate List to add it to the Authorization List. As discussed above, an assumption that SVHCs are better regulated through authorization is erroneous.

Seventh, in some cases a substance may be subjected to multiple regulatory measures, but the timing of adoption of each regulatory measure has an impact. A restriction under REACH or another EU law adopted prior to authorization could justify a general exemption from authorization. Once a substance is included in the Authorization List, however, the adoption of a restriction of the same substance under REACH is subject to conditions. Further, REACH provides that a general exemption from authorization based on existing EU law may be adopted upon inclusion of a substance on the Authorization List,207 but this rule does not apply if such EU law is adopted afterwards. The Commission could arguably amend the Authorization List accordingly, but there is no requirement for the Commission to do so.

In practice, differences with respect to jurisdiction, procedure and administrative burdens exercise substantial influence on the choice between authorization and restriction. In particular, the issue of administrative workload seems to be a consideration in deciding whether to pursue authorization or restriction. 208 Compared to dossiers for Candidate Listing, very few restriction dossiers have been proposed so far.209 A reason for this may be that the administrative burden associated with the preparation of a restriction dossier falls on the generally short-staffed Member State authorities, which may have difficulty compiling all information necessary to relate registered uses with end products (articles). In addition, Member States may not all have the resources necessary to conduct an analysis of risk management options, an analysis of substitutes and a socioeconomic analysis – all of which are required for the preparation of a restriction dossier.210 More than any other factor, Member States' reluctance to shoulder these administrative burdens may skew the process towards authorization.

From a substantive law perspective, assuming proven inadequately controlled risk arising from an SVHC, both authorization and restriction may be able to achieve the same regulatory ends. In fact, it is hard to think of an authorization requirement that cannot substantively be translated into a restriction. As a matter of law, authorization differs from restriction with respect to the assignment of the burden of proof of adequate risk control (which is imposed on regulated entities versus the government, respectively) and the additional conditions for authorization of PBT/vPvB and non-threshold substances that ‘socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance’ and ‘there are no suitable alternative substances or technologies’.211 Procedurally, a restriction, like authorization, could require a substitution plan, but it could probably not provide for case-by-case assessment of such plans. Whether these differences limit the choice between authorization and restriction, however, depends on the specific facts of each case. In many cases, restriction may serve as an effective and equivalent alternative for the authorization of an SVHC.

If the risks associated with an SVHC are adequately controlled in reality (which is not necessarily reflected in registration dossiers), there is no ‘unacceptable risk’ and restriction is not an option. This standard is met if the risk characterization ratio212 exceeds 1 and, thus, actual exposure levels exceed the levels that correspond with the ‘derived no effect level’ (DNEL) or ‘predicted no effect concentration (PNEC).213 In other words, it requires ‘[e]vidence … that implemented risk management measures … are not sufficient’.214 If the risk characterization ratio does not exceed 1 and evidence of insufficient risk management is not available, authorization is the only regulatory option. This raises the question of whether such regulation is necessary since all risks are adequately controlled. The EU legislature already answered this question, determining that authorization may be imposed also where risks are controlled. Under these circumstances, however, all users of the SVHC concerned will receive authorization,215 except if the SVHC is a PBT/vPvB or a ‘no threshold’ substance.216 The end result could be similar under an ‘authorization-resembling’ restriction approach, if it were permitted. The main difference would be that a restriction would impose one generally applicable set of terms and conditions, while authorization would impose terms and conditions that could, to some extent, be individualized (e.g., with respect to the duration). This analysis exposes a deficiency in the way REACH has been devised: if the relative benefits of such individualization are outweighed by the relative disadvantages, a generally binding restriction may be the preferred option, but REACH does not empower the EU to impose it absent unacceptable, uncontrolled risk.

To conclude, the choice between authorization and restriction is such a convoluted and skewed process because REACH suffers from fundamental design flaws. It does not establish an independent, coherent and unbiased framework for chemical risk assessment and policy analysis of alternative regulatory options. Instead, it establishes separate, diverging, chiefly hazard-based procedures that employ inconsistent safety standards.217 It is no wonder that REACH has not consistently produced predictable, balanced and reasonable results.

RMO Analysis

The prioritization of SVHCs is the first step in the authorization process.218 There are currently over 1,500 substances that meet the SVHC criteria based on their classification.219 ECHA indicated that it will be able to process no more than 20–30 substances per year. Thus, this process raises issues of prioritization for listing on the Candidate List. Due to the allocation of powers, the procedural specificities and the politics, the prioritization process has been plagued by a lack of transparency and predictability. In response to pressure to make the SVHC prioritization process more transparent, the Commission launched an initiative to better coordinate the Member States' intentions in 2012.220

As part of this initiative, the Commission recommended in its SVHC Roadmap to 2020 that an analysis of risk management options be completed before a formal proposal for inclusion on the Candidate List is submitted.221 The overall aim of the SVHC Roadmap is to define the approach to prioritizing substances for inclusion on the Candidate List. Pursuant to REACH, only CMRs, PBTs, vPvBs and ‘substances of equivalent concern’, such as endocrine disruptors, may be included on the Candidate List.222 The RMO is intended to identify the best regulatory option to manage the risk, either through REACH or outside of it.223 In this context, the main purpose of the RMO analysis would be ‘to either document that the authorization route is suggested for an (potential) SVHC or that there are specific reasons for an SVHC which would overrule going the authorisation route to achieve its substitution’. This analysis could lead to the conclusion that ‘a different risk management route (e.g. restriction or action under a different legislation)’ or ‘no action’ is the preferred option. The Roadmap acknowledges that RMO analysis224 should be at the heart of any prioritization decision of a competent authority.225 However, the Commission has also stated that a total of 440 substances should be listed by 2020, of which 80 substances should be assessed by the end of 2014.226 Unfortunately, this political commitment creates a risk that, despite the move towards RMO analysis, unsound decisions will be made under time pressure.

An RMO analysis is intended to assist in determining whether a substance is a ‘relevant SVHC’ in the context of the SVHC Roadmap. Relevant SVHCs are substances that: (i) meet the criteria for Candidate Listing; (ii) are produced and/or used in Europe in relevant quantities; (iii) have been registered for non-intermediate uses; and (iv) do not pose solely a risk that is not adequately controlled and should thus be subjected to a REACH restriction.227 For reasons that are unclear, the prioritization criteria for Annex XIV listing (PBT/vPvB properties, wide dispersive use and high volumes) play no role in this process. The main purpose is to determine whether risk management measures are necessary, and if so, ‘to identify the most appropriate instrument to address concerns’,228 which may be authorization, restriction, another measure or a combination thereof. Thus, RMO analysis involves policy analysis. A more expansive version of policy analysis is required in connection with a restriction proposal, as discussed above.

Although not required by REACH, RMO analysis is destined to become standard practice in connection with Candidate Listing.229 In some cases, RMO analysis appears to be more than a formality (e.g., the Commission has rejected proposed authorization of certain cobalt compounds on the ground that restriction would be more appropriate),230 but the current RMO analysis process leaves much to be desired. For instance, the documentation generated in the process is made available only to Member State authorities and the Commission; only a ‘public version’ of the conclusions is published.231 There is no transparency and no public consultation, except if the evaluating competent authority decides otherwise. The implementation of the SVHC Roadmap will address these concerns only partially.232 Further, from a substantive perspective, the RMO analysis falls far short of fledged policy analysis – for instance, it does not involve an analysis of the costs and benefits of various policy options.233 Political considerations may come into play,234 and are able to trump RMO analysis. In August 2012, the Commission asked ECHA to prepare 37 dossiers for substances to be listed on the Candidate List by December 2012.235 Due to the short timeline, ECHA did not manage to produce RMOs for these substances and Annex XV dossiers were published without proper analysis, contrary to the Commission's own recommendation.236 Both Member States and other stakeholders expressed disappointment with this deficiency.237 The future will tell whether this was a one-off incident.

A major problem with the current RMO process is that it is a rudimentary version of policy analysis with a tendency to be conclusory, rather than analytical, and a slant towards authorization. A recent case238 shows how basic and unenlightening RMO analysis can be. This lack of thoroughness is at least in part due to the fact that stakeholders are not consulted, which is a serious problem if the information required for a sound analysis is not publicly available. No serious attempt is made to compare risk management options, and to the extent any such analysis is produced, it is unable to inform sound decision making. If RMO analysis is to be a foundation for rigorous policy making, the authorities should at a minimum determine and document in detail what risk is to be addressed, what the objectives of risk management should be, whether any regulatory measure is required to achieve those objectives, and if so, what the costs and benefits are of the available options, and which of these options would be the most appropriate measure and why. The ‘no action’ option should be seriously considered, where appropriate. If action is required, a comparison of possible regulatory measures should be based on cost-benefit analysis, which could build on the criteria provided under Annex XV. These criteria include: effectiveness;239 practicality;240 monitorability;241 and a favourable socio-economic assessment.242 Other relevant considerations include: risk/risk tradeoffs;243 regulatory consistency (e.g., how would a new measure compare in terms of stringency to another comparable existing measure); and uncertainties (e.g., are the risk profiles of substitutes fully understood?).

The Role of General Principles of EU Law

Although neither REACH nor other EU legislation impose a robust general framework for choosing the most appropriate regulatory instrument to address a specific chemical risk, provisions of general EU law are relevant to this choice. Specifically, the general principles of EU law define the boundaries within which this choice has to be made. The most relevant general principles include: the principle of equal treatment; the proportionality principle; and the obligation to state reasons. We will deal with each of these in turn.

Under the principle of equal treatment,244 persons in the same situation must be treated in the same way unless a different treatment is objectively justified (and not arbitrary).245 This principle also prohibits different situations from being treated similarly without objective justification.246 REACH requires that each substance be analyzed and tested, as necessary, to determine its hazards and risks, irrespective of how similar the substance is to another substance that has already been analyzed and tested.247 Under certain conditions, REACH permits that substances be grouped into a category if they are structurally similar and have similar intrinsic properties. In some cases, however, the equality principle requires that substances be treated as a group, even if they do not meet the criteria for a category. For example, when considering Candidate Listing, ECHA should assess very hazardous substances that are deemed substitutes as a group at the same time. In its SVHC Roadmap, the Commission has adopted a category approach that covers intermediates, which would otherwise not be considered.248 Further, the equality principle requires that substances that are similarly positioned be treated equally (e.g., substances that are substitutable and have similar properties). If, say, three substances are substitutable and have similar hazardous properties, a regulatory measure targeting only one of them would unfairly impose regulatory burdens on the manufacturer or users of that particular substance, thus providing an unfair advantage to the manufacturers or users of the other two substances.

The proportionality principle249 requires that ‘measures adopted by Community institutions do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued’.250 The measure must thus be: suitable or reasonably likely to achieve its purpose; necessary to achieve its purpose; and the least detrimental.251 In the case of three similar, substitutable substances, for instance, a more onerous regulatory measure applied to only one or two of these substances would not be the least detrimental and thus be disproportional. The proportionality principle applies not only to the choice between authorization, restriction or other regulatory measures, but also to the substantive and procedural requirements of any such measure.

Decisions must state the reasons on which they are based.252 The statement of reasons

must show clearly and unequivocally the reasoning of the institution which adopted the measure, … enable the persons concerned to understand the full significance of and the reasons for the measure at issue in order to enable them to safeguard their rights and … enable the EU judicature to exercise its powers of review of legality.253

The required extent and detail of the statement of reasons is a function of the measure, its context and the applicable legal rules.254 Where the persons concerned were involved in the process by which a measure has been adopted, the requirement to state reasons may be circumscribed as they may have had an opportunity to learn about the reasons through their involvement.255 This obligation also requires that the decision maker, where relevant, explain why a particular measure should be preferred over alternative measures.

Conclusions

The REACH Regulation sets forth only a few provisions aimed at coordinating between authorization and restriction. Likewise, the relationship between REACH and other chemical laws is not addressed in any significant detail. Specifically, REACH does not require policy analysis or a structured cost-benefit (or similar) analysis of alternative approaches to regulating chemicals, except, to some extent with respect to proposed restrictions.

To reduce this gap, the Commission has developed the RMO analysis, which is aimed at confirming that the right regulatory tool is used to address the risks associated with a specific SVHC. RMO analysis might help somewhat to ensure that the most appropriate regulatory measure is applied to a particular substance or a group of substances. However, the process is limited as it does not include policy analysis or cost-benefit analysis of alternative regulatory measures. Moreover, it is biased towards authorization, as the default assumption is that authorization is the most appropriate measure.

The Case of Dipolar Aprotic Solvents

The problems arising under REACH in relation to the choice of the most suitable regulatory instrument can be illustrated with reference to dipolar aprotic solvents. These are powerful solvents that are used in specialty applications, such as certain polymerization reactions, which require polar solvents that do not donate protons and thereby react. They can dissolve relatively large quantities of organic salts and are essential for chemical reactions involving strong bases, which would react with protic solvents. This group of solvents includes NMP,256 DMAc257 and DMF;258 their properties and applications are summarized below.

The case of dipolar aprotic solvents highlights the trouble authorities may have in identifying the most suitable regulatory instrument in the absence of an overarching framework for policy analysis and instrument selection. It also demonstrates that the ‘one substance at a time’ regulatory approach does not work well in cases where substances can substitute each other. Eventually, however, the authorities identified a coherent, consistent and logical way forward for this group of substances. As discussed below, the first proposed solution, authorization, appeared not to be the most suitable way to address risks arising from these substances.

Chemical Properties and Uses

The three dipolar aprotic solvents share several important similarities, including those regarding chemical properties, uses, volumes, classifications and risk profiles. The polar nature of these substances enables them to act as a combined solvent and reaction catalyst.259 In addition, their high boiling point allows reactions to run at high temperature, without the need to operate under pressure.260 Applications of these substances are limited to industrial processes.261 Common uses include the manufacturing of pharmaceuticals, agrochemicals, fine chemicals, coatings and fibres.262 DMAc, for instance, is used as solvent in a polymerization reaction of fibres such as acrylic and meta-aramid. The annual volume of these substances that is estimated to be imported and/or manufactured in the EU ranges between 10,000 and 100,000 tonnes a year (t/y) for DMF, 10,000 and 50,000 t/y for NMP, and 11,000 and 19,000 t/y for DMAc.263 All of these substances are high volume and have been registered by the first REACH registration deadline in December 2010. All three substances are classified as toxic for reproduction, category 1B.264 DMAc and DMF are also classified for acute toxicity, category 4 (harmful if inhaled or in contact with skin);265 DMF as eye irritant, category 2;266 and NMP as specific target organ toxicity – simple exposure (‘STOT SE’) (may cause respiratory irritation), category 3, and eye and skin irritant, category 2.267 All three substances have similar uses and risk profiles. In industrial applications, they pose some occupational risk, which has been addressed under EU worker safety legislation. They do not pose environmental risk,268 however, and there is no evidence of any relevant exposure of consumers, and thus no consumer risk.269

Based on these similarities, in many applications, these substances are interchangeable.270 They pose similar risks, which, by and large, are limited to potential occupational exposure. The situation is different when it comes to substitution of a dipolar aprotic solvent with another substance that does not belong to this group. There are no generally accepted substitutes for these substances in most applications, including in the production of fibres.271 Dimethyl sulfoxide is considered to have higher permeability, thermal instability and less solvating power for polymer. Moreover, its decomposition products cause an unpleasant odour.272 Sulfolane has a higher melting point and thus is often operationally impracticable.273 Acetone and acetonitrile have less solvating power.274 The lack of adequate substitutes in some applications should inform the choice between possible regulatory tools.

Regulatory Measures Applicable to Dipolar Aprotic Solvents

Before the recent regulatory activity under REACH, the three solvents were already regulated pursuant to EU legislation. The existing regulatory measures applicable to dipolar aprotic solvents are summarized below.

  • Harmonized classification and labelling: As noted above, these solvents are subject to similar harmonized classification and labelling. Under the pre-REACH legislation, they were similarly classified.
  • REACH restrictions: Annex XVII of REACH provides that substances classified as toxic to reproduction, which includes the three dipolar aprotic solvents, may not be supplied to the general public if the individual concentration of the substance is equal to or exceeds a concentration threshold above which a mixture including the substance is regarded as hazardous. The concentration threshold for DMAc and NMP is 5%. No specific concentration threshold has been specified for DMF, which implies that it is subject to the generic concentration limit of the Dangerous Preparation Directive of 0.5%, which will go down to 0.3% under the CLP Regulation as of 1 June 2015. Suppliers have to label these substances and mixtures visibly, legibly and indelibly with the statement ‘restricted to professional users’.
  • Indicative OELs: The three substances are subject to iOELs under EU occupational health and safety legislation. These limits relate to presence in air, and are expressed in ‘milligrams per cubic metre of air at 20°C and 101,3 KPa’ (mg/m3) and ‘parts per million by volume in air (ml/m3)’ (ppm). There are eight-hour time-weighted average (TWA) limits and short-term limits. The applicable limits for the three solvents at issue are as follows (note that national limits may be lower ): NMP: 40 mg/m3 and 10 ppm (eight hours TWA) and 80 mg/m3 and 20 ppm (short term); DMAc: 36 mg/m3 and 10 ppm (eight hours TWA) and 72 mg/m3 and 20 ppm (short term); and DMF: 15 mg/m3 and 5 ppm (eight hours TWA) and 30 mg/m3 and 10 ppm (short term).
  • Legislative pressure for substitution: Because the solvents are classified as toxic for reproduction, they must be substituted under both the Directive 2010/75 and Directive 98/24. Pursuant to Directive 2010/75, CMR substances, such as the three solvents, must be substituted ‘within the shortest possible time’. Under Directive 98/24, employers are required to eliminate risks or reduce them to a minimum, with a preference for substitution.

In short, the dipolar aprotic solvents are classified as repro-toxic and covered by iOELs pursuant to EU occupational health and safety regulation. In addition, these substances are earmarked for substitution under solvent and occupational safety regulations.

Early Steps in the Procedure: Diverging Approaches

Despite the existing regulatory measures and the absence of any assessment of the adequacy thereof, efforts were launched to regulate dipolar aprotic solvents under the REACH Regulation. These efforts were fuelled by the classification of these substances as repro-toxic under the CLP Regulation.289 The first actions under REACH were listing on the Candidate List.290

Thus, in the initial stages of regulation pursuant to the REACH Regulation, these substances proceeded along a similar regulatory path. ECHA earmarked all three solvents for authorization, but then their regulatory paths diverged. The divergence resulted from a proposal submitted by the Netherlands to impose restrictions on NMP.291 The Dutch proposal involved a reduction of the current occupational exposure limits to 5 mg/m3 (eight-hour TWA) with peak exposures below 10 mg/m3 (15 minute STEL).292 These limits would be mandatory, rather than indicative, as is currently the case under the Directive 2000/39. In addition, companies would be required to deploy preventive measures to avoid dermal exposure in professional and industrial settings.293 Further, manufacturers and industrial and professional users of NMP would have to be able to demonstrate at the request of the local authorities that they comply with these limits and obligations by maintaining an exposure monitoring programme.294 The next step in the procedure is the preparation and release of opinions by ECHA's Risk Assessment and Socioeconomic Analysis Committees; the deadline for the final opinions is September 2014.295

In addition to this proposal, the Netherlands submitted two proposals for ‘reclassification’ of NMP and DMAc.296 These proposals seek to withdraw the specific concentration limits for classification of mixtures containing these substances as repro-toxic category 1B. Such withdrawal would result in the generic concentration limit of 0.3% for repro-toxic category 1B297 becoming applicable to mixtures containing NMP and DMAc298 as of 1 June 2015.299 In the case of NMP, this lower concentration limit is intended to effectively eliminate the use of NMP in consumer applications, as ‘[t]he use of NMP in concentrations below 0.3% will have no functionality in the present consumer applications’.300 Finally, Italy has signaled its intention to submit a restriction proposal for DMF in articles and for professional uses by 16 January 2015.301

No analysis has been done of the effects of the proposed diverging measures on the relative competitiveness of the three solvents and the potential for market distortion or disruption. Although REACH does not explicitly require such analysis in connection with listing for authorization, sound policy making in accordance with general principles of EU law presupposes an understanding of such market impacts. It is entirely conceivable that even minor differences in regulatory treatment could have significant effects in the markets for interchangeable substances. Any such substitution effects may result in adverse impacts on the environment and health and safety (e.g., where companies switch to a product that causes more serious adverse effects). This suggests that a systematic process is required to ensure that such substances are assessed jointly before policy action is proposed. The Commission's RMO analysis approach should be adapted to incorporate this feature.

The current situation with respect to the regulation of the three solvents pursuant to the REACH authorization and restrictions regimes is as follows. DMAc is covered by: ECHA's 4th Annex XIV Recommendation,302 but its inclusion has been put on hold by the Commission;303 a reclassification proposal;304 and REACH, Annex XVII, entry 30. DMF is: included in ECHA's 5th Annex XIV Recommendation;305 is covered by REACH, Annex XVII, entry 30; being considered for further restriction under REACH with a proposal to be submitted by January 2015;306 and covered by a reclassification proposal.307 NMP is: not included in an Annex XIV Recommendation; covered by REACH, Annex XVII, entry 30; the subject of a reclassification proposal; and being considered for further restriction under REACH. Thus, all three solvents were initially on diverging regulatory paths. The authorities realized, however, that this is a problem.

Towards a Consistent Approach

The initial situation created a risk of inconsistent treatment of three very similar substances. While a restriction proposal is pending for NMP, DMAc and DMF are being reviewed for possible authorization. This divergence is not the result of an objective policy decision; it is due to the fact that various authorities have the power to initiate measures under REACH, and the significant overlap between risk regulatory programmes under REACH and under other chemicals-related legislation.

When the facts were established, however, authorities became uncomfortable with the inexplicable incoherence in proposed regulatory approaches for these three solvents.308 They seem to have realized that divergence would have significant risk management consequences and greatly affect the relative demand for each of the three substances causing market distortion and possible disruption, without there being any rational explanation. These commercial consequences may well have made the authorities wary of proceeding along the initial paths.

The initial incoherent approach is also questionable from policy and legal perspectives. From a policy perspective, in light of the similarities in terms of chemical properties, uses and risk profiles, there would appear to be no justification for treating the three solvents differently. Any differential treatment would cause unjustified distortions in the markets for these solvents by imposing significant additional costs for the industry on the use of DMAc and DMF in comparison to NMP. The protection of human health and the environment would not in any way be advanced by such differential treatment, and may be positively harmed – for instance, due to unfavourable substitution effects.309 In the absence of any other justification for such difference in treatment, the need for another, coherent approach became apparent.

From a legal perspective, the general principles of EU law strongly suggest that the risks arising from the solvents should be addressed through one coherent, consistent regulatory measure that avoids unjustified distinctions between them. Under the principle of equal treatment, any treatment favouring or disfavouring one of the substances would not be justified by relevant differences. The proportionality principle would argue against the use of authorization for any of the three substances since authorization would not have any benefits, but the cost for industry would be high. If a restriction is sufficient to control the risks posed by any of the three substances and pressure for substitution exists, subjecting one or more of these substances to authorization would, by definition, not be the least onerous and thus be disproportional.

If the authorities were to proceed with diverging regulatory approaches for dipolar aprotic solvents, manufacturers, importers and users would have a cause of action. They could challenge a Commission decision to subject one or two of the solvents to authorization before the European court. In this case, no appeal could be made to the ECHA Board of Appeal, which has limited jurisdiction.310 If no action is brought before the European courts, the invalidity of any such decision could be invoked in enforcement actions before national courts.

The Least Onerous and Most Appropriate Measure

EU law requires that the three solvents be subjected to the same or a very similar regulatory measure. This raises the issue as to what the most appropriate, least onerous measure is. The analysis of this issue proceeds in two steps. First, authorization should be compared to restriction. Second, if restriction is the least onerous measure, it has to be determined whether a REACH restriction or a restriction pursuant to other legislation is most appropriate.

With respect to the choice between authorization and restriction, our analysis above shows that, in general, authorization is more onerous for industry. Authorization requires individual applications, which are burdensome, limited in time and subject to withdrawal; if there already is pressure for substitution,311 there would appear to be no justification for the added burden associated with authorization. Authorization also consumes more government and industry resources than restriction since it involves an individual permitting programme.312 In the case of the three solvents, the risk concerned is occupational exposure. This is the kind of risk that can be addressed effectively through exposure limits and protection measures. Such general measures are less onerous than company-specific and use-specific authorizations.

In-depth policy and legal analysis supports the conclusion that restriction is the preferred approach. First, it is plausible that an RMO analysis313 for the three solvents, which includes, among other things, an assessment of whether there is a risk that is not adequately controlled and needs to be addressed at EU level314 and whether there already is pressure for substitution provided by specific EU legislation, would confirm that a restriction or a binding occupational exposure limit is the most appropriate option.

In this case, authorization is less effective than restriction because authorization can address only any risks associated with the specific property for which the solvent concerned would be listed (repro-toxicity). Consequently, in practice, authorization often has to be complemented with restrictions for risks that may not be considered in the authorization procedure. Restrictions, on the other hand, are not so limited and can address the full range of risks. There are only a few specific uses that are likely to result in exposure, and these are all in industrial settings, thus posing occupational risks. Occupational risks lend themselves well to control through work place safety measures.

Authorization is not necessary to achieve proper risk control and substitution and would have unintended adverse consequences for competition and the internal market. There is no indication that existing EU legislation does not already impose minimum requirements that properly control the risks, at least in most uses. Authorization is not necessary because existing EU laws on worker safety and solvent emissions already fully protect workers and require substitution of the solvents. Additionally, substitution is not realistic in the absence of any less hazardous suitable alternatives.315

The adverse effects of subjecting the substances to authorization would be serious, predominantly, but not exclusively, in the economic and commercial area. EU manufacturers of certain products that rely on the solvents concerned, such as man-made polymer fibres, would be put at a competitive disadvantage compared to non-EU manufacturers of the same products, without any benefit for human health. The unintended adverse consequences of authorization would hit small and medium-sized enterprises particularly hard because they would not be able to afford the resources necessary to obtain authorization and would be de facto excluded from using these solvents. Further, if authorization results merely in imposing exactly the same risk management measures that are already in place, there would be no additional health or environmental benefit while administrative cost would mushroom. In other words, authorization lacks any added value.

The case of these solvents is comparable to the cobalt compounds, which the Commission, despite ECHA's recommendation, decided not to add to Annex XIV and for which it recommended restriction.316 Cobalt compounds have a similar profile to NMP, DMAc and DMF: high volume, and posing occupational risks.317 Thus, the risks posed by the solvents concerned could be effectively managed through restrictions.

The proportionality principle suggests that, as in the case of cobalt compounds, a binding occupational exposure limit or a restriction of exposure to the solvents at issue, for which only a few specific uses are likely to result in exposure, is a more appropriate regulatory measure than authorization. Conversely, for the following reasons, authorization would be manifestly disproportional:

  • Suitability of the measure: The authorization regime is aimed at proper risk control, substitution and good functioning of the internal market. Authorization would impose strict risk control measures, but for most, if not all, uses, existing regulatory and industry measures already impose proper risk controls. Substitution of these solvents is not realistic since all existing suitable substitutes are also classified as very hazardous. As far as possible, pre-existing legislation already provides incentives for substitution – that is, the development of less hazardous suitable alternatives. As discussed above, subjecting these solvents to authorization would impede the functioning of the internal market. Adding these solvents to Annex XIV would thus not be suitable for achieving the objectives of the authorization regime. On the other hand, authorization would further stigmatize these solvents and affect demand, but these commercial effects are not included in an RMO analysis.
  • Necessity of the measure to achieve its purpose: As discussed above, authorization would not be necessary to achieve its purpose, since workers are properly protected under EU occupational health and safety law; consumers and the environment are not at risk; and Directives 2010/75 and 98/24 already provide pressure for substitution.

Based on these arguments, further specific restrictions are to be preferred over authorization. However, restrictions can be imposed pursuant to REACH or other chemicals-related legislation. As the risks posed by the three solvents concerned are occupational, two main types of possible measures should be considered: REACH restrictions including occupational measures, and binding occupational exposure limits and other measures pursuant to occupational legislation. A measure under the latter, a specific worker health and safety framework, is the most appropriate regulatory measure to address the risks associated with these substances. Consequently, with a restriction proposal currently being considered for NMP, no further regulatory action is justified in the interim to include DMAc and DMF on Annex XIV. Rather, if a revised OEL is the most appropriate way to address the risks concerned, all three solvents could be subjected to a revised OEL under occupational safety legislation.

With respect to the most appropriate way to impose further specific restrictions, additional REACH restrictions would appear to be superfluous given the existing occupational exposure controls. As discussed above, indicative exposure limits under the worker safety legislation are already in place; if these limits are found to be too lax, they could be amended, and be made mandatory, to ensure a high level of worker protection. The EU occupational legislation requires also that companies take all appropriate measures to eliminate or reduce chemical risks.319 There is no objective reason to prefer REACH restrictions over these occupational exposure limits, and the applicable procedures and effects associated with the two types of measures point in different directions. If a substance poses only risk for workers, the occupational safety law provides a more appropriate framework for protective measures. Unless persuasive evidence to the contrary is provided, the EU should conclude that the risks posed by dipolar aprotic solvents can be adequately addressed through EU occupational safety legislation.

If there is such persuasive evidence, it does not follow that all dipolar aprotic solvents and all of their uses should be subjected to REACH authorization, which is aimed at phase-out and substitution.320 For example, assuming that there are risks, they would arise only in certain specific applications and uses, and not in other applications and uses. If this appears to be the case, the uses that raise only occupational risks could be addressed through occupational exposure limits, and the uses that cause other risks could be subjected to restriction, which is aimed at managing identified risks. Any residual uses that cannot be managed properly through restrictions could possibly be considered for authorization. REACH contemplates this type of situation, and allows uses already subject to proper risk control to be exempt from authorization.321 Only if it appears that the uses of dipolar aprotic solvents pose such diverging risks, the combination of occupational exposure limits, restrictions and, maybe, authorization might constitute the least onerous and most appropriate set of measures.

The Current Situation

Although there are clear signs that the authorities are moving towards a coherent approach, there is no final resolution as of April 2014. While the Commission recently adopted a clear position, ECHA appears to remain ambiguous.322 In December 2013, the Commission decided not to include DMAc in its draft amendment to Annex XIV. It provided the following reasons for its decision:

[I]n view of the similarities of the two substances [DMAC and NMP], both in the intrinsic properties and in the industrial applications, and in order to ensure a consistent regulatory approach for both, the Commission considers it appropriate to postpone the decision on the inclusion of DMAC in Annex XIV until the Agency submits to the Commission the opinions of the Committees for Risk Assessment and Socio-economic Analysis on NMP in accordance with Article 72 of Regulation (EC) No 1907/2006.323

Based on this clear signal from the Commission, one would expect ECHA to adjust its approach to conform to the Commission's position. On legalistic grounds that are not entirely persuasive, however, ECHA included DMF in its Fifth Recommendation for authorization. It provided the following justification:

The MSC opinion notes that also other polar aprotic solvents than DMF, namely DMAC and NMP, are currently considered for potential further regulatory action under the REACH Regulation. ECHA agrees with the view expressed in the MSC opinion that it is not appropriate for ECHA to assess the pertinence of other regulatory risk management instruments in the Annex XIV recommendation, which is one step in the authorisation process. Considering that DMAC is included in ECHA's 4th Annex XIV recommendation and given that the outcome of the ongoing restriction process for NMP is not known, ECHA has included DMF in this 5th recommendation to enable a consistent approach.324

It could be that ECHA is just very cautious, does not want to prejudge any policy outcomes, and therefore leaves all options open. It would be helpful, however, for the policy makers to be clear about where the process is going.

In its restrictions proposal, the Netherlands argues that a REACH restriction is to be preferred over authorization, as the authorization process is ‘costly and time-consuming both for industry as for authorities’ and creates ‘large uncertainty to industry regarding the continuation of their business because an authorisation request will only be given for a limited period of time’.325 This analysis is consistent with the facts, and is sound. The Netherlands' report, however, goes on to reject the option of reducing the exposure limits under the occupational legislation, invoking three arguments, all of which are weak. First, the SCOEL would use a method of deriving an OEL that differs from the REACH methodology. No argument is presented by the Netherlands, however, to the effect that the SCOEL method would be inferior to the REACH method. Second, the report notes that ‘harmonised implementation of [a revised] indicative OEL by all Member States is not guaranteed’.326 It fails to mention, however, that if the OEL is made binding, this issue would be resolved. Third, the Netherlands observes that ‘the OEL by definition only protects workers from the risks following inhalatory exposure’ – not from risks following dermal exposure. Under the occupational legislation, however, additional risk management measures to reduce dermal exposure can be required.327

Conclusions and Recommendations

The analysis of the REACH restriction and authorization regimes presented in this article has revealed a significant gap in the regulatory framework. To a large extent, the various REACH regimes operate as stand-alone programmes. REACH does not require a structured policy analysis of alternative approaches to regulating chemicals. It does not require, or establish a framework for, comparison of alternative regulatory measures to determine which one is the least onerous and most appropriate, as required by general principles of EU law. In addition, REACH contemplates that regulation proceeds ‘one chemical at a time’. This means that it is up to the authorities, on a case-by-case basis, to decide whether any analysis of alternative regulatory instruments is necessary, and if so, which substances should be included in such analysis, what options should be reviewed and how it should be conducted. To remedy this design defect, the EU needs a flexible, independent, coherent and unbiased framework for risk assessment of single or appropriately defined groups of substances and efficient cost-benefit analysis of alternative regulatory options.

In an attempt to remedy this gap to some extent, the Commission has developed the RMO analysis. This process is intended to ensure that the right regulatory tool is used to address the risks associated with a specific SVHC. RMO analysis is aimed at preventing the use of unnecessarily costly or otherwise inefficient instruments and reducing the risk of a measure violating general principles of EU law. Indeed, RMO analysis will help to ensure that the most appropriate regulatory measures are applied for a particular substance or a group of substances. The RMO process, however, does not properly reflect the EU's basic principles of transparency and consultation, and proceeds with limited involvement of and disclosure to stakeholders. Moreover, RMO analysis is currently done only in connection with Candidate Listing, while some limited version is conducted in connection with restriction proposals. Policy analysis, including cost-benefit analysis, however, should be applied systematically and comprehensively before any regulatory measures are proposed.

The proper role of REACH authorization, which is not well defined by the EU legislature, is at the heart of RMO analysis. Authorization is not necessarily the least onerous and most appropriate measure for risks associated with the manufacture and use of an SVHC. As a general rule, SVHCs should be subjected to REACH authorization only if that is the best regulatory instrument in light of the specific properties, uses and risks posed by the substances concerned and their substitutes. Listing for authorization cannot be automatic and based entirely on hazard. Instead, a choice between authorization, restriction, a measure under other legislation (such as an occupational exposure limit) or no mandatory regulation at all should be made on the basis of a sound comparison of the costs and benefits (including strengths and weaknesses) of these tools in the specific context. Pursuant to general principles of EU law, the least restrictive effective instrument should be used. Although the EU has left the issue of double regulation (i.e., authorization and restriction of the same substance) open, given the substantial administrative costs associated with authorization and the lack of clear, proven advantages of authorization over generally binding restrictions (including with respect to substitution), there is a question as to whether and, if so, when, such double regulation will be the least restrictive measure. More generally, the REACH authorization regime illustrates the pitfalls of hazard-based regulation. Once the role of authorization has been properly defined, it may well become clear that authorization is justified only in exceptional cases.

The case of dipolar aprotic solvents was explored to illustrate these issues, and the possible solutions within the context of REACH and other legislation. Dipolar aprotic solvents have similar properties, classifications, industrial uses and exposure and risk profiles. Nevertheless, the authorities initially launched diverging procedures to further regulate these chemicals without comprehensive risk assessment or comparative cost-benefit analysis. Subsequently, the Commission recognized that this uncoordinated process had to be rectified and started pursuing a coherent, structured approach for all three solvents.

An RMO analysis for dipolar aprotic solvents would likely show that the least onerous and most appropriate regulatory instrument for this group of substances is not authorization and not even restriction based on REACH. Rather, all known risks associated with these solvents can be handled under occupational legislation. In light of the specific concerns about these solvents, which are limited to the potential for worker exposure, appropriate occupational exposure limits and possibly other work place measures would be the most targeted effective measure; the existing indicative limits should be reviewed in light of the evidence and, if necessary, they could be made binding and lowered. The Commission appears to have reached this conclusion, but ECHA's position remains somewhat ambiguous in light of its recent recommendation that DMF be listed for authorization. Since no justification has been provided for singling out DMF, and no such justification is likely to exist, the Commission should ensure that the coherent approach it proposed is followed by all actors involved. Occupational protection measures can adequately address the concerns associated with the use of dipolar aprotic solvents. There is a risk, however, that the choice of regulatory instrument is skewed by politics and ‘turf battles’ between authorities. Within the Commission, Directorate-General Enterprise is responsible for REACH restrictions, while Directorate-General Employment handles occupational safety measures. The EU leadership should ensure that any internal conflicts, if they arise, do not affect the public interest in regulation based on objective policy analysis.

Based on the analysis presented in this article, we offer the following recommendations to the various bodies involved with regulating chemical risk arising from SVHCs. These recommendations can be implemented through reinterpretation of the REACH Regulation, without amendments being necessary, and through changes in administrative practices.

First, the Commission should confirm that the Candidate List is a part of the authorization procedure and should not be used for purposes other than adding substances to Annex XIV. In other words, if there is no intent to consider an SVHC for listing for authorization, it should not be added to the Candidate List.

Second, substances should be prioritized for assessment based on a set of criteria that is indicative of the degree of risk arising from their actual use. The REACH criteria for prioritizing substances for Authorization Listing (hazardous properties, the degree of dispersiveness of use and the volumes) are a good starting point for drafting such criteria.

Third, before procedures are launched to regulate chemical risk arising from an SVHC, a fledged risk assessment and policy analysis, including cost-benefit analysis, should be conducted. As part of this process, substitutes for the substance to be regulated are identified, and an assessment is made as to whether one or more of the substitute substances should be regulated alongside the target substance as a group or category. Risk/risk trade-offs are then examined, and the available regulatory options identified and compared in terms of their costs and benefits. In addition to the Commission, experts from ECHA's advisory bodies could play a role in this process. The objective is to select the regulatory option that best achieves the desired regulatory ends at lowest costs. This procedure is transparent, and public consultations are held, as appropriate, throughout the process. To implement these recommendations, it may be possible to reform the current RMO analysis by converting it into a stand-alone procedure, expanding it to include risk assessment and policy analysis, and eliminating the bias in favour of authorization. Once a regulatory pathway has been selected, the work already done should be fed into this process to avoid duplication of efforts.

Fourth, in order to enable the authorities to select the best regulatory tool for managing risks associated with SVHCs, REACH's provisions on restrictions should be interpreted to require no more than a showing of unacceptable risk if recommended risk management measures are not applied (and that EU-wide action is required). The current interpretation eliminates the restrictions option in cases where it could be the preferred regulatory instrument.

Fifth, in order to assist decision makers, a comprehensive, multidisciplinary study should be conducted on the costs and benefits of authorization and of ‘double regulation’ (authorization plus restriction) of the same substance. The current understanding of the pros and cons of these options is incomplete. A better understanding can help to better define the role of authorization in the spectrum of regulatory instruments.

Sixth, if the sole risk arising from an SVHC is occupational risk, regulation of that risk should proceed pursuant to EU occupational health legislation, unless this legislation does not promote substitution and substitution is deemed to be a regulatory end. Under the EU occupational health legislation, specific specialized procedures have been established for addressing occupational risks in an integrated fashion. Unless there are good reasons for doing so, REACH should not interfere with these processes.

Seventh, if the risks arising from an SVHC are product-related rather than occupational, on the other hand, risk assessment and policy analysis should proceed pursuant to REACH. At the EU level, there is no integrated framework for assessing and managing product-related chemical risk, which implies that outside of the REACH context, chemical restrictions may be adopted on the basis of limited ad hoc procedures, which undermines the quality of decision making. In the risk assessment and policy analysis programme under the REACH umbrella, the available regulatory options can be identified and assessed. These options include the REACH restrictions programme and product-specific regulations, such as RoHS.

Once these recommendations are implemented, the regulation of SVHCs will become a more transparent, cooperative and objective process. More generally, our suggestions are intended to cause the EU to move away from a dogmatic-theoretical approach to regulating SVHCs to a science-based, pragmatic process. These improvements, in turn, will help to ensure that regulatory decisions under REACH are in the public interest.

Footnotes

  1. 1

    Regulation 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’).

  2. 2

    See L. Bergkamp (ed.), The European Union REACH Regulation for Chemicals: Law and Practice (Oxford University Press, 2013).

  3. 3

    See, 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).

  4. 4

    Regulation 440/2008 of 30 May 2008 Laying Down Test Methods Pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), [2008] OJ L142/1.

  5. 5

    Regulation 1272/2008/EC of 16 December 2008 on Classification, Labelling and Packaging of Substances and Mixtures, [2008] OJ L353/1.

  6. 6

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

  7. 7

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

  8. 8

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

  9. 9

    See, 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’, Executive Counsel (2004), 9; E. Fisher, ‘The “Perfect Storm” of REACH: Charting Regulatory Controversy in the Age of Information, Sustainable 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. 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. 11

    See, e.g., G. Schoeters, ‘The REACH Perspective: Toward a New Concept of Toxicity Testing’, 13:24 Journal of Toxicology and Environmental 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. 12

    See L. Bergkamp, n. 2 above; D. Drohmann and M. Townsend, n. 3 above.

  13. 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 Evaluation Services (CSES), Interim Report: Impact of the REACH Regulation 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, Technical 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 Analysts, 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 Analysts, 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. 14

    European Commission, Report from the Commission to the European 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. 15

    E. Stokes and S. Vaughan, ‘Great Expectations: Reviewing 50 Years of Chemicals Legislation in the EU’, 25:3 Journal of Environmental Law (2013), 411, at 415–417.

  16. 16

    Directive 96/59/EC of 16 September 1996 on the Disposal of Polychlorinated Biphenyls and Polychlorinated Terphenyls (PCB/PCT), [1996] OJ L243/31.

  17. 17

    For a review, see Milieu Ltd, n. 3 above.

  18. 18

    Regulation 1005/2009/EC of 16 September 2009 on Substances that Deplete the Ozone Layer, [2009] OJ L286/1.

  19. 19

    Directive 67/548/EEC on the Approximation of the Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labeling of Dangerous Substances, [1967] OJ L196/1.

  20. 20

    Directive 1999/45/EC Concerning the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Classification, Packaging and Labelling of Dangerous Preparations, [1999] OJ L200/1.

  21. 21

    Regulation 793/93/EC on the Evaluation and Control of the Risks of Existing Substances, [1993] OJ L84/1.

  22. 22

    Directive 76/769/EEC of 27 July 1976 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to Restrictions on the Marketing and Use of Certain Dangerous Substances and Preparations, [1976] OJ L262/201.

  23. 23

    See F. Fleurke and H. Somsen, n. 9 above; E. Fisher, n. 9 above.

  24. 24

    Regulation 1272/2008/EC, n. 5 above, Article 50.

  25. 25

    Directive 98/24/EC of 7 April 1998 on the Protection of the Health and Safety of Workers from the Risks Related to Chemical Agents at Work, [1998] OJ L131/11.

  26. 26

    Directive 2000/53/EC of 18 September 2000 on End-of life Vehicles, [2000] OJ L266/34.

  27. 27

    Directive 2011/65/EU of 8 June 2011 on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, [2011] OJ L174/88.

  28. 28

    Directive 2009/48/EC of 18 June 2009 on the Safety of Toys, [2009] L170/1.

  29. 29

    Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, [1993] OJ L169/1.

  30. 30

    Regulation 1223/2009/EC of 30 November 2009 on Cosmetic Products, [2009] OJ L342/59.

  31. 31

    L. Bergkamp and N. Herbatschek, ‘Key Concepts and Scope’, in: L. Bergkamp, n. 2 above, 40, at 53–55.

  32. 32

    See L. Bergkamp, G. Michaux and N. Herbatschek, n. 9 above.

  33. 33

    See L. Bergkamp and N. Herbatschek, n. 31 above, at 47.

  34. 34

    Regulation 793/93/EC on the Evaluation and Control of the Risks of Existing Substances, [1993] OJ L84/1.

  35. 35

    Directive 2001/83/EC of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, [2001] OJ L311/67.

  36. 36

    B. Hansen, ‘Background and Structure of REACH’, in: L. Bergkamp, n. 2 above, 17, at 21–22.

  37. 37

    Ibid., at 17–18.

  38. 38

    This is the ‘no data, no market’ concept. REACH, n. 1 above, Article 5.

  39. 39

    As A. Abelkop and J.D. Graham, Regulation of Chemical Risk: Lessons for TSCA Reform from Canada and the European Union (forthcoming) argue: ‘[T]he EU processes for the production of data and determinations of safety for specific uses entail an iterative process of shared burdens.’

  40. 40

    REACH, n. 1 above, Article 68.1.

  41. 41

    Ibid., Article 55.

  42. 42

    Treaty on the Functioning of the European Union, [2010] OJ C83/47 (‘TFEU’), Article 191.

  43. 43

    European Commission, White Paper, Strategy for a Future Chemicals Policy, COM(2001) 88, at 6.

  44. 44

    Directive 79/831/EEC Amending for the Sixth Time Directive 67/548/EEC on the Approximation of the Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Substances, [1979] OJ L259/10, Article 5.

  45. 45

    See generally R.E. Lofstedt, ‘Risk versus Hazard: How to Regulate in the 21st Century’, 2:2 European Journal of Risk Regulation (2011), 149.

  46. 46

    C.J. van Leeuwen, ‘General Introduction’, in: C.J. van Leeuwen and T.G. Vermeire (eds), Risk Assessment of Chemicals: An Introduction (Springer, 2007), 1, at 3.

  47. 47

    Ibid.

  48. 48

    See L. Bergkamp and N. Herbatschek, n. 31 above, at 52.

  49. 49

    See also R. Lofstedt, ‘The Substitution Principle in Chemical Regulation: A Constructive Critique’, 17:5 Journal of Risk Research (2013), 543. Cf. A.D.K. Abelkop and J.D. Graham, ‘Principles and Tools of Chemical Regulation: A Comment on “The Substitution Principle in Chemical Regulation: A Constructive Critique” ’, 17:5 Journal of Risk Research (2013), 581.

  50. 50

    REACH, n. 1 above, Annex I, sections 0.3 and 5.2.2.

  51. 51

    Ibid., Article 77.

  52. 52

    Ibid., Articles 58.3, 59, 64 and 69–72.

  53. 53

    L. Bergkamp and D.Y. Park, ‘The Organizational and Administrative Structures’, in: L. Bergkamp, n. 2 above, 23.

  54. 54

    REACH, n. 1 above, Article 6.1.

  55. 55

    Ibid., Articles 40–43, 49–51 and 53–54.

  56. 56

    Ibid., Articles 44–50 and 52–54.

  57. 57

    Ibid., Article 55.

  58. 58

    Ibid., Article 68.1.

  59. 59

    Ibid., Article 7.2.

  60. 60

    See, in particular, ibid., Articles 31–34.

  61. 61

    Ibid., Articles 37–39.

  62. 62

    L. Bergkamp and M. Penman, ‘Conclusions’, in: L. Bergkamp, n. 2 above, 427.

  63. 63

    Ibid., Articles 14.6 and 37.5.

  64. 64

    Ibid., Article 55.

  65. 65

    Ibid., Article 56.1.

  66. 66

    Ibid.

  67. 67

    Ibid., Article 64.8.

  68. 68

    Ibid., Article 60.2.

  69. 69

    Ibid., Article 60.4.

  70. 70

    Ibid., Article 61.3.

  71. 71

    Ibid., Article 61.2.

  72. 72

    Ibid., Articles 56.1–2.

  73. 73

    Ibid., Article 66.

  74. 74

    Ibid., Article 59.

  75. 75

    Ibid., Article 58.

  76. 76

    Ibid., Article 60.1.

  77. 77

    Candidate Listing, for instance, is regulated in ibid., Articles 60–64.

  78. 78

    Ibid., Articles 7.2, 31.1(c) and 31.2(b).

  79. 79

    See, e.g., European Commission, n. 14 above, at 72.

  80. 80

    ECHA makes the final decisions. REACH, n. 1 above, Articles 59.6 and 59.8. However, the Commission decides if ECHA's Member State Committee cannot reach unanimous agreement. Ibid., Article 59.9.

  81. 81

    Input can be provided by stakeholders and Member States. Ibid., Article 59.

  82. 82

    Ibid., Article 57.

  83. 83

    Ibid., Article 56.1.

  84. 84

    Ibid., Article 60.2.

  85. 85

    Ibid., Article 60.4.

  86. 86

    See L. Bergkamp and N. Herbatschek, n. 31 above, at 75–81.

  87. 87

    European Commission, ‘Roadmap on Substances of Very High Concern, Communication to COREPER/Council’ (6 February 2013), at 8.

  88. 88

    See N. Herbatschek, L. Bergkamp and M. Mihova, ‘The REACH Programmes and Procedures’, in: L. Bergkamp, n. 2 above, 82, at 133.

  89. 89

    REACH, n. 1 above, Article 60.4.

  90. 90

    Ibid., Article 62.4(f).

  91. 91

    Ibid., Article 60.8.

  92. 92

    Ibid., Article 61.1.

  93. 93

    Ibid., Article 61.2.

  94. 94

    Ibid., Article 58.2.

  95. 95

    Regulation 143/2011/EU of 17 February 2011 Amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (‘REACH’), [2011] OJ L44/2.

  96. 96

    ECHA, ‘Recommendation of 1 June 2009 for the Inclusion of Substances in Annex XIV’.

  97. 97

    See, e.g., ECHA, ‘ “Responses to Comments” Document for 4,4′-diaminophenylmethane (MDA) (EC No. 202-974-4)’ (1 June 2009), at 13–26.

  98. 98

    ECHA, ‘Recommendation of the ECHA of 20 December 2011 on the Inclusion of Substances in Annex XIV’.

  99. 99

    Directive 98/24/EC, n. 25 above; Directive 2004/37/EC of 29 April 2004 on the Protection of Workers from the Risks Related to Exposure to Carcinogens or Mutagens at Work, [2004] OJ L229/23.

  100. 100

    See European Commission, n. 14 above, at 72.

  101. 101

    REACH, n. 1 above, Article 57.

  102. 102

    Ibid., Article 58.3.

  103. 103

    J.D. Graham and J.B. Wiener (eds), Risk versus Risk: Tradeoffs in Protecting Human Health and the Environment (Harvard University Press, 1995).

  104. 104

    Regulation 348/2013/EU of 17 April 2013 Amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), [2013] OJ L108/1, recitals 11 and 12.

  105. 105

    European Commission, REACH in Brief (European Commission, 2007), at 13.

  106. 106

    Ibid.

  107. 107

    REACH, n. 1 above, Article 69.4.

  108. 108

    Ibid., Articles 69–72.

  109. 109

    Ibid., Articles 69.1 and 73.

  110. 110

    Ibid., Articles 69.6 and 71.1.

  111. 111

    See ibid., Annex XV.

  112. 112

    Ibid., Article 3.31.

  113. 113

    Ibid., Article 67.1.

  114. 114

    Ibid., Articles 2.1–2, 67.1–2 and 68.1.

  115. 115

    See N. Herbatschek, L. Bergkamp and M. Mihova, n. 88 above, at 147.

  116. 116

    See, e.g., Communication in the Framework of the Implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), [2012] OJ C142/8.

  117. 117

    REACH, n. 1 above, Article 68.1.

  118. 118

    Ibid., Articles 69.1–2 and 69.4.

  119. 119

    Ibid., Annex XV, section I.

  120. 120

    See also ECHA, ‘Guidance for the Preparation of an Annex XV Dossier for Restrictions’ (June 2007), at 49.

  121. 121

    REACH, n. 1 above, Article 68.1.

  122. 122

    See ECHA, n. 120 above, at 51.

  123. 123

    See generally TFEU, n. 42 above, Article 5.

  124. 124

    See, e.g., REACH, n. 1 above, Annex XVII, entry 18a, second column, section 6(b).

  125. 125

    Ibid., Annex XV, section II.3.

  126. 126

    Ibid.

  127. 127

    Ibid.

  128. 128

    See, e.g., CJEU, Case T-368/11 Polyelectrolyte Producers Group and others v. Commission, [2013] ECR II-0000, at paragraph 88.

  129. 129

    REACH, n. 1 above, Article 68.1.

  130. 130

    Ibid., Article 68.1, first sub-paragraph, Annex XV, section II.3 and Annex XVI.

  131. 131

    Ibid., Articles 68.1 and 69–73.

  132. 132

    Ibid., Article 68.2.

  133. 133

    Ibid., Articles 69.1 and 69.3.

  134. 134

    Ibid., Article 69.2.

  135. 135

    Ibid., Article 69.4.

  136. 136

    Ibid., Articles 70–72.

  137. 137

    Ibid., Article 68.1.

  138. 138

    Ibid., Article 73.3.

  139. 139

    Ibid., Article 73.1.

  140. 140

    Ibid., Article 68.2.

  141. 141

    Ibid.

  142. 142

    Ibid., Article 68.1.

  143. 143

    Ibid., Article 56.1.

  144. 144

    Directive 76/769/EEC, n. 22 above.

  145. 145

    See also Milieu Ltd, n. 3 above.

  146. 146

    REACH, n. 1 above, Article 68.1.

  147. 147

    Ibid., Articles 67.1 and 68.1.

  148. 148

    Ibid., Article 57.

  149. 149

    Ibid., Article 55.

  150. 150

    ECHA, The Operation of REACH and CLP (ECHA, 2011), at 32.

  151. 151

    European Commission, General Report on REACH, Report from the Commission to the European 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, COM(2013) 49.

  152. 152

    See European Commission, n. 14 above, at 71–72.

  153. 153

    See ECHA, n. 3 above.

  154. 154

    REACH, n. 1 above, Article 58.5.

  155. 155

    Ibid., Article 58.6.

  156. 156

    Ibid., Articles 56.1 and 69.2.

  157. 157

    Ibid., Article 69.2.

  158. 158

    Ibid., Article 60.6.

  159. 159

    Ibid., Article 58.7.

  160. 160

    Ibid., Article 58.2.

  161. 161

    See European Commission, n. 87 above, at 8–9.

  162. 162

    An example is cobalt compounds, which were recommended for listing by ECHA but not listed by the Commission. Regulation 348/2013/EU, n. 104 above, recital 12.

  163. 163

    See European Commission, n. 14 above, at 72.

  164. 164

    REACH, n. 1 above, Article 57(a)–(e) versus (f).

  165. 165

    See also L. Bergkamp and N. Herbatschek, n. 31 above, at 60–62.

  166. 166

    Ibid.

  167. 167

    See also Milieu Ltd, n. 3 above.

  168. 168

    REACH, n. 1 above, Article 2.1(d).

  169. 169

    Ibid., Article 2.2.

  170. 170

    E.g., ibid., Article 2.5(a).

  171. 171

    Ibid., Article 2.6.

  172. 172

    Directive 2011/65/EU, n. 27 above.

  173. 173

    Umweltbundesamt, Study for the Review of the List of Restricted Substances under RoHS2 (Umweltbundesamt, 2014).

  174. 174

    Directive 2000/53/EC, n. 26 above.

  175. 175

    The Directive restricts the following chemicals: mercury, cadmium and hexavalent chromium. Ibid., Article 4.2(a).

  176. 176

    Regulation 528/2012/EU Concerning the Making Available on the Market and Use of Biocidal Products, [2012] OJ L167/1.

  177. 177

    Regulation 1107/2009/EC Concerning the Placing of Plant Protection Products on the Market and Repealing Council Directives 79/117/EEC and 91/414/EEC, [2009] OJ L309/1.

  178. 178

    Directive 2009/48/EC, n. 28 above.

  179. 179

    Regulation 1223/2009/EC, n. 30 above.

  180. 180

    European Commission, Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, COM(2012) 542.

  181. 181

    For a discussion on the role of science in REACH, see N. Herbatschek, L. Bergkamp and M. Mihova, n. 88 above, at 165–170.

  182. 182

    E.g., REACH, n. 1 above, at Annex I, section 5.1.1.

  183. 183

    ECHA, ‘Minutes of the 21st Meeting of the Committee for Socio-economic Analysis, 10–12 December 2013’, SEAC/M/21/2013 FINAL, at 6.

  184. 184

    REACH, n. 1 above, Articles 68–73.

  185. 185

    Directive 98/24/EC, n. 25 above, Article 3.4.

  186. 186

    Cf. ECHA, n. 183 above.

  187. 187

    Directive 98/24/EC, n. 25 above, Article 3.5.

  188. 188

    TFEU, n. 42 above, Article 5.

  189. 189

    See N. Herbatschek, L. Bergkamp and M. Mihova, n. 88 above, at 159.

  190. 190

    This is non sequitur reasoning: if there is a problem with the implementation of the occupational safety legislation, this issue should be addressed but cannot serve as a justification for imposing more requirements under other legislative regimes.

  191. 191

    Regulation 348/2013/EU, n. 104 above.

  192. 192

    See European Commission, n. 14 above, at 12.

  193. 193

    Ibid.

  194. 194

    <http://echa.europa.eu/web/guest/candidate-list-table>.

  195. 195

    See European Commission, n. 14 above, at 12.

  196. 196

    See ECHA, n. 3 above.

  197. 197

    REACH, n. 1 above, Article 60.2. See also ECHA, n. 3 above, at 35.

  198. 198

    REACH, n. 1 above, Article 56.1.

  199. 199

    Note the discrepancy here: all uses of a listed substance are subject to authorization, irrespective of whether a specific use exposes the environment or human beings to the risks associated with the properties for which the substance was listed, but authorization must be granted if the risks associated with these properties are adequately controlled, even if the use concerned involves other uncontrolled risks not associated with such properties.

  200. 200

    Restrictions may cover the full range of risks that are not adequately controlled. REACH, n. 1 above, Article 67.1.

  201. 201

    C. Schulte, L. Tietjen, A. Bambauer and A. Fleischer, ‘Five Years REACH: Lessons Learned and First Experiences. I – An Authorities' View’, 24:31 Environmental Sciences Europe (2012).

  202. 202

    REACH, n. 1 above, Articles 60.8 and 61.

  203. 203

    Ibid., Articles 60.4–5 and 61.2(b).

  204. 204

    L. Bergkamp, ‘Does REACH Present a Business Opportunity?’, in: L. Bergkamp, n. 2 above, 396, at 400.

  205. 205

    REACH, n. 1 above, Article 61.

  206. 206

    Ibid., Article 61.3.

  207. 207

    Ibid., Article 58.2.

  208. 208

    See ECHA, n. 3 above, at 44 and 53.

  209. 209

    As of 27 June 2014, more than 160 dossiers for Candidate Listing and less than 30 restriction dossiers have been prepared. See <http://echa.europa.eu/addressing-chemicals-of-concern/registry-of-intentions>.

  210. 210

    See N. Herbatschek, L. Bergkamp and M. Mihova, n. 88 above, at 152.

  211. 211

    REACH, n. 1 above, Article 60.3–4.

  212. 212

    Ibid., Annex XV, under II.3.

  213. 213

    Ibid., Annex I, under 6.4.

  214. 214

    Ibid., Annex XV, under II.3.

  215. 215

    Authorization would have to be granted to each applicant pursuant to the adequate control route. Ibid., Article 60.2.

  216. 216

    If the SVHC concerned is a PBT/vPvB or a ‘no threshold’ substance, the end result would be that uses will be authorized only if their socio-economic benefits outweigh their risks and no suitable alternative is available. Ibid., Article 60.4.

  217. 217

    A.D.K. Abelkop, Á. Botos, L.R. Wise and J.D. Graham, ‘How Can REACH Be Improved?’, in: L. Bergkamp, n. 2 above, 390.

  218. 218

    REACH, n. 1 above, Article 59.

  219. 219

    See N. Herbatschek, L. Bergkamp and M. Mihova, n. 88 above, at 152.

  220. 220

    Ibid., at 154.

  221. 221

    See European Commission, n. 87 above.

  222. 222

    REACH, n. 1 above, Article 57.

  223. 223

    See European Commission, n. 87 above, at 3.

  224. 224

    RMO analysis is coordinated by ECHA, while the Commission handles the policy issues. ECHA, ‘SVHC Roadmap to 2020: Implementation Plan’ (9 December 2013), at 15.

  225. 225

    See European Commission, n. 87 above, at 3.

  226. 226

    Ibid., at 14.

  227. 227

    Ibid., at 8–9.

  228. 228

    See ECHA, n. 224 above, at 5.

  229. 229

    See European Commission, n. 87 above.

  230. 230

    Regulation 348/2013/EU, n. 104 above, recitals 11–12.

  231. 231

    See ECHA, n. 224 above, at 18.

  232. 232

    Ibid., at 17–19.

  233. 233

    See European Commission, n. 87 above, at 9.

  234. 234

    A. Hanschmidt, M. Lulei and A. Paetz, ‘Five Years REACH: Lessons Learned and First Experiences – An Industry's View’, 25:19 Environmental Sciences Europe (2013), at 6.

  235. 235

    See N. Herbatschek, L. Bergkamp and M. Mihova, n. 88 above, at 154.

  236. 236

    Ibid., at 154.

  237. 237

    International Lead Association, ‘Commission Undermines Credibility of REACH Candidate List’ (21 August 2012).

  238. 238

    Denmark, ‘Annex XV Report – Proposal for Identification of a Substance as a CMR 1A or 1B, PBT, vPvB or a Substance of an Equivalent Level of Concern – Sodium Peroxometaborate’ (February 2014), at 24.

  239. 239

    REACH, n. 1 above, Annex XV, section 3(i).

  240. 240

    Ibid., Annex XV, section 3(ii).

  241. 241

    Ibid., Annex XV, section 3(iii).

  242. 242

    Ibid., Annex XV, section 3.

  243. 243

    See J.D. Graham and J.B. Wiener, n. 103 above.

  244. 244

    Charter of Fundamental Rights of the European Union, [2000] OJ C364/1, Article 20.

  245. 245

    ECJ, Case 20/71, Sabbatini v. European Parliament, [1972] ECR 345.

  246. 246

    E.g., ECJ, Case 14/59, Sociétés des Fonderies de Pont-à-Mousson v. High Authority, [1959] ECR 215.

  247. 247

    REACH, n. 1 above, Articles 6.1 and 10.

  248. 248

    See European Commission, n. 87 above, at 8. Intermediates are exempt from the REACH authorization regime. REACH, n. 1 above, Article 2.8(b).

  249. 249

    TFEU, n. 42 above, Article 5.4.

  250. 250

    ECJ, Case C-15/10, Etimine, [2011] ECR I-06681, at paragraph 124.

  251. 251

    P. Craig and G. De Burca, EU Law: Text, Cases and Materials, 5th edn (Oxford University Press, 2011), at 526.

  252. 252

    TFEU, n. 42 above, Article 296.

  253. 253

    E.g., CJEU, Case T-368/11, Polyelectrolyte Producers Group and others v. Commission, [2013] ECR II-0000, at paragraph 101.

  254. 254

    ECJ, Case C-380/03, Germany v. Parliament and Council, [2006] ECR I-11573, at paragraphs 107–108.

  255. 255

    Case C-15/10, n. 250 above, at paragraph 116.

  256. 256

    N-Methyl-2- pyrrolidone.

  257. 257

    N,N-Dimethylacetamide.

  258. 258

    N,N-Dimethylformamide.

  259. 259

    ECHA, ‘Background document for N,N-Dimethylacetamide (DMAC)’ (29 November 2012).

  260. 260

    Ibid.

  261. 261

    Ibid., at 6.

  262. 262

    Ibid., at 3–6.

  263. 263

    ECHA, ‘Draft Results of the Fifth Prioritization of the SVHCs on the Candidate List with the Objective to Recommend Priority Substances for Inclusion in Annex XIV’ (24 June 2013), at 4; ECHA, ‘Draft Results of the Fourth Prioritization of the SVHCs on the Candidate List with the Objective to Recommend Priority Substances for Inclusion in Annex XIV’ (20 June 2012), at 26 and 33.

  264. 264

    Regulation 1272/2008/EC, n. 5 above, Annex VI.

  265. 265

    Ibid.

  266. 266

    Ibid.

  267. 267

    Ibid.

  268. 268

    Organization for Economic Cooperation and Development (OECD),SIDS Initial Assessment Report for 13th SIAM on N,N-dimethylacetamide (DMAC)’ (November 2001), at 4.

  269. 269

    The ECHA background documents on DMF and DMAc, and the Netherlands' Annex XV restrictions report on NMP, provide information on consumer exposure to the three substances concerned. There were only four notifications to ECHA on the presence of these substances in articles above 0.1% and ‘no consumer use of articles’. This suggests that there is no consumer exposure, if the small number of notifications cannot be explained by the exemption for uses already covered by a registration dossier. ECHA, ‘Data on Candidate List Substances in Articles’, found at: <http://echa.europa.eu/information-on-chemicals/candidate-list-substances-in-articles>.

  270. 270

    See, e.g., ECHA, n. 259 above, at 11.

  271. 271

    Ibid.

  272. 272

    Ibid.

  273. 273

    Ibid.

  274. 274

    Ibid.

  275. 275

    Directive 67/548/EEC, n. 19 above, Annex I.

  276. 276

    REACH, n. 1 above, Annex XVII, entry 30.

  277. 277

    Regulation 1272/2008/EC, n. 5 above, Annex VI.

  278. 278

    REACH, n. 1 above, Annex XVII, entries 28–30, column 2, juncto DPD, Annex II, Part B, Table VI.

  279. 279

    Regulation 1272/2008/EC, n. 5 above, Annex I, Table 3.7.2, fourth line, third column.

  280. 280

    REACH, n. 1 above, Annex XVII, entry 30.

  281. 281

    Directive 98/24/EC, n. 25 above; Directive 2000/39/EC of 8 June 2000 Establishing a First List of Indicative Occupational Exposure Limit Values in Implementation of Council Directive 98/24/EC on the Protection of the Health and Safety of Workers from the Risks Related to Chemical Agents at Work, [2000] OJ L142/47; Directive 2009/161/EU of 17 December 2009 Establishing a Third List of Indicative Occupational Exposure Limit Values in Implementation of Council Directive 98/24/EC and Amending Commission Directive 2000/39/EC, [2009] OJ L338/87.

  282. 282

    Directive 98/24/EC, n. 25 above, Article 3.3.

  283. 283

    Commission Directive 2009/161/EU, n. 281 above.

  284. 284

    Directive 2000/39/EC, n. 281 above.

  285. 285

    Directive 2009/161/EU, n. 281 above.

  286. 286

    Directive 98/24/EC, n. 25 above.

  287. 287

    Directive 2010/75/EU of 24 November 2010 on Industrial Emissions (Integrated Pollution Prevention and Control), [2010] OJ L334/17, Article 58.

  288. 288

    Directive 98/24/EC, n. 25 above, Article 6.2.

  289. 289

    Regulation 1272/2008/EC, n. 5 above, Annex V, Table 3.1, entries 606-021-00-7, 613-286-00-2 and 616-011-00-4.

  290. 290

    ECHA, ‘Inclusion of Substances of Very High Concern in the Candidate List (Decision of the European Chemicals Agency)’ (20 June 2011); ECHA, ‘Inclusion of Substances of Very High Concern in the Candidate List (Decision of the European Chemicals Agency)’ (19 December 2011); ECHA, ‘Inclusion of Substances of Very High Concern in the Candidate List (Decision of the European Chemicals Agency)’ (18 December 2012).

  291. 291

    See <http://echa.europa.eu/restrictions-under-consideration/-/substance/4506/search/+/term>.

  292. 292

    Regulation 1272/2008/EC, n. 5 above.

  293. 293

    The Netherlands, ‘Annex XV Restriction Report: Proposal for a Restriction – N-Methylpyrrolidone (NMP)’ (9 August 2013).

  294. 294

    Ibid.

  295. 295

    REACH, n. 1 above, Articles 70 and 71.1.

  296. 296

    The Netherlands, ‘CLH Report: Proposal for Harmonised Classification and Labelling – 1 – methyl-2-pyrrolidone’ (August 2013).

  297. 297

    Regulation 1272/2008/EC, n. 5 above, Annex I, Table 3.7.2, fourth line, third column.

  298. 298

    REACH, n. 1 above, Annex XVII, entry 30, column 3, section 1, second paragraph, second indent.

  299. 299

    Regulation 1272/2008/EC, n. 5 above, Articles 59.7 and 62.

  300. 300

    See The Netherlands, n. 296 above, at 12.

  301. 301

    ECHA, ‘Registry of Current Restriction Proposal Intentions’, found at: <http://echa.europa.eu/registry-of-current-restriction-proposal-intentions/-/substance/5202/search/+/term>.

  302. 302

    ECHA, ‘Recommendation of the European Chemicals Agency of 17 January 2013 for the Inclusion of Substances in Annex XIV to REACH (List of Substances Subject to Authorisation)’.

  303. 303

    European Commission, Draft Commission Regulation Amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council Concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) (2013), recital 11.

  304. 304

    <http://echa.europa.eu/harmonised-classification-and-labelling-previous-consultations/-/substance/766/search/+/term>.

  305. 305

    ECHA, ‘Recommendation of the European Chemicals Agency of 6 February 2014 for the Inclusion of Substances in Annex XIV to REACH (List of Substances subject to Authorisation)’.

  306. 306

    See ECHA, n. 301 above.

  307. 307

    ECHA, ‘Registry of Intentions’, found at: <http://echa.europa.eu/registry-of-submitted-svhc-intentions/-/substance/2443/search/+/term>.

  308. 308

    See European Commission, n. 303 above, recital 11.

  309. 309

    E.g., for technical reasons, a company that switches to another solvent to avoid the authorization process may need to use more of the substitute solvent to achieve the same level of production.

  310. 310

    REACH, n. 1 above, Article 91.1.

  311. 311

    Any other regulation may create pressure for substitution, but it may be hard to quantify such pressure or compare it to the pressure that would be generated by authorization.

  312. 312

    Fees are charged to companies applying for authorization, which shifts part of the cost to industry.

  313. 313

    An RMO analysis was conducted for DMAc, but did not include restriction as a risk management option. UK Statement for Dimethylacetamide, in: ECHA, ‘Minutes of the 27th Meeting of the Member State Committee (MSC-27)’ (December 2012), at 33 (‘UK Statement’).

  314. 314

    REACH, n. 1 above, Article 68.1.

  315. 315

    See UK Statement, n. 313 above. See also J.D. Graham and J.B. Wiener, n. 103 above; R. Lofstedt, n. 49 above; A.D.K. Abelkop and J.D. Graham, n. 49 above.

  316. 316

    Regulation 348/2013/EU, n. 104 above, recital 12.

  317. 317

    See, e.g., ECHA, ‘Background Document for Cobalt Dichloride’ (20 December 2011).

  318. 318

    Directive 2010/75/EU, n. 287 above, Article 58.

  319. 319

    Ibid., Articles 5–6.

  320. 320

    REACH, n. 1 above, Article 55.

  321. 321

    Ibid., Article 58.2.

  322. 322

    See, e.g., the inclusion of DMF in ECHA, n. 305 above.

  323. 323

    See European Commission, n. 303 above, recital 11.

  324. 324

    See ECHA, n. 305 above, Annex I, 3.

  325. 325

    See The Netherlands, n. 296 above, at 14.

  326. 326

    Ibid.

  327. 327

    Directive 89/391/EEC on the Introduction of Measures to Encourage Improvements in the Safety and Health of Workers at Work, [1989] OJ L183/1, Article 16.1; Directive 98/24/EC, n. 25 above.

Biographies

  • Lucas Bergkamp is a partner in the law firm of Hunton & Williams, which provides advice on regulations such as REACH. He also heads the European Regulatory Practice.

  • Nicolas Herbatschek is an associate in the law firm Hunton & Williams.

    The authors thank Adam Abelkop, John Graham and an anonymous reviewer for comments on previous drafts of this article. The opinions expressed in this article are the personal views of the authors – not of Hunton & Williams or its clients. Any errors or omissions remain the sole responsibility of the authors.

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