Regulatory Risk Management of Chemicals
In order to achieve “sustainable consumption and production patterns,” SDG 12.4 calls for a management of chemicals defined as “the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment.” To this end, an institutional framework is needed stipulating sufficient incentives to reduce the emissions and providing guidance for defining the steps to identify the risks occurring from exposure to chemicals and take the appropriate risk mitigation measures.
Chemicals Management in the Context of Sustainable Development Goal 12
As the United Nations Environment Programme (UNEP) Governing Council notes, “the challenges posed by chemicals and wastes are global, enduring and constantly evolving and […] they are interrelated with crucial environmental issues such as environment-dependent human health, the health of ecosystems and better ecosystem management, the preservation of biodiversity, and the link between poverty and environment, environmental disasters, climate change and sustainable consumption” (UNEP 2013).
Silent Spring, the novel by Rachel Carson (1962), highlighted the toxic effects of pesticides to birdlife and initiated a debate on the issue. In 1969 the Japanese author Michiko Ishimure with her book Paradise in the Sea of Sorrow: Our Minamata Disease describing the deadly effects of mercury in the Minamata scandal contributed also to a process of raising global awareness. For heavy metals the hazardous effects are common knowledge since the ancient world. In contrast, the effects on men and the environment of the over 100,000 newly synthesized substances are to a large extent unknown, a situation characterized by the phrase “toxic ignorance” (EDF 1997).
In the area of chemicals, risk to human health and the environment is a function of a substance’s inherent hazard potential, i.e., for instance, carcinogenic, mutagenic, or reprotoxic properties, and its exposure. In this respect, uncertainties play an important role due to lack of data and methodical challenges. Any risk is, by definition, characterized by a twofold uncertainty that exists with respect to the realization of an event and its specific effect and consequences. Specifically, chemical substance-related risk assessment entails numerous uncertainties due to its complexity in terms of potential exposure pathways, lack of data, and methodical deficiencies (van Leeuwen 2007).
Ubiquitous exposure of societies to chemicals and uncertainties as to the determination of risks render chemicals management a tremendous challenge. Notwithstanding certain success stories of international chemicals control diplomacy, i.e., the Protocol on Substances that Deplete the Ozone Layer (“Montreal Protocol” of 16 Sept 1987, in force 1989, 26 ILM 154) on ozone-depleting substances, it is clear that all attempts to align the handling of chemicals with the criteria of sustainable development by sovereign means governed by public authorities soon reach their limits. Measures such as “command and control,” including substance bans as in the Convention on Persistent Organic Pollutants (“Stockholm Convention” of 22 May 2001; in force 17 May 2004, 40 ILM 532) or the monitoring mechanisms of the Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal (“Basle Convention” of 22 Mar 1989, in force 1992, 28 ILM 657), are indispensable, but they are lagging behind the problem dynamics (“reactive control”): in view of the diversity of the substances and the complexity of the flows of goods, other (“proactive”) approaches are required, which already begin in an early phase of the substance or product development. Innovation processes are not subject to legal enforcement; it is therefore important to shape the regulatory framework in a way that strengthens the self-responsibility of the actors and stipulates innovative behavior of individual actors as well as interaction along the supply chain (Führ and Schenten 2018) with the long-term goal of “sustainable chemistry” (Blum et al. 2017).
Political and Normative Context: Johannesburg Goals and SAICM Process
SDG 12 aims to “[e]nsure sustainable consumption and production patterns” (SCP) (UN 2015). In this respect, SDG 12.4 specifies to achieve “[by] 2020 […] the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment.” SDG 12.4 reaffirms the chemical policy goal already formulated at the 2002 World Summit on Sustainable Development (WSSD) in Johannesburg (UN 2002).
Criteria for “sound management” can be found inter alia in the principles of the Rio Declaration (UN 1992; Viñuales 2015), which provide the normative backbone of international policies aimed at sustainable development (Sands et al. 2012). With respect to reduced use of hazardous materials and toxic chemicals, Rio Principle 15, concerning the “precautionary approach,” gains momentum. Thereafter protective measures to prevent serious or irreversible damage can be taken without full scientific certainty about the possible extent of damage, for example, in cases where the actual hazards of a chemical substance or the conditions of its exposure are not yet fully known. Besides, Rio Principle 10 and the more specific UNECE Aarhus Convention throw a spotlight on transparency and participation in environmental matters. This does not only include a “right to know” of the general public regarding chemical risks it might be exposed to but also paves the way for learning processes based on inclusive governance in order to fully exploit available knowledge resources for sustainable development.
As a step toward the ambitious 2020 goal, the Strategic Approach to International Chemicals Management (SAICM) was agreed in Dubai in 2006. The SAICM process involves various stakeholders and addresses all industrial sectors where chemicals are used. It stresses that chemical safety must be an element of sustainable development and that resources must be mobilized at different levels. Both governments and intergovernmental organizations have joined these goals. In their 2012 resolution, “The Future We Want,” the United Nations calls for the implementation of SAICM (UN 2012a). The Dubai declaration and the related action plan (SAICM 2006) identify tasks of the individual stakeholders. The Secretariat of SAICM is organised by UNEP.
Legal frameworks that address the life cycle of chemicals and waste
Relevant enforcement and compliance mechanisms
Implementation of chemical- and waste-related multilateral environmental agreements, as well as health, labor, and other relevant conventions and voluntary mechanisms
Strong institutional frameworks and coordination mechanisms among relevant stakeholders
Collection and systems for the transparent sharing of relevant data and information among all relevant stakeholders using a life cycle approach, such as the implementation of the Globally Harmonized System of Classification and Labelling of Chemicals
Industry participation and defined responsibility across the life cycle, including cost recovery policies and systems as well as the incorporation of sound chemicals management into corporate policies and practices
Inclusion of the sound management of chemicals and waste in national health, labor, social, environment, and economic budgeting processes and development plans
Chemicals risk assessment and risk reduction through the use of best practices
Strengthened capacity to deal with chemicals accidents, including institutional strengthening for poison centers
Monitoring and assessing the impacts of chemicals on health and the environment
Development and promotion of environmentally sound and safer alternatives
In 2012, the UN General Assembly adopted (UN 2012a) a “10-Year Framework of Programmes on Sustainable Consumption and Production Patterns” (10YFP, UN 2012b) that explicitly calls to draw on experiences from SAICM. The 10YFP provides structure to SCP policies (Führ and Schenten 2018). Its implementation is the aim of SDG 12.1.
The Johannesburg 2020 goal and the SAICM process provide normative orientation for the legal framework on chemicals management in the European Union. The European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation (EC) No 1907/2006, 2006 OJ L 396/1) was designed to contribute to the 2020 goal (REACH Recital 4) and to SAICM (REACH Recital 6), and indeed all SAICM basic elements fall in the scope of REACH or related EU legislation. REACH, which already entered into force on 1 June 2007, can thus be seen a benchmark; in fact, the UNEP (2013) “Global Chemicals Outlook” sees REACH as the “gold standard” with respect to “comprehensive, broad-spectrum, and preventive chemicals management strategies”; third countries such as China and Korea have adopted chemical legislation inspired by REACH (ECSIP Consortium 2016). Section “REACH: Legal Framework Addressing the Life Cycle of Chemicals” thus outlines how REACH operationalizes the SAICM basic elements. Prior to this, section “International Agreements” provides an overview of international agreements mentioned in SDG 12.4 and SAICM basic element 3.
International law on chemical regulation was characterized by non-binding measures (“soft law”) by the end of the 1980s. At that time international organizations such as the World Health Organization (WHO), the Organisation for Economic Cooperation and Development (OECD), or UNEP had already been involved in the risk assessment or, for example, the classification of individual substances. The “Earth Summit” in Rio de Janeiro was the cornerstone for concrete commitments in 1992: at the UN Conference for Environment and Development (UNCED), the heads of state and government agreed on the “Agenda 21.” In chapter “Environmentally Sound Management of Toxic Chemicals, Including Prevention of Illegal International Traffic in Toxic and Dangerous Products” it establishes the principles for an internationally effective chemical safety and formulates objectives for the environmentally sound handling of hazardous chemicals. This also includes the development of a globally harmonized standard for the classification and labelling of chemical hazards (Globally Harmonized System – GHS). However, this was only one building block on the way to a global chemicals framework.
Binding regulations at the level of international law, which led to specific restrictions on the import and export of hazardous substances or specific prohibitions on substances, were added at the turn of the century. One example is the Rotterdam Convention, which establishes a prior informed consent procedure for certain hazardous industrial chemicals and for pesticides in cross-border trade (Prior Informed Consent, “PIC Convention”). The Convention obliges Parties, inter alia, to notify the receiving state of the planned trade before the export of certain dangerous substances, in particular to transmit safety-relevant information and to await approval. If this is refused by the importing country, this results in the duty of the Contracting States to prohibit the import or export of the substance. As of July 2018, 160 countries and the EU have signed or ratified the Convention.
The Stockholm Convention on Persistent Organic Pollutants (POPs Convention) came into effect almost simultaneously with the PIC Convention in 2004. The POPs Convention lists 21 substances (originally 12: “dirty dozen”), which are toxic and difficult to degrade and accumulate in organisms such as plankton, fish, and polar bears. The Minamata Convention on Mercury of 10 Oct 2013 (in force 16 Aug 2017) is the latest achievement of international chemicals diplomacy, aimed at controlling the anthropogenic releases of the ubiquitous heavy metal throughout its life cycle. In addition, there are a remarkable number of international agreements with limited geographical scope (Sands et al. 2012; UNEP 2013).
REACH: Legal Framework Addressing the Life Cycle of Chemicals
REACH emphasizes the “self-responsibility” of the industry actors along the supply chains of industrial chemicals (cf. section “Regulatory Approach”). The mechanisms of the regulation cover the entire life cycle of chemicals (sections “Registration of Substances (No Data, No Market),” “Dossier and Substance Evaluation,” “Authorisation,” and “Restriction”). In addition, a separate regulation implements the UN GHS system in EU law (section “Inclusive Governance”).
With a view to implementing international agreements, the EU has adopted separate regulations as well (POP: 850/2004, PIC: 649/2012, Minamata: 852/2017), with the effect that all three conventions are part of the EU legal system.
In the following articles, recitals and annexes as well as chapters and titles without further indication are those of the REACH Regulation.
Pursuant to REACH Article 1(3)1, the “Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.” In the following sentence, Article 1(3)2 emphasizes “Its provisions are underpinned by the precautionary principle.” Consequently, the regulation strengthens the self-responsibility (Führ and Lahl 2006) of the economic actors.
This regulatory approach marks a paradigm shift compared to previous EU law, which placed the responsibility of risk control on administrative programs aimed at assessing priority substances but was not capable of significantly reducing “toxic ignorance” (Führ and Bizer 2007). REACH in turn obliges industry actors to control the substance-related risks “adequately,” which presupposes closing the gaps in the knowledge base. This approach is in strong contrast to chemical legislation in other jurisdictions, such as the USA, where chemicals management is steered by imperative control and the burden of proof lies predominantly with authorities.
To achieve the intended “high level of protection of human health and the environment” (Article 1(1)), REACH establishes different mechanisms, which primarily aim at information, communication, and cooperation (“IC&C instruments”) of the economic actors, but to a considerable degree give leeway as long as “adequate risk management” is achieved. In globalized production processes based on the division of labor, innovations can rarely be managed by a single actor; rather, all actors along the value chain have to contribute to the innovation process (Fleurke and Somsen 2011). The IC&C impulses initiated by REACH are therefore aiming to trigger processes that lead to innovations in material, technical, or organizational terms, thus also contributing to the subordinate aims of REACH, namely, “enhancing competitiveness and innovation.”
Registration of Substances (No Data, No Market)
Substance responsibility allocation is unfolded particularly in the REACH mechanisms establishing a duty for manufacturers or importers to register every substance placed on the market above the threshold of one ton per year. In accordance with the principle “no data, no market,” as laid down in Article 5, the precondition for registration is twofold. Firstly, the set of data determining the risks related to the substance has to be generated and uploaded to an information system hosted by the European Chemicals Agency (ECHA) – an independent agency created for the implementation of REACH. ECHA puts essential registration dossier contents into freely accessible online databases. Secondly, the registrant has to demonstrate that for each stage of the life cycle of the substance, the risks are “adequately controlled” (as defined in Article 14).
For a transitional period, preregistered “phase-in substances” (i.e., the “existing substances” already marketed by the registrant) were exempted from this obligation (Article 23). The last transitional period ended in June 2018. After this date each and every substance has to be registered by the manufacturer or importer given he brings more than one ton per year to the market.
The information requirements within the framework of the registration obligation follow a tonnage per year concept. The standard data set always includes the full physicochemical characterization as well as some basic data on (eco)toxicological effects of the substances. Above 1,000 t/y the data set is quite comprehensive and includes, e.g., long-term toxicological effects on several species up to reproductive toxicity to predatory birds. The range of (eco)toxicological data declines according to the tonnage bands 100–1,000, 10–100, and 1–10 per year according to Articles 10 and 12 (the details are to be found in the Annexes VII–X).
A Chemical Safety Report (CSR), as provided for in Article 14, is mandatory for substances above 10 t/y. Every CSR has to derive limit values for human exposure and for different environmental compartments. In the case of “problematic substances” pursuant to Article 14(4), the risks of the uses considered must also be described. Exposure scenarios to be communicated with the safety data sheet in the supply chain must be established in the context of the exposure assessment. In the next step, derived limit values and actual exposure are appraised in a “risk characterization.” On this basis, risk management measures are to be developed to enable identified risks to be adequately controlled. According to REACH Annex I, Section 6.4 evidence of adequate control is provided when throughout the “life cycle” of the substance for each exposure scenario the estimated exposure and concentration levels do not exceed the derived no-effect level (DNEL) for effects toxic to humans and the predicted no-effect concentration (PNEC) for ecotoxic effects. Only uses, for which the “risk characterization” comes to this conclusion, are legitimated under REACH (Bergkamp 2013).
Downstream users, such as formulators or producers of products (articles in terms of REACH; c.f. Article 3(3)), are encouraged to support their suppliers in compiling all necessary risk information. Under certain conditions, however, if they are, e.g., not willing to comply with risk management instructions communicated in the safety data sheet, they might be obliged, in accordance with Article 37, to prepare a CSR on their own behalf. In other words, REACH allocates primary responsibility to manufacturers and importers, but downstream users are secondarily responsible, too.
After receipt of the registration dossier, the Agency (ECHA) has to check the completeness. ECHA has to “ascertain” that all provided data contain a meaningful content with regard to the information requirements laid down in Articles 10 and 12. In the past this was a predominantly formal examination, which has been largely automated so far. After a ruling of the Board of Appeal (2016; judicial body deciding on appeals against decisions taken by the Agency; see Articles 90 and 91), the ECHA had to change its policy in this respect and introduced additional nonautomated completeness checks.
As a result of the completeness check, the Agency assigns a registration number and a registration date to the substance and notifies the registrant (Article 20.3). With the registration, the marketing ban of Article 5 is lifted for all uses supported by an exposure scenario.
Dossier and Substance Evaluation
In the dossier evaluation, a more thorough examination of the information provided by registrants takes place. Under Article 41, the Agency can examine individual registration dossiers to ascertain whether the relevant requirements are met. At least 5% of the dossiers submitted must be examined for each quantity band. If the examination reveals deficits of the dossier, ECHA requests the registrant to complete the dossier within a reasonable period.
As mentioned above, in the past a significant number of insufficient dossiers passed the IT-based completeness check. The legal consequences in cases where the evaluation uncovers substantive deficiencies are not laid down in the text of REACH. Hence the registration remains valid, and the “no data, no market” principle is violated: a situation providing an open invitation for free riders. Ultimately the incentive system established by REACH is undermined. Thus a “fresh completeness check” has to be conducted with the possible outcome that the registration number is revoked, based on general (European) administrative principles.
In addition to the examination of individual registration dossiers, the regulation also provides for a more detailed examination of substances (or structurally related substances). The substance evaluation process is coordinated by the Agency; the EU Member States are carrying out the in-depth assessment (for details, see Article 45).
to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
The starting point of the procedural cascade is the informal compilation of “candidates for the candidate list.” To this end, lists are drawn up by different actors, including nongovernmental organizations. Legal consequences are not associated, but this does not mean that they are without effect. Rather, they can act as a kind of “early warning system,” which can be used by companies in the context of their product and process development. In some cases, it is also used as part of company ratings.
The formal procedure begins with a proposal from the European Commission or a Member State addressing the requirements of Annex XV. After having given the “interested parties” an opportunity to comment via the Internet, the decision to add the substance to the candidate list (i.e., SVHC status) will normally be taken by the committee of the Member States. The European Court (2013) has so far not granted any legal protection against inclusion in the candidate list, which was sought with reference to the economic disadvantages accompanying it. Linked to the candidate status are the consumer “right to know” request pursuant to Article 33(2) as well as other obligations such as notification of SVHC in articles (Article 7) and update of the safety data sheet (Article 31).
The first list of substances with candidate status, published by ECHA in 2008, included 15 substances. By mid-2018, the candidate list had grown to 191 substances. By 2020 several hundred substances are expected to be on the list of candidates. Further information on the substances under consideration to be included in the candidate list are accessible online (cf. the “registry of intentions” under https://echa.europa.eu/registry-of-current-svhc-intentions).
The next step is ECHA’s recommendation on priority substances. According to Article 58(3), priority “shall normally be given” to substances with PBT (persistent, bioaccumulative, and toxic) or vPvB (very persistent, very bioaccumulative) properties, or wide dispersive use, or high volumes.
The final decision to include a SVHC in Annex XIV is made by the European Commission through comitology “regulatory procedures with scrutiny.” It takes the form of an amendment to the REACH Regulation. Once included in Annex XIV, a substance cannot be placed on the market for a use or used after a given date (the so-called sunset date) unless the companies concerned are granted an authorization for the specific use(s). On 17 February 2011, the first six substances were included in Annex XIV. The transitional arrangements for these substances ran until 21 July 2014 and 2016. Applications for authorization must be submitted 6 months before the respective sunset dates. By July 2018 Annex XIV lists 43 substances.
With the granting of an authorization, the responsibility for risk control is not transferred to the state authorities. Rather, the actors in the value chains are responsible for ensuring compliance with the requirements laid down in the authorization decision. For example, they have to present a concept for “monitoring” as part of the approval documents, which must be implemented and documented during the duration of the authorization (often in cooperation with other actors along the supply as well as with the authorities).
Title VIII provides the strongest sovereign powers to intervene, i.e., imposing restrictions as general risk-mitigating measures. This legal instrument already existed under the previous law; restrictions dated from this era continue to apply under REACH and are listed in Annex XVII. They add up to 450 pages of substance prohibitions and restrictions in the Official Journal of the European Union in 2006: 52 substances (or groups of substances) from asbestos and lead to toluene and trichlorobenzene already were regulated before REACH. Phthalates were covered, too, which are added as softeners to, among other things, children’s toys and baby articles made of plastic.
REACH extends the scope of application. Not only the use or the placing on the market of a substance can be regulated but also the production process itself. The prerequisite is that an unacceptable risk to human health or the environment has been identified “which needs to be addressed on a Community-wide basis” (Article 68). According to Article 67, the economic actors are obliged to observe these restrictions and to adapt their behavior to the restrictions.
This instrument is classical sovereign “risk regulation.” The burden of proof, i.e., presenting the risks and the adequacy of the restrictions, lies with the authorities (Article 69). A publicly accessible register and a web-based commentary procedure (Article 69(6)) serve to prepare the restriction (cf. https://echa.europa.eu/registry-of-current-restriction-proposal-intentions). Since 2007 not more than 20 restrictions have been added to Annex XVII.
REACH contains several elements of inclusive governance (Heyvaert 2008). The participation of the general public and the stakeholders is foreseen in a wide variety of ways, both in the ECHA committees and in the application of the different REACH mechanisms, showing that REACH aims to establish an institutional framework for a “learning system.”
In the highest decision body of the Agency, the Management Board, three representatives of interested parties are appointed by the Commission (Article 79(1)). The only difference to the other board members is the fact that they have no voting rights, in all other means they are full-fledged members with all rights and obligations. They are involved in the deliberations not only in the plenary sessions but also in the written procedure.
At the meetings of the Committees for Risk Assessment and for Socioeconomic Analysis as well as of the Forum for Exchange of Information on Enforcement (cf. Article 76 as regards the mandates of these bodies), interested parties are in principle allowed to participate as observers as foreseen in Article 85(4) or Article 86(1). Based on these provisions, the Management Board in February 2008 decided to actively promote the participation of interested parties, laying down procedures and criteria for the selection of stakeholder organizations. The rules of procedure for the individual committees describe the conditions of participation more closely (including the obligation to maintain confidentiality and the possibility of confidential consultations).
The public and in particular “interested parties” or “third parties” are also involved in the various stages of the authorization scheme as well as in the preparation of restrictions. However, third parties may also pass on to the Agency the substance information available to them (Article 41(6)). In dossier evaluation ECHA has to take this into account, together with information submitted by the authorities pursuant to Article 124.
Stakeholders are contributing also to the preparation of guidelines (Guidance Documents) which are of great importance for the implementation of REACH. In addition, Article 108 obliges the Management Board, in agreement with the Commission, to develop appropriate contacts between the Agency and relevant stakeholder organizations.
It should also be emphasized that Article 40(2) provides the Agency with the possibility to publish proposals for tests on vertebrate animals on the Internet and to give all interested parties the opportunity to comment on them. The same applies to proposals for a harmonized classification and labelling of substances under the CLP Regulation (section “Classification and Labelling”).
In the field of SVHC, the IC&C mechanisms are playing an important role. According to Article 33(2), if requested by a consumer, every supplier of an article (a physical product that is not a substance or a mixture of substances, i.e., e.g., textiles, toys, electronics; c.f. the definition in Article 3(3)) has to provide an answer within 45 days in cases where a SVHC is present in the article or one of its components in a concentration above 0,1% weight by weight (w/w). However, to be in a position to provide an accurate answer to the consumers as a precondition, the compliance of the supply chain with Article 33(1) is essential. Under this provision all actors in the supply chain face an equivalent obligation, namely, to provide their professional recipients of the article containing SVHC “with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.” These obligations are triggering strong impulses toward substitution and thus also toward innovations, in the sense that all actors in the supply chain, in particular brands and retailers of consumer-oriented products, have a strong incentive to avoid “candidate list” substances – long before these SVHC enter Annex XIV and become thus subject to the authorization requirement.
Moreover, the entire institutional framework is designed in a way that allows responding to deficits identified in the course of monitoring and evaluation efforts. The “progress reports,” published annually on February 28, provide not only an update of the actual situation over the previous calendar year but also recommendations to industry actors to improve their performance (Article 54). At the same date, the new version of the “rolling action plan,” listing the substances which are due to be evaluated by the Member States, is published (Article 44(2)). As for the regulatory framework itself, a set of additional reporting obligations for Member States as well as for the Agency is foreseen (Article 117), providing the basis for the review steps – already defined and timed (Article 138) when the regulation entered into force.
The general report of the Commission on the experience acquired with the operation of REACH (Article 117(4)) also entails monitoring of the performance of REACH and its central elements. To this end, Eurostat, the statistical office of the European Union, in collaboration with the Commission, has developed a set of indicators to monitor the implementation of REACH. The methodology to derive the risk score (risk posed by a substance) and the quality score (quality of the data available to assess the risk associated with a substance) was established in 2007 (baseline); first progress reports have been issued in 2012 and 2015 (European Commission 2018).
Classification and Labelling
Closely interlinked with the REACH Regulation are the requirements of the regulation on classification, labelling, and packaging (CLP Regulation (EC) No 1272/2008, 2008 OJ L 353/1) of chemicals and mixtures transferring the UN “harmonized system” to the EU internal market. “Classification” means the substance-related classification of hazardous properties (e.g., toxic, carcinogenic, explosive, or environmentally hazardous) on the basis of legally established criteria. According to the “definition principle,” the manufacturer, importer, or downstream user is obliged to follow the self-classification scheme in accordance with Article 1(1)(b)(i) and based on Annex I of the CLP Regulation. Under certain conditions, the authorities issue a “harmonized” classification, listed in Part 3 of Annex VI of the CLP Regulation. Unlike the results of the self-classification, which can vary – as numerous examples in the CLP inventory demonstrate – the harmonized classifications are legally binding for all actors.
Substances and mixtures placed on the market shall be labelled and packaged by the supplier according to their classification pursuant to the provisions of the CLP Regulation (Articles 1(1)(b) CLP and 17 et subs. CLP). It is intended to give evidence of the associated hazards to persons who deal with a substance or mixture. The CLP Regulation introduced new pictograms and signal words as well as hazard phrases and safety instructions.
In June 2007 REACH entered into force. More than 10 years later, the practical experiences demonstrate the difficulties a society faces in the transformation process as outlined in the 2020 Johannesburg goal and the SDGs. This holds true for REACH elements specifically based on self-responsibility, such as registration and authorization, but also for evaluation and restriction fostered by administrative intervention.
The registration process is handled electronically via REACH-IT. As described in section “Dossier and Substance Evaluation,” ECHA’s handling of the completeness check in the first 9 years was clearly deficient. In fact, the Board of Appeal decision referred to above shows that the Agency did not perform its duties, i.e., acting in non-compliance itself. Consequently, a high number of incompliant registration dossiers entered the system. This puts the incentives related to the “no data, no market” principle at risk.
Even more invoking are the findings of the latest “progress report” (Article 54) on the results of the evaluation (ECHA 2017): Overall, ECHA checked a total of 184 dossiers for compliance during 2016. In 91% (168) of these, ECHA concluded that the non-compliances found were severe enough to require further action and generation of new information. These results have to be interpreted in the light of the screening process identifying relevant dossiers. Nevertheless the fact that nine out of ten dossiers had severe deficiencies puts the entire approach of industry self-responsibility into question. These numbers give a taste of the enormous challenges that remain with respect to the main objectives of the legislative framework, namely, to overcome the situation of “toxic ignorance” and to achieve a safe use of chemicals.
In the field of authorization, there is still room for improvement with regard to the involvement of those third parties which might benefit from a limited or even refused authorization. Up to now, the means offered by the Agency to enhance contributions from those third parties are in a rather basic state. Moreover, the European Commission tends to be quite generous in granting authorization decisions even in case were alternatives are well established on the market (e.g., for lead in paints). Thus, the innovation effects are rather limited.
The restriction processes up to now have not profited from the data gathered by REACH. Only two substances per year have been tackled in the first 10 years; under the previous legislation, the pace was not slower.
Conclusion: SAICM Basic Elements in REACH
Reflecting the SAICM “11 basic elements” critical for sound management of chemicals, REACH can be seen as benchmark legal framework addressing the life cycle of chemicals (element no 1), including industry participation and defined responsibility across the life cycle (no 6). GHS is implemented via the separate CLP Regulation, and public access to registration data, communication on problematic substances and mixtures (safety data sheets), as well as SVHC in articles (Art. 33) allow for the transparent sharing of relevant data and information among all relevant stakeholders (no 5). In addition, REACH establishes a strong institutional framework with coordination mechanisms among relevant stakeholders (no 4), supplemented by a monitoring of the impacts of chemicals on health and the environment (no 10).
REACH is designed as a “learning system” in itself, at the same time initiating and steering “learning processes” of actors, individually in a single company, collectively along the supply chain, as well as in the administration and the scientific community, and, last but not least, triggered by interventions of “third parties.” This learning system and transparency established set strong incentives for best practice risk assessment and risk reduction (no 8). Interventions against problematic substances, SVHC in particular, shall contribute to the development and promotion of environmentally sound and safer alternatives (no 11). However, due to generous exemption for process-oriented research and development, REACH does not interfere directly in the design phase of substances. Green chemistry, advocating a “benign by design” approach for chemicals (Anastas and Warner 1998), thus offers huge development perspectives for REACH, also preventing legacy toxicants in products and materials in a circular economy (Führ et al. 2019).
The transformation toward a constellation where industry actors de facto “ensure that they manufacture, place on the market, or use such substances that do not adversely affect human health or the environment” is depending on incentives triggering the necessary change processes. A precondition is the compliance with the data requirements formulated in the registration regime. Hence, relevant enforcement and compliance mechanisms are necessary (no 2). In this respect, REACH establishes an appropriate frame; however, the practical experiences show that on the operative level, further improvements are pivotal.
For the most part not covered by the scope of REACH are only elements no 7 (inclusion of the sound management of chemicals in national health, labor, social, environment, and economic budgeting processes and development plans; cf. UNEP 2015) and 9 (strengthened capacity to deal with chemicals accidents, including institutional strengthening for poison centers), whereas the latter aspect is appropriately covered by separate pieces of EU legislation, namely, the Industrial Emissions Directive (2010/75/EU, 2010 OJ L 334/17, cor. 2012 OJ L 158/25) and Directive on the control of major accident hazards involving dangerous substances (Seveso II Directive; 96/82/EC 1997 OJ L 10/13).
In SDG 12.4, the United Nations seek to, by 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle. To induce chemicals management fit for SCP, governance frameworks should encourage proactive behavior of all actors, openness to cooperate with other actors, and willingness to undergo learning processes. To this end, a traditional “command and control” approach is reaching its limits. SCP behavior cannot be induced via mechanistic and monocausal control systems; rather the various incentives and impediments in the institutional context need to be taken into account and fully utilized. Measured by the Strategic Approach to International Chemicals Management’s (SAICM) 11 “basic elements” deemed critical to attain the 2020 goal, the European REACH Regulation can be seen as a benchmark solving the regulatory choice problem of sustainable management of chemicals. REACH is designed as a “learning system” in itself, at the same time initiating and steering “learning processes” of actors, individually in a single company, collectively along the supply chain, as well as in the administration and the scientific community, and, last but not least, triggered by interventions of “third parties.”
- Anastas PT, Warner JC (1998) Green chemistry: theory and practice. Oxford University Press, New YorkGoogle Scholar
- Bergkamp L (ed) (2013) The European Union REACH regulation for chemicals. Law and practice. Oxford University Press, OxfordGoogle Scholar
- Board of Appeal (2016) ECHA, “charcoal” case (A-022-2013). Accessible under https://echa.europa.eu/documents/10162/13575/a-022-2013_decision_en.pdf
- Carson R (1962) Silent spring. Houghton Mifflin Company, Cambridge, MAGoogle Scholar
- ECHA (2017) Evaluation under REACH. Progress Report 2016. Evaluation in ECHA’s Integrated Regulatory Strategy. Ref ECHA-17-R-03-EN, Helsinki. https://doi.org/10.2823/588707, https://echa.europa.eu/documents/10162/13628/evaluation_report_2016_en.pdf/f43e244f-7c90-75bd-e1b2-3771bcb1f8e8. Accessed 13 July 2018
- ECSIP Consortium (2016) Impacts of REACH and corresponding legislation governing the conditions for marketing and use of chemicals in different countries/regions on international competitiveness of EU industry. Final Report. https://publications.europa.eu/en/publication-detail/-/publication/67415a33-aafe-11e6-aab7-01aa75ed71a1. Accessed 13 July 2018
- European Commission (2018) Reach studies. http://ec.europa.eu/growth/sectors/chemicals/reach/studies_en. Accessed 13 July 2018
- European Court of First Instance. T-93/10, OJ EU 2013, C 114, 30. 7 Mar 2013Google Scholar
- Fleurke FM, Somsen H (2011) Precautionary regulation of chemical risk: how REACH confronts the regulatory challenges of scale, uncertainty, complexity and innovation. Common Mark Law Rev 48(2):357–393Google Scholar
- Führ M, Lahl U (2006) Self-responsibility as a regulatory concept – as illustrated by the REACH decision-making process. In: Ormond T, Führ M, Barth R (eds) Environmental law and policy at the turn to the 21st century. Lexxion, Berlin, pp 209–220Google Scholar
- Führ M, Schenten J (2018) Sustainable production and consumption. In: Krämer L, Orlando E (eds) Principles of environmental law. Edward Elgar Publishing, CheltenhamGoogle Scholar
- Führ M, Schenten J, Kleihauer S, Niebler R (2018) Integrating “Green Chemistry” into the regulatory framework of European chemicals policy. sofia-Studien zur Institutionenanalyse, DarmstadtGoogle Scholar
- Heyvaert V (2008) The EU chemicals policy: towards inclusive governance? Society and economy working papers 7/2008, London school of economics and political science, Law Department, LSE Law. www.lse.ac.uk/law/working-paper-series/2007-08/WPS2008-07-Heyvaert.pdf. Accessed 17 Jan 2019
- Ishimure M (1969) Paradise in the sea of sorrow: our minamata disease, published University of Michigan Center For Japanese Studies (January 3, 2003)Google Scholar
- Roe D, Pease W, Florin K, Silbergeld E (1997) Toxic ignorance: the continuing absence of basic health testing for top-selling chemicals in the United States. EDF (Environmental Defense Fund), New YorkGoogle Scholar
- SAICM (2006) SAICM texts and resolutions of the international conference on chemicals management. UNEP, GenevaGoogle Scholar
- SAICM (2015) Overall orientation and guidance for achieving the 2020 goal of sound management of chemicals. http://www.saicm.org/Portals/12/Documents/OOG%20document%20English.pdf. Accessed 12 July 2018
- UN (1992) United Nations Rio declaration on environment and development (13 June 1992), 31 ILM 874Google Scholar
- UN (2002) United Nations, Plan of Implementation of the Johannesburg World Summit on Sustainable Development, UN Doc A/Conf199/20Google Scholar
- UNEP (2013) Global chemicals outlook – towards sound management of chemicals. https://sustainabledevelopment.un.org/content/documents/1966Global%20Chemical.pdf. Accessed 17 July 2018
- UNEP (2015) UNEP Guidance on the development of legal and institutional infrastructures and measures for recovering cost of national administration for sound management of chemicals. http://hdl.handle.net/20.500.11822/12224. Accessed 17 July 2018
- United Nations (2012a) UN Doc. A/RES/66/288 (The future we want)Google Scholar
- United Nations (2012b) A 10-year framework of programmes on sustainable consumption and production patterns, UN Doc. A/CONF.216/5. Annex (10YFP)Google Scholar
- United Nations (2015) UN General Assembly, transforming our world: the 2030 Agenda for Sustainable Development. Resolution adopted by the General Assembly. 25.9.2015, A/70/L.1Google Scholar
- Viñuales JE (ed) (2015) The Rio declaration on environment and development: a commentary. Oxford University Press, OxfordGoogle Scholar