Danail
Hristozov
*a,
Alex
Zabeo
b,
Lya G.
Soeteman-Hernández
c,
Lisa
Pizzol
b and
Stella
Stoycheva
d
aEast European Research and Innovation Enterprise Ltd, Sofia, Bulgaria. E-mail: danail.hristozov@emerge.bg
bGreenDecision Srl., Venezia, Italy
cNational Institute of Public Health and the Environment (RIVM), Centre for Safety of 4 Substances and Products, Bilthoven, The Netherlands
dYordas Group, Lancaster, UK
First published on 31st May 2023
The Green Deal aims at transforming the European economy for safer and more sustainable chemicals, materials, processes and products. The goal is to encourage technological progress, while maximizing health and environmental protection as part of an ambitious approach to tackle pollution from all sources and move towards a toxic-free environment. To be able to fulfil these policy ambitions, the Chemicals Strategy for Sustainability and the Zero Pollution Action Plan describe the need for a paradigm shift towards prevention-based risk governance via a transition towards safe-and-sustainable-by-design (SSbD). The SSbD approach pro-actively ensures that safety, functionality and sustainability are embedded in the early design stages of new chemicals, materials and products. This is opposed to the current regulatory paradigm that retro-actively imposes measures to mitigate risks/impacts once the products are already on the market. The complexity of advanced materials, their enabling nature, as well as the roles of the different stakeholders involved in the risk governance process result in significant difficulties to define any trade-offs among safety, functionality and sustainability when it comes to developing and regulating new materials and products. Defining metrics of these fundamental aspects and integrating them for decision making cannot be a technocratic task – it should be a co-creative process that involves key actors along entire supply chains of production and downstream use and balances the perspectives of stakeholders from industry, regulation and policy. The establishment of such an ecosystem of actors and the application of approaches from decision science as well as digital tools can provide a significant contribution towards the practical operationalization of SSbD and can support the ongoing policy transition towards prevention-based risk governance of chemicals and advanced materials.
Sustainability spotlightThe new generations of chemicals and advanced materials present unprecedented opportunities but also pose complex environmental, health and safety risks as well as challenges to ensure environmental, social and economic sustainability. The adequate management of these risks/challenges requires a paradigm shift towards Safe and Sustainable by Design (SSbD) systems approach that integrates technical data on safety, functionality, and sustainability with decision makers' trade-offs already in the early R&D stages of innovation. Defining metrics of these fundamental aspects and integrating them into a multi-criteria decision analysis model is one way to support the development of safer and more sustainable technologies in line with the United Nations sustainable development goals (SDG 3, 6, 9, 12, 13). |
Risk governance is the totality of actors, rules, conventions, processes and mechanisms concerned with how relevant risk information is collected, analysed or communicated and how the risk management decisions are taken.9,10 This involves the implementation of widely agreed strategies and tools for risk prevention, assessment, communication, and management.11 The fast pace and complex nature of developments in nanotechnology has put high demands on risk governance, which have not been sufficiently addressed despite continuous efforts by the EU to promote development of relevant scientific knowledge, data, and tools, and to facilitate their uptake into policy, standards, and regulation.12
Indeed, the initial EC's strategy on risk governance of nanotechnologies was based on inclusion of new EHS knowledge into existing regulations, a process pioneered in Europe by the flagship H2020 NANoREG project.13 The need for transformation towards regulatory preparedness, effective transdisciplinary alignment, and optimal use of research data has been recognized as an essential prerequisite for effective and sustainable risk governance of nanotechnologies only at a later stage in the NANoREG 2 project.14,15 Moreover, besides increased transparency, effective risk communication is needed, and similarly to other emerging technologies, the advanced (nano)materials require a risk governance paradigm that is resilient and adaptive so that it can successfully keep pace with innovations.10,16 The role of regulators is key but the needs for gathering scientific evidence and for engaging in a dialogue with other stakeholders, including the civil society are considered equally important.10
The evolution of the risk governance paradigm for nanotechnology has been reflected in several conceptual schemes. ISO 31000:2009 represents one of the first guidelines for new technologies.17 This standard reflects the early trends in the field being focused mostly on the technocratic aspects of risk assessment, while other important factors such as the need for improved risk communication are somewhat underestimated. In 2012, the International Risk Governance Council (IRGC) published its nano-specific risk governance framework, which was revised in 2017.18 The IRGC framework again focused on risk assessment, but emphasizes that the risks should be framed, defined, and governed by societal values and stakeholder judgment is essential for making the trade-offs between risks and benefits. Therefore, communication, stakeholder context, and public engagement are essential cross-cutting aspects that should not be neglected.10
The above conceptual schemes were used as a basis for the EU H2020 caLIBRAte, Gov4Nano, RiskGone and NanoRiGo projects, which have worked together to develop and implement a risk governance system for nanotechnology that is applicable for governing EHS risks of also other emerging technologies such as the advanced (nano)materials. The joint efforts of these projects have resulted in an operational transdisciplinary governance framework that involves a network of stakeholders, established processes to ensure collaboration, and tools to support different aspects of the risk governance process (e.g., risk prevention, assessment, communication, and management).
During the lifetime of these EU projects The European Green Deal1 was signed, and its policy for achieving a toxic-free environment has been implemented via the Chemicals Strategy for Sustainability (CSS), which in turn has called for a transition towards a Safe-and-Sustainable-by-Design (SSbD) approach for chemicals and emerging (advanced) materials.2,5,19 In response to this, the European Commission (EC) published its recommendation for establishing a European assessment framework for SSbD of chemicals and materials,20 which is based on a holistic approach proposed by the EC's Joint Research Centre (EC JRC).21
The CSS describes the SSbD as: ‘a pre-market approach to chemicals design that focuses on providing a function (or service), while avoiding volumes and chemical properties that may be harmful to human health or the environment, in particular groups of chemicals likely to be (eco) toxic, persistent, bio-accumulative, or mobile. In this context, the overall sustainability should be ensured by minimizing the environmental footprint of chemicals in particular on climate change, resource use, ecosystems, and biodiversity from a life cycle perspective’.2
The EC JRC has made initial steps towards an operational framework for the definition of SSbD criteria and an evaluation procedure for chemicals and advanced materials.21 The recent EC JRC report describes the framework in a two-step process: a (re)design phase in which guiding principles are proposed to support the design of chemicals and materials, and a safety and sustainability assessment phase in which the safety, environmental and socio-economic sustainability of the chemical/material are assessed. In this latter phase, minimising or, as far as possible, eliminating the impact on human health, climate and the environment already in the early chemical/material/product design stages is central.
Therefore, as already identified through various initiatives and funded projects, the idea that a paradigm shift towards prevention-based risk governance of emerging chemicals and advanced (nano)materials is needed was confirmed also by the EC JRC framework. Prevention-based risk governance seeks to avoid or mitigate hazard, effects, and exposure by mandating or encouraging the adoption of inherently safer alternative technologies.22–24 In SSbD, this definition is extended by the idea that the alternatives should perform comparably or better also in terms of functional performance, as well as environmental, economic, and social sustainability (triple bottom line concept). This is opposed to the conventional risk management paradigm in which risks are quantified in absolute units and if they turn out to be unacceptable, then they are controlled by means of applying risk reduction measures. This traditional approach has several limitations when applied to the governance of emerging materials and technologies. It is based on the notion that uncertainty in risk predictions can be quantified, and risks can be reliably controlled. Therefore, this approach can be effective where (i) hazards are well understood, (ii) the set of potential effects is known, and (iii) exposure can be quantified and reliably mitigated.24 However, these assumptions are often challenged in decision scenarios involving novel emerging chemicals and (advanced) materials. This is because the available information regarding the potential hazards and exposures of such materials is limited and so is also the fundamental understanding of their often more complex biological and environmental interactions. In such scenarios, the application of the risk control paradigm often generates unacceptable levels of uncertainties that prevent robust decision making; therefore, in these cases the prevention-based approach to risk governance is clearly preferable.
In fact, regulators and policy makers have expressed a preference for risk prevention over control for decades, but the idea of prevention has not been widely included in regulation or governance. This is to a large extent due to the lack of rigorous, tractable, and transparent methods that enable comparative assessment of alternatives for design of safer and more sustainable chemicals/materials.24 This is because such an assessment would involve measuring the relative performance of alternatives according to heterogenous criteria and indicators (pertaining to e.g., safety, technological functionality, and sustainability), and considering different (often divergent) stakeholder perspectives. Therefore, to make prevention-based risk governance more practical and achievable, we advocate the adoption of decision analytical methods such as multi-criteria decision analysis (MCDA),23,25,26 as demonstrated in the illustrative case study below.
SSbD is a systems approach aimed at pro-actively addressing safety and sustainability beginning at the early stages of innovation and throughout the lifetime of the products instead of retro-actively managing EHS and environmental impacts once the products are already on the market. To make this paradigm operational, it needs to be tailored and adapted to specific industrial areas such as, for example, the sectors enabled by advanced (nano)materials (e.g., construction, structural and functional materials, active ingredients, food, healthcare, energy, cosmetics, electronics).21 Moreover, it cannot be applied in isolation, but should be combined in an integrated Safe and Sustainable Innovation Approach (SSIA)21 which combines SSbD with the Regulatory Preparedness concept.14
The goal of the SSbD is to increase the safety and sustainability of chemicals and advanced materials without compromising the technological functionality of the products enabled by them.14,21 ‘Safety’ is seen as ‘transversal to all sustainability dimensions (environmental, social and economic)’.21 ‘Functionality’ can be defined as the ability of a product to be useful and to achieve the goal for which it was designed. To achieve safety, one can modify products and processes to reduce the potential for release of reactive chemicals/materials, accelerate their degradation in physiological or environmental media, and/or decrease their biopersistence, bioaccumulation and hazard. The recent EC JRC report21 expressed the opinion that safety dominates the other sustainability criteria because a chemical, material or a product cannot be sustainable if not proven safe. Theoretically this is true, but we believe that in practice safety, functionality, and sustainability should be addressed simultaneously from the very early stages of product development. The reason is that if for example an industry develops a product that is safe but turns out not to be sustainable (e.g., not climate-friendly, or excessively costly to produce), then even if this product can pass the regulatory approval process it may end up not being competitive on the market. If this problem is not addressed early enough, the industry may not have the resources to go back in the innovation process and revise the product by selecting more sustainable design alternatives. The result will be loss of investment and a failure to deliver a viable product on the market. Therefore, we advocate an approach that integrates the evaluation of safety, sustainability, and functionality, rather than treating those as independent parameters. This evaluation of the safety-functionality-sustainability balance of the materials/products should be performed at each stage of the innovation process, so that any potential concerns are addressed early enough before the innovation reaches a point of no return. To this end, it is practical to structure the decision making according to the Gates of the Agile Stage-Gate Idea-to-Launch innovation model27 (cf.Fig. 1). Agile Stage-Gate is a standard industrial approach that divides the innovation process into five stages and requires analysis at each gate to inform decisions on: (1) termination if the technical or commercial probability of success are compromised, or if the EHS risks are considered unacceptable; (2) stage reiteration to improve the safety, performance and/or sustainability of the material/product being developed; or (3) progression to the next stage if those are in the desired ranges. In this way the Agile Stage-Gate approach continuously challenges the early stages of innovation to cost-efficiently develop safer, functional and more sustainable materials/products.
Dialogue between industry and regulators in a trusted environment is necessary: for industry so they can become aware of regulatory issues; and for both regulators and industry to address how to deal with these issues in a timely manner, preferably during the R&D stages. Regulatory preparedness refers to the capacity of regulators, including policy makers, to anticipate the regulatory challenges posed by emerging technologies such as nanotechnology, particularly human and environmental safety challenges.14 This requires that regulators become aware of and understand innovations sufficiently early to take appropriate action to ensure high levels of health and environmental protection. Regulatory preparedness would help to ensure that emerging chemicals and advanced (nano)materials would undergo suitable safety assessment before entering the market. Regulatory preparedness requires dialogue and knowledge-sharing among regulators and between regulators and innovators, producers, downstream users and other stakeholders. This communication and interaction help regulators to anticipate the need for new or modified regulatory tools, and reduce the uncertainties for industry associated with the future development of the safety legislation and regulations applicable to emerging technologies.15 It can also help to raise awareness and address regulatory concerns in the early stages of innovation, which can substantially shorten the time of novel materials and products to reach the market.
To enable the benefits of co-creation outlined above, we advocate the application of a digital framework such as the e-infrastructure described in the following section 4. Such an IT infrastructure, using tools for controlled and secure exchange of information (e.g., blockchain technology) to facilitate collaboration along the value chain can speed up safe and sustainable innovation. It can also be instrumental for establishing a trusted environment, where industries can engage in an early dialogue and exchange of data with regulators, which can help to raise awareness and address regulatory concerns in the early stages of innovation, thereby helping to bring novel products faster to the market.
There are already several Decision Support Systems (DSS) and IT platforms for SSbD of engineered nanomaterials and advanced materials that have been developed in EU research projects.28 This includes but is not limited to the SUN, SbD4Nano, SAbyNA, ASINA, HARMLESS, RiskGONE and DIAGONAL DSSs and the data and modelling software platforms NanoSolveIT, SCENARIOS, NanoInformaTIX, NanoCommons, DIAMONDS and Jaqpot. These software hubs provide access to several databases and more than 100 relevant modelling and assessment tools. However, these systems of tools only partially address the complexity of the SSbD topic, focusing mainly on EHS and in some cases on environmental impacts but neglecting the complex social and economic implications of emerging chemicals and advanced materials. Therefore, there is need for computational infrastructure that makes use of the current developments, but also enables in-depth analysis of all relevant aspects and considers stakeholders’ trade-offs in SSbD decision making and prototyping.
To this end, we see the need for a digital e-infrastructure that provides access and structured guidance to the existing/emerging digital platforms/tools and is designed to foster dialogue, collaboration and information exchange between supply chain actors, and between industries and regulators. The aim is not only to promote design of safer and more sustainable products enabled by emerging chemicals and advanced (nano)materials, but also to support the transitional nature of SSbD through learning by doing and by quickly adapting to the generation of new knowledge (state of the art). All actors will benefit from the insights of lessons learned and updating state of the art. Such an e-infrastructure should be inclusive – it should be developed by engaging the ecosystem of key actors described above to ensure that it addresses their decision-making needs. It can be instrumental in creating a trusted environment by ensuring secure and controlled exchange of information between industries as well as between innovators and regulators. It should be aligned to the European Open Data policy by providing open access to the emerging FAIR (Findable, Accessible, Interoperable and Reusable) EHS and sustainability databases and can greatly benefit from a tool to assess data readiness.29 If sufficient data are not yet available in the databases (a typical scenario for emerging chemicals and materials), there should be detailed guidance to applying state-of-the-art tools to cost-effectively identify and acquire existing data for analogous substances (e.g., approaches for similarity assessment, grouping and read across), or to generate new data. The acquired information would then be used by the system to assess the safety-functionality-sustainability balance of the target chemicals/materials/products at each Gate of the Agile Stage-Gate innovation process to inform ‘Go to development’ and ‘Go to market’ decisions.
The development of new EHS knowledge and data can be done in tiers of increasing specificity and complexity of the adopted experimental, modelling and assessment tools. Similarly, to ensure the sustainability of the materials/products being designed, a tiered approach can be implemented based on eco-design and circularity criteria and respective indicators and tools.21
In our opinion, there is need for an SSbD assessment approach composed of 3 tiers that align with the Agile Stage-Gate Idea-to-Launch concept (cf., Fig. 2). Specifically, tier 1 can be applied before the strategic decision ‘Go to development’ at Gate 3, whereas tier 2 provides feedback during performance optimisation in the development stages, without incurring too much cost. Therefore, the first two tiers support SSbD decision making by stopping the innovation process if profitability and/or commercial probability of success are compromised, or if the (uncertainties on) EHS risks and/or the sustainability of the target material/product are considered unacceptable. Tier 3 is designed to assess risks and sustainability performances before the decision ‘Go to launch’ at Gate 5 to validate the outcomes of the previous two tiers and ensure the regulatory compliance, technical functionality and sustainability performance needed to successfully bring the products to the market and ensure that they are commercially viable.
Fig. 2 Tiered SSbD assessment approach aligned to the Agile Stage-Gate innovation decision making process. |
Tier 1 will enable qualitative self-assessment by industry at the early R&D stages of the innovation process that aims to identify sources (or hotspots) of possible EHS and/or sustainability concerns along the lifecycle of the target material/product. The results can inform corrective actions by the company prior to Gate 3 to address these issues before significant resources are invested into developing the material/product. To this end, tier 1 can apply a qualitative self-assessment questionnaire. Tier 1 will rely mostly on qualitative data already available to the manufacturer and will require relatively low levels of expertise, which will make it particularly suitable for application by SMEs. The required information is aimed at identifying those hotspots in the lifecycle of the material/product that can cause health, environmental, social and/or economic impacts. This includes, but is not limited to, data related to physicochemical identity, (eco)toxicity, environmental emissions/releases, energy and water consumption, waste generation etc. Furthermore, additional questions can be asked from a circular economy perspective to obtain information on recyclability, options for recovery and/or re-use after the end of life, or possible transformations of the materials after disposal in landfills or during final treatment and incineration processes.
In tier 2 a more targeted analysis should be performed to understand if the issues identified in the tier 1 pre-screening have been resolved and if new issues can be identified. Tier 2 may comprise (semi)-quantitative scoring methodologies30,31 to assess the health, environmental, social, and economic impacts and the circularity of the materials/products. This analysis will rely on a combination of more detailed qualitative information from the manufacturer but also on quantitative data. Such quantitative data can be derived from safety (e.g., eNanoMapper) and sustainability (e.g., Ecoinvent, Social HotspotsDB, etc.) databases. If the required data are not available in the data repositories or are incomplete, guidance should be provided on how to generate new data by means of applying specific experimental approaches, in silico modelling methods.
Tier 3 will involve quantitative safety and sustainability impacts assessment for materials/products ready to be released on the market (Gate 5). The more detailed analysis of safety impacts would involve regulatory risk assessment (e.g., REACH Chemical Safety Assessment) but in the medium term the emerging Next Generation Risk Assessment (NGRA) approaches32 should be adopted to reduce testing costs and the use of experimental animals. To assess sustainability impacts tier 3 will employ the established Life Cycle Analysis (LCA), Social Life Cycle Analysis (S-LCA), Life Cycle Costing (LCC), Cost-Benefit Analysis (CBA) and Circularity analysis approaches.
The assessment of the safety-functionality-sustainability balance of the SSbD-modified chemicals/materials/products should be performed at each Gate of the Agile Stage-Gate process. The ability to integrate safety, functionality and sustainability criteria is essential for SSbD decision making, but it is challenging as it requires aggregation of heterogeneous information (e.g., qualitative vs. quantitative data presented in different units) as well as different stakeholder trade-offs. To illustrate how to effectively aggregate such information for supporting structured SSbD decision making, a simple methodology based on the Multi-Attribute Value Theory (MAVT) is proposed. MAVT is an MCDA approach, which was first described in theoretical concepts by Fishburn33 and Keeney and Raiffa.34 It applies value functions to aggregate criteria and metrics that can be presented in native units (e.g., $, size, solubility) or in ordinal scale (e.g., high, medium, low) into numerical scores for alternative choices in order to compare them for making a decision. It is a deterministic additive model where value functions vj(a) for each Alternative a to each criterion j are aggregated through weighted average using preference weights kj to obtain the global value V(a) of the different alternatives . The aggregation process can be hierarchically organized so that results from a branch's aggregation become criteria in the higher aggregation level.
In this illustrative methodology, safety, functionality and sustainability pillars form the first level of a decision tree, which is further branched into subsequent levels of relevant criteria, measurable indicators and their respective metrics. The MAVT model comprises (a) metrics associated with criteria and (b) weights representing stakeholder preferences at each branch of the decision tree. This enables the users to decide which criteria are more important than others to consider in the design of their products. These criteria/indicators are normalised to a single scale (e.g., 0–5) and are aggregated to obtain final scores for safety, functionality and sustainability. These final indices can then be used in a traffic light system to compare different design alternatives. This comparison should be done at each decision point of the Agile Stage-Gate Idea-to-Launch process, to ensure that profitability as well as technical and/or commercial probability of success are not compromised, and any possible health and/or environmental risks are within acceptable ranges.
Weights | |||
---|---|---|---|
Stakeholders | Safety | Functionality | Sustainability |
Manufacturers | 2 | 5 | 1 |
Consumers | 4 | 4 | 4 |
Regulators | 5 | 2 | 5 |
Alternatives | |||
---|---|---|---|
Alternative | Safety | Functionality | Sustainability |
Baseline | 5 | 1 | 5 |
Low-end | 4 | 3 | 3 |
High-end | 2 | 5 | 1 |
Results | |||
---|---|---|---|
Stakeholders/alternatives | Baseline | Low-end | High-end |
Manufacturers | 2.50 | 3.25 | 3.75 |
Consumers | 3.67 | 3.33 | 2.67 |
Regulators | 4.33 | 3.42 | 2.08 |
The conclusion of this simple illustrative exercise is that there is no universal understanding of what SSbD means in practice. Therefore, the successful implementation of a SSbD approach for emerging chemicals and advanced (nano)materials should be based on a multi-stakeholder co-creative process underpinned by dialogue and collaboration among industry, regulators, policy makers, and the civil society. Such a dialogue requires to build an environment of trust between these stakeholders, which is not a trivial task, but can bring significant benefits in terms of developing new innovative products and bringing them faster to the market. In this regard, the recent JRC Report (2022): ‘safe-and-sustainable-by-design chemicals and materials: framework for the definition of criteria and evaluation procedure for chemicals and materials’ can provide a first guide for the practical operationalization of SSbD.21
Footnote |
† Electronic supplementary information (ESI) available. See DOI: https://doi.org/10.1039/d3su00045a |
This journal is © The Royal Society of Chemistry 2023 |