The Safe and Sustainable by Design (SSbD) framework is an innovative strategy that proactively incorporates safety and sustainability into the product development process. By incorporating these concepts from the start of product design, SSbD establishes a new standard for reducing environmental impact and protecting human health, which is critical for innovative and sustainable product design in numerous industries. The increasing growth and variety of businesses that explore alternatives for currently circulating materials that might not reach sustainability standards required by society necessitates an evolution in hazard characterisation techniques as well. Traditional methodologies frequently rely on substantial animal testing, which poses ethical concerns while also potentially failing to accurately predict real-world human and environmental interactions. New Approach Methods (NAMs) provide transformative tools that use cutting-edge scientific techniques to perform more accurate, ethical, and comprehensive assessments, embedded into SSbD decision making workflows.
SSbD methods can be used in product design to effectively support the early embedding of human safety, environmental safety and sustainability into product choices. To achieve this goal, full use of existing data, models and knowledge should be leveraged into providing relevant information supporting assessment and decision goals between alternatives in early stage innovation. Such data needs to be integrated with evidence-weighting and scoring schemes, including uncertainty, to reach initial decisions on alternatives and to plan for subsequent refinement phases. The findings may include recommendations for generating the most meaningful and useful data to address gaps and uncertainty.
Physical product design is concerned with function, ingredients, formulations, compositions, sourcing, manufacturing and packaging processes, and foreseeing the path of the product along the lifecycle from design through production through consumer use including logistics, use and recycling through to end of life cycle. Data, methods and tools are increasingly becoming available about many of these product design and lifecycle aspects. Exploiting that data for the benefit of reduced health hazards and improved environmental footprints can lead to safer and more sustainable designs of new products, but also greener redesigns of existing products. Knowledge and application of SSbD also helps manufacturers to comply with emerging regulations such as digital product passports, ecodesign and sustainability requirements, and enhancing export opportunities of higher quality products.
The SSbD4CheM project (https://www.ssbd4chem.eu/) aims to develop, test and refine the combination of methods required to successfully implement the practical implementation of SSbD methods as tested against industrial case studies. The goal of our implementation framework is to provide structured knowledge guidance on the organisation of SSbD tasks as carried out in case studies documented against workflows integrating all sources of evidence with integrity. The framework specifies our strategy, methodology and concepts for implementation against SSbD goals. Our strategy involves a tiered iterative approach to SSbD with all activities described in workflows documenting case study tasks, results and decisions. Its implementation during the project involves the development and deployment of a knowledge infrastructure and portal including databases and methods documentation providing information to software for workflows, calculators and dashboards documenting the work status, and supporting user entered information and communications.
The JRC SSbD framework (see background section at end below; JRC SSbD; 2022) foresees the assessment of the entire life cycle of a chemical or material, including the design phase and considering among others its functionality and end-use(s). It is stated that “even if the evaluation of products is outside the scope of this framework, the use of the chemicals/materials in products is considered.”; we pursue the approach that both products and their functions and components, in addition to all feasible alternatives, should be considered together in the SSbD analysis.
The SSbD4CheM framework aims to integrate heterogeneous data and knowledge generated by diverse workflows bringing results from the different SSbD pillars into a common weighted decision-making mechanism presenting accessible and actionable results to product design and development decision makers. Furthermore, our system design is aimed to support workflows based on problem formulation and a tiered strategy supporting lower tier activities enriching data and reducing uncertainties on impact factors as needed. We aim to support temporal updates both within a tier and across tiers for a phased project approach as tested against case studies. These include the SSbD-specified pillars of hazard characterization, human and environmental exposure and risk assessment, sustainability, life cycle analysis, economic and societal analysis. An overview of the main SSbD4CheM project activities is provided in the Figure below.
Recent developments with regards to chemical hazard characterization and risk assessment and regulatory frameworks including the development and acceptance of New Approach Methods (NAMs) supporting goals in hazard characterization, risk assessment and risk management provide useful knowledge inputs into SSbD implementation. Such a background provides a useful context for the proposed SSbD4CheM framework described, tested in case studies addressing novel materials like wood plastic composites with optimized emissions for automotive components, renewable coatings for textile applications and sustainable bio-based additives for different cosmetic products
SSbD4CheM proposes to take a tiered strategy approach supported by integrated approaches to testing and assessment (IATAs), where different methods (e.g., an «in silico first» approach in a top tier) can be applied as needed to problem formulations, with different resource, time and cost commitments; if an acceptable solution is found, an exit can be made without need for additional effort and cost. Operationally, SSbD4CheM envisages developing and implementing such a solution through workflows tested by the three case studies (textile, cosmetics, automotive), connecting different sources of knowledge within the SSbD4CheM knowledge infrastructure.
The SSbD4CheM solution proposes a framework including well-documented scientific methods and processes connected reliably with data used in decision-making tasks including assemblies of heterogeneous workflows and sources of data including from in silico protocols and models. The SSbD4CheM project has established a process for the problem formulation definition by an individual company of an industry case study, whose goal is to use the SSbD4CheM methodology and resources to solve a problem of commercial importance, and to eventually share learning from it within a community of practice element both within the project and supported by outreach activities to other projects and stakeholders.
The SSbD4CheM testing strategy and WP interactions are depicted in the Figure below. Our work within the project is oriented towards how we transform the SSbD4CheM Work Plan into a sustainable implementation, including both public and commercial factors. In addition to the case study, scientific, resource development and risk assessment activities, we will include factors such as selection and refinement for market fit-for-purpose, individual and collective exploitation, need to consider developing market and regulatory factors, and business case and planning aspects.
It is expected that specific SSbD4CheM solutions will be developed for the proposed case studies but in parallel it is considered whether SSbD4CheM framework and methods have more general extensibility and sustainability potential, i.e., the project ambition is not just to develop methods for a specific problem formulation (although that of course can have a significant value) but rather to develop a systematic approach to SSbD and chemical risk assessment and its practical implementation with valuable knowledge sharing with sister SSbD cluster projects (starting from the RESILIENCE 01-21) sister projects: CheMatSustain (https://chematsustain.eu/), CHIASMA (https://chiasma-project.eu/) and TOXBOX (https://toxbox.eu/).
The progress beyond the state of the art includes development of new methods and the associated data for safety and sustainability assessment of chemicals and materials during the product design phase to support Ecodesign for Sustainable Products Regulation (Ecodesign, 2024), the EU Ecolabel, REACH or CLP (CLP, 2008). SSbD4CheM supports the objectives of the Green Deal (Green Deal, 2019), the new EU Strategy on Adaptation to Climate Change (Green Deal, 2021), and the Chemicals Strategy for Sustainability (CSS, 2020), in which a zero- pollution ambition for a toxic-free environment is among the priorities, as well as EU strategy for sustainable textiles (Textiles, 2022).
SSbD4CheM is constructed as a toolbox with a collection of resources and tools designed to support the development of safe and sustainable products and processes. The toolbox includes a range of tools, guidance documents, databases, and other resources that can be used by stakeholders in industry, government, academia, and civil society to incorporate safety and sustainability considerations into their product and process design.
To implement the SSbD framework, the SSbD4CheM partners have designed a feedback loop between work packages (WPs) to address key objectives. This approach integrates safety and sustainability requirements into developing new materials for the automotive, textile, and cosmetics value chains. These materials will undergo health-risk and environmental assessments to establish criteria for safe and sustainable design based on computational, experimental, and life cycle assessment (LCA) analysis.
Specific requirements have been identified regarding data, metadata, methods, and protocols, serving as a roadmap for implementing an SSbD framework based on computational models (in silico, data-driven and AI-assisted), physico-chemical characterization, LCA analysis, and human and environmental risk and hazard assessment. These criteria will be validated through the SSbD4CheM case study use cases.
The project leverages the characteristics of the materials being examined to minimize potential hazards. This involves a computer-aided (re)design approach within in silico modeling, data-driven modeling, and data-driven LCA estimation, gathering data on the physico-chemical characterization of the materials, and conducting in vitro or non-animal toxicological analyses.
Integrating Knowledge Infrastructure Development
Edelweiss Connect is currently responsible for knowledge infrastructure, workflow and application development on the SSbD4CheM project (Methodology is currently being tested on the project against case studies in the cosmetics, textile and automobile industries. Our SmartSafety software (https://smartsafety.edelweissconnect.com) supporting formulation and ingredient risk assessment is being extended in this work to incorporate SSbD assessment modules supported by AI-assisted data collection and curation and use of evidence from New Approach Methods (NAMs) including modelling. Workflows developed with the Alternative Safety Profiling Algorithm (ASPA) concept on the RISK-HUNT3R project for structuring and documenting risk assessment tasks and decision points based on in silico and in vitro NAMs evidence (https://www.risk-hunt3r.eu/aspa/) are also being extended to SSbD tasks such as worker occupational safety evaluation, environmental assessment, life cycle analysis and substitution scoring and comparison. Such modelling and software development by Edelweiss Connect and partners is supporting solution workflows provided through SaferWorldbyDesign. We will discuss these approaches in our SaferWorldbyDesign Webinar on March 6 on Modelling and AI-assisted Safe and Sustainable by Design (link) and related topics from partners in subsequent SaferWorldbyDesign Webinars which will have a theme this Spring of in silico based risk assessment and SSbD combined with generating supporting experimental evidence required by lower tier assessments.
A dashboard summarising the results of the sustainability assessment has been proposed as a tool to facilitate informed conclusions/decisions based on a holistic SSbD assessment. The result of the evaluation can be expressed either as a class of SSbD (poor, good, very good) or with a numerical score derived from the combination of the individual scores of each aspect (subject to e.g. weighting). The evaluation procedure should take into account the lack of data and data uncertainty inherent to the assessment. This SSbD goal fits well into our goals for SSbD4CheM: using modeling approaches we can add such SSbD scoring data to our substance database and provide such information through a dashboard on the SSbD4CheM knowledge sharing portal; we can also extend the intelligence using ML/AI approaches to suggest greener substitutions for consideration in formulation decision situations.
Background
The SSbD framework proposed by the EC JRC (see Figure below) foresees the assessment of the entire life cycle of a chemical or material, including the design phase and considering among others its functionality and end-use(s).
Framework structure: a stepwise approach
The SSbD framework entails two components:
A (re)design phase in which design 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 is assessed.
The safety and sustainability assessment herein presented allows the identification of “SSbD chemicals and materials, in particular how criteria can be defined. It comprises five Steps that can be carried out sequentially or in parallel, depending on the data and tools availability and the specific purpose of the exercise. Moreover, the assessment can be done and, in many cases, should be done iteratively to optimise the results. The steps are:
Step 1 - Hazard assessment of the chemical/material
The first step looks at the intrinsic properties of the chemical or material in order to understand their hazard potential before further assessing the safety during production or use.
Step 2 - Human health and safety aspects in the chemical/material production and processing phase
In this step, the health and safety aspects related to the chemical/material production and processing are assessed. It covers all processes from the raw material extraction (from natural resources) to production (e.g. substance manufacturing), processing (e.g. mixing), recycling or waste management. It addresses occupational safety and health (OSH) related aspects in each of them.
Step 3 - Human health and environmental aspects in the final application phase
This step assesses the application/use-specific exposure to the chemical/material and the associated risks, both for human health and the environment.
Step 4 - Environmental sustainability assessment
The fourth step considers impacts along the entire chemical/ material life cycle by means of Life Cycle Assessment, assessing several environmental impact categories such as climate change and resource use.
Step 5 - Social and economic sustainability assessment
The fifth step relates to Social and Economic Sustainability assessment, to provide information on the scientific basis and available approaches for the assessment of socio-economic impacts. Given the limited level of implementation and methodological maturity this step is in an exploratory phase.
Evaluation
The evaluation of the chemicals/materials should be performed considering:
The adherence to the SSbD principles;
The sustainability assessment, namely the detailed figures on the performance of the chemical/material against the SSbD criteria.
References
(CLP, 2008) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
(CSS, 2020) The EU’s chemicals strategy for sustainability towards a toxic-free environment https://environment.ec.europa.eu/strategy/chemicals-strategy_en
(Ecodesign, 2009) Ecodesign Directive 2009/125/EC
(Green Deal, 2019) The European Green Deal (COM (2019)640).
(Green Deal, 2021) Forging a climate-resilient Europe - the new EU Strategy on Adaptation to Climate Change COM/2021/82
(JRC SSbD, 2022) Caldeira, C., Farcal, R., Garmendia Aguirre, I., Mancini, L., Tosches, D., Amelio, A., Rasmussen, K., Rauscher, H., Riego Sintes, J. and Sala, S., Safe and sustainable by design chemicals and materials - Framework for the definition of criteria and evaluation procedure for chemicals and materials, EUR 31100 EN, Publications Office of the European Union, Luxembourg, 2022, ISBN 978-92-76-53280-4, doi:10.2760/404991, JRC128591. https://publications.jrc.ec.europa.eu/repository/handle/JRC128591
(Textiles, 2022) EU strategy for sustainable textiles COM/2022/141 final
Bình luận