RiskGONE material
Intro | Decision trees | TGs - Guidelines | Project deliverables | Data and DBs | Regulatory information | RG framework overview | SSbD
RG framework overview
This page presents information collected and adapted from Isigonis et al. 2019, Isigonis et al. 2020 and public repositories, such as the NanoReg Toolbox. Useful information can be found also at the Nanorisk Governance Portal
RiskGONE RG framework
Responsible and sustainable nanotechnology innovation requires the development and implementation of widely agreed strategies and tools for prevention, assessment, communication and management of risks and impacts, across materials and product life cycles. It should also reflect contiguous concerns, such as the circular economy, critical raw materials, the water and waste framework directives and guidance in food and feed chains, ultimately leading to the development of a holistic RG framework for nanotechnologies and NMs. Within the RiskGONE project, a modular RG framework has been envisioned, based on the state-of-the-art in the nanotechnology sector, the incorporation of risk/benefit ratio and ethical assessments and the efforts to couple the notions of life cycle thinking, prevention-based RG, SSbD, safe innovation governance, contiguous frameworks and open data initiatives with the existing four main pillars of the RG process, as shown in the next figure.
Schematic illustration of the holistic and implementable RiskGONE universal nanotechnologies RG framework
The principal components of RG frameworks, such as risk pre-assessment, risk appraisal, risk evaluation and risk management have been described extensively in various previous studies. They are accepted by the scientific community as important steps in chemical and material assessment and are used in the most recent research regarding RG processes for NMs. Our study uses the pre-existing principal components as the basis of the envisioned RG framework and focuses on the development and incorporation of specific elements that are currently missing and are considered essential towards the establishment of science-based RG of NMs, as also seen in Table 1. These elements include the following:
- Promotion of the incorporation of the SSbD concept, alongside the Sustainability by design and Quality by Design concepts, within assessment frameworks and their operationalisation through comprehensive tools, which are currently in their infancy or missing completely. This effort is meant both to help innovation governance, to support responsible research and innovation with practical and operational tools and to enhance predictive actions and measures covering the life cycle of NMs or even precede their realization via in silico screening.
- Guidance and standardization documents, for enhancing the regulatory compliance and acceptance of the developed framework and the incorporated tools.
- Strengthening of the scientific efforts towards open data and global data availability, through the development of open databases and repositories supporting FAIR data and promoting the FAIRification processes.
- Utilization of RG tools (both existing and those to be developed) and incorporation of decision trees that will guide the users (covering regulators, industry and the public) in the use of the cloud platform (thus the applied framework) and the redirection to available resources for the needs of each stakeholder group. Resources will include guidance documents, standardization documents, public summaries, internet resources (databases, information portals), communication tools and scientific tools.
The RG frameworks developed so far have not been designed with exclusive consideration of how they would be operationalised, i.e., outlining how the framework would support the work of stakeholders such as regulators, industry, society and other groups. The foundation of the RG activities, based on the RiskGONE consortium vision, should be based on various key steps for creating a strong formal framework: i) using FAIR (Findable, Accessible, Interoperable and Reusable [34]) scientific data; ii) making use of OECD / EURL ECVAM (European Union Reference Laboratory for alternatives to animal testing / European Centre for the Validation of Alternative Methods) validated datasets and nanoinformatics tools; iii) enabling the operationality of the tools for aligning the RG practices through accessible cloud platforms; and iv) aligning with open data initiatives and supporting the validation processes for data and models.
The vision is thus to design a framework for supporting stakeholders through the early adoption of scientific advances and emerging data and their translation via functional tools, all within a transparent, guided decision scheme considering the needs and expectations of the various stakeholders. The RG framework is available as an interoperable cloud platform with a user-friendly interface and operationalised via a set of decision trees implemented into a modular decision support tool providing instruments, guidance and guidelines for different aspects of the RG of NMs, such as:
- Characterisation, Fate, and Dosimetry of NMs
- Human Hazard Assessment
- Environmental Hazard/Effect Assessment
- Exposure Assessment
- Risk Assessment
- Life Cycle Analysis
- Economic Assessment
- Ethical Impact Assessment
The RiskGONE decision trees are available at the relevant page of the RiskGONE Cloud platform.
Risk Governance – Main phases
Risk pre-assessment is the stage in which the risk governance processes lead to framing the risk, provide early warning and preparations for handling the risk. Usually, pre-assessment involves relevant actors and stakeholder groups, in order to capture the various perspectives on the risk, its associated opportunities, and potential strategies for addressing it. This phase of the risk governance cycle includes a systematic review of public and stakeholder groups framing their relevant risks topics.
The IRGC framework includes the notions of Risk and Concern assessment and Safety assessment in the Risk appraisal term, which is used for describing the process of assessing the technical and perceived causes and consequences of the risk. This process can be used for developing and synthesising the knowledge base for the decision on whether a risk should be taken and/or managed or not, and, if so, for identifying and selecting which options may be available for preventing, mitigating, adapting to or sharing the risk. The appraisal process is dominated by scientific analyses but, in contrast to the traditional risk governance model, the scientific process includes both the natural/technical as well as the social sciences, including economics for producing the best possible scientific estimate of the physical, economic and social consequences of a risk source.
Risk evaluation is the process of comparing the outcome of risk appraisal (risk and concern assessment/safety assessment) with specific criteria, to determine the significance and acceptability of the risk, and to formulate decisions. Risk characterisation is collecting relevant evidence to make an informed choice of acceptability of the risk, whereas risk evaluation applying societal values and norms to judge the acceptability and the need of risk reduction. Risk characterisation and evaluation are therefore linked and are done by risk assessors and risk mangers mostly in a joint effort.
Risk management is a process that involves the design and implementation of the actions and remedies required to avoid, reduce (prevent, adapt, mitigate), transfer or retain the risks. Risk management includes the generation, assessment, evaluation and selection of appropriate management options, the decision about a specific strategy and options, and implementation. It starts with a review from information gathered from the risk appraisal, includes the judgement made in the risk evaluation and formulate different risk management options.
Monitoring refers to the evaluation, review and continuous improvement of the risk governance process.
Toolboxes for each stage of the Risk Governance process can be found at the following pages. Interested users can check the “Library of Tools” and the “Platforms” pages of the Nanorisk Governance Portal for additional information on tools and platforms relevant to Risk Governance of nanomaterials.
- Risk pre-assessment toolbox
- Risk appraisal toolbox
- Risk characterisation and evaluation toolbox
- Risk management toolbox
Risk pre-assessment
| Tool name | Description | References | Sector |
| Nano-Risk Radar | Automatic identification of new risks previously developed for the insurance sector to assess internet-based sources measuring singularity and ubiquity of new information. The tool will also include NM-specific methods to consider cognitive factors (interdependencies between context, objectives and biases) for risk perception. | caLIBRAte / http://www.nanoriskgov-portal.org/ | Scanning |
| Causal diagram assessement | The causal diagram has been developed as a method to handle the complexity of issues on NP safety, from their exposure to the effects on the environment and health. It gives an overview of available scientific information starting with common sources of NPs and their interactions with various environmental processes that may pose threats to both human health and the environment. | Smita et al. 2012 | Scanning |
| iNTeg-Risk Radar | The iNTeg-Risk Radar uses the social media and widely used internet search streams to predict the trends. The output can be viewed in different visual displays and charts. | Jovanovic et al. 2013 | Scanning |
| IKnow | Identification of Wild Cards (WI) and Weak Signals (WE) in the field of Science, Technology and Innovation (STI). | Raban et al. 2015 | Scanning |
| FORCE IDSS | FORCE EU project provides a mapping of past foresight and horizon scanning activities and development of an Intelligent Decision Support System (IDSS). | EU: CORDIS 2016 | Scanning |
| UK Gov Horizon Scanning Centre | The Horizon Scanning Centre is linked to the UK’s foresight program and further linked to the government top officials and relevant Ministers. There are two main scans consisting of Delta and Sigma Scans. It is oriented mainly towards public policy. | UK Government 2014 | Scanning |
| RAHS | The Risk Assessment and Horizon Scanning (RAHS), as part of National Security Coordination Secretariat (NSCS) explores methods and tools that complement scenario planning in anticipating strategic issues with significant possible impact on Singapore. | Habegger 2009 | Scanning |
| Cranfield U Horizon Scanning | The Cranfield University has developed a horizon scanning approach, mainly using four types of methods and covers largely 13 key areas, that potentially have an impact on UK. | Garnett et al. 2016 | Scanning |
| Swiss Re SONAR | The Swiss Re’s SONAR is an internal tool for Swiss Re to scan for early signals related to the emerging risks and trends and inform the Swiss Re’s employees about them. Certain information is also shared with external stakeholders. | Swiss Re 2016 | Scanning |
| Allianz Risk Barometer | The Allianz’s Risk Barometer collate the insights from field experts dispersed in various countries. The top risks are categorised across different regions, countries, industry sectors and sizes. | Allianz Risk Barometer report 2017 | Scanning |
| Futurescaper’s HS platform | The Futurescaper provides software to clients engaged in foresight, scenario planning and other complex strategic issues, especially those involving multiple stakeholders and geographies. | UK Govt. 2017, Raford 2015 | Scanning |
| MCDA procedure for prioritization of Occupational Risks from NMs | This paper proposes such a quantitative risk prioritisation tool, based on a multi-criteria decision analysis algorithm, which combines advanced exposure and dose-response modelling to calculate margins of exposure (MoE) for a number of MN in order to rank their occupational risks. | Hristozov et al. 2016 | Ranking / priorisation |
| MCDA procedure for hazard screening of ENMs | A quantitative WOE framework that utilizes Multi-Criteria Decision Analysis methodology for integrating individual studies on nanomaterial hazard resulting from physicochemical and toxicological properties of nanomaterials. The WOE approach explicitly integrates expert evaluation of data quality of available information. Application of the framework is illustrated for titanium dioxide nanoparticles (nano-TiO2), but the approach is designed to compare the relative hazard of several nanomaterials as well as emerging stressors in general. | Hristozov et al. 2014 | Ranking / priorisation |
| MCDA procedure for prioritization of Occupational exposure scenarios of NMs | An approach for relative exposure screening of ENMs.An exposure model explicitly implementing quantitative weight of evidence (WoE) methods and utilizes expert judgment for filling data gaps in the available evidence-base. Application of the framework is illustrated for screening of exposure scenarios for nanoscale titanium dioxide, carbon nanotubes and fullerenes, but it is applicable to other nanomaterials as well. | Hristozov et al. 2013 | Ranking / priorisation |
| Tool for ENM-Application Pair Risk Ranking (TEARR) | This study examines the use of one risk ranking tool that incorporates both quantitative and qualitative information regarding the potential human health risks of ENMs, focused primarily on worker and soldier health. Using a case study involving Army materiel (i.e., equipment), a relative risk ranking algorithm is proposed that accounts for not only the physicochemical characteristics of the ENMs, but also the characteristics of the Army materiel. In this way, the resulting risk potential for soldiers and workers is not solely based on the inherent characteristics of the ENMs but is also influenced within the context of the technology being developed. | Grieger et al. 2015 | Ranking / priorisation |
| Stochastic multicriteria acceptability analysis (SMAA-TRI) | A decision support system for classifying nanomaterials into different risk categories. The classification system is based on a set of performance metrics that measure both the toxicity and physico-chemical characteristics of the original materials, as well as the expected environmental impacts through the product life cycle. Stochastic multicriteria acceptability analysis (SMAA-TRI), a formal decision analysis method, was used as the foundation for this task. This method allowed us to cluster various nanomaterials in different ecological risk categories based on our current knowledge of nanomaterial physico-chemical characteristics, variation in produced material, and best professional judgments. SMAA-TRI uses Monte Carlo simulations to explore all feasible values for weights, criteria measurements, and other model parameters to assess the robustness of nanomaterial grouping for risk management purposes. | Tervonen et al. 2009 | Classification |
| NRST (Nanomaterial Risk Screening Tool) | A decision support framework relating key nanomaterial physicochemical and product characteristics to important hazard and exposure indicators. This framework for aiding risk managers’ decisions under uncertainty provides the foundation for the development of a transparent and adaptable screening tool that can inform the management of potential risks. | Beaudrie et al. 2015 | Screening |
| NanoRiskCat | A screening tool that is able to identify, categorize and rank exposures and effects of nanomaterials used in consumer products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers as, as well as nanomaterials released into the environment. The wider goal of NanoRiskCat is to help manufacturers, down-stream endusers, regulators and other stakeholders to evaluate, rank and communicate the potential for exposure and effects through a tiered approach in which the specific applications of a given nanomaterial are evaluated. | Hansen et al. 2011, Hansen et al. 2014 | Screening |
| CB NanoTool | The tool estimates an emission probability (without considering exposure controls) and severity band and provides advice on what engineering controls to use. It includes nine domains covering handling of liquids, powders and abrasion of solids. Combines hazard “severity”and exposure “probability” scores in a matrix to obtain a level of risk and associated controls out of 4 possible levels of increasing risk and associated controls. | Paik et al. 2008, Murashov et al. 2009, Zalk et al. 2009 | Control banding |
| MFA based tool | MFA (Material flow analysis) based tool. Ranks the exposure potential of metallic MN in the aquatic environment. It involves 3 steps: i) predict releases of MN from products and processes; ii) rank the behaviour of the MN and their aquatic concentrations; and iii) combine the concentration and the behaviour rankings into a qualitative aquatic exposure potential ranking. Probability distributions are used to represent the uncertainty and variability of the input parameters. | O’Brien et al. 2010, O’Brien et al. 2011 | Ranking / priorisation |
| Precautionary Matrix for Synthetic Nanomaterials (Swiss Precautionary Matrix) | This tool helps to determine if exposure needs to be controlled, providing advice on whether a precautionary approach is required under normal working conditions, in the worst case scenario and for the environment. | Höck et al. 2013 | Screening |
| Screening Tree Tool | A screening tool to combine the LCA approach with chemical hazard information (human health and environmental hazard) and exposure pathways. This enabled the product designers to efficiently identify which chemicals and raw materials pose significant hazards and the important exposure pathways. This tool can also be used as a screening tool for new designs/product formulations. | Askham C, 2011, Askham et al. 2012, Askham et al. 2013 | Screening |
| NanoGRID | Designed to guide users through a tiered testing framework to help characterize the durability, degradation, potential for nano-scale material release and environmental health and safety implications of nano-enabled products. | Collier et al. 2015 | Screening |
| ANSES Nano | The ANSES CB nanotool was developed by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) to be applied for conducting risk assessment and risk management of work with manufactured nanomaterials or nano-enabled products in industrial settings. | Ostiguy et al. 2010, Riediker et al., 2012 | Control banding |
| Dana knowledge base | The core section of the DaNa2.0 web platform (www.nanopartikel.info/en) is a knowledge database, which provides a wealth of facts and data for engineered nanomaterials with regard to actual applications and their respective effects on humans and the environment. The content within the knowledge base is derived from scientific literature and from various reports by an international and interdisciplinary expert team making use of a structured, criteria-based evaluation of the published literature. | D. Kühnel et al. 2017 | Scanning |
| QNAR (Quantitative Nanostructure-Activity Relationship) | The overall objective of QNAR models is to relate a set of descriptors characterizing MNPs with their measured biological effects, e.g., cell viability, or cellular uptake. Such models can then be applied to newly-designed or commercially available MNPs in order to quickly and efficiently assess their potential biological effects. | Fourches et al. 2010 | Prioritisation |
Risk appraisal
| Tool name | Description | References | Sector |
| SUNDS | The Sustainable Nanotechnology Decision Support System (SUNDS) addresses current nanotechnology risk assessment and management needs. The SUNDS conceptual decision framework expands the locus from nanotechnology risk assessment and management to emerging risk governance needs. It has a two tier structure comprising screening and advanced tools to address varying data availability and stakeholder needs. | Subramanian et al. 2016 | Risk assessment |
| Nanosafer | "NanoSafer is a combined control-banding and risk management tool that enables assessment of the risk level and recommended exposure control associated with production and use of manufactured nanomaterials (e.g., nanoparticles, nanoflakes, nanofibers, and nanotubes) in specific work scenarios. In addition to manufactured nanomaterials, the tool can also be used to assess and manage emissions from nanoparticle-forming processes. Uses data on material properties, processes and production facilities to estimate occupational risk. The tool uses the Risk Quotient (i.e. the ratio of an exposure dose to a human effect threshold) to estimate risk deterministically. The upcoming new version, NanoSafer 2, will be capable of estimating exposure from spray processes. In addition, NanoSafer 2 can perform nano-specific Hazard Assessment based on read-across between MNs based on specific material properties and hazard indicators, tested for performance against in vivo experiments. " | Jensen et al., 2014 | Risk assessment |
| GUIDEnano | Assessment and mitigation of nano-enabled product risks on human and environmental health. To develop innovative methodologies to evaluate and manage human and environmental health risks of nano-enabled products, considering the whole product life cycle. Using this Tool, industry will be able to evaluate and efficiently mitigate possible health risks for workers, consumers and the environment associated to the use of nanotechnologies. | Park et al. 2018 / http://www.guidenano.eu/ | Risk assessment |
| ECETOC TRA v3.1 | To assess risks associated with nanotechnology operations. Control banding (CB) strategies (a qualitative risk characterization and management strategy) offer simplified solutions for controlling worker exposures to constituents that are found in the workplace in the absence of firm toxicological and exposure data. Combines hazard “severity” and exposure “probability” scores in a matrix to obtain a level of risk and associated controls out of 4 possible levels of increasing risk and associated controls. | User Guide for the TRA integrated tool – TRAM, version 3.1, 2017 | Risk assessment |
| LICARA nanoscan | The main goal of LICARA is to develop a structured life cycle approach for nanomaterials that enables to balance health/environmental risks of nanomaterials in view of paucity of data against their benefits, and that further allows a comparison with the risks and the benefits of the conventional (non-nano) products. It estimates economic, environmental and social opportunities. This tool is specifically intended for use by SME to support them in communicating with regulators, and potential clients and investors. | van Harmelen et al 2016 | Risk assessment |
| EGRET2 | "ESIG has developed a tool (termed the ESIG GES Risk and Exposure Tool or ""EGRET"") that enables users to construct their own consumer CSA/ES for a particular area of use within the ESIG/ESVOC library. This library was constructed based on the results of the various communication and use mapping activities that have been undertaken with major Downstream User (DU) groups (e.g. the consumer use of solvents in coatings, which is in turn described by a set of product categories and sub-categories). " | Zaleski et al. 2014 | Risk assessment |
| BAUA Sprayexpo 2.3 | SprayExpo is an Excel model for calculation the airborne concentration of the respirable, the thoracic and the inhalable fraction of aerosols containing biocidal substances in indoor enviromnets originating from the release of liquid biocidal sprays. | Koch et al. 2012 | Risk assessment |
| Stoffenmanager Nano | Stoffenmanager Nano allows you to qualitatively assess occupational health risks from inhalation exposure to Manufactured Nano Objects (MNO). Risk Management Measures may be selected or included in the Action Plan. Stoffenmanager Nano is a ‘work-in-process’ online tool that reflects the current knowledge on risks related to working with nanomaterials. | van Duuren-Stuurman et al. 2012 | Risk assessment |
| ANSES Nano | The ANSES CB nanotool was developed by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) to be applied for conducting risk assessment and risk management of work with manufactured nanomaterials or nano-enabled products in industrial settings (Ostiguy et al., 2010 ; Riediker et al., 2012). | Claude et al. 2010, Ostiguy et al. 2010 | Risk assessment |
| Control banding nanotool | Control banding (CB) strategies offer simplified solutions for controlling worker exposures to constituents that are found in the workplace in the absence of firm toxicological and exposure data. These strategies may be particularly useful in nanotechnology applications, considering the overwhelming level of uncertainty over what nanomaterials present as potential work-related health risks and how these risks can be assessed and managed appropriately. The CB Nanotool is a novel CB approach being used at the Lawrence Livermore National Laboratory (LLNL), by both experts and non-experts, to assess risks associated with nanotechnology operations and prescribe appropriate engineering controls.e CB Nanotool creates a severity and probability risk matrix as an output, which contains four different risk levels. | Paik et al. 2008, Murashov et al. 2009, Zalk et al. 2009 | Risk assessment |
| Precautionary Matrix for Synthetic Nanomaterials (Swiss Precautionary Matrix) | This tool helps to determine if exposure needs to be controlled, providing advice on whether a precautionary approach is required under normal working conditions, in the worst case scenario and for the environment. | Höck et al. 2013 | Risk assessment |
| SimpleBox4Nano (SB4N) | Multimedia mass balance model, development of the SimpleBox model. Air, water, soil, sediment compartments. Computes steady state concentrations in all compartments at local, regional or continental scale. Mechanistic representations of processes. Parameters may be estimated from theory or experiment. Could be applied to dynamic predictions. | Meesters et al. 2014 | Risk assessment |
| NanoDUFLOW | Nano enable extention fo the DUFLOW hydrological mode. NanoDUFLOW accounts for the ENP transformation processes homo- and heteroaggregation, dissolution and degradation, coupled with the transport processes sedimentation, resuspension and burial to deeper sediment layers. Aggregation and sedimentation is based on Von Smoluchowski and Stokes theories. Aggregation is calculated from the collision frequency for peri- and ortho-kinetic aggregation as well as aggregation due to differential settling, and attachment efficiencies. Heteroaggregation is modelled for five ENP size classes interacting with five SS size classes leading to 25 classes of heteroaggregates, all modelled in place and time. | Quik et al. 2015, deKlein et al. 2016 | Risk assessment |
| MendNano | Multimedia mass balance model. Air, water, soil, sediment, biota compartments. Handles size distributions of ENM. Computes concentrations in each compartment over time. Processes: dry and wet deposition to foliage and ground, foliage washoff, aerosolisation, wind resuspension, soil-water runoff, heteroaggregation, dissolution, sedimentation, sediment resuspension and burial, biotic uptake and elimination, plant root uptake. | Liu et al. 2014 | Risk assessment |
| RedNano | Integrated simulation tool for assessing the potential release and environmental distribution of nanomaterials based on life cycle assessment approach and multimedia compartmental modeling coupled with mechanistic intermedia transport processes. The RedNano simulation tool and its web-based software implementation enables scenario analysis in order to assess the response of an environmental system to various release scenarios. RedNano incorporates the MendNano model. | Liu et al. 2015 | Risk assessment |
| GWAVA with water quality module | Aquatic-only model, predicts PECs for river reaches across Europe. Hydrolology includes STP discharges, runoff and water abstraction. Emissions based on per capita NM loadings to sewage and sewage discharge per grid cell. NM transformations modelled via lumped 1st order kinetic loss. | Dumont et al. 2012, 2015 | Risk assessment |
| ConsExpo nano | Tool for the assessment of consumer exposure to nanomaterials via inhalation (spray scenario as well as custom scenarios). The outcome of the assessment is an alveolar load in the lungs as one of the most critical determinants of inflammation of the lungs is both the magnitude and duration of the alveolar load of a nanomaterial. To estimate the alveolar load arising from the use of nano-enabled spray products, ConsExpo nano combines models that estimate the external aerosol concentration in indoor air, with models that estimate the deposition in and clearance of inhaled aerosol from the alveolar region. | Delmaar 2006 / https://www.consexponano.nl/ | Risk assessment |
| Stochastic Materials Flow Model | This model treats input parameters, such as nano-specific production and consumption volumes, fate pathways and transfer coefficients as probability distributions (Monte Carlo, Bayesian and Markov Chain) that are built based on empirical data and expert judgment. Therefore, the outputs of the model are distributions of possible PECs, and its application always includes analysis of variability and uncertainty. | Gottschalk et al. 2010a, Gottschalk et al. 2010b. | Risk assessment |
| Dynamic probabilistic material flow model (DP-MFA) | A customized dynamic probabilistic material flow model (DP-MFA) to predict the former, current and future mass-flows of four ENM (nano-TiO2, nano-ZnO, nano-Ag, and CNT) to technical and environmental compartments and the resulting concentrations in these compartments over time. | Bornhöft et al. 2016 | Risk assessment |
| MFA model 1 | MFA (Material flow analysis) model for estimating PECs for MNs. Simple system of mathematical algorithms for estimating concentrations in water, soil, and air for a range of exposure scenarios based on data on MN production volumes and uses. | Boxall et al. 2007 | Risk assessment |
| MFA model 2 | MFA (Material flow analysis) model for estimating PECs for MNs. First model to consider releases of MNs from consumer products in different lifecycle stages; concentrations in air, soil, water, groundwater and sediments. Certain processes considered important for MNs (aggregation/agglomeration, sedimentation, re-suspension, degradation and transformation) not considered in the estimations. | Mueller et al. 2008 | Risk assessment |
| Explorative particle flow analysis (PFA) | Dynamic, quantitative environmental fate model based on colloidal chemistry. Estimates particle number concentrations in the aquatic environments resulting from processes such as materials inflow, homo- and heteroagglomeration/aggregation and sedimentation, which are considered driving forces behind the transport of MN in waters and their potential elimination from them. | Arvidsson et al. 2011a, 2011b. | Risk assessment |
| REACHnano ToolKit | A web-based toolkit to support the risk assessment and promote the safe use of NMs along their life cycle. Contains an inventory with information about ca. 30 commonly used NMs. Environmental risk assessment is done through a model flow analysis probabilistic matter (PMFA). The occupational risk assessment tool is based on a combination of control banding approach, exposure estimation tools and new templates of exposure scenarios developed specifically for the case of NMs. Users may estimate the exposure depending on the operative conditions and applied risk management measures. Once all the necessary data is introduced, the model estimates if one (or more) scenarios can be dangerous for the worker. | http://tools.lifereachnano.eu/ | Risk assessment |
| NanoRiskCat | A screening tool that is able to identify, categorize and rank exposures and effects of nanomaterials used in consumer products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers as, as well as nanomaterials released into the environment. The wider goal of NanoRiskCat is to help manufacturers, down-stream endusers, regulators and other stakeholders to evaluate, rank and communicate the potential for exposure and effects through a tiered approach in which the specific applications of a given nanomaterial are evaluated. | Hansen et al. 2011, Hansen et al. 2014 | Risk assessment |
| PBPK model | A generic physiologically-based pharmacokinetic (PBPK) model for nanomaterials, kinetic tool for estimating internal human exposure (post-exposure absorption, distribution and excretion (ADME) of MN). Can be used to characterize the ADME profiles of the MN for a diverse range of species based on particle type and physicochemical properties. Can also help to develop MN-specific uncertainty factors for interspecies differences in kinetics (e.g. between rodents and humans). PBPK modelling may facilitate extrapolation in exposure duration, e.g. tissue concentration levels for chronic exposure. An adaptation and extension of an earlier PBPK model for larger particles, calibrated using data from EU ENPRA, NANOMMUNE and NANOTEST projects. | Riviere JE, 2014 | Risk assessment |
| NANEX Exposure Scenario Data Library | Library of 9 occupational exposure scenarios for a variety of manufactured nanomaterials | Hristozov et al. 2013, Hristozov et al. 2016 | Risk assessment |
| Nano to go! | Guidance document prepared within the EU FP7 NanoValid project for the safe handling of nanomaterials. Contents include a brochure on “Safe handling of nanomaterials and other advanced materials at workplaces” and reports on case studies. | http://www.nanosafetycluster.eu/nanoToGo/ | Risk assessment |
| Multiple-Path Particle Dosimetry Model (MPPD v 2.11) | Particle dosimetry model for airborne particles. The MPPD model is a computational model that can be used for estimating human and rat airway particle dosimetry. The model is applicable to risk assessment, research, and education. The MPPD model calculates the deposition and clearance of monodisperse and polydisperse aerosols in the respiratory tracts of rats and human adults and children (deposition only) for particles ranging in size from ultrafine (0.01 µm) to coarse (20 µm). | Anjilvel et al. 1995, RIVM 2002 | Risk assessment |
| SOP Tiered Approach for the assessment of exposure to airborne nanoobjects in work-places | This SOP covers the overall strategy of assessing exposure to airborne nano-objects in workplaces, following a tiered approach, which contains 3 hierarchical tiers: tier 1: information gathering, tier 2: basic assessment and tier 3: expert assessment. This SOP describes the general procedure, whereas the measurements in tier 2 and tier 3 are described in three main SOPs: Screening, Sampling and Expanded Measurement. Each of these main SOPs is accompanied by sub-SOPs describing the use of instruments, sample preparation and data evaluation. | Asbach et al. 2012 | Risk assessment |
| AMBIT2 tool | Software tool designed to support companies by facilitating high quality chemical safety prediction. Based on a ‘predictive toxicity model’, applies the principles of read-across and categorisation. AMBIT supports nanomaterials storage (components, physicochemical and biological characterisation) and query (connected with eNanoMapper). | Jeliazkova et al. 2015 | Risk assessment |
| NanoNextNL DSS (under development) | The NanoNextNL DSS aims at helping to identify ENPs and applications that should get priority in the risk assessment. | Marvin et al. 2013 | Risk assessment |
| NanoGRID | Designed to guide users through a tiered testing framework to help characterize the durability, degradation, potential for nano-scale material release and environmental health and safety implications of nano-enabled products. | Collier et al. 2015 | Screening |
| Work health and safety assessment tool for handling engineered nanomaterials | A nano risk assessment tool to assist regulators, research laboratories, and organizations in managing engineered nanomaterials. This tool consists of a questionnaire, which helps to register the chemical composition and the physical form of the nanomaterials manufactured or used, and the safety measures applied to nanoparticle exposure prevention at the workplace. | Safe Work Australia, 2014 | Concern assessment |
| FINE (Forecasting the Impacts of Nanomaterials in the Environment) | Baseline probabilistic model that incorporates nano-specific characteristics and environmental parameters, along with elements of exposure potential, hazards, and risks from MN. Bayesian networks in combination with expert elicitation as a tool for nanomaterial risk forecasting. | Money et al. 2012. Money et al. 2014 | Concern assessment |
| NanoCommission assessment tool | A downloadable questionnaire (available only in German). The set of assessment criteria applied to all life-cycle stages are probability of exposure, physicochemical properties, environmental fate and toxicology/ecotoxicology. A similar product not containing nanoparticles is used as a reference. Benefits and risks are considered for consumers, society, environment and companies at different stages of the life-cycle of a nanomaterial. A classification into two groups is made depending on whether there is cause for concern or not. | Reihlen et al. 2012 | Concern assessment |
| Species Sensitivity Distribution (SSD) for nanomaterials | A Monte Carlo probabilistic approach is used to generate Species Sensitivity Distribution (SSD) that is then compared with probability distributions of Predicted Environmental Concentrations (PEC) to estimate environmental risks | Gottschalk et al. 2013, Semenzin et al. 2015 | Risk assessment / characterisation |
| MARINA Risk Assessment Strategy | An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy. | Bos et al. 2015 | Risk assessment |
| Flow chart for a nanospecific risk assessment approach | A new approach for nanospecific prioritisation and risk assessment developed within NANoREG. A nanospecific risk assessment approach which can be used to prioritise those nanomaterial applications that may lead to high risks for human health and to identify the most important information needed to address the nanospecific issues within the risk assessment, depending on the specific nanomaterial application, life cycle stage and exposure situation. The approach can also be used to identify those situations where the use of nanospecific grouping, read across and (Q)SAR tools is likely to become feasible in the future, and to point towards the generation of the type of data that is needed for scientific justification, which may lead to regulatory acceptance. | Dekkers et al. 2016 | Risk assessment |
| DF4nanoGrouping | A decision analytical tool to facilitate the grouping of MN for the purpose of read-across for RA was proposed by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) ”Nano Task Force”. The tool consists of 3 tiers to assign MN to 4 main groups: i) soluble MN, ii) biopersistent high aspect ratio MN, iii) passive MN, and iv) active MN. The tool performs sub-grouping within the main groups to determine and refine nano-specific information needs. The DF4nanoGrouping covers all relevant aspects of MN life cycles and biological pathways such as intrinsic material and system-dependent properties, biopersistence, uptake and biodistribution, cellular and apical toxic effects. Use, release and route of exposure are applied as “qualifiers” in order to determine if MN can be released from a product matrix; if not the tool could suggest waiving of irrelevant testing. One distinguishing nano-specific feature of DF4nanoGrouping is that it groups MN by their specific modes of action that result in apical toxic effects. | Arts et al. 2015 | Risk assessment |
| Nano LCRA (Nano-Life Cycle Risk Analysis) | The NANO LCRA framework is a screening level assessment and management tool to identify and prioritize key health and environmental issues. It applies adaptive management for NMs and adopts risk analysis and life cycle thinking as tools to characterize the potential for exposure and risk in specific NM applications. It may be applied at a very early stage of nanomaterial development when little information is available for risk assessment. The framework is iterative and adaptive, allowing decision-making under uncertainty, and presents a path forward to address the uncertainties. The first application of the framework identifies the information really needed to make a better decision; however, it also allows early decisions to be made, with the intention that they will be revisited when more information becomes available. This dynamic approach is applicable to a broad array of hazards, materials, and technologies. It allows an evaluation to occur at any stage of the supply chain; it can be equally applied to a raw material producer, or to a downstream user of a product containing a nanomaterial in a composite, or both. | Shatkin JA, 2008 | Risk assessment |
| Comprehensive Environmental Assessment | CEA combines a product life-cycle framework with the risk assessment paradigm. Risk assessment relates exposure and effects information for a substance or stressor; CEA expands on this paradigm by including life-cycle stages and considering both indirect and direct ramifications of the substance or stressor. The CEA approach considers primary and secondary contaminants, multiple environmental media, fate and transport processes, cumulative and aggregate exposure, and ecological as well as human health risks across the life cycle of a product. The implications of the collected information are analysed in a transparent collective judgment process involving different viewpoints (different types of expertise and stakeholder perspectives). | Davis JM, 2013, Powers et al. 2012 | Risk assessment |
| SCENIHR | SCENIHR has developed a four-stage approach to the assessment of the human and environmental risks of NMs and decision trees for exposure assessment and identifying the human and environmental risks from nanoparticles. | SCENIHR, 2007 | Risk assessment |
| Nano Risk Framework | The Nano Risk Framework for the evaluation and management of the potential risks of nanomaterials provides a method for identifying, managing and reducing the environmental, health and safety risks of nanomaterials at every stage of the product life-cycle. This framework provides guidance on the critical issues that should be taken into account when dealing with nanomaterials as well as offering support on the information required for performing risk evaluation and risk management decisions. | Environmental Defense–DuPont Nano Partnership. 2007 | Risk assessment |
| GreenScreen | GreenScreen allows users to screen and compare chemicals based on inherent hazards. It help users identify hazards associated with chemicals, to optimize product development and to identify suitable replacements." | Sass et al. 2016 | Risk assessment |
| XL Insurance Database | An assessment strategy, based on the protocol that XL Insurance uses for calculating insurance premiums for chemical industries. The protocol is mainly used to perform risk assessment for the manufacture of nanomaterials , by focusing on the characteristics of the materials and production processes. | Sellers 2009, Robichaud et al. 2005 | Risk assessment / Insurance sector |
Risk characterisation and evaluation
| Tool name | Description | References | Sector |
| SUNDS | The Sustainable Nanotechnology Decision Support System (SUNDS) addresses current nanotechnology risk assessment and management needs. The SUNDS conceptual decision framework expands the locus from nanotechnology risk assessment and management to emerging risk governance needs. It has a two tier structure comprising screening and advanced tools to address varying data availability and stakeholder needs. | Subramanian et al. 2016 | Risk characterisation |
| NanoSafer | NanoSafer is a combined control-banding and risk management tool that enables assessment of the risk level and recommended exposure control associated with production and use of manufactured nanomaterials (e.g., nanoparticles, nanoflakes, nanofibers, and nanotubes) in specific work scenarios. In addition to manufactured nanomaterials, the tool can also be used to assess and manage emissions from nanoparticle-forming processes. | Jensen et al., 2014 | Risk characterisation |
| NanoRiskCat | A screening tool that is able to identify, categorize and rank exposures and effects of nanomaterials used in consumer products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers as, as well as nanomaterials released into the environment. The wider goal of NanoRiskCat is to help manufacturers, down-stream endusers, regulators and other stakeholders to evaluate, rank and communicate the potential for exposure and effects through a tiered approach in which the specific applications of a given nanomaterial are evaluated. | Hansen et al. 2011, Hansen et al. 2014 | Risk characterisation |
| REACHnano ToolKit | A web-based toolkit to support the risk assessment and promote the safe use of NMs along their life cycle. Contains an inventory with information about ca. 30 commonly used NMs. Environmental risk assessment is done through a model flow analysis probabilistic matter (PMFA). The occupational risk assessment tool is based on a combination of control banding approach, exposure estimation tools and new templates of exposure scenarios developed specifically for the case of NMs. Users may estimate the exposure depending on the operative conditions and applied risk management measures. Once all the necessary data is introduced, the model estimates if one (or more) scenarios can be dangerous for the worker. | http://tools.lifereachnano.eu/ | Risk characterisation |
| LICARA nanoSCAN | Determines and weighs of the benefits and risks over the lifecycle of MN-based products. This tool is specifically intended for use by SME to support them in communicating with regulators, and potential clients and investors. It uses principles and assessment criteria from the Precautionary Matrix, NanoRiskCat and Stoffenmanager Nano, and integrates them with expert judgement through MCDA. | van Harmelen et al 2016 | Risk characterisation |
| NanoGRID | Designed to guide users through a tiered testing framework to help characterize the durability, degradation, potential for nano-scale material release and environmental health and safety implications of nano-enabled products. | Collier et al. 2015 | Screening |
| Species Sensitivity Distribution (SSD) for nanomaterials | A Monte Carlo probabilistic approach is used to generate Species Sensitivity Distribution (SSD) that is then compared with probability distributions of Predicted Environmental Concentrations (PEC) to estimate environmental risks | Gottschalk et al. 2013, Semenzin et al. 2015 | Risk assessment / characterisation |
Risk management
| Tool name | Description | References | Sector |
| SUNDS | The Sustainable Nanotechnology Decision Support System (SUNDS) addresses current nanotechnology risk assessment and management needs. The SUNDS conceptual decision framework expands the locus from nanotechnology risk assessment and management to emerging risk governance needs. It has a two tier structure comprising screening and advanced tools to address varying data availability and stakeholder needs. | Subramanian et al. 2016 | Risk management |
| CB Nanotool | The tool estimates an emission probability (without considering exposure controls) and severity band and provides advice on what engineering controls to use. It includes nine domains covering handling of liquids, powders and abrasion of solids. Combines hazard “severity”and exposure “probability” scores in a matrix to obtain a level of risk and associated controls out of 4 possible levels of increasing risk and associated controls. | Paik et al. 2008, Murashov et al. 2009, Zalk et al. 2009 | Risk management |
| Stoffenmanager Nano | Ranks potential health risks from workplace inhalation exposure to MN and proposes effective RMM. It concerns single particles as well as agglomerates or aggregates and applies to MN that meet all of the following criteria: i) particles are not (water) soluble; ii) particles are synthetically produced and not released as unintentional by-product of e.g. incomplete combustion processes; iii) the size of the primary particles is smaller than 100 nm and/or the specific surface area of the nanopowder is larger than 60 m2/g | Duuren-Stuurman et al. 2011 | Risk management |
| ANSES Nano | The ANSES CB nanotool was developed by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) to be applied for conducting risk assessment and risk management of work with manufactured nanomaterials or nano-enabled products in industrial settings. | Ostiguy et al. 2010, Riediker et al., 2012 | Risk management |
| Precautionary Matrix for Synthetic Nanomaterials (Swiss Precautionary Matrix) | This tool helps to determine if exposure needs to be controlled, providing advice on whether a precautionary approach is required under normal working conditions, in the worst case scenario and for the environment. | Höck et al. 2013 | Risk management |
| NanoSafer | NanoSafer is a combined control-banding and risk management tool that enables assessment of the risk level and recommended exposure control associated with production and use of manufactured nanomaterials (e.g., nanoparticles, nanoflakes, nanofibers, and nanotubes) in specific work scenarios. In addition to manufactured nanomaterials, the tool can also be used to assess and manage emissions from nanoparticle-forming processes. | Jensen et al., 2014 | Risk management |
| NanoRiskCat | A screening tool that is able to identify, categorize and rank exposures and effects of nanomaterials used in consumer products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers as, as well as nanomaterials released into the environment. The wider goal of NanoRiskCat is to help manufacturers, down-stream endusers, regulators and other stakeholders to evaluate, rank and communicate the potential for exposure and effects through a tiered approach in which the specific applications of a given nanomaterial are evaluated. | Hansen et al. 2011 | Risk management |
| A low-cost/evidence-based tool | A low-cost/evidence-based for assessing and managing the risks associated with exposure to Carbon Nanofiber | Genaidy et al., 2009 | Risk management |
| Nano-specific Risk Management Library | The main purpose of the tool is to provide small and medium sized enterprises (SMEs), large companies, and other relevant stakeholders with an easy to use tool to select proper measures to achieve a high level of protection of the human health and the environment against ENMs, assisting them in the selection of adequate personal protective equipment (PPE) and engineering controls (EC) in order to prevent exposure to ENMs and release in the workplace. | RIVM | Risk management |
| nanoinfo.org | A web-platform built to support the nanoinformatics effort by developing and providing state-of-the-art resources and tools dedicated to environmental impact assessment of engineered nanomaterials (ENMs). Consists of: -LearNano: life-cycle assessment of the environmental release of ENMs -MendNano: multimedia compartmental simulation model of the environmental distribution of ENMs -ToxNano: toxicity data analysis of ENMs that supports high-throughput screening and high content studies -NanoEIA: in silico environmental impact analysis platform that enables evaluation of potential impacts and thus can assist in developing risk management options in support of safe-by-design of ENMs considering multi-criteria analyses" | Liu et al. 2015 | Risk characterisation |