Assessing safety and sustainability performance of advanced nanomaterials: A tiered approach along the innovation process.

Recently there has been an increasing policy drive towards adopting the EC-JRC Safe and Sustainable by Design (SSbD) framework for chemicals and materials. The European Green Deal policy ambitions, as outlined in the Chemicals Strategy for Sustainability and the Zero Pollution Action Plan, have determined this path. The H2020 SUNSHINE project has developed an approach for SSbD assessment and decision making, tested in the case of products enabled by advanced multi-component nanomaterials (MCNMs).

Inflammation related to inhalation of nano and micron sized iron oxides: a systematic review.

Inhalation exposure to iron oxide occurs in many workplaces and respirable aerosols occur during thermal processes (e.g. welding, casting) or during abrasion of iron and steel products (e.

Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives.

This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs.

A Decision Support System for preclinical assessment of nanomaterials in medical products: the REFINE DSS.

The application of nanomaterials in medicine has led to novel pharmaceuticals and medical devices that have demonstrated a strong potential for increasing the efficacy/performance and safety of therapeutic and diagnostic procedures to address a wide range of diseases. However, the successful translation of these technologies from their inception (proof-of-concept) to clinical practice has been challenged by substantial gaps in the scientific and technical capacity of R&D companies, especially SMEs, to keep up with the ever-evolving regulatory expectations in the emerging area of nanomedicine. To address these challenges, the EU Horizon 2020 project REFINE has developed a Decision Support System (DSS) to support developers of nanotechnology-enabled health products in bringing their products to the clinic.

Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products.

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products.

Use of multiple indicators to compare sustainability performance of organic vs conventional vineyard management.

The wine sector is paying more attention to sustainable wine production practices, but this topic is highly debated because organic viticulture aims to a reduction of environmental impacts, while conventional viticulture ensures an increase of yield. This work provides an economic and environmental comparison using different indicators whereas no previous studies on viticulture have faced on both aspects of sustainability. Two distinct vineyards within the same case study farm were considered, where conventional and organic viticulture practices were applied for 5 years.

Controlling the risks of nano-enabled products through the life cycle: The case of nano copper oxide paint for wood protection and nano-pigments used in the automotive industry.

The widespread use of engineered nanomaterials (ENMs) in consumer products and the overwhelming uncertainties in their ecological and human health risks have raised concerns regarding their safety among industries and regulators. There has been an ongoing debate over the past few decades on ways to overcome the challenges in assessing and mitigating nano-related risks, which has reached a phase of general consensus that nanotechnology innovation should be accompanied by the application of the precautionary principle and best practice risk management, even if the risk assessment uncertainties are large. We propose a quantitative methodology for selecting the optimal risk control strategy based on information about human health and ecological risks, efficacy of risk mitigation measures, cost and other contextual factors.

Risk Governance of Nanomaterials: Review of Criteria and Tools for Risk Communication, Evaluation, and Mitigation.

Nanotechnologies have been increasingly used in industrial applications and consumer products across several sectors, including construction, transportation, energy, and healthcare. The widespread application of these technologies has raised concerns regarding their environmental, health, societal, and economic impacts. This has led to the investment of enormous resources in Europe and beyond into the development of tools to facilitate the risk assessment and management of nanomaterials, and to inform more robust risk governance process.

Comparison of Water-focused Life Cycle Assessment and Water Footprint Assessment: The case of an Italian wine.

In recent decades, the debate on how to implement and measure sustainability in food production gained increasing importance and interest for agriculture. In the wine sector, producers are increasingly pursuing sustainable practices, including measures for water preservation from degradation and overuse. But methodologies for assessing and communicating the impacts on water resources need to be understood in detail to guide the selection of the most appropriate management practices, support environmental labelling and promote environmental-friendly products to consumers.

Quantitative human health risk assessment along the lifecycle of nano-scale copper-based wood preservatives.

The use of nano-scale copper oxide (CuO) and basic copper carbonate (Cu(OH)CO) in both ionic and micronized wood preservatives has raised concerns about the potential of these substances to cause adverse humans health effects. To address these concerns, we performed quantitative (probabilistic) human health risk assessment (HHRA) along the lifecycles of these formulations used in antibacterial and antifungal wood coatings and impregnations by means of the EU FP7 SUN project's Decision Support System (SUNDS, www.sunds.

An Information System for Brownfield Regeneration: providing customised information according to stakeholders' characteristics and needs.

In the EU brownfield presence is still considered a widespread problem. Even though, in the last decades, many research projects and initiatives developed a wealth of methods, guidelines, tools and technologies aimed at supporting brownfield regeneration. However, this variety of products had and still has a limited practical impact on brownfield revitalisation success, because they are not used in their entire potential due to their scarce visibility.

Points of attention in designing tools for regional brownfield prioritization.

The regeneration of brownfields has been increasingly recognized as a key instrument in sustainable land management, since free developable land (or so called "greenfields") has become a scare and more expensive resource, especially in densely populated areas. However, the complexity of these sites requires considerable efforts to successfully complete their revitalization projects, thus requiring the development and application of appropriate tools to support decision makers in the selection of promising sites where efficiently allocate the limited financial resources. The design of effective prioritization tools is a complex process, which requires the analysis and consideration of critical points of attention (PoAs) which has been identified considering the state of the art in literature, and lessons learned from previous developments of regional brownfield (BF) prioritization processes, frameworks and tools.

Probabilistic approach for assessing infants' health risks due to ingestion of nanoscale silver released from consumer products.

Silver nanoparticles (n-Ag) are widely used in consumer products and many medical applications because of their unique antibacterial properties. Their use is raising concern about potential human exposures and health effects. Therefore, it is informative to assess the potential human health risks of n-Ag in order to ensure that nanotechnology-based consumer products are deployed in a safe and sustainable way.

Comparison of international approaches to sustainable remediation.

Since mid-to-late 2000s growing interest for sustainable remediation has emerged in initiatives from several international and national organisations as well as other initiatives from networks and forums. This reflects a realisation that risk-management activities can about bring environmental, social, and economic impacts (positive or negative) in addition to achieving risk-based remediation goals. These ideas have begun to develop as a new discipline of "sustainable remediation".

Targeted selection of brownfields from portfolios for sustainable regeneration: User experiences from five cases testing the Timbre Brownfield Prioritization Tool.

Prioritizing brownfields for redevelopment in real estate portfolios can contribute to more sustainable regeneration and land management. Owners of large real estate and brownfield portfolios are challenged to allocate their limited resources to the development of the most critical or promising sites, in terms of time and cost efficiency. Authorities worried about the negative impacts of brownfields - in particular in the case of potential contamination - on the environment and society also need to prioritize their resources to those brownfields that most urgently deserve attention and intervention.

Timbre Brownfield Prioritization Tool to support effective brownfield regeneration.

In the last decade, the regeneration of derelict or underused sites, fully or partly located in urban areas (or so called "brownfields"), has become more common, since free developable land (or so called "greenfields") has more and more become a scare and, hence, more expensive resource, especially in densely populated areas. Although the regeneration of brownfield sites can offer development potentials, the complexity of these sites requires considerable efforts to successfully complete their revitalization projects and the proper selection of promising sites is a pre-requisite to efficiently allocate the limited financial resources. The identification and analysis of success factors for brownfield sites regeneration can support investors and decision makers in selecting those sites which are the most advantageous for successful regeneration.

Risk-based prioritization methodology for the classification of groundwater pollution sources.

Water management is one of the EU environmental priorities and it is one of the most serious challenges that today's major cities are facing. The main European regulation for the protection of water resources is represented by the Water Framework Directive (WFD) and the Groundwater Directive (2006/118/EC) which require the identification, risk-based ranking and management of sources of pollution and the identification of those contamination sources that threaten the achievement of groundwater's good quality status. The aim of this paper is to present a new risk-based prioritization methodology to support the determination of a management strategy for the achievement of the good quality status of groundwater.

Regional risk assessment approaches to land planning for industrial polluted areas in China: the Hulunbeier region case study.

The rapid industrial development and urbanization processes that occurred in China over the past 30years has increased dramatically the consumption of natural resources and raw materials, thus exacerbating the human pressure on environmental ecosystems. In result, large scale environmental pollution of soil, natural waters and urban air were recorded. The development of effective industrial planning to support regional sustainable economy development has become an issue of serious concern for local authorities which need to select safe sites for new industrial settlements (i.

Regional risk assessment for contaminated sites part 3: spatial decision support system.

Large scale (e.g. regional or national) assessments of contaminated sites may be very costly in terms of investigation and methodological (i.

Regional risk assessment for contaminated sites part 2: ranking of potentially contaminated sites.

Environmental risks are traditionally assessed and presented in non spatial ways although the heterogeneity of the contaminants spatial distributions, the spatial positions and relations between receptors and stressors, as well as the spatial distribution of the variables involved in the risk assessment, strongly influence exposure estimations and hence risks. Taking into account spatial variability is increasingly being recognized as a further and essential step in sound exposure and risk assessment. To address this issue an innovative methodology which integrates spatial analysis and a relative risk approach was developed.

A spatial risk assessment methodology to support the remediation of contaminated land.

When soil and groundwater contaminations occur over large areas, remediation measures should be spatially prioritized on the basis of the risk posed to human health and in compliance with technological and budget constraints. Within this scope, the application of human health risk assessment algorithms in a spatially resolved environment raises a number of methodological and technical complexities. In this paper, a methodology is proposed and applied in a case study to support the entire formulation process of remediation plans, encompassing hazard assessment, exposure assessment, risk characterisation, uncertainty assessment and allocation of risk reduction measures.