Besa Maliqi Syla Besa Maliqi Syla

A Conceptual Framework for Safe-and-Sustainable-by-Design to Support Sustainable Business Model Innovation and New Product Development

January 24, 2025

Authors: Stoycheva et al.

To achieve a sustainable future and meet the UN’s Sustainable Development Goals (SDGs), business model innovation (BMI) must integrate traditional innovation management (IM) and new product development (NPD) with sustainability considerations. The European Green Deal and EU Chemicals Strategy for Sustainability (CSS) challenge existing BMI and NPD theories, with the Safe-and-Sustainable-by-Design (SSbD) concept being central to the CSS. SSbD demands a novel approach that integrates safety and sustainability into innovation without compromising functionality or commercial viability. Companies need to design products with minimal environmental impact, adopt circular economy principles, and ensure social responsibility while maintaining economic viability. A conceptual framework is proposed to integrate traditional IM tools with SSbD, using life cycle thinking, and considering both external and internal drivers. The framework suggests embedding SSbD and life cycle thinking in training for IM professionals, as they play a key role in driving this transition.

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Besa Maliqi Syla Besa Maliqi Syla

Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH

January, 2025

Authors: Hunt et al.

In 2018, the European Commission revised REACH's Annexes to include nanomaterial-specific provisions. This paper examines REACH's readiness for multicomponent nanomaterials (MCNMs), which have complex structures. It highlights uncertainties in applying REACH definitions to MCNMs, such as when surface modifications or physisorption occur, or when the nanoform definition no longer applies. The paper concludes that REACH's guidance should be updated, particularly to align the definition of "nanoform" with the latest European Commission recommendations.

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Besa Maliqi Syla Besa Maliqi Syla

Form-Specific Prospective Environmental Risk Assessment of Graphene-Based Materials in European Freshwater

November 27, 2024

Authors: Hong & Nowack

This study evaluates the environmental risks of graphene-based materials (GBMs) using dynamic probabilistic material flow analysis (DPMFA) to estimate future production and distribution in European freshwaters. Predicted environmental concentrations by 2030 are minimal: 0.67 ng/L for pristine graphene and 0.33 ng/L for graphene oxide and reduced graphene oxide. Hazard assessments based on species sensitivity distributions indicate negligible risk (RCRs < 1) for all GBM forms. These findings support sustainable material design and provide a foundation for regulatory decisions and further research into GBM environmental fate.

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Besa Maliqi Syla Besa Maliqi Syla

Chronic toxicity of core–shell SiC/TiO2 (nano)-particles to Daphnia magna under environmentally relevant food rations in the presence of humic acid

February 29, 2024

Authors: Serwatowska et al.

This study evaluates the long-term, size-dependent toxicity of novel SiC/TiO2 core–shell nanostructures to Daphnia magna, highlighting their potential environmental impact. Experiments under realistic conditions showed that humic acid exacerbates toxicity by reducing nanoparticle aggregation and sedimentation. The EC50 values for 60nm and 500nm particles revealed increased toxicity with higher humic acid concentrations. These findings emphasize the need to consider environmental factors in nanomaterial risk assessments, particularly for advanced materials.

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Sarah Preidt Sarah Preidt

Similarity of multicomponent nanomaterials in a safer-by-design context: the case of core–shell quantum dots

January 15 2024

Authors: Battista et al.

This study explores multi-dimensional similarity assessment methods for multicomponent nanomaterials (MCNMs), focusing on core–shell quantum dots (QDs) composed of various heavy metals with diverse morphologies and surface chemistries. Motivated by the need to balance functionality and safety in a safe and sustainable by design (SSbD) context, the study compares QDs to benchmark materials (e.g., ZnO, BaSO4, TiO2, CuO) using two approaches: one based on predefined descriptors like dissolution and oxidative damage, and another utilizing raw multidimensional data. Strengths and limitations of each method are discussed, with potential for broader application to other advanced materials.

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Sarah Preidt Sarah Preidt

Predicting environmental concentrations of nanomaterials for exposure assessment - a review

January 2024

Authors: Keller et al.

This review discusses advancements in predicting the environmental concentrations of nanomaterials, focusing on Material Flow Analyses (MFAs) and Environmental Fate Models (EFMs). While MFAs have evolved from limited data to more refined models, they still don't account for crucial fate processes like aggregation and transformation. EFMs, which include multimedia compartment and watershed models, improve upon this by considering these processes and predicting environmental concentrations (PECs) in different compartments. However, challenges remain, such as the lack of field data for validation, uncertainties in market data, and gaps in analytical techniques for measuring nanomaterial properties. The review also highlights the adaptation of these models for nano- and microplastics, noting that these materials present new challenges due to their non-engineered nature and differing fate processes.

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Besa Maliqi Syla Besa Maliqi Syla

Roadmap Safe and Sustainable Advanced and Innovative Materials 2024-2030

January 1, 2024

Authors: Brunelli et al.

This review highlights the need for standardized protocols in assessing the ecotoxicity of engineered nanomaterials (NMs) in marine environments, which remain underexplored compared to freshwater systems. Analyzing 89 studies since 2010, it found that less than 5% used standardized dispersion protocols with NM characterization, while many lacked complete procedural details. Metal oxide NMs were most studied, with growing attention to nanoplastics and multicomponent NMs. Primary producers like algae and bacteria dominated research focus, while higher trophic organisms were less represented. The review emphasizes adopting standardized methods to improve ecological hazard assessments of NMs in marine ecosystems.

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Besa Maliqi Syla Besa Maliqi Syla

Understanding the role of biomolecular coronas in human exposure to nanomaterials

January 1, 2024

Authors: Antonello & Fenoglio

This review explores the impact of biomolecular coronas on the transformation and behavior of nanomaterials (NMs) following various exposure routes, including inhalation, ingestion, blood, and dermal or ocular contact. It highlights how coronas formed in different biological media alter NM properties and influence their biological fate. Emphasizing the need for detailed characterization of coronas, particularly in lung and gastric fluids, the review underscores the importance of understanding NM interactions to predict in vivo outcomes and address nanosafety concerns.

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Sarah Preidt Sarah Preidt

A structure–activity approach towards the toxicity assessment of multicomponent metal oxide nanomaterials

September 26, 2023

Authors: Gakis et al.

The challenging nature of in vivo and in vitro toxicity assessment methods for ENMs, has led to emerging in silico techniques for ENM toxicity assessment, such as structure–activity relationship (SAR) models. Although such approaches have been extensively developed for the case of single-component nanomaterials, the case of multicomponent nanomaterials (MCNMs) has not been thoroughly addressed. In this paper, we present a SAR approach for the case metal and metal oxide MCNMs.

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Sarah Preidt Sarah Preidt

Screening level approach to support companies in making safe and sustainable by design decisions at the early stages of innovation

September, 2023

Authors: Pizzol et al.

The European Green Deal, through the Chemicals Strategy for Sustainability and the Zero Pollution Action Plan, emphasizes the transition to Safe and Sustainable by Design (SSbD) chemicals and materials. The H2020 SUNSHINE project has developed a tiered approach to implement SSbD, focusing on multi-component nanomaterials (MCNMs). This approach evaluates safety and sustainability at each product development stage from a lifecycle perspective using qualitative (Tier 1), semi-quantitative (Tier 2), and quantitative (Tier 3) methods. The Tier 1 self-assessment methodology was tested on two industrial case studies, showing that these innovative materials offer better safety, functionality, and sustainability compared to conventional materials.

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Sarah Preidt Sarah Preidt

CEC05-05: Using Integrated Approaches to Testing and Assessment to streamline Grouping and Read-Across of solid nanomaterials

September, 2023

Authors: Stone et al.

This study discusses the use of Integrated Approaches to Testing and Assessment (IATAs) in the GRACIOUS project to aid in the grouping of nanomaterials for hazard assessment. Grouping involves using evidence to demonstrate the similarity of nanomaterials based on their physicochemical characteristics, fate, toxicokinetics, and hazard. Data for assessing hazard similarity can come from tier 1 methods (in vitro, in chemico, or in silico) or more advanced tier 2 methods (such as 3D multilineage in vitro models). For regulatory purposes, one member of a group should have tier 3 animal data, which can then be used for read-across to fill data gaps for other substances.

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Sarah Preidt Sarah Preidt

Life cycle thinking and safe-and-sustainable-by-design approaches for the battery innovation landscape

February 1, 2023

Authors: Lya Soeteman-Hernández, Carlos Felipe Blanco, Maarten Koese, Adrienne Sips, Cornelle Noorlander, Willie Peijnenburg

Technical and policy-related literature was surveyed for battery technologies and recommendations were provided for a broad SSbD approach that remains firmly grounded in Life Cycle Thinking principles. The approach integrates functional performance and sustainability aspects throughout the life cycle of materials, products and processes. It evaluates how their interactions reflect on SSbD parameters.

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Sarah Preidt Sarah Preidt

Development of a transferable coarse-grained model of polydimethylsiloxane

October 7, 2022

Authors: Sonia Cambiaso, Fabio Rasera, Giulia Rossi, Davide Bochicchio

This paper develops a transferable coarse-grained model of PDMS, compatible with the recent Martini 3 force field, using structural and thermodynamic properties as targets in the parametrization, including a vast set of experimental free energies of transfer.

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Sarah Preidt Sarah Preidt

International Network Initiative on Safe and Sustainable Nanotechnologies (INISS-nano)

June 21, 2021

Author: Andreas Falk

The “international network initiative on safe and sustainable nanotechnology” (INISS-nano) was formed, aiming to bring together science, industry and government from partners all over the world. The focus shall be on the collaboration in different fields pertaining to nanotechnology research in general and nano-safety research in particular.

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Sarah Preidt Sarah Preidt

Safe-and-sustainable-by-design chemicals and advanced materials: a paradigm shift towards prevention-based risk governance is needed

May 31 2023

Authors: Hristozov et al.

The Green Deal aims to transform the European economy towards safer, more sustainable chemicals, materials, processes, and products, prioritizing health and environmental protection while tackling pollution. To achieve this, the Chemicals Strategy for Sustainability and Zero Pollution Action Plan advocate for a shift towards Safe-and-Sustainable-by-Design (SSbD), ensuring safety, functionality, and sustainability are integrated early in the design process. Unlike the current reactive regulatory system, SSbD proactively embeds these factors. Given the complexity of advanced materials and the involvement of various stakeholders, defining and balancing trade-offs in safety, functionality, and sustainability requires a co-creative, decision-science-driven approach. This collaboration, supported by digital tools, is key to implementing SSbD and advancing prevention-based risk governance.

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Sarah Preidt Sarah Preidt

In Vitro Cytokinesis Block Micronucleus (CBMN) Assay to Evaluate the Genotoxicity of Multicomponent Nanomaterials – a Tiered Testing Approach

May 10, 2023

Authors: Saccardo et al.

This study evaluates the human hazard potential of complex multicomponent nanomaterials (MCNMs) using a tiered testing approach. Tier1 involves a simple in vitro assay, while Tier2 uses a more complex model to simulate inhalation exposure. The genotoxic and cytotoxic effects of selected MCNMs were tested using the cytokinesis-blocked micronucleus (CBMN) assay and population doubling. Results showed that combining core components in MCNMs could lead to synergistic effects, with differences in dose-response relationships observed between the tiers. The study compares the results to assess if advanced culture models provide more physiologically relevant data than standard in vitro systems.

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Sarah Preidt Sarah Preidt

Status, implications and challenges of European safe and sustainable by design paradigms applicable to nanomaterials and advanced materials

February 2, 2023

Authors: Furxhi et al.

This article discusses the EU’s Green Deal and its focus on Safe and Sustainable by Design (SSbD) practices for managing chemicals, including nanomaterials (NMs) and advanced materials (AdMas). It highlights the shift towards prevention-based approaches in design to minimize environmental and health impacts and promote a circular economy. Drawing from a 2022 workshop in Venice, the article explores the challenges and progress in implementing SSbD concepts, focusing on industrial, technical, and organizational hurdles, and the future financial support needed for their adoption by industry and regulators.

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Sarah Preidt Sarah Preidt

How to formulate hypotheses and IATAs to support grouping and read-across of nanoforms

January 12, 2023

Authors: Murphy et al.

Manufacturing materials at the nanoscale has led to a diverse range of nanoforms (NFs) with varying size, morphology, and surface characteristics. Testing each unique NF for adverse effects is impractical due to financial, time, and ethical constraints. Hypothesis-driven grouping and read-across approaches, supported by the GRACIOUS Framework, offer an efficient alternative to individual testing. This framework facilitates the assessment of similarity between NFs, supporting grouping and read-across, and minimizing the need for new testing, in line with the 3R principles of animal testing reduction. The GRACIOUS template organizes data collection into structured categories—lifecycle, environmental release, human exposure, physicochemical characteristics, environmental fate, and toxicity—allowing for logical, evidence-based expansion of grouping and read-across across a broader range of NFs.

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