Suchergebnisse

In the context of the recently finalized H2020 project, NanoReg 2 , a new framework for a more comprehensive assessment of the environmental and human implication for engineered nanomaterials (ENMs) and related nano-enabled products has been developed. The developed framework is based on the integration of Life Cycle Assessment (LCA) and Risk Assessment (RA) methodologies during each stage of the innovation process for ENM products. Following a standard stage model, the framework is structured into four distinct phases: in stage one ("business idea"), the core business idea is described, an initial qualitative scoping of possible potential impacts and risks is established and the main legislative requirements are considered; in stage two ("business concept"), a simplified screening LCA-RA of potential benefits and risks (for workers, consumers and the environment) is performed, allowing a first rough evaluation of the sustainability of the product, based on qualitative/quantitative data from literature; stage three commences as experimental testing starts (stages 3a and 3b-"Prototype ENM/Prototype industrial sector"), and entails the undertaking of an LCA and RA at the lab and industrial scales, providing a first quantitative evaluation of the product; in the fourth and final stage ("validation and market"), REACH, product-related regulations/requirements and labelling requirements are integrated into the assessment. At each stage, different tools (e.g. LICARA, NanoRiskCat, Nanosafer, Swiss precautionary matrix) are used to provide valuable insights into performance to support the company in the process of the evaluation of the risk and sustainability of their product. Thus, our framework serves to help identify and minimise risks at an early stage in the innovation cycle and ensure that safety and sustainability implications are considered from the onset. For emerging products this is of high relevance as it enables risk and product management options to be enacted prior to the nanoproducts entering the market. ...

In the context of the recently finalized H2020 project, NanoReg 2 , a new framework for a more comprehensive assessment of the environmental and human implication for engineered nanomaterials (ENMs) and related nano-enabled products has been developed. The developed framework is based on the integration of Life Cycle Assessment (LCA) and Risk Assessment (RA) methodologies during each stage of the innovation process for ENM products. Following a standard stage model, the framework is structured into four distinct phases: in stage one ("business idea"), the core business idea is described, an initial qualitative scoping of possible potential impacts and risks is established and the main legislative requirements are considered; in stage two ("business concept"), a simplified screening LCA-RA of potential benefits and risks (for workers, consumers and the environment) is performed, allowing a first rough evaluation of the sustainability of the product, based on qualitative/quantitative data from literature; stage three commences as experimental testing starts (stages 3a and 3b-"Prototype ENM/Prototype industrial sector"), and entails the undertaking of an LCA and RA at the lab and industrial scales, providing a first quantitative evaluation of the product; in the fourth and final stage ("validation and market"), REACH, product-related regulations/requirements and labelling requirements are integrated into the assessment. At each stage, different tools (e.g. LICARA, NanoRiskCat, Nanosafer, Swiss precautionary matrix) are used to provide valuable insights into performance to support the company in the process of the evaluation of the risk and sustainability of their product. Thus, our framework serves to help identify and minimise risks at an early stage in the innovation cycle and ensure that safety and sustainability implications are considered from the onset. For emerging products this is of high relevance as it enables risk and product management options to be enacted prior to the nanoproducts entering the market. In this presentation, this stage-based, integrated RA-LCA framework will be presented in more detail and its applicability will be demonstrated through several case studies regarding ENM production and application. In addition to the LCA and RA activities, the feasibility for adding a socio-economic component to this framework will be discussed.

Abstract
Risk governance, sustainability and safety-by-design have high attention in current research projects and policy. In the EU H2020 Gov4Nano project, we refined the EU H2020 caLIBRAte phase-gate nano-risk innovation governance framework, its guidance and expanded the list of supporting risk governance tools. Stakeholder wishes were mapped from previous projects and consultations made within Gov4Nano and across the two other EU H2020 NMBP-13 governance projects (NANORIGO and RiskGone) and considered in the refinement. The revised framework considers three pre-defined phase-gate models for minor (fast-track/low risk), intermediate (medium risk) and novel (high-risk) developments. The guidance was further elaborated to direct users though sustainability and safety-by-design considerations and risk mitigation actions. ISO21505 was used as the backbone for the risk governance framework. The approach allows design of the specific nano-risk governance project and information requirements for decision-making. The list of recommended nano-risk governance tools was expanded and selected considering their reliability and performance. An important step in this process was an evaluation of tools made under the umbrella of the OECD (ENV/CBC/MONO(2021)23; ENV/CBC/MONO(2021)27/REV; ENV/CBC/MONO(2021)28; ENV/CBC/MONO(2021)29/REV) and development of a new tool assessment framework called TRAAC (Transparency, Reliability, Accessibility, Applicability and Reliability). Limitations in application domains remains an issue for future developments. The approach and tools are made accessible via a nano-risk governance portal produced by the three NMBP-13 projects (http://nanoriskgov.eu/).
Funding: European Union's Horizon 2020 Research and Innovation Programme under Grant Agreement 814401.