Community Research and Development Information Service - CORDIS


SUN Report Summary

Project ID: 604305
Funded under: FP7-NMP
Country: Italy


Project Context and Objectives:
Nanotechnology is one of the Key Emerging Technologies identified in the European Union (EU) 2020 Strategy. It has enormous potential to contribute to innovation and economic growth, which fosters large investments in developing new industrial applications and has led to a large number of nanoproducts on the market (
Nevertheless, the current uncertainties around the Environmental, Health and Safety (EHS) risks of manufactured nanomaterials (MN) are raising societal concerns that can block the benefits from nanotechnology. There have been other technologies (e.g. asbestos) that revealed unexpected health or ecological effects only several years after their broader market introduction. In the worst cases this caused tremendous costs for society and the enterprises in the form of liabilities, over-balancing regulations and demolished consumer confidence.
SUN is based on the hypothesis that the current knowledge on the EHS risks of MN, while limited, can nevertheless guide nano-manufacturing to avoid future liabilities, provided that an integrated approach addressing the entire product lifecycle of manufacturing, use and disposal is applied.
The concept of SUN is to combine RISK ASSESSMENT and LIFECYCLE ASSESSMENT in developing the user-friendly, versatile, software-based SUN DECISION SUPPORT SYSTEM (SUNDS) for practical use by industries and regulators. The industrial partners in the SUN Consortium have evaluated and “reality-checked” SUNDS against real products in terms of cost/benefit and insurance risk. This validation has culminated in GUIDELINES FOR SAFE NANOSCALE PRODUCT AND PROCESS DESIGN. As a “by-product” SUN identified needs for future research and assigned priorities for current regulation. We have involved major international stakeholders in implementing the SUN results into practice and regulation.
SUN consists of 11 Work Packages (WP) distributed among three main themes:
WP1 and WP2 are both the start point and end point of SUN: Real products and processes set the stage for all activities in WP 3-6. The outcomes, both in terms of direct feedback from WP3-6 and the results of WP7 and WP8, namely SUNDS and the guidelines, feed into the current practice of the industry partners.
WP 3-6 produced data on physicochemical characteristics, hazard, exposure, risk and environmental impact in a number of “real-life” case studies. WP 3-6 benefited from the excellent network of the partners; major European projects provided data, which SUN did not have to duplicate. WP7 developed practices, methods and tools to facilitate safe production, handling and disposal of MN and incorporated them into case-specific guidelines for safe product and process design. Finally, the tools and data generated in WP 1-7 were integrated into SUNDS in WP8.

Project Results:
For the second reporting period, there are notable achievements in SUN. The procedures for implementing the administrative and scientific management are in place. The continuous review of the quality of the project’s scientific results is ongoing, with regular meetings and telephone conferences. Strong external collaborations and information sharing with other projects, especially NANoREG, GUIDEnano, eNanoMapper, and ProSafe have taken place.
SUN has further developed and maintained its data portfolio, consisting of data generated internally or collected from other sources in regards to seven case studies. These case studies correspond to supply chains of real industrial products (coatings and composites for the energy, transportation and construction industries as well as nanomaterials used in food). The products embed the following MN: Tungsten Carbide/Cobalt (WCCo), Copper Oxide (CuO), Silica (SiO2) Titanium Dioxide (TiO2), organic and inorganic (Fe2O3) pigments, and Multi-walled Carbon Nanotubes (MWCNT). Data on the release, exposure and (eco)toxicity of these materials have been collected for different lifecycle stages of these products in the SUN operational database. The physicochemical properties of the MN have been characterized in relevant biological media for the purpose of (eco)toxicological testing and fate experiments, activities that ultimately generated useful results for RA.
Prospective lifecycle analyses of the SUN case studies were completed, the results of which have been compared to conventional products with similar uses and functionality. Criteria and guiding principles for green nano-manufacturing were derived from them. These results were already exploited for one of the SUN case studies (i.e. nano-TiO2 used in the air purification system “Proebe”) by the large industrial company COLORROBIA.
SUN has aimed at risk analysis of not only pristine MN, but also materials released from products and aged in the environment. In the second reporting period, the project has made significant progress in developing tools to analyze MN releases and characterize the released materials in complex matrices. Specifically, the project focused on optimizing the methods developed in the first reporting period so that they can better discriminate MN from background materials. In order to generate released MN for experimental purposes, manual and mechanical grinding methods were developed as better alternatives of the cryomilling approach proposed in the first reporting period. One important focus in the last 18 months of SUN was the measurement of MN release from nano-enabled products (NEP) during end-of-life (EoL) treatment (e.g. recycling) and disposal. In this regard the project 1) developed analytical capabilities for measuring the content of MN in different EoL products as well as by-products from waste processes (e.g. leachate); 2) completed tests to assess the recovery of MN during samples preparation prior to lab analysis; 3) established procedures for leaching tests aiming at assessing the release of MN when NEP come in contact with water in EoL scenarios; 4) performed measurements campaigns targeting the release of MN during pre-treatment of waste prior to recycling processes; and 5) performed release tests on several of the SUN case studies. The obtained results demonstrated that: 1) the current procedures for sample preparation may be inadequate for dealing with nanowaste; 2) losses of MN during recycling processes are significant and may induce workplace and environmental exposure; 3) leaching tests aiming at assessing release of MN need adjustments compared with the standard protocols and additional tests (e.g. TEM) may be required. Moreover, in the last 18 months we studied the environmental transformation of released particles using bench scale and mesocosm scale studies. Predicted Environmental Concentrations were estimated for the aquatic compartment and probabilistic models were developed to assess environmental exposure, hazard and risks. These models were delivered as R-packages, which were incorporated in the SUN DSS (SUNDS).
The above release work has relevance not only to estimating environmental, but also occupational and consumer exposure. In this regard SUN has significantly progressed in developing a versatile tiered approach to assess MN inhalation and ingestion exposure of workers and consumers based on state-of-the-art tools (calibrated/improved in SUN) and on a quantitative nano aerosol dynamic model (newly developed in the project). The conceptual framework behind this approach was developed in the first reporting period, while the last 18 months of the project focused on model development and integration with SUNDS. In order to test and validate these exposure models, high-quality measurement data and contextual information were collated in libraries and generated in collaboration with the EU FP7 MARINA and NANoREG projects.
The risks of MN are function of exposure and hazard. Therefore, in the second reporting period SUN has further investigated methods to assess the long-term environmental consequences of the pristine and released MN on ecosystem services. This has resulted in new nano-specific testing methods for sewage treatment plants (STP) (e.g. ammonium oxidizing bacteria), terrestrial environments (e.g. Enchytraeus crypticus, Eisenia andrei), aquatic sediments (i.e. Lymnaea stagnalis, Daphnia magna), and pelagic parts (e.g. fish gut, zebrafish embryos). Moreover, longer-term ecotoxicity tests with lower exposure concentrations have been performed focusing on transformation, bioaccumulation, biotransfer, gene-pool/diversity loss and ecosystem service damage/loss. In this regard a large number of long-term in vivo test systems were evaluated or developed de novo. The STP tests have shown that the passage through a STP may increase the ecotoxicity of CuO MN. There is no evidence that microbial toxicity differs following single or repeated exposures to MN, provided the same final concentration. In the terrestrial environment, advanced single species and multispecies long term tests have shown pronounced long term CuO toxicity in contrast to lower toxicity of the rest of the SUN MN. In the aquatic sediment, all MN have been screened in two species (i.e. Lymnaea stagnalis, Daphnia magna) using short-term tests. Long-term tests have been performed with Lymnea. In the aquatic pelagic environment, the results demonstrate that the toxicity of CuO MN is dependent on the water pH. An in vitro test has been designed to show the impact of CuO along gut line of a fish. Moreover, a large number of test systems were evaluated or developed de novo for testing in vitro and in fast mode the long term effect of nanomaterials. Specifically, epigenetics tests have shown low methylation in collembolan and 1% global methylation in enchytraeids. Metylation of specific genes were also measured. In vitro test systems have been established showing effects of the SUN materials on fish cell lines and worm cells with decreased viability and disturbance of cellular stability. Modified CuO nanomaterial was used as primary test compound, although all materials were tested for the fish cells line. For earthworms, the cells of five species were tested. Repeated exposures have been performed showing effects different from non-repeated long-term exposure.
In order to investigate human health hazards, in vitro epigenetics and transcriptomic tests were performed with the CuO case study in collaboration with Health Canada. In the epigenetic study the levels of gene methylation were found to be low (< 1%) overall for all genes, and highly variable. No significant differences between any experimental treatments were observed. The transcriptomics study showed that exposure to the higher dose for 5 days yielded the most significant changes in gene expression, accounting for significantly changed mRNA of about 1,000 genes, the majority of which were up-regulated. In contrast, animals collected after recovery yielded < 20 dysregulated genes, thus indicating return to levels similar to the controls. Most of the deregulated genes related to inflammation and cell proliferation in a dose-response manner, which was reversible after the recovery period.
In order to generate in vivo data for RA, SUN improved the already existing Short Term Inhalation Study (STIS) protocol and developed a novel Short Term Oral Study (STOS) protocol. In the first reporting period a STIS was conducted with the pristine CuO MN, inducing a dose-dependent inflammatory response in the lung at day 6, which almost recovered at day 28. In the second reporting period SUN performed a second and a third STIS using two SbyD surface-modified CuO MN. The results revealed interstitial/alveolar inflammation and hypertrophy/hyperplasia of bronchioles/alveoli with accompanying alveolar (cellular) debris in the lung and paracortical histiocytosis in the mediastinal lymph node. Moreover, we performed STOS with pristine CuO and CuCO3 and both MN induced similar histological changes in the kidney, bone marrow and spleen, but at significantly higher doses for the CuCO3 than the CuO. The STIS and STOS generated kinetic data suitable for pharmacokinetic (PBPK) modelling and a methodology was developed on this basis to derive MN-specific interspecies extrapolation factors for human health RA. In the second reporting period we performed probabilistic human health RA of the SUN CuO and organic pigment case studies with data from the STIS and STOS and relevant occupational and consumer exposure scenarios. The underlying probabilistic RA methodology was programmed in SUNDS
SUN is built around the idea to develop and promote safer nanotechnology products and processes through molecular and process design strategies. In the second reporting period the work on molecular design has focused mostly on the WCCo case study, for which micronization SbyD techniques (i.e. spray and freeze drying) were applied. On the side of process control, the ultrasonic probe system NanoSonic and its supporting software were developed in the first period to provide online size distribution measurements during nano-manufacturing processes. The testing and validation of this system is still ongoing. Moreover, detailed guidelines for safe production, handling and disposal of NEP have been developed.
SUN completed a review of existing risk reduction and control measures for MN that led to the development of the Technological Alternatives and Risk Management Measures (TARMM) inventory, which was incorporated in SUNDS. SUNDS is one of the highlights of the project. In the second reporting period this online user-friendly software system has been tailored to the needs of various stakeholders (e.g. industry, regulators and the insurance sector) who were engaged in a discussion on its design and functionality by means of workshops. The SUNDS modules were completed and tested in the CuO and organic pigment case studies.

Potential Impact:
As with any new technology, the large-scale production and commercialization of nanotechnologies require an understanding of their ESH impacts, and must develop strategies for their safe production, use and disposal. Today we face a challenge to achieve reproducibility in industrial performance; and to understand and mitigate the potential risks emerging from nanotechnology innovations. The fundamental issue is that nanomaterials undergo complex transformations during their lifecycles, which affect not only their environmental and health effects, but also their industrial applications.
The overall impact of SUN is to provide the nanotechnology industry and regulators with data and tools to address the above challenges. In the last 18 months of the project this has been achieved through development and application of new methods and tools for: 1) prediction of release of MN from real industrial products as well as their transformations and exposure in the environment (WP3); 2) estimation of the longer term effects of the pristine MN in ecosystems and in humans; 3) occupational and consumer exposure assessment; and 4) risk prevention and control. The SUN approach has covered the entire lifecycles of real nanoproducts, aiming at developing safer by design strategies in order to open new possibilities for innovators to design greener nanotechnologies. SUN aims to protect innovation also by providing industries with prospective tools to streamline effective decision making about safer products and processes.
To test and validate the proposed tools and to maximize the impact of the project, we carefully scoped the data generation and analysis to address the most important concerns that industries and regulators currently face. The markets covered by the SUN case studies TiO2, SiO2 and organic pigments are large: 235.000.000 tons/year of plastics worldwide, thereof € 295 billion worth sales and 1.450.000 jobs in Europe; pigments: 317.000 tons, worth €4 billion; and nano-fillers: 242.000 tons.
Sustainable innovation in the above enormous markets requires clear guidance on the safe production, handling, use and disposal of MN, informed by rigorous understanding of their potential environmental and health risks.
SUN has shifted the research focus from risk analysis to risk prevention and control by developing innovative safety by molecular and process design strategies. These strategies could reduce the release, exposure and bioavailability of MN or to accelerate their environmental alteration or degradation in order to secure their ultimate fate. We anticipate that increasing the safety of nanotechnologies without compromising their successful scale-up will have a positive impact on their societal acceptance. This will inevitably lead to an innovation boost, increasing the European technological and economic competitiveness.
In the pursuit to increase the impact of its activities SUN has identified complementarities and created synergies with other NSC projects such as NANoREG, GUIDEnano, eNanoMapper and NanoRELEASE. Results of SUN have been shared with key actors in the OECD Sponsorship Programme and also within important research networks such as PEROSH, NanoFutures and the MODENA Cost Action.

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