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NanoSafetyCluster - Compendium 2012 opinion on the appropriateness of existing risk assessment methodologies. SCENIHR concluded that nanomaterials may have different (eco-) toxicological properties than the substances in bulk form and therefore their risks need to be assessed on a case by case basis and the risk assessment methods and instruments may require further development. There is now a need to assess the suitability of current risk assessment methods in more detail in order to guide how to deal in practice with nanomaterials in an appropriate manner. Furthermore, opinions by the SCENIHR conclude that current risk assessment methodologies for micro/macroscale chemicals require modification in order to deal with the risks associated with nanotechnologies and, in particular, that existing toxicological and ecotoxicological methods may not be sufficient to address all of the issues arising from nanoparticles as size confers unique properties to nanomaterials. The opinions also indicate that very little is known about the physiological responses to nanoparticles and that there are major gaps in the knowledge necessary for risk assessment. To date, the widely accepted view is that there are many unanswered questions on the potential environmental and health risks associated with the manufacture, use, distribution and disposal of nanomaterials. There is a need for a rapid improvement of the scientific knowledge basis to support the regulatory work. In particular, research is needed in areas underpinning risk assessments and risk management like: § Data on toxic and eco-toxic effects as well as test methods to generate such data. § Data on uses and exposures throughout the lifecycle of nanomaterials or products containing nanomaterials, as well as exposure assessment approaches. § Characterisation of nanomaterials, development of uniform standards and nomenclature, as well as analytical measurement techniques. § For occupational health aspects, the effectiveness of a range of risk management measures including process enclosure, ventilation, personal protective equipment like respiratory protective equipment and gloves. Although Europe is at the forefront of this promising field of science, many knowledge gaps remain in relation to the impact of these technologies on human health and the environment. Concerns over ethics and the respect of fundamental rights are also linked to N&N. The key motivations for NEPHH project are: 1. In early studies, engineered nanoparticles have shown toxic potentially properties. They can enter the human body in various ways, reach vital organs via the blood stream, and possibly damage tissue. Due to their small size, the properties of nanoparticles not only differ from bulk material of the same composition but also show different interaction patterns with the human body. The risk assessment for bulk materials is therefore not sufficient to characterise the same materials in nanoparticulate form. Information on the bioaccumulation and potential toxic effects of inhalation and/or ingestion of free engineered nanoparticles and their long-term implications for public health is needed. The environmental consequences associated with the ultimate disposal of these materials also need to be evaluated carefully. There is a dearth of evidence about effects of pollution nanoparticles on environment. Moreover, in common with other chemicals, nanoparticles may reach humans and other organisms by a wide variety of environmental routes. 2. Prioritizing and obtaining materials to evaluate are major challenges when studying nanomaterials. Specific nanomaterials with the highest exposure potentials are not well known, making it difficult to identify the most important materials to study. Obtaining materials is also an impediment. In many cases, information about the nanoscale material is proprietary. Consequently, the EU may be unable to study those materials that pose the highest potential exposure to humans. In other cases, the material may be available, but not in sufficient quantities to allow an adequate hazard evaluation, particularly regarding long term, repeated exposure studies. 3. Characterization of nanomaterials has proven to be more difficult than anticipated for several reasons. First, a standard nomenclature has not been developed. Second, biologists, physicists, and materials scientists working in this area do not always communicate effectively. In addition, an analytical infrastructure to allow characterization is not consistently available or welllocated. The high degree of variability in size and surface chemistry of nanoscale materials and in the coatings, crystal structure, shape, and composition used in preparing these materials increase both their complexity and the multiple permutations that must be considered in their evaluation. 4. Adequate methods to detect nanomaterials in cells and tissues also need further development. Some of these impediments could be addressed by, for example, the development of a repository of well characterized model of nanomaterials for use in both toxicological and biomedical research/ reference standards for nanoscale particles targeted for the biomedical and toxicological research. This development would significantly enhance the quality research investigating the health effects of nanoscale materials. 5. Health, safety and environmental risks that may be associated with products and applications of Nanotechnology and Nanosciences (N&N) need to be addressed upfront and throughout their life cycle. Doing complete life cycle analysis on newly developed products, and considering all the ecological as well as the socioeconomic components, will help to ensure growth and employment in the European Economic Area (EEA). Furthermore, material science will play an important role in contributing to the solutions for some emerging societal needs and in increasing the quality of life of European citizens. 6. The implications of the special properties of nanoparticles with respect to health and safety have not yet been taken into account by regulators. Size effects are not addressed in the framework of the new European chemicals policy REACH. Although production volumes for the most commonly used nanomaterials are already approaching the REACH threshold of 1 tonne per year per company. This is why nanoparticles raise a number of safety and regulatory issues that governments are now starting to tackle. 218 Compendium of Projects in the European NanoSafety Cluster
3 NEPHH’s Approach and Overall Objectives The aim of NEPHH is to identify and rate important forms of nanotechnology-related environmental pollution and health hazards that could result from activities involved in nanostructures throughout their life cycle, and to suggest means that might reduce or eliminate these impacts. The NEPHH project considers the safety, environmental and human health implications of nanotechnology-based materials and products. Nanomaterials selected are Silicon based laboratory materials which will be supplemented with nanomaterials from industry. On the one hand, Silicon based nanoparticles including (nano)silica (SiO2), layered silicates (MMT), glass (nano)fibres and foam-glass-crystal materials have been selected. On the other hand, a total number of three engineering polymeric matrixes have been selected, including polyamides and polypropylenes as bulk materials and polyurethanes as foamed polymeric materials, which will be used to produce nanoinduced polyurethane foams. According to this selection, 12 polymer composites will be produced on the combination of all nanomaterials and polymeric matrixes. Finally, industrial Silicon based nanomaterials from leading companies (Bayer, Honeywell Polymer, RTP Company, Basell, Blackhawk Automotive Plastics Inc, Gitto Global, Akzo Nobel Polymer Chemicals, Laviosa Chimica, Southern Clay and Sud Chemie) will be acquired. Developed polymer nanocomposites will be used to fabricate macro-scale structural specimens, to be used to simulate Crash Test Laboratories. Dust particles form macro-scale nanostructures will also be obtained from Industrial Silicon based materials, establishing a collection of different samples: which will correspond to laboratory materials including selected Silicon based nanoparticles, polymeric matrixes and polymer nanocomposites resulting from their combination with selected polymeric matrixes and acquired industrial materials. Considering that for most applications nanoparticles can be surface modified and generally are embedded in the final product and therefore do not come into direct contact with consumers or the environment, NEPHH will be going beyond the primary nanomaterials and looking into the secondary and tertiary nanoproducts in a wide range of typical applications from automotive to household usage. It will look into end-use products – ranging from nanocomposites to energy absorption foams in automotive and aerospace applications. An integrated holistic life-cycle approach is considered. NanoSafetyCluster - Compendium 2012 Fig 1: Diagram representing different stages of Nanotechnology based Applications / Products’ Life Cycle. The specific objectives of the project are the following: 1. Development of a systematic, continuous practice for selecting and prioritizing engineered nanomaterials in order to assess their safety, environmental and human health impacts. Since currently, there is a substantial interest to develop and introduce into market dispersions of nano-scale reinforcements in polymers, NEPHH will constantly review novel applications and products along with their potential impacts in human health and environment. 2. Contribution to the standardization and validation of test methods and test schemes for nanomaterials as adaptation of the current physicochemical sampling protocols to present research is envisaged. 3. Collection of nanocomposites samples, including laboratory and industrial Silicon based materials. Targeted materials represent an innovative selection supplementing ongoing investigations and setting a basis for future ones. 4. Achievement of a better understanding of the health impacts of the selected nanomaterials. 5. Assessment of the environmental exposure throughout the life cycle. 6. Assessment of the potential of nanomaterials to damage the environment (or human health through the environment). 7. Selection and dissemination of the best practices (in the fields of manufacture and disposal mainly), and actuation guidelines for exposed workers. 8. Contribution to the 'Code of Conduct for Responsible Nanosciences and Nanotechnologies Research' action to ensure that nanotechnologies are developed in a safe manner. 9. Contribution to the regulatory frameworks which are applicable to nanomaterials (chemicals, worker protection, environmental legislation, product specific legislation, etc). 4 NEPHH Project Execution In order to ensure that the research and innovation objectives of this project are achieved, a clearly defined work-programme has been set up and divided into a number of Work Packages (WP) and Tasks to allow the team of researchers to focus on the development of the project, currently under execution. Present section includes some of the main outcomes achieved in the course of the first year. WP1 – Technological Surveillance System Although nanotechnologies are quite an incipient activity area, they are increasingly produced for use in a wide range of industrial and consumer products and many authors are working in their possible impact in human health and Compendium of Projects in the European NanoSafety Cluster 219
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Compendium of Projects in the Europ
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EDITED BY Michael Riediker, PD Dr.s
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CONTENTS NanoSafetyCluster - Compen
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Project Acronym ENNSATOX ENPRA EURO
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Foreword NanoSafetyCluster - Compen
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ENNSATOX ENgineered Nanoparticle Im
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The biological membrane and its dep
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distinguishes between the interacti
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Figure 10. Schematic representation
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WP5: • Permeability of NPs in hyd
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NanoSafetyCluster - Compendium 2012
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ENPRA RISK ASSESSMENT OF ENGINEERED
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vitro findings with in vivo models;
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protocols with real biological samp
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and it was organised in the frame o
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First Name Last Name Affiliation Ad
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EURO-NanoTox European Center for Na
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silver nanoparticles, iron nanopart
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The core functions of the Center, h
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8 Directory Table 1 Directory of pe
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HINAMOX Health Impact of Engineered
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High Resolution Electron Microscopy
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integrated risk assessment. Integra
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powders: What is the difference in
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InLiveTox Intestinal, Liver and End
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- to develop and validate a novel m
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environments, IEEE Industrial Elect
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INSTANT Innovative Sensor for the f
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complementary research which will l
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7 Copyright NanoSafetyCluster - Com
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ITS-NANO Intelligent testing strate
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approach to conveying the appropria
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in the discussion. The integration
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MARINA MANAGING RISKS of NANOMATERI
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for risk analysis, these tools need
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environmental ENM toxicity, but tox
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propose it as a Method Validation F
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and SiO2-NM200 and NM203, and a SiO
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ModNanoTox Modelling nanoparticle t
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3) To model environmental exposure
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Nanodetector European Network on th
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measurement interval. Measurements
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5 Directory Table 1 Directory of pe
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NANODEVICE Novel Concepts, Methods,
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ENP in order to be sure of their sa
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4.3 Exploring the association betwe
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NanoFATE Nanoparticle Fate Assessme
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or proteins associated with particu
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sludge. Information on rates of slu
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The exposures to be conducted will
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NanoFATE progression beyond the “
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