Summaries of Dossiers in English and Download
This page provides short summaries and the conclusions of the
Dossiers. For the full text please follow the links after each title. Some of
the Dossiers have already been translated to English.
Note: English
versions of Dossiers have the suffix "en", updates the suffix "-v2" attached to
the number. Differences between different versions are included in separate one
page documents (with the suffix "add"), which are also attached to each
version.
039 Definition of the notion "nano material" ('Definition des Begriffs...' – April 2013)
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info follows soon...
038 Nano-governance by dialogs ('Nano-Governance durch Dialoge' – March 2013)
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info follows soon...
037 Nano in the media – On the reporting in representative daily newspapers in Austria, Germany and Switzerland (October 2012)
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Summary
The media play an important role in the formation of society's opinion by drawing attention to selected topics and bringing them closer to the public. This applies in particular to areas with which a large percentage of the population would otherwise have no direct points of contact, such as nanotechnology. The current study of selected print media in the German-speaking countries now reveals the general picture of nanotechnology in the media, what topics are given significant treatment, which actors are consulted, and explains that (at least as yet) there is no need for any concerns about risk-centred controversial reporting on this technology.
Conclusions
The reporting on nanotechnology in the media in the three German-speaking countries is largely science-centred and attracts a generally low level of attention amongst the broad public thanks to its less emphasised placing. There is hardly any opinion-focused reporting, with classical news reports and reports relating to current research activities or events predominating. In all three countries, the newspapers' science departments play a dominant role, and scientists also play a central role as actors.
There are reasons for assuming that the newspapers largely refrain from proactive science journalism on the topic of nanotechnology. Investigative journalism and reports that result from a journalist's own research are rare. The reports themselves could be referred to as unruffled and conflict-free, frequently serving as a means for presenting outstanding achievements. An event-focused positive representation predominates. A focus on risks and controversial reporting, a concern raised regularly in expert circles, was not proven in the present study. Risk topics play a role in fewer than 20% of articles; the benefits and opportunities of nanotechnology, on the other hand, are mentioned in 80% of all articles. Benefits are seen above all for science. Scientific actors are likewise mentioned relatively frequently, which indicates the close connections between science and business, and the economic expectations of nanotechnology. One would have to examine the extent to which the absence of controversies can be attributed to the hitherto lack of evidence of possible dangers and risks or to well-functioning strategic scientific PR work.
036 The EU code of conduct for nanosciences and nanotechnologies research (December 2012)
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Summary
The code of conduct for responsible nanosciences and nanotechnologies research (code of conduct) is the Annex to the first nanotechnology-specific legal measure by the EU (2008), a Commission recommendation that is legally non-binding. The nanotechnologies code of conduct contains principles and guidelines for integrated, safe and responsible (ethical) nanoscience and nanotechnologies (N&N) research. The central control mechanisms are research prioritisation, technology assessment, ethical and fundamental law clauses/restrictions, defensibility checks and accountability. The EU Commission appeals to the Member States to comply with the voluntary guidelines and principles; encourages funding bodies to only fund research that complies with the code and to implement the code; encourages researchers to commit themselves to compliance with the code and civil society organisations to participate in N&N research. As yet, only a few implementation measures have been adopted. From a legal point of view, the code is controversial, and nevertheless it has an influence on the ongoing discussion on the topic of "responsible research and innovation" at EU level.
Conclusions
The acceptance and dissemination of the code has hitherto remained within limits. This is in part due to the vague wording of the regulations and the lack of control, monitoring and penalty possibilities. In addition, questions remain whether such a code of conduct is at all justified in the field of nanotechnology research.
The Commission's proposal to extend the code to emerging technologies and the entire life cycle ("framework for responsible research and innovation") is, as the legal discussion on the nanotechnology code of conduct shows, faced by legal challenges. Currently, it appears improbable that the generally worded nanotechnology code of conduct will become a practicable general standard.
035 Nano-titanium dioxide, part 3
(published only in german language)
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Summary
Nano-titanium dioxide (nano-TiO2) is the nanomaterial produced in the greatest amounts and is already a component in many products, both in its regular and nano-scale size. This also makes it the best-investigated nanoparticle. Many in-vivo and in-vitro studies have been conducted to test for potential environmental risks. Nonetheless, the possible long-term effects remain unknown. Short-term exposures to high doses showed damage both in aquatic and in terrestrial ecosystems. No specific regulations for nano-TiO2 are currently in place.
Conclusions
TiO2 is a widely distributed substance that is currently incorporated in many different products including sunscreens and foods. This explains why TiO2 is so well studied, even if no long-term studies on nano-TiO2 are available. In epidemiological studies, regular TiO2 showed no TiO2-specific effects related to cancer incidence. Nonetheless, based on animal experiments, international bodies have classified this material as “possibly carcinogenic in humans”. Although specific studies conducted by the FDA clearly point to an extremely low risk, the remaining uncertainties and discrepancies lead to the recommendation to use caution when applying nano-TiO2-containing cosmetics to injured skin.
Many studies have been conducted to describe the potential environmental effects of nano-TiO2. As most of these studies involved extremely high doses, any definitive statements on the environmentally relevant risks remain speculative. Nonetheless, the consensus is that small amounts represent a rather low risk to the environment, whereby the long-term effects with low doses of nano-TiO2 remain unclear. There are currently no actually measured data on environmental exposure; another unclarified issue is how TiO2-NPs behave in food chains. Whether a transfer of the particles takes place from animal to animal or from plant to animal through feeding also remains unclear. We have no information about the effects that the particles may exert over the long term on aquatic and terrestrial ecosystems. This calls for urgent and targeted research in this field.
034 Nano-titanium dioxide, part 2
(published only in german language)
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Summary
Nano-titanium dioxide (nano-TiO2) is the nanomaterial produced in the largest amounts and is already contained in numerous products, both in the regular and in nano-scale size. It is therefore also the best investigated nanoparticle. Many in-vivo and in-vitro studies have been conducted to test for potential health hazards, although the epidemiological studies have not demonstrated any TiO2-specific effects. Currently, however, no nano-TiO2-specific epidemiological studies and no data are available on potential exposure. Nonetheless, various international bodies have classified the material as “possibly carcinogenic in humans” based on animal experiments and have pointed to the risks. There is no specific regulation for nano-TiO2 and therefore the regulation for (ultra-)fine particulate emission is applied.
Conclusions
See conclusions Dossier 035.
033 Nano-titanium dioxide, part 1: Basics, Production, Applications (November 2012)
(published only in german language)
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Summary
The basic component of titanium dioxide (TiO2) is the element titanium, which is among the ten most abundant metals in the Earth’s crust. In nature, TiO2 is present in three different crystal structures, whereby all three exhibit different physical properties that find different applications. This makes TiO2 a widely used product component that improves the texture of paints and lacquers, cosmetics, textiles, paper, plastics as well as foods. In sunscreens, nano-TiO2 has been incorporated as a so-called physical UV-filter since about 1990. The photocatalytic effect of nano-TiO2 is also exploited in a wide range of products. The high oxidation potential of nano-TiO2 coatings is used to produce self-cleaning surfaces because this property helps decompose organic pollutants and therefore also kills bacteria. In the future, the photochromic and electrochromic properties (reversible color changes due to light or electric current) will find greater use. Finally, current research is focusing on the use of nano-TiO2 in alternative energy production.
Conclusions
See conclusions Dossier 035.
032 Nano in the Construction Industry (August 2012)
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Summary
In the construction industry and in architecture, nanotechnology and nanomaterials provide new opportunities. “Nano-products” for construction purposes are currently found in four main sectors: cement-bound construction materials, noise reduction and thermal insulation or temperature regulation, surface coatings to improve the functionalities of various materials, and fire protection. At the present time, nanomaterials – and therefore “nano-products” – remain considerably more expensive than conventional alternatives due to the required production technology, and the technical performance of many products remains to be demonstrated. Both industry workers as well as end users can come into contact with nanomaterials when using a “nano-construction material” and need to be protected from potential health hazards. Information on which nanomaterial is found in which form and concentration in a product is often unavailable, particularly to end users. Once a nanomaterial is solidly embedded in a matrix, for example in concrete or in insulation material, then the probability of exposure is very low or non-existent according to current knowledge, as long as the product is not destructively worked or processed. When workers spray a nano-surface layer or mix mortar at a construction site, for example, they are subject to a potential health hazard by inhaling the dust or tiny droplets of liquid (aerosols). As “nano-construction products” currently play a subordinate role on the market, the current environmental threat due to nanomaterials appears to be low. Nonetheless, virtually no data are available on exposure, so that no comprehensive risk assessment can currently be undertaken for any nanomaterial.
Conclusions
In the research and development sectors, great efforts are being undertaken to improve material properties and introduce new nanotechnology-based products that could be of interest to the construction industry. This stands in contrast to the conventional behavior of the construction industry so that, in reality, “nano-construction products” still play a very subordinate role in this business. Greater acceptance can only be expected when such products become available at competitive process and their technical behavior is sufficiently substantiated. Determining the environmental and health threats of construction products with nanomaterials will require additional studies under realistic conditions. Equally important is the development and adaptation of measuring instruments to analyze the workplace and environmental exposure.
031 On voluntary and obligatory nano-labelling (July 2012)
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Summary
Labelling is a central regulatory tool for risk governance. It aims at meeting a number of goals: It should enable consumers to make informed purchase decisions, avoid consumers being misled and promote innovation. Hence, consumers take part in the risk management of different product groups. Labelling of nano-products has been part of the early discussion on nano-regulation, both at national and EU level. Member states have refrained from independent national initiatives. However, nano-specific labelling obligations have been adopted in European law for cosmetics, food and biocidal products. In contrast, international initiatives for voluntary labelling have not succeeded on the market.
Conclusions
For several years now, environmental and consumer protection organisations in particular have called for the labelling of “nano-products” to enable consumers to make informed purchasing decisions. While voluntary initiatives can be regarded as having failed due to opposition from industry – and probably also a lack of demand from the consumers up until now – the coming years will see labelling requirements for certain product groups through provisions of EU law.
Within the EU, a model for labelling has been established; the provisions in question hardly differ from each other. Accordingly, nano-substances need to be labelled and the word “nano” added in brackets. An obligation to indicate possible risks is so far only intended for biocidal products. There are, however, differences as to what nano-materials are. Although legal uncertainties exist, this seems justified or even necessary considering the fact that there are strong divergences in application. Within the separate legal materials, the power of definition is delegated to the administration (the Commission, so to speak), but not in all aspects. The legislator obviously wants to keep the question of what constitutes a nano-material within the field of legislation, given that the question is not just technically but also politically relevant. Industry is responsible for proper labelling. Depending upon law and subject matter, the persons who primarily bear responsibility vary. Control, monitoring and sanctions are, however, within the competence of the member states.
Due to the relatively high effort involved in labelling, the obligations are indeed controversial. The industry needs to comply with them alongside extensive product information for security assessments and possible registration requirements. Additionally, only evidently risky products originally needed to be labelled within the EU framework and this labelling should to some extent have replaced governmental risk assessment. If now only a few product groups are generally labelled irrespective of whether a certain material or product proves to be a risk, whether it has undergone risk assessment or has even been subject to an authorisation procedure, this leads to unequal treatment of different material and product groups. Furthermore, it would have the unwelcome effect of making risk regulation opaque, thus possibly leading to systemic weakness. What the effects of labelling are depends largely upon the renown of certain technologies within society.
030 Research projects on EHS aspects of nanotechnology in the 7th framework program of the EU
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Summary
The funds for research on nanotechnologies (NMP – nanotechnology and nanosciences, new materials and new production processes), a funding priority established in 2002 by the EU Commission, were increased in the current 7th Framework Program. The expenditures for research on the environmental and health impacts of nanoparticles have shown a particularly large jump. Beyond increasing the budget for additional research projects, the funding structure was also improved. The Commission is pursuing two main goals. The first is to create synergies and help avoid redundancies on the national level by more strongly interlinking the scientific institutions. The second is to intensify the information exchange between the respective institutions by establishing international networks and communication platforms. EU institutions such as the Joint Research Centre are also substantially involved in these networks. One such network is the NanoSafety Cluster, which to date has encompassed more than thirty EHS projects (five of them still from the 6thFramework Programme). In the past, the research focus was mostly on the potential health impacts of synthetic nanomaterials; increasingly, efforts are being made to study the potential impacts on the environment and the protection of employees that produce and process nano-components. Finally, the funding of research proposals that deal with the necessary implementation of regulatory approaches (laboratory analytics, detection methodologies, development and adaptation of measuring instruments) was intensified.
Conclusions
In the 7thRP, the EU Commission has massively increased funding for research projects that deal with the risk- and safety-relevant aspects of nanotechnologies (compared with preceding periods). Numerous approaches promise a significant knowledge gain within the 7thRP timeframe and beyond. Much like in the 6thRP, the Austrian participation in these EU-wide EHS projects has been minimal up to the present time. The direction that the EU has taken in promoting safety research in the nanotechnology sector is clearly recognizable: beyond the clearly increased funding level, priority is being given to projects that feature a higher level of networking both in their thematic scope and among participating institutions, and that therefore create synergies. This reveals a trend away from the funding of purely standalone projects. An additional focus lies in the funding of projects designed to promote information processing and the exchange of knowledge.
029 Nanomaterials and workers' safety – an Overview
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Summary
Nanomaterials and products containing such materials are already in widespread use because they exhibit technologically interesting, nano-specific features such as increased tensile strength, improved electrical conductivity, special optical characteristics or special medico-chemical properties. Nonetheless, the same features that make these substances so interesting technologically potentially harbor risks for those persons who handle them. This is because small particle size, coupled with increased reactivity due to special surface features, determines their biological activity and therefore toxicity. The increasing applications are exposing ever more employees – especially those working in research laboratories or in industrial production and processing – to nanosubstances. This makes occupational safety a major issue from a regulatory standpoint. Based on the available literature on occupational safety, the following nanomaterial-relevant topics have been identified: health risks, adaptation of detection and measurement methods, actual exposure scenarios at the workplace, definition and compilation of existing worksites for nanomaterials, recommendations for worker safety by the authorities and by industry, as well as preventive occupational medical care.
Conclusions
Worker protection and lab safety are priority topics because the most exposed persons – those who are the first to come into contact with nanomaterials – are those involved in the production, transport and processing of these materials. Although improvements are constantly being made to occupational safety (identification of workplaces, guidelines for recommendations in handling nanomaterials, exposure scenarios, modification of analytical techniques, etc.), occupational safety continues to pose major challenges to the responsible authorities. As far as identifying and characterizing actual gaps in our knowledge is concerned, the following specific areas deserve mention: (1) the classification of particularly hazardous nanomaterials, (2) resolving the question of whether synthetic nanoparticles can be interpreted as beings "new substances", (3) which characteristic features and which analytical techniques should be used to determine exposure levels to nanoparticles, (4) which exposure levels to nanoparticles are present at the workplace, (5) what measures are adequate to protect workers and (6) how can these measures be implemented and controlled.
028 Why is the question concerning the right (nano-)dosage so important?
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Summary
Paracelsus postulated that every substance is toxic and that only the dose makes the poison. The question is how to define a certain „dose“ for nanomaterials and for nanoparticles, respectively. Why is it impossible to calculate a distinct dose for nanoparticles? The problem is that nanoparticles are very diverse and heterogeneous regarding their chemical and physical properties. It seems rather unlikely that uniform units of measures or parameters characterizing these properties and reflecting the biological effectiveness could be developed. However, the dose calculation for nanoparticles is of high relevance, especially for risk assessment, limit values regulation and recommendations, respectively. Therefore this dossier outlines the correlation between exposition, dose and dose response and it explains why the knowledge of these crucial points is essential and where the gaps in knowledge still remain.
Conclusions
Thus, do nanomaterials question the paradigm of toxicology „only the dose makes the poison“ (Paracelsus)? Or only does the dose have to be correctly defined in order to be able to answer the question with „no“? The issue still remains unanswered.
First of all, dose calculation for nanoparticles would be important for risk assessment, for definition of limit values and for recommendations, respectively.
Due to missing data, parameters for dose calculation of nanoparticles cannot be defined. In order to fill the knowledge gaps by systematic studies, and in order to develop a realistic dose concept for nanoparticles, there is still an urgent research need.
027 Nano and the Environment, Part II: Risk Potentials
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Summary
There is currently no clear evidence that engineered nanoparticles (ENPs) pose a significant threat to the environment. Nonetheless, major gaps in our knowledge exist:
Environmental analytics: Suitable methods to determine nanoparticle concentrations and properties in complex environmental media such as water, soil, sediment or sewage sludge, as well as in organisms, remain to be developed.
Fate and behavior in natural environmental compartments: The special properties of artificial nanomaterials complicate predictions. The current dearth of data is a major stumbling block in comprehensively assessing the fate and behavior of nanomaterials in the environment.
Ecotoxicology: Research is concentrated primarily on controlled laboratory studies using cell cultures or model organisms. One of the major critiques here is the use of unrealistically high doses. No detailed ecotoxicological studies are available that can explain the mechanisms of uptake, distribution, metabolization and excretion of nanoparticles.
Environmental exposure: The most probable entry pathways of nanomaterials into the environment are via sewage water and wastes, but to date no quantitative exposure data are available for nanoparticles. The available studies are based exclusively on model calculations and estimates, which considerably hampers comprehensive risk assessment.
Overall, no definitive conclusions can be drawn on whether environmental damage can be expected or not.
Conclusions
Little is known about the fate and behavior of synthetic nanomaterials in the environment, and suitable methods to detect them in complex environmental media are only in the development stage. Model calculations on exposure alone are insufficient for comprehensive risk assessments. This calls for developing methods to monitor nanomaterials in the environment. Ecotoxicological investigations show a certain hazard potential of some nanomaterials. Even though scientific uncertainties still exist, the precautionary principle should be applied in the sense of preventive risk minimization. Environmental inputs should be avoided to the extent possible. Ecotoxicological research should increasingly focus on the environmental relevance of the materials and consider the complexity of natural systems. Long-term studies would be necessary to determine delayed impacts of environmental exposure to ENPs and to help determine potential adaptive mechanisms. More studies on bioaccumulation in the food chain are also necessary, as are studies on the interaction of ENPs with other pollutants in the environment. Under certain conditions, ENPs might change the transport and effects of such pollutants.
026 Nano and the Environment, Part I: Relief Potentials and Sustainability
(published only in german language:
"Nano und Umwelt, Teil I: Entlastungspotenziale und Nachhaltigkeitseffekte")
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Summary
Nanotechnology products, processes and applications have the potential to make important contributions to environmental and climate protection by helping save raw materials, energy and water as well as by reducing greenhouse gases and problematic wastes. Nanomaterials, for example, can increase the durability of materials; dirt- and water-repellant coatings are designed to help reduce cleaning efforts; novel insulating materials can improve the energy efficiency of buildings; adding nanoparticles to reduce the weight of materials can help save energy during transport. Great hopes are being placed on nano-technologically optimized products and processes that are currently under development in the energy production and storage sectors.
Emphasis is often placed on the sustainable potential of nanotechnology, but this in fact represents a poorly documented expectation. Determining a product’s actual effect on the environment – both positive and negative – requires considering the entire life cycle from the production of the base materials to disposal at the end of its useful life. Only few life cycle analyses have been conducted, but some show clearly reduced environmental impacts or energy and resource savings for certain products that use nanomaterials or nanotechnology processes. Nonetheless, not every “nano-product” is a priori environmentally friendly or sustainable, and the production of nanomaterials often requires large amounts of energy, water and environmentally problematic chemicals.
Conclusions
Based on their special properties, nanomaterials have the potential to make products or production processes more environmentally friendly. The focus lies mostly on energy and resource efficiency. Several consumer products that promise environmental advantages are already available, and certain applications have already been implemented in the industrial sector. Much is currently in the research and development stage, especially in the sectors energy and environmental technology. The high expectations for potential environmental benefits of nano-technologically optimized products are contrasted by fears that the high consumption of energy and resources in industrial-scale nanomaterial production will negate any potential advantages. Unfortunately, in most cases no comprehensive life cycle analyses are available to evaluate the actual environmental effects – both the potential advantages as well as the risks – during the entire lifespan of a product. Manufacturers are therefore called upon to provide the necessary evidence to support claims of environmental advantages or to provide the data required for analyses and evaluations. As in other cases of technological innovation, the focus in nanotechnology is primarily on the intended functions of the respective nanomaterials. Positive environmental effects are rarely the reason for using a nanomaterial, but such an influence is clearly a welcome side effect. Depending on the actual conditions, negative effects or no effects at all can occur. This calls for actively creating conditions under which positive effects can be realized.
025 Measuring and Characterisation of Nanoparticles in the Air
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Summary
As far as concerns the risks of nanotechnology, the focus of attention is on nanomaterials and in particular on free nanoparticles. Alongside the investigation of their possible toxicity, the question of the exposure of humans and the environment is an essential element of their risk assessment. Nanoparticles suspended (distributed and embedded) freely in the air are of particular relevance, since they can easily penetrate the human body via the lungs. In addition, it is extremely difficult to monitor the spread of nanoparticles in the air.
Commercially available particle counters can be used to determine the concentration of particles and droplets in the air down to a size of a few nanometres. In the light of the high background concentration of natural nanoparticles and those generated by human activity, the first priority is to distinguish between natural and synthetic nanoparticles. While an on-site concentration measurement can be carried out in a few minutes, the analysis of the nanoparticles contained in the air, that is the determination of their form and composition is only possible using complex electron microscopy procedures in the laboratory. This situation currently constitutes the main problem for determining the concentration of synthetic nanoparticles and will do so for the near future.
Conclusions
At first sight, it might be assumed that determining the exposure of synthetic nanoparticles in outside air is so difficult because there are no measurement devices that can detect particles down to the nanometre size range. However, this is not the case. There are a number of particle counters that can detect nanoparticles with sufficient accuracy. The problem of determining the concentration of synthetic nanoparticles is that these devices cannot distinguish between natural and synthetic nanoparticles. This is all the more serious because the background load of natural nanoparticles and those accidentally generated by human activity (e.g. through combustion processes) is very high. Against a high background concentration, a small increase in concentration of synthetic nanoparticles is therefore hardly detectable.
Admittedly, electron microscopy also provides instruments for the detailed analysis of nanoparticles, but their time and labour-intensive operation means that these are only of limited suitability for practical application for the comprehensive monitoring of production facilities. Even if technically appropriate methods could be developed, the systematic monitoring of the concentration of synthetic nanoparticles in the air would also require a significant increase in personnel efford.
024 Carbon Nanotubes – Part II: Risks and Regulations
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Summary
Carbon nanotubes (CNTs) can be inhaled and thus deposited in the lungs. Studies have shown that specific CNTs, namely those that are long (10-20 µm), thin (5-10nm), needle-shaped and non-soluble (biopersistent), can promote the formation of lung diseases and show behaviour similar to that of asbestos fibres. Short or long fibres that are not needle-shaped will not, however, induce inflammatory changes, no more than a single carbon particle would. Comprehensive life-cycle analyses regarding the potential environmental benefits arising from the use of CNTs (such as resource savings owing to more light-weight materials) are not available to date. At present, the production of CNTs still requires a high energy input, which offsets any potential environmental benefits. Their high reactivity and ability to transport other substances raises concerns about a possible ecotoxicity of CNTs. The data available are still restricted in scope, and the discussion of results is controversial. Given the lack of reliable data on exposure, an adequate assessment of health and/or environmental risks is not possible for the time being.
At present, specific regulations for CNTs or other nanomaterials exist neither in the laws governing chemicals nor in regulations for occupational health and safety. Hence, the relevant authorities recommend that the precautionary principle should be applied and measures taken to avoid exposure or keep it as low as possible.
Conclusions
There are indications that high concentrations of very specifically structured CNTs (needle-shaped, long, thin, biopersistent) have an adverse pulmonary effect. In order to make meaningful statements on the risk involved, the mechanisms of action and dose-effect ratio have to be clarified. To avoid potential risks, the recommendation of many publications – endorsed by this dossier – is to avoid contaminations with and, if possible, the use of pathogenic needle-shaped CNTs.
Although CNT-optimized materials promise environmental benefits through resource savings, a comprehensive life cycle analysis has yet to be conducted. Available data on CNT ecotoxicity are limited and controversial. There is also a lack of reliable information on exposure that would be required for environmental risk assessment. Neither hazardous chemicals legislation nor occupational health and safety regulations offer specific requirements for the handling of CNTs. Although CNTs, like all other chemicals, are covered by the requirements of REACH, the volume-thresholds for registration (1 JT) and the mandatory chemical safety report (10 JT) have been set at levels that may not include all CNT manufacturers. In addition, CNT-specific characteristics are not taken into account. In the field of occupational health and safety, efforts are under way at international level to fix limits for occupational airborne CNT exposure. Specific regulations have yet to be adopted. In addition, there is a significant need for research and development in the field of analytical and detection methods. In order to protect employees, the relevant authorities suggest that the precautionary principle be applied and exposure kept as low as possible.
023 The Proportion of EHS and ELSI Research Regarding Nanotechnology in Germany, the United Kingdom and in the EU Research Framework Programmes
(published only in german language:
"Der Anteil der Begleitforschung zur Nanotechnologie in Deutschland, Großbritannien und im EU-Forschungsprogramm")
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Summary
Compared to other technologies, research accompanying R&D activities has been demanded for nanotechnology relatively early. The overall aim of such research is mostly consensual, namely the prevention of hazards for human health and the environment and of other possible adverse effects of nanotechnology. However, the kind of research or the activities to reach this goal were, and still are, highly disputed, in particular the amount of necessary funding. Often a rate of 5% of the overall budget was considered adequate, while some parliaments demanded an even higher rate (Germany 10 %, Netherlands 15 %).
The controversies summarised in this dossier exemplarily show that due to a lack of a national and a European reporting system on the budget of nanotechnology research, the amount of funding for accompanying research cannot be determined unambiguously. The reason for this shortcoming is the very concept of nanotechnology bridging various disciplines and technolo-gies as well as its character as a cross-sectional enabling technology. Thus, nanotechnology is orthogonal to department affiliations and administrative structures. Since research is orga-nized mostly along administrative competencies, and because funding is not listed according to the purpose of the research, the implementation of a meaningful reporting system is a huge challenge. However, without such a reporting system a discussion on the orientation of and the financial support for accompanying research does not make much sense.
Conclusions
In summary, one can conclude that, despite considerable efforts in co-ordination, no reporting system providing an overview over the budgetary allocation to the different research activities in nanotechnology and accompanying research has been developed at the EU level or at the national level. As long as funding is organised according to administrative structures, which do not differentiate research according to goals but list expenditures along institutions (uni-versities, research centres, grants etc.), and without a harmonized reporting system the discus-sion about focus and rate of accompanying research will stay at the level of claims and unsub-stantiated promises.
022 Carbon Nanotubes – Part I: Basics, Production, Applications
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Summary
As the basic element of life on Earth, carbon boasts a greater diversity of compounds than any other chemical element. Even elementary carbon occurs in several structural forms, including diamonds, graphite, fullerenes and carbon nanotubes (CNTs). The latter are well known and promising nanomaterials. CNTs have exceptional properties, combining high resistance, tensile strength and electrical conductivity with a very low weight. Carbon nanotubes are produced in numerous industries worldwide, with CVD (chemical vapour deposition) currently being the most relevant processing technology. CNTs are used as additives to various plastics in electronics, car manufacturing and shipbuilding or for the production of sports equipment. In the future, CNTs are expected to be used particularly in environmental and energy engineering, possible applications including enhanced batteries, solar and fuel cells, as well as in the construction industry for high-performance concrete, but also in medicine for drug delivery.
021 Are there any neurological effects and risks from nanoparticles to expect?
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Summary
There are certain concerns regarding the safety for the environment and human health from the use of engineered nanoparticles (ENPs), which leads to unintended exposures, in contrast to the use of ENPs for medical purposes. Animal experiments have shown that investigated ENPs (metallic nanoparticles, quantum dots, carbon nanotubes) can translocate to the brain from different entry points (skin, blood, respiratory pathways). After inhalation or instillation into parts of the respiratory tract a very small fraction of the inhaled or instilled ENPs reaches the blood and subsequently secondary organs, including the central nerve system, at a low translocation rate. Experimental in vivo and in vitro studies have shown that several types of ENPs can have various biological effects in the nervous system. However, the relevance of these data for risk assessment is far from clear. It is, however, unlikely that acute high dose exposures would occur. The risk from such exposures to damage the central nerve system is thus probably even lower. This dossier focuses on the unintended human exposure of ENPs. In particular, possible effects on the functions or processes in the brain are discussed and an attempt to assess the risks is performed. However, the present state of knowledge is unsatisfactory for a proper risk assessment in this area.
Conclusions
The aim of the present Dossier is to assess whether there is a risk, in particular, to the CNS after unintended exposure to inhaled ENPs. A possible risk has two components, viz. exposure and hazard. Regarding exposure, there are at present very few if any data on exposure of the general public to either acute high dose exposure or on chronic exposure to low dose levels of air-borne ENPs. Furthermore, it is unlikely, with exception of possibly a few occupational situations, that acute high dose exposures could happen. Probably, the risks from such exposures for damaging CNS effects is thus very low, irrespective of any biological effects that ENPs could have.
The situation is more complicated regarding chronic exposures, at low doses. There is no access to exposure data for the general public regarding ENPs. It is also known that translocation to the brain via respiratory organs and the circulation is very low, even in cases where ENPs have such surface modifications as to enable them to pass the BBB. At higher concentrations, ENP can possibly enter the olfactory bulb via the olfactory nerve, and then possibly distribute to other areas of the brain. It has also been shown in both in vivo and in vitro studies that several types of ENP have various kinds of biological effects. The relevance of these data is unclear. However, the possibility remains that chronic exposures, and/or biopersistent ENPs, can influence processes within the brain that are triggering or aggravating pathological processes.
In general, the present state of knowledge is unsatisfactory for a proper risk assessment in this area. Improvements of the study qualities as well as increased number of relevant studies are strongly recommended.
020 Self-cleaning, water- and dirt-repellent coatings on the basis of nanotechnology
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Summary
Self-cleaning, water and dirt-repellent coatings
have differing properties, functional principles and manufacturing processes.
Self- cleaning of the "Lotus Effect®" type has its basis in chemical-
physical principles - these surfaces are characterised by a special roughness
and are strongly water-repellent; in the ideal case, rain is sufficient for
cleaning. "Easy-to-Clean" materials, in contrast, have a particularly flat
surface, which is both water and dirt- repellent on the basis of chemical
aspects. Although the amount of mechanical cleaning may be reduced, they are
not self-cleaning. A third form of self-cleaning is that based on photo
catalysis by nano titanium dioxide. On such surfaces UV radiation produces
oxygen radicals that decompose organic material, which in turn is removed in
the rain by a water film. Self-cleaning, water and dirt-repellent coatings may
reduce the amount of cleaning necessary and hence contribute to reducing the
burden on the environment. However, eco- balances and life cycle assessments
are still lacking. Risks for the environment and human health by nanoscale
coatings or nanoparticles firmly embedded in a coating matrix are currently
deemed rather unlikely. Initial investigations however indicate that titanium
dioxide nanoparticles from house paint may erode and end up in the environment.
This aspect needs to be analysed in the framework of an all-encompassing risk
assessment.
019 Nano regulation in Austria (II): Workplace Safety, Industrial Law and Environmental Law
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| Current version(s): | 019en | 019 | ||
| Addenda: | – | |||
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Summary
This dossier focuses on workplace safety,
industrial law as well as on environmental law (water, air, soil, waste). These
fields of law are likewise influenced by EU law and are very complex due to
their interlocking with Austrian law. Discussion and conclusion refer to both
dossiers on nano-regulation in Austria. They tentatively conclude that current
legislation covers in principle nanotechnologies, especially in those cases
where nano materials / nano products endanger legal interests. Existing
knowledge gaps, the brisk and to some extent unforeseeable development of
technologies and their wide range of applications (often across all disciplines
and thus across all fields of law) will in some fields lead to specific
improvements (sporadically as well to legal reorientation) in order to
guarantee an adequate risk and innovation management.
Conclusions
A desirable extensive examination of the
domestic legal framework for nanotechnologies is still pending. Due to the
strong influence from international, in particular EU law, an increased
Austrian collaboration in international and European matters is necessary.
Because of the Single Market, national efforts seem unpromising. According to
preliminary legal analysis and due to increasing regulatory activities on EU
level, it can be maintained that the existing regulatory framework is basically
but not entirely suited to deal with potential hazards and risks of
nanotechnology. The fact that environmental concerns are lacking in current
legislation is problematic. In addition thereto, the increasing shift of risk
management to private companies is likely problematic for small and
medium-sized companies.
018 Nano regulation in Austria (I): Chemicals and Product Safety
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| Current version(s): | 018en | 018 | ||
| Addenda: | – | |||
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Summary
Compared to international standards, an Austrian
debate on regulation of nanotechnologies was only initiated in 2006. A first
parliamentary inquiry was made in 2007. The same year, the Bioethics Commission
at the Federal Chancellery adopted a recommendation on nanotechnology. The
regulation of nanotechnology is also mentioned in the Program of the Austrian
federal government for the (current) 24th. Legislative Period. A legal inquiry
into this topic has just begun with only preliminary conclusions. The
complexity of the matter, the remembrance of the experiences with public
communication about genetic engineering and in particular the strong influence
of this field of law by EU legislation served in the beginning of the political
debate as justification for the restraint concerning an independent positioning
of Austria. Since 2008 the debate gained momentum with several conferences and
the enactment of the Austrian Nanotechnology Action Plan (NAP) in 2010. This
dossier concentrates on chemicals, biocidal products, pesticides, medicinal
products, medical devices, cosmetics and food as well as on general product
safety.
Conclusions
A desirable extensive examination of the
domestic legal framework for nanotechnologies is still pending. Due to the
strong influence from international, in particular EU law, an increased
Austrian collaboration in international and European matters is necessary.
Because of the Single Market, national efforts seem unpromising. According to
preliminary legal analysis and due to increasing regulatory activities on EU
level, it can be maintained that the existing regulatory framework is basically
but not entirely suited to deal with potential hazards and risks of
nanotechnology. The fact that environmental concerns are lacking in current
legislation is problematic. In addition thereto, the increasing shift of risk
management to private companies is likely problematic for small and
medium-sized companies.
017 Nano regulation in the European Union
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Summary
The European Union intensified its regulatory
efforts from 2004 onwards. New legislation is based on existing regulations.
While at the beginning the assumption that nanotechnologies are covered in
principle by current legislation was prevailing, some fields have started to
adapt; in particular chemicals, cosmetics and food. This dossier describes the
changing EU regulatory strategy and further gives an overview of the legal
fields, important to nanotechnology. These fields range from workplace safety,
chemicals and product safety to industrial and environmental law.
Conclusions
The EU Commission considered the legal
framework for nanotechnologies in principle as suitable. Meanwhile amendments
for chemicals, cosmetics and food have been enacted. Primary force to these
amendments was the European Parliament and regulatory changes (e.g. workplace
safety, biocidal products, medicinal products, medical devices and waste) can
be expected. A new communication on regulatory aspects of nano materials as
well as an index of products on the market is scheduled for 2011. Besides, the
commission will focus on an improved implementation and application of the
statutory provisions as well as on those products, which are not subject to any
relevant examination before being placed on the market. Protection clauses,
health monitoring measures, market surveillance, formal objections against
rules, preventive measures, follow-up and reporting procedures, early warning
systems will gain particular importance in this context. The discussion about
European regulatory issues of nanotechnology will further proceed. Meanwhile
all of us should be aware of the fact that certain adjustments of existing
regulations are essential in order to adequately deal with possible risks of
nanotechnology, in particular with nano particles.
016 Voluntary approaches by industry in the field of nanomaterials
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Summary
The current voluntary approaches to the
regulation of nanotechnology are characterised by a broad variety and major
differences. At present, there are registers, codes of conducts, certification
schemes and risk management systems. In addition, even within the same type
noticeable differences can be observed. For instance the BASF code of conduct
is restricted to enterprises while that of the IG-DHS is restricted to a
certain region and to a specific sector (food). In contrast, the EU code of
conduct not only applies to the whole of the EU, but encompasses also many
sectors and even social sub-systems such as the economy, research and politics.
However, it is restricted to research activities and their organisation. Apart
from the certifications for textiles and the IG-DHS code of conduct, all
voluntary measures are characterised by an openness concerning the fields of
application of nanotechnology. With respect to the registration of industrially
produced nanoparticles, a trend towards the establishment of a mandatory system
(register) can be observed.
Conclusions
With respect to nanomaterials at present,
there is considerable debate whether the existing legal framework sufficiently
regulates their responsible use. This discussion over the last few years has
been accompanied by the launch of several initiatives aimed at regulating this
field on a voluntary basis. In essence, the aim of these initiatives is to
reduce the health risks in production and ensure safe consumer products. Some
of them also aim at quality assurance, e.g. certifications for textiles.
Hitherto, it has remained an open question whether these initiatives will
guarantee a sufficient level of commitment despite their voluntary character in
order to achieve their goals. Beyond doubt, these initiatives represent an
important contribution towards the coordination of stakeholder activities
concerning the responsible use of nanomaterials.
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| Current version(s): | 015en | 015 | ||
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Summary
The use of nanotechnology in textiles aims to
improve the material’s functionalities and/or give it new characteristics
(“Smart Clothes”). At present there are dirt and water-repellent as
well as antibacterial textiles on the market. Many manufacturing processes are
still rather cost-intensive, but there are already “nano-textiles” on
the market, although it can be assumed, that “nano” is being used to
advertise otherwise conventional products. The “The Hohensteiner
Institutes” have therefore introduced a quality label for nano-textiles.
Theoretically, nanoparticles can be released by mechanical load, abrasion and
other external influences. There have been no experimental investigations on
these issues. In particular carbon nanotubes are considered to be harmful, with
the result that employees in the industry have first to be protected. , There
have been no long-term studies on the effects of nano-silver in textiles with
antibacterial function on the human skin flora. Investigations of the use of
materials containing nano-silver show that some products lose a substantial
part of the silver into the washing water - and thus into the environment -
after only a single wash. Nano-silver is toxic for aquatic organisms and also
for the microorganisms in the soil. There have been no studies of the possible
effects of nano-silver in ecosystems, or of nano-titanium dioxide, which is
classified as hazardous due to its possible impact on the environment.
Conclusions
Although a number of nano-textiles are
already available on the market, it is questionable whether these materials
have been manufactured by modern nanotechnologies. There are several
manufacturing processes still in the research stage and the production of
nano-textiles is to a degree still cost-intensive. It can be assumed that some
conventional textiles are promoted using the term “nano”. However it
is certain that nanomaterials can be released by mechanical load, abrasion and
other external influences. It is likely that nanoparticles enter the
environment when textiles are washed. Some in-vivo and in-vitro studies provide
indications about the hazardous potential of certain nanoparticles. For this
reason, appropriate measures against exposure to CNT are needed to protect
employees in the industry in particular. Nano-silver and nano-titanium dioxide
- both materials used in textile production - are toxic for aquatic
microorganisms. However, there have been no investigations on the exposure and
the effects on ecosystems. Therefore, at present a health and environmental
risk assessment of synthetic nanoparticles in textiles is not possible.
Transparency and better information from the industry could substantially
contribute to the elimination of possible ambiguity and consumer
uncertainty.
014 May nanoparticles end up in the brain?
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Summary
The use of small carriers for pharmaceuticals
– like nanoparticles for a purposeful therapy – is a very old idea
and dream of medical research. In certain cases it seems that this dream is to
realise, since there are individual so-called nanocarrier systems coated with
drugs (pharmaceuticals) already in clinical applications. It has already been
shown, that in a specific target tissue a selective enrichment of certain
pharmaceuticals can be achieved. Nano-particles can also be used as carrier
systems to overcome biological barriers like the blood-brain barrier, to
transport specific drugs into those regions of the brain, where they normally
would not enter. Nanocarrier systems can be applied so that the spatial and
temporal distribution of the pharmaceutical drug in the brain can be improved,
which serves the treatment and healing of so far not treatable diseases. There
are only a few studies available how nanoparticles are unintentionally passing
the blood-brain barrier and also about other mechanisms like the transport by
the olfactory nerve, so that a final statements about health effects can only
be speculative.
Conclusions
Artificially manufactured particles can be
applied so that natural physiological barriers like the blood-brain barrier can
be overcome. This phenomenon can be used so that drugs can be purposefully
transported to areas of the organism where they are needed, like to the brain.
The question, whether nanoparticles are able to reach the brain by other
mechanisms like along the olfactory nerve, is in focus of ongoing research.
Likewise it is not well-known whether nanoparticles are passing unintentionally
the blood-brain barrier and causing possible damages. The few accomplished
studies about risks of nanoparticles within the central nervous system are
controversial. Therefore at present no clear statement about health effects of
unintentional exposure of nanoparticles of the brain can be achieved.
013 Discussion on the Proportion of EHS and ELSI Research in the US Research Programme on Nanotechnologies
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| Current version(s): | – | 013 | ||
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Summary
At the beginning of the US-American research
programme on nanotechnology it was already claimed that alongside research and
technological development a part of the funding should be reserved for the
investigation of social impacts of nanotechnology. Its aim should be to
investigate unintended impacts and prevent society from negative side effects
as well as reduce related risks. In the German-speaking world, such research is
called “Begleitforschung” (accompanying research), but it is not only
in Germany that it is highly unclear what exactly has to be assigned to
accompanying research. Therefore, the aim and amount of such research performed
within the National Nanotechnology Initiative (NNI) has been the subject of
controversial discussion. The main subject of this controversy was the
assignment of different research activities to accompanying research, which are
summarised as EHS-, ELSI-research and education. This controversy has led to a
revision of the new law related to the NNI, with for instance structural and
content related changes having been suggested. According to official figures,
during this controversy the total efforts for accompanying research already
increased disproportionately from 5.4 % to 6.4 %. In addition, within the
accompanying research activities there has been a shift in priorities in favour
of EHS-research. This dossier presents the different part of the budget for
accompanying research in the NNI and summarises the said controversy as well as
the consequences which have followed.
Conclusions
Because the NNI is a cross-subject and
agency research programme, coordination is a considerable challenge. This is
aggravated by the special organisational construction of the NNI (coordination
of autonomous agencies, no budget authority) and the broad and hardly limitable
field of nanotechnology. This explains the number of bodies that serve as
observers and reporters. In addition it explains why it was only partly
possible to develop a research strategy for accompanying research. One main
barrier seems to be the lack of a consistent and cross-agency harmonisation of
the assignment of the different research activities to the different subjects
of the accompanying research. Especially concerning EHS research criticism has
been expressed that the strategy is inadequate, coordination is deficient,
transparency is lacking, and that the subject has been given too little
priority altogether. Accordingly, the budget spent on such research within the
NNI is difficult to determine. The obligatory internal and external evaluation
has lead to an intensive discussion about these shortcomings of the NNI.
Especially the involvement of various committees and organizations in the
evaluation process seems to be an effective measure for a corrected practice.
The fact that the law related to the NNI has to be renewed regularly means that
the evaluation procedure plays an important role. Perhaps even more significant
than the budgetary reorientation might be the structural changes within the
management, which are planned under the revised NNI law. They encompass
measures for a more precise assignment of the different research activities to
the different subjects of the accompanying research as well as a more
transparent reporting on the expenses. Should these measures prove to be
effective, the complex process of the US-American research policy of the NNI
could developed into an interesting example of the governance of major research
programmes.
012 Nanoparticles, Free Radicals and Oxidative Stress
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Summary
Free radicals are unsteady atoms or molecules
with free outside electrons. Thereby they are highly reactive, since such free
electrons are always anxious to go over in a stable form. To stabilize an
electron will be taken from another molecule by which a chain reaction is
starting. Such reactions are constantly present in the human body, however
under certain circumstances damages on biomolecules can occur. There is a
discussion whether intracellular taken up nanoparticles can activate the
production of free radicals. Presently there are also ongoing studies
investigating whether the amount of free radicals released on the surface of
the nanoparticles is sufficient to introduce cellular effects. In this dossier
an overview is given what free radicals are, as they originate, why they are
needed in the organism, how they are neutralised, and what is already known
about the connection between nanoparticles and the production of free
radicals.
Conclusions
Intracellular taken up nanoparticles can
induce cellular effects, however they biological relevance is not yet
clarified. Experimental studies have shown that nanoparticles can release the
production of free radicals. The chronic release of such reactive molecules can
lead to tissue degeneration. In most of the studies very high concentrations of
nanoparticles has been used and investigations were carried out after
relatively short exposition times. Therefore health risk assessment due the
available data is hardly possible. Since the homeostatic capacity of cells and
organisms counteracts the exposure of nanoparticles, is not clear yet, when the
system comes out of balance leading to biological and health relevant effects.
Therefore it is necessary to carry out specific, standardised and
dose-dependent long-term studies to attain knowledge about the mechanisms.
011 What in actual fact is "Accompanying Research"?
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| Current version(s): | 011en | 011 | ||
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Summary
The German expression
“Begleitforschung” is a notion with multiple meanings that are the
subject of controversial discussions meanings, and has no equivalent in
English. It could be directly translated as “accompanying research”
and covers research activities which are commonly covered by the abbreviation
EHS (Environment, Health, Safety) and ELSI (ethical, legal, social issues).
Although there is no direct translation, research with the purpose of
“Begleitforschung” is also financed and performed in almost all
industrialised countries. In this dossier the variety of the meanings and uses
of “accompanying research” is elaborated. As the outcome of this
analysis, it is argued that the notion only makes sense in the political
context and cannot be deduced from any disciplinary perspective. It is a
relational notion which aims at the ratio between the efforts applied for
R&D and the efforts for exploring and analysing social aspects which could
be related to this technology. Despite practical difficulties, due to the fact
that a general criterion (such as origin of funding) is not sufficient, it is
only possible to decide on a case by case basis whether a research activity
could be assigned to “accompanying research” or not. The dossier will
close with a plea for a differentiated use of the notion and for a
specification of explicitly what kind of research is meant.
Conclusions
“Begleitforschung” (accompanying
research) is a notion which only makes sense in the context of research policy,
where it serves as a projection screen for claims. A more precise analysis
reveals that the meaning of the notion is multiple, fuzzy, and not at all
clearly defined. However, a clarification of the notion is in principle
possible and is provided in this dossier. The suggested definition with regard
to content (in contrast to a formal one) leads to practical problems related to
assignment. It should be mentioned that our definition is not commonly used and
thus the available data on the expenses related to accompanying research are
not collected according to our definition. Therefore, if general data about the
efforts of accompanying research is presented, there needs to be a careful
investigation of what exactly is meant. For this reason it is suggested that
use should be made in the related debate of the differentiated notions
elaborated in this dossier. If possible it should be explicitly indicate which
kind of accompanying research is the subject of the argumentation. At least, a
distinction should be made between accompanying research on EHS and other
accompanying research and both should be differentiated from accompanying
measures, such as communication activities.
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Summary
Silver is used since long time due to its
biocides characteristics against bacteria, fungi and algae. Since several years
silver is applied increasingly also in its nano-size, which shows a higher
toxic potential than other silver compounds. For humans silver is toxic only in
very high dosages. Products containing nano-silver is one of the most
significant classes of nano-products, it plays an important role in clinical
application as coating of surfaces against germs. In addition, nano-silver is
already used in a number of consumer products. Nevertheless, the unspecific
application of nano-silver as a bactericide encounters doubt because of the
possible development of multiresistant germ variants, especially by the use of
too low silver concentrations. Moreover, it is to consider, that the useful
bacterial microflora on the skin could be impaired by cosmetics containing
nano-silver. Silver has an environmental relevance if it reaches the sewage and
leads to a rise of the content of silver within water bodies. In that case,
damages can be caused in aquatic organisms, on useful bacteria in purification
plants and in the farmland as well.
Conclusions
The use of nano-silver for medical
application has large advantages because of its broad effectiveness against a
multiplicity of pathogens. Even against such, where modern antibiotics are
already resistant. In the everyday life, the present trend to nano-products
leads, however to the expansion of applications with indefinite use and
possible hazard for health and environment. The development of silver-resistant
bacteria is possible a consequence of a broad application of nano-silver with
low concentrations, whereby the advantages of medical applications could get
lost. Regulations for a prudent and purposeful use of this effective biocide
could this counteract.
It is still little known regarding environmental
toxicity and behaviour arising from silver nano-particles. Analogies to
classical silver compounds are limited, since nano-particles exhibit other
characteristics. First investigations refers that silver nano-particles are
more toxic than other silver compounds or silver ions. This is, among others,
because of the depot characteristic of a nano-particle within a cell, where
continuously silver ions can be released. Therefore there are research needs
also regarding biopersistence and bioaccumulation in natural ecological
systems.
For health and environmental responsible authorities it is a
difficult challenge because of the variety of nano-silver products and their
different spreading possibilities. Moreover, the knowledge about negative
effects and propagation pathways of nano-silver is still incomplete. Therefore
is it necessary to establish adequate, scientifically based monitoring and
signalling systems, since the number of commercial applications is constantly
growing.
009 Nanotechnology consumer products in Austria
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| Current version(s): | – | 009 | ||
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Summary
Within the framework of our research in the
NanoTrust project, we collected comprehensive information about consumer
products available in Austria that contain nano materials or nano particles.
This information was fed into an internal database, which contained over 450
entries by March 2009. It is, however, not possible to make the database
publicly accessible because we have neither the personnel nor time resources to
validate the entries properly. However, the contents of the database,
summarised in this dossier, give a first overview of the Austrian nano products
market.
Conclusions
In sum, we determined that already a number
of nano consumer products are on the Austrian market. However, it is not
possible to determine for sure how many as the investigation methodology is not
sufficiently robust. According to our research the main trust lays with
textiles and cosmetics.
008 Nanotechnology in Cosmetics
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| Previous version(s): | – | – | ||
Summary
Like other sectors, the cosmetics industry
resorts to developments in the field of nanotechnologies. Encapsulation and
carrier systems like liposoms, nano emulsions, micro emulsions or lipid nano
particles serve to transport agents to deeper skin layers. Nano particles of
titan dioxide and zinc oxide are used as UV filters in sunscreens. According to
the producers, cosmetic products with nano minerals, nano-scaled gold and
silver or fullerenes can be found on the market. While, according to our
present state of knowledge, soluble or degradable nano materials are not
considered critical for health, there are as yet no unambiguous results for the
assessment of the potential toxic effects on humans and the ecosystem of
non-soluble or non-degradable nano materials. Some studies, however, give hints
of potential negative health effects. This needs to be studied in more detail
within the framework of a comprehensive risk assessment – as insisted on
by, among others, the EU Scientific Committee on Consumer Products (SCCP) and a
number of environmental and consumer organisations.
Conclusions
Producers of cosmetics that contain nano
materials and nano particles claim that according to current legal requirements
their products have to be submitted to a security assessment and are therefore
safe. However, it is debatable whether the applied testing and analytical
methods, in particular for non-soluble and non-degradable nano particles, are
suitable for determining the specific risk relevant-properties of nano
particles. Adequate in vivo and in vitro testing methods are currently being
developed. Of specific importance is the establishment of meaningful
dose-effect relationshipd, because we do not as yet know the threshold levels
that trigger an effect.
007 Impact of nanoparticles on cellular functions
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Summary
Nano-particles are able to enter cells actively
or passively and can cause different effects. Often, these effects are coupled
with the formation of free radicals, which can be released within the cell but
can also be produced on the surface of the particles. Free radicals can induce
reactions which in turn lead to various effects like inflammation, cell death
and also DNA damage, causing health impairment. The threshold value, i.e. the
quantity of the nanomaterials taken up which causes an effect, is not known.
According to the present knowledge there are no known nanoparticle-specific
cellular reactions. However, it is only the knowledge of basic cellular
processes that allows us to understand the magnitude of an induced effect,
which in turn allows the purposeful use of substances and medicines. For this
reason, the goal of this dossier is to provide an overview of the cell and some
of the functional and molecular pathways and thus indicate how nanoparticles
possibly induce damage.
Conclusions
It is well-known that the active or passive
uptake of nanoparticles can cause cellular effects. The biological relevance of
these effects can be assessed in a few cases only. Unfortunately, there is
still no data concerning dose dependency or knowledge about threshold values.
Therefore, if we are to investigate synthetic nanoparticles with
nanotoxicological approaches, new techniques and devices have to be developed
in order to evaluate the possible adverse health effects of nanoparticles.
However, it seems that the effects induced are well known thanks to cellular
and molecular mechanisms. This means that no specific or exclusively
nanoparticle-caused cellular effects are to be expected. For this reason, it is
necessary to understand the induced cellular processes so as to avoid adverse
effects, and in addition e.g. to use the possibilities of the nanotechnologies
in medical applications.
006 Production of Nanoparticles and Nanomaterials
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| Current version(s): | 006en | 006 | ||
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Summary
Materials in the range of nanometers have been
produced for several decades. Carbon Black for example has been used in tyres
since 1930. However, the production capabilities for designed nanomaterial are
increasing considerably. Most synthetically produced nanomaterials are
nanoparticles (80%). Depending on the application, precisely defined
characteristics - shape, composition and size distribution - of the
nanoparticles are necessary. For this reason, there are a number of production
processes to meet the characteristics required. This dossier describes the most
common production processes such as milling, gaseous phase and liquid phase
procedures.
005 Environmental and Health Impacts of Nanoparticles – EU Projects in the 6th FP
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| Current version(s): | – | 005 | ||
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Summary
Within the 6th framework program, the European
Commission invested more than 30 million Euros into research into the
environmental and health effects of nanoparticles (NP) and nanomaterials.
Initially, the emphasis was on the possible health effects, but has shifted
increasingly to environment effects. The four main topics of the projects
are:
• Creation of a knowledge base: environmental and health effects
of NP (IMPART NANOTOX); carbonanotubes and their applications (CANAPE);
international strategy and risk evaluation of NP (IMPART NANOTOX)
•
Toxicology: connection between the physicochemical characteristics of NP and
their possible toxic potential (CELLNANOTOX); statements regarding the possible
toxicity of carbonanotubes (CANAPE)
• Cell and organ-specific
research: interactions between NP and living cells (NANO-INTERCACT); cell model
on NP-induced immune toxicity (DIPNA)
• Work and environmental
protection: characterisation of NP, definition and description of exposure
levels in laboratory and workplace (NANOSH); procedure for risk analysis of
industrially manufactured NP and a risk management system (NANOSAFE2);
controlled development of multi-functional nano-structured products including
the entire life cycle (SAPPHIRE); nanotechnologies in connection with
environment and work (NANOCAP).
004 Nanoparticles and Nanostructured Materials in the Food Industry
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Summary
Nanotechnology offers interesting manufacturing
and processing opportunities for the food production industry and promises a
large market potential. On the other hand consumers object to the use of
nanoparticles and nanomaterials in food. For this reason, the industry’s
communications on this sensible subject are only very cautious, and information
on current developments and applications is rare. Industry seems to be
especially interested in “delivery systems” and nano-capsules for the
protection of active food ingredients during manufacturing, distributation and
storage. Nanoparticulate colouring agents are in use for beverages and silica
nanoparticles serve as flow aid for powdered ingredients in food. Nanoscale
vitamins, minerals and herbs in food supplements are on the market.
Nanotechnology can also be found in food packaging, in the area of food safety
and in sensor techniques.
Conclusions
An increasing number of products containing
nanoparticles and nanomaterials are entering the market. As a result, increased
attention was paid to nanotechnology in food production. But many questions
remain unanswered due to the lack of communication between the food industry
and the public about possible applications and developments. More transparency
and dialogue is necessary to discuss potential benefits and risks on a solid
base.
003 How Nanoparticles Enter the Human Body and What Effects They Have There
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Summary
The various applications using nanomaterials
bring human beings into contact with these compounds in different ways. For
this reason, it is important to analyze the extent to which nanoparticles
penetrate the human body, and the health consequences that can be expected. At
present, there is a general consensus that the smaller the nanoparticles, the
more pronounced their toxic effects. However, it is not only the size but also
the shape and the chemical composition of nanomaterials that play an important
role in inducing effects. It is known that nanoparticles can cause inflammation
in the lungs, and one study reported the induction of lung fibrosis. There are
some indications that nanoparticles penetrate the vascular walls, causing
certain dysfunctions, or interact with the heart-circulatory system. A recent
study showed in an animal model that needle-shaped asbestos-like nanotubes
induce chronic inflammations. Only little data is available regarding the
effects within the gastrointestinal tract, in the nervous system, and about
transport of nanoparticles through the skin into the blood stream. This paper
presentds the different possibilities for nanoparticle uptake and discusses the
most important data.
Conclusions
Nanoparticles with a diameter of up to 100
nm, such as carbon or metallic oxide particles, are already present in the
environment. They can induce biological effects via cell membrane penetration
and are more reactive than larger particles. However, the use of nanoparticles
can improve the efficiency of for instance cosmetic products and makes it
possible to create new coatings (e.g. scratch-proof paints). Moreover, they are
considered as candidates for new and promising medical applications and
therapies. However, due to the increasing use of nanoparticles, there is a need
for further research in order to be able to perform risk assessment. In
particular, it is important to investigate the actual exposure of different
groups such as consumers, occupationally exposed persons, and patients as well
as both users and producers of nanoparticles. In addition the material uptake
mechanisms need to be investigated for a better understanding of the
effects.
002 What are Synthetic Nanoparticles?
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Summary
Synthetically produced nano particles play an
important role in nanotechnology. They are the basis of many applications that
are already being used on a large scale, and they bear a great potential for
the development of new materials. The diversity of synthetic nano particles is
considerable. They are distinct in their properties and their applications. In
addition to their size, synthetic nano particles vary in their chemical
composition, their shape, surface characteristics and how they develop. The aim
of this dossier is to provide an overview on the various characteristics of
nano particles.
001 On the Definition of Nanotechnology
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Summary
At present, there are several definitions of
nanotechnology. However, none of them is precise and generally accepted.
Against the background of an increasing demand for standardisation, regulation,
and harmonisation in the field of nanotechnology, the need for unambiguous
differentiations and attributions are increasing. These attributions are not
only important in the field of policy but also for the economy. On the other
hand, Leaving aside the practical difficulties of defining nanotechnology,there
are vested interests that argue against a standard definition . For example for
many scientists the openness of the notion helps to establish new
interdisciplinary research fields and to build up new scientific coalitions. In
addition, the flexibility of the notion plays an important role in the media
based discourse, as already described for other “Plastic words”. This
dossier provides an overview of the most common definitions of nanotechnology
and an explanation of the background to important political and scientific
strategies related to the definition of Nanotechnology.
Conclusions
For political and economic reasons a
precise definition of Nanotechnology or at least of parts of nanotechnology
would be desirable. Due to its intrinsic variety, which is related to its
characterisation on the basis of size, it does not seem to be useful to aim at
a single definition for the whole field of nanotechnology. This applies not
only for technical reasons but also due to the social and political phenomena
discussed above which are an obstacle to the development of a single
definition. Instead, the tendencies against a single and generally accepted
definition must be perceived as a essential property of nanotechnology itself.
But a way out of the dilemma seems to be on the horizon. For more and more
individual nanotechnologies, specific definitions are being introduced. These
definitions are not only restricted to parts of nanotechnology, for instance to
distinguish different types of nanoparticles, but are also designed for a
certain purpose, for instance for the systematisation of nanoparticles in terms
of toxicological aspects.