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dossiers

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.



029 Nanomaterials and workers' safety – an Overview
(published only in german language:
"Nanomaterialien und Aspekte des ArbeitnehmerInnenschutzes – Eine Übersicht")

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Current version(s):     029
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028 Why is the question concerning the right (nano-)dosage so important?
(published only in german language:
"Warum ist die Frage nach der (Nano-)Dosis so wichtig?")

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Current version(s):     028
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027 Nano and the Environment, Part II: Risk Potentials
(published only in german language:
"Nano und Umwelt, Teil II: Gefährdungspotenziale und Risiken")

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Current version(s):     027
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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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Current version(s):     026
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025 Measuring and Characterisation of Nanoparticles in the Air
(published only in german language:
"Messung und Charakterisierung von Nanopartikeln in der Luft")

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Current version(s):     025
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024 Carbon Nanotubes – Part II: Risks and Regulations
(published only in german language:
"Kohlenstoff-Nanoröhrchen (Carbon Nanotubes) – Teil II: Risiken und Regulierung")

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Current version(s):     024
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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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Current version(s):     023
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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 technologies as well as its character as a cross-sectional enabling technology. Thus, nanotechnology is orthogonal to department affiliations and administrative structures. Since research is organized mostly along administrative competencies, and because funding in 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 nor 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 (universities, research centres, grants etc.), and without a harmonized reporting system the discussion about focus and rate of accompanying research will stay at the level of claims and unsubstantiated promises.

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022 Carbon Nanotubes – Part I: Basics, Production, Applications
(published only in german language:
"Kohlenstoff-Nanoröhrchen (Carbon Nanotubes) – Teil I: Grundlagen, Herstellung, Anwendung")

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Current version(s):     022
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Summary
Carbon is the basis of life on Earth and out of all chemical elements it has the greatest diversity of compounds. Elementary carbon occurs in several different structural forms to which diamond, graphite, fullerenes and carbon nanotubes (CNTs) are belonging to. The latter are well known and promising nanomaterials. CNTs have exceptional properties including high resistance, tensile strength and electrical conductivity, coupled with a very low weight. Carbon nanotubes are produced in numerous industries worldwide, whereby the CVD-technology (chemical vapor deposition) is presently the most relevant processing technology. CNTs are currently used as additives to various plastics in electronics, car manufacturing, and shipping or for the production of sports equipment. In the future, CNTs are expected to be used particularly in energy and environmental technologies, such as enhanced batteries, solar and fuel cells as well as in the construction industry for high performance concrete, but also in medicine for drug delivery.

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021 Are there any neurological effects and risks from nanoparticles to expect?

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Current version(s):   021en   021
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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.

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020 Self-cleaning, water- and dirt-repellent coatings on the basis of nanotechnology

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Current version(s):   020en   020
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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.

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019 Nano regulation in Austria (II): Workplace Safety, Industrial Law and Environmental Law

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Current version(s):   019en   019
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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.

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018 Nano regulation in Austria (I): Chemicals and Product Safety

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Current version(s):   018en   018
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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.

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017 Nano regulation in the European Union

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Current version(s):   017en   017
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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.

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016 Voluntary approaches by industry in the field of nanomaterials

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Current version(s):   016en   016
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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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015 Nano textiles

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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.

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014 May nanoparticles end up in the brain?

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Current version(s):   014en   014
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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.

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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.

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012 Nanoparticles, Free Radicals and Oxidative Stress

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Current version(s):   012en   012
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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.

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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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010 Nanosilver

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Current version(s):   010en 010
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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.

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009 Nanotechnology consumer products in Austria

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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.

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008 Nanotechnology in Cosmetics

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Current version(s):   008en   008
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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.

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007 Impact of nanoparticles on cellular functions

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Current version(s):   007en   007
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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.

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006 Production of Nanoparticles and Nanomaterials

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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.

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005 Environmental and Health Impacts of Nanoparticles – EU Projects in the 6th FP

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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).

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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.

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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.

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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.

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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.

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