Documents Institute of Technology Assessment of the Austrian Academy of Sciences, Vienna 6 results

"In order to regulate nanomaterials and to determine mandatory product labelling a generally accepted agreement what the term “nanomaterial” means has to be reached beforehand. The EU Parliament requires that a definition shall be science-based and comprehensive. Furthermore, for regulatory measures in individual sectors, it shall be unambiguous, flexible, easy and practical to handle. During the past few years various institutions came up with suggestions for a definition, leading to a recommendation of the EU commission, which finally is being accepted into new and existing EU legislation. Some provisions in this proposal are controversial and the implementation into specific sectoral legislation constitutes a major challenge."

"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."

"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."

"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."

"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."

"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."