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AbstractThe uncertainties about potential health and safety effects of manufactured nanomaterials raise the need for proactive risk assessment and risk monitoring by the industry. A Swiss service company offers the certifiable nanospecific risk management and monitoring system, which is of interest for manufacturers and distributors of nanomaterials, retailers as well insurance, investment and authorities. Collaboration sought: technical cooperation and/or commercial agreement with technical assistance.DetailsIntroductionNanotechnology offers enormous potential for innovation and growth. Both in consumer products (cosmetics, paints, electronics, etc.) and industrial applications (packaging and construction materials, etc.) manufactured nanomaterials (MN) and nanoparticles (MNP) are widely used already. However, the exciting new properties of MN could also pose risks, as mid- and long-term effects on human health and the environment are not well understood yet. Uncertainties and Liability of Nanomaterial Manufacturers Manufacturers and distributors of products containing MN are responsible for the safety of their products. In addition to implicit liability risks, manufacturers also face volatile regulatory frameworks, dynamic market conditions, and societal risks arising from risk perception by the general public and stakeholders. The uncertainties regarding potential negative impacts of MN and MNP remain within the manufacturer’s responsibility. They should thus observe and update their products in response to the availability of new safety data. The continuous identification, assessment and documentation of the scientific and technical information lead to vital inputs to strategic decision making. The above mentioned uncertainties raise the need for proactive risk assessment and risk monitoring activities by the manufacturers and distributors of products containing MN. These needs can be comprehensively covered by the certifiable, nanospecific risk management and monitoring system. Description The certifiable, nanospecific risk management and monitoring system and its tools enable manufacturers and distributors of products based on MN to systematically identify, assess and document potential nanospecific risks and impacts on the basis of the state-of-the-art knowledge at an early stage of emerging risks, thus enabling objective risk assessment to be performed in a rapidly developing market characterised by a high level of uncertainty. Potential partners will gain access to a set of innovative tools, proven risk management methodology, profound expert knowledge, and support with the implementation of the necessary structures into the existing risk management system. Societal, legal and market-related trends relevant for the company's business strategy will continuously be monitored and analysed both in order to prevent future liability cases, but also to fulfil requirements concerning the transfer of safety data along the value chain (REACH, Material Safety Data Sheets). The certifiable, nanospecific risk management and monitoring system has been developed by a globally active, Germany-based testing and certification organization and a Swiss Research SME. It is modularly built and easy to embed into existing risk or quality management systems (e.g. ISO 9000 ff / ISO 14000 ff). It encompasses four individually combinable parts: 1. Risk assessment and evaluation provide a comprehensive product and process-related risk analysis prior to a product’s market release, 2. 360° risk monitoring continuously reveals the relevant trends in science, technology, society and regulation as a foresight instrument and feeds them into risk management, 3. Issues management and communication tools allow to react quickly and responsibly in critical situations, 4. Certification by the external auditing documents the safety efforts towards customers, authorities and the public. The 360° risk monitoring methodology represents a novel approach optimally suitable to be used under conditions of change and uncertainty related to emerging scientific knowledge, risk perception, and regulatory changes. With the open publication of the requirements to acquire the unique trademarked certificate, companies have the opportunity to adapt their risk management system according to clear principles, and to let an external examination body approve its appropriateness. This lays the foundations to transparently transfer safety information along the value chain, and it allows fulfilling various requirements concerning general product safety, product liability and chemical substances legislation (REACH). Innovative Aspects: A. The nanospecific risk management and monitoring system supports businesses in better understanding their product and process risk portfolio as related to manufactured nanomaterials. It helps them to identify which health and safety, regulatory, technical, economic and societal risks are relevant to the company. B. With the 360° risk monitoring system, a set of analytical tools and procedures to identify, analyse and document trends in scientific literature and in community/media is provided. This information is made available for strategic decisions in risk management, data sharing along the value chain, awareness raising and training. C. The uniqueness of the 360° monitoring approach lies in systematically and continuously processing input from all relevant areas: science and research, society and regulation, market and competition.
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