Browsing by Keyword "Nanomaterials"
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Item Implementation of a safe-by-design approach in the development of new open pilot lines for the manufacture of carbon nanotube-based nano-enabled products(2017-06-01) López de Ipiña, J.M.; Hernan, Angel; Cenigaonaindia, Xabier; Insunza, Mario; Florez, Sonia; Seddon, Richard; Vavouliotis, Antonios; Kostopoulos, Vasilios; Latko, Paulina; Durałek, Paweł; Kchit, Nadir; Duralek, Paweł; Tecnalia Research & Innovation; SMART_MON; POLIMEROSThe project PLATFORM (H2020, GA 646307) aims to develop three new pilot lines (PPLs) for the manufacture of carbon nanotube-based nano-enabled products (buckypapers, treated prepregs, doped veils), for the European aeronautics and automotive industries (a Technology Readiness Level 6 - TRL6 -is expected at the end of the project). The Machinery Directive 2006/42/EC (MD) - transposed into the respective national legislations -is the European regulatory framework for the design and construction of new machinery, as the future PPLs. PPLs are not required to comply with the provisions of the MD until they are put into service - expected in 2020, after project completion - but then, the MD will be fully applicable. In this regulatory context, the project PLATFORM is aligning the design of the PPLs according to the MD requirements, in order to facilitate the CE marking in 2020 (TRL9) and avoid potential economic costs associated with future re-adaptations or modifications needed to ensure compliance with the MD. This paper discusses the methodological approach followed by the project PLATFORM to integrate all the nanosafety aspects in the design of the PPLs, in order to achieve safe designs in conformity with the relevant Essential Health and Safety Requirements (EHSRs) of the MD. Since machinery must be designed and constructed taking into account the results of the risk assessment (RA), this paper describes the systematic and iterative approach for RA and risk reduction followed to eliminate hazards as far practicable and to adequately reduce risks by the implementation of protective measures. This process has been guided by the harmonized standards EN ISO 12100 and EN ISO 14123, taking the relevant phases of life cycle, expected uses and operation modes of the PPLs into account. A specific tool to guide the safe design of the PPLs and facilitate the RA process has also been produced by the project (PLATFORM -SbD toolkit).Item Limitations and information needs for engineered nanomaterial-Specific exposure estimation and scenarios: Recommendations for improved reporting practices(2012-09) Clark, Katherine; Van Tongeren, Martie; Christensen, Frans M.; Brouwer, Derk; Nowack, Bernd; Gottschalk, Fadri; Micheletti, Christian; Schmid, Kaspar; Gerritsen, Rianda; Aitken, Rob; Vaquero, Celina; Gkanis, Vasileios; Housiadas, Christos; De Ipĩa, Jesús María López; Riediker, Michael; PRINTEX; SMART_MONThe aim of this paper is to describe the process and challenges in building exposure scenarios for engineered nanomaterials (ENM), using an exposure scenario format similar to that used for the European Chemicals regulation (REACH). Over 60 exposure scenarios were developed based on information from publicly available sources (literature, books, and reports), publicly available exposure estimation models, occupational sampling campaign data from partnering institutions, and industrial partners regarding their own facilities. The primary focus was on carbon-based nanomaterials, nano-silver (nano-Ag) and nano-titanium dioxide (nano-TiO2), and included occupational and consumer uses of these materials with consideration of the associated environmental release. The process of building exposure scenarios illustrated the availability and limitations of existing information and exposure assessment tools for characterizing exposure to ENM, particularly as it relates to risk assessment. This article describes the gaps in the information reviewed, recommends future areas of ENM exposure research, and proposes types of information that should, at a minimum, be included when reporting the results of such research, so that the information is useful in a wider context.Item A methodology on how to create a real-life relevant risk profile for a given nanomaterial(2018-01-01) Schimpel, Christa; Resch, Susanne; Flament, Guillaume; Carlander, David; Vaquero-Moralejo, Celina; Bustero, Izaskun; Falk, Andreas; Tecnalia Research & Innovation; PRINTEXWith large amounts of nanotoxicology studies delivering contradicting results and a complex, moving regulatory framework, potential risks surrounding nanotechnology appear complex and confusing. Many researchers and workers in different sectors are dealing with nanomaterials on a day-to-day basis, and have a requirement to define their assessment/management needs. This paper describes an industry-tailored strategy for risk assessment of nanomaterials and nano-enabled products, which builds on recent research outcomes. The approach focuses on the creation of a risk profile for a given nanomaterial (e.g., determine which materials and/or process operation pose greater risk, where these risks occur in the lifecycle, and the impact of these risks on society), using state-of-the-art safety assessment approaches/tools (ECETOC TRA, Stoffenmanager Nano and ISO/TS 12901-2:2014). The developed nanosafety strategy takes into account cross-sectoral industrial needs and includes (i) Information Gathering: Identification of nanomaterials and hazards by a demand-driven questionnaire and on-site company visits in the context of human and ecosystem exposures, considering all companies/parties/downstream users involved along the value chain; (ii) Hazard Assessment: Collection of all relevant and available information on the intrinsic properties of the substance (e.g., peerreviewed (eco)toxicological data, material safety data sheets), as well as identification of actual recommendations and benchmark limits for the different nano-objects in the scope of this projects; (iii) Exposure Assessment: Definition of industry-specific and application-specific exposure scenarios taking into account operational conditions and risk management measures; (iv) Risk Characterisation: Classification of the risk potential by making use of exposure estimation models (i.e., comparing estimated exposure levels with threshold levels); (v) Refined Risk Characterisation and Exposure Monitoring: Selection of individual exposure scenarios for exposure monitoring following the OECD Harmonized Tiered Approach to refine risk assessment; (vi) Risk Mitigation Strategies: Development of risk mitigation actions focusing on risk prevention.