Safer by design strategies

Throughout the EU funded FP7 project GUIDENano, we are trying to control and monitor the evolution of nano-enable products during their lifecycle. Small alterations of the nanoparticle (NP) state may have critical consequences on the NP behaviour and performance. For this reason it is important to highlight the importance of an extensive and proper characterization to define the NP physico-chemical characteristics under several environmental conditions. Furthermore, this characterization is necessary to ensure that obtained results are reproducible and allow understanding the behaviour of the NP on biological systems. In this paper different strategies reported in the literature regarding the safety-by-design concept are summarized. Several strategies from the synthetic point of view that help us to modulate the main factors which determine the safety of nanomaterials are proposed

Body fat percentage, emotional intelligence, and personality traits in working men and women

Artículo original[ES] Introducción: el exceso de peso en las personas tiene implicaciones negativas en la productividad laboral. La inteligencia emocional y los rasgos de personalidad han mostrado diferencias entre personas con peso normal y con exceso de peso (de acuerdo con el IMC). Sin embargo, la evidencia de asociaciones con indicadores más objetivos como el porcentaje de grasa corporal es escasa. El objetivo del estudio fue determinar si existe relación entre el porcentaje de grasa corporal, la inteligencia emocional y los rasgos de personalidad en población joven trabajadora. Método: se realizó un estudio transversal-analítico en 125 jóvenes de Xalapa, Veracruz, México, con edad promedio de 24.6 años (DEedad±2.6). Se aplicó un cuestionario de datos sociodemográficos, la Escala de Inteligencia Emocional (EQ-i-M20), el Inventario de Rasgos de Personalidad (BFI-15p) y se midió el porcentaje de grasa corporal mediante análisis de bioimpedancia. Resultados: la inteligencia emocional y los rasgos de personalidad presentan diferencias entre los sexos. Las mujeres presentan menor inteligencia emocional y mayor neuroticismo que los hombres. En la muestra total, se identificaron como predictores del porcentaje de grasa corporal algunas dimensiones de la inteligencia emocional como manejo de estrés, adaptabilidad y ánimo general, así como los rasgos de neuroticismo y apertura. Conclusión: es indispensable que los entornos laborales consideren las dimensiones de la inteligencia emocional y los rasgos de personalidad, en la planeación de estrategias para la promoción de la salud y la prevención de enfermedades asociadas al exceso de peso. [EN] Introduction: Being overweight has negative implications for work productivity. Emotional intelligence and per-sonality traits have shown differences between normal-weight and overweight people (according to BMI). However, the evidence of associations with more objective indicators, such as body fat percentage, is scarce. The objective of the study was to determine the relationship between body fat percentage, emotional intelligence, and personality traits in young workers. Methods: A cross-analytical study was carried out on 125 young people living in Xalapa, Veracruz, Mexico, with a mean age of 24.6 years (SDage ± 2.6). A sociodemographic data questionnaire, the Emotional Intelligence Scale (EQ-i-M20), and the Personality Traits Inventory (BFI-15p) were used. Bioimpedance analysis (BIA) was used to quantify body fat percentage. Results: Both emotional intelligence and personality traits showed differences by sex. Women had lower emotional intelligence and higher neuroticism than men. Some domains of emotional intelligence, such as stress management, adaptability, and general mood, as well as neuroticism and openness traits, were identified as predictors for body fat percentage. Conclusions: Work environments must consider the dimensions of emotional intelligence and personality traits in planning strategies for health promotion and the prevention of diseases associated with excess weightN

Safe(r)-by-design principles in the thermoplastics industry: guidance on release assessment during manufacture of nano-enabled products

Background: The application of nanomaterials (NMs) and nano-enabled products (NEPs) across many industries has been extensive and is still expanding decades after first being identified as an emerging technology. Additive manufacturing has been greatly impacted and has seen the benefits of integrating NMs within products. With the expansion of nanotechnology, there has been a need to develop more adaptive and responsive methods to ascertain risks and ensure technology is developed safely. The Safe(r)-by-Design (SbD) concept can be used to establish safe parameters and minimise risks during the materials’ lifecycle, including the early stages of the supply chain. Exposure monitoring has advanced in recent years with the creation of standardised protocols for occupational exposure assessment of nano-objects and their aggregates and agglomerates (NOAA).Methods: To aid in the development of an online SbD-supporting platform by the EU-funded project SAbyNA, we adopt a Europe Standard for monitoring release of NOAA to identify if a greater release of NOAA is associated with incorporation of NMs within NEPs compared to a polymer matrix alone. Case studies included filaments of polypropylene (PP) with nano-Ag or polycarbonate (PC) with single-walled carbon nanotubes (SWCNTs). NMs were received in masterbatch, and therefore previously modified to align with SbD interventions. Results were collected in line with European Standard recommendations: monitoring particle concentrations using direct reading instruments (DRI), sampling for offline chemical and morphological analysis, and collecting contextual information.Results and discussion: Based on the criteria described in the European standard (BS EN 17058), data from both case studies identified that inhalation exposure relating to NM was “unlikely”. Despite this, during the production of the SWCNT-PC filaments, some noteworthy observations were made, including several DRI activity measurements shown to be higher than background levels, and material morphologically similar to the reference SWCNT/polymeric masterbatch observed in offline analysis. The data collected during this campaign were used to discuss choices available for data interpretation and decision-making in the European Standard for monitoring release of NOAA and also to facilitate the development of SAbyNA’s user-friendly industry platform for the SbD of NMs and NEPs

Metadata stewardship in nanosafety research: learning from the past, preparing for an "on-the-fly" FAIR future

Introduction: Significant progress has been made in terms of best practice in research data management for nanosafety. Some of the underlying approaches to date are, however, overly focussed on the needs of specific research projects or aligned to a single data repository, and this "silo" approach is hampering their general adoption by the broader research community and individual labs.Methods: State-of-the-art data/knowledge collection, curation management FAIrification, and sharing solutions applied in the nanosafety field are reviewed focusing on unique features, which should be generalised and integrated into a functional FAIRification ecosystem that addresses the needs of both data generators and data (re)users.Results: The development of data capture templates has focussed on standardised single-endpoint Test Guidelines, which does not reflect the complexity of real laboratory processes, where multiple assays are interlinked into an overall study, and where non-standardised assays are developed to address novel research questions and probe mechanistic processes to generate the basis for read-across from one nanomaterial to another. By focussing on the needs of data providers and data users, we identify how existing tools and approaches can be re-framed to enable "on-the-fly" (meta) data definition, data capture, curation and FAIRification, that are sufficiently flexible to address the complexity in nanosafety research, yet harmonised enough to facilitate integration of datasets from different sources generated for different research purposes. By mapping the available tools for nanomaterials safety research (including nanomaterials characterisation, nonstandard (mechanistic-focussed) methods, measurement principles and experimental setup, environmental fate and requirements from new research foci such as safe and sustainable by design), a strategy for integration and bridging between silos is presented. The NanoCommons KnowledgeBase has shown how data from different sources can be integrated into a one-stop shop for searching, browsing and accessing data (without copying), and thus how to break the boundaries between data silos.Discussion: The next steps are to generalise the approach by defining a process to build consensus (meta)data standards, develop solutions to make (meta)data more machine actionable (on the fly ontology development) and establish a distributed FAIR data ecosystem maintained by the community beyond specific projects. Since other multidisciplinary domains might also struggle with data silofication, the learnings presented here may be transferrable to facilitate data sharing within other communities and support harmonization of approaches across disciplines to prepare the ground for cross-domain interoperability

A roadmap towards safe and sustainable by design nanotechnology: implementation for nano-silver-based antimicrobial textile coatings production by ASINA project

This report demonstrates a case study within the ASINA project, aimed at instantiating a roadmap with quantitative metrics for Safe(r) and (more) Sustainable by Design (SSbD) options. We begin with a description of ASINA’s methodology across the product lifecycle, outlining the quantitative elements within: Physical-Chemical Features (PCFs), Key Decision Factors (KDFs), and Key Performance Indicators (KPIs). Subsequently, we delve in a proposed decision support tool for implementing the SSbD objectives across various dimensions—functionality, cost, environment, and human health safety—within a broader European context. We then provide an overview of the technical processes involved, including design rationales, experimental procedures, and tools/models developed within ASINA in delivering nano-silver-based antimicrobial textile coatings. The result is pragmatic, actionable metrics intended to be estimated and assessed in future SSbD applications and to be adopted in a common SSbD roadmap aligned with the EU’s Green Deal objectives. The methodological approach is transparently and thoroughly described to inform similar projects through the integration of KPIs into SSbD and foster data-driven decision-making. Specific results and project data are beyond this work’s scope, which is to demonstrate the ASINA roadmap and thus foster SSbD-oriented innovation in nanotechnology

A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment

According to some legislation grouping can streamline data gap filling for the hazard assessment of substances. The GRACIOUS Framework aims to facilitate the application of grouping of nanomaterials or nanoforms (NFs), in a regulatory context and to support innovation. This includes using grouping to enable read-across from (a) source(s), for which data and information exist, to a similar target NF where information is lacking. The Framework provides an initial set of hypotheses for the grouping of NFs which take into account the identity and use(s) of the NFs, as well as the purpose of grouping. Initial collection of basic information allows selection of an appropriate pre-defined grouping hypothesis and a tailored Integrated Approach to Testing and Assessment (IATA), designed to generate new evidence to support acceptance or rejection of the hypothesis. Users needing to develop their own user-defined hypothesis (and IATA) are also supported by the Framework. In addition, the IATA guides acquisition of the information needed to support read-across. This approach gathers information to render risk assessment more efficient, affordable, as well as reducing the use of test animals

Workshop on Regulatory Preparedness for Innovation in Nanotechnology

This report summarises the presentations and discussions at the first NanoReg2 Workshop on Regulatory Preparedness for Innovation in Nanotechnology held in Ispra, Italy 5 to 6 October 2017 and attended by approximately 60 regulators, industry representatives and other stakeholders. NanoReg2 is a European Union (EU) Horizon 2020 project. At the workshop, Regulatory Preparedness was defined as the regulators' timely awareness of innovations and the regulator's actions to check whether present legislation covers all safety aspects of each innovation, including initiating revision of the legislation as appropriate. Regulatory Preparedness, and Safe-by-Design (SbD) jointly constitute the NanoReg2 Safe Innovation Approach (SIA) for developing innovative products based on nanotechnology. The workshop aimed to gather views and identify current practices in regulatory work on safety of innovative products, tools already in use or needed, and potential difficulties in implementing Regulatory Preparedness in the EU. Presentations addressed the current state of the safety of nanotechnology innovation. The viewpoints included the regulatory framework, the principles behind it and the agencies and authorities enforcing it; nanosafety research projects and their support system (e.g. the current EU Horizon 2020 Framework Programme); national nanosafety initiatives; and the development of tools, such as foresight tools and harmonised test guidelines by the OECD for data generation. The workshop served to generate ideas for achieving Regulatory Preparedness. The participants recognised that while regulators deal with the safety of innovations, only few systematic approaches to this work exist. Some innovative products may reach the market before their safety has been appropriately assessed, as illustrated by RAPEX, the Rapid Exchange of Information System. A continuous and proactive combination of interconnected activities was considered to be required for ensuring Regulatory Preparedness. Thus, anticipation, e.g. horizon scanning, was seen as important, as was communication between regulators, innovators (industry) and other stakeholders. Regulators need to become aware of innovative products under development to ensure that the legislation and methods for safety assessment are available and adequate. Innovators must be aware of regulatory requirements and their likely development. This mutual awareness helps to develop safe products and to avoid delays or other problems in obtaining market approval. Awareness can be achieved through communication, which requires trust, e.g. promoted via "trusted environments" for confidential inquiries and information sharing. Furthermore, regulators need early access to the existing information and data relevant to safety assessment of innovative products to provide timely guidance and advice to Industry as well as to develop strategies for dealing with uncertainty, e.g. by applying the precautionary principle. Regulatory Preparedness was discussed as part of the SIA, and a "road map" of actions was suggested and outlined. The workshop has thus contributed towards acceptance of implementing Regulatory Preparedness for innovation in nanotechnology through the participation of a variety of stakeholders. This paves the way for a better dialogue among stakeholders in a fast economic development cycle, where it is even more important to quickly identify emerging needs for new approaches to regulatory issues for innovationJRC.F.2-Consumer Products Safet

Influence of nanomaterial compatibilization strategies on polyamide nanocomposites properties and nanomaterial release during the use phase

et al.The incorporation of small amounts of nanofillers in polymeric matrices has enabled new applications in several industrial sectors. The nanofiller dispersion can be improved by modifying the nanomaterial (NM) surface or predispersing the NMs to enhance compatibility. This study evaluates the effect of these compatibilization strategies on migration/release of the nanofiller and transformation of polyamide-6 (PA6), a thermoplastic polymer widely used in industry during simulated outdoors use. Two nanocomposites (NCs) containing SiO2 nanoparticles (NPs) with different surface properties and two multiwalled carbon nanotube (MWCNT) NCs obtained by different addition methods were produced and characterized, before and after accelerated wet aging conditions. Octyl-modified SiO2 NPs, though initially more aggregated than uncoated SiO2 NPs, reduced PA6 hydrolysis and, consequently, NM release. Although no clear differences in dispersion were observed between the two types of MWCNT NCs (masterbatch vs direct addition) after manufacture, the use of the MWCNT masterbatch reduced PA6 degradation during aging, preventing MWCNT accumulation on the surface and further release or potential exposure by direct contact. The amounts of NM released were lower for MWCNTs (36 and 108 mg/m2) than for SiO2 NPs (167 and 730 mg/m2), being lower in those samples where the NC was designed to improve the nanofiller–matrix interaction. Hence, this study shows that optimal compatibilization between NM and matrix can improve NC performance, reducing polymer degradation and exposure and/or release of the nanofiller.This work has been supported by the Generalitat de Catalunya, Departament d’Innovacio, Universitat i Empresa, and by the Spanish Government, Ministerio de Ciencia e Innovacion.Peer Reviewe

Sección de crustáceos de la colección de referencia de bentos costero de ECOSUR

In this work, the crustaceans species deposited in the Reference Collection of Coastal Benthos at Colegio de la Frontera Sur (ECOSUR) are included. This is one of the few collections of marine invertebrates of the Southeast of Mexico whose crustacean section is one of the most important of the region because of the number of species and lots. The Reference Collection has 1,172 lots and 311 species of crustaceans grouped in nine orders: Thoracic, Leptostraca, Stomatopoda, Mysidacea, Amphipoda, Isopoda, Tanaidacea, Cumacea and Decapoda. The adjustment used in the list of species was done according to Martin & Davis (2001). In addition, a digital photo library was organised. It includes up to the moment images of 172 species (55% of advance). This photo library will serve as first hand referenceEn este trabajo se incluyen las especies de crustáceos depositadas en la Colección de Referencia de Bentos Costero de El Colegio de la Frontera Sur (ECOSUR), la cual es una de las pocas colecciones de invertebrados marinos con las que cuenta el Sureste de México, cuya sección de crustáceos es la más importante de la región, tanto por el número de especies como de lotes. La Colección de Referencia contiene 1,172 lotes y 311 especies de crustáceos agrupados en nueve órdenes: Thoracica, Leptostraca, Stomatopoda, Mysidacea, Amphipoda, Isopoda, Tanaidacea, Cumacea y Decapoda. El arreglo utilizado en la lista de especies sigue a Martin & Davis (2001). Así mismo, se formó una fototeca digital que hasta el momento incluye imágenes de 172 especies (55% de avance). Esta fototeca servirá como referencia de primera man